Ten-year results of the Freedom Solo stentless heart valve: excellent haemodynamics but progressive valve dysfunction in the long term.
Freedom Solo (FS) is a pericardial stentless heart valve showing excellent haemodynamic performance at mid-term. The aim of this study was to evaluate the long-term performance of such bioprostheses.



Between December 2004 and November 2009, 109 patients (31 men; mean age 76 ± 6 years) underwent aortic valve replacement with FS. Preoperatively, the mean NYHA class was 2.5 ± 0.7, the mean EuroSCORE II, 2.8 ± 2.5. Mean prosthesis size was 22.7 ± 1.9 mm; concomitant procedures were performed in 65 patients. Structural valve deterioration (SVD) was diagnosed according to the Valve Academic Research Consortium-2 definition.



Two patients (1.8%) died within 30 days. Follow-up (72 ± 36 months) was 100% completed. The 1-, 5- and 10-year actuarial survival rates were 89, 73 and 42%, respectively, with 8 valve-related deaths; the actuarial freedom from SVD was 99, 93 and 76%. During 61 ± 39 months of follow-up, echocardiographic findings worsened progressively: At discharge, 3-5 and 7-9 years, the mean gradient was 8 ± 4, 12 ± 11 and 19 ± 19 mmHg ( P  < 0.01); the indexed effective orifice area was 1.0 ± 0.2, 0.9 ± 0.2 and 0.8 ± 0.3 cm 2 /m 2 ( P  < 0.01). Of the 13 patients who developed SVD, it was due to aortic stenosis in 11. SVD was a predictor of cardiovascular mortality at univariate analysis (HR 2.87, 1.12-7.29); 2 explanted prostheses showed massive calcium deposits with mean calcium and phosphorus contents of 234 ± 16 and 116 ± 7 mg/g dry weight, respectively.



The FS bioprosthesis shows excellent mid-term clinical and haemodynamic results and offers an alternative to other valves, particularly in the case of a small aortic annulus. Worsening of FS performance was observed at late follow-up because of progressive SVD with stenosis, questioning whether it should be used in patients with a long life expectancy.
Cardiothoracic Department, University Hospital of Udine, Udine, Italy.
Sandro
S
Sponga
Cardiac, Thoracic and Vascular Department, University of Padua, Padua, Italy.
Mila Della
MD
Barbera
Cardiothoracic Department, University Hospital of Udine, Udine, Italy.
Daisy
D
Pavoni
Cardiothoracic Department, University Hospital of Udine, Udine, Italy.
Andrea
A
Lechiancole
Cardiothoracic Department, University Hospital of Udine, Udine, Italy.
Enzo
E
Mazzaro
Cardiac, Thoracic and Vascular Department, University of Padua, Padua, Italy.
Marialuisa
M
Valente
Cardiothoracic Department, University Hospital of Udine, Udine, Italy.
Gaetano
G
Nucifora
Cardiac, Thoracic and Vascular Department, University of Padua, Padua, Italy.
Gaetano
G
Thiene
Cardiothoracic Department, University Hospital of Udine, Udine, Italy.
Ugolino
U
Livi
D000368:Aged; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D005544:Forecasting; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D010496:Pericardium / Q000637:transplantation*; D011474:Prosthesis Design; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
Freedom Solo; Stentless valve; Structural valve deterioration