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TAVI Outcome Analysis in Off-Label Anatomic Settings
Session:
SESSÃO DE POSTERS 34 - TAVI 2
Speaker:
Antonio Maria Rocha de Almeida
Congress:
CPC 2025
Topic:
H. Interventional Cardiology and Cardiovascular Surgery
Theme:
25. Interventional Cardiology
Subtheme:
25.3 Non-coronary Cardiac Intervention
Session Type:
Cartazes
FP Number:
---
Authors:
António Maria Rocha De Almeida; Rafael Viana; Marta Paralta Figueiredo; Rita Louro; Renato Fernandes; Ângela Bento; David Neves; David Brás; Kisa Congo; Manuel Trinca; Álvaro Laranjeira Santos; Lino Patrício
Abstract
<p><strong>Background</strong></p> <p>Transcatheter aortic valve implantation (TAVI) has expanded the treatment options for severe aortic stenosis (AS). Still, in anatomic settings, such as bicuspid aortic valve, severe aortic valve (AV) calcification, and horizontal aorta, TAVI is considered off-label. These features pose challenges and may impact procedural outcomes. This study evaluates the outcomes of TAVI in normal versus off-label anatomic settings.</p> <p><strong>Methods</strong><br /> A retrospective cohort of 300 TAVI procedures with self-expandable Evolut Core Valve was analyzed. Off-label was defined as bicuspid AV, severe AV calcification (calcium score [AVCS] >3000 A.U.), or horizontal aorta (angle of aortic annulus >60°). Standard anatomic settings were verified in 169 and off-label in 131, of which 90 had AVCS >3000 A.U., 41 had horizontal aortas, and 17 had bicuspid AV. Baseline characteristics and outcomes of death at 30 days, 1 year, stroke, and hospital readmission were analyzed.</p> <p><strong>Results</strong></p> <p>Mean age was similar across groups (81–83 years, p=0.1). Female patients were more common in the on-label (71%) compared to the off-label group (33%, p<0.001). There were no significant differences in STS scores, with 19% of on-label patients and 14% of off-label having STS>8 (p=0.4). Clinical characteristics, including NYHA > II and previous hospitalization for AS, were similar. Left ventricular ejection fraction, transaortic mean gradient, AV area, and systolic pulmonary artery pressure showed no significant differences. The AVCS was higher in the severe AV calcification group (4308±1214 vs. 1984±642, p<0.001). Creatinine and NT-proBNP tended to be higher in off-label subgroups, particularly in bicuspid AV.</p> <p>There were no significant differences in events between groups. Death at 30 days occurred in 2% of on-label and 3% of off-label patients (p=0.9), and 1-year death rates of 9% and 12%, respectively (p=0.4). Stroke rates were similar, with 4% in on-label and 3% in off-label groups (p=0.7). Hospital readmissions tended to be lower in off-label patients (18% vs. 30%, p=0.09). Combined death and stroke rates were 5% in on-label and 4% in off-label groups (p=0.7). Vascular (8% vs. 8%, p=1) and major bleeding complications (5.3% vs. 8%, p=0.5) were like. There was no significant difference in pacemaker implantation between on-label and off-label patients (17% vs 22%, p=0.3), with the highest rate in the bicuspid subgroup (29%, p=0.3).</p> <p>Despite the challenges posed by off-label anatomic features, like bicuspid, severe AV calcification, and horizontal aorta, TAVI with self-expandable Evolut Core Valve demonstrated comparable safety and efficacy outcomes to standard settings. There were no significant differences in mortality, stroke, or major complications at 30 days and 1 year. These findings support TAVI as a viable option even in anatomically complex cases, broadening its applicability to previously considered higher-risk cases.</p>
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