Repositionable Versus Balloon‐Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis

Background The safety and effectiveness of the fully repositionable LOTUS valve system as compared with the balloon‐expandable Edwards SAPIEN 3 prosthesis for the treatment of aortic stenosis has not been evaluated to date. Methods and Results All patients undergoing transcatheter aortic valve impla...

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Bibliographic Details
Published in:Journal of the American Heart Association 2016-11, Vol.5 (11), p.n/a
Main Authors: Pilgrim, Thomas, Stortecky, Stefan, Nietlispach, Fabian, Heg, Dik, Tueller, David, Toggweiler, Stefan, Ferrari, Enrico, Noble, Stéphane, Maisano, Francesco, Jeger, Raban, Roffi, Marco, Grünenfelder, Jürg, Huber, Christoph, Wenaweser, Peter, Windecker, Stephan
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Aortic Valve Insufficiency - epidemiology
aortic valve regurgitation
Aortic Valve Stenosis - surgery
Cohort Studies
Female
Heart Valve Prosthesis
Humans
Male
newer‐generation devices
Original Research
permanent pacemaker
Postoperative Complications - epidemiology
Proportional Hazards Models
Prospective Studies
Prosthesis Design
Registries
Switzerland - epidemiology
transcatheter aortic valve replacement
Transcatheter Aortic Valve Replacement - instrumentation
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Summary:Background The safety and effectiveness of the fully repositionable LOTUS valve system as compared with the balloon‐expandable Edwards SAPIEN 3 prosthesis for the treatment of aortic stenosis has not been evaluated to date. Methods and Results All patients undergoing transcatheter aortic valve implantation with the Edwards SAPIEN 3 or the LOTUS valve system were included into the Swiss Transcatheter Aortic Valve Implantation Registry. An adjusted analysis was performed to compare the early clinical safety outcome according to the Valve Academic Research Consortium‐2 definition. Between February 2014 and September 2015, 140 and 815 patients were treated with the LOTUS and the Edwards SAPIEN 3 valve, respectively. There was no difference in crude and adjusted analyses of the early safety outcome between patients treated with LOTUS (14.3%) and those treated with Edwards SAPIEN 3 (14.6%) (crude hazard ratio, 0.97; 95% CI, 0.61–1.56 [P=0.915]; adjusted hazard ratio, 1.03; 95% CI, 0.64–1.67 [P=0.909]). More than mild aortic regurgitation was
ISSN:2047-9980
2047-9980
DOI:10.1161/JAHA.116.004088