Small Aortic Annulus - a New Solution to the Old Problem

Study Overview
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Brief Summary
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In this prospective single-center study included 60 patients with a severe degenerative aortic stenosis and small aortic annulus (<21 mm) who underwent standard AVR with stented bioprosthesis (group 1, n=30) and aortic valve reconstruction using autologus pericardium (Ozaki procedure) (group 2, n=30)

Detailed Description
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Aortic valve replacement (AVR) in patients with a small aortic annulus is a challenging problem. Implantation of a small aortic valve sometimes leads to high residual gradients, despite a normally functioning prosthesis. Patients with a small aortic annulus, especially those with a large body surface area, are at higher risk of prosthesis-patient mismatch, which is associated with worse clinical outcomes and decreased survival. The purpose of this study was to compare the hemodynamic performance among the 2 management strategies (standard AVR with stented bioprosthesis and Ozaki procedure) in the context of a small aortic annulus (<21 mm)

Official Title
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Small Aortic Annulus - a New Solution to the Old Problem

Conditions
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Aortic Valve Replacement

Intervention / Treatment
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* Procedure: aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe degenerative aortic valve stenosis Exclusion Criteria: redo operation, infective endocarditis

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stented bioprosthesis<br>Standard aortic valve replacement with stented bioprosthesis. Surgery is performed through median sternotomy, aortic and right or bicaval venous cannulation, normothermic perfusion, antegrade cardioplegia with use cardioplegic solution Custodiol. A transverse aortotomy was performed 1 to 2 cm above the right coronary artery. The aortic annulus was thoroughly débrided of calcium. Valve sizing was performed with standard manufacturers' sizers, with selection of the size that would comfortably fit within the aortic annulus. A noneverting suture technique was used in all patients with interrupted horizontal mattress 2-0 braided sutures placed around the aortic annulus, with the pledgets on the ventricular aspect. | Procedure: aortic valve replacement<br>* Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium<br>|
| Ozaki procedure<br>Aortic valve reconstruction using autologus pericardium (Ozaki procedure). The autologous pericardium is harvested after routine median sternotomy. Harvested pericardium is then treated with a 0.6% glutaraldehyde solution for 10 min and then rinsed 3 times with sterilized saline each time for 6 min. After resection of the diseased aortic valve cusps, the distance between each commissure is measured using a self-developed sizing instrument. Glutaraldehyde-treated autologous pericardium is trimmed with a self-developed template corresponding to the measured value. The annular margin of the pericardial leaflet is then running-sutured to each annulus with 3-0 monofilament sutures. Commissural coaptation is secured with additional 4-0 monofilament sutures. The coaptation of the 3 cusps is then checked with negative pressure on the left ventricular vent. | Procedure: aortic valve replacement<br>* Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indexed effective orifice area, cm²/m² | Assessment of aortic valve dimension | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prosthesis-patient mismatch (PPM) | Indicator of the effectiveness of aortic valve replacement | 12 months after surgery | 
| Peak pressure gradient, mm.Hg | Indicator of the effectiveness of aortic valve replacement | 12 months after surgery | 
| Mean pressure gradient, mm.Hg | Indicator of the effectiveness of aortic valve replacement | 12 months after surgery | 
| Effective orifice area, EOA, cm² | Assessment of aortic valve dimension | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic stenosis, aortic valve replacement, pericardium