TY  - BOOK
AU  - Ben-Dor, Itsik
AU  - Case, Brian C
AU  - Merdler, Ilan
AU  - Reddy, Pavan
AU  - Rogers, Toby
AU  - Satler, Lowell F
AU  - Sawant, Vaishnavi
AU  - Waksman, Ron
AU  - Zhang, Cheng
TI  - Two-year follow-up of transcatheter aortic valve replacement in low-risk patients with symptomatic severe bicuspid aortic valve stenosis
SN  - 1522-1946
PY  - 2024///
KW  - IN PROCESS -- NOT YET INDEXED
KW  - MedStar Heart & Vascular Institute
KW  - MedStar Washington Hospital Center
KW  - Advanced Cardiac Catheterization Research Fellowship
KW  - Journal Article
N1  - Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006
N2  - BACKGROUND: 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; CONCLUSION: 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; METHODS: 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; RESULTS: 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
UR  - https://dx.doi.org/10.1002/ccd.31170
ER  -