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a Department of Cardio-Thoracic Surgery, Erasmus Medical Center, Thoraxcenter, Rotterdam, The Netherlands
b Department of Interventional Cardiology, Erasmus Medical Center, Thoraxcenter, Rotterdam, The Netherlands
c Department of Interventional Cardiology, Clinique Pasteur, Toulouse, France
Received 26 November 2008; received in revised form 23 April 2009; accepted 27 April 2009.
* Corresponding author. Address: Department of Cardiac Surgery, Erasmus Medical Centre, Thoraxcenter, Bd569, 's-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands. Tel.: +31 10 7034476; fax: +31 10 7039933. (Email: a.kappetein{at}erasmusmc.nl).
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 TranzapTM 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. Conclusion: This study demonstrates the acute safety and feasibility of the CoreValve TranzapTM delivery system for the transapical implantation of the CoreValve self-expanding aortic valve bioprosthesis in a porcine animal model.
Key Words: Heart valve Bioprosthesis Cardiac catheterisation/intervention
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