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- Title
Early Outcomes With Direct Flow Medical Versus First-Generation Transcatheter Aortic Valve Devices: A Single-Center Propensity-Matched Analysis.
- Authors
Giustino, Gennaro; Latib, Azeem; Panoulas, Vasileios F.; Montorfano, Matteo; Chieffo, Alaide; Taramasso, Maurizio; Sato, Katsumasa; Agricola, Eustachio; Alfieri, Ottavio; Colombo, Antonio
- Abstract
<bold>Objectives: </bold>To compare early outcomes between Direct Flow Medical (DFM) and 1(st) -generation transcatheter aortic valve replacement (TAVR) devices.<bold>Background: </bold>The effectiveness of new-generation TAVR devices compared with earlier generations is unclear.<bold>Methods and Results: </bold>Overall, 496 patients treated between November 2007 and March 2014 were included: 44 (8.7%) treated with DFM, 179 (36.9%) with Medtronic CoreValve (MCV) and 273 (54.4%) with Edwards Sapien / Sapien XT (SXT) valve. Because of differences in baseline characteristics, propensity-score matching among patients treated in the same time span (March 2012-March 2014) was performed. The primary objective was the VARC-2 device success composite endpoint. Propensity-score matching identified 41 patients in each group. A higher device success composite endpoint was observed in DFM (DFM 97.6% vs. MCV 65.9% vs. SXT 92.7%; P < 0.001). This was attributed to a significantly lower incidence of moderate-to-severe post-procedural aortic regurgitation (AR; 2.4% vs. 22% vs. 7.3%; P < 0.001), lower rate of valve embolization (0% vs. 7.3% vs. 0%; 0.041) and need for a 2nd valve implantation (0% vs. 7.3% vs. 0%; P = 0.041).<bold>Conclusions: </bold>DFM was associated with higher rates of device success and a lower incidence of post-procedural AR. New generation devices appear to address several of the limitations of earlier generation devices.
- Subjects
CARDIAC catheterization; AORTIC valve surgery; AORTIC valve insufficiency; DISEASE incidence; ARTIFICIAL implants; AORTIC stenosis treatment; AORTIC stenosis; PROSTHETIC heart valves; PROBABILITY theory; PROSTHETICS; TIME; TREATMENT effectiveness; DISEASE complications
- Publication
Journal of Interventional Cardiology, 2015, Vol 28, Issue 6, p583
- ISSN
0896-4327
- Publication type
journal article
- DOI
10.1111/joic.12248