Abstract
Background
The European CE Mark approval study and the MOMENTUM 3 trial
demonstrated safety and a reduction in hemocompatibility-related adverse
events with 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-March 2020.
Patients were divided into trial group and postapproval group. 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 pre-operative 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% vs. 93.8%
(p =0.88). The postapproval group demonstrated a statistically
significant lower incidence of re-explorative surgery for bleeding
(10.9% vs 46.3, p=0.01 ) 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.