000			03950nam a22005177a 4500
008			241030s20242024 xxu||||| |||| 00| 0 eng d
022			_a1522-1946
040			_aOvid MEDLINE(R)
099			_a39109463
245			_aTwo-year follow-up of transcatheter aortic valve replacement in low-risk patients with symptomatic severe bicuspid aortic valve stenosis.
251			_aCatheterization & Cardiovascular Interventions. 2024 Aug 07
252			_aCatheter Cardiovasc Interv. 2024 Aug 07
253			_aCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
260			_c2024
260			_fFY2025
260			_p2024 Aug 07
265			_saheadofprint
265			_tPublisher
266			_d2024-10-30
266			_z2024/08/07 05:33
501			_aAvailable online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006
520			_aBACKGROUND: In 2019, the US Food and Drug Administration (FDA) approved transcatheter aortic valve replacement (TAVR) for low-risk patients with symptomatic severe tricuspid aortic stenosis. However, bicuspid aortic valve (BAV) patients were included only in single-arm registries of pivotal low-risk TAVR trials, resulting in limited data for this subgroup.
520			_aCONCLUSION: The 2-year follow-up confirms commendable clinical outcomes of TAVR in patients with bicuspid aortic stenosis, establishing its evident safety. Copyright © 2024 Wiley Periodicals LLC.
520			_aMETHODS: The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and the first FDA-approved investigational device exemption trial to evaluate the feasibility of TAVR with balloon-expandable or self-expanding valves in low-risk patients with symptomatic severe BAV stenosis. This analysis reports 2-year follow-up, assessing the primary outcome of all-cause mortality and evaluating clinical outcomes.
520			_aRESULTS: From 2016 to 2019, a total of 72 low-risk patients diagnosed with symptomatic, severe BAV stenosis underwent TAVR across six centers. Six patients were lost to follow-up. At 2-year follow-up, mortality was 1.5% (1 of 66 patients). Among the remaining 65 patients, four experienced nondisabling strokes (6.2%), while 2 (3.1%) developed infective endocarditis. No new permanent pacemakers were required beyond the 30-day follow-up, and no patients, including those with endocarditis, needed aortic valve re-intervention. At the 2-year echocardiography follow-up (n = 65), 27.8% of BAV patients showed mild aortic regurgitation, with none exhibiting moderate or severe regurgitation. The mean aortic gradient was 12.1 +/- 4.1 mmHg, and the mean valve area was 1.7 +/- 0.5 cm2.
546			_aEnglish
650			_aIN PROCESS -- NOT YET INDEXED
651			_aMedStar Heart & Vascular Institute
651			_aMedStar Washington Hospital Center
656			_aAdvanced Cardiac Catheterization Research Fellowship
657			_aJournal Article
700			_aBen-Dor, Itsik _bMHVI
700			_aCase, Brian C _bMHVI
700			_aMerdler, Ilan _bMHVI
700			_aReddy, Pavan _bMWHC _cAdvanced Cardiac Catheterization Research Fellowship _dMD
700			_aRogers, Toby _bMHVI
700			_aSatler, Lowell F _bMHVI
700			_aSawant, Vaishnavi _bMHVI
700			_aWaksman, Ron _bMHVI
700			_aZhang, Cheng _bMHVI
790			_aMerdler I, Rogers T, Case BC, Zhang C, Gordon P, Ehsan A, Parikh P, Bilfinger T, Buchbinder M, Roberts D, Hanna N, Ben-Dor I, Reddy PK, Sawant V, Satler LF, Waksman R
856			_uhttps://dx.doi.org/10.1002/ccd.31170 _zhttps://dx.doi.org/10.1002/ccd.31170
858			_ySatler, Lowell F _uhttp://orcid.org/0000-0001-6446-2683 _zhttp://orcid.org/0000-0001-6446-2683
858			_yWaksman, Ron _uhttp://orcid.org/0000-0002-4063-9226 _zhttp://orcid.org/0000-0002-4063-9226
942			_cART _dArticle
999			_c14703 _d14703