Repositionable Versus Balloon‐Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis
Open Access
- 26 October 2016
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Journal of the American Heart Association
- Vol. 5 (11)
- https://doi.org/10.1161/jaha.116.004088
Abstract
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 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.Keywords
This publication has 22 references indexed in Scilit:
- Meta-Analysis of the Effectiveness and Safety of Transcatheter Aortic Valve Implantation Without Balloon PredilationThe American Journal of Cardiology, 2016
- Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS ValveJACC: Cardiovascular Interventions, 2016
- Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in SwitzerlandCirculation: Cardiovascular Interventions, 2015
- Increased Risk of Cerebral Embolization After Implantation of a Balloon-Expandable Aortic Valve Without Prior Balloon ValvuloplastyJACC: Cardiovascular Interventions, 2015
- Chronic pacing and adverse outcomes after transcatheter aortic valve implantationHeart, 2015
- Short-term clinical outcomes among patients undergoing transcatheter aortic valve implantation in Switzerland: the Swiss TAVI registryEuroIntervention, 2014
- Transcatheter Aortic Valve Replacement for Severe Symptomatic Aortic Stenosis Using a Repositionable Valve SystemJournal of the American College of Cardiology, 2014
- Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve SystemInternational Journal of Cardiology, 2013
- Updated Standardized Endpoint Definitions for Transcatheter Aortic Valve ImplantationJournal of the American College of Cardiology, 2012
- Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve ReplacementNew England Journal of Medicine, 2012