Abstract
Background
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 "nontrial like" (NTL) and "trial like" (TL) patients who underwent commercial HM3 implantation.Methods
We conducted a multicenter, retrospective cohort study of 231 consecutive patients who underwent primary HM3 implant from October 2017 to December 2021. Patients were identified as NTL if they met ≥1 exclusion criteria from the Mulitcenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (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.Results
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 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 hazard ratio (HR) [95% confidence interval (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 veno-arterial extracorporeal membrane oxygenation support prior to HM3 (adjusted HR [95%CI]: 1.9[1.08-3.4], p = 0.026).Conclusions
In this multicenter cohort of HM3 patients, those outside of traditional clinical trial eligibility had a significantly lower 1-year event-free survival.