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Two-Year Outcome After Implantation of Full Magnetically Levitated LVAD
Quick Takes
- At 2 years, the overall survival rate of patients who received the HeartMate 3 as a primary implant (n = 463) was 83.4%.
- The composite survival free from nonsurgical bleeding, stroke, or pump thrombosis was 65.5%, whereas the stroke rate (10.2%) as well as suspected pump thrombosis rate (1.5%) were low.
- Functional capacity and quality of life showed a significant improvement at 6 months (p < 0.001 in both) and the improvement was sustained through the duration of the study.
Study Questions:
What are the long-term outcomes with the HeartMate 3 (HM3), a fully magnetically levitated centrifugal left ventricular assist device (LVAD), in a real-world population?
Methods:
The study cohort was comprised of 540 patients in the ELEVATE Registry (Evaluating the HeartMate 3 With Full MagLev Technology in a Post-Market Approval Setting) and is a prospective, observational, multinational registry including patients implanted with the HM3 LVAD after commercial approval and after CE mark in Europe (October 2015). The ELEVATE Registry concluded its 2-year follow-up period in February 2019, and the final results of the post-approval experience with HM3 are reported in this analysis. The registry included 463 patients receiving the HM3 as primary implant (Primary Implant Cohort), 19 patients underwent a pump upgrade from another device (Pump Exchange Cohort), and 58 patients who had experienced an outcome before having the possibility to sign the Informed Consent, for which only outcome data were collected (Anonymized Cohort). Data collection included demographics, survival, adverse events, EQ-5D Visual Analog Score quality of life (EQ-5D VAS QOL) questionnaire, and 6-minute walk distance. Continuous data are presented as mean with standard deviation or median with interquartile values, unless otherwise specified. Categorical data are reported as frequencies and percentages. Survival data are presented using the Kaplan–Meier product method.
Results:
Mean age was 55.6 ± 11.7 years (89% male, 48% ischemic cardiomyopathy); 70% of patients were in INTERMACS Profile 1–3 and 12.7% were on temporary mechanical circulatory support. Of the 463 patients in the Primary Implant Cohort, 426 (92%) were successfully discharged from the hospital. Median in-hospital stay was 29 days (21–47) and median intensive care unit (ICU) stay was 7.5 days (4–21). Twenty-four–month survival in the Primary Implant Cohort was 83.4% (95% confidence interval [CI], 79.9–86.8%) and the median duration spent out of hospital was 671.5 days (range 592–698). The majority of patients (73.2%) were alive on their initial device. In the Primary Implant Cohort, strokes were observed in 10.2%, gastrointestinal bleedings in 9.7%, pump thrombosis in 1.5%, and outflow graft twists in 3.5%. In the Full Cohort, 2-year survival was 74.5% (95% CI, 70.8–78.2%). The majority of patients (64.4%) were alive on their initial device. Only 8.2% of patients were transplanted within the first 2 years after HM3 implantation, 25.0% of patients expired on their device, the device was explanted in 1.3%, and 0.7% of patients were lost to follow-up. In the Full Cohort, multiorgan failure (31%) was the most frequent cause of death, followed by infection (24%) and stroke (11%). HM3 implantation resulted in a significant and sustained improvement of functional capacity and QOL.
Conclusions:
The study authors concluded that in a real-world population, in the cohort implanted with the HM3 LVAD, there is good long-term survival, sustained improvement of functional capacity, and low rates of adverse events (including pump thrombosis).
Perspective:
Postsurgical outcomes are determined by preoperative considerations including patient demographics (such as INTERMACS-level, age, incidence of ischemic cardiomyopathy, history of stroke or atrial fibrillation, therapy goal [bridge to transplant vs. destination therapy]), and patient selection. This study shows that HM3 has good outcomes and adverse event profile at the end of 2 years. Longer-term data are required to compare it with heart transplantation given that there is a ceiling on donor heart availability. Also, the next step would be to compare this device head-to-head with the HeartWare HVAD System.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Acute Heart Failure, Heart Transplant, Mechanical Circulatory Support
Keywords: Cardiomyopathies, Cardiac Surgical Procedures, Heart Failure, Heart-Assist Devices, Heart Transplantation, Hemorrhage, Outcome Assessment, Health Care, Patient Discharge, Length of Stay, Quality of Life, Stroke, Thrombosis
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