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Hammer Y, Xie J, Yang G, Bitar A, Haft JW, Cascino TM, Likosky DS, Pagani FD, Zhang M, Aaronson KD. Gastrointestinal bleeding following Heartmate 3 left ventricular assist device implantation: The Michigan Bleeding Risk Model. J Heart Lung Transplant 2024; 43:604-614. [PMID: 38065237 DOI: 10.1016/j.healun.2023.11.016] [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] [Received: 06/20/2023] [Revised: 11/21/2023] [Accepted: 11/27/2023] [Indexed: 12/25/2023] Open
Abstract
BACKGROUND Gastrointestinal bleeding (GIB) results in frequent hospitalizations and impairs quality of life in durable left ventricular assist device (LVAD) recipients. Anticipation of these events before implantation could have important implications for patient selection and management. METHODS The study population included all adult HeartMate 3 (HM3) primary LVAD recipients enrolled in the STS Intermacs registry from January 2017 to December 2020. Using multivariable modeling methodologies, we investigated the relationships between preimplantation characteristics and postimplant bleeding, bleeding and death, and additional bleeding episodes on subsequent bleeding episodes and created a risk score to predict the likelihood of post-LVAD GIB based solely on preimplantation factors. RESULTS Of 6,425 patients who received an HM3 LVAD, 1,010 (15.7%) patients experienced GIB. Thirteen preimplantation factors were independent predictors of post-LVAD GIB. A risk score was created from these factors and calculated for each patient. By 3 years postimplant, GIB occurred in 11%, 26%, and 43% of low-, medium- and high-risk patients, respectively. Experiencing 1 post-LVAD GIB event was associated with an increased risk for further GIB events, with 33.9% of patients experiencing at least 1 recurrence. While post-LVAD GIB was associated with mortality, there was no relationship between number of GIB events and death. CONCLUSIONS The Michigan Bleeding Risk Model is a simple tool, which facilitates the prediction of post-LVAD GIB in HM3 recipients using 13 preimplant variables. The implementation of this tool may help in the risk stratification process and may have therapeutic and clinical implications in HM3 LVAD recipients.
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Affiliation(s)
- Yoav Hammer
- Division of Cardiovascular Disease, Michigan Medicine - University of Michigan, Ann Arbor, Michigan.
| | - Jiaheng Xie
- Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan
| | - Guangyu Yang
- Institute of Statistics and Big Data, Renmin University of China, Beijing, China
| | - Abbas Bitar
- Division of Cardiovascular Disease, Michigan Medicine - University of Michigan, Ann Arbor, Michigan
| | - Jonathan W Haft
- Department of Cardiac Surgery, Michigan Medicine - University of Michigan, Ann Arbor, Michigan
| | - Thomas M Cascino
- Division of Cardiovascular Disease, Michigan Medicine - University of Michigan, Ann Arbor, Michigan
| | - Donald S Likosky
- Department of Cardiac Surgery, Michigan Medicine - University of Michigan, Ann Arbor, Michigan
| | - Francis D Pagani
- Department of Cardiac Surgery, Michigan Medicine - University of Michigan, Ann Arbor, Michigan
| | - Min Zhang
- Tsinghua Univeristy, Vanke School of Public Health, Beijing, China
| | - Keith D Aaronson
- Division of Cardiovascular Disease, Michigan Medicine - University of Michigan, Ann Arbor, Michigan
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Dailey J, Nguyen LH, Kohli A, Ha JB, Russell MB, Dhingra R, Kiernan MS, Thomas MF, Coglianese EC, Sterling MJ, Yacavone RF, Natov N, Richter JM. A Multicenter Study of Left Ventricular Assist Device-Related Gastrointestinal Bleeding. Clin Transl Gastroenterol 2022; 13:e00526. [PMID: 36007177 PMCID: PMC9624495 DOI: 10.14309/ctg.0000000000000526] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/03/2022] [Accepted: 08/10/2022] [Indexed: 11/17/2022] Open
Abstract
INTRODUCTION Continuous left ventricular assist devices (LVADs) offer hemodynamic support in advanced and decompensated heart failure but are often complicated by gastrointestinal bleeding (GIB) in medically fragile patients. METHODS We performed a retrospective analysis of 475 consecutive patients who underwent LVAD implantation at the Massachusetts General Hospital and Tufts Medical Center from 2008 to 2019 and identified 128 patients with clinically significant GIB. Clinical characteristics of each bleeding event, including procedures and interventions, were recorded. We examined LVAD patients with overt and occult presentations to determine diagnostic endoscopic yield and analyzed predictors of recurrent GIB. RESULTS We identified 128 unique patients with LVAD implantation complicated by GIB. No significant difference was observed based on study center, underlying cardiomyopathy, race/ethnicity, serum indices, and medications used. Overt bleeders presented more commonly during LVAD implantation admission ( P = 0.001) than occult bleeders. Occult bleed presentations had only 1 lower and no middle GI bleed source identified, despite similar workups to overt bleeds. Destination therapy (e.g., among nontransplant candidates) LVAD implantation (odds ratio 2.38, 95% confidence interval 1.05-5.58) and a history of GIB (odds ratio 3.85, 95% confidence interval 1.29-12.7) were independently associated with an increased risk of recurrent GIB-related hospitalization. DISCUSSION Our findings confirm a high rate of GIB, especially in destination LVAD patients, and show a low diagnostic yield for colonoscopy and middle GI bleed assessments in LVAD patients with occult bleeds. Overt bleeding was more common and associated with vascular malformations. Although endoscopic interventions stopped active hemorrhage, GIB often recurred.
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Affiliation(s)
- Joseph Dailey
- Division of Gastroenterology, Boston Medical Center, Boston, Massachusetts, USA
| | - Long H. Nguyen
- Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA
- Massachusetts General Hospital Clinical and Translational Epidemiology Unit, Boston, Massachusetts, USA
| | - Arushi Kohli
- Division of Gastroenterology, Boston Medical Center, Boston, Massachusetts, USA
| | - Jasmine B. Ha
- Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA
| | - Michael B. Russell
- Division of Gastroenterology, Tufts Medical Center, Boston, Massachusetts, USA
| | - Rohit Dhingra
- Division of Gastroenterology, Tufts Medical Center, Boston, Massachusetts, USA
| | - Michael S. Kiernan
- Department of Cardiology, Tufts Medical Center, Boston, Massachusetts, USA
| | - Molly F. Thomas
- Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA
| | - Erin C. Coglianese
- Cardiology Division, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA
- Massachusetts General Hospital Transplant Center, Boston, Massachusetts, USA
| | - Mark J. Sterling
- Division of Gastroenterology, Tufts Medical Center, Boston, Massachusetts, USA
| | - Robert F. Yacavone
- Division of Gastroenterology, Tufts Medical Center, Boston, Massachusetts, USA
| | - Nikola Natov
- Division of Gastroenterology, Tufts Medical Center, Boston, Massachusetts, USA
| | - James M. Richter
- Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA
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Felix SEA, Bagheri A, Ramjankhan FR, Spruit MR, Oberski D, de Jonge N, van Laake LW, Suyker WJL, Asselbergs FW. A data mining-based cross-industry process for predicting major bleeding in mechanical circulatory support. EUROPEAN HEART JOURNAL. DIGITAL HEALTH 2021; 2:635-642. [PMID: 36713101 PMCID: PMC9707970 DOI: 10.1093/ehjdh/ztab082] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 12/13/2020] [Revised: 02/17/2021] [Accepted: 09/27/2021] [Indexed: 02/01/2023]
Abstract
Aims Over a third of patients, treated with mechanical circulatory support (MCS) for end-stage heart failure, experience major bleeding. Currently, the prediction of a major bleeding in the near future is difficult because of many contributing factors. Predictive analytics using data mining could help calculating the risk of bleeding; however, its application is generally reserved for experienced researchers on this subject. We propose an easily applicable data mining tool to predict major bleeding in MCS patients. Methods and results All data of electronic health records of MCS patients in the University Medical Centre Utrecht were included. Based on the cross-industry standard process for data mining (CRISP-DM) methodology, an application named Auto-Crisp was developed. Auto-Crisp was used to evaluate the predictive models for a major bleeding in the next 3, 7, and 30 days after the first 30 days post-operatively following MCS implantation. The performance of the predictive models is investigated by the area under the curve (AUC) evaluation measure. In 25.6% of 273 patients, a total of 142 major bleedings occurred during a median follow-up period of 542 [interquartile range (IQR) 205-1044] days. The best predictive models assessed by Auto-Crisp had AUC values of 0.792, 0.788, and 0.776 for bleedings in the next 3, 7, and 30 days, respectively. Conclusion The Auto-Crisp-based predictive model created in this study had an acceptable performance to predict major bleeding in MCS patients in the near future. However, further validation of the application is needed to evaluate Auto-Crisp in other research projects.
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Affiliation(s)
- Susanne E A Felix
- Department of Cardiology, Division Heart & Lungs, University Medical Centre Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands,Corresponding author. Tel: +31887555555. S.E.A.
| | - Ayoub Bagheri
- Department of Cardiology, Division Heart & Lungs, University Medical Centre Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands,Department of Methodology and Statistics, Faculty of Social Sciences, Utrecht University, Utrecht, the Netherlands
| | - Faiz R Ramjankhan
- Department of Cardiothoracic Surgery, University Medical Centre of Utrecht, University of Utrecht, Utrecht, the Netherlands
| | - Marco R Spruit
- Department of Information and Computing Sciences, Utrecht, Utrecht, the Netherlands
| | - Daniel Oberski
- Department of Methodology and Statistics, Faculty of Social Sciences, Utrecht University, Utrecht, the Netherlands
| | - Nicolaas de Jonge
- Department of Cardiology, Division Heart & Lungs, University Medical Centre Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands
| | - Linda W van Laake
- Department of Cardiology, Division Heart & Lungs, University Medical Centre Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands
| | - Willem J L Suyker
- Department of Cardiothoracic Surgery, University Medical Centre of Utrecht, University of Utrecht, Utrecht, the Netherlands
| | - Folkert W Asselbergs
- Department of Cardiology, Division Heart & Lungs, University Medical Centre Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands,Institute of Cardiovascular Science, Faculty of Population Health Sciences, University College London, London, UK,Health Data Research UK London and Institute of Health Informatics, University College London, London, UK
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Stern B, Maheshwari P, Gorrepati VS, Bethards D, Chintanaboina J, Boehmer J, Clarke K. Initial endoscopic intervention is not associated with reduced risk of recurrent gastrointestinal bleeding in left ventricular assist device patients. Ann Gastroenterol 2021; 34:660-668. [PMID: 34475736 PMCID: PMC8375646 DOI: 10.20524/aog.2021.0656] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/23/2020] [Accepted: 09/23/2020] [Indexed: 11/11/2022] Open
Abstract
Background Left ventricular assist devices (LVADs) are increasingly used for mechanical support of end-stage heart failure. Gastrointestinal bleeding (GIB) confers a significant morbidity in LVAD patients, with rates of up to 30% at 5 years. We assessed predictors of index and recurrent GIB (rGIB) in LVAD patients to risk stratify patients and evaluate if endoscopic approach and intervention at index GIB impacted rGIB. Methods A retrospective chart review of all LVAD patients at our institution from 01/01/2006 to 31/10/2016 was completed. Predictors for index and recurrent GIB were analyzed. Multivariate logistic regression analysis was created using only statistically significant dependent variables and adjusted for demographic variables. Results A total of 77/214 (36%) patients developed GIB, and 38/214 (17.8%) developed rGIB. Destination therapy (P=0.01), longer duration of LVAD (P=0.03), and low albumin (<3.5 g/dL) (P<0.001) were associated with increased risk of index GIB. Charlson Comorbidity Index, heart failure etiology, and Medicare were predictors of index GIB on univariate analysis, but this was not seen on multivariate analysis. Performing an endoscopy with/without intervention, non- angioectasia lesions, and location of bleeding were not statistically significant predictors of rGIB. Longer duration of hospitalization appeared to be protective for rGIB on univariate analysis. Conclusions Index endoscopy and intervention is not associated with reduced risk of rGIB in LVAD patients. Several independent factors are associated with the risk of index GIB. Albumin is a potentially modifiable risk factor, and likely contributes to bleeding through poor nutrition. It is a surrogate marker for systemic illness, and may have pharmacologic implications.
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Affiliation(s)
- Benjamin Stern
- Division of Gastroenterology and Hepatology, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA (Benjamin Stern, Venkata S. Gorrepati, Deborah Bethards, Kofi Clarke)
| | - Parth Maheshwari
- Department of Internal Medicine, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA (Parth Maheshwari)
| | - Venkata S Gorrepati
- Division of Gastroenterology and Hepatology, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA (Benjamin Stern, Venkata S. Gorrepati, Deborah Bethards, Kofi Clarke)
| | - Deborah Bethards
- Division of Gastroenterology and Hepatology, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA (Benjamin Stern, Venkata S. Gorrepati, Deborah Bethards, Kofi Clarke)
| | - Jayakrishna Chintanaboina
- Division of Gastroenterology, University of California San Francisco Fresno, Fresno, CA, USA (Jayakrishna Chintanaboina)
| | - John Boehmer
- Division of Cardiology, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA (John Boehmer)
| | - Kofi Clarke
- Division of Gastroenterology and Hepatology, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA (Benjamin Stern, Venkata S. Gorrepati, Deborah Bethards, Kofi Clarke)
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Palchaudhuri S, Dhawan I, Parsikia A, Birati EY, Wald J, Siddique SM, Fisher LR. Does endoscopic intervention prevent subsequent gastrointestinal bleeding in patients with left ventricular assist devices? A retrospective study. World J Gastroenterol 2021; 27:3877-3887. [PMID: 34321851 PMCID: PMC8291026 DOI: 10.3748/wjg.v27.i25.3877] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/14/2021] [Revised: 04/19/2021] [Accepted: 06/02/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Patients with left ventricular assist devices (LVADs) are at increased risk for recurrent gastrointestinal bleeding (GIB) and repeat endoscopic procedures. We assessed the frequency of endoscopy for GIB in patients with LVADs and the impact of endoscopic intervention on preventing a subsequent GIB.
AIM To evaluate for an association between endoscopic intervention and subsequent GIB. Secondary aims were to assess the frequency of GIB in our cohort, describe GIB presentations and sources identified, and determine risk factors for recurrent GIB.
METHODS We conducted a retrospective cohort study of all patients at a large academic institution who underwent LVAD implantation from January 2011 – December 2018 and assessed all hospital encounters for GIB through December 2019. We performed a descriptive analysis of the GIB burden and the outcome of endoscopic procedures performed. We performed multivariate logistic regression to evaluate the association between endoscopic intervention and subsequent GIB.
RESULTS In the cohort of 295 patients, 97 (32.9%) had at least one GIB hospital encounter. There were 238 hospital encounters, with 55.4% (132/238) within the first year of LVAD implantation. GIB resolved on its own by discharge in 69.8% (164/235) encounters. Recurrent GIB occurred in 55.5% (54/97) of patients, accounting for 59.2% (141/238) of all encounters. Of the 85.7% (204/238) of encounters that included at least one endoscopic evaluation, an endoscopic intervention was performed in 34.8% (71/204). The adjusted odds ratio for subsequent GIB if an endoscopic intervention was performed during a GIB encounter was not significant (odds ratio 1.18, P = 0.58).
CONCLUSION Patients implanted with LVADs whom experience recurrent GIB frequently undergo repeat admissions and endoscopic procedures. In this retrospective cohort study, adherence to endoscopic guidelines for performing endoscopic interventions did not significantly decrease the odds of subsequent GIB, thus suggesting the uniqueness of the LVAD population. A prospective study is needed to identify patients with LVAD at risk of recurrent GIB and determine more effective management strategies.
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Affiliation(s)
- Sonali Palchaudhuri
- Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA 19104, United States
| | - Ishita Dhawan
- Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA 19104, United States
| | - Afshin Parsikia
- Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA 19104, United States
| | - Edo Y Birati
- Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, PA 19104, United States
| | - Joyce Wald
- Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, PA 19104, United States
| | - Shazia Mehmood Siddique
- Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA 19104, United States
| | - Laurel R Fisher
- Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA 19104, United States
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Leebeek FWG, Muslem R. Bleeding in critical care associated with left ventricular assist devices: pathophysiology, symptoms, and management. HEMATOLOGY. AMERICAN SOCIETY OF HEMATOLOGY. EDUCATION PROGRAM 2019; 2019:88-96. [PMID: 31808855 PMCID: PMC6913502 DOI: 10.1182/hematology.2019000067] [Citation(s) in RCA: 26] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/10/2023]
Abstract
Chronic heart failure (HF) is a growing health problem, and it is associated with high morbidity and mortality. Left ventricular assist devices (LVADs) are nowadays an important treatment option for patients with end-stage HF not only as a bridging tool to heart transplantation but also, as a permanent therapy for end-stage HF (destination therapy). The use of LVAD is associated with a high risk for bleeding complications and thromboembolic events, including pump thrombosis and ischemic stroke. Bleeding is the most frequent complication, occurring in 30% to 60% of patients, both early and late after LVAD implantation. Although the design of LVADs has improved over time, bleeding complications are still the most common complication and occur very frequently. The introduction of an LVAD results in an altered hemostatic balance as a consequence of blood-pump interactions, changes in hemodynamics, acquired coagulation abnormalities, and the strict need for long-term anticoagulant treatment with oral anticoagulants and antiplatelet therapy. LVAD patients may experience an acquired coagulopathy, including platelet dysfunction and impaired von Willebrand factor activity, resulting in acquired von Willebrand syndrome. In this educational manuscript, the epidemiology, etiology, and pathophysiology of bleeding in patients with LVAD will be discussed. Because hematologist are frequently consulted in cases of bleeding problems in these individuals in a critical care setting, the observed type of bleeding complications and management strategies to treat bleeding are also reviewed.
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Affiliation(s)
| | - R Muslem
- Cardio-Thoracic Surgery, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands
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Simon MA, Bachman TN, Watson J, Baldwin JT, Wagner WR, Borovetz HS. Current and Future Considerations in the Use of Mechanical Circulatory Support Devices: An Update, 2008–2018. Annu Rev Biomed Eng 2019; 21:33-60. [DOI: 10.1146/annurev-bioeng-062117-121120] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
Our review in the 2008 volume of this journal detailed the use of mechanical circulatory support (MCS) for treatment of heart failure (HF). MCS initially utilized bladder-based blood pumps generating pulsatile flow; these pulsatile flow pumps have been supplanted by rotary blood pumps, in which cardiac support is generated via the high-speed rotation of computationally designed blading. Different rotary pump designs have been evaluated for their safety, performance, and efficacy in clinical trials both in the United States and internationally. The reduced size of the rotary pump designs has prompted research and development toward the design of MCS suitable for infants and children. The past decade has witnessed efforts focused on tissue engineering–based therapies for the treatment of HF. This review explores the current state and future opportunities of cardiac support therapies within our larger understanding of the treatment options for HF.
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Affiliation(s)
- Marc A. Simon
- Department of Medicine, Vascular Medicine Institute, and Heart and Vascular Institute, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
- Department of Bioengineering, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
- McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
| | - Timothy N. Bachman
- Department of Medicine, Vascular Medicine Institute, and Heart and Vascular Institute, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
- Department of Bioengineering, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
- McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
| | - John Watson
- Department of Bioengineering, University of California, San Diego, La Jolla, California 92093, USA
| | - J. Timothy Baldwin
- National Heart, Blood, and Lung Institute, Bethesda, Maryland 20892, USA
| | - William R. Wagner
- Department of Bioengineering, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
- McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
- Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
- Department of Chemical and Petroleum Engineering, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
| | - Harvey S. Borovetz
- Department of Bioengineering, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
- McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
- Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
- Department of Chemical and Petroleum Engineering, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA
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