PMID: 15216148Jan 1, 1976Paper

AN INTRACORPOREAL (ABDOMINAL) LEFT VENTRICULAR ASSIST DEVICE [ALVAD], XXX: CLINICAL READINESS AND INITIAL TRIALS IN MAN

Cardiovascular Diseases
John C. Norman

Abstract

The purpose of this report is to present documenting evidence of the clinical readiness of an abdominal left ventricular assist device (ALVAD) according to NHLI criteria,( double dagger ) and the initiation of clinical trials of this device in otherwise irretrievable adult post-cardiotomy patients at the Texas Heart Institute of St. Luke's Episcopal and Texas Children's Hospitals. The ALVAD system has been developed, modified, and improved under NHLI auspices over the last eight years,( double dagger double dagger ) with annual reviews. Over 20,000 hours of in-vivo testing in the calf have been accomplished in our laboratories. The current clinical trials underwent two federal reviews (May 22, 1973 and October 17, 1974) and were the topic of an Ad Hoc Workshop at NHLI on October 28, 1973.( double dagger double dagger double dagger ) More recently, a consecutive series of 26 bovine ALVAD implantations were undertaken; acute and chronic hemodynamic effectiveness with maintenance or augmentation of the systemic circulation during profound ventricular unloading without undue blood trauma, intra-or extra-prosthetic thrombosis, or sepsis was demonstrated; no biomaterials problems were encountered. In-vivo realibility and durability, ...Continue Reading

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