Small Aortic Annulus - a New Solution to the Old Problem
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Stented bioprosthesis 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
Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium
|
| Ozaki procedure 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
|
Outcome Measures
Primary Outcome Measures
- Indexed effective orifice area, cm²/m² [12 months after surgery]
Assessment of aortic valve dimension
Secondary Outcome Measures
- prosthesis-patient mismatch (PPM) [12 months after surgery]
Indicator of the effectiveness of aortic valve replacement
- Peak pressure gradient, mm.Hg [12 months after surgery]
Indicator of the effectiveness of aortic valve replacement
- Mean pressure gradient, mm.Hg [12 months after surgery]
Indicator of the effectiveness of aortic valve replacement
- Effective orifice area, EOA, cm² [12 months after surgery]
Assessment of aortic valve dimension
Other Outcome Measures
- Age (years) [12 months after surgery]
Description and comparison of groups patients
- Body mass index, kg/m² [12 months after surgery]
Description and comparison of groups patients
- Body surface area, m² [12 months after surgery]
Description and comparison of groups patients
- Aortic annulus diameter, mm [12 months after surgery]
Description and comparison of groups patients
- Indexed aortic annulus diameter, mm/m² [12 months after surgery]
Description and comparison of groups patients
- Myocardial mass index, g/m² [12 months after surgery]
Assessment of reverse remodeling of the left ventricle
Eligibility Criteria
Criteria
Inclusion Criteria:
- severe degenerative aortic valve stenosis
Exclusion Criteria:
- redo operation, infective endocarditis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | FederalCCS | Penza | Russian Federation | 440071 |
Sponsors and Collaborators
- The Federal Centre of Cardiovascular Surgery, Russia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- FederalCCS002