Transcatheter or Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial

Abstract

BACKGROUNDThe optimal treatment in patients with severe aortic stenosis (AS) and small aortic annulus (SAA) remains to be determined. The objectives of this study were to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA.METHODSProspective multicenter international randomized trial performed in 15 university hospitals. Participants were 151 patients with severe AS and SAA (mean diameter <23 mm) were randomized (1:1) to TAVR (n=77) vs SAVR (n=74), The primary outcome was impaired valve hemodynamics (i.e. severe prosthesis patient mismatch [PPM] or moderate-severe aortic regurgitation [AR]) at 60 days as evaluated by Doppler-echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes.RESULTSThe mean age of the participants was 75±5 years, with 93 of women, a median STS of 2.5 (1.7-3.3)%, and a mean annulus diameter of 21.1±1.2 mm.CONCLUSIONSThis trial will provide clinicians with scientific evidence to determine if population with smaller aortic anatomy in the setting of severe AS maybe better suited to TAVR compared with SAVR.TRIAL REGISTRATIONClinicaltrials.gov:NCT03383445