Outcomes in Patients with Commercial HeartMate 3 LVAD: A Comparative Analysis of Non-Trial versus Trial Like Cohorts

Abstract

<h3>Purpose</h3> Patient selection for real world use of the HeartMate 3 (HM3) left ventricular assist device differs from that of clinical trials. We assessed adverse event rates between "non-trial like" (NTL) and "trial like" (TL) patients who underwent commercial HM3 implantation. <h3>Methods</h3> A single-center, retrospective cohort study of 79 consecutive patients who underwent primary HM3 implant from 1/2019 to 10/2020 with ≥ 1-year follow-up was performed. Patients were identified as NTL if they met ≥ 1 exclusion criteria from the MOMENTUM 3 clinical trial and TL if they met no exclusion criteria. The primary outcome was freedom from composite events of death, LVAD-related infection (LVADI), and hemocompatibility-related adverse events (HRAE) including major gastrointestinal bleed, all-cause stroke, and pump thrombosis. <h3>Results</h3> Of the 79 patients, 32 (41%) were categorized as NTL due to: low prealbumin (<15 mg/dL) and/or albumin (<3 g/dL) levels (n=23), ongoing ECMO support prior to implant (n=3), psychosocial factors (n=2), creatinine >2.5mg/dL (n=2), total bilirubin >2.5mg/dL (n=1), and peripheral vascular disease (n=1). Both NTL and TL patients were similar in age, sex, race, and INTERMACS profiles. Compared to the TL group, the NTL group had a lower 1-year event-free survival (28% vs. 68%, unadjusted HR [95% CI]: 3.2 [1.7-6.1], p=0.001; Fig1A&B). One year survival was 84% in NTL group vs. 98% in TL group (p=0.06). The NTL group had an increase in HRAEs (p=0.005) and a trend toward more LVADI (p=0.051). There were more episodes of major gastrointestinal bleeds (p=0.006) and use of post-operative RVAD (p=0.014) in the NTL group. In an unadjusted analysis of all patients, having both low prealbumin and albumin was associated with increased risk of the primary outcome (unadjusted HR [95% CI]: 2.2 [1.2-4.2], p=0.016). <h3>Conclusion</h3> In a single-center experience of HM3 patients, those outside of traditional clinical trial eligibility had a significantly lower event-free survival.