Evaluation of an implantable ventricular assist system for humans with chronic refractory heart failure. Device explant protocol.
An explant protocol was developed to investigate the effects of implantation of a left ventricular assist system (LVAS) manufactured by Novacor Division, Baxter Healthcare Corporation on the function of end organs (such as the brain, the kidney, the liver), with particular interest in examining possible complications due to LVAS support. Emphasis was placed on an analysis at the time of device removal and/or autopsy of 1) the local LVAS-host interface; 2) remote cardiovascular and end-organ effects; and 3) the impact of chronic circulatory support on the native heart. To accomplish these objectives, tissue and device samples must be obtained in an appropriate fashion to ensure photographic documentation, microscopic examination, microbiologic and biochemical assays, and compliance with regulatory and manufacturer requirements. This article describes the techniques and protocol that were proposed to ensure the quality of device explant and tissue analysis.
Borovetz
H S
HS
Department of Surgery, University of Pittsburgh, Pennsylvania.
Ramasamy
N
N
Zerbe
T R
TR
Portner
P M
PM
D001344:Autopsy; D001921:Brain / Q000502:physiology; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000592:standards*; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects / Q000592:standards*; D006801:Humans; D007668:Kidney / Q000502:physiology; D008099:Liver / Q000502:physiology; D011786:Quality Control