SUTURELESS PERCEVAL S AORTIC VALVE REPLACEMENT: Multicentric, Prospective, Pilot Trial
Malakh Shrestha1, Thierry Folliguet2, Paul Herijgers3, Alain Debie2, Christoph Bara1, Marie-Christin Herregods3, Nawid Khaladj1, Christian Hagl1, Willem Flameng3, Franscois Laborde2, Axel Haverich1; 1Cardiothoracic Surgery, Hannover Medical School, Hannover, Germany; 2Institut Mutualiste Montsouris, Paris, France; 3U.Z. Gasthuisberg, Leuven, Belgium
Comment on this Abstract
Objective: A European, multicentric, prospective, non-randomized, clinical pilot trial was designed to evaluate the safety (mortality and morbidity at 30 days) of the Perceval S prosthesis in 30 high surgical risk patients requiring aortic valve replacement with standard surgical procedure. Perceval S is a bovine pericardium tri-leaflet prosthetic valve fixed in a self-expanding Nitinol stent. The exclusive shape of the stent provides a reliable anchoring of the prosthesis within the patient aortic root. This prosthesis is available in two sizes, 21 and 23 mm. Mortality, morbidity and echocardiographic haemodymanic performance evaluation is planned at discharge, 1, 3, 6 and 12 months.
Methods: The valve is implanted following sternotomy, extracorporeal circulation, aortic cross clamping, cardioplegic arrest and removal of the native valve. No suture is required. Optimal annular sealing is obtained with brief low pressure balloon dilation. When indicated, distal coronary anastomoses were performed before valve deployment.
Results: From April to September 2007, 23 patients (5 males, mean age: 78 ± 4 years, 76-88) have undergone aortic valve replacement. Pure aortic stenosis prevalence was 82.6%, while a mixed lesion was present in 17.4%. Mean Logistic Euroscores was 12.2% and NYHA class was III and IV in 91.3%, 8.7% respectively. Implanted valve size was 21 and 23 mm in 39.1% and 60.9% respectively. 9 (39.1%) patients received CABGs (9 IMAs, 3 vein grafts). Mean aortic cross clamp time and cardiopulmonary were 38 min and 61 min, respectively. There were no failures of deployment. One trivial paravalvular leakage (4.3%) was noticed peri-operatively at TEE; no new onset of paravalvular leakages. Tamponade was the cause of early surgical revision in 1 (4.3%) patient, a sternal wound infection (4.3%) required debridement in another one and there was a peripheral thromboembolic event (4.3%). One (4.3%) patient required PM implantation because of III° AVBlock.
One (4.3%) in hospital death and one (4.3%) late death, both not-valve related. Mean length of stay was 9 days. Mean follow-up is 80 days: 18, 12 Pts. have respectively reached 1 and 3 month follow-up. No migration or dislodgement occurred.
Conclusion: The preliminary results of this trial confirmed the safety and efficacy of this sutureless aortic valve. In this high risk subset of patients, the reduction of the aortic clamping and CPB time among other advantages has proven to reduce the mortality and morbidity related to the surgical procedure.
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