Adverse outcomes in nontrial like patients on commercial HeartMate 3 LVAD support

Le résumé fourni par la source

Patient selection for real-world use of HeartMate 3 left ventricular assist device (HM3 LVAD) 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. We conducted a multicenter, retrospective cohort study of 231 consecutive patients who underwent primary HM3 implant from 10/2017 to 12/2021. Patients were identified as NTL if they met ≥1 exclusion criteria from the MOMENTUM 3 trial and TL if they had no exclusion criteria. The primary outcome was freedom from death, heart failure hospitalization, LVAD-related infection, and hemocompatibility related adverse events including major gastrointestinal bleed, all-cause stroke, and pump thrombosis. Of the 231 patients (median age 59 years, 24% female), 105 (45%) were categorized as NTL, most commonly due to low albumin and/or prealbumin levels alone (n=48) followed by the use of temporary mechanical circulatory support (tMCS) alone (n=10) and having ≥2 exclusion criteria (n=26). Compared to the TL group, the NTL group had a lower 1-year event-free survival (34% vs. 48%, adjusted HR [95%CI]: 1.5[1.01-2.0], P=0.043). One-year overall survival was 82% in NTL group vs. 95% in TL group (adjusted HR [95%CI]: 3.3[1.1-8.7], P=0.013). Post-HM3 adverse events were associated with the presence of ≥2 exclusion criteria (adjusted HR [95%CI]: 1.8[1.06-3.1], P=0.028); and VA-ECMO support prior to HM3 (adjusted HR [95%CI]: 1.9[1.08-3.4], P=0.026). In this multicenter cohort of HM3 patients, those outside of traditional clinical trial eligibility had a significantly lower 1-year event-free survival.

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