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Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus
Howard C Herrmann1, Roxana Mehran1, Daniel J Blackman1
1From Perelman School of Medicine at the University of Pennsylvania (H.C.H.) and Lankenau Heart Institute (B.R.), Philadelphia, Allegheny General Hospital, Allegheny Health Network, Pittsburgh (S. Bailey), and the University of Pittsburgh Medical Center, Harrisburg (H.G.) - all in Pennsylvania; Icahn School of Medicine at Mount Sinai, New York (R.M.); Leeds Teaching Hospitals, Leeds, United Kingdom (D.J.B.); St. Johannes Hospital Dortmund, Dortmund (H.M.), Heart Center Leipzig at University of Leipzig, Leipzig (M.A.-W.), the Department of Cardiovascular Surgery, Institute Insure, German Heart Center Munich, School of Medicine and Health, Technical University of Munich, Munich (H.R.), and Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bochum (S. Bleiziffer) - all in Germany; Montreal Heart Institute, Montreal (W.B.A.), and the Centre for Cardiovascular Innovation, University of British Columbia, Vancouver (D.A.W.) - both in Canada; Sentara Heart Hospital, Norfolk (P.D.M.), and Inova Schar Heart and Vascular, Falls Church (W.B.B.) - both in Virginia; the University of Pisa, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy (A.S.P.); Tufts Medical Center, Boston (C.D.R.); Corewell Health, Grand Rapids (W.M.), and the University of Michigan Health Systems-University Hospital, Ann Arbor (G.M.D.) - both in Michigan; Hospital Vall D'Hebron, CIBER CV (Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares), Barcelona (B.G.B.); Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland (G.F.A.); Morristown Medical Center, Atlantic Health System, Morristown, NJ (L.D.G.); the Echocardiography Core Laboratory (R.P.), Mayo Clinic (M.G.), Rochester, and Medtronic, Minneapolis (M.T.F., A.D.A.) - both in Minnesota; MedStar Washington Hospital Center, Washington, DC (T.R.); Morton Plant Hospital, Clearwater, FL (J.D.R.); Baylor Scott and White Heart Hospital, Plano, TX (M.S.); Intermountain Medical Center, Murray, UT (B.W.); Emory University, Atlanta (K.J.G.); and Clinique Pasteur, Toulouse, France (D.T.).
Background:
Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR).
Methods:
We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority).
Results:
A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups.
Conclusions:
Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).
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