Early Outcomes With Direct Flow Medical Versus First-Generation Transcatheter Aortic Valve Devices: A Single-Center Propensity-Matched Analysis.
OBJECTIVE
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.


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.
Interventional Cardiology Unit and Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
Gennaro
G
Giustino
Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.
Azeem
A
Latib
Imperial College London, National Heart and Lung Institute, London, UK.
Vasileios F
VF
Panoulas
Interventional Cardiology Unit and Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
Matteo
M
Montorfano
Interventional Cardiology Unit and Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
Alaide
A
Chieffo
Interventional Cardiology Unit and Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
Maurizio
M
Taramasso
Interventional Cardiology Unit and Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
Katsumasa
K
Sato
Interventional Cardiology Unit and Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
Eustachio
E
Agricola
Interventional Cardiology Unit and Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
Ottavio
O
Alfieri
Interventional Cardiology Unit and Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.|Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.
Antonio
A
Colombo
D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000453:epidemiology / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000150:complications / Q000628:therapy*; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D057216:Propensity Score; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome