Left ventricular assist device performance with long-term circulatory support: lessons from the REMATCH trial

Area of Science:

• Cardiology
• Biomedical Engineering
• Clinical Trials

Background:

• Left ventricular assist device (LVAD) failure and malfunction rates are crucial for assessing long-term viability in heart failure patients.
• Existing bridge-to-transplantation literature inadequately characterizes LVAD device performance metrics.

Purpose of the Study:

• To compare survival rates between patients receiving LVAD implantation and those managed medically.
• To evaluate LVAD device performance, including malfunction and system failure rates.

Main Methods:

• The Randomized Evaluation of Mechanical Cardiac Support (REMS) trial compared optimal medical management with LVAD implantation.
• Patient outcomes were adjudicated by an independent committee, with survival analyzed by intention-to-treat.
• Device performance was analyzed by disaggregating confirmed malfunctions and system failures.

Main Results:

• One-year survival was 52% for LVAD patients versus 28% for medical patients; two-year survival was 29% for LVAD patients versus 13% for medical patients.
• The system failure rate was 0.13 per patient-year, and the confirmed LVAD malfunction rate was 0.90.
• Freedom from device replacement was 87% at 1 year and 37% at 2 years.

Conclusions:

• LVAD implantation offers a significant survival benefit over medical management for end-stage heart failure, despite observed device malfunction rates.
• Future device modifications and improved infection management strategies are expected to enhance LVAD performance.