We aimed to characterize center-specific variability in HeartMate 3 (HM3) patient survival within the MOMENTUM 3 studies and to examine the correlation between implanting center survival and major adverse events (AEs).
Center HM3 implant volume during the MOMENTUM 3 pivotal (n=515) and continued access protocol (n=1685) trials were tallied. Centers implanting ≤16 HM3 patients (25th percentile) were excluded. De-identified center variability in mortality was assessed at 90 days and 2 years using direct adjusted survival while accounting for key baseline risk factors. The 90-day frequency and 2-year rates of stroke, bleeding, and infection were compared across centers and correlations between survival and event rate variability were assessed.
Among 48 centers, 1957 HM3 patients were included in this analysis with site implants ranging between 17 to 103 patients. Patient cohorts differed across the sites by age (average 52-68 years), sex (60-95% male), destination therapy intent (25-100%), and %INTERMACS profile 1-2 (2-81%). At 90 days, center adjusted median mortality was 6.5%, nadiring at ≤3.2% (25th percentile) and peaking at ≥10.5% (75th percentile). Median 2-year center adjusted mortality was 18.6%, nadiring at ≤14.0% and peaking at ≥25.2% (figure A). AEs were also highly variable across centers; centers with low mortality tended to have lower AE rates at 2 years (figure B).
Patient characteristics and outcomes were highly variable across MOMENTUM 3 centers despite trial preoperative inclusion/exclusion criteria. Many centers had exemplary risk-adjusted HM3 patient outcomes. Studies are needed to improve our understanding of top performing centers’ best practices as they relate to HM3 care in the pre, interoperative, and chronic support stages in an effort to further improve HM3 LVAD-associated clinical outcomes.
© 2022 Published by Elsevier Inc.