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1
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Bricker RS, Cleveland JC, Messenger JC. Mechanical Complications of Transcatheter Aortic Valve Replacement. Interv Cardiol Clin 2021; 10:465-480. [PMID: 34593110 DOI: 10.1016/j.iccl.2021.06.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/13/2023]
Abstract
Mechanical complications after transcatheter aortic valve replacement are fortunately rare with the current generation of devices. Unfortunately, life-threatening complications will occur and it is the responsibility of operators to be familiar with strategies to prevent and manage these challenging scenarios. Because these cases will not occur often, it is important for us to highlight and talk about those that do occur, to learn best practices in how to manage and prevent them going forward. We can learn much from each other's good crash landings.
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Affiliation(s)
- Rory S Bricker
- Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, 12631 East 17th Avenue, B130, Aurora, CO 80045, USA
| | - Joseph C Cleveland
- Department of Surgery, Division of Cardiothoracic Surgery, University of Colorado School of Medicine, 12631 East 17th Avenue, 6111, Aurora, CO 80045, USA
| | - John C Messenger
- Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, 12631 East 17th Avenue, B130, Aurora, CO 80045, USA.
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2
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Ihdayhid AR, Sathananthan J, Brown R, Blanke P, Webb JG. Repeat Transcatheter Aortic Valve Replacement and Follow-Up of Embolized Transcatheter Heart Valve After 13 Years. JACC Case Rep 2021; 3:633-635. [PMID: 34317592 PMCID: PMC8302774 DOI: 10.1016/j.jaccas.2020.12.011] [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: 11/13/2020] [Accepted: 12/04/2020] [Indexed: 11/04/2022]
Abstract
A 79-year-old woman was treated with a 23-mm balloon-expandable transcatheter heart valve (THV) that was initially complicated by an embolized THV requiring deployment in the descending aorta. She presented 13-years later with a degenerated bioprosthesis requiring redo THV. Pre-procedural computed tomography was important in highlighting underexpansion of the initial THV and open leaflets in the embolized valve. (Level of Difficulty: Advanced.)
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Affiliation(s)
- Abdul Rahman Ihdayhid
- Centres for Heart Valve Innovation and for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, Vancouver, Canada
| | - Janarthanan Sathananthan
- Centres for Heart Valve Innovation and for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, Vancouver, Canada
| | - Richard Brown
- Centres for Heart Valve Innovation and for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, Vancouver, Canada
| | - Philipp Blanke
- Centres for Heart Valve Innovation and for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, Vancouver, Canada
| | - John G Webb
- Centres for Heart Valve Innovation and for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, Vancouver, Canada
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3
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A Completely Endovascular Solution for Transcatheter Aortic Valve Implantation Embolisation and Inversion into the Aortic Arch. EJVES Vasc Forum 2021; 52:13-16. [PMID: 34278368 PMCID: PMC8264528 DOI: 10.1016/j.ejvsvf.2021.06.003] [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: 10/12/2020] [Revised: 05/17/2021] [Accepted: 06/03/2021] [Indexed: 11/24/2022] Open
Abstract
Introduction Transcatheter aortic valve implantation (TAVI) has evolved into the preferred alternative to surgical valve replacement for severe aortic valve stenosis with high surgical risk. With expanding indications, life threatening complications including transcatheter aortic valve embolisation and inversion (TAVEI), in which the valve dislodges, inverts, and migrates caudally, may increase concomitantly. Report An 80 year old male with severe aortic valve stenosis underwent balloon expandable transcatheter aortic valve implantation (TAVI). Valve embolisation into the aortic arch inverted the bioprothesis, excluding the option of fixation in the descending aorta. Through-valve thoracic endovascular aortic repair (TEVAR) was performed after bifemoral snaring using a through-and-through wire technique and pulling the valve into the descending aorta. Discussion TAVI is emerging as the preferred treatment for severe aortic valve stenosis and comes with unique procedural complications, such as life threatening transcatheter aortic valve embolisation and inversion (TAVEI). Although some authors prefer treating embolisation of a non-inverted balloon expandable valve into the aorta by using the valvuloplasty balloon to pull the valve distally and fixing it in the descending aorta, this risks further expansion of the valve and consequently fixing it in an undesirable position and is not possible if the valve inverts. Downstream placement of the valve by snaring with a guiding catheter covering/protecting a through-and-through wire technique, combined with through-valve TEVAR, provides a new bail out strategy for this serious complication and may reduce TAVEI associated mortality and morbidity.
TAVI is preferred to open replacement when treating severe aortic valve stenosis. An embolized valve may invert (TAVEI) risking hemodynamical obstruction. Snaring with a through-and-through wire allows downstream valve placement. A covered through-and-through wire protects the aortic wall during snaring. Thoracic stent-grafting provides a completely endovascular solution for TAVEI.
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4
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Binder RK, Webb JG. Transcatheter heart valve migration and embolization: rare and preventable? Eur Heart J 2020; 40:3166-3168. [PMID: 31377802 DOI: 10.1093/eurheartj/ehz562] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/31/2023] Open
Affiliation(s)
| | - John G Webb
- St. Paul's Hospital, University of British Columbia, Vancouver, Canada
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5
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Jones BM, Jobanputra Y, Krishnaswamy A, Mick S, Bhargava M, Wilkoff BL, Kapadia SR. Rapid ventricular pacing during transcatheter valve procedures using an internal device and programmer: A demonstration of feasibility. Catheter Cardiovasc Interv 2020; 95:1042-1048. [PMID: 31429191 DOI: 10.1002/ccd.28450] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/12/2019] [Accepted: 08/01/2019] [Indexed: 11/08/2022]
Abstract
OBJECTIVES To develop a protocol for using a pre-existing, permanent pacemaker or defibrillator device for rapid ventricular pacing during transcatheter valve procedures and demonstrate feasibility. BACKGROUND Placement of a passive fixation, temporary pacemaker wire is considered routine during most transcatheter valve procedures to facilitate controlled or rapid ventricular pacing at the time of balloon expansion or valve deployment. Many patients presenting for such procedures have a pre-existing, permanent pacemaker or defibrillator device which could be used for the same function, obviating the need for temporary pacemaker wire placement. METHODS We developed a strategy for rapid pacing from the pre-existing device using a programmer during transcatheter valve procedures in consecutive patients over a 3-month period. Complications and clinical outcomes were recorded. RESULTS There were 135 transcatheter valve procedures performed during the study. Of these, 28 (20.7%) had pre-existing devices (17 transcatheter aortic valve replacement, 3 aortic valve-in-valve, 2 mitral valve-in-valve, and 6 balloon aortic valvuloplasty). All patients underwent rapid ventricular pacing using a commercially available device programmer. There were no adverse events related to device pacing and no patients required placement of a temporary pacemaker wire during the procedure. At 30-days follow-up, there were no deaths, one major vascular complication related to arterial access, and one patient with renal failure requiring dialysis. CONCLUSION Pacing from a commercially available device programmer is safe, feasible, and may reduce both procedural cost and complications such as cardiac tamponade by avoiding placement of a temporary pacemaker lead during transcatheter valve procedures.
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Affiliation(s)
- Brandon M Jones
- Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
| | - Yash Jobanputra
- Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
| | - Amar Krishnaswamy
- Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
| | - Stephanie Mick
- Department of Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio
| | - Mandeep Bhargava
- Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
| | - Bruce L Wilkoff
- Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
| | - Samir R Kapadia
- Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
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6
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Fox H, Hemmann K, Lehmann R. Comparison of transthoracic and transesophageal echocardiography for transcatheter aortic valve replacement sizing in high-risk patients. J Echocardiogr 2019; 18:47-56. [PMID: 31630329 DOI: 10.1007/s12574-019-00448-7] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/19/2018] [Revised: 09/02/2019] [Accepted: 10/01/2019] [Indexed: 01/24/2023]
Abstract
BACKGROUND Untreated symptomatic high-grade aortic stenosis remains a lethal disease requiring individually adapted valve replacement. High-risk surgical patients benefit from transcatheter aortic valve replacement (TAVR), but there is no uniform standard for patient selection and valve sizing and it is still unclear whether transthoracic (TTE) or transesophageal (TEE) echocardiography is superior in preprocedural aortic annulus sizing. As preprocedural sizing of the native aortic annulus diameter is crucial to outcome and survival, we report the results of a direct comparison between preprocedural sizing with TTE and TEE including subsequent outcomes in a high-risk TAVR population. METHODS A total of 149 TAVR patients were enrolled for TTE and TEE comparison, and an additional 15 patients without structural heart disease were investigated as control group to determine the influence of aortic valve calcification on TTE and TEE aortic annulus diameter measurements. RESULTS Overall standardized TTE and TEE measurements for aortic annulus sizing showed excellent correlation at good image quality (p < 0.01, r = 0.934). Calcification of the aortic annulus diameter was not found to exert a noteworthy negative influence on measurements for both standardized TTE and TEE and complication rates did not differ for mortality, periprocedural stroke and paraprosthetic regurgitation. CONCLUSIONS Transthoracic echocardiography and TEE are both equally suitable methods of preprocedural aortic annulus size evaluation in preparation of TAVR procedures.
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Affiliation(s)
- Henrik Fox
- Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstr. 11, 32545, Bad Oeynhausen, Germany.
| | - Katrin Hemmann
- Department of Cardiology, Johann Wolfgang Goethe-University Frankfurt, Frankfurt, Germany
| | - Ralf Lehmann
- Department of Cardiology, Krankenhaus Barmherzige Brüder, Regensburg, Germany
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7
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Nagabandi AK, Panchal H, Srivastava R, Beohar N. When Prosthetic Valves Compete for Space: A Case of Transcatheter Aortic Valve Embolization Due to Prosthetic Mitral Valve. Cureus 2019; 11:e4299. [PMID: 32190431 PMCID: PMC7055012 DOI: 10.7759/cureus.4299] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/11/2019] [Accepted: 03/22/2019] [Indexed: 11/05/2022] Open
Abstract
Transcatheter aortic valve replacement (TAVR) is now the preferred choice of treatment for severe symptomatic aortic stenosis (AS) patients who are at intermediate to high risk for surgery. Rare complications like valve embolization have been described and we report a case with unique cause for such complication. A 79-year-old female presented with new onset dyspnea on exertion for evaluation and work up to the outside hospital and was found to have severe AS and referred to us for TAVR evaluation. She had a history of coronary artery bypass grafts surgery and bioprosthetic mitral valve replacement (MVR) 10 years ago. Preoperative transesophageal echocardiogram (TEE) revealed normally functioning bioprosthetic mitral valve and severe AS with peak/mean gradients of 67/44 mm Hg. She underwent transfemoral TAVR using a 26-mm Edwards Sapien S3 TAVR valve. During the slow deployment of the TAVR valve while rapid pacing, the valve appeared to move a little. Shortly after the removal of the delivery system out of the valve, the TAVR valve embolized to ascending aorta. It was carefully withdrawn into the aortic arch past the great vessels with an inflated balloon aortic valvuloplasty (BAV) catheter. Then, BAV was performed x 2 to plan for TAVR with a second valve, but the BAV balloon water-melon seeded repeatedly. We concluded that in this case, the rigid struts of bioprosthetic mitral valve encroaching on LVOT resulted in TAVR valve embolization and a decision was made to abort further attempts at TAVR valve implantation. This patient later under surgical aortic valve replacement (SAVR) and is clinically doing well at six months of clinical follow-up.
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Affiliation(s)
- Arun K Nagabandi
- Interventional Cardiology, Mount Sinai Medical Center, Miami Beach, USA
| | - Hemang Panchal
- Interventional Cardiology, Mount Sinai Medical Center, Miami Beach, USA
| | - Rohit Srivastava
- Interventional Cardiology, University of California San Francisco - Fresno Medical Education Center, Fresno, USA
| | - Nirat Beohar
- Interventional Cardiology, Mount Sinai Medical Center, Miami Beach, USA
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8
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Indolfi C, Bartorelli AL, Berti S, Golino P, Esposito G, Musumeci G, Petronio S, Tamburino C, Tarantini G, Ussia G, Vassanelli C, Spaccarotella C, Violini R, Mercuro G, Romeo F. Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis: expert opinion of the Italian Society of Cardiology and GISE. J Cardiovasc Med (Hagerstown) 2018; 19:197-210. [PMID: 29578921 DOI: 10.2459/jcm.0000000000000636] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Abstract
: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.
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Affiliation(s)
- Ciro Indolfi
- Cattedra di Cardiologia, Università degli Studi Magna Graecia, Catanzaro, Italy
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9
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CoreValve Double Jeopardy: Embolized Valve Capture With Subsequent Valve. INNOVATIONS-TECHNOLOGY AND TECHNIQUES IN CARDIOTHORACIC AND VASCULAR SURGERY 2018; 13:365-367. [PMID: 30153118 DOI: 10.1097/imi.0000000000000532] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
During transcatheter aortic valve replacement with a self-expanding prosthesis, prosthesis embolization represents a rare but severe complication. Etiologies of prosthesis embolization include improper sizing and malpositioning, specifically high deployment with respect to the aortic annulus. Treatment of embolization into the aorta relies upon repositioning of the prosthesis using endovascular snares or removal with open surgery. Patients with prosthesis embolization have a high risk of mortality and morbidity including stroke and aortic dissection associated with manipulation of the prosthesis in the ascending aorta. We describe a case of self-expanding prosthesis embolization and present a solution using a second prosthesis to capture the embolized one.
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10
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Sakrana AAS, Abuelatta RA, Ali SAF, Adalany MAEL, Amoudi OA, Al Ghamdi SS, Al Harbi IH. Variables affecting the accuracy of MDCT in prediction of the proper prosthesis deployment projection for transcatheter aortic valve implantation. THE EGYPTIAN JOURNAL OF RADIOLOGY AND NUCLEAR MEDICINE 2017. [DOI: 10.1016/j.ejrnm.2017.01.013] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022] Open
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11
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Hachinohe D, Kobayashi K, Furugen A, Koshima R. Left Ventricular Outflow Tract Migration of a Balloon-Expandable Prosthesis During Transcatheter Aortic Valve Implantation. Int Heart J 2017; 58:290-293. [PMID: 28321026 DOI: 10.1536/ihj.16-288] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/18/2022]
Abstract
Valve migration into the left ventricular outflow tract (LVOT) during transcatheter aortic valve implantation (TAVI) is a life-threatening complication. An 89-year-old female patient was admitted for TAVI due to severe symptomatic aortic stenosis. After deployment of a balloon-expandable prosthesis, the prosthesis had migrated into the LVOT. The prosthesis was reimpacted to the aortic annulus by a balloon-assisted recapture procedure. Immediately after recapturing the prosthesis with an oversized balloon, the patient's vital signs deteriorated due to acute aortic regurgitation (AR), and a prompt valve-in-valve (V-in-V) procedure allowed us to stabilize the patient's condition. This is the first reported case of a V-in-V procedure using an oversized balloon and a larger prosthesis to treat migration of the initial prosthesis into the LVOT. Balloon recapture and V-in-V procedure using an oversized balloon and larger prosthesis for a migrated balloonexpandable prosthesis into the LVOT is feasible, but hemodynamic support should be prepared before recapture and Vin-V because overdilatation of the first prosthesis might cause hemodynamic collapse due to severe AR.
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12
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Barbash IM, Bogdan A, Fefer P, Spiegelstein D, Raanani E, Beinart R, Guetta V, Segev A, Eggebrecht H, Zierer A, Dworakowski R, MacCarthy P. How should I treat a left ventricular outflow tract-migrated balloon-expandable transcatheter heart valve? EUROINTERVENTION 2016; 11:1442-5. [PMID: 26999684 DOI: 10.4244/eijv11i12a278] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Affiliation(s)
- Israel M Barbash
- The Heart Center, Chaim Sheba Medical Center, Tel Hashomer, Sackler School of Medicine, Tel Aviv University, Israel
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13
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Fetterly K, Greason K, Mathew V. Balloon Valvuloplasty to Predict X-ray Projection Angles that are Perpendicular to Cardiovascular Structures: A TAVI Patient Feasibility Study. Catheter Cardiovasc Interv 2016; 90:480-485. [PMID: 27896912 DOI: 10.1002/ccd.26879] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/23/2016] [Accepted: 11/08/2016] [Indexed: 11/10/2022]
Abstract
OBJECTIVES The purpose of this work is to describe methods to measure the 3D angular orientation of cardiovascular structures based on a planar image of a valvuloplasty balloon. These methods facilitate X-ray beam alignment with respect to the anatomy of interest. BACKGROUND X-ray beam projections which are perpendicular to the long axis of cardiovascular structures are required to support interventional procedures, including transcatheter aortic valve implant (TAVI). METHODS During the TAVI procedure, the 3D angular orientation of the LVOT of 10 patients was measured from a single planar image of an aortic valvuloplasty balloon and the continuous range of X-ray projection angles which are aligned with the aortic valve plane were calculated (research method). Misalignment of the X-ray beam and TAVI valve frame was measured from images of the deployed valve. The accuracy of the research method was compared to clinical standard method to determine appropriate X-ray projection angles, which utilized CT and aortography. RESULTS Using the clinical standard method, the median misalignment of the X-ray beam and TAVI valve frame was 8.6° (range 2.6° to 21°). Misalignment was reduced to 2.5° (range 0° to 10°) using the research method. CONCLUSIONS The 3D angular orientation of cardiovascular structures can be measured accurately from a single X-ray projection image of a known cardiovascular device contained within the anatomy of interest. For TAVI procedures, improved X-ray beam alignment may help facilitate procedural success. © 2016 Wiley Periodicals, Inc.
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Affiliation(s)
| | - Kevin Greason
- Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota
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14
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Bernardi FL, Ribeiro HB, Carvalho LA, Sarmento-Leite R, Mangione JA, Lemos PA, Abizaid A, Grube E, Rodés-Cabau J, de Brito FS. Direct Transcatheter Heart Valve Implantation Versus Implantation With Balloon Predilatation. Circ Cardiovasc Interv 2016; 9:CIRCINTERVENTIONS.116.003605. [DOI: 10.1161/circinterventions.116.003605] [Citation(s) in RCA: 35] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/15/2016] [Accepted: 06/23/2016] [Indexed: 11/16/2022]
Abstract
Background—
Direct transcatheter aortic valve replacement (TAVR) is regarded as having potential advantages over TAVR with balloon aortic valve predilatation (BAVP) in reducing procedural complications, but there are few data to support this approach.
Methods and Results—
Patients included in the Brazilian TAVR registry with CoreValve and Sapien-XT prosthesis were compared according to the implantation technique, with or without BAVP. Clinical and echocardiographic data were analyzed in overall population and after propensity score matching. A total of 761 consecutive patients (BAVP=372; direct-TAVR=389) were included. Direct-TAVR was possible in 99% of patients, whereas device success was similar between groups (BAVP=81.2% versus direct-TAVR=78.1%;
P
=0.3). No differences in clinical outcomes at 30 days and 1 year were observed, including all-cause mortality (7.6% versus 10%;
P
=0.25 and 18.1% versus 24.5%;
P
=0.07, respectively) and stroke (2.8% versus 3.8%;
P
=0.85 and 5.5% versus 6.8%;
P
=0.56, respectively). Nonetheless, TAVR with BAVP was associated with a higher rate of new onset persistent left bundle branch block with the CoreValve (47.7% versus 35.1%;
P
=0.01 at 1 year). Mean gradient and incidence of moderate/severe aortic regurgitation were similar in both groups at 1 year (11% versus 13.3%;
P
=0.57 and 9.8±5.5 versus 8.7±4.3;
P
=0.09, respectively). After propensity score matching analysis, all-cause mortality and stroke remained similar. By multivariable analysis, BAVP and the use of CoreValve were independent predictors of new onset persistent left bundle branch block.
Conclusions—
The 2 TAVR strategies, with or without BAVP, provided similar clinical and echocardiographic outcomes over a midterm follow-up although BAVP was associated with a higher rate of new onset persistent left bundle branch block, particularly in patients receiving a CoreValve.
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Affiliation(s)
- Fernando L.M. Bernardi
- From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia
| | - Henrique B. Ribeiro
- From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia
| | - Luiz A. Carvalho
- From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia
| | - Rogerio Sarmento-Leite
- From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia
| | - José A. Mangione
- From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia
| | - Pedro A. Lemos
- From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia
| | - Alexandre Abizaid
- From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia
| | - Eberhard Grube
- From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia
| | - Josep Rodés-Cabau
- From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia
| | - Fábio S. de Brito
- From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia
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15
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Mourad MAF. Approach of multi-slice computed tomography (MSCT) in assessment of transcatheter aortic valve implantation (TAVI). THE EGYPTIAN JOURNAL OF RADIOLOGY AND NUCLEAR MEDICINE 2016. [DOI: 10.1016/j.ejrnm.2016.03.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022] Open
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16
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Lo J, Hill C. Intensive care unit management of transcatheter aortic valve recipients. Semin Cardiothorac Vasc Anesth 2016; 19:95-105. [PMID: 25975594 DOI: 10.1177/1089253215575183] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Severe aortic stenosis is an increasingly prevalent disease that continues to be associated with significant mortality. Transcatheter aortic valve replacements have been used as an alternative to surgical aortic valve replacement in high-risk patients with multiple comorbidities. In this review, we discuss postoperative considerations pertinent to the successful management of these complicated patients in the intensive care unit.
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Affiliation(s)
- Joyce Lo
- Stanford University, Stanford, CA, USA
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17
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Hahn RT, Kodali S, Tuzcu EM, Leon MB, Kapadia S, Gopal D, Lerakis S, Lindman BR, Wang Z, Webb J, Thourani VH, Douglas PS. Echocardiographic imaging of procedural complications during balloon-expandable transcatheter aortic valve replacement. JACC Cardiovasc Imaging 2015; 8:288-318. [PMID: 25772835 DOI: 10.1016/j.jcmg.2014.12.013] [Citation(s) in RCA: 44] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/05/2014] [Revised: 12/19/2014] [Accepted: 12/22/2014] [Indexed: 02/06/2023]
Abstract
Transcatheter aortic valve replacement (TAVR) using a balloon-expandable valve is an accepted alternative to surgical replacement for severe, symptomatic aortic stenosis in high risk or inoperable patients. Intraprocedural transesophageal echocardiography (TEE) offers real-time imaging guidance throughout the procedure and allows for rapid and accurate assessment of complications and procedural results. The value of intraprocedural TEE for TAVR will likely increase in the future as this procedure is performed in lower surgical risk patients, who also have lower risk for general anesthesia, but a greater expectation of optimal results with lower morbidity and mortality. This imaging compendium from the PARTNER (Placement of Aortic Transcatheter Valves) trials is intended to be a comprehensive compilation of intraprocedural complications imaged by intraprocedural TEE and diagnostic tools to anticipate and/or prevent their occurrence.
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Affiliation(s)
- Rebecca T Hahn
- Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.
| | - Susheel Kodali
- Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York
| | | | - Martin B Leon
- Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York
| | | | | | | | - Brian R Lindman
- Washington University School of Medicine, St. Louis, Missouri
| | - Zuyue Wang
- Medstar Health Research Institute, Washington, DC
| | - John Webb
- University of British Columbia and St. Paul's Hospital, Vancouver, Ontario, Canada
| | | | - Pamela S Douglas
- Division of Cardiovascular Medicine, Duke University Medical Center, and Duke Clinical Research Institute, Durham, North Carolina
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18
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Tiroch K, Schleiting H, Karpettas N, Schmitz E, Vetter HO, Seyfarth M, Vorpahl M, Thomas M, Abdel-Wahab M, Sier H, Richardt G. How should I treat dislocation of a TAVI SAPIEN prosthesis into the left ventricle? EUROINTERVENTION 2015; 10:1370-2. [PMID: 25244641 DOI: 10.4244/eijy14m09_04] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
BACKGROUND Despite the technical advancements of the transcatheter aortic valve implantation (TAVI) procedure, valve embolisation into the left ventricle remains a challenging situation requiring expedited management through the Heart Team. INVESTIGATION The advantages and pitfalls of an interventional transfemoral approach, a transapical extraction of the dislocated prosthesis or the conversion to open heart surgery have to be balanced depending on the overall situation and the specific characteristics of the patient. DIAGNOSIS A transfemoral approach would be the first choice for most TAVI implanters. We discuss the different options and present an elegant solution solving this challenging situation, leading to a good immediate and long-term outcome. MANAGEMENT Attempts at pulling the prosthesis out of the ventricle using a balloon remained unsuccessful. After grasping of the prosthesis with a goose-neck snare, the valve was pulled into the annulus. A second SAPIEN XT prosthesis was implanted and fixed the first prosthesis within the annulus. After post-dilatation, there was a good result without relevant gradient and minimal aortic regurgitation.
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Affiliation(s)
- Klaus Tiroch
- Department of Cardiology, HELIOS Klinikum Wuppertal, Witten/Herdecke University, Wuppertal, Germany
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19
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Prosthetic Valve Escaping During Transcatheter Aortic Valve Implantation. INNOVATIONS-TECHNOLOGY AND TECHNIQUES IN CARDIOTHORACIC AND VASCULAR SURGERY 2015; 10:425-7. [PMID: 26650617 DOI: 10.1097/imi.0000000000000210] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
We performed transapical transcatheter aortic valve implantation on an 87-year-old woman with severe aortic valve stenosis. Because of the narrow left ventricular outflow tract, annular positioning of the prosthetic valve proved challenging. During positioning, the prosthetic valve was accidentally dislodged from the balloon catheter and dropped into the left ventricle. Attempted catheter retrieval was unsuccessful. We therefore converted to open surgery without delay. After aortotomy, to our surprise, the prosthesis could not be found, neither in the left ventricle nor in the ascending aorta. Transesophageal echocardiography failed to reveal the location of the missing prosthesis. Fluoroscopy finally displayed the prosthesis in the descending aorta at the level of the left atrium. We proceeded with aortic and mitral valve replacement and closed the sternum. Under fluoroscopic guidance, the prosthetic valve was secured to the wall of the abdominal aorta in an infrarenal position by dilatation with a balloon catheter. This case shows that we should be alert to septum hypertrophy or a narrow left ventricular outflow tract during transapical aortic valve implantation. In such anatomical situations, we recommend advancing the sheath of the application system directly below the annular plane and positioning the prosthesis from this point.
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20
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Furukawa N, Scholtz W, Scholtz S, Faber L, Ensminger S, Gummert J, Börgermann J. Prosthetic Valve Escaping during Transcatheter Aortic Valve Implantation. INNOVATIONS-TECHNOLOGY AND TECHNIQUES IN CARDIOTHORACIC AND VASCULAR SURGERY 2015. [DOI: 10.1177/155698451501000611] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Affiliation(s)
- Nobuyuki Furukawa
- Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany
| | - Werner Scholtz
- Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany
| | - Smita Scholtz
- Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany
| | - Lothar Faber
- Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany
| | - Stephan Ensminger
- Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany
| | - Jan Gummert
- Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany
| | - Jochen Börgermann
- Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany
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21
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Clinical Aspects and Current Evidence Base for Transcatheter Aortic Valve Implantation. J Thorac Imaging 2015; 30:341-8. [DOI: 10.1097/rti.0000000000000166] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
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22
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Crowhurst JA, Poon KK, Murdoch D, Incani A, Raffel OC, Liddicoat A, Walters D. The effect of X-ray beam distortion on the Edwards Sapien XT(™) trans-catheter aortic valve replacement prosthesis. J Med Radiat Sci 2015; 62:239-45. [PMID: 27512569 PMCID: PMC4968560 DOI: 10.1002/jmrs.131] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/09/2015] [Revised: 07/17/2015] [Accepted: 07/18/2015] [Indexed: 02/01/2023] Open
Abstract
Introduction Profiling the Aortic root perpendicular to the fluoroscopic image plane will achieve a more successful implant position for trans‐catheter aortic valve replacement (TAVR). This study aimed to investigate whether the divergent nature of the X‐ray beam from the C‐arm altered the appearance of the TAVR device. Methods Under bench‐top testing, a 23, 26 and 29 mm Edwards Sapien XT valve was positioned coaxially at the bottom of a fluoroscopic image utilising 22 and 32 cm fields of view (FOV). The table was then moved so that the valve was positioned at the top of the image. The valve's appearance was scored using a previously published three tier classification tool (excellent, satisfactory and poor) and quantified with measurements. The number of degrees of C‐arm rotation that were required to bring the valve back to a coaxial appearance was recorded. Results When using the 32 cm FOV, the valve's appearance changes from excellent to satisfactory. When a 22 cm FOV was used, the change is less marked. More C‐arm rotation is required to bring the appearance back to coaxial with the 32 cm FOV. Conclusion Not maintaining the valve in the centre of the image can distort the valves appearance. This has the potential to affect the final implantation depth.
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Affiliation(s)
- James A Crowhurst
- Heart and Lung Institute The Prince Charles Hospital Chermside Queensland Australia; University of Queensland St Lucia, Brisbane Queensland Australia; Medical Imaging Department The Prince Charles Hospital Chermside Queensland Australia
| | - Karl K Poon
- Heart and Lung Institute The Prince Charles Hospital Chermside Queensland Australia
| | - Dale Murdoch
- Heart and Lung Institute The Prince Charles Hospital Chermside Queensland Australia; University of Queensland St Lucia, Brisbane Queensland Australia
| | - Alexander Incani
- Heart and Lung Institute The Prince Charles Hospital Chermside Queensland Australia
| | - Owen C Raffel
- Heart and Lung Institute The Prince Charles Hospital Chermside Queensland Australia; University of Queensland St Lucia, Brisbane Queensland Australia
| | - Annelise Liddicoat
- Medical Imaging Department The Prince Charles Hospital Chermside Queensland Australia
| | - Darren Walters
- Heart and Lung Institute The Prince Charles Hospital Chermside Queensland Australia; University of Queensland St Lucia, Brisbane Queensland Australia
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23
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Larion S, Moore JR, Ammar C, Panneton JM. TEVAR Rescue of an Embolized Edwards SAPIEN XT Valve Following TAVR. J Endovasc Ther 2015; 22:819-23. [DOI: 10.1177/1526602815599163] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Purpose: To report a successful method of managing an embolized Edwards SAPIEN XT aortic valve prosthesis using a thoracic endovascular aortic repair rescue. Case Report: An 84-year-old man underwent transcatheter aortic valve replacement using a 26-mm Edwards SAPIEN XT valve, which immediately embolized into the ascending aorta. Because of the severe tapering of the patient’s transverse aortic arch, the embolized valve was unable to be maneuvered further down the aorta. Therefore, a Cook 36×80-mm Zenith Dissection Endovascular System (ZDES) bare metal stent was used on a compassionate basis to append the embolized valve between the patient’s coronary artery ostia and the innominate artery takeoff within the ascending aorta, with no neurological or cardiovascular complications at 12-month follow-up. Conclusion: A Cook ZDES bare metal stent may be successfully used to append an embolized Edwards SAPIEN XT valve within the ascending aorta.
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Affiliation(s)
- Sebastian Larion
- Division of Vascular Surgery, Eastern Virginia Medical School, Norfolk, VA, USA
| | - Jason R. Moore
- Division of Vascular Surgery, Eastern Virginia Medical School, Norfolk, VA, USA
| | - Chad Ammar
- Division of Vascular Surgery, Eastern Virginia Medical School, Norfolk, VA, USA
| | - Jean M. Panneton
- Division of Vascular Surgery, Eastern Virginia Medical School, Norfolk, VA, USA
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24
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Ibebuogu UN, Giri S, Bolorunduro O, Tartara P, Kar S, Holmes D, Alli O. Review of reported causes of device embolization following trans-catheter aortic valve implantation. Am J Cardiol 2015; 115:1767-72. [PMID: 25882773 DOI: 10.1016/j.amjcard.2015.03.024] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2015] [Revised: 03/13/2015] [Accepted: 03/13/2015] [Indexed: 10/23/2022]
Abstract
Transcatheter heart valve (THV) embolization is a rare but serious complication of transcatheter aortic valve implantation. Studies, including case reports, case series, and original reports published between 2002 and 2013, with regard to THV embolization were identified with a systemic electronic search using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. A total of 19 publications describing 71 patients were identified. Most patients (64%) were men, with a mean age of 80 ± 6 years and a mean logistic European System for Cardiac Operative Risk Evaluation score of 22.4 ± 9.3%. Balloon-expandable valves were used in 72% of the patients. The reported transcatheter aortic valve replacement access site was transfemoral in 80% of patients. Most cases (90%) occurred <1 hour after implantation, whereas 10% had late embolization (range 4 hours to 43 days). The most common site of embolization was the ascending aorta (38%), followed by the left ventricle (31%), descending aorta (23%), and aortic arch (8%). Open-heart surgery was required in 28% for valve retrieval and replacement. The 30-day stroke and mortality rates were 11% and 17%, respectively. Ventricular embolization and urgent conversion to open-heart surgery were significantly associated with death during hospitalization (p = 0.017 and p = 0.029, respectively). Likely causes of embolization were identified in 59 patients, with positioning error as the most commonly reported (47%), followed by pacing error (13%). In conclusion, THV embolization occurred early after transcatheter aortic valve implantation. The ascending aorta was the most common site of embolization. Higher 30-day stroke and mortality rates were associated with THV embolization compared with most published series of transcatheter aortic valve implantation outcomes.
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25
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Nijhoff F, Agostoni P, Samim M, Ramjankhan FZ, Kluin J, Doevendans PA, Stella PR. Optimisation of transcatheter aortic balloon-expandable valve deployment: the two-step inflation technique. EUROINTERVENTION 2015; 9:555-63. [PMID: 24058073 DOI: 10.4244/eijv9i5a91] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
AIMS To evaluate the two-step inflation technique aimed at achieving optimal valve implantation depth (defined as 40% of prosthesis height extending below the lower sinus border on angiography) during balloon-expandable transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS Between September 2010 and March 2013, 103 patients (67 females, mean age 80.9±5.6 years) were treated with the Edwards SAPIEN XT prosthesis using the two-step inflation technique. Implantation depth was measured on angiography. A historical control group (treated with Edwards SAPIEN) was used for comparison (n=20). Deviation from the defined optimum implantation depth (expressed as a percentage of stent frame height) was significantly less in the study group versus controls (7.0 [3.4-14.1]% vs. 13.9 [5.4-18.9]%; p=0.048). Valve placement was graded "as intended"/"within range"/"out of range" (defined as ≤10%, >10% but ≤20% and >20% deviation, respectively) in 66%/22%/12% of the study group and 35%/40%/25% of historical controls (p=0.02). Corrections in valve position were made in 20 procedures (20%), resulting in placement as intended in 16 cases (80%), with highest efficacy in the transapical and direct aortic approaches. CONCLUSIONS The two-step inflation technique improves valve placement towards optimal implantation depth and may thereby prevent adverse events due to malpositioning.
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Affiliation(s)
- Freek Nijhoff
- Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands
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26
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The effects of positioning of transcatheter aortic valves on fluid dynamics of the aortic root. ASAIO J 2015; 60:545-552. [PMID: 25010918 DOI: 10.1097/mat.0000000000000107] [Citation(s) in RCA: 37] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
Transcatheter aortic valve implantation is a novel treatment for severe aortic valve stenosis. Due to the recent use of this technology and the procedural variability, there is very little data that quantify the hemodynamic consequences of variations in valve placement. Changes in aortic wall stresses and fluid retention in the sinuses of Valsalva can have a significant effect on the clinical response a patient has to the procedure. By comprehensively characterizing complex flow in the sinuses of Valsalva using digital particle image velocimetry and an advanced heart-flow simulator, various positions of a deployed transcatheter valve with respect to a bioprosthetic aortic valve (valve-in-valve) were tested in vitro. Displacements of the transcatheter valve were axial and directed below the simulated native valve annulus. It was determined that for both blood residence time and aortic Reynolds stresses, it is optimal to have the annulus of the transcatheter valve deployed as close to the aortic valve annulus as possible.
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27
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Lee YT, Yin WH, Yu HP, Tsai SK, Wei J. Transcatheter Aortic Valve Implantation in a Woman with Porcelain Aorta, Previous Sternotomy for Coronary Artery Bypass Grafting, and Critical Aortic Stenosis. ACTA CARDIOLOGICA SINICA 2015; 31:78-82. [PMID: 27122851 DOI: 10.6515/acs20140422a] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
UNLABELLED A 74-year-old woman who was diagnosed with right breast cancer at age 39 had been treated with mastectomy, and repeated cycles of chemotherapy and radiotherapy. She also had a history of coronary artery disease, wherein two coronary artery bypass grafts were performed 3 years ago. At that time, porcelain aorta was detected during surgery. In the year prior to admission, the patient presented with severe symptomatic critical aortic stenosis. Due to the prohibitively high surgical risk and need for aortic valve replacement, she underwent successful transcatheter aortic valve implantation with transfemoral implantation of a 29 mm Medtronic CoreValve prosthesis. The patient experienced a good result with reduction of the transaortic gradient and mild residual aortic regurgitation. KEY WORDS Aortic stenosis; Coronary artery bypass grafting; Porcelain aorta; Radiation; Transcatheter aortic valve implantation.
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Affiliation(s)
| | - Wei-Hsian Yin
- Heart Center; ; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan
| | | | - Shen Kou Tsai
- Department of Anesthesiology, Cheng-Hsin General Hospital
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28
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Fetterly KA, Mathew V. Method to measure the 3D angular orientation of the aortic valve plane from a single image of a valvuloplasty balloon: Findings of a large animal proof of concept experiment. J Med Eng Technol 2014; 39:99-104. [DOI: 10.3109/03091902.2014.981308] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/11/2023]
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29
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Dipoce J, Bernheim A, Spindola-Franco H. Radiology of cardiac devices and their complications. Br J Radiol 2014; 88:20140540. [PMID: 25411826 DOI: 10.1259/bjr.20140540] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2022] Open
Abstract
This article familiarizes the reader with several different cardiac devices including pacemakers and implantable cardioverter defibrillators, intra-aortic balloon pumps, ventricular assist devices, valve replacements and repairs, shunt-occluding devices and passive constraint devices. Many cardiac devices are routinely encountered in clinical practice. Other devices are in the early stages of development, but circumstances suggest that they too will become commonly found. The radiologist must be familiar with these devices and their complications.
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Affiliation(s)
- J Dipoce
- 1 Department of Radiology, Hadassah Medical Center, Jerusalem, Israel
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30
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Salgado RA, Leipsic JA, Shivalkar B, Ardies L, Van Herck PL, Op de Beeck BJ, Vrints C, Rodrigus I, Parizel PM, Bosmans J. Preprocedural CT Evaluation of Transcatheter Aortic Valve Replacement: What the Radiologist Needs to Know. Radiographics 2014; 34:1491-514. [DOI: 10.1148/rg.346125076] [Citation(s) in RCA: 40] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
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A simple and accurate method for computer-aided transapical aortic valve replacement. Comput Med Imaging Graph 2014; 50:31-41. [PMID: 25306532 DOI: 10.1016/j.compmedimag.2014.09.005] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/14/2014] [Revised: 07/21/2014] [Accepted: 09/12/2014] [Indexed: 11/22/2022]
Abstract
BACKGROUND AND PURPOSE Transapical aortic valve replacement (TAVR) is a recent minimally invasive surgical treatment technique for elderly and high-risk patients with severe aortic stenosis. In this paper, a simple and accurate image-based method is introduced to aid the intra-operative guidance of TAVR procedure under 2-D X-ray fluoroscopy. METHODS The proposed method fuses a 3-D aortic mesh model and anatomical valve landmarks with live 2-D fluoroscopic images. The 3-D aortic mesh model and landmarks are reconstructed from interventional X-ray C-arm CT system, and a target area for valve implantation is automatically estimated using these aortic mesh models. Based on template-based tracking approach, the overlay of visualized 3-D aortic mesh model, landmarks and target area of implantation is updated onto fluoroscopic images by approximating the aortic root motion from a pigtail catheter motion without contrast agent. Also, a rigid intensity-based registration algorithm is used to track continuously the aortic root motion in the presence of contrast agent. Furthermore, a sensorless tracking of the aortic valve prosthesis is provided to guide the physician to perform the appropriate placement of prosthesis into the estimated target area of implantation. RESULTS Retrospective experiments were carried out on fifteen patient datasets from the clinical routine of the TAVR. The maximum displacement errors were less than 2.0mm for both the dynamic overlay of aortic mesh models and image-based tracking of the prosthesis, and within the clinically accepted ranges. Moreover, high success rates of the proposed method were obtained above 91.0% for all tested patient datasets. CONCLUSION The results showed that the proposed method for computer-aided TAVR is potentially a helpful tool for physicians by automatically defining the accurate placement position of the prosthesis during the surgical procedure.
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Samim M, Agostoni P, Nijhoff F, Budde RPJ, Abrahams AC, Kluin J, Ramjankhan F, Doevendans PA, Stella PR. Three-dimensional aortic root reconstruction derived from rotational angiography for transcatheter balloon-expandable aortic valve implantation guidance. Int J Cardiol 2014; 176:1318-20. [PMID: 25131920 DOI: 10.1016/j.ijcard.2014.07.152] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/09/2014] [Accepted: 07/27/2014] [Indexed: 12/01/2022]
Affiliation(s)
- Mariam Samim
- Department of Cardiology, University Medical Center, Utrecht, The Netherlands
| | | | - Freek Nijhoff
- Department of Cardiology, University Medical Center, Utrecht, The Netherlands
| | - Ricardo P J Budde
- Department of Radiology, University Medical Center, Utrecht, The Netherlands
| | - Alferso C Abrahams
- Department of Nephrology, University Medical Center, Utrecht, The Netherlands
| | - Jolanda Kluin
- Department of Thoracic Surgery, University Medical Center, Utrecht, The Netherlands
| | - Faiz Ramjankhan
- Department of Thoracic Surgery, University Medical Center, Utrecht, The Netherlands
| | - Pieter A Doevendans
- Department of Cardiology, University Medical Center, Utrecht, The Netherlands
| | - Pieter R Stella
- Department of Cardiology, University Medical Center, Utrecht, The Netherlands.
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33
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Ayhan H, Durmaz T, Keleş T, Kasapkara HA, Erdoğan KE, Bozkurt E. A rare complication with Edwards Sapien: aortic valve embolization in TAVI. Vascular 2014; 23:102-4. [PMID: 24788062 DOI: 10.1177/1708538114532923] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
One of the problems is valve embolization at the time of transcatheter aortic valve implantation, which is a rare but serious complication. In this case, we have shown balloon expandable aortic valve embolization TAVI which is a rare complication and we managed with second valve without surgery. Although there is not enough experience in the literature, embolized valve was re-positioned in the arch aorta between truncus brachiocephalicus and left common carotid artery.
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Affiliation(s)
- Hüseyin Ayhan
- Department of Cardiology, Faculty of Medicine, Yildirim Beyazit University, Ankara, Turkey
| | - Tahir Durmaz
- Department of Cardiology, Faculty of Medicine, Yildirim Beyazit University, Ankara, Turkey
| | - Telat Keleş
- Department of Cardiology, Faculty of Medicine, Yildirim Beyazit University, Ankara, Turkey
| | - Hacı Ahmet Kasapkara
- Department of Cardiology, Faculty of Medicine, Yildirim Beyazit University, Ankara, Turkey
| | - Kemal Eşref Erdoğan
- Department of Cardiovascular Surgery, Faculty of Medicine, Yildirim Beyazıt University, Ankara, Turkey
| | - Engin Bozkurt
- Department of Cardiology, Faculty of Medicine, Yildirim Beyazit University, Ankara, Turkey
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Witkowski A, Jastrzebski J, Dabrowski M, Chmielak Z. Second transcatheter aortic valve implantation for treatment of suboptimal function of previously implanted prosthesis: review of the literature. J Interv Cardiol 2014; 27:300-7. [PMID: 24731263 DOI: 10.1111/joic.12120] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022] Open
Abstract
OBJECTIVES To systematically review reported cases of second transcatheter aortic valve deployment within a previously implanted prosthesis (TAV-in-TAV). BACKGROUND TAV-in-TAV deployment is one of the rescue strategies undertaken due to an unsuccessful or suboptimal transcatheter aortic valve implantation (TAVI) result. Currently, there are no clear indications for second valve implantation and outcomes of patients with 2 prostheses deployed remain poorly known. METHODS The MEDLINE and PubMed databases were searched for cases of TAV-in-TAV implantations of aortic valve. RESULTS Forty-three articles reporting on TAV-in-TAV deployment were included in the review. The most frequently observed indication for second valve implantation was aortic regurgitation (AR) occurring shortly after TAVI. There was a strong dominance of paravalvular over intravalvular AR, with prosthesis malposition being the main underlying cause of TAVI failure (81% of all identified cases). Perioperative echocardiographic images are crucial in identifying causes of failure and helpful in optimal rescue strategy selection. Success rate of TAV-in-TAV implantation varies from 90% to 100% with mortality rate of 0-14.3% at 30 days. Despite similar aortic valve function in follow-up, TAV-in-TAV may be an independent predictor of increased cardiovascular mortality. CONCLUSIONS TAV-in-TAV implantation is feasible and results in favorable short- and mid-term outcomes in patients with acute failure of TAVI without recourse to open-heart surgery. Further studies are needed to establish algorithm of the management of unsuccessful or suboptimal implantation results.
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Affiliation(s)
- Adam Witkowski
- Interventional Cardiology and Angiology Department, Institute of Cardiology, Warsaw, Poland
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Tas MH, Koza Y, Simsek Z. Infraannular dislocation and its successful management: A rare complication following TAVI. J Cardiol Cases 2014; 9:148-150. [DOI: 10.1016/j.jccase.2013.12.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/08/2013] [Revised: 11/14/2013] [Accepted: 12/17/2013] [Indexed: 10/25/2022] Open
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Negi SI, Loyalka P, Gregoric I, Kar B. Retrieval of Ruptured Valves and Their Accessories During Transcatheter Aortic Valve Replacement. J Card Surg 2014; 29:209-212. [DOI: 10.1111/jocs.12285] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 08/29/2023]
Affiliation(s)
- Smita I. Negi
- Division of Cardiology; Department of Medicine; University of Texas at Houston; Houston Texas
| | - Pranav Loyalka
- Center for Advanced Heart Failure; University of Texas at Houston; Houston Texas
| | - Igor Gregoric
- Center for Advanced Heart Failure; University of Texas at Houston; Houston Texas
| | - Biswajit Kar
- Center for Advanced Heart Failure; University of Texas at Houston; Houston Texas
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Shannon J, Mussardo M, Latib A, Takagi K, Chieffo A, Montorfano M, Colombo A. Recognition and management of complications during transcatheter aortic valve implantation. Expert Rev Cardiovasc Ther 2014; 9:913-26. [DOI: 10.1586/erc.11.84] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
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Clayton B, Morgan-Hughes G, Roobottom C. Transcatheter aortic valve insertion (TAVI): a review. Br J Radiol 2013; 87:20130595. [PMID: 24258463 DOI: 10.1259/bjr.20130595] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/29/2023] Open
Abstract
The introduction of transcatheter aortic valve insertion (TAVI) has transformed the care provided for patients with severe aortic stenosis. The uptake of this procedure is increasing rapidly, and clinicians from all disciplines are likely to increasingly encounter patients being assessed for or having undergone this intervention. Successful TAVI heavily relies on careful and comprehensive imaging assessment, before, during and after the procedure, using a range of modalities. This review outlines the background and development of TAVI, describes the nature of the procedure and considers the contribution of imaging techniques, both to successful intervention and to potential complications.
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Affiliation(s)
- B Clayton
- Cardiology Department, Derriford Hospital, Plymouth, UK
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Khalique OK, Kodali SK, Paradis JM, Nazif TM, Williams MR, Einstein AJ, Pearson GD, Harjai K, Grubb K, George I, Leon MB, Hahn RT. Aortic annular sizing using a novel 3-dimensional echocardiographic method: use and comparison with cardiac computed tomography. Circ Cardiovasc Imaging 2013; 7:155-63. [PMID: 24221192 DOI: 10.1161/circimaging.113.001153] [Citation(s) in RCA: 131] [Impact Index Per Article: 10.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
BACKGROUND Previous studies have shown cross-sectional 3-dimensional (3D) transesophageal echocardiographic (TEE) measurements to severely underestimate multidetector row computed tomographic (MDCT) measurements for the assessment of aortic annulus before transcatheter aortic valve replacement. This study compares annulus measurements from 3D-TEE using off-label use of commercially available software with MDCT measurements and assesses their ability to predict paravalvular regurgitation. METHODS AND RESULTS One hundred patients with severe, symptomatic aortic stenosis who had both contrast MDCT and 3D-TEE for annulus assessment before balloon-expandable transcatheter aortic valve replacement were analyzed. Annulus area, perimeter, and orthogonal maximum and minimum diameters were measured. Receiver operating characteristic analysis was performed with mild or greater paravalvular regurgitation as the classification variable. Three-dimensional TEE and MDCT cross-sectional perimeter and area measurements were strongly correlated (r=0.93-0.94; P<0.0001); however, the small differences (≤1%) were statistically significant (P=0.0002 and 0.0074, respectively). Discriminatory ability for ≥ mild paravalvular regurgitation was good for both MDCT (area under the curve for perimeter and area cover index=0.715 and 0.709, respectively) and 3D-TEE (area under the curve for perimeter and area cover index=0.709 and 0.694, respectively). Differences in receiver operating characteristic analysis between MDCT and 3D-TEE perimeter and area cover indexes were not statistically significant (P=0.15 and 0.35, respectively). CONCLUSIONS Annulus measurements using a new method for analyzing 3D-TEE images closely approximate those of MDCT. Annulus measurements from both modalities predict mild or greater paravalvular regurgitation with equivalent accuracy.
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Loeser H, Wittersheim M, Puetz K, Friemann J, Buettner R, Fries JW. Potential complications of transcatheter aortic valve implantation (TAVI)—an autopsy perspective. Cardiovasc Pathol 2013; 22:319-23. [DOI: 10.1016/j.carpath.2013.01.006] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/02/2012] [Revised: 01/09/2013] [Accepted: 01/11/2013] [Indexed: 11/28/2022] Open
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41
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Latsios G, Toutouzas K, Tousoulis D, Michelongona A, Synetos A, Stathogiannis K, Mastrokostopoulos A, Stefanadis C. Case reports of bail-out maneuvers for implantation of a second core valve prosthesis during the same TAVI procedure. Int J Cardiol 2013; 167:e134-e136. [PMID: 23684600 DOI: 10.1016/j.ijcard.2013.04.027] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/19/2013] [Accepted: 04/05/2013] [Indexed: 11/13/2022]
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Patrice Mwipatayi B, Nair R, Papineau JL, Vijayan V. A difficult case of retrieval of an aortic valve and balloon during a transcatheter aortic valve implantation. Int J Surg Case Rep 2013; 4:846-8. [PMID: 23959416 DOI: 10.1016/j.ijscr.2013.06.018] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2013] [Accepted: 06/20/2013] [Indexed: 01/07/2023] Open
Abstract
INTRODUCTION Transcatheter aortic valve implantation (TAVI) represents an emerging therapy for valve replacement in patients not suitable for traditional open repair. As awareness of the procedure grows, case numbers are increasing worldwide. Though this procedure represents a less invasive approach to aortic valve replacement, it is not without complications. PRESENTATION OF CASE This case presentation describes a serious, previously unreported, complication incurred in an 83-year-old male in whom TAVI was attempted. During deployment of the valve at the aortic annulus, both the valve and accompanying balloon embolised into the thoracic aorta and this was further complicated by migration of the balloon into the abdominal aorta and an aortic dissection. The false lumen of the dissection at the level of the infrarenal aorta was tacked to the aortic adventitial wall using interrupted sutures through a laparotomy. A completion angiogram demonstrated that a flow limited dissection did extend up to both common iliac arteries. This was managed with balloon-expandable covered stents deployed in both common iliac arteries with satisfactory outcome. DISCUSSION This case occurred as a combination of multiple factors that include lack of burst pacing and poor timing of the balloon inflation. The aortic balloon and the valve had to be removed urgently to avoid ventricular embolization of these structures that can result in a fatal situation. CONCLUSION This case presentation describes the management of these complications using a combined open and endovascular approach in a well-equipped hybrid operating theatre, resulting in the patient survival.
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Affiliation(s)
- Bibombe Patrice Mwipatayi
- Department of Vascular Surgery, Royal Perth Hospital, Perth, Australia; School of Surgery, Faculty of Medicine, Dentistry and Health Sciences, Western Australia, Australia.
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Schoenhagen P, Zimmermann M, Falkner J. Advanced 3-D analysis, client-server systems, and cloud computing-Integration of cardiovascular imaging data into clinical workflows of transcatheter aortic valve replacement. Cardiovasc Diagn Ther 2013; 3:80-92. [PMID: 24282750 PMCID: PMC3839191 DOI: 10.3978/j.issn.2223-3652.2013.02.08] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/29/2013] [Accepted: 02/25/2013] [Indexed: 11/14/2022]
Abstract
Degenerative aortic stenosis is highly prevalent in the aging populations of industrialized countries and is associated with poor prognosis. Surgical valve replacement has been the only established treatment with documented improvement of long-term outcome. However, many of the older patients with aortic stenosis (AS) are high-risk or ineligible for surgery. For these patients, transcatheter aortic valve replacement (TAVR) has emerged as a treatment alternative. The TAVR procedure is characterized by a lack of visualization of the operative field. Therefore, pre- and intra-procedural imaging is critical for patient selection, pre-procedural planning, and intra-operative decision-making. Incremental to conventional angiography and 2-D echocardiography, multidetector computed tomography (CT) has assumed an important role before TAVR. The analysis of 3-D CT data requires extensive post-processing during direct interaction with the dataset, using advance analysis software. Organization and storage of the data according to complex clinical workflows and sharing of image information have become a critical part of these novel treatment approaches. Optimally, the data are integrated into a comprehensive image data file accessible to multiple groups of practitioners across the hospital. This creates new challenges for data management requiring a complex IT infrastructure, spanning across multiple locations, but is increasingly achieved with client-server solutions and private cloud technology. This article describes the challenges and opportunities created by the increased amount of patient-specific imaging data in the context of TAVR.
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Affiliation(s)
| | | | - Juergen Falkner
- Fraunhofer Institute for Industrial Engineering IAO, Stuttgart, Germany
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Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. EUROINTERVENTION 2013; 8:782-95. [PMID: 23022744 DOI: 10.4244/eijv8i7a121] [Citation(s) in RCA: 166] [Impact Index Per Article: 13.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
OBJECTIVES The aim of the current Valvular Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI)- clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand understanding of patient risk stratification and case selection. BACKGROUND A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. METHODS AND RESULTS Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, The Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the United States Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document also provides an overview of risk assessment and patient stratification that needed to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding, acute kidney injury, vascular complications, conduction disturbances & arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for evaluation of prosthetic valve (dys)function. Definitions for quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. CONCLUSIONS This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of study results, supplying an increasingly growing body of evidence with respect to transcatheter aortic valve implantation and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair).
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Affiliation(s)
- A Pieter Kappetein
- Erasmus University Medical Center, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands.
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Latsios G, Toutouzas K, Tousoulis D, Stathogiannis K, Tentolouris C, Synetos A, Filis K, Stefanadis C. Prosthetic aortic valve removal from the abdominal aorta after successful "valve-through" TAVI. Int J Cardiol 2013; 164:e27-e28. [PMID: 23068569 DOI: 10.1016/j.ijcard.2012.09.164] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/13/2012] [Accepted: 09/25/2012] [Indexed: 11/22/2022]
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PEREIRA EULÁLIA, FERREIRA NUNO, CAEIRO DANIEL, PRIMO JOÃO, ADÃO LUÍS, OLIVEIRA MARCO, GONÇALVES HELENA, RIBEIRO JOSÉ, SANTOS ELISABETH, LEITE DANIEL, BETTENCOURT NUNO, BRAGA PEDRO, SIMÕES LINO, VOUGA LUÍS, GAMA VASCO. Transcatheter Aortic Valve Implantation and Requirements of Pacing Over Time. PACING AND CLINICAL ELECTROPHYSIOLOGY: PACE 2013; 36:559-69. [DOI: 10.1111/pace.12104] [Citation(s) in RCA: 54] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/14/2012] [Revised: 11/26/2012] [Accepted: 12/28/2012] [Indexed: 11/29/2022]
Affiliation(s)
| | | | | | | | | | | | | | | | | | | | | | | | | | - LUÍS VOUGA
- Department of Cardiothoracic Surgery; Centro Hospitalar de Vila Nova de Gaia/Espinho; Vila Nova de Gaia; Portugal
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Dumonteil N, Marcheix B, Grunenwald E, Roncalli J, Massabuau P, Carrié D. Left Ventricular Embolization of an Aortic Balloon-Expandable Bioprosthesis. JACC Cardiovasc Interv 2013; 6:308-10. [DOI: 10.1016/j.jcin.2012.08.028] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/22/2012] [Accepted: 08/02/2012] [Indexed: 11/27/2022]
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Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J 2013; 33:2403-18. [PMID: 23026477 DOI: 10.1093/eurheartj/ehs255] [Citation(s) in RCA: 876] [Impact Index Per Article: 73.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
Abstract
OBJECTIVES The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI)clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. BACKGROUND A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. METHODS AND RESULTS Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, the Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. CONCLUSIONS This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavours of applying definitions to other transcatheter valve therapies (for example, mitral valve repair).
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Affiliation(s)
- A Pieter Kappetein
- Erasmus University Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands.
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Tseng EE, Wisneski A, Azadani AN, Ge L. Engineering perspective on transcatheter aortic valve implantation. Interv Cardiol 2013. [DOI: 10.2217/ica.12.73] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022] Open
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50
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Schoenhagen P, Falkner J, Piraino D. Transcatheter aortic valve repair, imaging, and electronic imaging health record. Curr Cardiol Rep 2013; 15:319. [PMID: 23250656 DOI: 10.1007/s11886-012-0319-1] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
Degenerative aortic stenosis (AS) is a common valvular pathology in developed nations. Secondary to advanced age and often multiple co-morbidities, a significant percentage of patients are not considered surgical candidates. For these high-risk patients, transcatheter aortic valve replacement (TAVR) is a rapidly emerging less-invasive treatment alternative. Because of the lack of direct exposure and visualization of the operative field, pre-procedural planning and intra-procedural guidance relies on imaging. Large 3-dimensional data files are acquired, which are reconstructed on advanced workstations during review and interpretation. Optimally, the imaging data is organized into a comprehensive digital file as an integral part of the electronic health record (EHR) following the patient. This manuscript will discuss the role of image data management in the context of TAVR.
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Affiliation(s)
- Paul Schoenhagen
- Cleveland Clinic, Imaging Institute and Heart & Vascular Institute, OH 44195, USA.
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