An observational study in Aortic Valve Replacement, sponsored by The Federal Centre of Cardiovascular Surgery, Russia. Status unknown at 1 site in Russian Federation. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by The Federal Centre of Cardiovascular Surgery, Russia · Observational
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)
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)
Patients with severe degenerative aortic stenosis and small aortic annulus (\<21 mm) were enrolled in this study
Exclusion Criteria:
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
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
Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium
Indexed effective orifice area, cm²/m²
Assessment of aortic valve dimension
Time frame: 12 months after surgery
prosthesis-patient mismatch (PPM)
Indicator of the effectiveness of aortic valve replacement
Time frame: 12 months after surgery
Peak pressure gradient, mm.Hg
Indicator of the effectiveness of aortic valve replacement
Time frame: 12 months after surgery
Mean pressure gradient, mm.Hg
Indicator of the effectiveness of aortic valve replacement
Time frame: 12 months after surgery
Effective orifice area, EOA, cm²
Assessment of aortic valve dimension
Time frame: 12 months after surgery
Age (years)
Description and comparison of groups patients
Time frame: 12 months after surgery
Body mass index, kg/m²
Description and comparison of groups patients
Time frame: 12 months after surgery
Body surface area, m²
Description and comparison of groups patients
Time frame: 12 months after surgery
Aortic annulus diameter, mm
Description and comparison of groups patients
Time frame: 12 months after surgery
Indexed aortic annulus diameter, mm/m²
Description and comparison of groups patients
Time frame: 12 months after surgery
Myocardial mass index, g/m²
Assessment of reverse remodeling of the left ventricle
Time frame: 12 months after surgery
Plan to share: Yes
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The Federal Centre of Cardiovascular Surgery, Russia