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

Journal of the American Heart Association, 2016-11, Vol.5 (11), p.n/a [Peer Reviewed Journal]

2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell. ;ISSN: 2047-9980 ;EISSN: 2047-9980 ;DOI: 10.1161/JAHA.116.004088 ;PMID: 27856487

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Title:
Repositionable Versus Balloon‐Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis
Author: 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
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
Is Part Of: Journal of the American Heart Association, 2016-11, Vol.5 (11), p.n/a
Description: 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 <2% for both devices. A total of 34.3% of patients treated with LOTUS and 14.1% of patients treated with Edwards SAPIEN 3 required a permanent pacemaker (HR, 2.76; 95% CI, 1.97–3.87 [P<0.001]). Conclusions The repositionable LOTUS valve system and the balloon‐expandable Edwards SAPIEN 3 prosthesis appeared comparable in regard to the Valve Academic Research Consortium‐2 early safety outcome, and the rates of more than mild aortic regurgitation were exceedingly low for both devices. The need for new permanent pacemaker implantation was more frequent among patients treated with the LOTUS valve.
Publisher: England: John Wiley and Sons Inc
Language: English
Identifier: ISSN: 2047-9980
EISSN: 2047-9980
DOI: 10.1161/JAHA.116.004088
PMID: 27856487
Source: GFMER Free Medical Journals
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Wiley Online Library Open Access
ROAD: Directory of Open Access Scholarly Resources
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Repositionable Versus Balloon‐Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis

2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell. ;ISSN: 2047-9980 ;EISSN: 2047-9980 ;DOI: 10.1161/JAHA.116.004088 ;PMID: 27856487

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