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Completed

NCT Number: NCT03976817

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. In-hospital mortality

    Time frame: Hospital discharge, an average 10 days

Secondary outcomes

  1. Functional status

    Time frame: 1 year after the surgery

    New York Heart Association functional class (from I to IV)

Sponsors and collaborators

Lead sponsor

Centre Chirurgical Marie Lannelongue

Other

Registry information

Official study title

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

Acronym: SA-AVR

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 6, 2019
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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