Real World Experience with HeartMate 3 - One Year Follow-Up

 

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Objective: The HeartMate 3 (HM3; St. Jude Medical Cooperation, St. Paul, MN, USA) is a new compact LVAD which is associated with several new technical features (e.g., fully magnetically levitated pump, artificial pulse, large pump gaps, modular driveline, etc.). These benefits are supposed to lead to superior outcomes compared with its predecessor HeartMate II (HMII; Thoratec Corporation, Pleasanton, CA, USA) and other comparable assist devices. With this study, we present the first study on outcomes and adverse events of a single-center cohort 1 year after HM3 implantation.

Methods: We retrospectively studied a patient cohort of 27 patients who were supported with the continuous flow left ventricular assist devices Heartmate 3 at a single institution between June 2014 and April 2016. Data was determined through examination of medical records. Exclusion criteria were biventricular assist devices and other types of assist devices as well as LVAD exchange and re-operative procedures. All patients underwent HM3 implantation via full sternotomy. Anticoagulation protocol constituted Phenprocoumon (INR 2.0–2.5) and daily 100 mg of Aspirin per os.

Results: Twenty-seven patients were enrolled into the study. Within 1 year after HM3 implantation, one patient received a heart transplant and three patients died. Thirty-day survival was 88.9%; 6 months, 85.2%; and 1 year, 85.2%. There were no strokes or pump thrombosis in the study group at one year. The most frequent complications were minor bleedings not requiring surgery and LVAD related as well as non-LVAD related infections. Within one year after HM3 implantation, a total of 12 bleeding events in 8 patients were observed. Out of those, one required surgery (3.7%) due to late cardiac tamponade. One GI bleeding was observed (3.7%). No pump thrombosis and no strokes were observed within the first year. Six LVAD-related infections were documented in four patients (14.8%) and eight non-LVAD related infections were documented in seven patients (33.3%). Right heart failure was diagnosed in one patient after surgery (3.7%). No technical complications of the pump were documented. No pump exchanges were necessary.

Conclusion: The novel LVAD HeartMate 3 has already shown good CE mark trial results. Within this first report on real world experience, the one year survival after HM3 implantation was 85.2%. The HM3 showed excellent midterm results with 0% stroke and 0% pump thrombosis rates one year after implantation.