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Early outcomes with direct flow medical versus first-generation transcatheter aortic valve devices: a single-center propensity-matched analysis


Giustino, Gennaro; Latib, Azeem; Panoulas, Vasileios F; Montorfano, Matteo; Chieffo, Alaide; Taramasso, Maurizio; Sato, Katsumasa; Agricola, Eustachio; Alfieri, Ottavio; Colombo, Antonio (2015). Early outcomes with direct flow medical versus first-generation transcatheter aortic valve devices: a single-center propensity-matched analysis. Journal of Interventional Cardiology, 28(6):583-593.

Abstract

OBJECTIVES: To compare early outcomes between Direct Flow Medical (DFM) and 1(st) -generation transcatheter aortic valve replacement (TAVR) devices.
BACKGROUND: The effectiveness of new-generation TAVR devices compared with earlier generations is unclear.
METHODS AND RESULTS: 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).
CONCLUSIONS: 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. (J Interven Cardiol 2015;28:583-593).

Abstract

OBJECTIVES: To compare early outcomes between Direct Flow Medical (DFM) and 1(st) -generation transcatheter aortic valve replacement (TAVR) devices.
BACKGROUND: The effectiveness of new-generation TAVR devices compared with earlier generations is unclear.
METHODS AND RESULTS: 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).
CONCLUSIONS: 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. (J Interven Cardiol 2015;28:583-593).

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2 citations in Web of Science®
3 citations in Scopus®
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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiovascular Surgery
Dewey Decimal Classification:610 Medicine & health
Language:German
Date:December 2015
Deposited On:02 Feb 2016 12:53
Last Modified:05 Apr 2016 19:57
Publisher:Wiley-Blackwell Publishing, Inc.
ISSN:0896-4327
Publisher DOI:https://doi.org/10.1111/joic.12248
PubMed ID:26487433

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