First clinical trials of a totally implantable destination therapy ventricular assist system

A. Snyder, Walter Pae, John Boehmer, Gerson Rosenberg, William Weiss, W. Pierce, J. Thompson, J. Lewis, D. Frank, H. Zintak, S. Scholl, R. Körfer, A. El-Banayosy, L. Arusoglu, O. Fey, M. Morshuis

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Abstract

Our artificial heart research team at the Pennsylvania State University has been engaged since 1971 in the development of mechanical circulatory support systems, including those that provide left ventricular assistance. While for many years these systems were suitable for use only for short-term support, the technology on which they were based was always intended for application to devices and systems for long-term use. We have recently begun the first clinical trials of a left ventricular assist system that operates without percutaneous leads and is intended for application as destination therapy. The sac-type blood pump uses a smooth segmented polyurethane surface and careful design of transitions to valves and connectors to discourage thrombus formation. The pump is coupled to a roller-screw energy converter. Implanted electronics with a back-up battery, a thoracic compliance chamber, and inductive energy transmission enable the system to operate without percutaneous lines. External subsystems provide the recipient with multiple options for maintaining power to the system and carrying the necessary equipment. The clinician is provided with a simple interface to determine the status of the system and make limited adjustments through a radio frequency telemetry link. The Clinical Utility Baseline Study (CUBS) is a nonrandomized trial designed to determine the system's utility for treatment of end-stage heart disease patients who are not candidates for heart transplantation. Early experience with the system indicates that the technology necessary to achieve intact-skin operation - the inductive energy transmission and compliance chamber - perform well and will be practical for use in patients, and that the system has considerable potential for treatment of the intended patient population.

Original languageEnglish (US)
Pages (from-to)185-192
Number of pages8
JournalJournal of Congestive Heart Failure and Circulatory Support
Volume1
Issue number4
StatePublished - Dec 1 2000

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All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Cardiology and Cardiovascular Medicine

Cite this

Snyder, A., Pae, W., Boehmer, J., Rosenberg, G., Weiss, W., Pierce, W., Thompson, J., Lewis, J., Frank, D., Zintak, H., Scholl, S., Körfer, R., El-Banayosy, A., Arusoglu, L., Fey, O., & Morshuis, M. (2000). First clinical trials of a totally implantable destination therapy ventricular assist system. Journal of Congestive Heart Failure and Circulatory Support, 1(4), 185-192.