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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03976817
Acronym
SA-AVR
Enrollment
117
Registered
2019-06-06
Start date
2018-02-01
Completion date
2019-04-01
Last updated
2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

bioprosthesis, surgery, supra-annular

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.

Interventions

PROCEDUREaortic valve replacement

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.

Sponsors

Centre Chirurgical Marie Lannelongue
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
In-hospital mortalityHospital discharge, an average 10 days

Secondary

MeasureTime frameDescription
Functional status1 year after the surgeryNew York Heart Association functional class (from I to IV)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026