Clinical trial NCT03258333: Small Aortic Annulus - a New Solution to the Old Problem
Official title: Small Aortic Annulus - a New Solution to the Old Problem
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Replacement
Keywords: aortic stenosis, aortic valve replacement, pericardium
Lead sponsor: The Federal Centre of Cardiovascular Surgery, Russia
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe degenerative aortic stenosis and small aortic annulus (\<21 mm) were enrolled in this study

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)

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)

Eligibility criteria: Inclusion Criteria:

* severe degenerative aortic valve stenosis

Exclusion Criteria:

* redo operation, infective endocarditis

Primary outcomes:
measure: Indexed effective orifice area, cm²/m²
timeFrame: 12 months after surgery
Secondary outcomes:
measure: prosthesis-patient mismatch (PPM)
timeFrame: 12 months after surgery
measure: Peak pressure gradient, mm.Hg
timeFrame: 12 months after surgery
measure: Mean pressure gradient, mm.Hg
timeFrame: 12 months after surgery
measure: Effective orifice area, EOA, cm²
timeFrame: 12 months after surgery
Other outcomes:
measure: Age (years)
timeFrame: 12 months after surgery
measure: Body mass index, kg/m²
timeFrame: 12 months after surgery
measure: Body surface area, m²
timeFrame: 12 months after surgery
measure: Aortic annulus diameter, mm
timeFrame: 12 months after surgery
measure: Indexed aortic annulus diameter, mm/m²
timeFrame: 12 months after surgery
measure: Myocardial mass index, g/m²
timeFrame: 12 months after surgery
Locations:
city: Penza
country: Russian Federation
facility: FederalCCS
Study officials:
References:
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.