Unexpected abrupt increase in left ventricular assist device thrombosis

Area of Science:

• Cardiovascular Surgery
• Medical Device Engineering
• Biomedical Research

Background:

• An observed increase in HeartMate II left ventricular assist device thrombosis rates compared to initial data.
• Investigation into pump thrombosis, elevated lactate dehydrogenase (LDH) levels, and associated hemolysis.
• Evaluation of management strategies for device thrombosis in a multi-institutional setting.

Purpose of the Study:

• To investigate the increasing incidence of pump thrombosis in HeartMate II devices.
• To analyze the correlation between elevated LDH levels and pump thrombosis.
• To assess the outcomes of different management strategies for HeartMate II thrombosis.

Main Methods:

• Data collected from 837 patients across three institutions (2004-2013).
• Analysis of 895 HeartMate II device implantations.
• Primary endpoint: confirmed pump thrombosis; secondary endpoints: suspected thrombosis, LDH levels, and post-thrombosis outcomes.

Main Results:

• Confirmed pump thrombosis occurred in 72 patients; 36 additional suspected cases.
• Confirmed pump thrombosis at 3 months increased from 2.2% to 8.4% after March 2011.
• Median time to thrombosis decreased from 18.6 months to 2.7 months post-March 2011; elevated LDH levels preceded thrombosis.
• Mortality was 48.2% at 6 months for patients not receiving transplantation or pump replacement.

Conclusions:

• The rate of HeartMate II pump thrombosis is increasing.
• Pump thrombosis is associated with significant morbidity and mortality.
• Early detection via LDH levels and timely intervention are crucial.