Long-term follow-up of the Shelhigh (TM) superstentless bioprosthesis aortic valve and valved conduit in a monocentric experience - Université de Rennes Accéder directement au contenu
Article Dans Une Revue Journal of Cardiovascular Surgery Année : 2021

Long-term follow-up of the Shelhigh (TM) superstentless bioprosthesis aortic valve and valved conduit in a monocentric experience

Résumé

BACKGROUND: The Shelhigh (TM) SuperStentless (Shelhigh, INC., Union, NJ, USA) 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 Shelhigh (TM) Few data are available over late durability of this device. We performed a long-term follow-up of Shelhigh (TM) devices implanted at our center. METHODS: Between 2002 and 2007, 44 patients underwent aortic valve replacement with a Shelhigh (TM) 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 hemodynamic performance of the Shelhigh (TM) aortic bioprostheses was unexpectedly suboptimal. Despite this, hemodynamic performance remained stable over time. Patients survival at follow-up was satisfactory, however, continued surveillance is necessary.
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Dates et versions

hal-03227947 , version 1 (17-05-2021)

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Florent Le Bars, Jacques Tomasi, Reda Belhaj Soulami, Fabrice Colas, Amedeo Anselmi, et al.. Long-term follow-up of the Shelhigh (TM) superstentless bioprosthesis aortic valve and valved conduit in a monocentric experience. Journal of Cardiovascular Surgery, 2021, 61 (6), pp.776-783. ⟨10.23736/S0021-9509.20.11219-9⟩. ⟨hal-03227947⟩
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