Long-Term Clinical and Echocardiographic Follow-Up of the Freestyle Stentless Aortic Bioprosthesis

Abstract

Background-Stentless aortic bioprostheses were designed to provide enhanced hemodynamic performance and potentially greater longevity. The present report describes the outcomes of patients with the Freestyle stentless bioprosthesis followed for Յ18 years. Methods and Results-Between 1993 and 2011, 430 patients underwent primary aortic valve replacement with a Freestyle bioprosthesis in the subcoronary position. Mean age was 68.2Ϯ8.2 years. All of the clinical and echocardiographic data were collected prospectively. Mean overall follow-up was 9.1Ϯ4.4 years and was complete in all of the patients. In-hospital mortality was 3.5% (nϭ15). Overall, 10-and 15-year survival were 60.7% and 35.0%, respectively. Fifty-one patients required reoperation during follow-up, including 27 for structural valve deterioration (SVD). Overall, freedom from reoperation was 91.0% and 75.0% at 10 and 15 years, whereas freedom from reoperation for SVD was 95.9% and 82.3%, respectively. At 10 and 15 years, freedom from reoperation for SVD was 94.0% and 62.6% for patients Ͻ60 years of age and 96.3% and 88.4% for patients Ն60 years of age (Pϭ0.002). The median time to explant for SVD was 10.7 years. SVD presented mostly as acute, severe aortic insufficiency attributed to leaflet tear (77.8%).The independent risk factors for reoperation for SVD were age Ͻ60 years (Pϭ0.001) and dyslipidemia (Pϭ0.02). Conclusions-Aortic valve replacement with the Freestyle bioprosthesis in a subcoronary position provides good long-term clinical and echocardiographic outcomes for patients Ͼ60 years of age. Severe aortic insufficiency with leaflet tear is the major mode of SVD leading to reoperation in these patients. (Circulation. 2012;126[suppl 1]:S198 -S204.)

Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)

“…19 A study of 430 patients treated with a stentless bioprosthesis reported freedom from reoperation in 91.0% and 75.0% at 10 and 15 years, and freedom from reoperation for SVD in 95.9% and 82.3%, respectively. 17 Notably, outcomes vary with different surgical bioprostheses as demonstrated in recent post-market surveillance of 43 782 valves in England and Wales. 20 …”

Long Term Outcomes Following Freestyle Stentless Aortic Bioprosthesis Implantation: An Australian Experience

“…The immediate need for re-operation for haemostasis following FSB implantation is inconsistently reported in the literature [7,11] but has been reported as up to 9.5% [13]. This is not unexpected given the extent of additional aortic replacement surgery that may be required and associated coagulopathy that can develop.…”

“…Ltd.) is a porcine aortic bioprosthesis particularly suitable for use where concurrent aortic root replacement surgery is necessitated by thoracic aortic disease. Long-term clinical and echocardiographic data are available up to 15 years post-operatively for the Freestyle, with promising results evident thus far [6][7][8].…”

“…We report the multicentre clinical and echocardiographic outcomes up to 10 years post-operatively following the use of the FSB for aortic valve and root surgery in a cohort of comparatively younger patients [7][8][9].…”

Echocardiographic evaluation of heart valve prosthetic dysfunction

“…Transvalvular regurgitation occurs as a result of restricted leaflet motion or leaflet destruction and improper sizing or overdilatation of the valve during the implantation. If the prosthesis has been implanted too low in the aortic position a special form of regurgitation termed supraskirtal could develop (28)(29)(30)(31).…”