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

Gennaro Giustino, Azeem Latib, Vasileios F. Panoulas, Matteo Montorfano, Alaide Chieffo, Maurizio Taramasso, Katsumasa Sato, Eustachio Agricola, Ottavio Alfieri, Antonio Colombo

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10 Citations (Scopus)

Abstract

Objectives To compare early outcomes between Direct Flow Medical (DFM) and 1st-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.

Original languageEnglish
Pages (from-to)583-593
Number of pages11
JournalJournal of Interventional Cardiology
Volume28
Issue number6
DOIs
Publication statusPublished - Dec 1 2015

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Aortic Valve
Equipment and Supplies
Propensity Score
Aortic Valve Insufficiency
Incidence

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Cite this

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.

In: Journal of Interventional Cardiology, Vol. 28, No. 6, 01.12.2015, p. 583-593.

Research output: Contribution to journalArticle

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abstract = "Objectives To compare early outcomes between Direct Flow Medical (DFM) and 1st-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.",
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AU - Montorfano, Matteo

AU - Chieffo, Alaide

AU - Taramasso, Maurizio

AU - Sato, Katsumasa

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AU - Alfieri, Ottavio

AU - Colombo, Antonio

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N2 - Objectives To compare early outcomes between Direct Flow Medical (DFM) and 1st-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.

AB - Objectives To compare early outcomes between Direct Flow Medical (DFM) and 1st-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.

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