ORIGINAL ARTICLE  CARDIAC SECTION 

The Journal of Cardiovascular Surgery 2020 December;61(6):776-83

DOI: 10.23736/S0021-9509.20.11219-9

Copyright © 2020 EDIZIONI MINERVA MEDICA

lingua: Inglese

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

Florent LE BARS, Jacques TOMASI, Reda BELHAJ SOULAMI, Fabrice COLAS, Amedeo ANSELMI ✉, Jean-Philippe VERHOYE

Division of Thoracic and Cardiovascular Surgery, Pontchaillou University Hospital Center, Rennes, France

BACKGROUND: The Shelhigh™ 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 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 hemodynamic performance of the Shelhigh™ 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.

KEY WORDS: Heart valve prosthesis implantation; Aortic valve; Vascular surgical procedures