Key result
Real-world 6-month survival in postapproval HeartMate 3 patients was 93.3%, which was comparable to the 93.8% survival observed in the trial cohort (p=0.88).
Why the study?
Following trial evidence demonstrating safety and reduced hemocompatibility-related adverse events with HeartMate 3, this study evaluated real-world experience since FDA approval.
Does real-world postapproval use of the HeartMate 3 LVAD result in comparable 6-month survival compared to trial patients?
Observational (n=174)
No
Does real-world postapproval use of the HeartMate 3 LVAD result in comparable 6-month survival compared to trial patients?
Absolute Event Rate: 93.3% vs 93.8%
p-value: p=0.88
Real-world 6-month survival in postapproval HeartMate 3 patients is comparable to clinical trial results, with a significantly lower incidence of re-explorative surgery for bleeding.
Real-world postapproval HM3 survival matches trial results at 6 months; confirms short-term safety but leaves open long-term durability.
BACKGROUND: The European CE Mark approval study and the MOMENTUM 3 trial demonstrated safety and a reduction in hemocompatibility-related adverse events with the use of HeartMate 3 (HM3) device. This single-center study investigated the real-world experience in HM3 patients since FDA approval. METHODS: This retrospective, observational study included patients implanted with the HM3 LVAD as a primary implant between October 2017 and March 2020. Patients were divided into trial group and postapproval group. The primary endpoint was survival at 6 months. Secondary endpoints were adverse events including pump thrombosis (requiring pump exchange), stroke, renal failure, acute limb ischemia, re-exploratory for bleeding, gastrointestinal bleeding, right ventricular failure, and driveline infection. RESULTS: A total of 189 patients were implanted with HM3 device during the study period. 174 patients met the inclusion criteria: 82 patients in the trial group and 92 patients in the postapproval group. The postapproval group had younger patients, higher preoperative mean international normalized ratio, and greater numbers of patients with bridge to transplant (BTT) indications, IINTERMACS profile 1, and use of mechanical assist devices (other than IABP) than the trial group. Other characteristics between the two groups were comparable. Overall survival at 6 months in the postapproval group was 93.3% versus 93.8% (p = .88). The postapproval group demonstrated a statistically significant lower incidence of re-explorative surgery for bleeding (10.9% vs. 46.3, p = .01) than the trial group. CONCLUSION: In this single-center study, the real-world 6-month survival in the postapproval group was comparable to the trial results. Further studies are needed to monitor long-term outcomes.
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Bansal et al. (2022) conducted an observational in Advanced heart failure (n=174). HeartMate 3 LVAD (postapproval phase) vs. HeartMate 3 LVAD (trial phase) was evaluated on Survival at 6 months (p=0.88). Real-world 6-month survival in postapproval HeartMate 3 patients was 93.3%, which was comparable to the 93.8% survival observed in the trial cohort (p=0.88).
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