Methods:

The study investigators performed a 6-month secondary analysis of HRAE (survival free of any nonsurgical bleeding, thromboembolic event, pump thrombosis, or neurological event) in the short-term cohort (as-treated cohort n = 289) of the MOMENTUM 3 trial (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3). They also assessed the net burden of HRAE by using a hemocompatibility score (HCS), which uses four escalating tiers of hierarchal severity to derive a total score for events encountered during the entire follow-up experience for each patient. Mild events (e.g., ≤2 nonsurgical) contributed a single point to the HCS, whereas serious events (e.g., disabling stroke) contributed a higher grade to the HCS (e.g., disabling stroke contributes 4 points). They conducted three separate analyses: a) comparison of HRAEs between HM3 and HMII LVAS, b) comparison of the net burden of HRAEs (assessed by the HCS) between the Heart Mate 3 (HM3) and Heart Mate II (HMII), and c) exploratory determination of clinical correlates predictive of HRAEs (based on an HCS >0). They used a multivariable logistic regression analysis to identify factors that were independently predictive of any HRAEs (HCS >0) or death in the full cohort of patients, with device type included as a covariate. They incorporated variables with p values < 0.1 on univariable analysis into the multivariable regression analysis.