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- W3036583622 abstract "Background The Shelhigh™ SuperStentless (Shelhigh, INC., Union, United States) is a stentless aortic valve bioprosthesis and aortic root valved conduit. In 2007, this device was recalled by FDA due to malfunction, and subsequently reintegrated by BioIntegral Surgical™ Few data are available over late durability of this device. We performed a long-term follow-up of Shelhigh™ devices implanted at our center. Methods Between 2002 and 2007, 44 patients underwent aortic valve replacement with a Shelhigh™ device (40 aortic valve bioprosthesis and 4 valved conduit). We performed a clinical and echocardiographic follow-up (9.2 years ± 4.3). Standardized definitions of valve-related events were adopted. Results At discharge, maximum and mean aortic gradients averaged 36.1 ± 11.3 and 21.0 ± 6.8 mmHg, respectively. The 30-days mortality was 2.3%. Over the follow-up period, 29 patients died (65.9%); 2 deaths were valve related. Overall survival at 1, 5 and 10 years was 97.7%, 85.8% and 54% respectively. At last echocardiography, average transvalvular gradients had remained globally stable in the population (33.6 ± 12 and 20.4 ± 10.5 mmHg). Eight (19%) Structural Valve Deterioration (SVD) events were reported. Two (5%) Non-Structural Valve Dysfunction (NSVD) events occurred (periprosthetic leak). Two (5%) infectious endocarditis events and two (5%) valve thromboses were also deplored. Three (7%) patients required re-operation (2 due to SVD and 1 due to endocarditis). Conclusions The immediate haemodynamic performance of the Shelhigh™ aortic bioprostheses was unexpectedly suboptimal. Despite this, haemodynamic performance emained stable over time. Patients survival at follow-up was satisfactory, however, continued surveillance is necessary." @default.
- W3036583622 created "2020-06-25" @default.
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- W3036583622 date "2021-01-01" @default.
- W3036583622 modified "2023-09-23" @default.
- W3036583622 title "Long-term follow-up of the Shelhigh™ superstentless bioprosthesis aortic valve and valved conduit in a monocentric experience" @default.
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- W3036583622 doi "https://doi.org/10.23736/s0021-9509.20.11219-9" @default.
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