Abstract 15780: Aortic Valve Replacement With Sutureless Perceval S Prosthesis: An European Multicenter, Prospective Trial
OBJECTIVES: This clinical trial was designed to evaluate the safety and effectiveness of aortic valve replacement (AVR) with Perceval S (Sorin (R)) in patients ≥ 75 years of age. The Perceval S sutureless prosthesis is a bovine pericardium valve fixed in a metal cage made of nitinol.
METHODS: From 04/2007 to 01/2009, 180 patients (mean age: 81±4 years, 76 % female) with symptomatic aortic valve stenosis were included in this trial. Pure aortic stenosis was present in 84%. The mean logistic EuroSCORE was 13±9%. NYHA class was ≥ III in 99% of all patients. The valve was implanted surgically after removal of the native valve using extracorporeal circulation (ECC) and cardioplegic arrest. Implantation suturing was not required. Optimal annular sealing was obtained with brief low pressure balloon dilation. Concomitant procedures were performed if necessary. Clinical and echocardiographic follow-up was performed at the time of hospital discharge and at intervals thereafter.
RESULTS: There was no intra-procedural death, 30 day mortality due to all causes was 3% (n=5). The study valve was successfully implanted in 173 patients (96%). In isolated AVR (64%), mean aortic cross clamp and ECC times were 29±10 min and 49±20 min, respectively. AV block leading to pacemaker implantation was seen in 13 patients (7%), two (1%) suffered from stroke. 19 patients died during follow-up. Only two of whom were valve related. 166 patients were assessed 1 month post-implantation, 129 patients at twelve months and nine patients at two years, respectively. No migration or dislodgement of the valve has occurred. There were four paravalvular leakages > 2+. At 12 months 82% of the patients were in NYHA class I or II.
CONCLUSIONS: This trial confirms the safety and efficacy of the Perceval S sutureless aortic valve. It is a technically simple and reproducible alternative for conventional surgical AVR, especially in high risk patient. Furthermore, it can be combined with other cardiac procedures in contrast to transfemoral/transapical implantation techniques. As the valve does not need to be sutured, the myocardial ischemia and ECC time is reduced. This may be especially an advantage in complex and more time consuming procedures. This valve may also enable broader application of minimal invasive AVR.
- © 2011 by American Heart Association, Inc.