The HeartWare Ventricular Assist Device (HVAD): A Single Institutional 10-Year Experience

Abstract

Objectives The aim of this study was to analyze our 10-year experience with the HVAD in a real-world scenario in a high-volume German heart center.

Methods We retrospectively analyzed outcomes of adults (≥18 years) with terminal heart failure (HF), who underwent HVAD implantation for durable LVAD therapy in our center between October 2009 and March 2020. Primary and secondary end points were all-cause death after implantation and LVAD-associated complications, respectively. We focused the distinct analyses on risk profiles at the time of implantation and implant strategies, i.e., bridge-to-transplant (BTT) or destination therapy (DT).

Results A total of 510 patients were included, with 229 and 281 individuals in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 1 (45%) and 2 to 4, respectively. Median follow-up was 26 months (IQR: 5–54 months). Overall survival at 1, 3, and 5 years after HVAD implantation was 66% (95% CI; 61.7–70%), 49.4% (95% CI; 44.9–53.8%), and 37.4% (95% CI; 32.8–42%), not censored for LVAD exchange, LVAD explantation, or heart transplantation. INTERMACS level 1 and peri-operative temporary right heart assistance were independent risk factors for survival. Survival was best in BTT patients undergoing heart transplantation at any time during follow-up. The INTERMACS level at time of HVAD implantation did not affect survival after heart transplantation. Freedom from the combined end point of any device-associated severe complication and death was 44.5% (95% CI; 40–48.8%) at 1-year after implantation.

Conclusion The HVAD is a reliable pump for durable mechanical circulatory support even in high-risk patients. Still, heart transplantation outperforms durable MCS therapy for a superior long-term survival.

Keywords

left ventricular assist device - heart transplantation - survival - complications - HeartWare ventricular assist device

Authors' Contribution

T.G. did the conceptualization of the study, data retrieval, data analyses, and revision of the manuscript. S.V.R. contributed toward data analysis, writing, and revision of the manuscript. H.F. did the data retrieval, writing, and revision of the manuscript. M.-A.D. contributed toward data analysis, writing, and revision of the manuscript. M.R.C. worked upon data retrieval, data analysis, and revision of the manuscript. K.H.-M. did the data analysis and revised the manuscript. J.F.G. Conceptualized the study and revised the manuscript. M.M. contributed toward the conceptualization of the study, data retrieval, data analyses, writing and revision of the manuscript. R.S. did the conceptualization of the study, data retrieval, data analyses, writing and revision of the manuscript.

^* These authors contributed equally.

Publikationsverlauf

Eingereicht: 18. Oktober 2021

Angenommen: 15. Dezember 2021

Artikel online veröffentlicht:
02. März 2022

• References

• 1 Gummert JF, Haverich A, Schmitto JD, Potapov E, Schramm R, Falk V. Permanent implantable cardiac support systems. Dtsch Arztebl Int 2019; 116 (50) 843-848
• 2 Schramm R, Morshuis M, Schoenbrodt M. et al. Current perspectives on mechanical circulatory support. Eur J Cardiothorac Surg 2019; 55 (Suppl. 01) i31-i37
• 3 Aaronson KD, Slaughter MS, Miller LW. et al; HeartWare Ventricular Assist Device (HVAD) Bridge to Transplant ADVANCE Trial Investigators. Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation 2012; 125 (25) 3191-3200
• 4 Rogers JG, Pagani FD, Tatooles AJ. et al. Intrapericardial left ventricular assist device for advanced heart failure. N Engl J Med 2017; 376 (05) 451-460
• 5 Mehra MR, Goldstein DJ, Uriel N. et al; MOMENTUM 3 Investigators. MOMENTUM 3 investigators two-year outcomes with a magnetically levitated cardiac pump in heart failure. N Engl J Med 2018; 378 (15) 1386-1395
• 6 Kirklin JK, Pagani FD, Kormos RL. et al. Eighth annual INTERMACS report: special focus on framing the impact of adverse events. J Heart Lung Transplant 2017; 36 (10) 1080-1086
• 7 de By TMMH, Mohacsi P, Gahl B. et al; EUROMACS members. The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) of the European Association for Cardio-Thoracic Surgery (EACTS): second report. Eur J Cardiothorac Surg 2018; 53 (02) 309-316
• 8 Arabía FA, Cantor RS, Koehl DA. et al. Interagency registry for mechanically assisted circulatory support report on the total artificial heart. J Heart Lung Transplant 2018; 37 (11) 1304-1312
• 9 Stevenson LW, Pagani FD, Young JB. et al. INTERMACS profiles of advanced heart failure: the current picture. J Heart Lung Transplant 2009; 28 (06) 535-541
• 10 Schramm R, Zittermann A, Morshuis M. et al. Comparing short-term outcome after implantation of the HeartWare® HVAD® and the Abbott® HeartMate 3®. ESC Heart Fail 2020; 7 (03) 908-914
• 11 Potapov EV, Antonides C, Crespo-Leiro MG. et al. 2019 EACTS expert consensus on long-term mechanical circulatory support. Eur J Cardiothorac Surg 2019; 56 (02) 230-270
• 12 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 (05) 486-491
• 13 Haglund NA, Davis ME, Tricarico NM. et al. Perioperative blood product use: a comparison between HeartWare and HeartMate II devices. Ann Thorac Surg 2014; 98 (03) 842-849
• 14 Birschmann I, Dittrich M, Eller T. et al. Ambient hemolysis and activation of coagulation is different between HeartMate II and HeartWare left ventricular assist devices. J Heart Lung Transplant 2014; 33 (01) 80-87
• 15 Zimpfer D, Strueber M, Aigner P. et al. Evaluation of the HeartWare ventricular assist device Lavare cycle in a particle image velocimetry model and in clinical practice. Eur J Cardiothorac Surg 2016; 50 (05) 839-848
• 16 Rojas SV, Hanke JS, Avsar M. et al. Left ventricular assist device therapy for destination therapy: is less invasive surgery a safe alternative?. Rev Esp Cardiol (Engl Ed) 2018; 71 (01) 13-17
• 17 Akin S, Soliman O, de By TMMH. et al; EUROMACS investigators. Causes and predictors of early mortality in patients treated with left ventricular assist device implantation in the European Registry of Mechanical Circulatory Support (EUROMACS). Intensive Care Med 2020; 46 (07) 1349-1360
• 18 Al Masri E, Al Shakaki M, Welp H, Scherer M, Dell'Aquila AM. Long-term follow-up of patients supported with the HeartWare left ventricular assist system. Artif Organs 2020; 44 (10) 1061-1066
• 19 Kiernan MS, Grandin EW, Brinkley Jr M. et al. Early right ventricular assist device use in patients undergoing continuous-flow left ventricular assist device implantation: incidence and risk factors from the interagency registry for mechanically assisted circulatory support. Circ Heart Fail 2017; 10 (10) 10
• 20 Ruiz-Cano MJ, Morshuis M, Koster A. et al. Risk factors of early right ventricular failure in patients undergoing LVAD implantation with intermediate Intermacs profile for advanced heart failure. J Card Surg 2020; 35 (08) 1832-1839
• 21 Dandel M, Potapov E, Krabatsch T. et al. Load dependency of right ventricular performance is a major factor to be considered in decision making before ventricular assist device implantation. Circulation 2013; 128 (11, suppl 1): S14-S23
• 22 Kirklin JK, Naftel DC, Pagani FD. et al. Seventh INTERMACS annual report: 15,000 patients and counting. J Heart Lung Transplant 2015; 34 (12) 1495-1504
• 23 Gyoten T, Schenk S, Rochor K. et al. Outcome comparison of mitral valve surgery and MitraClip therapy in patients with severely reduced left ventricular dysfunction. ESC Heart Fail 2020; 7 (04) 1781-1790
• 24 Obadia JF, Messika-Zeitoun D, Leurent G. et al; MITRA-FR Investigators. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med 2018; 379 (24) 2297-2306
• 25 Maltais S, Aaronson KD, Teuteberg JJ. et al. Adverse event rates change favorably over time for patients bridged with the HeartWare left ventricular assist device. ASAIO J 2017; 63 (06) 745-751
• 26 Milano CA, Rogers JG, Tatooles AJ. et al; ENDURANCE Investigators. HVAD: The ENDURANCE Supplemental Trial. JACC Heart Fail 2018; 6 (09) 792-802
• 27 Goldstein DJ, Aaronson KD, Tatooles AJ. et al; ADVANCE Investigators. Gastrointestinal bleeding in recipients of the HeartWare Ventricular Assist System. JACC Heart Fail 2015; 3 (04) 303-313
• 28 Previato M, Osto E, Kerkhof PLM, Parry G, Tona F. Heart transplantation survival and sex-related differences. Adv Exp Med Biol 2018; 1065: 379-388
• 29 Crespo-Leiro MG, Barge-Caballero E. Heart transplantation and left ventricular assist systems. Not too early, not too late. Eur J Heart Fail 2018; 20 (01) 161-163