@article{e966342b01e84270bca3f595f71b38c8,
title = "Transcatheter aortic valve replacement in patients with severe mitral or tricuspid regurgitation at extreme risk for surgery",
abstract = "Objectives: Patients with symptomatic severe aortic stenosis and severe mitral regurgitation or severe tricuspid regurgitation were excluded from the major transcatheter aortic valve replacement trials. We studied these 2 subgroups in patients at extreme risk for surgery in the prospective, nonrandomized, single-arm CoreValve US Expanded Use Study. Methods: The primary end point was all-cause mortality or major stroke at 1 year. A favorable medical benefit was defined as a Kansas City Cardiomyopathy Questionnaire overall summary score greater than 45 at 6 months and greater than 60 at 1 year and with a less than 10-point decrease from baseline. Results: There were 53 patients in each group. Baseline characteristics for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were age 84.2 ± 6.4 years and 84.9 ± 6.5 years; male, 29 (54.7%) and 22 (41.5%), and mean Society of Thoracic Surgeons score 9.9% ± 5.0% and 9.2% ± 4.0%, respectively. Improvement in valve regurgitation from baseline to 1 year occurred in 72.7% of the patients with severe mitral regurgitation and in 61.8% of patients with severe tricuspid regurgitation. A favorable medical benefit occurred in 31 of 47 patients (66.0%) with severe mitral regurgitation and 33 of 47 patients (70.2%) with severe tricuspid regurgitation at 6 months, and in 25 of 44 patients (56.8%) with severe mitral regurgitation and 24 of 45 patients (53.3%) with severe tricuspid regurgitation at 1 year. All-cause mortality or major stroke for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were 11.3% and 3.8% at 30 days and 21.0% and 19.2% at 1 year, respectively. There were no major strokes in either group at 1 year. Conclusions: Transcatheter aortic valve replacement in patients with severe mitral regurgitation or severe tricuspid regurgitation is reasonable and safe and leads to improvement in atrioventricular valve regurgitation.",
keywords = "Aortic stenosis, Mitral valve regurgitation, Transcatheter aortic valve replacement, Tricuspid valve regurgitation",
author = "Little, {Stephen H.} and Popma, {Jeffrey J.} and Kleiman, {Neal S.} and Deeb, {G. Michael} and Gleason, {Thomas G.} and Yakubov, {Steven J.} and Stan Checuti and Daniel O'Hair and Tanvir Bajwa and Mubashir Mumtaz and Brijeshwar Maini and Alan Hartman and Stanley Katz and Newell Robinson and George Petrossian and John Heiser and William Merhi and Moore, {B. Jane} and Shuzhen Li and Adams, {David H.} and Reardon, {Michael J.}",
note = "Funding Information: S.H.L. has served on the speaker's bureau for St Jude Medical and has received grant support from Abbott Vascular and institutional support from Medtronic. J.J.P. reports grants to his institution from Medtronic and Boston Scientific, consultant fees from Direct Flow, and fees for serving on a medical advisory board from Boston Scientific. N.S.K. reports personal fees from Medtronic during the conduct of the study. G.M.D. is a clinical trial investigator for Medtronic and a research investigator for Gore Medical and receives consulting fees paid to his institution from Medtronic, Terumo, and Edwards Lifesciences. T.G.G. receives institutional grant support from Medtronic but receives no personal remunerations. S.J.Y. reports grant support, personal fees, and other support from Medtronic during the conduct of the study and grant support from Boston Scientific outside the submitted work. S.C. reports grants and fees for proctoring and consulting from Medtronic. D.O. has received grants from and served as a proctor for Medtronic, and received grant support from Edwards Lifesciences. T.B. has served as a proctor for Medtronic. M.M. reports personal fees from Medtronic during the conduct of the study, personal fees from Abbott, Edwards Lifesciences, and AtriCure outside the submitted work, serving as Chairman of Clinical Events Committee for Millipede, Inc, and serving as a member of the Clinical Events Committee for Abiomed. B.M. has served as speaker and a proctor, and has received institutional research grants from Medtronic, Boston Scientific, Abbott Vascular, and Direct Flow Medical. A.H., S.K. N.R., G.P., J.H., and W.M. report no conflicts. B.J.M. and S.L. are employees and shareholders of Medtronic, plc. D.H.A. reports other support from Medtronic during the conduct of the study, other support from NeoChord and Medtronic outside the submitted work, and patent royalties from Edwards Lifesciences (US9526615 B2 and US9011529 B2) and Medtronic (US8764821 B2). M.J.R. reports consulting fees paid to his institution from Medtronic. Publisher Copyright: {\textcopyright} 2018 The American Association for Thoracic Surgery",
year = "2018",
doi = "10.1016/j.jtcvs.2017.11.108",
language = "English (US)",
volume = "155",
pages = "1991--1999",
journal = "Journal of Thoracic and Cardiovascular Surgery",
issn = "0022-5223",
publisher = "Mosby Inc.",
number = "5",
}