Long term follow-up of patients who have undergone aortic valve replacement by the Freestyle stentless xenograft at St-Luc Hospital.
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- ABSTRACT Objectives: Our objective has been to assess the early and late clinical outcomes of the aortic valve replacement by the The Freestyle® Stentless Xenograft (Medtronic, Inc., Minneapolis, MN, USA) as well as the prosthesis durability, the valve related events, valve reoperation among the patients operated at our institution. The study aims at comparing our short and longterm results regarding the Freestyle stentless bioprosthesis with the published medicalliterature. The main endpoints of this study are thereby postoperative morbidity, the freedom from all-cause death, cardiac death, valve-related death and the freedom from valve reoperation. Methods: 290 patients (mean age was 67,1 ± 8,2 years; 67,9% male) underwent an aortic valve replacement with a Freestyle Stentless Xenograft from 1998 to 2016 at our institution, SaintLuc hospital in Brussels. Survival analysis was performed with the Kaplan-Meier method. The predictors of death and aortic valve reoperation were identified and analysed using the coxregression method. Results: The mean clinical follow-up of our study was 7,3 ± 4,7 years. The 30-days mortality was 5,9% amongst which no patients died from aortic valve dysfunction. 122 (42,1%) patients died during the long term follow-up. The overall survival at 5, 10 and 13 years were measured as 79,9 ± 2,5%, 62,3 ± 3,4 % and 39,0 ± 4,3 % respectively in our patient population. Freedom from AV reoperation at 5, 10 and 13 years were reported as 97,8 ± 1,1%, 91,2 ± 2,9% and 85,8 ± 4,1% respectively. Freedom from cardiac-related deaths at 5, 10 and 13 years were reported as 84,4 ± 2,3%, 70,7 ± 3,3% and 50,7 ± 4,7% respectively while the freedom from valve related deaths were as following at the same time intervals: 93,0 ± 1,6%, 92,4 ± 1,7 % and 90,3 ± 2,8 %. Valve-related events included endocarditis in 12 patients, thromboembolic events in 13 and a major bleeding event in 4 patients. Significant multivariate predictors of all-cause mortality were pre-operative creatinine clearance and shortening fraction. Conclusions: The Freestyle Stentless Xenograft offered good clinical outcomes in terms of survival, freedom from cardiac-related and valve-related mortality. The use of the Freestyle bioprosthesis for aortic valve replacement also resulted in good freedom from reoperation in this cohort irrespective of age at implantation - a comparable freedom from re-operation at 10 years was observed in both young (< 65 years) and old (> 65 years) patients. In addition, the low rate of valve-related events highlighted the benefit of the Freestyle Stentless Xenograft. The Freestyle valve is thereby a viable option as bioprosthesis in patients undergoing aortic valve replacement with a good long-term durability