For treatment of advanced heart failure, current strategies include cardiac transplantation or blood-contacting pump technology associated with complications, including stroke and bleeding. This study investigated an individualized biventricular epicardial augmentation technology in a drug-induced porcine failing heart model. A total of 11 pigs were used, for the assessment of hemodynamics and cardiac function under various conditions of support pressures and support durations (n = 4), to assess device positioning and function by in vivo computer tomographic imaging (n = 3) and to investigate a minimally invasive implantation on the beating heart (n = 4). Support pressures of 20–80 mm Hg gradually augmented cardiac function parameters in this animal model as indicated by increased left ventricular stroke volume, end-systolic pressures, and decreased end-diastolic pressures. Strong evidence was found regarding the necessity of mechanical synchronization of support end with the isovolumetric relaxation phase of the heart. In addition, the customized, self-expandable implant enabled a marker-guided minimally invasive implantation through a 4 cm skin incision using fluoroscopy. Correct positioning was confirmed in computer tomographic images. Continued long-term survival investigations will deliver preclinical evidence for further development of this concept.
From the *Mechanics and High Performance Computing Group, Technical University of Munich, Garching, Germany
†Institut für Anästhesiologische Pathophysiologie und Verfahrensentwicklung, Universitätsklinikum Ulm, Ulm, Germany
‡AdjuCor GmbH, Garching, Germany
§Klinik für Diagnostische und Interventionelle Radiologie, Universitätsklinikum Ulm, Ulm, Germany
¶Institute for Cardiovascular Prevention (IPEK), LMU, Munich, Germany
‖I. Medizinische Klinik, Klinikum Rechts der Isar, TUM, Munich, Germany
#DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
**Klinik für Anästhesiologie, Universitätsklinikum Ulm, Ulm, Germany.
Submitted for consideration March 2017; accepted for publication in revised form August 2017.
This work was supported by the Bavarian Research Foundation (AZ 1020-12, AZ 1114-14); the Federal Ministry for Economic Affairs and Energy of Germany (KF3349001CR); and the 7th framework program of the European Union (AMCARE).
Dr. Andreas Maier serves as CTO and Dr. Stephen Wildhirt serves as CEO for AdjuCor GmbH. AdjuCor GmbH holds patents for the technology described. Prof. Radermacher received grants from AdjuCor GmbH during the conduct of the study. The rest of the authors have nothing to disclose.
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Correspondence: Sebastian Hafner, Institut für Anästhesiologische Pathophysiologie und Verfahrensentwicklung, Universitätsklinikum Ulm, Helmholtzstrasse 8-1, 89081 Ulm, Germany. Email: email@example.com.