Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aortic valve replacement | Procedure | Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium |
|
| Measure | Description | Time Frame |
|---|---|---|
| Indexed effective orifice area, cm²/m² | Assessment of aortic valve dimension | 12 months after surgery |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Age (years) | Description and comparison of groups patients | 12 months after surgery |
| Body mass index, kg/m² | Description and comparison of groups patients |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with severe degenerative aortic stenosis and small aortic annulus (<21 mm) were enrolled in this study
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FederalCCS | Penza | 440071 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16678590 | Background | Gerosa G, Tarzia V, Rizzoli G, Bottio T. Small aortic annulus: the hydrodynamic performances of 5 commercially available tissue valves. J Thorac Cardiovasc Surg. 2006 May;131(5):1058-64. doi: 10.1016/j.jtcvs.2005.12.034. | |
| 25818901 | Result | Ozaki S, Kawase I, Yamashita H, Uchida S, Takatoh M, Hagiwara S, Kiyohara N. Aortic Valve Reconstruction Using Autologous Pericardium for Aortic Stenosis. Circ J. 2015;79(7):1504-10. doi: 10.1253/circj.CJ-14-1092. Epub 2015 Mar 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 12 months after surgery |
| Body surface area, m² | Description and comparison of groups patients | 12 months after surgery |
| Aortic annulus diameter, mm | Description and comparison of groups patients | 12 months after surgery |
| Indexed aortic annulus diameter, mm/m² | Description and comparison of groups patients | 12 months after surgery |
| Myocardial mass index, g/m² | Assessment of reverse remodeling of the left ventricle | 12 months after surgery |
| 21273254 | Result | Ozaki S, Kawase I, Yamashita H, Uchida S, Nozawa Y, Matsuyama T, Takatoh M, Hagiwara S. Aortic valve reconstruction using self-developed aortic valve plasty system in aortic valve disease. Interact Cardiovasc Thorac Surg. 2011 Apr;12(4):550-3. doi: 10.1510/icvts.2010.253682. Epub 2011 Jan 27. |
| 17532395 | Result | Borger MA, Nette AF, Maganti M, Feindel CM. Carpentier-Edwards Perimount Magna valve versus Medtronic Hancock II: a matched hemodynamic comparison. Ann Thorac Surg. 2007 Jun;83(6):2054-8. doi: 10.1016/j.athoracsur.2007.02.062. |
| 27641297 | Result | Ghoneim A, Bouhout I, Demers P, Mazine A, Francispillai M, El-Hamamsy I, Carrier M, Lamarche Y, Bouchard D. Management of small aortic annulus in the era of sutureless valves: A comparative study among different biological options. J Thorac Cardiovasc Surg. 2016 Oct;152(4):1019-28. doi: 10.1016/j.jtcvs.2016.06.058. Epub 2016 Jul 28. |
| 27234223 | Result | Morita S. Aortic valve replacement and prosthesis-patient mismatch in the era of trans-catheter aortic valve implantation. Gen Thorac Cardiovasc Surg. 2016 Aug;64(8):435-40. doi: 10.1007/s11748-016-0657-9. Epub 2016 May 27. |
| 24818319 | Result | Minardi G, Pergolini A, Zampi G, Pulignano G, Pero G, Sbaraglia F, Pino PG, Cioffi G, Musumeci F. St. Jude Trifecta versus Carpentier-Edwards Perimount Magna valves for the treatment of aortic stenosis: comparison of early Doppler-echocardiography and hemodynamic performance. Monaldi Arch Chest Dis. 2013 Sep;80(3):126-32. doi: 10.4081/monaldi.2013.74. |
| D014694 |
| Ventricular Outflow Obstruction |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |