Hemocompatibility-Related Adverse Events: Is the Burden Different among Available Centrifugal Flow Pumps?

Abstract

Purpose Landmark work has demonstrated that hemocompatibility-related adverse event (HRAE) burden is significant lower with the newest centrifugal flow pump compared to the established axial flow pump. No study has compared HRAE among the approved centrifugal and axial flow pumps. The objective of this study was to evaluate the burden of HRAE between HeartMate II (HMII) and HeartWare HVAD (HW). Methods We performed a retrospective analysis of hemocompatibility related adverse events (nonsurgical bleeding, thromboembolic event, pump thrombosis , or neurological event) in patients following implantation of HMII or HW through 6 months follow-up. HRAE were categorized by type and severity of adverse event and assigned a hemocompatibility score (HCS) of 0-4 for no HRAE through life ending or disabling HRAE, respectively. Statistical analysis included assessment of survival free from HRAE from implantation to 6-month follow-up using Kaplan-Meier and Cox proportional-hazard models and comparison of net hemocompatibility score using proportional odds regression. Results The study cohort included 331 patients with 268 patients (81%) in the HMII group and 63 patients (19%) in HW group. Overall median age was 62.2 years; HMII patients were older (median 63.5 versus 58.1years, p Conclusion Freedom from and burden of HRAE were not significantly different between the HeartMate II and HeartWare HVAD which is distinct from findings in the MOMENTUM trial. This indicates that hemocompatibility may differ significantly among available centrifugal flow technology and direct comparison of centrifugal flow pumps is required.