An observational study in Aortic Valve Disease and Prosthesis; Cardiac, Heart, Functional Disturbance as Result, sponsored by Centre Chirurgical Marie Lannelongue. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by Centre Chirurgical Marie Lannelongue · Observational
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.
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.
231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.
This study's enrollment of 117 is below the median of 200 across 112 observational studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →Centre Chirurgical Marie Lannelongue is the lead sponsor of 40 studies on the registry; 3 are open to participants now.
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Patients who underwent aortic valve replacement in our institution
Exclusion Criteria:
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
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.
In-hospital mortality
Time frame: Hospital discharge, an average 10 days
Functional status
New York Heart Association functional class (from I to IV)
Time frame: 1 year after the surgery
Plan to share: No
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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Centre Chirurgical Marie Lannelongue