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Clinical Trials/NCT03976817
NCT03976817
Completed
Not Applicable

Supra-annular Aortic Valve Replacement: Surgical Techniques and Early Outcomes

Centre Chirurgical Marie Lannelongue1 site in 1 country117 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Valve Disease
Sponsor
Centre Chirurgical Marie Lannelongue
Enrollment
117
Locations
1
Primary Endpoint
In-hospital mortality
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Surgical valve replacement is commonly performed in patients with severe aortic valve disease. In small aortic annulus, implantation of bioprosthetic valves can be associated with limited functional capacity. To avoid this condition, we changed our surgical technique to implant a larger bioprosthesis. Briefly, the prosthesis is sutured to the aortic annulus along the left and right coronary sinuses, and in a supraannular position along the noncoronary sinus, therefore allowing us to insert a prosthetic valve with a one-size larger diameter than the native aortic annulus.

Detailed Description

Surgical aortic valve replacement (AVR) is recommended for severe aortic valve disease. Bioprosthesis remains the substitute of choice for elderly patients. However, it may be associated with patient-prosthesis mismatch particularly for patients with small aortic annulus. Moreover, "valve-in-valve" transcatheter aortic valve replacement (TAVR) has become a suitable therapeutic option for bioprosthesis structural degeneration, especially in patients with high surgical risk. It is therefore of great importance to implant the widest bioprosthesis as possible at the first AVR. The investigators report a surgical technique allowing the implantation of a larger bioprosthesis in patients with small aortic annulus: the supra-annular aortic valve replacement (SA-AVR) above the aortic annulus. The investigators analyzed the postoperative outcomes of the SA-AVR technique using the Perimount Magna Ease (Carpentier-Edwards, Irvine, California) bioprosthesis.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
April 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients older than 18 years who underwent a suprannular implantation of the Carpentier Edwards Magna Ease bioprosthetic valve between January 2010 and December 2017 in our institution, whatever the aetiology of the aortic valve disease.

Exclusion Criteria

  • patients younger than 18 years, patients who received a different bioprosthesis valve in the aortic position, patients who were lost of follow-up.

Outcomes

Primary Outcomes

In-hospital mortality

Time Frame: Hospital discharge, an average 10 days

Secondary Outcomes

  • Functional status(1 year after the surgery)

Study Sites (1)

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