BACKGROUND: The HeartMate 3 Left Ventricular Assist System (LVAS) (St. Jude Medical Inc., St Paul, MN) with full magnetic levitation allows for wide and consistent blood flow paths and an artificial pulse designed for enhanced hemocompatibility. The HeartMate 3 received market approval in the European Union in 2015 following completion of a multicenter study. After reaching the 6-month study endpoint, patients continue to be followed for 2 years with the 1-year results presented herein. METHODS: A prospective, non-randomized study included adults with advanced heart failure and ejection fraction (EF) ≤ 25%, cardiac index (CI) ≤ 2.2 L/min/m2 while not on inotropes, or inotrope dependent, or on optimal medical management for 45/60 days. RESULTS: Fifty patients-54% bridge to transplant (BTT) and 46% destination therapy (DT)-were enrolled and implanted with the HeartMate 3. At baseline, 92% of the patients were INTERMACS profiles 2-4, with cardiac index 1.8 + 0.5 L/min/m2 and 58% were supported with inotropes. At 1 year, 74% of the patients remain on support, 18% expired, 6% transplanted, and 2% explanted. The adverse events include 12% gastrointestinal bleeding, 16% driveline infections, 18% strokes, and 2% outflow graft thrombosis. There was no hemolysis, pump thrombosis or pump malfunction through 1 year. The six-minute walk test distance increased from a mean of 273 m to 371 m (P <0.0001). EQ-5D quality-of-life score increased from a mean of 52.7 to 70.8 (P = 0.0006). CONCLUSIONS: The 1-year HeartMate 3 LVAS results show survival and adverse-event profile are similar to other approved devices, with no pump thrombosis or pump failure. Patient's functional status and quality of life significantly improved over time. TRIAL REGISTRATION: Clinicaltrials.gov registration number: NCT02170363 . Registered June 19, 2014.

German Heart Center Deutsches Herzzentrum Berlin Augustenburger Platz 1 D 13353 Berlin Germany

Hannover Medical School Carl Neuberg Str 1 30625 Hannover Germany

Heart Center Leipzig Struempellstrasse 39 04289 Leipzig Germany

Herz und Diabeteszentrum NRW Georgstr 11 32545 Bad Oeynhausen Germany

Institute for Clinical and Experimental Medicine Vídenská 1958 9 Praha 4 Prague Czech Republic

National Research Cardiac Surgery Center 010000 38 Turan St Astana Kazakhstan

St Jude Medical 11 Da Vincilaan Zaventem 1935 Belgium

The Alfred Hospital 55 Commercial Road Prahran VIC 3181 Melbourne Australia

Toronto General Hospital 4N 464 200 Elizabeth St Toronto ON M5G 2C4 Canada

University Heart Center Freiburg Bad Krozingen Hugstetterstr 55 D 79106 Freiburg Germany

University of Vienna Waehringer Guertel 18 20 A 1090 Vienna Austria

Zobrazit více v PubMed

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;54:312–321. doi: 10.1016/j.jacc.2009.03.055. PubMed DOI

Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241–2251. doi: 10.1056/NEJMoa0909938. PubMed DOI

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;92:1406–1413. doi: 10.1016/j.athoracsur.2011.05.080. PubMed DOI

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;57:1890–1898. doi: 10.1016/j.jacc.2010.10.062. PubMed DOI

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;32:675–683. doi: 10.1016/j.healun.2013.04.004. PubMed DOI

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;33:486–491. doi: 10.1016/j.healun.2014.01.856. PubMed DOI

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;66:2590–2593. doi: 10.1016/j.jacc.2015.10.028. PubMed DOI

Pagani FD. Adverse event burden and mechanical circulatory support: looking toward the future. J Thorac Cardiovasc Surg. 2016;151:10–12. doi: 10.1016/j.jtcvs.2015.09.052. PubMed DOI

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;62:375–383. doi: 10.1097/MAT.0000000000000388. PubMed DOI

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;66:2579–2589. doi: 10.1016/j.jacc.2015.09.083. PubMed DOI

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;34:858–860. doi: 10.1016/j.healun.2015.03.001. PubMed DOI

Manual of operations; Protocol: Appedix A Adverse event definitions. https://www.uab.edu/medicine/intermacs/appendices/app-a-5-0.

Goldstein DJ, Aaronson KD, Tatooles AJ, et al. Gastrointestinal bleeding in recipients of the HeartWare ventricular assist system. JACC Heart Fail. 2015;3:303–313. doi: 10.1016/j.jchf.2014.11.008. PubMed DOI

Stern DR, Kazam J, Edwards P, et al. Increased incidence of gastrointestinal bleeding following implantation of the HeartMate II LVAD. J Card Surg. 2010;25:352–356. doi: 10.1111/j.1540-8191.2010.01025.x. PubMed DOI

Morgan JA, Paone G, Nemeh HW, et al. Gastrointestinal bleeding with the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2012;31:715–718. doi: 10.1016/j.healun.2012.02.015. PubMed DOI

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;33:60–64. doi: 10.1016/j.healun.2013.07.020. PubMed DOI

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;61:635–639. doi: 10.1097/MAT.0000000000000279. PubMed DOI

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;39:939–944. doi: 10.1111/aor.12471. PubMed DOI

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;61:266–273. doi: 10.1097/MAT.0000000000000191. PubMed DOI

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;95:170–177. doi: 10.1016/j.athoracsur.2012.08.052. PubMed DOI

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;2:141–145. doi: 10.1016/j.jchf.2013.10.008. PubMed DOI

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;56:1207–1213. doi: 10.1016/j.jacc.2010.05.016. PubMed DOI

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. doi: 10.1016/j.healun.2014.09.012. PubMed DOI

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;6:517–526. doi: 10.1161/CIRCHEARTFAILURE.112.000206. PubMed DOI

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;35:860–867. doi: 10.1016/j.healun.2016.05.019. PubMed DOI

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. doi: 10.1056/NEJMoa1313385. PubMed DOI

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. doi: 10.1016/j.healun.2013.12.002. PubMed DOI

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;61:144–149. doi: 10.1097/MAT.0000000000000170. PubMed DOI

McCarthy FH, Kobrin D, Rame JE, et al. Increasing frequency of left ventricular assist device exchanges in the united states. Ann Thorac Surg. 2015;100:1660–1664. doi: 10.1016/j.athoracsur.2015.04.072. PubMed DOI

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;100:1577–1580. doi: 10.1016/j.athoracsur.2015.05.033. PubMed DOI

Oezpeker C, Zittermann A, Ensminger S, et al. Systemic thrombolysis versus device exchange for pump thrombosis management: a single center experience. ASAIO J. 2016;62:246–251. doi: 10.1097/MAT.0000000000000340. PubMed DOI

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. doi: 10.1016/j.healun.2013.12.001. PubMed DOI

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;34:1515–1526. doi: 10.1016/j.healun.2015.10.024. PubMed DOI

Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC, Jr, 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;376:440–450. doi: 10.1056/NEJMoa1610426. PubMed DOI

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;376:451–460. doi: 10.1056/NEJMoa1602954. PubMed DOI

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;63:1751–1757. doi: 10.1016/j.jacc.2014.01.053. PubMed DOI

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;35:407–412. doi: 10.1016/j.healun.2016.01.002. PubMed DOI

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. PubMed

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;35:528–536. doi: 10.1016/j.healun.2016.01.021. PubMed DOI

2019 EACTS Expert Consensus on long-term mechanical circulatory support

Less invasive HeartMate 3 left ventricular assist device implantation

Zobrazit více v PubMed

ClinicalTrials.gov
NCT02170363