Aortic Valve Replacement Above the Aortic Annulus (SA-AVR) With the Carpentier-Edwards Magna-Ease Bioprosthesis

Completed

• Conditions: Prosthesis; Cardiac, Heart, Functional Disturbance as Result; Aortic Valve Disease
• Interventions: Procedure: aortic valve replacement

• Registration Number: NCT03976817
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

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.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-04-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-06-05
• Last Update Submitted: 2019-06-05
• Study First Posted: 2019-06-06
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SA-AVR group	aortic valve replacement	Patients who underwent the supra-annular aortic valve replacement (SA-AVR) technique in our institution between December 2010 and December 2017 were retrospectively reviewed.

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	Hospital discharge, an average 10 days

Secondary Outcome Measures

Name	Time	Method
Functional status	1 year after the surgery	New York Heart Association functional class (from I to IV)

Trial Locations

Locations (1)

Hopital Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France