Transapical implantation of a self-expanding aortic valve bioprosthesis--animal feasibility study.
BACKGROUND
Severe peripheral arterial disease may pose a limitation to the applicability of trans-arterial aortic valve implantation in patients who are otherwise candidates. For this reason, transapical aortic valve implantation has been proposed as a possible alternative.


OBJECTIVE
To evaluate the acute safety and performance of a specially designed delivery system, the CoreValve Tranzap delivery catheter, for the transapical implantation of a self-expandable aortic valve prosthesis in a porcine animal model.


METHODS
Thirteen pigs were implanted with a self-expandable aortic valve bioprosthesis using a 21F catheter delivery system through a transapical approach. The delivery system was evaluated for: (1) the ability to access the implantation site; (2) the ability to precisely position the delivery catheter; (3) control of the delivery of the prosthesis; (4) safe retrieval of the delivery catheter; and (5) the ability to close the apical access site of the heart.


RESULTS
Successful implantation was achieved in 100% of the cases. The following points were achieved in all animals: (1) passage of the delivery catheter through an incision in the left ventricular apex; (2) positioning of the delivery catheter on the implantation site; (3) controlled deployment of the aortic valve prosthesis; (4) the safe retrieval of the delivery catheter system; and (5) the adequate closure of the apex of the heart.


CONCLUSIONS
This study demonstrates the acute safety and feasibility of the CoreValve Tranzap delivery system for the transapical implantation of the CoreValve self-expanding aortic valve bioprosthesis in a porcine animal model.
Kappetein
Arie-Pieter
AP
Department of Cardio-Thoracic Surgery, Erasmus Medical Center, Thoraxcenter, Rotterdam, The Netherlands. a.kappetein@erasmusmc.nl
Piazza
Nicolo
N
Laborde
Jean-Claude
JC
de Jaegere
Peter P
PP
Serruys
Patrick W
PW
D000818:Animals; D001021:Aortic Valve / Q000601:surgery*; D001027:Aortography; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation; D004195:Disease Models, Animal; D004867:Equipment Design; D005240:Feasibility Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D019060:Minimally Invasive Surgical Procedures / Q000009:adverse effects / Q000379:methods; D034421:Sus scrofa