European multicenter study with the Soprano valve for aortic valve replacement: one-year clinical experience and hemodynamic data.
OBJECTIVE
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).


CONCLUSIONS
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.
Klinikum Nürnberg, Nuremberg, Germany. Theodor.Fischlein@klinikum-nuernberg.de
Theodor
T
Fischlein
Eduardo
E
Otero-Coto
Kalervo
K
Werkkala
Giancarlo
G
Passerone
Giuseppe
G
Marinelli
Matti R
MR
Tarkka
Peter
P
Feindt
Leopoldo
L
Perez de Isla
Jose L
JL
Zamorano
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging; D001024:Aortic Valve Stenosis / Q000601:surgery; D001705:Bioprosthesis; D004452:Echocardiography; D004696:Endocarditis / Q000453:epidemiology; D005060:Europe / Q000453:epidemiology; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000401:mortality*; D006439:Hemodynamics; D006470:Hemorrhage / Q000453:epidemiology; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology*; D011446:Prospective Studies; D012086:Reoperation; D013923:Thromboembolism / Q000453:epidemiology