Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses
Por:
Rodes-Cabau, J, Abbas, AE, Serra, V, Vilalta, V, Nombela-Franco, L, Regueiro, A, Al-Azizi, KM, Iskander, A, Conradi, L, Forcillo, J, Lilly, S, Calabuig, A, Fernandez-Nofrerias, E, Mohammadi, S, Panagides, V, Pelletier-Beaumont, E and Pibarot, P
Publicada:
16 ago 2022
Ahead of Print:
1 ago 2022
Resumen:
BACKGROUND Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies.
OBJECTIVES The purpose of this study was to compare the hemodynamic results between the balloon-expandable valve (BEV) SAPIEN (3/ULTRA, Edwards Lifesciences) and self-expanding valve (SEV) Evolut (R/PRO/PRO+, Medtronic) in ViV-TAVR.
METHODS Patients with a failed small (#23 mm) surgical valve were randomized to receive a BEV or an SEV. The primary endpoint was valve hemodynamics (maximal/mean residual gradients, severe prosthesis patient mismatch [PPM], or moderate-severe aortic regurgitation) at 30 days as evaluated by Doppler echocardiography.
RESULTS A total of 102 patients were randomized, and of these, 98 patients finally underwent a ViV-TAVR procedure (BEV: n = 46, SEV: n = 52). The procedure was successful in all cases, with no differences in clinical outcomes at 30 days between groups (no death or stroke events). Patients in the SEV group exhibited lower mean and maximal transvalvular gradient values (15 +/- 8 mm Hg vs 23 +/- 8 mm Hg; P < 0.001; 28 +/- 16 mm Hg vs 40 +/- 13 mm Hg, P < 0.001), and a tendency toward a lower rate of severe PPM (44% vs 64%; P = 0.07). There were no cases of moderate-severe aortic regurgitation. In total, 55 consecutive patients (SEV: n = 27; BEV: n = 28) underwent invasive valve hemodynamic evaluation during the procedure, with no differences in mean and peak transvalvular gradients between both groups (P = 0.41 and P = 0.70, respectively).
CONCLUSIONS In patients with small failed aortic bioprostheses, ViV-TAVR with an SEV was associated with improved valve hemodynamics as evaluated by echocardiography. There were no differences between groups in intraprocedural invasive valve hemodynamics and 30-day clinical outcomes (Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprostheses. The 'LYTEN' Trial; NCT03520101) (J Am Coll Cardiol 2022;80:681-693) (C) 2022 by the American College of Cardiology Foundation.
Filiaciones:
Rodes-Cabau, J:
Laval Univ, Quebec Heart & Lung Inst, Quebec City, PQ, Canada
Abbas, AE:
Beaumont Hosp, Royal Oak, MI USA
Serra, V:
Hosp Univ Vall dHebron, Barcelona, Spain
:
Hosp Badalona Germans Trias & Pujol, Badalona, Spain
Nombela-Franco, L:
Hosp Clin San Carlos, Cardiovasc Inst, IdISSC, Madrid, Spain
Regueiro, A:
Hosp Clin Barcelona, Barcelona, Spain
Al-Azizi, KM:
Baylor Scott & White Heart Hosp Plano, Plano, TX USA
Iskander, A:
SJH Cardiol Associates, Syracuse, NY USA
Conradi, L:
Univ Heart & Vasc Ctr, Hamburg, Germany
Forcillo, J:
Ctr Hosp Univ Montreal, Montreal, PQ, Canada
Lilly, S:
Richard M Ross Hosp, OSU Heart & Vasc Res Org, Columbus, OH USA
Calabuig, A:
Hosp Univ Vall dHebron, Barcelona, Spain
:
Hosp Badalona Germans Trias & Pujol, Badalona, Spain
Mohammadi, S:
Laval Univ, Quebec Heart & Lung Inst, Quebec City, PQ, Canada
Panagides, V:
Laval Univ, Quebec Heart & Lung Inst, Quebec City, PQ, Canada
Pelletier-Beaumont, E:
Laval Univ, Quebec Heart & Lung Inst, Quebec City, PQ, Canada
Pibarot, P:
Laval Univ, Quebec Heart & Lung Inst, Quebec City, PQ, Canada
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