One-year outcomes with the HeartMate 3 left ventricular assist device

J Thorac Cardiovasc Surg. 2018 Aug;156(2):662-669. doi: 10.1016/j.jtcvs.2018.01.083. Epub 2018 Feb 13.

Abstract

Background: The HeartMate 3 (HM3; Abbott Laboratories, Lake Forest, Ill) left ventricular assist device (LVAD) received its Conformité Européenne mark for Europe in October 2015 and is currently under investigation of the Food and Drug Administration to gain approval in the United States. Within this study, we present the first real-world experiences, 1-year outcomes, and adverse events of a single-center cohort treated with the HM3.

Methods: We prospectively studied midterm results of 27 consecutive patients receiving the HM3 at a single institution. After HM 3 implantation, survival, causes of death, and complications were recorded for all patients. Follow up was 100% complete.

Results: Twenty-seven patients were enrolled into the study. Within 1 year after HM3 implantation, 3 patients underwent heart transplantation and 3 patients died. Thirty-day survival was 88.9%, 6-month 85.2%, and 1-year survival 85.2%. No pump thrombosis and no strokes were observed within the study group. One incident of gastrointestinal bleeding was observed (3.7%). Right heart failure was diagnosed in 1 patient after HM3 implantation (3.7%). No technical complications of the pump were documented. No pump exchanges were necessary. The main complication was LVAD-related infection (22.2%).

Conclusions: The novel LVAD HM3 has already shown excellent Conformité Européenne mark trial results. Within this cohort, 1-year survival after HM3 implantation was 85%. The HM3 showed excellent midterm results with 0% stroke and 0% pump thrombosis rates 1 year after implantation.

Keywords: HeartMate 3; LVAD; complications; driveline infection; left ventricular assist device; one year; outcomes; pump thrombosis; survival.

MeSH terms

  • Aged
  • Cardiac Surgical Procedures* / adverse effects
  • Cardiac Surgical Procedures* / instrumentation
  • Cardiac Surgical Procedures* / mortality
  • Cardiac Surgical Procedures* / statistics & numerical data
  • Female
  • Heart Failure
  • Heart Transplantation
  • Heart-Assist Devices* / adverse effects
  • Heart-Assist Devices* / statistics & numerical data
  • Humans
  • Male
  • Middle Aged
  • Postoperative Complications / epidemiology
  • Prospective Studies
  • Prosthesis-Related Infections
  • Stroke