TY - JOUR
T1 - Matched Comparison of Self-Expanding Transcatheter Heart Valves for the Treatment of Failed Aortic Surgical Bioprosthesis
AU - Valve-in-Valve International Data Registry Investigators
AU - Alnasser, Sami
AU - Cheema, Asim N.
AU - Simonato, Matheus
AU - Barbanti, Marco
AU - Edwards, Jeremy
AU - Kornowski, Ran
AU - Horlick, Eric
AU - Wijeysundera, Harindra C.
AU - Testa, Luca
AU - Bedogni, Francesco
AU - Amrane, Hafid
AU - Walther, Thomas
AU - Pelletier, Marc
AU - Latib, Azeem
AU - Laborde, Jean Claude
AU - Hildick-Smith, David
AU - Kim, Won Keun
AU - Tchetche, Didier
AU - Agrifoglio, Marco
AU - Sinning, Jan Malte
AU - Van Boven, Ad J.
AU - Kefer, Joëlle
AU - Frerker, Christian
AU - Van Mieghem, Nicolas M.
AU - Linke, Axel
AU - Worthley, Stephen
AU - Asgar, Anita
AU - Sgroi, Carmelo
AU - Aziz, Mina
AU - Danenberg, Haim D.
AU - Labinaz, Marino
AU - Manoharan, Ganesh
AU - Cheung, Anson
AU - Webb, John G.
AU - Dvir, Danny
N1 - Publisher Copyright:
© 2017 American Heart Association, Inc.
PY - 2017/4/1
Y1 - 2017/4/1
N2 - Background - Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV). Methods and Results - Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm 2; P=0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; P=0.02), and lower core laboratory-adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; P=0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; P=0.03). Conclusions - In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation.
AB - Background - Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV). Methods and Results - Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm 2; P=0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; P=0.02), and lower core laboratory-adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; P=0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; P=0.03). Conclusions - In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation.
KW - aortic valve
KW - bioprosthesis
KW - hemodynamic
KW - transcatheter aortic valve replacement
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U2 - 10.1161/CIRCINTERVENTIONS.116.004392
DO - 10.1161/CIRCINTERVENTIONS.116.004392
M3 - Article
C2 - 28400461
AN - SCOPUS:85017655680
SN - 1941-7640
VL - 10
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 4
M1 - e004392
ER -