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One-year experience with the LionHeart fully implantable left ventricular assist device

El Banayosy, Aly; Arusoglu, Latif; Fey, Oliver; Sarnowski, Peter; Milting, Hendrik; Körfer, Reiner

ASAIO Cardiopulmonary Abstracts

Ruhr-Universität Bochum; Herz- und Diabeteszentrum NRW; Klinik für Thorax- und Kardiovaskularchirurgie; Georgstr. 11; D-32545 Bad Oeynhausen; Germany

Purpose of study: The increasing number of patients with end-stage heart failure and the lack of true therapeutic alternatives has paved the way for the development of the LionHeart, which is the first fully implantable destination therapy left ventricular assist device. In October 1999, the first implantation worldwide of this device was performed at our institution.

Patients and Methods: Since October 1999, 5 patients (all of them men) aged 55–69 years (mean 65±6) with end-stage heart failure for dilated (n=3) or ischemic (n=2) cardiomyopathy have received the device. All of them were ineligible for heart transplantation because of a malignancy (n=2), age (n=2), or systemic lupus erythematosus. Mean history of heart failure in these patients was 12.2 years. Prior to implantation, all patients were in NYHA functional class IV in spite of drug therapy with ACE inhibitors, beta-blocking agents, spiralactam, digitalis, and amiodarone (n=5), inotropic agents (n=4) and intraaortic balloon pumping (n=1). Pre-implant BUN was 47–126 (mean 75±34) mg/dl, creatinine 1.2–1.5 (mean 1.3±1.3) mg/dl, and bilirubin 0.6–2.3 (1.3±0.6) mg/dl.

Results: Until now, duration of support has been 17–350 (mean 157±137) days with our cumulative experience amounting to 786 days. Duration of intubation was 17–120 (mean 57±49) hours, duration of ICU stay 17–36 (27±9) days. Three patients are still alive, two of them could be discharged from hospital. Compliance chamber assessment performed every 3–6 weeks revealed an air loss of 1.6–4.7 (3.0±1.4) ml/day, which had to be compensated for. Major complications included bleeding (n=2), re-operation for bleeding (n=1), tamponade (n=1), mild hemolysis (n=3), arrhythmias (n=2), low pump output related to the compliance chamber (n=1) and cerebrovascular accident (n=1). The second and the fifth patient in our series died from multiple organ failure after 112 and 17 days of support, respectively. Conclusion: Our initial experience with 5 patients has shown the safety of the LionHeart without any pump failures occurring during the cumulative support time of 786 days. 2 patients are at home and are doing well.

Copyright © 2001 by the American Society for Artificial Internal Organs