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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.).
For patients with severe aortic stenosis and small aortic annuli, self-expanding supraannular valves demonstrated noninferior clinical outcomes compared to balloon-expandable valves after transcatheter aortic-valve replacement (TAVR). The self-expanding valve also showed superiority in reducing bioprosthetic-valve dysfunction.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Severe aortic stenosis with a small aortic annulus poses risks for poor hemodynamic performance and adverse outcomes post-transcatheter aortic-valve replacement (TAVR).
- Prosthesis-patient mismatch can significantly impact TAVR outcomes, particularly in patients with small aortic annuli.
Purpose of the Study:
- To compare the clinical outcomes and bioprosthetic-valve dysfunction between self-expanding supraannular valves and balloon-expandable valves in patients with severe aortic stenosis and small aortic annuli undergoing TAVR.
- To assess the noninferiority of self-expanding valves versus balloon-expandable valves for a composite of death, disabling stroke, or rehospitalization for heart failure.
- To evaluate the superiority of self-expanding valves versus balloon-expandable valves for bioprosthetic-valve dysfunction.
Main Methods:
- A randomized controlled trial involving 716 patients with severe aortic stenosis and an aortic annulus area ≤430 mm².
- Patients were assigned 1:1 to receive either a self-expanding supraannular valve or a balloon-expandable valve.
- Coprimary endpoints assessed at 12 months included a composite of death, disabling stroke, or heart failure rehospitalization (noninferiority) and bioprosthetic-valve dysfunction (superiority).
Main Results:
- The composite clinical endpoint occurred in 9.4% of patients receiving the self-expanding valve versus 10.6% receiving the balloon-expandable valve (P<0.001 for noninferiority).
- Bioprosthetic-valve dysfunction was significantly lower with the self-expanding valve (9.4%) compared to the balloon-expandable valve (41.6%) (P<0.001 for superiority).
- The self-expanding valve group showed a lower mean aortic-valve gradient (7.7 vs 15.7 mm Hg) and a higher effective orifice area (1.99 vs 1.50 cm²) at 12 months.
Conclusions:
- In patients with severe aortic stenosis and small aortic annuli, the self-expanding supraannular valve is noninferior to the balloon-expandable valve for clinical outcomes.
- The self-expanding supraannular valve demonstrated superiority in reducing bioprosthetic-valve dysfunction at 12 months post-TAVR.
- These findings suggest a potential benefit of self-expanding supraannular valves in this high-risk patient population, particularly regarding valve performance.
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