Postmarket Experience With HeartMate 3 Left Ventricular Assist Device: 30-Day Outcomes From the ELEVATE Registry

Jens Garbade1, Finn Gustafsson2, Steven Shaw3

  • 1University Department for Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany.

Insights

Outcomes for HeartMate 3 left ventricular assist device patients in the ELEVATE registry were comparable to the CE Mark trial, even with sicker patients. Improved surgical techniques led to low adverse events and no early pump thrombosis.

Area of Science:

  • Cardiovascular Surgery
  • Medical Devices
  • Heart Failure Management

Background:

  • The HeartMate 3 left ventricular assist device (LVAD) offers enhanced hemocompatibility for advanced heart failure.
  • Surgical outcomes require comparison between initial clinical trials and post-market real-world data.

Purpose of the Study:

  • To compare surgical outcomes of HeartMate 3 LVAD implantation between the CE Mark (CEM) clinical trial and the post-market ELEVATE registry.
  • To evaluate the safety and efficacy of the HeartMate 3 in a broader patient population.

Main Methods:

  • Prospective, observational, multinational ELEVATE registry data were compared with data from the CEM trial.
  • Patient characteristics, 30-day survival, intensive care unit (ICU) stay, and adverse event rates were analyzed.
  • Statistical adjustments were made for baseline differences between groups.

Main Results:

  • The ELEVATE registry (N=463) included sicker patients (INTERMACS 1-2: 32% vs 10%) than the CEM trial (N=50).
  • 30-day survival was comparable (95% vs 98%; p=0.46) after adjustment.
  • Adverse event rates were similar, with lower arrhythmias in ELEVATE (13% vs 28%; p=0.009) and no early pump thrombosis.

Conclusions:

  • Comparable 30-day outcomes were achieved in the ELEVATE registry despite a sicker patient cohort.
  • Evolving implant techniques, including less invasive and off-pump approaches, contribute to favorable outcomes.
  • The HeartMate 3 demonstrates continued safety and efficacy in real-world post-market use.
Abstract

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