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PRECLINICAL STUDY

Valve-in-a-Valve Concept for Transcatheter Minimally Invasive Repeat Xenograft Implantation

Thomas Walther, MD, PhD^_*,_*, Volkmar Falk, MD, PhD^_*, Todd Dewey, MD, Jörg Kempfert, MD^_*, Fabian Emrich, MD^_*, Bettina Pfannmüller, MD^_*, Petra Bröske, DVM^_*, Michael A. Borger, MD, PhD^_*, Gerhard Schuler, MD, PhD, Michael Mack, MD and Friedrich W. Mohr, MD, PhD^_*

^_* Klinik für Herzchirurgie, Leipzig, Germany
Kardiologie, Herzzentrum, Universität Leipzig, Leipzig, Germany
Department of Cardiac Surgery, Cardiopulmonary Research Science and Technology Institute, Dallas, Texas.

Manuscript received January 5, 2007; revised manuscript received February 28, 2007, accepted March 5, 2007.

^_* Reprint requests and correspondence: Dr. Thomas Walther, Universität Leipzig, Herzzentrum, Klinik für Herzchirurgie, Strümpellstrasse 39, 04289 Leipzig, Germany. (Email: walt{at}medizin.uni-leipzig.de).

Objectives: This study sought to evaluate the feasibility of minimally invasive transapical repeat valve-in-a-valve (VinV) implantation.

Background: Reoperative heart valve replacement for degenerated xenografts is associated with an increased surgical risk.

Methods: Conventional Carpentier Edwards porcine aortic (n = 5) and mitral (n = 2) valve prostheses were implanted in 7 pigs. Transapical VinV implantation of a pericardial xenograft fixed within a 23-mm stainless steel, balloon expandable stent (Cribier Edwards, Edwards Lifesciences, Irvine, California) was then performed under fluoroscopic and echocardiographic visualization on the beating heart with ventricular unloading via cardiopulmonary bypass and rapid ventricular pacing.

Results: Valve deployment was successfully performed in all cases. The radiopaque marking within the stent of the conventional aortic or mitral xenograft allowed for optimal positioning of the stent-delivered valve. All valves were firmly positioned without any migration. There were neither paravalvular nor transvalvular leaks, and good hemodynamic function was observed in all cases. All coronary arteries remained patent. Positioning and function were confirmed by autopsy in all animals.

Conclusions: The VinV concept is promising for minimally invasive beating heart repeat aortic or mitral valve replacement, using a stent-fixed sutureless prosthesis.

Abbreviations and Acronyms   AVR = aortic valve replacement   CPB = cardiopulmonary bypass   MVR = mitral valve replacement   VinV = valve-in-a-valve

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