Trade-Off Between Bleeding and Ischemic Events From Left Ventricular Assist Devices: A EUROMACS Registry Analysis

Area of Science:

• Cardiovascular Surgery
• Biomedical Engineering
• Clinical Research

Background:

• The HeartMate 3 (HM3) is a fully magnetically levitated centrifugal-flow pump for left ventricular assist device (LVAD) patients.
• HM3 has shown potential in reducing thromboembolic events, possibly altering the balance of ischemic versus bleeding complications.

Purpose of the Study:

• To analyze the competing risks of ischemic and bleeding hemocompatibility-related adverse events (HRAEs) in LVAD patients using contemporary practices.
• To compare HRAEs between the HM3 and HeartWare (HVAD) LVAD devices.

Main Methods:

• A total of 4,320 patients from the EUROMACS registry were included: 2,088 in the HVAD cohort and 2,232 in the HM3 cohort.
• Evaluated first ischemic HRAEs (stroke, pump thrombosis, embolism) and first major bleeding HRAEs (intracranial, non-intracranial) from 2 weeks to 2 years post-implantation.

Main Results:

• The HM3 cohort exhibited lower incidences of both ischemic (2.9% vs 15.3% per 100 patient-years) and bleeding (11.8% vs 18% per 100 patient-years) HRAEs compared to the HVAD cohort (P < 0.001).
• The reduction in ischemic HRAEs was particularly pronounced with HM3.
• Despite lower absolute risks, the HM3 cohort showed a less favorable trade-off between bleeding and ischemic events (8.9% vs 2.7% difference), with a persistently higher bleeding risk.

Conclusions:

• Advancements in LVAD pump technology, like HM3, have substantially decreased HRAEs and modified the ischemic-bleeding risk profile.
• The persistent elevated bleeding risk in HM3 patients highlights the need for novel antithrombotic strategies tailored to their specific risk profile.