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OBJECTIVES: This study sought to present the U.K. experience to date with the second-generation LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts). BACKGROUND: First-generation transcatheter aortic valves have limitations. Second-generation repositionable valves may improve on some of those limitations. METHODS: Prospectively collected data relating to procedural and in-hospital outcome was analyzed from 10 implantation centers in the United Kingdom. RESULTS: Implants in 228 patients age 81.4 ± 7.6 years were studied; 53.5% were male. Mean logistic EuroScore was 17.5 ± 12.4. One hundred eighty-seven (82.0%) were undertaken for aortic stenosis, 7 (3.1%) for aortic regurgitation, and 34 (14.9%) for mixed aortic valve disease. A total of 67.1% of cases were done under local anesthetic and/or sedation with transfemoral access in 94.7% and transaortic in 5.3%. Three device sizes were used: 23 mm (n = 66, 28.9%), 25 mm (n = 39, 17.1%), and 27 mm (n = 123, 53.9%). The valve was successfully deployed in 99.1% of procedures. After implantation, the mean aortic gradient was 11.4 ± 5.4 mm Hg and aortic valve area 1.6 ± 0.5 cm(2). In-hospital mortality was 1.8% (n = 4). Complications included cardiac tamponade (1.8%), conversion to sternotomy (1.3%), stroke (3.9%), vascular access-related (7.0%), and acute kidney injury (7.9%). The incidence of moderate/severe aortic regurgitation was 0.8% (n = 2). A total of 31.8% of patients required new permanent pacemaker implantation. CONCLUSIONS: This analysis represents the largest published series on use of the LOTUS valve. Outcomes using this valve are excellent. In-hospital mortality is very low. Complication rates are low, and the LOTUS valve improves on first-generation valves, particularly with regard to residual aortic regurgitation.

Original publication

DOI

10.1016/j.jcin.2015.12.012

Type

Journal article

Journal

JACC Cardiovasc Interv

Publication Date

22/02/2016

Volume

9

Pages

367 - 372

Keywords

LOTUS, aortic stenosis, complication, outcome, transcatheter aortic valve, Aged, Aged, 80 and over, Aortic Valve, Aortic Valve Insufficiency, Aortic Valve Stenosis, Arrhythmias, Cardiac, Cardiac Catheterization, Cardiac Pacing, Artificial, Catheterization, Peripheral, Female, Femoral Artery, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Hemodynamics, Hospital Mortality, Humans, Male, Prosthesis Design, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, United Kingdom