Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure -1 year results from the Ce mark trial

Journal of Cardiothoracic Surgery

Volumn 12, Issue 1, 2017, Pages

  Krabatsch, Thomas ^a   Netuka, Ivan ^b   Schmitto, Jan D ^c   Zimpfer, Daniel ^d   Garbade, Jens ^e   Rao, Vivek ^f   Morshuis, Michiel ^g   Beyersdorf, Friedhelm ^h   Marasco, Silvana ⁱ   Damme, Laura ^j   Pya, Yuriy ^k  

^a DEUTSCHES HERZZENTRUM BERLIN   (Germany)

^b INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE   (Czech Republic)

^c HANNOVER MEDICAL SCHOOL   (Germany)

^d UNIVERSITY OF VIENNA   (Austria)

^e UNIVERSITY OF LEIPZIG HEART CENTER   (Germany)

^f TORONTO GENERAL HOSPITAL   (Canada)

^g RUHR UNIVERSITY BOCHUM   (Germany)

^h UNIVERSITY HEART CENTER FREIBURG BAD KROZINGEN   (Germany)

ⁱ ALFRED HOSPITAL   (Australia)

^j St Jude Medical   (Belgium)

^k National Research Cardiac Surgery Center   (Kazakhstan)

more..

Author keywords

Heart failure; HeartMate 3; LVAS; Magnetic levitation

Indexed keywords

CLINICAL TRIAL; EQUIPMENT DESIGN; FEMALE; FOLLOW UP; HEART ASSIST DEVICE; HEART FAILURE; HEMODYNAMICS; HUMAN; MAGNET; MALE; MIDDLE AGED; PATHOPHYSIOLOGY; PHYSIOLOGY; PROSPECTIVE STUDY; QUALITY OF LIFE; TIME FACTOR; TREATMENT OUTCOME;

EQUIPMENT DESIGN; FEMALE; FOLLOW-UP STUDIES; HEART FAILURE; HEART-ASSIST DEVICES; HEMODYNAMICS; HUMANS; MAGNETS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; QUALITY OF LIFE; TIME FACTORS; TREATMENT OUTCOME;

EID: 85016982306     PISSN: None     EISSN: 17498090     Source Type: Journal    
DOI: 10.1186/s13019-017-0587-3     Document Type: Article

References (39)

1. Pagani FD, Miller LW, Russell SD, et al. Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device. J Am Coll Cardiol. 2009;54:312-21.
2. Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241-51.
3. John R, Naka Y, Smedira NG, et al. Continuous flow left ventricular assist device outcomes in commercial use compared with the prior clinical trial. Ann Thorac Surg. 2011;92:1406-13. discussion 13.
4. Starling RC, Naka Y, Boyle AJ, et al. Results of the post-U.S. Food and drug administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation a prospective study using the INTERMACS (interagency registry for mechanically assisted circulatory support). J Am Coll Cardiol. 2011;57:1890-8.
5. Slaughter MS, Pagani FD, McGee EC, 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. 2013;32:675-83.
6. Strueber M, Larbalestier R, Jansz P, et al. Results of the post-market registry to evaluate the HeartWare left ventricular assist system (ReVOLVE). J Heart Lung Transplant. 2014;33:486-91.
7. Uriel N, Adatya S, Mehra MR. Evolution in mechanical circulatory support: Are We at the precipice of a disruptive innovation? J Am Coll Cardiol. 2015;66:2590-3.
8. Pagani FD. Adverse event burden and mechanical circulatory support: looking toward the future. J Thorac Cardiovasc Surg. 2016;151:10-2.
9. Bourque K, Cotter C, Dague C, Harjes D, Dur O, Duhamel J, Spink K, Walsh K, Burke E. Design rationale and preclinical evaluation of the HeartMate 3 left ventricular assist system for hemocompatibility. ASAIO J. 2016;62:375-83.
10. Netuka I, Sood P, Pya Y, et al. Fully magnetically levitated left ventricular assist system for treating advanced HF: a multicenter study. J Am Coll Cardiol. 2015;66:2579-89.
11. Schmitto JD, Hanke JS, Rojas SV, Avsar M, Haverich A. First implantation in man of a new magnetically levitated left ventricular assist device (HeartMate III). J Heart Lung Transplant. 2015;34:858-60.
12. Manual of operations; Protocol: Appedix A Adverse event definitions. https://www.uab.edu/medicine/intermacs/appendices/app-a-5-0.
13. Goldstein DJ, Aaronson KD, Tatooles AJ, et al. Gastrointestinal bleeding in recipients of the HeartWare ventricular assist system. JACC Heart Fail. 2015;3:303-13.
14. Stern DR, Kazam J, Edwards P, et al. Increased incidence of gastrointestinal bleeding following implantation of the HeartMate II LVAD. J Card Surg. 2010;25:352-6.
15. Morgan JA, Paone G, Nemeh HW, et al. Gastrointestinal bleeding with the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2012;31:715-8.
16. Stulak JM, Lee D, Haft JW, et al. Gastrointestinal bleeding and subsequent risk of thromboembolic events during support with a left ventricular assist device. J Heart Lung Transplant. 2014;33:60-4.
17. Holley CT, Harvey L, Roy SS, et al. Gastrointestinal bleeding during continuous-flow left ventricular assist device support is associated with lower rates of cardiac transplantation. ASAIO J. 2015;61:635-9.
18. Lopilato AC, Doligalski CT, Caldeira C. Incidence and risk factor analysis for gastrointestinal bleeding and pump thrombosis in left ventricular assist device recipients. Artif Organs. 2015;39:939-44.
19. Tsiouris A, Paone G, Nemeh HW, et al. Lessons learned from 150 continuous-flow left ventricular assist devices: a single institutional 7 year experience. ASAIO J. 2015;61:266-73.
20. Dell'Aquila AM, Schneider SR, Schlarb D, et al. Initial clinical experience with the HeartWare left ventricular assist system: a single-center report. Ann Thorac Surg. 2013;95:170-7.
21. Meyer AL, Malehsa D, Budde U, Bara C, Haverich A, Strueber M. Acquired von willebrand syndrome in patients with a centrifugal or axial continuous flow left ventricular assist device. JACC Heart Fail. 2014;2:141-5.
22. Uriel N, Pak SW, Jorde UP, et al. Acquired von willebrand syndrome after continuous-flow mechanical device support contributes to a high prevalence of bleeding during long-term support and at the time of transplantation. J Am Coll Cardiol. 2010;56:1207-13.
23. Moazami N, Dembitsky WP, Adamson R, et al. Does pulsatility matter in the era of continuous-flow blood pumps? J Heart Lung Transplant. 2015;34:999-1004.
24. Wever-Pinzon O, Selzman CH, Drakos SG, et al. Pulsatility and the risk of nonsurgical bleeding in patients supported with the continuous-flow left ventricular assist device HeartMate II. Circ Heart Fail. 2013;6:517-26.
25. Netuka I, Kvasnicka T, Kvasnicka J, Hrachovinova I, Ivak P, Marecek F, Bilkova J, Malikova I, Jancova M, Maly J, Sood P, Sundareswaran KS, Connors JM, Mehra MR. Evaluation of von willebrand factor with a fully magnetically levitated centrifugal continuous-flow left ventricular assist device in advanced heart failure. J Heart Lung Transplant. 2016;35:860-7.
26. Starling RC, Moazami N, Silvestry SC, et al. Unexpected abrupt increase in left ventricular assist device thrombosis. N Engl J Med. 2014;370:33-40.
27. Mehra MR, Stewart GC, Uber PA. The vexing problem of thrombosis in long-term mechanical circulatory support. J Heart Lung Transplant. 2014;33:1-11.
28. Levin AP, Uriel N, Takayama H, et al. Device exchange in HeartMate II recipients: long-term outcomes and risk of thrombosis recurrence. ASAIO J. 2015;61:144-9.
29. McCarthy FH, Kobrin D, Rame JE, et al. Increasing frequency of left ventricular assist device exchanges in the united states. Ann Thorac Surg. 2015;100:1660-4. discussion 1665.
30. Soleimani B, Stephenson ER, Price LC, El-Banayosy A, Pae WE. Clinical experience with sternotomy versus subcostal approach for exchange of HeartMate II left ventricular assist device. Ann Thorac Surg. 2015;100:1577-80.
31. Oezpeker C, Zittermann A, Ensminger S, et al. Systemic thrombolysis versus device exchange for pump thrombosis management: a single center experience. ASAIO J. 2016;62:246-51.
32. Najjar SS, Slaughter MS, Pagani FD, 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. 2014;33:23-34.
33. Kirklin JK, Naftel DC, Pagani FD, et al. Pump thrombosis in the thoratec HeartMate II device: an update analysis of the INTERMACS registry. J Heart Lung Transplant. 2015;34:1515-26.
34. Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland Jr JC, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C, Investigators M. A fully magnetically levitated circulatory pump for advanced heart failure. N Engl J Med. 2017;376:440-50.
35. Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter M, Birks EJ, Boyce SW, Najjar SS, Jeevanandam V, Anderson AS, Gregoric ID, Mallidi H, Leadley K, Aaronson KD, Frazier OH, Milano CA. Intrapericardial left ventricular assist device for advanced heart failure. N Engl J Med. 2017;376:451-60.
36. Jorde UP, Kushwaha SS, Tatooles AJ, et al. Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS registry (interagency registry for mechanically assisted circulatory support). J Am Coll Cardiol. 2014;63:1751-7.
37. Kirklin JK, Cantor R, Mohacsi P, et al. First annual IMACS report: a global international society for heart and lung transplantation registry for mechanical circulatory support. J Heart Lung Transplant. 2016;35:407-12.
38. Uriel N, Adatya S, Maly J, Kruse E, Rodgers D, Heatley G, Herman A, Sood P, Berliner D, Bauersachs J, Haverich A, Želízko M, Schmitto JD, Netuka I. Clinical hemodynamic evaluation of patients implanted with a fully magnetically levitated left ventricular assist device (HeartMate 3). J Heart Lung Transplant. 2017;36:28-35.
39. Heatley G, Sood P, Goldstein D, et al. Clinical trial design and rationale of the multicenter study of MagLev technology in patients undergoing mechanical circulatory support therapy with HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol. J Heart Lung Transplant. 2016;35:528-36.