New mechanical circulatory support devices as an alternative to the heart transplantation in end-stage heart failure patients
Abstract
Aim. National Research Center for Cardiac Surgery was one of the enrolling centers in the HeartMate
3 assist device CE Mark Study in 2014. Post-approval application of HeartMate 3 started in January
2015 first in the world in Kazakhstan. The objective of this report was to determine outcomes
of patients with pre- and post-approval HeartMate 3 assist device.
Methods. A total number of cases with the HeartMate 3 assist devices included 63 patients. We
analyzed data from 62 patients (8 patients were within the CE Mark Study and 54 patients – in the
HeartMate 3 post-approval period). Most of them (96.7%) were men. Mean age was 49±13 years.
The median duration of support is 398±248 days. Maximum duration of support is 903 days (patient
remains ongoing).
Results. The patients used the device as a “bridge to transplantation” (66%) and “destination
therapy” (34%) patients. Patients were in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profiles 3–4 in most of cases (n=60, 96.7%). Currently 48 patients are
ongoing with HeartMate 3 support, 6 transplanted and 7 died. One patient was explanted on post-implant day 233 due to outflow-graft thrombosis secondary to infection, underwent an extracorporeal membrane oxygenation, and died in 1 month. Kaplan–Meier survival estimates for patients with
HeartMate 3 assist device were 95% after 1 month, 93% after 6 and 12 months, 87% after 1 year and
6 months and 73% after 2 years. The main reason of death was the hemorrhagic stroke (n=4, 6.4%).
17 patients (27.4%) experienced right ventricular failure resulted in right ventricular assist device
setting only in 1 (1.6%) case, driveline infections were observed in 7 (11.3%) patients. No patients
had hemolysis or pump thrombosis.
Conclusion. Overall experience with the HeartMate 3 has been positive with the high survival rates.
No cases of hemolysis or pump thrombosis were observed. We hope that additional work with patients,
their families, the local coordinators will help to improve the use of HeartMate 3 assist device.
Keywords:left ventricular assist device, mechanical circulatory support, heart failure, Kazakhstan, heart transplantation
Clin. Experiment. Surg. Petrovsky J. 2017; 5 (1): 7–14.
DOI: 10.24411/2308-1198-2017-00014
Received: 18.01.2017. Accepted: 18.02.2017.
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