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(Circulation. 2009;120:S185-S190.)
© 2009 American Heart Association, Inc.

Cardiac Transplantation and Surgery for Heart Failure

Novel Implantable Device to Detect Cardiac Allograft Rejection

Tetsuya Horai, MD; Hideyuki Fumoto, MD; Diyar Saeed, MD; Roula Zahr, MD; Tomohiro Anzai, MD; Yoko Arakawa, MD; Shanaz Shalli, MD; Chiyo Ootaki, MD; Jacquelyn Catanese, MA; Masatoshi Akiyama, MD, PhD; Carmela D. Tan, MD; E. Rene Rodriguez, MD; James B. Young, MD; Kiyotaka Fukamachi, MD, PhD

From Department of Biomedical Engineering (T.H., H.F., D.S., R.Z., T.A., Y.A., S.S., C.O., J.C., M.A., K.F.), Lerner Research Institute, Department of Anatomic Pathology (C.D.T., E.R.R.), Pathology & Laboratory Medicine Institute, and Department of Cardiovascular Medicine (J.B.Y.), Heart & Vascular Institute, Cleveland Clinic, Cleveland, Ohio.

Correspondence to Kiyotaka Fukamachi, MD, PhD, Department of Biomedical Engineering/ND20, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195. E-mail fukamak{at}ccf.org

Background— Allograft rejection remains the nemesis of solid organ transplantation. Soul Mate is a novel implantable wireless data transmission system that analyzes 9 intramyocardial electrogram parameters recorded from 4 or 6 configurations of 2 or 3 epicardial leads to detect allograft rejection. This study determined the ability of the Soul Mate to detect early rejection of transplanted hearts.

Methods and Results— Five dogs underwent heterotopic cervical heart transplantation and simultaneous implantation of the Soul Mate’s Cardiac Rejection Monitoring Device. Dogs were initially immunosuppressed, but subsequent drug discontinuation allowed allograft rejection to appear. Allograft biopsies were performed at regular intervals to determine rejection grade, which was compared to a calculated rejection score determined as percent change from baseline of values for each intramyocardial electrogram. There was significant correlation between the biopsy results and the evolution of 5 parameters. The strongest correlation (r=0.939; P<0.001) was obtained using the "general median" parameter from 4 configurations, assessed 1 day before the biopsy, with a sensitivity of 85.7% and a specificity of 100% compared to the myocardial biopsy results.

Conclusions— The Soul Mate allograft rejection monitoring system accurately detected transplanted heart rejection in a canine model noninvasively with continuous sampling. This proof-of-concept study suggests that the Soul Mate could be used to more intensely and more frequently monitor cardiac allografts for rejection.

Key Words: biopsy • heart failure • rejection • transplantation