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Abdelfattah OM, Sayed A, Al-Jwaid A, Hassan A, Abu Jazar D, Narayanan A, Link MS, Martinez MW. Global and Temporal Trends in Utilization and Outcomes of Implantable Cardioverter Defibrillators in Hypertrophic Cardiomyopathy. Circ Arrhythm Electrophysiol 2025:e013479. [PMID: 39895487 DOI: 10.1161/circep.124.013479] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/05/2024] [Accepted: 12/19/2024] [Indexed: 02/04/2025]
Abstract
BACKGROUND Over the past decades, hypertrophic cardiomyopathy has become a contemporary treatable disease. However, limited data exist on the global trends of implantable cardioverter defibrillator (ICD) utilization and its impact on mortality/morbidity burden reduction. METHODS Electronic databases were systematically searched up to March 2024 for studies reporting on ICD utilization rates in hypertrophic cardiomyopathy. A random effects model was used to pool study estimates across time-era, geographic region, and age group. Primary outcome was global trends in ICD utilization. Secondary outcomes included trends of sudden cardiac death, appropriate/inappropriate shocks, and ICD-related complications. RESULTS In total, 234 studies (N=92 500, 514 748 patient-years) met inclusion criteria. Mean age was 46.2 (12.4) years and 37.49% were women. A total of 12 139 patients (16.43%) received an ICD over 429 766 person-years of follow-up, with an ICD implantation rate of 2.79%/y ([95% CI, 2.35%-3.32%] I²=97.80%). Rates of ICD implantation steadily increased over time from 1990 (1.09%) to 2021 (4.01%; P=0.002), with noticeable geographic variation (P=0.008). The overall rate of appropriate ICD discharges and ICD-related complications was 3.44%/y ([95% CI, 3.08%-3.84%] I²=88.40%) and 1.98%/y ([95% CI, 1.52%-2.59%] I²=90.44%), respectively, with no significant trend over time. The overall rate of inappropriate discharges was 3.58%/y ([95% CI, 3.08%-4.16%] I2=88.03%), and declined significantly over time (P=0.044). There was a significant decline in the rates of sudden cardiac death from 1990 (0.84%/y) to 2020 (0.31%/y). CONCLUSIONS Dramatic increases in ICD utilization have occurred, representing a 3.7-fold increase, with appropriate therapies occurring in 3.44%/y. Dramatic increases in ICD utilization have occurred, representing a 3.7-fold increase, with appropriate therapies occurring in 3.44%/y, In parallel a significant reduction in sudden cardiac death was observed, but there are insufficient data to demonstrate that a causative relationship exists. Geographic disparities in ICD utilization were evident, highlighting the need to improve access to specialized care for patients with hypertrophic cardiomyopathy. Geographic disparities in ICD utilization were evident, highlighting the need to improve access to specialized care for patients with hypertrophic cardiomyopathy. REGISTRATION URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42023407126.
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Affiliation(s)
- Omar M Abdelfattah
- Hypertrophic Cardiomyopathy Center, Division of Cardiovascular Medicine, University of Texas Medical Branch, Galveston (O.M.A., D.A.J., A.N.)
| | - Ahmed Sayed
- Department of Cardiology, Houston Methodist DeBakey Heart & Vascular Center, Houston Methodist Hospital, TX (A.S.)
| | - Ahmed Al-Jwaid
- Department of Medicine, Morristown Medical Center, Atlantic Health System, NJ. (A.A.-J.)
| | - Ahmed Hassan
- Division of Cardiology, Department of Pediatrics, The Labatt Family Heart Center, Hospital for Sick Children & University of Toronto, Ontario, Canada (A.H.). Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas
| | - Deaa Abu Jazar
- Hypertrophic Cardiomyopathy Center, Division of Cardiovascular Medicine, University of Texas Medical Branch, Galveston (O.M.A., D.A.J., A.N.)
| | - Arun Narayanan
- Hypertrophic Cardiomyopathy Center, Division of Cardiovascular Medicine, University of Texas Medical Branch, Galveston (O.M.A., D.A.J., A.N.)
| | - Mark S Link
- Hypertrophic Cardiomyopathy Center, Gagnon Cardiovascular Institute, Department of Cardiovascular Medicine, Morristown Medical Center, Atlantic Health System, NJ. (M.S.L.)
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Biffi M, Statuto G, Calvi V, Iori M, De Maria E, Bolognesi MG, Allocca G, Notarangelo F, Carinci V, Ammendola E, Boggian G, Saporito D, Mancini L, Potenza D, Celentano E, Giorgi D, Ziacchi M. Inappropriate therapies in modern implantable cardioverter-defibrillators: A propensity score-matched comparison between single- and dual-chamber discriminators in single-chamber devices THe sINGle lead Study (THINGS Study). Heart Rhythm 2024:S1547-5271(24)03417-9. [PMID: 39370028 DOI: 10.1016/j.hrthm.2024.10.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/01/2024] [Revised: 09/17/2024] [Accepted: 10/01/2024] [Indexed: 10/08/2024]
Abstract
BACKGROUND In patients with implantable cardioverter-defibrillators (ICDs), inappropriate therapies (ITs) are often caused by supraventricular tachyarrhythmias (SVTs). OBJECTIVE We aimed to estimate the incidence of IT in modern single-lead ICDs. METHODS The THINGS study enrolled patients with single-lead ICDs with 2 SVT discrimination modalities: dual chamber (DC) with an atrial floating dipole or single chamber (SC) with morphology criterion. All devices were programmed with 2-zone therapy: ventricular tachycardia (VT) zone from 170 beats/min with ≥15 seconds (≥36 beats) detection time and SVT discriminators; and ventricular fibrillation (VF) zone from 214 beats/min with ≥7 seconds (≥24 beats) detection time. The primary end point was the first occurrence of IT, adjudicated by an independent board. RESULTS A total of 526 patients (median age, 66 years; 83% male), 183 (34.8%) with DC and 343 (65.2%) with SC discrimination, were observed for a median of 2.2 years. The incidence rate of IT was 4.2% (95% confidence interval [CI], 2.7%-6.4%) at 1 year and 7.1% (95% CI, 5.0%-9.9%) at 2 years. Younger age (adjusted hazard ratio, 0.97; 95% CI, 0.95-0.99; P = .013) and history of atrial fibrillation (adjusted hazard ratio, 2.67; 95% CI, 1.30-5.46; P = .007) were significantly associated with increased IT risk. In a propensity score-matched comparison, DC discrimination showed a trend toward reduced IT rates compared with SC discrimination in the VT zone (1-year incidence, 1.8% vs 3.5%; P = .105). CONCLUSION High-rate VF cutoff and prolonged detection time programming resulted in a low IT rate in single-lead ICD patients with modern SVT discriminators. A trend favoring the DC system was observed in the VT zone.
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Affiliation(s)
- Mauro Biffi
- Institute of Cardiology, University of Bologna, S. Orsola-Malpighi University Hospital, Bologna, Italy.
| | - Giovanni Statuto
- Institute of Cardiology, University of Bologna, S. Orsola-Malpighi University Hospital, Bologna, Italy
| | - Valeria Calvi
- Department of Cardiology, Azienda O.U. Policlinico "G. Rodolico"-San Marco, Catania, Italy
| | - Matteo Iori
- Department of Cardiology, Unità Operativa di Cardiologia, Azienda Ospedaliera S. Maria Nuova, Reggio Emilia, Italy
| | - Elia De Maria
- Cardiology Unit, Ramazzini Hospital, Carpi, Modena, Italy
| | | | - Giuseppe Allocca
- Department of Cardiology, S. Maria dei Battuti Hospital, AULSS 2 Veneto, Conegliano, Italy
| | | | - Valeria Carinci
- Cardiology Unit, Azienda AUSL, Maggiore Hospital, Bologna, Italy
| | - Ernesto Ammendola
- Department of Cardiology, Monaldi Hospital, University "Vanvitelli," Naples, Italy
| | | | | | | | - Domenico Potenza
- UOC Cardiology, Fondazione "Casa Sollievo della Sofferenza" IRCCS, S. Giovanni Rotondo, Foggia, Italy
| | - Eduardo Celentano
- Department of Electrophysiology, Humanitas Gavazzeni, Bergamo, Italy
| | | | - Matteo Ziacchi
- Institute of Cardiology, University of Bologna, S. Orsola-Malpighi University Hospital, Bologna, Italy
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3
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Crossley GH, Sanders P, Hansky B, De Filippo P, Shah MJ, Shoda M, Khelae SK, Richardson TD, Philippon F, Zakaib JS, Tse HF, Sholevar DP, Stellbrink C, Pathak RK, Milašinović G, Chinitz JS, Tsang B, West MB, Ramza BM, Han X, Bozorgnia B, Carta R, Geelen T, Himes AK, Platner ML, Thompson AE, Mason PK. Safety, efficacy, and reliability evaluation ofa novel small-diameter defibrillation lead: Global LEADR pivotal trial results. Heart Rhythm 2024; 21:1914-1922. [PMID: 38762820 DOI: 10.1016/j.hrthm.2024.04.067] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/06/2024] [Revised: 04/12/2024] [Accepted: 04/13/2024] [Indexed: 05/20/2024]
Abstract
BACKGROUND Implantable cardioverter-defibrillators last longer, and interest in reliable leads with targeted lead placement is growing. The OmniaSecure defibrillation lead is a novel, small-diameter, catheter-delivered lead designed for targeted placement, based on the established SelectSecure SureScan MRI Model 3830 lumenless pacing lead platform. OBJECTIVE This trial assessed safety and efficacy of the OmniaSecure defibrillation lead. METHODS The worldwide LEADR pivotal clinical trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator, all of whom received the study lead. The primary efficacy end point was successful defibrillation at implantation per protocol. The primary safety end point was freedom from study lead-related major complications at 6 months. The primary efficacy and safety objectives were met if the lower bound of the 2-sided 95% credible interval was >88% and >90%, respectively. RESULTS In total, 643 patients successfully received the study lead, and 505 patients have completed 12-month follow-up. The lead was placed in the desired right ventricular location in 99.5% of patients. Defibrillation testing at implantation was completed in 119 patients, with success in 97.5%. The Kaplan-Meier estimated freedom from study lead-related major complications was 97.1% at 6 and 12 months. The trial exceeded the primary efficacy and safety objective thresholds. There were zero study lead fractures and electrical performance was stable throughout the mean follow-up of 12.7 ± 4.8 months (mean ± SD). CONCLUSION The OmniaSecure lead exceeded prespecified primary end point performance goals for safety and efficacy, demonstrating high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures.
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Affiliation(s)
| | - Prashanthan Sanders
- Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Adelaide, South Australia, Australia
| | | | | | - Maully J Shah
- The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
| | - Morio Shoda
- Tokyo Women's Medical University Hospital, Tokyo, Japan
| | | | | | - François Philippon
- Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Québec, Canada
| | - John S Zakaib
- Minneapolis Heart Institute Foundation, Minneapolis, Minnesota
| | - Hung-Fat Tse
- Queen Mary Hospital, University of Hong Kong, Pok Fu Lam, Hong Kong
| | | | | | - Rajeev K Pathak
- Canberra Heart Rhythm and Australian National University, Garran, ACT, Australia
| | | | | | - Bernice Tsang
- Southlake Regional Health Centre, Newmarket, Ontario, Canada
| | | | - Brian M Ramza
- Saint Luke's Mid America Heart Institute, Kansas City, Missouri
| | - Xuebin Han
- Shanxi Cardiovascular Hospital, Taiyuan, China
| | | | | | - Tessa Geelen
- Medtronic Bakken Research Center, Maastricht, The Netherlands
| | | | | | | | - Pamela K Mason
- University of Virginia Medical Center, Charlottesville, Virginia.
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Sun H, Liu X, Fu J, Song Y, Qin X, Wang H. Cost effectiveness of implantable cardioverter defibrillators for 1.5 primary prevention of sudden cardiac arrest in China: an analysis from the Improve SCA study. J Med Econ 2024; 27:575-581. [PMID: 38566556 DOI: 10.1080/13696998.2024.2333187] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/29/2024] [Accepted: 03/18/2024] [Indexed: 04/04/2024]
Abstract
OBJECTIVES Implantable cardioverter defibrillator (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) is underutilized in developing countries. The Improve SCA study has identified a subset of 1.5 primary prevention (1.5PP) patients with a higher risk of SCA and a significant mortality benefit from ICD therapy. From the perspective of China's healthcare system, we evaluated the cost-effectiveness of ICD therapy vs. no ICD therapy among 1.5PP patients with a view to informing clinical and policy decisions. METHODS A published Markov model was adjusted and verified to simulate the course of the disease and describe different health states of 1.5PP patients. The patient characteristics, mortality, utility and complication estimates were obtained from the Improve SCA study and other literature. Cost inputs were sourced from government tender prices, medical service prices and clinical experts' surveys in 9 Chinese public hospitals. For both ICD and no ICD therapy, the total medical costs and quality-adjusted life-years (QALYs) were modelled over a lifetime horizon and the incremental cost-effectiveness ratio (ICER) was calculated. Deterministic and probabilistic sensitivity analyses were performed to assess the uncertainty of the model parameters. We used the willingness-to-pay (WTP) threshold recommended by China Guidelines for Pharmacoeconomic Evaluations, one to three times China's GDP per capita (CNY85,698-CNY257,094) in 2022 Chinese Yuan. RESULTS The incremental cost effectiveness ratio (ICER) of ICD therapy compared to no ICD therapy is 139,652 CNY/QALY, which is about 1-2 times China's GDP per capita. The probability that ICD therapy is cost effective was 92.1%. Results from sensitivity analysis supported the findings of the base case. CONCLUSIONS ICD therapy compared to no ICD therapy is cost-effective for the 1.5PP patients in China.
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Affiliation(s)
- Hui Sun
- Shanghai Medical Information Center, Shanghai Health Development Research Center, Shanghai, China
| | - Xin Liu
- Shanghai Medical Information Center, Shanghai Health Development Research Center, Shanghai, China
| | - Jin Fu
- Medtronic, Shanghai, China
| | | | - Xiaoxiao Qin
- Shanghai Medical Information Center, Shanghai Health Development Research Center, Shanghai, China
| | - Haiyin Wang
- Shanghai Medical Information Center, Shanghai Health Development Research Center, Shanghai, China
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Guşetu G, Caloian B, Tomoaia R, Frîngu F, Mocanu L, Irimie D, Comșa H, Cismaru G, Zdrenghea D, Pop D. Physical rehabilitation in heart failure with reduced ejection fraction: are the cardiac implantable devices a barrier? BALNEO AND PRM RESEARCH JOURNAL 2023; 14:596. [DOI: 10.12680/balneo.2023.596] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/11/2025] Open
Abstract
The development of implantable cardiac devices brought a spectacular improvement in the prognosis of patients with heart failure with reduced ejection fraction, reducing the risk of sudden cardiac death by implanting a cardiac defibrillator, improving ventricular remodeling through cardiac resynchronization and, at the same time, increasing the pa-tient's functional capacity, reducing decompensation episodes and hospitalization. Phys-ical training at moderate exercise intensity is safe and effective in patients with heart fail-ure and cardiac implantable devices; even if they have a severely impaired effort capacity and device-related issues, the assessment of the disease status and of the device parame-ters before the enrollment in the training program warrants the improvement of physical performance and disease outcomes without notable adverse events.
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Affiliation(s)
- Gabriel Guşetu
- University of Medicine and Pharmacy “Iuliu Haţieganu” Cluj-Napoca, Romania
| | - Bogdan Caloian
- University of Medicine and Pharmacy “Iuliu Haţieganu” Cluj-Napoca, Romania
| | - Raluca Tomoaia
- University of Medicine and Pharmacy “Iuliu Haţieganu” Cluj-Napoca, Romania
| | - Florina Frîngu
- University of Medicine and Pharmacy “Iuliu Haţieganu” Cluj-Napoca, Romania
| | - Lorena Mocanu
- University of Medicine and Pharmacy “Iuliu Haţieganu” Cluj-Napoca, Romania
| | - Diana Irimie
- University of Medicine and Pharmacy “Iuliu Haţieganu” Cluj-Napoca, Romania
| | - Horatiu Comșa
- Cardiology Department, Clinical Rehabilitation Hospital, Cluj-Napoca, Romania
| | - Gabriel Cismaru
- Cardiology Department, Clinical Rehabilitation Hospital, Cluj-Napoca, Romania
| | - Dumitru Zdrenghea
- Cardiology Department, Clinical Rehabilitation Hospital, Cluj-Napoca, Romania
| | - Dana Pop
- Cardiology Department, Clinical Rehabilitation Hospital, Cluj-Napoca, Romania
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Phan J, Cherrett C, Subbiah R, Lee W. When logic fails. Heart Rhythm O2 2023; 4:668-670. [PMID: 37936672 PMCID: PMC10626179 DOI: 10.1016/j.hroo.2023.08.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/09/2023] Open
Affiliation(s)
- Justin Phan
- Department of Cardiology, St Vincent’s Hospital Sydney, Darlinghurst, Australia
- St Vincent's Clinical School, University of New South Wales, Sydney, Australia
- Victor Chang Cardiac Research Institute, Darlinghurst, Australia
| | - Callum Cherrett
- Department of Cardiology, St Vincent’s Hospital Sydney, Darlinghurst, Australia
- St Vincent's Clinical School, University of New South Wales, Sydney, Australia
| | - Rajesh Subbiah
- Department of Cardiology, St Vincent’s Hospital Sydney, Darlinghurst, Australia
- St Vincent's Clinical School, University of New South Wales, Sydney, Australia
- Victor Chang Cardiac Research Institute, Darlinghurst, Australia
| | - William Lee
- Department of Cardiology, St Vincent’s Hospital Sydney, Darlinghurst, Australia
- St Vincent's Clinical School, University of New South Wales, Sydney, Australia
- Victor Chang Cardiac Research Institute, Darlinghurst, Australia
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7
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Francia P, Ziacchi M, Adduci C, Ammendola E, Pieragnoli P, De Filippo P, Rapacciuolo A, Rella V, Migliore F, Viani S, Musumeci MB, Biagini E, Lovecchio M, Baldini R, Falasconi G, Autore C, Biffi M, Cecchi F. Clinical course of hypertrophic cardiomyopathy patients implanted with a transvenous or subcutaneous defibrillator. Europace 2023; 25:euad270. [PMID: 37724686 PMCID: PMC10507661 DOI: 10.1093/europace/euad270] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/30/2023] [Accepted: 08/09/2023] [Indexed: 09/21/2023] Open
Abstract
AIMS The implantable cardioverter-defibrillator (ICD) is a life-saving therapy in patients with hypertrophic cardiomyopathy (HCM) at risk of sudden cardiac death. Implantable cardioverter-defibrillator complications are of concern. The subcutaneous ICD (S-ICD) does not use transvenous leads and is expected to reduce complications. However, it does not provide bradycardia and anti-tachycardia pacing (ATP). The aim of this study was to compare appropriate and inappropriate ICD interventions, complications, disease-related adverse events and mortality between HCM patients implanted with a S- or transvenous (TV)-ICD. METHODS AND RESULTS Consecutive HCM patients implanted with a S- (n = 216) or TV-ICD (n = 211) were enrolled. Propensity-adjusted cumulative Kaplan-Meier curves and multivariate Cox proportional hazard ratios were used to compare 5-year event-free survival and the risk of events. The S-ICD patients had lower 5-year risk of appropriate (HR: 0.32; 95%CI: 0.15-0.65; P = 0.002) and inappropriate (HR: 0.44; 95%CI: 0.20-0.95; P = 0.038) ICD interventions, driven by a high incidence of ATP therapy in the TV-ICD group. The S- and TV-ICD patients experienced similar 5-year rate of device-related complications, albeit the risk of major lead-related complications was lower in S-ICD patients (HR: 0.17; 95%CI: 0.038-0.79; P = 0.023). The TV- and S-ICD patients displayed similar risk of disease-related complications (HR: 0.64; 95%CI: 0.27-1.52; P = 0.309) and mortality (HR: 0.74; 95%CI: 0.29-1.87; P = 0.521). CONCLUSION Hypertrophic cardiomyopathy patients implanted with a S-ICD had lower 5-year risk of appropriate and inappropriate ICD therapies as well as of major lead-related complications as compared to those implanted with a TV-ICD. Long-term comparative follow-up studies will clarify whether the lower incidence of major lead-related complications will translate into a morbidity or survival benefit.
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Affiliation(s)
- Pietro Francia
- Cardiology, Department of Clinical and Molecular Medicine, Sant’Andrea Hospital, University Sapienza, Rome, Italy
| | - Matteo Ziacchi
- Institute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Italy
| | - Carmen Adduci
- Cardiology, Department of Clinical and Molecular Medicine, Sant’Andrea Hospital, University Sapienza, Rome, Italy
| | - Ernesto Ammendola
- Department of Translational Medical Sciences, University of Campania ‘Luigi Vanvitelli’, Monaldi Hospital, Naples, Italy
| | - Paolo Pieragnoli
- Careggi University Hospital, University of Florence, Florence, Italy
| | | | - Antonio Rapacciuolo
- Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy
| | - Valeria Rella
- Department of Cardiovascular, Neural and Metabolic Sciences, IRCCS, Istituto Auxologico Italiano, San Luca Hospital, Milan, Italy
| | - Federico Migliore
- Department of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova, Padova, Italy
| | - Stefano Viani
- Second Cardiology Division, Cardio-Thoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy
| | - Maria Beatrice Musumeci
- Cardiology, Department of Clinical and Molecular Medicine, Sant’Andrea Hospital, University Sapienza, Rome, Italy
| | - Elena Biagini
- Institute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Italy
| | | | - Rossella Baldini
- Cardiology, Department of Clinical and Molecular Medicine, Sant’Andrea Hospital, University Sapienza, Rome, Italy
| | - Giulio Falasconi
- Campus Clínic, University of Barcelona, Barcelona, Spain
- IRCCS Humanitas Research Hospital, Milan, Italy
| | - Camillo Autore
- Cardiology, Department of Clinical and Molecular Medicine, Sant’Andrea Hospital, University Sapienza, Rome, Italy
| | - Mauro Biffi
- Institute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Italy
| | - Franco Cecchi
- Careggi University Hospital, University of Florence, Florence, Italy
- Department of Cardiovascular, Neural and Metabolic Sciences, IRCCS, Istituto Auxologico Italiano, San Luca Hospital, Milan, Italy
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Dichtl W, De Sousa J, Rubin Lopez JM, Campo EG, Gutleben KJ, Poezevara Y, Probst V. Low rates of inappropriate shocks in contemporary real-world implantable cardioverter defibrillator patients: the CARAT observational study. Europace 2023; 25:euad186. [PMID: 37410910 PMCID: PMC10410192 DOI: 10.1093/europace/euad186] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/29/2023] [Accepted: 05/16/2023] [Indexed: 07/08/2023] Open
Affiliation(s)
- Wolfgang Dichtl
- University Hospital for Internal Medicine III (Cardiology and Angiology), Medical University Innsbruck, Anichstraße 35, A-6020 Innsbruck, Austria
| | - João De Sousa
- Centro Hospitalar Lisboa Norte—Hospital de Santa Maria, Lisbon, Portugal
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Guarracini F, Preda A, Bonvicini E, Coser A, Martin M, Quintarelli S, Gigli L, Baroni M, Vargiu S, Varrenti M, Forleo GB, Mazzone P, Bonmassari R, Marini M, Droghetti A. Subcutaneous Implantable Cardioverter Defibrillator: A Contemporary Overview. Life (Basel) 2023; 13:1652. [PMID: 37629509 PMCID: PMC10455445 DOI: 10.3390/life13081652] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/06/2023] [Revised: 07/23/2023] [Accepted: 07/25/2023] [Indexed: 08/27/2023] Open
Abstract
The difference between subcutaneous implantable cardioverter defibrillators (S-ICDs) and transvenous ICDs (TV-ICDs) concerns a whole extra thoracic implantation, including a defibrillator coil and pulse generator, without endovascular components. The improved safety profile has allowed the S-ICD to be rapidly taken up, especially among younger patients. Reports of its role in different cardiac diseases at high risk of SCD such as hypertrophic and arrhythmic cardiomyopathies, as well as channelopathies, is increasing. S-ICDs show comparable efficacy, reliability, and safety outcomes compared to TV-ICD. However, some technical issues (i.e., the inability to perform anti-bradycardia pacing) strongly limit the employment of S-ICDs. Therefore, it still remains only an alternative to the traditional ICD thus far. This review aims to provide a contemporary overview of the role of S-ICDs compared to TV-ICDs in clinical practice, including technical aspects regarding device manufacture and implantation techniques. Newer outlooks and future perspectives of S-ICDs are also brought up to date.
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Affiliation(s)
- Fabrizio Guarracini
- Department of Cardiology, S. Chiara Hospital, 38122 Trento, Italy; (E.B.); (A.C.); (M.M.); (S.Q.); (R.B.); (M.M.)
| | - Alberto Preda
- Electrophysiology Unit, Cardio-Thoraco-Vascular Department, ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy; (A.P.); (L.G.); (M.B.); (S.V.); (M.V.); (P.M.)
| | - Eleonora Bonvicini
- Department of Cardiology, S. Chiara Hospital, 38122 Trento, Italy; (E.B.); (A.C.); (M.M.); (S.Q.); (R.B.); (M.M.)
| | - Alessio Coser
- Department of Cardiology, S. Chiara Hospital, 38122 Trento, Italy; (E.B.); (A.C.); (M.M.); (S.Q.); (R.B.); (M.M.)
| | - Marta Martin
- Department of Cardiology, S. Chiara Hospital, 38122 Trento, Italy; (E.B.); (A.C.); (M.M.); (S.Q.); (R.B.); (M.M.)
| | - Silvia Quintarelli
- Department of Cardiology, S. Chiara Hospital, 38122 Trento, Italy; (E.B.); (A.C.); (M.M.); (S.Q.); (R.B.); (M.M.)
| | - Lorenzo Gigli
- Electrophysiology Unit, Cardio-Thoraco-Vascular Department, ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy; (A.P.); (L.G.); (M.B.); (S.V.); (M.V.); (P.M.)
| | - Matteo Baroni
- Electrophysiology Unit, Cardio-Thoraco-Vascular Department, ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy; (A.P.); (L.G.); (M.B.); (S.V.); (M.V.); (P.M.)
| | - Sara Vargiu
- Electrophysiology Unit, Cardio-Thoraco-Vascular Department, ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy; (A.P.); (L.G.); (M.B.); (S.V.); (M.V.); (P.M.)
| | - Marisa Varrenti
- Electrophysiology Unit, Cardio-Thoraco-Vascular Department, ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy; (A.P.); (L.G.); (M.B.); (S.V.); (M.V.); (P.M.)
| | - Giovanni Battista Forleo
- Department of Thoracic Surgery, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, 10060 Turin, Italy;
| | - Patrizio Mazzone
- Electrophysiology Unit, Cardio-Thoraco-Vascular Department, ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy; (A.P.); (L.G.); (M.B.); (S.V.); (M.V.); (P.M.)
| | - Roberto Bonmassari
- Department of Cardiology, S. Chiara Hospital, 38122 Trento, Italy; (E.B.); (A.C.); (M.M.); (S.Q.); (R.B.); (M.M.)
| | - Massimiliano Marini
- Department of Cardiology, S. Chiara Hospital, 38122 Trento, Italy; (E.B.); (A.C.); (M.M.); (S.Q.); (R.B.); (M.M.)
| | - Andrea Droghetti
- Cardiology Unit, Luigi Sacco University Hospital, 20157 Milan, Italy;
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10
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Llewellyn J, Barker E, Bowe C, Hallas N, Oghagbon R, Rao A. Assessing the Cost and Resource Use Impact of Implantable Cardiac Defibrillator Shocks in the UK CareLink Population. CLINICOECONOMICS AND OUTCOMES RESEARCH 2023; 15:425-432. [PMID: 37305155 PMCID: PMC10257399 DOI: 10.2147/ceor.s403712] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/09/2023] [Accepted: 05/12/2023] [Indexed: 06/13/2023] Open
Abstract
Objective High voltage devices (implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators referred to jointly as ICDs) reduce rates of sudden cardiac death in patients with cardiovascular disease. However, shocks from ICDs may be associated with healthcare resource use (HCRU) and costs. The aim of this study was to estimate the costs associated with both appropriate and inappropriate shocks from ICDs. Methods Patients with appropriate and inappropriate shocks from ICDs were identified via CareLink data from Liverpool Heart and Chest Hospital between March 2017 and March 2019. The devices were SmartShock activated, with anti-tachycardia pacing. Costs were estimated according to the dominant episode of healthcare, from an NHS payer perspective. Results There were 2445 patients on the CareLink system with ICDs. Over the two-year period, HCRU data from 143 shock episodes among 112 patients were reported. The total cost for all shocks was £252,552 with mean costs of £1608 and £2795 for appropriate and inappropriate shocks respectively. There was substantial variation in HCRU between shock episodes. Conclusion While there was a low rate of inappropriate shocks from ICDs, there were still substantial HCRU and costs incurred. In this study, the specific HCRU was not costed independently, meaning the costs reported are likely to be a conservative estimate. Whilst every attempt to reduce shocks should be made, appropriate shocks cannot be avoided. Strategies to reduce the incidence of inappropriate and unnecessary shocks should be implemented to reduce overall health care costs associated with ICDs.
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Affiliation(s)
| | - Erin Barker
- York Health Economics Consortium, University of York, Heslington, York, UK
| | - Catherine Bowe
- York Health Economics Consortium, University of York, Heslington, York, UK
| | | | | | - Archana Rao
- Liverpool Heart and Chest Hospital, Liverpool, UK
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11
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Samuel M, Healey JS, Nault I, Sterns LD, Essebag V, Gray C, Hruczkowski T, Gardner M, Parkash R, Sapp JL. Ventricular Tachycardia and ICD Therapy Burden With Catheter Ablation Versus Escalated Antiarrhythmic Drug Therapy. JACC Clin Electrophysiol 2023; 9:808-821. [PMID: 37380314 DOI: 10.1016/j.jacep.2023.01.030] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/18/2022] [Revised: 01/24/2023] [Accepted: 01/26/2023] [Indexed: 06/30/2023]
Abstract
BACKGROUND Catheter ablation improves ventricular tachycardia (VT) event-free (time to event) survival in patients with antiarrhythmic drug (AAD)-refractory VT and previous myocardial infarction (MI). The effects of ablation on recurrent VT and implantable cardioverter-defibrillator (ICD) therapy (burden) have yet to be investigated. OBJECTIVES This study sought to compare the VT and ICD therapy burden following treatment with either ablation or escalated AAD therapy among patients with VT and previous MI in the VANISH (Ventricular tachycardia AblatioN versus escalated antiarrhythmic drug therapy in ISchemic Heart disease) trial. METHODS The VANISH trial randomized patients with previous MI and VT despite initial AAD therapy to either escalated AAD treatment or catheter ablation. VT burden was defined as the total number of VT events treated with ≥1 appropriate ICD therapy. Appropriate ICD therapy burden was defined as the total number of appropriate shocks or antitachycardia pacing therapies (ATPs) delivered. The Anderson-Gill recurrent event model was used to compare burden between the treatment arms. RESULTS Of the 259 enrolled patients (median age, 69.8 years; 7.0% women), 132 patients were randomized to ablation and 129 patients were randomized to escalated AAD therapy. Over 23.4 months of follow-up, ablation-treated patients had a 40% lower shock-treated VT event burden and a 39% lower appropriate shock burden compared with patients who received escalated AAD therapy (P <0.05 for all). A reduction in VT burden, ATP-treated VT event burden, and appropriate ATP burden among ablation patients was only demonstrated in the stratum of patients with amiodarone-refractory VT (P <0.05 for all). CONCLUSIONS Among patients with AAD-refractory VT and a previous MI, catheter ablation reduced shock-treated VT event burden and appropriate shock burden compared with escalated AAD therapy. There was also lower VT burden, ATP-treated VT event burden, and appropriate ATP burden among ablation-treated patients; however, the effect was limited to patients with amiodarone-refractory VT.
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Affiliation(s)
- Michelle Samuel
- Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada
| | | | - Isabelle Nault
- Quebec Heart and Lung Institute, Quebec City, Quebec, Canada
| | | | - Vidal Essebag
- McGill University Health Centre, Montreal, Quebec, Canada; Hôpital Sacré-Coeur de Montréal, Montreal, Quebec, Canada
| | - Christopher Gray
- Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia, Canada
| | | | - Martin Gardner
- Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia, Canada
| | - Ratika Parkash
- Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia, Canada
| | - John L Sapp
- Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia, Canada.
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12
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Sterns LD, Auricchio A, Schloss EJ, Lexcen D, Jacobsen L, DeGroot P, Molan A, Kurita T. Antitachycardia pacing success in implantable cardioverter-defibrillators by patient, device, and programming characteristics. Heart Rhythm 2023; 20:190-197. [PMID: 36272710 DOI: 10.1016/j.hrthm.2022.10.015] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/15/2022] [Revised: 09/25/2022] [Accepted: 10/07/2022] [Indexed: 11/04/2022]
Abstract
BACKGROUND Antitachycardia pacing (ATP) is an established implantable cardioverter-defibrillator (ICD) therapy that terminates ventricular tachycardias (VTs) without painful ICD shocks. However, factors influencing ATP success are not well understood. OBJECTIVE The purpose of this study was to examine ATP success rates by patient, device, and programming characteristics. METHODS This retrospective analysis of the PainFree SmartShock Technology study included spontaneous ATP-treated monomorphic VT episodes. ATP success rates were calculated for various factors. Also, the relationship of ATP programming on shock burden and syncope were investigated. RESULTS Of the 2770 enrolled patients (2200 [79%] male; mean age 65 years), 1699 (61%) received an ICD and 1071 (39%) a cardiac resynchronization therapy - defibrillator. ATP had >80% rate of success for terminating VTs overall, with similar rates observed between ICD and cardiac resynchronization therapy - defibrillator devices (82.2% vs 80.3%, respectively; P = .81) as well as between primary and secondary prevention patients with ICDs (77.2% vs 83.9% respectively; P = .25). Arrhythmias with a median cycle length of ≥320 ms had a significantly higher ATP success rate (88.0%; 95% confidence interval 84.8%-90.6%). The cumulative percentage of ATP success increased from 71% at 1 ATP sequence delivered to 87% at ≥8 sequences delivered. Programming more ATP sequences was associated with lower shock burden (P = .0005). There was no evidence that more sequences were associated with higher rates of syncope (P = .16). CONCLUSION Delivering more ATP sequences resulted in a higher overall success of terminating VTs, while programming more ATP was associated with decreased shock burden and no evidence of increased syncope or acceleration. This suggests that more ATP sequences should be programmed when possible, but confirmation in prospective studies will be necessary.
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Affiliation(s)
- Laurence D Sterns
- Vancouver Island Arrhythmia Clinic, Victoria, British Columbia, Canada.
| | - Angelo Auricchio
- Division of Cardiology, Istituto Cardiocentro Ticino, Lugano, Switzerland
| | | | | | | | | | - Amy Molan
- Medtronic Inc., Mounds View, Minnesota
| | - Takashi Kurita
- Division of Cardiology, Department of Medicine, Kindai University School of Medicine, Osaka, Japan
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13
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Stegemann E, Weidmann M, Miyazawa AA, Shun-Shin MJ, Leyva F, Zegard A, Stegemann B. Laser Doppler flow for the hemodynamic differentiation of tachycardia. Pacing Clin Electrophysiol 2023; 46:114-124. [PMID: 36385259 DOI: 10.1111/pace.14618] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/14/2022] [Revised: 09/15/2022] [Accepted: 10/31/2022] [Indexed: 11/18/2022]
Abstract
BACKGROUND Implantable cardioverter defibrillators (ICDs) offer effective therapy for the prevention of sudden cardiac death (SCD) due to ventricular arrhythmias. However, inappropriate shocks have detrimental effects on survival and quality of life. The addition of hemodynamic monitoring may be useful in discriminating clinically important ventricular arrhythmias. OBJECTIVE In this study, we assess the ability of laser Doppler flowmetry to assess the hemodynamic effect of paced atrial and ventricular arrhythmias using mean arterial blood pressure as the reference. METHODS In this acute human study in patients undergoing an elective electrophysiological study, laser Doppler flowmetry, arterial blood pressure, and surface ECG were acquired during high-rate atrial and ventricular pacing to simulate supraventricular and ventricular tachycardias. RESULTS Arterial blood pressure and laser Doppler flow signals correlated well during atrial and ventricular pacing (rho = 0.694, p < .001). The hemodynamic impairment detected by both methods was greater during ventricular pacing than atrial pacing (-1.0% vs. 19.0%, p < .001). Laser Doppler flowmetry performed better than rate alone to identify hemodynamic impairments. CONCLUSION In this acute study, laser Doppler flowmetry tissue perfusion served as a good surrogate measure for arterial pressure, which could be incorporated into future ICDs.
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Affiliation(s)
- Emilia Stegemann
- Clinic for Internal Medicine & Angiology, Agaplesion Diakonie Kliniken Kassel, Kassel, Germany
- Klinik für Kardiologie und Angiologie, Medizinische Fakultät der Philipps-Universität Marburg, Marburg, Germany
| | - Mia Weidmann
- Medizinische Klinik II, Klinikum Kassel, Kassel, Germany
| | - Alejandra A Miyazawa
- National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, United Kingdom
| | - Matthew J Shun-Shin
- National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, United Kingdom
| | - Francisco Leyva
- Aston Medical School, Aston University, Birmingham, United Kingdom
- Queen Elizabeth Hospital, Birmingham, United Kingdom
| | - Abbasin Zegard
- Aston Medical School, Aston University, Birmingham, United Kingdom
- Queen Elizabeth Hospital, Birmingham, United Kingdom
| | - Berthold Stegemann
- National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, United Kingdom
- Aston Medical School, Aston University, Birmingham, United Kingdom
- Queen Elizabeth Hospital, Birmingham, United Kingdom
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14
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Crossley GH, Sanders P, De Filippo P, Tarakji KG, Hansky B, Shah M, Mason P, Maus B, Holloman K. Rationale and design of the Lead Evaluation for Defibrillation and Reliability study: Safety and efficacy of a novel ICD lead design. J Cardiovasc Electrophysiol 2023; 34:257-267. [PMID: 36378803 PMCID: PMC10107290 DOI: 10.1111/jce.15747] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/25/2021] [Revised: 09/24/2022] [Accepted: 09/27/2022] [Indexed: 11/16/2022]
Abstract
BACKGROUND Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, small-diameter, lumenless, catheter-delivered, defibrillator lead was developed with the aim to improve long-term reliability. METHODS AND RESULTS The Lead Evaluation for Defibrillation and Reliability (LEADR) study is a multi-center, single-arm, Bayesian, adaptive design, pre-market interventional pivotal clinical study. Up to 60 study sites from around the world will participate in the study. Patients indicated for a de novo ICD will undergo defibrillation testing at implantation and clinical assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure. Patients may be participating for a minimum of 18 months to approximately 3 years. Fracture-free survival will be evaluated using a Bayesian statistical method that incorporates both virtual patient data (combination of bench testing to failure with in-vivo use condition data) with clinical patients. The clinical subject sample size will be determined using decision rules for number of subject enrollments and follow-up time based upon the observed number of fractures at certain time points in the study. The adaptive study design will therefore result in a minimum of 500 and a maximum of 900 patients enrolled. CONCLUSION The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach.
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Affiliation(s)
| | | | | | | | | | - Maully Shah
- The Children's HospitalPhiladelphiaPennsylvaniaUSA
| | - Pamela Mason
- University of Virginia Medical CenterCharlottesvilleVirginiaUSA
| | - Baerbel Maus
- Bakken Research Center, Medtronic Inc.MaastrichtThe Netherlands
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15
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Gasperetti A, Schiavone M, Vogler J, Laredo M, Fastenrath F, Palmisano P, Ziacchi M, Angeletti A, Mitacchione G, Kaiser L, Compagnucci P, Breitenstein A, Arosio R, Vitali F, De Bonis S, Picarelli F, Casella M, Santini L, Pignalberi C, Lavalle C, Pisanò E, Ricciardi D, Calò L, Curnis A, Bertini M, Gulletta S, Dello Russo A, Badenco N, Tondo C, Kuschyk J, Tilz R, Forleo GB, Biffi M. The need for a subsequent transvenous system in patients implanted with subcutaneous implantable cardioverter-defibrillator. Heart Rhythm 2022; 19:1958-1964. [PMID: 35781042 DOI: 10.1016/j.hrthm.2022.06.030] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/06/2022] [Revised: 06/21/2022] [Accepted: 06/24/2022] [Indexed: 12/14/2022]
Abstract
BACKGROUND The absence of pacing capabilities may reduce the appeal of subcutaneous implantable cardioverter-defibrillator (S-ICD) devices for patients at risk for conduction disorders or with antitachycardia pacing (ATP)/cardiac resynchronization (CRT) requirements. Reports of rates of S-ICD to transvenous implantable cardioverter-defibrillator (TV-ICD) system switch in real-world scenarios are limited. OBJECTIVE The purpose of this study was to investigate the need for a subsequent transvenous (TV) device in patients implanted with an S-ICD and its predictors. METHODS All patients implanted with an S-ICD were enrolled from the multicenter, real-world iSUSI (International SUbcutaneouS Implantable cardioverter defibrillator) Registry. The need for a TV device and its clinical reason, and appropriate and inappropriate device therapies were assessed. Logistic regression with Firth penalization was used to assess the association between baseline and procedural characteristics and the overall need for a subsequent TV device. RESULTS A total of 1509 patients were enrolled (age 50.8 ± 15.8 years; 76.9% male; 32.0% ischemic; left ventricular ejection fraction 38% [30%-60%]). Over 26.5 [13.4-42.9] months, 155 (10.3%) and 144 (9.3%) patients experienced appropriate and inappropriate device therapies, respectively. Forty-one patients (2.7%) required a TV device (13 bradycardia; 10 need for CRT; 10 inappropriate shocks). Body mass index (BMI) >30 kg/m2 and chronic kidney disease (CKD) were associated with need for a TV device (odds ratio [OR] 2.57 [1.37-4.81], P = .003; and OR 2.67 [1.29-5.54], P = .008, respectively). CONCLUSION A low rate (2.7%) of conversion from S-ICD to a TV device was observed at follow-up, with need for antibradycardia pacing, ATP, or CRT being the main reasons. BMI >30 kg/m2 and CKD predicted all-cause need for a TV device.
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Affiliation(s)
- Alessio Gasperetti
- Cardiology Unit, Luigi Sacco University Hospital, Milan, Italy; Università degli Studi di Milano, Milan, Italy; Johns Hopkins University, Baltimore, Maryland; Department of Biomedical Sciences and Public Health, Marche Polytechnic University, Ancona, Italy.
| | | | - Julia Vogler
- Department of Rhythmology, Herzzentrum Lubeck, Lubeck, Germany
| | | | - Fabian Fastenrath
- Cardiology Unit, University Medical Centre Mannheim, Manheim, Germany
| | | | - Matteo Ziacchi
- Cardiology Unit, IRCCS, Department of Experimental, Diagnostic and Specialty Medicine, Sant'Orsola Hospital, University of Bologna, Bologna, Italy
| | - Andrea Angeletti
- Cardiology Unit, IRCCS, Department of Experimental, Diagnostic and Specialty Medicine, Sant'Orsola Hospital, University of Bologna, Bologna, Italy
| | - Gianfranco Mitacchione
- Cardiology Unit, Luigi Sacco University Hospital, Milan, Italy; Cardiology Unit, Spedali Civili Brescia, Brescia, Italy
| | | | - Paolo Compagnucci
- Department of Biomedical Sciences and Public Health, Marche Polytechnic University, Ancona, Italy; Cardiology and Arrhythmology Clinic, University Hospital Ospedali Riuniti, Ancona, Italy
| | | | | | - Francesco Vitali
- Cardiological Center, S. Anna University Hospital, Ferrara, Italy
| | - Silvana De Bonis
- Department of Cardiology, Castrovillari Hospital, Cosenza, Italy
| | | | - Michela Casella
- Cardiology and Arrhythmology Clinic, University Hospital Ospedali Riuniti, Ancona, Italy
| | - Luca Santini
- Cardiology Unit, Ospedale G.B. Grassi, Ostia, Italy
| | | | | | - Ennio Pisanò
- Cardiac Electrophysiology Unit, Vito Fazzi Hospital, Lecce, Italy
| | | | | | | | - Matteo Bertini
- Cardiological Center, S. Anna University Hospital, Ferrara, Italy
| | - Simone Gulletta
- Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS, Milan, Italy
| | - Antonio Dello Russo
- Department of Biomedical Sciences and Public Health, Marche Polytechnic University, Ancona, Italy; Cardiology and Arrhythmology Clinic, University Hospital Ospedali Riuniti, Ancona, Italy
| | | | - Claudio Tondo
- Heart Rhythm Center, Monzino Cardiology Center, IRCCS, Milan, Italy
| | - Jürgen Kuschyk
- Cardiology Unit, University Medical Centre Mannheim, Manheim, Germany
| | - Roland Tilz
- Department of Rhythmology, Herzzentrum Lubeck, Lubeck, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany
| | | | - Mauro Biffi
- Cardiology Unit, IRCCS, Department of Experimental, Diagnostic and Specialty Medicine, Sant'Orsola Hospital, University of Bologna, Bologna, Italy
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16
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Begisbayev T, Kosherbayeva L, Gaitova K, Brimzhanova M. Cost-Effectiveness of Cardioverter-Defibrillator Implantation in Kazakhstan. Vasc Health Risk Manag 2022; 18:813-821. [PMID: 36281286 PMCID: PMC9587701 DOI: 10.2147/vhrm.s369953] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/10/2022] [Accepted: 10/05/2022] [Indexed: 12/03/2022] Open
Abstract
ABSTRACT Cardiovascular disease is the leading cause of morbidity and mortality worldwide. The implementation of effective technologies such as Implantable cardioverter-defibrillator (ICD) for patients at risk of sudden cardiac death requires additional health system resources. OBJECTIVE To assess the economic effectiveness of ICD in comparison with conservative tactics for preventing life-threatening rhythm disturbances in Kazakhstan. METHODS A Markov model was built with a time horizon of 35 years. Mortality and utility data were obtained from the available literature. The economic parameters of the model are based on the approved tariffs for medical services in Kazakhstan and clinical protocols. Following WHO recommendations, a willingness to pay threshold of three times gross domestic product per capita was used to assess cost-effectiveness. A discount rate of 3.5% was applied to both costs and benefits. To deal with parameter uncertainties and to provide robust analysis, a probabilistic sensitivity analysis was performed, randomly varying all inputs subject to uncertainty assuming a statistical distribution. RESULTS The total costs in the primary prevention (PP) group by ICD implantation and in the control group were 8,903,786 tenges and 3,194,414 tenges, respectively. The discounted total quality-adjusted life-years saved (QALYs) in the ICD and control groups were 6.48 and 4.98, respectively. The indicator of incremental cost-effectiveness ratio amounted to3791604 tenge, which is below the willingness to pay threshold and indicates the cost-effectiveness of using ICD as a PP strategy in patients with sudden cardiac death risk factors in the health care of Kazakhstan. CONCLUSION The ICD for the primary prevention of the development of life-threatening rhythm disturbances and sudden cardiac death is a cost-effective health technology from the position of a payer in the health care system of Kazakhstan.
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Affiliation(s)
| | - Lyazzat Kosherbayeva
- Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan,Al-Farabi Kazakh National University, Almaty, Kazakhstan,Correspondence: Lyazzat Kosherbayeva, Asfendiyarov Kazakh National Medical University, 88 Tole bi Street, Almaty, Kazakhstan, Tel + 7 705 120 46 52, Email ;
| | - Kamilla Gaitova
- Health Technology Assessment Department, Republican Center for Health Development, Nur-Sultan, Kazakhstan
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17
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Friedman P, Murgatroyd F, Boersma LVA, Manlucu J, O'Donnell D, Knight BP, Clémenty N, Leclercq C, Amin A, Merkely BP, Birgersdotter-Green UM, Chan JYS, Biffi M, Knops RE, Engel G, Muñoz Carvajal I, Epstein LM, Sagi V, Johansen JB, Sterliński M, Steinwender C, Hounshell T, Abben R, Thompson AE, Wiggenhorn C, Willey S, Crozier I. Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator. N Engl J Med 2022; 387:1292-1302. [PMID: 36036522 DOI: 10.1056/nejmoa2206485] [Citation(s) in RCA: 79] [Impact Index Per Article: 26.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/19/2022]
Abstract
BACKGROUND The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. METHODS We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%. RESULTS A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period. CONCLUSIONS In this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.).
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Affiliation(s)
- Paul Friedman
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Francis Murgatroyd
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Lucas V A Boersma
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Jaimie Manlucu
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - David O'Donnell
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Bradley P Knight
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Nicolas Clémenty
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Christophe Leclercq
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Anish Amin
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Béla P Merkely
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Ulrika M Birgersdotter-Green
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Joseph Y S Chan
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Mauro Biffi
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Reinoud E Knops
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Greg Engel
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Ignacio Muñoz Carvajal
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Laurence M Epstein
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Venkata Sagi
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Jens B Johansen
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Maciej Sterliński
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Clemens Steinwender
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Troy Hounshell
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Richard Abben
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Amy E Thompson
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Christopher Wiggenhorn
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Sarah Willey
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
| | - Ian Crozier
- From Mayo Clinic, Rochester (P.F.), and Medtronic, Mounds View (A.E.T., C.W., S.W.) - both in Minnesota; King's College Hospital, London (F.M.); the Cardiology Department, St. Antonius Hospital, Nieuwegein (L.V.A.B.), and Amsterdam University Medical Centers, Amsterdam (L.V.A.B., R.E.K.) - both in the Netherlands; London Health Sciences Centre, London, ON, Canada (J.M.); Austin Hospital, Heidelberg, VIC, Australia (D.O.); Northwestern University, Evanston, IL (B.P.K.); Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours (N.C.), and Centre Hospitalier Universitaire de Rennes-Hôpital Pontchaillou, Rennes (C.L.) - both in France; Riverside Methodist Hospital, Columbus, OH (A.A.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.P.M.); the University of California, San Diego, La Jolla (U.M.B.-G.), and Sequoia Hospital, Redwood City (G.E.) - both in California; Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China (J.Y.S.C.); the Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (M.B.); Hospital Universitario Reina Sofía, Cordoba, Spain (I.M.C.); Northwell Health, Manhasset, NY (L.M.E.); Baptist Health, Jacksonville, FL (V.S.); Odense Universitetshospital, Odense, Denmark (J.B.J.); Klinika Zaburzeń Rytmu Serca/Narodowy Instytut Kardiologii-Stefana Kardynała Wyszyńskiego, Warsaw, Poland (M.S.); Kepler University Hospital, Linz, Austria (C.S.); the Iowa Heart Center, West Des Moines (T.H.); the Cardiovascular Institute of the South, Houma, LA (R.A.); and Christchurch Hospital, Christchurch, New Zealand (I.C.)
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van der Stuijt W, Smeding L, Olde Nordkamp LRA, Knops RE. Response by van der Stuijt et al to Letter Regarding Article, "Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial". Circulation 2022; 146:e10-e11. [PMID: 35877837 DOI: 10.1161/circulationaha.122.060879] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Affiliation(s)
- Willeke van der Stuijt
- Amsterdam UMC, location University of Amsterdam, Amsterdam Cardiovascular Sciences, Department of Clinical and Experimental Cardiology, The Netherlands
| | - Lonneke Smeding
- Amsterdam UMC, location University of Amsterdam, Amsterdam Cardiovascular Sciences, Department of Clinical and Experimental Cardiology, The Netherlands
| | - Louise R A Olde Nordkamp
- Amsterdam UMC, location University of Amsterdam, Amsterdam Cardiovascular Sciences, Department of Clinical and Experimental Cardiology, The Netherlands
| | - Reinoud E Knops
- Amsterdam UMC, location University of Amsterdam, Amsterdam Cardiovascular Sciences, Department of Clinical and Experimental Cardiology, The Netherlands
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Hakamata T, Otsuki S, Izumi D, Sakaguchi Y, Suzuki N, Ikami Y, Hasegawa Y, Yagihara N, Iijima K, Chinushi M, Koichi F, Inomata T. Clinical impact of ECG change on oversensing of subcutaneous implantable cardioverter-defibrillators. Heart Rhythm 2022; 19:1704-1711. [PMID: 35688344 DOI: 10.1016/j.hrthm.2022.05.037] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/20/2021] [Revised: 05/01/2022] [Accepted: 05/13/2022] [Indexed: 11/04/2022]
Abstract
BACKGROUND Inappropriate shocks delivered from subcutaneous implantable cardioverter-defibrillators (S-ICD) are most frequently caused by cardiac oversensing. However, the predictors for oversensing of S-ICD remain unclear. OBJECTIVE We aimed to investigate the predictors for oversensing of S-ICD, especially clinical impact of ECG change. METHODS We retrospectively enrolled 99 consecutive patients who underwent S-ICD implantation between 2013 and 2021. Oversensing events were defined as inappropriate charge of the capacitors induced by cardiac or noncardiac signals other than tachycardia. RESULTS During a median 34 month (IQR 20-50 months) of the follow-up period, 11 of the 99 patients experienced 34 oversensing events and 4 patients received inappropriate shocks during their events. Six patients exhibited ECG changes (bundle branch block, 3; ventricular pacing, 1; inverted T wave, 1; poor R progression, 1) during follow-up period. Oversensing events were observed in four of the six patients with ECG changes (67%), and three patients underwent S-ICD removal because of inevitable shock. Contrastingly, among the remaining patients without ECG change, all 7 patients who experienced oversensing events could continue using S-ICD with reprogramming sensing vector and/or restriction of excessive exercise. Logistic regression analysis showed lower voltage of Sokolow-Lyon ECG (V1S+V5R) was the predictor of oversensing event among the patients without ECG change. When the cut off value was 2.1mV, the sensitivity, specificity, positive predictive value, and negative predictive value were 85.7%, 62.7%, 15.7%, and 98.1%, respectively. CONCLUSION Unavoidable oversensing resulting in S-ICD removal is caused by ECG changes. Oversensing in patients without ECG change can be managed.
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Affiliation(s)
- Takahiro Hakamata
- Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
| | - Sou Otsuki
- Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
| | - Daisuke Izumi
- Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
| | - Yuta Sakaguchi
- Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
| | - Naomasa Suzuki
- Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
| | - Yasuhiro Ikami
- Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
| | - Yuki Hasegawa
- Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
| | - Nobue Yagihara
- Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
| | - Kenichi Iijima
- Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
| | - Masaomi Chinushi
- Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
| | | | - Takayuki Inomata
- Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
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20
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Migliore F, Corrado D. Implantable defibrillator in patients with inherited arrhythmogenic diseases: Are inapproppriate shocks preventable? Int J Cardiol 2022; 360:36-38. [PMID: 35568056 DOI: 10.1016/j.ijcard.2022.05.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/06/2022] [Accepted: 05/09/2022] [Indexed: 12/01/2022]
Affiliation(s)
- Federico Migliore
- Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.
| | - Domenico Corrado
- Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy
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21
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Friedli A, Burri H. S-ICDs: advantages and opportunities for improvement. Expert Rev Med Devices 2022; 19:237-245. [PMID: 35289702 DOI: 10.1080/17434440.2022.2054335] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2022]
Abstract
INTRODUCTION The subcutaneous implantable cardioverter defibrillator (S-ICD) is currently in its third generation and has been adopted in guidelines and in mainstream clinical practice. Considerable improvements have been made since the introduction of this device over a decade ago. AREAS COVERED A literature search was undertaken in Pubmed on articles relating to the S-ICD. EXPERT OPINION The therapy has been proven to be safe and effective and is a valuable option in selected patients. Nevertheless, there remain many shortcomings of the S-ICD which are discussed in this review, and which hopefully will be addressed by future generations of the device.
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Affiliation(s)
- Axel Friedli
- Department of Cardiology, University Hospital of Geneva, Geneva, Switzerland
| | - Haran Burri
- Department of Cardiology, University Hospital of Geneva, Geneva, Switzerland
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22
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Perioperative Management of Patients with Cardiac Implantable Electronic Devices and Utility of Magnet Application. J Clin Med 2022; 11:jcm11030691. [PMID: 35160149 PMCID: PMC8836758 DOI: 10.3390/jcm11030691] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/14/2021] [Revised: 01/19/2022] [Accepted: 01/26/2022] [Indexed: 11/16/2022] Open
Abstract
With the demographic evolution of the population, patients undergoing surgery today are older and have an increasing number of sometimes complex comorbidities. Cardiac implantable electronic devices (CIED) are also getting more and more complex with very sophisticated programming algorithms. It may be generally assumed that magnet application reverts pacing to an asynchronous mode in pacemakers and disables tachycardia detection/therapy in internal cardioverter-defibrillators. However, depending on device type, manufacturer and model, the response to magnet application may differ substantially. For these reasons, perioperative management of CIED patients is getting more and more challenging. With this review article we provide an overview of optimal perioperative management of CIED patients with a detailed description of CIED response to magnet application depending on manufacturer and device-type, which may help in providing a safe perioperative management plan for the CIED patient.
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23
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Auricchio A, Sterns LD, Schloss EJ, Gerritse B, Lexcen DR, Molan AM, Kurita T. Performance evaluation of implantable cardioverter-defibrillators with SmartShock technology in patients with inherited arrhythmogenic diseases. Int J Cardiol 2022; 350:36-40. [PMID: 34998948 DOI: 10.1016/j.ijcard.2022.01.007] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/18/2021] [Revised: 12/07/2021] [Accepted: 01/02/2022] [Indexed: 12/23/2022]
Abstract
BACKGROUND Patients with inherited arrhythmogenic diseases (IADs) are often prescribed preventative implantable cardioverter-defibrillators (ICDs) to manage their increased sudden cardiac arrest risk. However, it has been suggested that ICDs in IAD patients may come with additional risk. We aimed to leverage the PainFree SmartShock Technology dataset to compare inappropriate therapies, appropriate therapies, mortality, and complications in patients with and without IAD. METHODS This retrospective analysis included extracted, physician-adjudicated, arrhythmic episodes from ICD devices. The incidence of arrhythmic events was estimated with the Kaplan-Meier method using the log-rank test. Cox proportional hazards regression was used to estimate hazard ratios (HRs) with their 95% confidence intervals (CIs). RESULTS Of the 1699 ICD patients, 77 patients (4.5%) had IAD. Incidence of inappropriate shock was similar in both patients with (3.2% at 24 months) and without (3.8% at 24 months) IAD (HR: 0.80, CI: 0.19-3.30, p = 0.76). In a multivariable analysis IAD was not significantly associated with reduced mortality (HR: 0.64, CI: 0.08-4.80, p = 0.66). The rates of complications were numerically lower in patients with IAD vs without (8.8% vs 9.6% at 24 months respectively), but not statistically significant (HR: 0.83, CI: 0.20-3.38, p = 0.79). CONCLUSIONS IAD patients showed a very low annual rate of inappropriate therapy. This suggests that newer algorithms, such as the SST algorithm, are equally good at identifying and treating life-threatening arrhythmias in patients regardless of whether they have IAD.
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Affiliation(s)
- Angelo Auricchio
- Division of Cardiology, Istituto Cardiocentro Ticino, Lugano, Switzerland.
| | | | | | - Bart Gerritse
- Medtronic Bakken Research Center, Maastricht, Netherlands
| | | | | | - Takashi Kurita
- Division of Cardiovascular Center, Kindai University, School of Medicine, Japan
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24
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Samuel M, Elsokkari I, Sapp JL. Ventricular tachycardia burden and mortality: association or causality? Can J Cardiol 2022; 38:454-464. [DOI: 10.1016/j.cjca.2022.01.016] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2021] [Revised: 01/15/2022] [Accepted: 01/17/2022] [Indexed: 12/24/2022] Open
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25
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Mukherjee RK, Sohal M, Shanmugam N, Pearse S, Jouhra F. Successful Identification of and Discrimination Between Atrial and Ventricular Arrhythmia with the Aid of Pacing and Defibrillator Devices. Arrhythm Electrophysiol Rev 2021; 10:235-240. [PMID: 35106174 PMCID: PMC8785083 DOI: 10.15420/aer.2021.54] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/15/2021] [Accepted: 10/25/2021] [Indexed: 11/15/2022] Open
Abstract
The presence of supraventricular tachycardia is the leading cause of inappropriate shock in ICD recipients, and it can be a significant cause of morbidity, psychological distress and worsened clinical outcome. Modern pacing and ICD systems offer a number of discriminators that are integrated into algorithms to differentiate sustained ventricular tachycardia from supraventricular tachycardia. These algorithms can be adapted and optimised for each individual patient to ensure that only those arrhythmias that need treatment through the use of an ICD, are actually treated. This review summarises the single- and dual-chamber discriminators that can be used in the detection and classification of tachyarrhythmias.
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Affiliation(s)
- Rahul K. Mukherjee
- Department of Cardiology, St George’s University Hospital NHS Foundation Trust, London, UK
- Division of Imaging Sciences and Biomedical Engineering, St Thomas’ Hospital, King’s College London, UK
| | - Manav Sohal
- Department of Cardiology, St George’s University Hospital NHS Foundation Trust, London, UK
| | - Nesan Shanmugam
- Department of Cardiology, St George’s University Hospital NHS Foundation Trust, London, UK
| | - Simon Pearse
- Department of Cardiology, Kingston Hospital, London, UK
| | - Fadi Jouhra
- Department of Cardiology, St George’s University Hospital NHS Foundation Trust, London, UK
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26
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Patel AS, Cronin EM. Catheter ablation of atrial arrhythmias to prevent ventricular tachycardia in a patient with mobile left ventricular thrombus. HeartRhythm Case Rep 2021; 7:687-690. [PMID: 34712566 PMCID: PMC8530904 DOI: 10.1016/j.hrcr.2021.07.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022] Open
Affiliation(s)
- Arjun S Patel
- Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania
| | - Edmond M Cronin
- Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania
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27
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Khan P, Jahagirdar N, Laybourn M, Harding I, Cannatà A, Bromage DI, Shabeeh H, Kabunga P, Petzer E, Murgatroyd F, Scott PA. Generic ICD programming and outcomes. PACING AND CLINICAL ELECTROPHYSIOLOGY: PACE 2021; 44:1995-2004. [PMID: 34672370 DOI: 10.1111/pace.14386] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/25/2021] [Revised: 10/02/2021] [Accepted: 10/17/2021] [Indexed: 10/20/2022]
Abstract
INTRODUCTION Generic ICD programming, where shock-reduction programming is extrapolated from trials of one manufacturer to another, may reduce non-essential ICD therapies beyond that seen in randomized trials. However, the benefits and risks are unknown. The purpose of this retrospective cohort study was to evaluate the impact of a standardized programming protocol, based on generic programming, across manufacturers. METHODS We included all new ICDs in a single center (2009-2019). In 2013 a standardized programming protocol based on generic programming was introduced, incorporating high detection rates (200 bpm for primary prevention) and long detection (30/40 or equivalent in VF zone) for all patients. Patients were classified into three groups based on implant programming: pre-guideline (PS), post-guideline and guideline compliant (GC) and post-guideline but not guideline compliant (NGC). The end-points were the first occurrence of any device therapy (ATP or shock), ICD shock, syncope and all-cause mortality. Survival analysis was used to evaluate outcomes. RESULTS 1003 patients were included (mean follow-up 1519 ± 1005 days). In primary prevention patients (n = 583) freedom from ICD therapy (91.5% vs. 73.6%, p < .001) or shock (94.7% vs 84.8%, p = .02) were significantly higher in GC compared to PS patients, without significant increase in syncope or mortality. In secondary prevention patients (n = 420) freedom from any ICD therapy or any shock were non-significantly higher in GC compared to PS patients, without an increase in syncope or mortality. CONCLUSIONS In primary prevention patients a standardized programming protocol, incorporating generic programming, reduced the burden of ICD therapy without an increase in adverse outcomes.
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Affiliation(s)
- Parisha Khan
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK
| | - Nishat Jahagirdar
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK
| | - Micaela Laybourn
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK
| | - Idris Harding
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK
| | - Antonio Cannatà
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK.,School of Cardiovascular Medicine and Sciences, King's College London, London, UK
| | - Daniel I Bromage
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK.,School of Cardiovascular Medicine and Sciences, King's College London, London, UK
| | - Husain Shabeeh
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK
| | - Peter Kabunga
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK
| | - Edward Petzer
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK
| | - Francis Murgatroyd
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK
| | - Paul A Scott
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK
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28
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Itoh H, Murayama T, Kurebayashi N, Ohno S, Kobayashi T, Fujii Y, Watanabe M, Ogawa H, Anzai T, Horie M. Sudden death after inappropriate shocks of implantable cardioverter defibrillator in a catecholaminergic polymorphic ventricular tachycardia case with a novel RyR2 mutation. J Electrocardiol 2021; 69:111-118. [PMID: 34656916 DOI: 10.1016/j.jelectrocard.2021.09.015] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/15/2021] [Revised: 09/29/2021] [Accepted: 09/30/2021] [Indexed: 01/04/2023]
Abstract
BACKGROUND Catecholaminergic polymorphic ventricular tachycardia (CPVT) is an inherited arrhythmogenic syndrome and a cause of exercise-related sudden death. CPVT has been reported to be caused by gain of function underlying a mutation of cardiac ryanodine receptor (RyR2). METHODS In a family with a CPVT patient, genomic DNA was extracted from peripheral blood lymphocytes, and the RyR2 gene underwent target gene sequence using MiSeq. The activity of wild-type (WT) and mutant RyR2 channel were evaluated by monitoring Ca2+ signals in HEK293 cells expressing WT and mutant RyR2. We investigated a role of a RyR2 mutation in the recent tertiary structure of RyR2. RESULTS Though a 17-year-old man diagnosed as CPVT had implantable cardioverter defibrillator (ICD) and was going to undergo catheter ablation for the control of paroxysmal atrial fibrillation, he suddenly died at the age of twenty-one because of ventricular fibrillation which was spontaneously developed after maximum inappropriate ICD shocks against rapid atrial fibrillation. The genetic test revealed a de novo RyR2 mutation, Gln4936Lys in mosaicism which was located at the α-helix interface between U-motif and C-terminal domain. In the functional analysis, Ca2+ release from endoplasmic reticulum via the mutant RyR2 significantly increased than that from WT. CONCLUSION A RyR2 mutation, Gln4936Lys, to be documented in a CPVT patient with exercise-induced ventricular tachycardias causes an excessive Ca2+ release from the sarcoplasmic reticulum which corresponded to clinical phenotypes of CPVT. The reduction of inappropriate shocks of ICD is essential to prevent unexpected sudden death in patients with CPVT.
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Affiliation(s)
- Hideki Itoh
- Division of Patient Safety, Hiroshima University Hospital, Hiroshima, Japan; Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Shiga, Japan.
| | - Takashi Murayama
- Department of Cellular and Molecular Pharmacology, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Nagomi Kurebayashi
- Department of Cellular and Molecular Pharmacology, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Seiko Ohno
- Department of Bioscience and Genetics, National Cerebral and Cardiovascular Center, Suita, Japan
| | - Takuya Kobayashi
- Department of Cellular and Molecular Pharmacology, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Yusuke Fujii
- Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Shiga, Japan
| | - Masaya Watanabe
- Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan
| | - Haruo Ogawa
- Department of Structural Biology, Kyoto University Graduate School of Pharmaceutical Sciences, Kyoto, Japan
| | - Toshihisa Anzai
- Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan
| | - Minoru Horie
- Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Shiga, Japan
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29
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Guarracini F, Casella M, Muser D, Barbato G, Notarstefano P, Sgarito G, Marini M, Grandinetti G, Mariani MV, Boriani G, Ricci RP, De Ponti R, Lavalle C. Clinical management of electrical storm: a current overview. J Cardiovasc Med (Hagerstown) 2021; 22:669-679. [PMID: 32925390 DOI: 10.2459/jcm.0000000000001107] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
The number of patients affected by electrical storm has been continuously increasing in emergency departments. Patients are often affected by multiple comorbidities requiring multidisciplinary interventions to achieve a clinical stability. Careful reprogramming of cardiac devices, correction of electrolyte imbalance, knowledge of underlying heart disease and antiarrhythmic drugs in the acute phase play a crucial role. The aim of this review is to provide a comprehensive overview of pharmacological treatment, latest transcatheter ablation techniques and advanced management of patients with electrical storm.
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Affiliation(s)
| | - Michela Casella
- Heart Rhythm Center, Centro Cardiologico Monzino, Milan.,Department of Clinical, Special and Dental Sciences, Cardiology and Arrhythmology Clinic, University Hospital 'UmbertoI-Lancisi-Salesi', Marche Polytechnic University, Ancona
| | - Daniele Muser
- Cardiothoracic Department, University Hospital of Udine, Udine
| | | | | | - Giuseppe Sgarito
- Cardiology Division, ARNAS Ospedale Civico e Benfratelli, Palermo
| | | | | | - Marco V Mariani
- Department of Cardiology, Policlinico Universitario Umberto I, Roma
| | - Giuseppe Boriani
- Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, Modena
| | | | - Roberto De Ponti
- Department of Heart and Vessels, Ospedale di Circolo & Macchi Foundation, University of Insubria, Varese, Italy
| | - Carlo Lavalle
- Department of Cardiology, Policlinico Universitario Umberto I, Roma
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30
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Heidbuchel H, Arbelo E, D'Ascenzi F, Borjesson M, Boveda S, Castelletti S, Miljoen H, Mont L, Niebauer J, Papadakis M, Pelliccia A, Saenen J, Sanz de la Garza M, Schwartz PJ, Sharma S, Zeppenfeld K, Corrado D. Recommendations for participation in leisure-time physical activity and competitive sports of patients with arrhythmias and potentially arrhythmogenic conditions. Part 2: ventricular arrhythmias, channelopathies, and implantable defibrillators. Europace 2021; 23:147-148. [PMID: 32596731 DOI: 10.1093/europace/euaa106] [Citation(s) in RCA: 25] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022] Open
Abstract
This paper belongs to a series of recommendation documents for participation in leisure-time physical activity and competitive sports by the European Association of Preventive Cardiology (EAPC). Together with an accompanying paper on supraventricular arrhythmias, this second text deals specifically with those participants in whom some form of ventricular rhythm disorder is documented, who are diagnosed with an inherited arrhythmogenic condition, and/or who have an implanted pacemaker or cardioverter defibrillator. A companion text on recommendations in athletes with supraventricular arrhythmias is published in the European Journal of Preventive Cardiology. Since both texts focus on arrhythmias, they are the result of a collaboration between EAPC and the European Heart Rhythm Association (EHRA). The documents provide a framework for evaluating eligibility to perform sports, based on three elements, i.e. the prognostic risk of the arrhythmias when performing sports, the symptomatic impact of arrhythmias while performing sports, and the potential progression of underlying structural problems as the result of sports.
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Affiliation(s)
- Hein Heidbuchel
- Department of Cardiology, University Hospital Antwerp, University Antwerp, Wilrijkstraat 10, 2650 Antwerp, Belgium
| | - Elena Arbelo
- Arrhythmia Section, Cardiology Department, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.,Institut d'Investigació August Pi i Sunyer (IDIBAPS), Barcelona, Spain.,Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain
| | - Flavio D'Ascenzi
- Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy
| | - Mats Borjesson
- Centre for Health and Performance (CHP), Department of Food, Nutrition and Sport Sciences, Gothenburg University, Sweden.,Department of Neuroscience and Physiology, Gothenburg University, Gothenburg, Sweden
| | - Serge Boveda
- Cardiology Department, Clinique Pasteur, 45 Avenue de Lombez, 31076 Toulouse, France
| | - Silvia Castelletti
- Istituto Auxologico Italiano, IRCCS, Center for Cardiac Arrhythmias of Genetic Origin, Laboratory of Cardiovascular Genetics, Milan, Italy
| | - Hielko Miljoen
- Department of Cardiology, University Hospital Antwerp, University Antwerp, Wilrijkstraat 10, 2650 Antwerp, Belgium
| | - Lluis Mont
- Arrhythmia Section, Cardiology Department, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.,Institut d'Investigació August Pi i Sunyer (IDIBAPS), Barcelona, Spain.,Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain
| | - Josef Niebauer
- Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg, Salzburg, Austria
| | - Michael Papadakis
- Cardiology Clinical Academic Group, St. George's University of London, London, UK.,St. George's University Hospitals NHS Foundation Trust, London, UK
| | - Antonio Pelliccia
- National Institute of Sports Medicine, Italian National Olympic Committee, Via dei Campi Sportivi 46, Rome, Italy
| | - Johan Saenen
- Department of Cardiology, University Hospital Antwerp, University Antwerp, Wilrijkstraat 10, 2650 Antwerp, Belgium
| | | | - Peter J Schwartz
- Istituto Auxologico Italiano, IRCCS, Center for Cardiac Arrhythmias of Genetic Origin, Laboratory of Cardiovascular Genetics, Milan, Italy
| | - Sanjay Sharma
- Cardiology Clinical Academic Group, St. George's University of London, London, UK.,St. George's University Hospitals NHS Foundation Trust, London, UK
| | - Katja Zeppenfeld
- Department of Cardiology, Leiden University Medical Centre, Leiden, the Netherlands
| | - Domenico Corrado
- Department of Cardiology, University of Padova, Padova, Italy.,Department of Pathology, University of Padova, Padova, Italy
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31
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Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience. Heart Rhythm 2021; 18:2050-2058. [PMID: 34271173 DOI: 10.1016/j.hrthm.2021.07.008] [Citation(s) in RCA: 28] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/09/2021] [Revised: 06/21/2021] [Accepted: 07/07/2021] [Indexed: 11/23/2022]
Abstract
BACKGROUND Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. OBJECTIVE The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. METHODS Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. RESULTS A total of 1254 patients (median age 52.0 [interquartile range 41.0-62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8-37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3-3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028-1.100]; P < .001), chronic kidney disease (HR 1.960 [1.191-3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010-2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967-0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300-0.715]; P = .001) were protective factors. CONCLUSION The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.
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32
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Martinek M, Manninger M, Schönbauer R, Scherr D, Schukro C, Pürerfellner H, Petzl A, Strohmer B, Derndorfer M, Bisping E, Stühlinger M, Fiedler L. Expert consensus on acute management of ventricular arrhythmias - VT network Austria. IJC HEART & VASCULATURE 2021; 34:100760. [PMID: 33869728 PMCID: PMC8047164 DOI: 10.1016/j.ijcha.2021.100760] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/27/2021] [Revised: 03/07/2021] [Accepted: 03/09/2021] [Indexed: 12/11/2022]
Abstract
The Arrhythmia Working Group of the Austrian Society of Cardiology (ÖKG) has set the goal of systematically structuring and organizing the acute care of patients with ventricular arrhythmias (VA), i.e. ventricular tachycardia (VT) or ventricular fibrillation (VF) in Austria. Within a consensus paper, national recommendations on the basic diagnostic work-up of VA (12-lead ECG, medical history, family history, laboratory analyses, echocardiography, search for reversible causes, ICD interrogation), as well as further medical treatment and therapeutic measures (indication of coronary angiography, ablation therapy) are established. Since acute ablation of VT is indicated in the current ESC guidelines as a class IB indication for scar-associated incessant VT or electrical storm (ES; ≥ 3 ICD therapies in 24 h) as well as for ischemic cardiomyopathy (iCMP) with recurrent ICD shocks, organizational measures must be taken to ensure that these guidelines can be implemented. Therefore, a VT network will be established covering all areas in Austria, consisting of primary and secondary VT centers. Organizational aspects of an acute VT network are defined and should subsequently be implemented by the participating hospitals. All electrophysiologic centers in Austria that deal with VT ablation are to be integrated into the network in the medium-term. Centers that co-operate in the network are divided into primary and secondary VT centers according to predefined criteria.
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Affiliation(s)
- M. Martinek
- Ordensklinikum Linz Elisabethinen, Interne 2 mit Kardiologie, Angiologie und Intensivmedizin, Fadingerstrasse 1, 4020 Linz, Austria
- Universitätsklinikum St. Pölten, Interne 3 – Kardiologie, Dunant-Platz 1, 3100 St. Pölten, Austria
| | - M. Manninger
- Medizinische Universität Graz, Universitätsklinik für Innere Medizin – Klinische Abteilung für Kardiologie, Auenbruggerplatz 15, 8036 Graz, Austria
| | - R. Schönbauer
- Universitätsklinik für Innere Medizin II – Klinische Abteilung für Kardiologie, Währinger Gürtel 18-20, 1090 Wien, Austria
| | - D. Scherr
- Medizinische Universität Graz, Universitätsklinik für Innere Medizin – Klinische Abteilung für Kardiologie, Auenbruggerplatz 15, 8036 Graz, Austria
| | - C. Schukro
- Universitätsklinik für Innere Medizin II – Klinische Abteilung für Kardiologie, Währinger Gürtel 18-20, 1090 Wien, Austria
| | - H. Pürerfellner
- Ordensklinikum Linz Elisabethinen, Interne 2 mit Kardiologie, Angiologie und Intensivmedizin, Fadingerstrasse 1, 4020 Linz, Austria
| | - A. Petzl
- Universitätsklinikum St. Pölten, Interne 3 – Kardiologie, Dunant-Platz 1, 3100 St. Pölten, Austria
| | - B. Strohmer
- Universitätsklinik für Innere Medizin II – Paracelsus Medizinische Privatuniversität, Müllner Hauptstrasse 48, 5020 Salzburg, Austria
| | - M. Derndorfer
- Ordensklinikum Linz Elisabethinen, Interne 2 mit Kardiologie, Angiologie und Intensivmedizin, Fadingerstrasse 1, 4020 Linz, Austria
| | - E. Bisping
- Medizinische Universität Graz, Universitätsklinik für Innere Medizin – Klinische Abteilung für Kardiologie, Auenbruggerplatz 15, 8036 Graz, Austria
| | - M. Stühlinger
- Universitätsklinik für Innere Medizin III – Kardiologie und Angiologie, Anichstrasse 35, 6020 Innsbruck, Austria
| | - L. Fiedler
- Landesklinikum Wiener Neustadt, Abteilung für Innere Medizin, Kardiologie und Nephrologie, Corvinusring 3-5, 2700 Wiener Neustadt, Austria
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Guía ESC 2020 sobre cardiología del deporte y el ejercicio en pacientes con enfermedad cardiovascular. Rev Esp Cardiol 2021. [DOI: 10.1016/j.recesp.2020.11.026] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
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Pelliccia A, Sharma S, Gati S, Bäck M, Börjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J 2021; 42:17-96. [PMID: 32860412 DOI: 10.1093/eurheartj/ehaa605] [Citation(s) in RCA: 864] [Impact Index Per Article: 216.0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
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Mulder BJ, de Groot JR. ICD implantation as primary prevention in systemic RV? A cautious attitude is justified. INTERNATIONAL JOURNAL OF CARDIOLOGY CONGENITAL HEART DISEASE 2021. [DOI: 10.1016/j.ijcchd.2021.100130] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022] Open
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Maruyama M, Yasuoka R, Nagano T, Nakazawa G, Noda T, Nitta T, Aizawa Y, Ohe T, Kurita T. Impact of atrial fibrillation/flutter on outcomes of patients with implantable cardioverter defibrillators: A sub-analysis of the Nippon Storm study. J Cardiol 2021; 78:244-249. [PMID: 33941429 DOI: 10.1016/j.jjcc.2021.04.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/20/2021] [Revised: 03/17/2021] [Accepted: 03/24/2021] [Indexed: 11/17/2022]
Abstract
BACKGROUND Implantable cardioverter-defibrillator and cardiac resynchronization therapy using a defibrillator (ICD/CRT-D) are established means of reducing mortality due to ventricular arrhythmia. Although atrial fibrillation/flutter (AF) is the most common cardiac arrhythmia in patients with heart disease, the impact of AF on the prognosis of patients with ICD/CRT-D remains controversial. METHODS AND RESULTS We analyzed data from the Nippon Storm Study, a prospective observational study of 1570 patients that was conducted at 48 Japanese ICD centers. We allocated 1549 participants to AF and non-AF groups, compared their clinical data at the time of enrollment, and monitored the incidences of mortality, hospitalization, and appropriate and inappropriate ICD/CRT-D therapy during a median 28 months. When the AF (n = 257, 16.6%) and non-AF-(n = 1292, 83.4%) groups were compared, the AF group was older (67.7 vs. 61.4 years; p<0.0001), and had lower left ventricular ejection fraction (38.0 ± 17.0% vs. 43.5 ± 18.9%; p<0.0001). During follow up, mortality was significantly higher in the AF than the non-AF group (p<0.0001). In multivariate analysis, AF was significantly associated with all-cause mortality [p = 0.013; hazard ratio (HR)=1.62]. Inappropriate ICD/CRT-D therapy occurred in 40/257 patients (15.6%) and AF was associated with a higher prevalence of inappropriate ICD/CRT-D therapy (p<0.0001; HR=2.25). CONCLUSION The presence of AF at ICD/CRT-D implantation carries subsequent independent risks of 1.62-fold for death and 2.25-fold for inappropriate therapy.
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Affiliation(s)
- Masahiro Maruyama
- Department of Internal Medicine, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan
| | - Ryobun Yasuoka
- Department of Internal Medicine, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan
| | - Tomoya Nagano
- Department of Internal Medicine, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan
| | - Gaku Nakazawa
- Department of Internal Medicine, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan
| | - Takashi Noda
- Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan
| | - Takashi Nitta
- Department of Cardiovascular Surgery, Nippon Medical School, Tokyou, Japan
| | - Yoshifusa Aizawa
- Department of Research and Development, Tachikawa Medical Center, Tachikawa, Japan
| | - Tohru Ohe
- Okayama City Hospital, Okayama, Japan
| | - Takashi Kurita
- Department of Internal Medicine, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan.
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Nishii N, Noda T, Nitta T, Aizawa Y, Ohe T, Kurita T. Risk factors for the first and second inappropriate implantable cardioverter-defibrillator therapy. IJC HEART & VASCULATURE 2021; 34:100779. [PMID: 33997254 PMCID: PMC8100615 DOI: 10.1016/j.ijcha.2021.100779] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2021] [Revised: 03/31/2021] [Accepted: 04/01/2021] [Indexed: 11/24/2022]
Abstract
Introduction Various risk factors for the first inappropriate implantable cardioverter-defibrillator (ICD) therapy event have been reported, including a history of atrial fibrillation/atrial flutter (AF/AFL), younger age, and multiple zones. Nonetheless, which factors are concordant with real-world data has not been clarified, and risk factors for the second inappropriate ICD therapy event have not been well examined. This study aimed to clarify the risk factors for the first and second inappropriate ICD therapy events. Methods We conducted a post-hoc secondary analysis of data from a multicenter, prospective observational study (the Nippon Storm Study) designed to clarify the risk factors for electrical storm. Results The analysis included data from 1549 patients who received ICD or cardiac resynchronization therapy with defibrillator (CRT-D). Over a median follow-up of 28 months, 293 inappropriate ICD therapy events occurred in 153 (10.0%) patients. On multivariate Cox regression analysis, the risk factors for the first inappropriate ICD therapy event were younger age (hazard ratio [HR], 0.986; p = 0.028), AF/AFL (HR, 2.324; p = 0.002), ICD without CRT implantation (HR, 2.377; p = 0.004), and multiple zones (HR, 1.852; p = 0.010). “No-intervention” after the first inappropriate ICD therapy event was the sole risk factor for the second inappropriate ICD therapy event. Conclusions Risk factors for the first inappropriate ICD therapy event were similar to those previously reported. Immediate intervention after the first inappropriate ICD therapy event could reduce the risk of the second inappropriate event.
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Affiliation(s)
- Nobuhiro Nishii
- Department of Cardiovascular Therapeutics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Takashi Noda
- Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan
| | - Takashi Nitta
- Department of Cardiovascular Surgery, Nippon Medical School, Tokyo, Japan
| | - Yoshifusa Aizawa
- Department of Research and Development, Tachikawa Medical Center, Niigata, Japan
| | - Tohru Ohe
- Okayama City Hospital, Okayama, Japan
| | - Takashi Kurita
- Department of Internal Medicine, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan
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Ioannou A, Kay J, Tomson J. A standardised pathway increases clinicians' confidence and ability to manage implantable cardioverter defibrillator shocks. Am J Emerg Med 2021; 49:434-436. [PMID: 33715906 DOI: 10.1016/j.ajem.2021.02.069] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/26/2021] [Revised: 02/28/2021] [Accepted: 02/28/2021] [Indexed: 11/18/2022] Open
Affiliation(s)
- Adam Ioannou
- Royal Free NHS Foundation Trust, United Kingdom.
| | - Jamie Kay
- Royal Free NHS Foundation Trust, United Kingdom
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Gierula J, Paton MF, Witte KK. Advances in cardiac resynchronization and implantable cardioverter/defibrillator therapy: Medtronic Cobalt and Crome. Future Cardiol 2021; 17:609-618. [PMID: 33635121 DOI: 10.2217/fca-2020-0117] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022] Open
Abstract
Cardiovascular implantable electronic devices have revolutionized the management of heart failure with reduced ejection fraction. New device generations tend to be launched every few years, with incremental improvements in performance and safety and with an expectation that these will improve patient management and outcomes while remaining cost-effective. As a result, today's cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator devices are quite different from the pioneering but often bulky devices of the late 20th century. This review discusses new and improved features developed to target specific needs in managing heart failure patients, some of which are especially pertinent to the current worldwide healthcare situation, with focus on the latest generation of CRTs with defibrillator (CRT-Ds) and implantable cardioverter defibrillators from Medtronic.
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Affiliation(s)
- John Gierula
- Leeds Institute of Cardiovascular & Metabolic Medicine, University of Leeds, Leeds, UK
| | - Maria F Paton
- Leeds Institute of Cardiovascular & Metabolic Medicine, University of Leeds, Leeds, UK
| | - Klaus K Witte
- Leeds Institute of Cardiovascular & Metabolic Medicine, University of Leeds, Leeds, UK
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Ruwald MH, Ruwald AC, Johansen JB, Gislason G, Lindhardt TB, Nielsen JC, Torp-Pedersen C, Riahi S, Vinther M, Philbert BT. Temporal Incidence of Appropriate and Inappropriate Therapy and Mortality in Secondary Prevention ICD Patients by Cardiac Diagnosis. JACC Clin Electrophysiol 2021; 7:781-792. [PMID: 33516705 DOI: 10.1016/j.jacep.2020.11.005] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/24/2020] [Revised: 11/10/2020] [Accepted: 11/12/2020] [Indexed: 11/17/2022]
Abstract
OBJECTIVES This study sought to estimate the temporal development in rates and incidences of appropriate and inappropriate implantable cardioverter-defibrillator (ICD) therapy and shocks by cardiac diagnosis in a real-world population of patients with secondary prevention ICDs. BACKGROUND Data on cardiac diagnoses and temporal development of ICD therapies in patients with secondary prevention ICDs are limited. METHODS Patients (N = 4,587) with a secondary prevention ICD were identified from the Danish Pacemaker and ICD Register (January 1, 2007, to December 31, 2016) and linked to nationwide administrative registers. The outcome of appropriate and inappropriate ICD therapy and all-cause mortality were analyzed by annual event rates, cumulative incidence plots, and Cox regression models. RESULTS During a mean follow-up of 3.6 ± 2.4 years, 1,362 patients (30%) experienced appropriate ICD therapy (16.8% shocks), and 350 patients (7.6%) experienced inappropriate ICD therapy (4.6% shocks). From 2007 to 2016, there was a significant temporal reduction in both appropriate and inappropriate ICD therapy from 28.2 (95% confidence interval [CI]: 21.6 to 37.0) to 7.9 (95% CI: 6.8 to 9.1) and 10.0 (95% CI: 6.4 to 15.5) to 1.0 (95% CI: 0.7 to 1.5) per 100 person-years (p for trends <0.001). Multivariate Cox regression analyses showed that arrhythmogenic right ventricular cardiomyopathy was associated with the highest probability of appropriate ICD therapy (hazard ratio: 2.45; 95% CI: 1.77 to 3.39; p < 0.0001), whereas patients with hypertrophic cardiomyopathy had the lowest probability (hazard ratio: 0.62; 95% CI: 0.42 to 0.93; p = 0.0196) when compared to patients with ischemic heart disease. CONCLUSIONS In this nationwide real-life cohort of patients with secondary prevention ICDs, we observed a significant temporal decline in delivered appropriate and inappropriate shocks and ICD therapies in the last decade. A large proportion of patients still experienced ICD therapy but with significant differences by cardiac diagnosis.
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Affiliation(s)
- Martin H Ruwald
- Department of Cardiology, Herlev-Gentofte University Hospital, Hellerup, Denmark.
| | - Anne-Christine Ruwald
- Department of Cardiology, Herlev-Gentofte University Hospital, Hellerup, Denmark; Department of Cardiology, Zealand University Hospital, Roskilde, Denmark
| | - Jens Brock Johansen
- Department of Cardiology, Odense University Hospital, University of Southern Denmark, Odense, Denmark
| | - Gunnar Gislason
- Department of Cardiology, Herlev-Gentofte University Hospital, Hellerup, Denmark; National Institute of Public Health, Copenhagen, Denmark; The Danish Heart Foundation, Copenhagen, Denmark
| | - Tommi B Lindhardt
- Department of Cardiology, Herlev-Gentofte University Hospital, Hellerup, Denmark
| | | | - Christian Torp-Pedersen
- Departments of Clinical investigation and Cardiology, North Zealand Hospital, Hillerod, Denmark
| | - Sam Riahi
- Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark
| | - Michael Vinther
- Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen, Denmark
| | - Berit T Philbert
- Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen, Denmark
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Higuera L, Holbrook R, Wherry K, Rodriguez DA, Cuesta A, Valencia J, Arcos J, López Gómez A. Comparison of cost-effectiveness of implantable cardioverter defibrillator therapy in patients for primary prevention in Latin America: an analysis using the Improve SCA study. J Med Econ 2021; 24:173-180. [PMID: 33471579 DOI: 10.1080/13696998.2021.1877451] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/22/2022]
Abstract
OBJECTIVE The mortality benefit of implantable cardioverter defibrillators (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) has been well-established, but ICD therapy remains globally underutilized. The results of the Improve SCA study showed a 49% relative risk reduction in all-cause mortality among ICD patients with 1.5 primary prevention (1.5PP) characteristics (patients with one or more risk factors, p < 0.0001). We evaluated the cost-effectiveness of ICD compared to no ICD therapy among patients with 1.5PP characteristics in three Latin American countries and analyzed the factors involved in cost-effectiveness. METHODS We used a published Markov model that compares costs and outcomes of ICD to no ICD therapy from local payers' perspective and included country-specific and disease-specific inputs from the Improve SCA study and current literature. We used WHO-recommended willingness-to-pay (WTP) thresholds to assess cost-effectiveness and compared model outcomes between countries. RESULTS Incremental costs per QALY (quality-adjusted life year) saved by ICD compared to no ICD therapy are Colombian Pesos COP$46,729,026 in Colombia, Mexican Pesos MXN$246,016 in Mexico, and Uruguayan Pesos UYU$1,213,614 in Uruguay in the base case scenario; all three figures are between 1-3-times GDP per capita for each country. One-way and probabilistic sensitivity analyses confirm the base case scenario results. Non-cardiac accumulated deaths are lower in Mexico, resulting in a comparatively increased cost-effective ICD therapy. LIMITATIONS The Improve SCA study was not randomized, so clinical results could be biased; however, measures were taken to reduce this bias. Costs and benefits were modelled beyond the timeline of direct observation in the Improve SCA study. CONCLUSIONS ICD therapy is cost-effective in Mexico and Uruguay and potentially cost-effective in Colombia for a 1.5PP population. Variability in ICER estimates by country can be explained by differences in non-cardiac deaths and cost inputs.
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Affiliation(s)
- Lucas Higuera
- Health Economics and Outcomes Research, CRHF, Medtronic plc, Mounds View, MN, USA
| | - Reece Holbrook
- Health Economics and Outcomes Research, CRHF, Medtronic plc, Mounds View, MN, USA
| | - Kael Wherry
- Health Economics and Outcomes Research, Diabetes, Medtronic plc, Northridge, CA, USA
| | - Diego A Rodriguez
- Cardiology - Electrophysiology, Fundación Cardioinfantil, Bogotá DC, Colombia
| | - Alejandro Cuesta
- Centro Cardiovascular Universitario, Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay
| | - Juan Valencia
- Reimbursement and Health Economics, Latin America, Medtronic plc, Miami, FL, USA
| | - Julián Arcos
- Clinical Affairs, Latin America, Medtronic plc, Bogotá DC, Colombia
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Briongos-Figuero S, García-Alberola A, Rubio J, Segura JM, Rodríguez A, Peinado R, Alzueta J, Martínez-Ferrer JB, Viñolas X, Fernández de la Concha J, Anguera I, Martín M, Cerdá L, Pérez L. Long-Term Outcomes Among a Nationwide Cohort of Patients Using an Implantable Cardioverter-Defibrillator: UMBRELLA Study Final Results. J Am Heart Assoc 2020; 10:e018108. [PMID: 33356406 PMCID: PMC7955463 DOI: 10.1161/jaha.120.018108] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Background Large‐scale studies describing modern populations using an implantable cardioverter‐defibrillator (ICD) are lacking. We aimed to analyze the incidence of arrhythmia, device interventions, and mortality in a broad spectrum of real‐world ICD patients with different heart disorders. Methods and Results The UMBRELLA study is a prospective, multicenter, nationwide study of contemporary patients using an ICD followed up by remote monitoring, with a blinded review of arrhythmic episodes. From November 2005 to November 2017, 4296 patients were followed up. After 46.6±27.3 months, 16 067 episodes of sustained ventricular arrhythmia occurred in 1344 patients (31.3%). Appropriate ICD therapy occurred in 27.3% of study population. Patients with ischemic cardiomyopathy (hazard ratio [HR], 1.51; 95% CI, 1.29–1.78), dilated cardiomyopathy (HR, 1.28; 95% CI, 1.07–1.53), and valvular heart disease (HR, 1.94; 95% CI, 1.43–2.62) exhibited a higher risk of appropriate ICD therapies, whereas patients with hypertrophic cardiomyopathy (HR, 0.72; 95% CI, 0.54–0.96) and Brugada syndrome (HR, 0.25; 95% CI, 0.14–0.45) showed a lower risk. All‐cause death was 13.4% at follow‐up. Ischemic cardiomyopathy (HR, 3.09; 95% CI, 2.58–5.90), dilated cardiomyopathy (HR, 3.33; 95% CI, 2.18–5.10), and valvular heart disease (HR, 3.97; 95% CI, 2.25–6.99) had the worst prognoses. Delayed high‐rate detection was enabled in 39.7% of patients, and single‐zone programming occurred in 52.6% of primary prevention patients. Both parameters correlated with lower risk of first appropriate ICD therapy, with no excess risk of mortality. The rate of inappropriate shocks at follow‐up was low (6%) and did not differ among type of ICD but was lower in SmartShock‐capable devices. Conclusions Irrespective of the cause, contemporary ICD patients with heart failure–related disorders had a similar risk of ICD life‐saving interventions and death. Current ICD programming recommendations still need to be implemented. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NTC01561144.
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Affiliation(s)
- Sem Briongos-Figuero
- Hospital Universitario Infanta Leonor Madrid Spain.,Universidad Complutense de Madrid Madrid Spain
| | | | - Jerónimo Rubio
- Hospital Clínico Universitario de Valladolid Valladolid Spain
| | | | | | | | - Javier Alzueta
- Hospital Universitario Virgen de la Victoria Málaga Spain
| | | | | | | | | | | | | | - Luisa Pérez
- Complexo Hospitalario Universitario de A Coruña A Coruña Spain
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Holbrook R, Higuera L, Wherry K, Phay D, Hsieh YC, Lin KH, Liu YB. Implantable cardioverter defibrillator therapy is cost effective for primary prevention patients in Taiwan: An analysis from the Improve SCA trial. PLoS One 2020; 15:e0241697. [PMID: 33211698 PMCID: PMC7676667 DOI: 10.1371/journal.pone.0241697] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2020] [Accepted: 10/20/2020] [Indexed: 11/30/2022] Open
Abstract
Objective Implantable cardiac defibrillators (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) are well-established but underutilized globally. The Improve SCA study has identified a cohort of patients called 1.5 primary prevention (1.5PP) based on PP patients with the presence of certain risk factors. We evaluated the cost-effectiveness of ICD therapy compared to no ICD among the PP population and the subset of 1.5PP patients in Taiwan. Methods A Markov model was run over a lifetime time horizon from the Taiwan payer perspective. Mortality and utility estimates were obtained from the literature (PP) and the IMPROVE SCA trial (1.5PP). Cost inputs were obtained from the Taiwan National Health Insurance Administration (NHIA), Ministry of Health and Welfare. We used a willingness-to-pay (WTP) threshold of NT$2,100,000, as established through standard WTP research methods and in alignment with World Health Organization recommendations. Results The total discounted costs for ICD therapy and no ICD therapy were NT$1,664,259 and NT$646,396 respectively for PP, while they were NT$2,410,603 and NT$905,881 respectively for 1.5PP. Total discounted QALYs for ICD therapy and no ICD therapy were 6.48 and 4.98 respectively for PP, while they were 10.78 and 7.71 respectively for 1.5PP. The incremental cost effectiveness ratio was NT$708,711 for PP and NT$441,153 for 1.5PP, therefore ICD therapy should be considered cost effective for PP and highly cost effective for 1.5PP. Conclusions ICD therapy compared to no ICD therapy is cost-effective in the whole PP population and highly cost-effective in the subset 1.5PP population in Taiwan.
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Affiliation(s)
| | | | | | | | - Yu-Cheng Hsieh
- Department of Cardiology, Taichung Veterans General Hospital and National Yan-Ming University School of Medicine, Taichung, Taiwan
| | - Kuo-Hung Lin
- Department of Cardiology, China Medical Center University Hospital
| | - Yen-Bin Liu
- Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
- * E-mail:
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Kowlgi GN, Cha YM. Management of ventricular electrical storm: a contemporary appraisal. Europace 2020; 22:1768-1780. [DOI: 10.1093/europace/euaa232] [Citation(s) in RCA: 19] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/10/2020] [Accepted: 07/15/2020] [Indexed: 12/13/2022] Open
Abstract
Abstract
Ventricular electrical storm (VES) is a clinical scenario characterized by the clustering of multiple episodes of sustained ventricular arrhythmias (VA) over a short duration. Patients with VES are prone to psychological disorders, heart failure decompensation, and increased mortality. Studies have shown that 10–28% of the patients with secondary prevention ICDs can sustain VES. The triad of a susceptible electrophysiologic substrate, triggers, and autonomic dysregulation govern the pathogenesis of VES. The rate of VA, underlying ventricular function, and the presence of implantable cardioverter-defibrillator (ICD) determine the clinical presentation. A multi-faceted approach is often required for management consisting of acute hemodynamic stabilization, ICD reprogramming when appropriate, antiarrhythmic drug therapy, and sedation. Some patients may be eligible for catheter ablation, and autonomic modulation with thoracic epidural anesthesia, stellate ganglion block, or cardiac sympathetic denervation. Hemodynamically unstable patients may benefit from the use of left ventricular assist devices, and extracorporeal membrane oxygenation. Special scenarios such as idiopathic ventricular fibrillation, Brugada syndrome, Long and short QT syndrome, early repolarization syndrome, catecholaminergic polymorphic ventricular tachycardia, arrhythmogenic right ventricular cardiomyopathy, and cardiac sarcoidosis have been described as well. VES is a cardiac emergency that requires swift intervention. It is associated with poor short and long-term outcomes. A structured team-based management approach is paramount for the safe and effective treatment of this sick cohort.
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Affiliation(s)
- Gurukripa N Kowlgi
- Department of Cardiovascular Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
| | - Yong-Mei Cha
- Department of Cardiovascular Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
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Over- and undersensing-pitfalls of arrhythmia detection with implantable devices and wearables. Herzschrittmacherther Elektrophysiol 2020; 31:273-287. [PMID: 32767089 PMCID: PMC7412442 DOI: 10.1007/s00399-020-00710-x] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/03/2020] [Accepted: 07/08/2020] [Indexed: 01/30/2023]
Abstract
Cardiac implantable electronic devices (CIEDs) are a cornerstone of arrhythmia and heart failure detection as well as management. In recent years new kinds of devices have emerged which can be used subcutaneously or worn on the skin. In particular for large-scale arrhythmia monitoring, small, unobtrusive gadgets seem positioned to upend paradigms and care delivery. However, the performance of CIEDs and wearables is only as good as their sensing and detection capacities. Whether for pacing, defibrillation or diagnostic monitoring, the device must be able to process and filter the sensed signal to reduce noise and to exclude irrelevant physiological signals. The demands on sensing and detection quality will differ depending on how the information is applied. With a pacemaker or implantable cardioverter/defibrillator, withheld or erroneous therapy can have severe consequences and accurate and reliable detection of cardiac function is crucial. Monitoring devices are usually used in risk assessment and management, with greater tolerance for isolated artefacts or lower quality of readings. This review discusses sensing and detection and the performance to date by CIEDs as well as subcutaneous and wearable devices.
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Cheng A, Joung B, Brown ML, Koehler J, Lexcen DR, Sanders P, Ellenbogen KA. Characteristics of ventricular tachyarrhythmias and their susceptibility to antitachycardia pacing termination in patients with ischemic and nonischemic cardiomyopathy: A patient-level meta-analysis of three large clinical trials. J Cardiovasc Electrophysiol 2020; 31:2720-2726. [PMID: 32700390 DOI: 10.1111/jce.14688] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/30/2020] [Revised: 06/03/2020] [Accepted: 06/21/2020] [Indexed: 11/29/2022]
Abstract
BACKGROUND Implantable cardioverter defibrillators (ICDs) reduce all-cause mortality among cardiomyopathy patients. Whether or not antitachycardia pacing (ATP) is equally effective in ischemic (ICM) and nonischemic (NICM) cardiomyopathy patients remains poorly understood. We describe the distribution of monomorphic (MVT) and non-monomorphic (polymorphic ventricular tachycardia/ventricular fibrillation [PVT/VF]) ventricular tachyarrhythmias among ICM and NICM primary prevention patients. METHODS This patient-level meta-analysis included primary prevention patients from the Shock-Less (n = 3519), PainFree SST (n = 1917), and PREPARE (n = 690) studies. Distribution of MVT and PVT/VF events were compared with χ2 tests. ATP success was estimated using a generalized estimating equation model to correct for multiple episodes for a patient between cohorts for slow (≥320 ms) and fast (240-310 ms) MVTs. RESULTS Among 6126 patients, 714 (29% NICM, age 66 ± 13 years, female 18%, EF = 29 ± 12%) had a total of 4444 treated ventricular tachyarrhythmia episodes. The rate of individuals treated for MVT or PVT/VF was comparable between ICM (11.9%) and NICM (11.2%) over 21 ± 10 months. In addition, the distribution of MVT (76% ICM vs. 71% NICM) and PVT/VF (15% ICM vs. 20% NICM) was not significantly different (p = .28). Among MVT episodes, the average tachycardia cycle lengths (332 ± 58 ms ICM vs. 313 ± 40 ms NICM; p = .27) were similar, as was the likelihood of ATP-associated termination (74.6% ICM vs. 76.4% NICM; p = .58). Overall, ATP success was higher for slow (≥320 ms) MVT versus faster (240-310 ms) episodes (84.1% vs. 69%; p < .001). CONCLUSION In a large cohort of primary prevention ICD patients, ICM and NICM patients have similar rates and proportions of MVT and PVT/VF episodes. ATP-associated termination of MVT was comparable between the two groups.
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Affiliation(s)
| | - Boyoung Joung
- Division of Cardiology, Yonsei University College of Medicine, Seoul, Republic of Korea
| | | | | | | | - Prashanthan Sanders
- Department of Cardiology, Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia
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Ho G, Birgersdotter-Green U. Antitachycardia pacing: A worthy cause? J Cardiovasc Electrophysiol 2020; 31:2727-2729. [PMID: 32700345 DOI: 10.1111/jce.14684] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/15/2020] [Revised: 07/15/2020] [Accepted: 07/18/2020] [Indexed: 10/23/2022]
Affiliation(s)
- Gordon Ho
- Department of Medicine, Division of Cardiology Cardiac Electrophysiology, Cardiovascular Institute, University of California San Diego, San Diego, California, USA
| | - Ulrika Birgersdotter-Green
- Department of Medicine, Division of Cardiology Cardiac Electrophysiology, Cardiovascular Institute, University of California San Diego, San Diego, California, USA
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Reduction of inappropriate implantable cardioverter-defibrillator therapies using enhanced supraventricular tachycardia discriminators: the ReduceIT study. J Interv Card Electrophysiol 2020; 61:339-348. [PMID: 32661865 DOI: 10.1007/s10840-020-00816-9] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/13/2019] [Accepted: 06/29/2020] [Indexed: 10/23/2022]
Abstract
PURPOSE Inappropriate implantable cardioverter-defibrillator (ICD) shocks are associated with greater healthcare resource utilization, poorer quality-of-life, and higher mortality. We aimed to investigate the performance of enhanced supraventricular tachycardia (SVT) discrimination algorithms (morphology discrimination, rate stability, and sudden or chamber onset) for reducing inappropriate ICD therapies in patients with ICD/cardiac resynchronization therapy devices. METHODS This prospective, non-randomized, multicenter study (ReduceIT) study took place at 56 sites across Germany and Estonia. Adults at risk of sudden cardiac death undergoing St. Jude Medical™ ICD or CRT-D implantation were included. The primary endpoint was freedom from inappropriate ICD shock at 12 months and was analyzed in the intention to treat (ITT) and per-protocol population. RESULTS Overall, 733 patients (65.9 ± 11.4 years) were included, of which 40.9% and 59.1% received a single- and dual-chamber detection device, respectively. During follow-up (median 11.9 [0-21.6] months), 96.3% of patients experienced no inappropriate therapy (ITT). The sensitivity, specificity, and accuracy for VT/VF were 91.9%, 95.5%, and 94.7%, respectively. In the per-protocol population (n = 620), the proportion of patients free from inappropriate shock at 12 months was 98.4% (n = 610; 95% CI 97.1-99.2%) and exceeded the expected value of 93% (p < 0.0001) which was derived from the rates in the SPICE, ATPonFastVT, and DECREASE studies. A total of 44 patients (6.0%) died during follow-up, 19 deaths were cardiac-related which is consistent with a meta-analysis of EMPIRIC, MADIT-RIT, ADVANCE III, and PROVIDE. Serious device and procedure-related adverse effects occurred in 9.8% of patients. CONCLUSIONS In ICD/CRT-D devices with advanced SVT discriminators, device programming according to clinical setting and detection chamber significantly reduces the rate of inappropriate ICD shocks without compromising patient safety. The algorithms and settings described herein have particular clinical importance and their employment may be of benefit to ICD recipients.
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Ananwattanasuk T, Tanawuttiwat T, Chokesuwattanaskul R, Lathkar-Pradhan S, Barham W, Oral H, Thakur RK, Jongnarangsin K. Programming implantable cardioverter–defibrillator in primary prevention: Guideline concordance and outcomes. Heart Rhythm 2020; 17:1101-1106. [DOI: 10.1016/j.hrthm.2020.02.004] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/16/2019] [Accepted: 02/01/2020] [Indexed: 01/19/2023]
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L.Goldenthal I, Rosenbaum MS, Lewis M, Sciacca RR, Garan H, Biviano AB. Inappropriate implantable cardioverter-defibrillator shocks in repaired tetralogy of fallot patients: Prevalence and electrophysiological mechanisms. IJC HEART & VASCULATURE 2020; 28:100543. [PMID: 32490149 PMCID: PMC7256636 DOI: 10.1016/j.ijcha.2020.100543] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2020] [Accepted: 05/18/2020] [Indexed: 11/26/2022]
Abstract
Background Patients with Tetralogy of Fallot (TOF) are at increased risk for sudden cardiac death, often undergo implantable cardioverter defibrillator (ICD) implantation at younger ages, and are at greater risk of experiencing inappropriate shocks. We investigated occurrences of ICD shocks in TOF patients to identify prevalence, characteristics associated with inappropriate shocks, and therapeutic interventions after inappropriate shocks. Methods Records of patients with repaired TOF and ICD implantation who were followed at Columbia University Irving Medical Center between 1/1/2000 and 5/1/2019 were analyzed. Results 44 patients with repaired TOF and ICD implantation were reviewed. Mean age at implantation was 39 ± 13 years. Eight (18%) patients received both appropriate and inappropriate shocks, 6 (14%) received only appropriate shocks, and 3 (7%) received only inappropriate shocks. Three patients received inappropriate shocks for sinus tachycardia, 7 for atrial arrhythmias, and 1 for noise artifact. Inappropriately shocked patients had lower beat per minute (bpm) cutoff values for ICD therapy (mean = 162 ± 24 bpm vs. 182 ± 16 bpm, p = 0.007). After inappropriate shocks, 1 patient underwent lead replacement, 1 had the VT cutoff increased, and 6 were treated with medications. Conclusions One quarter of TOF patients with ICDs experienced inappropriate shock therapy, the timing of which was most often clustered within the first two years after implant or years later. Lower shock therapy zones were associated with increased risk for inappropriate shocks, and the majority of inappropriate shocks resulted from atrial arrhythmias with rapid ventricular response. Treatments for inappropriate shocks included increasing VT therapy bpm and rhythm and/or rate control medications.
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Affiliation(s)
| | | | | | | | | | - Angelo B. Biviano
- Corresponding author at: Associate Professor of Medicine, Cardiology at Columbia University, Columbia University Medical Center, 161 Fort Washington Ave #546, New York, NY 10032, USA.
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