Background and aim of the study: During recent years, pericardial bioprostheses have gained widespread acceptance as cardiac valve substitutes. The study aim was to evaluate the early clinical and hemodynamic performance of the Sorin SopranoTM supra-annular aortic bioprosthesis, as used for aortic valve replacement (AVR).
Methods: Between January 2004 and August 2006, a total of 501 patients (55% males; mean age 75 +/- 6.4 years) was prospectively enrolled into the study, which involved 10 European institutions. The indications for AVR were aortic stenosis in 91% of patients, aortic incompetence in 8%, and redo surgery in 1%. Preoperatively, 62% of the patients were in NYHA class III, and 12% in class IV. The mean prosthesis size was 21.4 +/- 1.8 mm. A non-everting technique was used in 88% of patients. Concomitant procedures were performed in 52% of cases (mainly coronary artery bypass grafts; 41%). The mean cross-clamp and cardiopulmonary bypass times were 70 +/- 27.2 min and 99 +/- 39.7 min, respectively. Doppler echocardiography performed at one and 12 months after surgery was evaluated by an independent core laboratory.
Results: Postoperatively, there were 25 early deaths (5%) and 13 late deaths, with an overall survival at one year of 92.9% (95% CI: 90.2-94.8) and freedom from valve-related death of 98.6% (95% CI: 97.5-99.6). After 12 months, most patients (87%) were in NYHA classes I-II. Actuarial freedoms from thromboembolism, bleeding, endocarditis and paraprosthetic leak at one year were 97.1% (CI: 95.1-98.2), 98.9% (CI: 97.4-99.5), 99.1% (CI: 97.7-99.7), and 99.6% (CI: 98.3-99.9), respectively. No events of thrombosis and structural valve deterioration (SVD) were observed. Subsequent echocardiographic evaluation showed low mean (11.1 +/- 5.1 mmHg at one year) and peak (19.5 +/- 8.9 mmHg at one year) transvalvular gradients, and a significant reduction in left ventricular mass, from 211 +/- 78.5 g at one month to 185 +/- 64.7 g at 12 months (p <0.0001).
Conclusion: After 12 months, the clinical outcome with the Soprano bioprosthesis, when used for AVR, was excellent. The bioprosthesis also showed good hemodynamic performance, with a significant reduction of left ventricular hypertrophy.