TY - JOUR
T1 - Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses
T2 - Results From an International Registry Study
AU - Sawaya, Fadi J.
AU - Deutsch, Marcus André
AU - Seiffert, Moritz
AU - Yoon, Sung Han
AU - Codner, Pablo
AU - Wickramarachchi, Upul
AU - Latib, Azeem
AU - Petronio, A. Sonia
AU - Rodés-Cabau, Josep
AU - Taramasso, Maurizio
AU - Spaziano, Marco
AU - Bosmans, Johan
AU - Biasco, Luigi
AU - Mylotte, Darren
AU - Savontaus, Mikko
AU - Gheeraert, Peter
AU - Chan, Jason
AU - Jørgensen, Troels H.
AU - Sievert, Horst
AU - Mocetti, Marco
AU - Lefèvre, Thierry
AU - Maisano, Francesco
AU - Mangieri, Antonio
AU - Hildick-Smith, David
AU - Kornowski, Ran
AU - Makkar, Raj
AU - Bleiziffer, Sabine
AU - Søndergaard, Lars
AU - De Backer, Ole
N1 - Publisher Copyright:
© 2017 American College of Cardiology Foundation
PY - 2017/5/22
Y1 - 2017/5/22
N2 - Objectives The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR). Background Limited data are available about the “off-label” use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR. Methods The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria. Results A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m2, STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively. Conclusions TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option.
AB - Objectives The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR). Background Limited data are available about the “off-label” use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR. Methods The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria. Results A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m2, STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively. Conclusions TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option.
KW - aortic regurgitation
KW - efficacy
KW - safety
KW - transcatheter aortic valve replacement
KW - valve-in-valve
UR - http://www.scopus.com/inward/record.url?scp=85019237281&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85019237281&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2017.03.004
DO - 10.1016/j.jcin.2017.03.004
M3 - Article
C2 - 28521923
AN - SCOPUS:85019237281
SN - 1936-8798
VL - 10
SP - 1048
EP - 1056
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 10
ER -