Clinical trial NCT03976817: Aortic Valve Replacement Above the Aortic Annulus (SA-AVR) With the Carpentier-Edwards Magna-Ease Bioprosthesis
Official title: Supra-annular Aortic Valve Replacement: Surgical Techniques and Early Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Keywords: bioprosthesis
surgery
supra-annular
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent aortic valve replacement in our institution

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.

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.

Primary outcomes:
measure: In-hospital mortality
timeFrame: Hospital discharge, an average 10 days
Secondary outcomes:
measure: Functional status
timeFrame: 1 year after the surgery
Other outcomes:
Locations:
city: Le Plessis-Robinson
country: France
facility: Hopital Marie Lannelongue
Study officials:
affiliation: Marie Lannelongue Hospital
name: Elie Fadel, MD PhD
role: STUDY_CHAIR
References: