Small Aortic Annulus - a New Solution to the Old Problem

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)

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Replacement
• Intervention / Treatment: Procedure: aortic valve replacement

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Russian Federation
  • Penza, Russian Federation, 440071
    • FederalCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with severe degenerative aortic stenosis and small aortic annulus (<21 mm) were enrolled in this study

Description

Inclusion Criteria:

• severe degenerative aortic valve stenosis

Exclusion Criteria:

• redo operation, infective endocarditis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The Federal Centre of Cardiovascular Surgery, Russia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2017
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: August 20, 2017
• First Posted (ACTUAL): August 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 20, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: aortic stenosis, aortic valve replacement, pericardium
• Other Study ID Numbers: FederalCCS002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No