Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses
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Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses. / Rodés-Cabau, Josep; Abbas, Amr E; Serra, Vicenç; Vilalta, Victoria; Nombela-Franco, Luis; Regueiro, Ander; Al-Azizi, Karim M; Iskander, Ayman; Conradi, Lenard; Forcillo, Jessica; Lilly, Scott; Calabuig, Alvaro; Fernandez-Nofrerias, Eduard; Mohammadi, Siamak; Panagides, Vassili; Pelletier-Beaumont, Emilie; Pibarot, Philippe.
In: J AM COLL CARDIOL, Vol. 80, No. 7, 16.08.2022, p. 681-693.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses
AU - Rodés-Cabau, Josep
AU - Abbas, Amr E
AU - Serra, Vicenç
AU - Vilalta, Victoria
AU - Nombela-Franco, Luis
AU - Regueiro, Ander
AU - Al-Azizi, Karim M
AU - Iskander, Ayman
AU - Conradi, Lenard
AU - Forcillo, Jessica
AU - Lilly, Scott
AU - Calabuig, Alvaro
AU - Fernandez-Nofrerias, Eduard
AU - Mohammadi, Siamak
AU - Panagides, Vassili
AU - Pelletier-Beaumont, Emilie
AU - Pibarot, Philippe
N1 - Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PY - 2022/8/16
Y1 - 2022/8/16
N2 - 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).
AB - 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).
KW - Aortic Valve/diagnostic imaging
KW - Aortic Valve Insufficiency/surgery
KW - Aortic Valve Stenosis/surgery
KW - Bioprosthesis
KW - Heart Valve Prosthesis
KW - Hemodynamics
KW - Humans
KW - Prosthesis Design
KW - Retrospective Studies
KW - Transcatheter Aortic Valve Replacement/methods
KW - Treatment Outcome
U2 - 10.1016/j.jacc.2022.05.005
DO - 10.1016/j.jacc.2022.05.005
M3 - SCORING: Journal article
C2 - 35597385
VL - 80
SP - 681
EP - 693
JO - J AM COLL CARDIOL
JF - J AM COLL CARDIOL
SN - 0735-1097
IS - 7
ER -
