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

NCT03976817 | Completed

• 1 other identifier: TPS 59185
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease; Prosthesis; Cardiac, Heart, Functional Disturbance as Result

Keywords

bioprosthesis; surgery; supra-annular

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Hospital discharge, an average 10 days

Secondary Outcomes (1)

• Functional status

  1 year after the surgery

Study Arms (1)

SA-AVR group

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

Procedure: aortic valve replacement

Interventions

aortic valve replacement PROCEDURE

After median sternotomy, cardiopulmonary bypass (CPB) was established between the ascending aorta and the right atrium. The aorta was cross-clamped and a high potassium warm cardioplegia was infused and repeated every 15 minutes. The aortotomy was made above the sinuses and the aortic valve was removed. The prosthesis was chosen one size larger than the maximal sizer that could be inserted, which was also used to determine the appropriate height for insertion of the sutures along the wall of the non-coronary sinus.

SA-AVR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent aortic valve replacement in our institution

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (1)

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Elie Fadel, MD PhD

  Marie Lannelongue Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 6, 2019
• Study Start: February 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: April 1, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)