Download PDF
Thorac Cardiovasc Surg 2022; 70(06): 482-492
DOI: 10.1055/s-0042-1742779
Original Cardiovascular

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

Takayuki Gyoten
1   Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
,
Sebastian V. Rojas
1   Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
,
Henrik Fox
2   Clinic for Interventional Cardiology, Heart and Diabetes Centre North Rhine Westphalia, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
,
Marc-Andre Deutsch
1   Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
,
Maria Ruiz-Cano
1   Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
,
Kavous Hakim-Meibodi
1   Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
,
Jan F. Gummert
1   Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
,
Michiel Morshuis‡   *
1   Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
,
René Schramm‡   *
1   Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
› Author Affiliations Funding None.
› Further Information
   Permissions and Reprints All articles of this category

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.




Publication History

Received: 18 October 2021

Accepted: 15 December 2021

Article published online:
02 March 2022

© 2022. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 26 Milano CA, Rogers JG, Tatooles AJ. et al; ENDURANCE Investigators. HVAD: The ENDURANCE Supplemental Trial. JACC Heart Fail 2018; 6 (09) 792-802
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar