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ELEVATE Registry: HeartMate 3 LVAD Long-Term Outcomes
Quick Takes
- In a real-world registry of patients with HeartMate 3 LVADs, 5-year survival was 63.3%. This is comparable to clinical trial data.
- Rates of LVAD-related adverse events remained relatively low.
Study Questions:
What are the real-world, long-term clinical outcomes after HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation for heart failure (HF)?
Methods:
The ELEVATE registry was a prospective, observational, multinational study (26 centers in primarily Europe as well as the Middle East and Asia) designed to collect real-world outcomes after HM3 LVAD implantation between March 2015 and February 2017. There were 540 patients in the total cohort followed for 2 years. Of these patients, 463 underwent primary LVAD implant and 19 underwent pump exchange. Data on baseline demographics, survival, adverse events, quality of life, and functional capacity were collected. An additional 58 patients with anonymized data were included assessing only survival (registry consent unable to be collected prior to implant). A total of 254 patients consented to an extended 5-year follow-up, 247 from the primary implant group and seven from the exchange group.
Results:
Key baseline demographics of the primary implant group included: mean age 56 years, 89% male, and 48% ischemic cardiomyopathy etiology. At 2 years, survival in the primary implant group was 83.4% (95% confidence interval [CI], 79.9-86.8%). At 5 years, survival in the primary implant group was 63.3% (95% CI, 58.2-67.9%) and in the combined primary implant + anonymized group was 56.3% (95% CI, 51.5-60.8%). At 5 years, the rate of survival free of stroke, pump thrombosis, or nonsurgical bleeding was 43.8% (95% CI, 38.8-48.8%). Patients demonstrated sustained improvements in quality of life and functional capacity during the study.
Conclusions:
In a prospective registry of patients with HM3 LVAD implants, long-term survival at 5 years was over 60% with acceptable adverse event rates and sustained improvements in functional capacity and quality of life.
Perspective:
For patients with advanced HF, durable LVADs represent an important life-prolonging therapy. The HM3 device represents the continued improvement and innovation in this technology. Compared to older-generation devices, survival is improved and adverse event rates have decreased based on clinical trial data. Prior to this registry study, it was unclear how much of this benefit with the HM3 would persist in a real-world setting without the strict oversight of a clinical trial. Thankfully, the findings from the ELEVATE registry demonstrate that patients have comparable 5-year survival rates with similar adverse event rates. Sustained functional capacity and quality-of-life improvements also provide a significant benefit to the advanced HF patient population. While future innovation is still needed in LVAD technology and management, the HM3 LVAD represents a lifesaving option for many patients.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support
Keywords: Advanced Heart Failure, Heart-Assist Devices
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