Adverse events in contemporary continuous-flow left ventricular assist devices: A multi-institutional comparison shows significant differences

Journal of Thoracic and Cardiovascular Surgery

Volumn 151, Issue 1, 2016, Pages 177-189

  Stulak, John M ^a   Davis, Mary E ^b   Haglund, Nicholas ^b   Dunlay, Shannon ^a   Cowger, Jennifer ^c   Shah, Palak ^d   Pagani, Francis D ^e   Aaronson, Keith D ^e   Maltais, Simon ^a  

^a Mayo Clinic   (United States)

^b VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^c St Vincent s Heart Center of Indiana   (United States)

^d INOVA FAIRFAX HOSPITAL   (United States)

^e UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

Author keywords

heart failure; mechanical circulatory support; ventricular assist device

Indexed keywords

BILIRUBIN; CREATININE;

ADULT; CATHETER INFECTION; CEREBROVASCULAR ACCIDENT; CONFERENCE PAPER; CONTINUOUS FLOW LEFT VENTRICULAR ASSIST DEVICE; DRIVELINE INFECTION; FEMALE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HEART FAILURE; HEART RIGHT VENTRICLE FAILURE; HUMAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; INFECTION; LEFT VENTRICULAR ASSIST DEVICE; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; MEDICAL DEVICE COMPLICATION; OVERALL SURVIVAL; PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER; PREOPERATIVE EVALUATION; PRIORITY JOURNAL; PROSTHESIS THROMBOSIS; STERNOTOMY; SURVIVOR; ADOLESCENT; ADVERSE EFFECTS; AGED; CHI SQUARE DISTRIBUTION; CLINICAL TRIAL; COMPARATIVE STUDY; HEART ASSIST DEVICE; HEART LEFT VENTRICLE FUNCTION; HEART RIGHT VENTRICLE FUNCTION; INCIDENCE; KAPLAN MEIER METHOD; MICROBIOLOGY; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; MULTIVARIATE ANALYSIS; PATHOPHYSIOLOGY; PROPORTIONAL HAZARDS MODEL; PROSTHESIS; PROSTHESIS-RELATED INFECTIONS; REGISTER; RETROSPECTIVE STUDY; RISK ASSESSMENT; RISK FACTOR; STROKE; THROMBOSIS; TIME; TREATMENT OUTCOME; UNITED STATES; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CHI-SQUARE DISTRIBUTION; FEMALE; GASTROINTESTINAL HEMORRHAGE; HEART FAILURE; HEART-ASSIST DEVICES; HUMANS; INCIDENCE; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; PROPORTIONAL HAZARDS MODELS; PROSTHESIS DESIGN; PROSTHESIS-RELATED INFECTIONS; REGISTRIES; RETROSPECTIVE STUDIES; RISK ASSESSMENT; RISK FACTORS; STROKE; THROMBOSIS; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; VENTRICULAR FUNCTION, LEFT; VENTRICULAR FUNCTION, RIGHT; YOUNG ADULT;

EID: 84958587026     PISSN: 00225223     EISSN: 1097685X     Source Type: Journal    
DOI: 10.1016/j.jtcvs.2015.09.100     Document Type: Conference Paper

References (26)

1. J.K. Kirklin, D.C. Naftel, F. Pagani, R.L. Kormos, L.W. Stevenson, E.D. Blume, and et al. Sixth INTERMACS annual report: a 10,000-patient database J Heart Lung Transplant 33 2014 555 564
2. K.D. Aaronson, M.S. Slaughter, L.W. Miller, E.C. McGee, W.G. Cotts, M.A. Acker, and et al. Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation Circulation 125 2012 3191 3200
3. S.D. Lalonde, A.C. Alba, A. Rigobon, H.J. Ross, D.H. Delgado, F. Billia, and et al. Clinical differences between continuous flow ventricular assist devices: A comparison between HeartMate II and HeartWare HVAD J Card Surg 28 2013 604 610
4. US Food and Drug Administration. Summary of safety and effectiveness data (SSED). HeartWare Ventricular Assist System P100047. Available at: http://www.accessdata.fda.gove/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p100047. Accessed August 23, 2015.
5. F.D. Pagani, C.A. Milano, A.J. Tatooles, M.S. Bhat, E.J. Slaughter, E.J. Birks, and et al. HeartWare HVAD for the treatment of patients with advanced heart failure ineligible for cardiac transplantation: results of the ENDURANCE Destination Therapy trial J Heart Lung Transplant 34 2015 S9 [Abstract]
6. R. John, Y. Naka, S.J. Park, C. Sai-Sudhakar, C. Salerno, K.S. Sundareswaran, and et al. Impact of concurrent surgical valve procedures in patients receiving continuous-flow devices J Thorac Cardiovasc Surg 147 2014 581 589
7. S.T. Coffin, D.R. Waguespack, N.A. Haglund, S. Maltais, J.P. Dwyer, and M.E. Keebler Kidney dysfunction and left ventricular assist device support: a comprehensive perioperative review Cardiorenal Med 5 2015 48 60
8. S. Crow, D. Chen, C. Milano, W. Thomas, L. Joyce, V. Piacentino III, and et al. Acquired von Willebrand syndrome in continuous-flow ventricular assist device recipients Ann Thorac Surg 90 2010 1263 1269 discussion 1269
9. A.J. Boyle, S.D. Russell, J.J. Teuteberg, M.S. Slaughter, N. Moazami, F.D. Pagani, and et al. Low thromboembolism and pump thrombosis with the HeartMate II left ventricular assist device: analysis of outpatient anticoagulation J Heart Lung Transplant 28 2009 881 887
10. A.J. Boyle, U.P. Jorde, B. Sun, S.J. Park, C.A. Milano, O.H. Frazier, and et al. Preoperative risk factors of bleeding and stroke during left ventricular assist device support: an analysis of more than 900 HeartMate II outpatients J Am Coll Cardiol 63 2014 880 888
11. S. Maltais, G.A. Ewald, M.E. Keebler, S.S. Boyce, F.D. Najjar, F.D. Pagani, and et al. Update on post-approval INTERMACS registry of the HVAD system in commercial use J Heart Lung Transplant 34 2015 S195 [Abstract]
12. D.J. Goldstein, D. Naftel, W. Holman, L. Bellumkonda, S.V. Pamboukian, F.D. Pagani, and et al. Continuous-flow devices and percutaneous site infections: clinical outcomes J Heart Lung Transplant 31 2012 1151 1157
13. M.S. Slaughter, R. Bostic, K. Tong, M. Russo, and J.G. Rogers Temporal changes in hospital costs for left ventricular assist device implantation J Card Surg 26 2011 535 541
14. R. John, K.D. Aaronson, W.E. Pae, M.A. Acker, D.R. Hathaway, K.B. Najarian, et al. HeartWare Bridge to Transplant ADVANCE Trial Investigators Driveline infections and sepsis in patients receiving the HVAD system as a left ventricular assist device J Heart Lung Transplant 33 2014 1066 1073
15. L.W. Miller, F.D. Pagani, S.D. Russell, R. John, A.J. Boyle, K.D. Aaronson, et al. HeartMate II Clinical Investigators Use of a continuous-flow device in patients awaiting heart transplantation N Engl J Med 357 2007 885 896
16. F.D. Pagani, L.W. Miller, S.D. Russell, K.D. Aaronson, R. John, A.J. Boyle, and et al. Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device J Am Coll Cardiol 54 2009 312 321
17. V. Sharma, S.V. Deo, J.M. Stulak, L.A. Durham III, R.C. Daly, S.J. Park, and et al. Driveline infections in left ventricular assist devices: implications for destination therapy Ann Thorac Surg 94 2012 1381 1386
18. S.J. Park, C.A. Milano, A.J. Tatooles, J.G. Rogers, R.M. Adamson, D.E. Steidley, et al. HeartMate II Clinical Investigators Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy Circ Heart Fail 5 2012 241 248
19. J.A. Morgan, R.J. Brewer, H.W. Nemeh, B. Gerlach, D.E. Lanfear, C.T. Williams, and et al. Stroke while on long-term left ventricular assist device support: incidence, outcome, and predictors ASAIO J 60 2014 284 289
20. J.M. Stulak, S. Deo, J. Schirger, K.D. Aaronson, S.J. Park, L.D. Joyce, and et al. Preoperative atrial fibrillation increases risk of thromboembolic events after left ventricular assist device implantation Ann Thorac Surg 96 2013 2161 2167
21. R.C. Starling, N. Moazami, S.C. Silvestry, G. Ewald, J.G. Rogers, C.A. Milano, and et al. Unexpected abrupt increase in left ventricular assist device thrombosis N Engl J Med 370 2014 33 40
22. J.K. Kirklin, D.C. Naftel, R.L. Kormos, F.D. Pagani, S.L. Myers, L.W. Stevenson, and et al. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device J Heart Lung Transplant 33 2014 12 22
23. S.S. Najjar, M.S. Slaughter, F.D. Pagani, R.C. Starling, E.C. McGee, P. Eckman, and et al. An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial J Heart Lung Transplant 33 2014 23 34
24. J.M. Stulak, and S. Maltais A different perspective on thrombosis and the HeartMate II N Engl J Med 370 2014 1467 1468
25. M.S. Slaughter, Y. Naka, R. John, A. Boyle, J.V. Conte, S.D. Russell, and et al. Postoperative heparin may not be required for transitioning patients with a HeartMate II left ventricular assist system to long-term warfarin therapy J Heart Lung Transplant 29 2010 616 624
26. M.S. Slaughter, F.D. Pagani, E.C. McGee, E.J. Birks, W.G. Cotts, I. Gregoric, and et al. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial J Heart Lung Transplant 32 2013 675 683