Home > Journals > The Journal of Cardiovascular Surgery > Past Issues > Articles online first > The Journal of Cardiovascular Surgery 2020 Jun 19

CURRENT ISSUE
 

JOURNAL TOOLS

eTOC
To subscribe
Submit an article
Recommend to your librarian
 

ARTICLE TOOLS

Publication history
Reprints
Permissions
Cite this article as

 

 

The Journal of Cardiovascular Surgery 2020 Jun 19

DOI: 10.23736/S0021-9509.20.11219-9

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

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


PDF


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.


KEY WORDS: Shelhigh™; Stentless; Aortic valve replacement; Long-term follow-up

top of page