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JOURNAL ARTICLE
MULTICENTER STUDY

The Freedom SOLO valve for aortic valve replacement: clinical and hemodynamic results from a prospective multicenter trial

Sven Beholz, Alberto Repossini, Ugolino Livi, Marc Schepens, Mohamed El Gabry, Klaus Matschke, Uday Trivedi, Lothar Eckel, Otto Dapunt, José Luis Zamorano
Journal of Heart Valve Disease 2010, 19 (1): 115-23
20329497

BACKGROUND AND AIM OF THE STUDY: The study aim was to investigate the early results, hemodynamics and left ventricular remodeling after aortic valve replacement (AVR) with the Freedom SOLO valve, a bovine pericardial valve bioprosthesis, using a single running suture line in a supra-annular position.

METHODS: Between July 2004 and September 2006, a total of 256 patients (116 males; 140 females; mean age 74.5 +/- 6.4 years; range: 41-89 years) who underwent AVR with the Freedom SOLO valve in nine European institutions were enrolled in the study. The indications for AVR were stenosis in 182 patients, regurgitation in 15, and combined in 57. Preoperatively, 37%, 59% and 4% of the patients were in NYHA classes I-II, III, and IV, respectively. Concomitant procedures were performed in 91 patients (36%). A patient subgroup underwent echocardiography preoperatively (n=192), and at one (n=194) and 12 (n=165) months postoperatively.

RESULTS: The early mortality was 2.3% (n=6). There were 18 late deaths (6.2%/pt-yr). After 12 months, 82% of the patients were in NYHA class I-II. Linearized rates were 0.69%/pt-yr for bleeding, 0.34%/pt-yr for thromboembolism, 0.0%/pt-yr for structural degeneration and thrombosis, 1.37%/pt-yr for paravalvular leak, and 2.06%/pt-yr for endocarditis. Five patients required reoperation. Twelve-month transprosthetic regurgitation was graded as absent in 92% of cases. The mean gradient was 42.3 +/- 20.2 mmHg preoperatively, 6.5 +/- 3.8 mmHg at one month, and 6.7 +/- 4.1 mmHg at 12 months. The effective orifice area was improved from 0.78 +/- 0.35 cm2 preoperatively to 1.90 +/- 0.56 cm2 at one month and 1.89 +/- 0.56 cm2 at 12 months. The left ventricular mass was decreased by 23%, from 217.8 +/- 77.2 g/m2 preoperatively to 167.4 +/- 68.2 g/m2 at one year. The mean left ventricular ejection fraction was 65.5 +/- 14.2% preoperatively, and 64.5 +/- 12.5% and 66.0 +/- 10.6% at one month and at 12 months, respectively.

CONCLUSION: The data obtained suggest that the Freedom SOLO stentless bioprosthesis shows excellent early clinical and hemodynamic results, resulting in a significant regression of left ventricular hypertrophy and improvement in left ventricular systolic function.

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