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Published on: August 16, 2021
Unexpected abrupt increase in left ventricular assist device thrombosis
Randall C Starling1, Nader Moazami, Scott C Silvestry
1From the Departments of Cardiovascular Medicine (R.C.S., M.M.M.), Thoracic and Cardiovascular Surgery (N.M., E.H.B., E.G.S., B.W.L., N.G.S.), and Quantitative Health Sciences (E.H.B., J.E., L.T.) and Kaufman Center for Heart Failure (R.C.S., N.M., E.H.B., M.M.M., E.G.S., N.G.S.), Cleveland Clinic, Cleveland; the Division of Cardiovascular Surgery (S.C.S.) and the Cardiovascular Division (G.E.), Barnes-Jewish Hospital, Washington University School of Medicine, St. Louis; the Cardiology Division (J.G.R.) and the Cardiovascular Surgery Division (C.A.M.), Duke University School of Medicine, Durham, NC; and the Divisions of Cardiology (J.E.R.) and Cardiovascular Surgery (M.A.A.), University of Pennsylvania, Philadelphia.
Insights
Pump thrombosis in HeartMate II left ventricular assist devices has increased significantly since March 2011. This complication, often preceded by elevated lactate dehydrogenase (LDH) levels, is linked to substantial morbidity and mortality.
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.
Background:
We observed an apparent increase in the rate of device thrombosis among patients who received the HeartMate II left ventricular assist device, as compared with preapproval clinical-trial results and initial experience. We investigated the occurrence of pump thrombosis and elevated lactate dehydrogenase (LDH) levels, LDH levels presaging thrombosis (and associated hemolysis), and outcomes of different management strategies in a multi-institutional study.
Methods:
We obtained data from 837 patients at three institutions, where 895 devices were implanted from 2004 through mid-2013; the mean (±SD) age of the patients was 55±14 years. The primary end point was confirmed pump thrombosis. Secondary end points were confirmed and suspected thrombosis, longitudinal LDH levels, and outcomes after pump thrombosis.
Results:
A total of 72 pump thromboses were confirmed in 66 patients; an additional 36 thromboses in unique devices were suspected. Starting in approximately March 2011, the occurrence of confirmed pump thrombosis at 3 months after implantation increased from 2.2% (95% confidence interval [CI], 1.5 to 3.4) to 8.4% (95% CI, 5.0 to 13.9) by January 1, 2013. Before March 1, 2011, the median time from implantation to thrombosis was 18.6 months (95% CI, 0.5 to 52.7), and from March 2011 onward, it was 2.7 months (95% CI, 0.0 to 18.6). The occurrence of elevated LDH levels within 3 months after implantation mirrored that of thrombosis. Thrombosis was presaged by LDH levels that more than doubled, from 540 IU per liter to 1490 IU per liter, within the weeks before diagnosis. Thrombosis was managed by heart transplantation in 11 patients (1 patient died 31 days after transplantation) and by pump replacement in 21, with mortality equivalent to that among patients without thrombosis; among 40 thromboses in 40 patients who did not undergo transplantation or pump replacement, actuarial mortality was 48.2% (95% CI, 31.6 to 65.2) in the ensuing 6 months after pump thrombosis.
Conclusions:
The rate of pump thrombosis related to the use of the HeartMate II has been increasing at our centers and is associated with substantial morbidity and mortality.
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