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Updated: Feb 4, 2026

In Vitro Thrombosis Test for Ventricular Assist Devices
Published on: March 21, 2025
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.
Background:
The HeartMate 3 left ventricular assist device (Abbott, Chicago, IL) is designed to provide circulatory support with enhanced hemocompatibility for patients with advanced heart failure. The purpose of this study was to compare the surgical outcomes between patients treated during the European Conformity Mark (CE Mark [CEM]) clinical trial and those treated in the postmarket era.
Methods:
The prospective, observational, multinational ELEVATE (Evaluating the HeartMate 3 with Full MagLev Technology in a Post-Market Approval Setting) registry includes patients receiving the HeartMate 3 following CEM approval. Outcomes of patients in the ELEVATE registry are compared with patients in the CEM trial.
Results:
Compared with the CEM trial (N = 50), the ELEVATE registry group (N = 463) was more severely ill, with more patients classified as INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 1 to 2 (32% versus 10%; p < 0.001). The CEM trial group was younger and underwent fewer concomitant valve procedures. After adjustment for differences in baseline characteristics, the 30-day survival was comparable between the ELEVATE registry and CEM trial groups (95% versus 98%; p = 0.46). Length of intensive care unit stay was similar between the ELEVATE registry (7 days) and CEM trial (6 days) groups. Most adverse event rates were comparable between the 2 groups. ELEVATE registry patients had a lower rate of cardiac arrhythmias (13% versus 28%; p = 0.009). With increasing experience, the implant technique has evolved to include more versatile approaches such as less invasive and off-pump implantation.
Conclusions:
The 30-day outcomes for ELEVATE registry patients are comparable despite being sicker than CEM trial patients. Adverse event rates remain low, with no cases of pump thrombosis within the first 30 days. Implant techniques have evolved to include more versatile approaches.
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