Lessons learned from experience with over 100 consecutive HeartMate II left ventricular assist devices

Area of Science:

• Cardiology
• Medical Devices
• Heart Failure Management

Background:

• Continuous-flow left ventricular assist devices (LVADs) are primary therapy for end-stage heart failure.
• The HeartMate II LVAD is a widely used device for hemodynamic support.
• This study evaluates single-center outcomes of HeartMate II LVAD implantation.

Purpose of the Study:

• To report outcomes of HeartMate II LVAD implantation in bridge-to-transplant (BTT) patients.
• To review lessons learned from a single center's experience with the HeartMate II LVAD.
• To assess the impact of FDA approval on BTT patient outcomes.

Main Methods:

• A retrospective review of 102 consecutive BTT patients receiving the HeartMate II LVAD from June 2005 to June 2010.
• Analysis of patient survival, adverse events, and comparison of pre- and post-FDA approval outcomes.
• Focus on BTT patients, including those receiving the device before and after FDA approval in April 2008.

Main Results:

• Overall 1-year survival for BTT patients was 78.8%.
• Major adverse events included driveline infections (24.5%), gastrointestinal bleeding (17.6%), and neurologic events (9.8%).
• No statistically significant difference in 6-month survival was observed between pre- and post-FDA approval periods.

Conclusions:

• The HeartMate II LVAD provides excellent hemodynamic support and survival for BTT patients.
• Significant morbidity exists, particularly gastrointestinal bleeding, driveline infections, and neurologic events.
• Improvements in managing adverse events are crucial for LVADs to serve as long-term alternatives to heart transplantation.