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

• Published in: JHLT Open Vol. 2; p. 100008
• Main Authors: Laura Coyle, APN, Colleen Gallagher, BSN, Nicole Graney, APN, Lisa Kukla, APN, Robin Paliga, APN, Kylie Hughes, APN, Rachel Pedersen, BA, Kathleen Schultz, APN, Adam JT Schuldt, MD, PhD, Nasir Sulemanjee, MD, Gregory P. Macaluso, MD, Sunil Pauwaa, MD, James Monaco, MD, Mark Dela Cruz, MD, William G. Cotts, MD, Nikhil Narang, MD, Patroklos S. Pappas, MD, Antone J. Tatooles, MD, Vinh Q. Chau, MD
• Format: Journal Article
• Language: English
• Published: Elsevier 01-12-2023
• Subjects: heart failure; HeartMate 3; left ventricular assist device; patient selection; survival
• ISSN: 2950-1334

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.