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Observational Study
. 2017 May 22;10(10):1048-1056.
doi: 10.1016/j.jcin.2017.03.004.

Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study

Fadi J Sawaya  1 , Marcus-André Deutsch  2 , Moritz Seiffert  3 , Sung-Han Yoon  4 , Pablo Codner  5 , Upul Wickramarachchi  6 , Azeem Latib  7 , A Sonia Petronio  8 , Josep Rodés-Cabau  9 , Maurizio Taramasso  10 , Marco Spaziano  11 , Johan Bosmans  12 , Luigi Biasco  13 , Darren Mylotte  14 , Mikko Savontaus  15 , Peter Gheeraert  16 , Jason Chan  17 , Troels H Jørgensen  18 , Horst Sievert  19 , Marco Mocetti  13 , Thierry Lefèvre  11 , Francesco Maisano  10 , Antonio Mangieri  7 , David Hildick-Smith  6 , Ran Kornowski  5 , Raj Makkar  4 , Sabine Bleiziffer  5 , Lars Søndergaard  18 , Ole De Backer  18
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Free article
Observational Study

Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study

Fadi J Sawaya et al. JACC Cardiovasc Interv. .
Free article

Abstract

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.

Keywords: aortic regurgitation; efficacy; safety; transcatheter aortic valve replacement; valve-in-valve.

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