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Comparative outcomes of on-label and off-label transcatheter aortic valve replacement for aortic regurgitation: a systematic review and meta-analysis

openhrt · 2025-10-17 · canonical JSON source

3 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment for aortic regurgitation (AR) in patients at high surgical risk. However, evidence comparing outcomes of different new-generation devices remains limited.Objectives To compare clinical outcomes of on-label, off-label self-expanding (SE) and off-label balloon-expandable (BE) TAVR devices in AR patients.Methods A systematic review and meta-analysis were conducted, including studies reporting clinical outcomes of new-generation TAVR devices in AR. The primary outcome was 1-year all-cause mortality. Secondary outcomes included procedural success, moderate or severe AR and perioperative complications. Subgroup and meta-regression analyses assessed the impact of valve type and clinical variables.Results 32 studies involving 2682 patients were included. 1-year mortality was 10.4% (95% CI: 7.2% to 14.7%) with no significant difference among valve types. Technical success was highest with on-label devices (97%), followed by off-label:BE (92%) and off-label:SE (85%) (p<0.001). Valve migration occurred in 2% of on-label, 7% of off-label:BE and 10% of off-label:SE cases (p=0.004). Moderate or severe AR was observed in 2% of on-label, 4% of off-label:BE and 8% of off-label:SE recipients (p<0.001). Meta-regression identified coronary heart disease as an independent predictor of 1 year mortality (p=0.026), while other factors showed no significant association.Conclusions On-label devices were associated with improved procedural outcomes, including lower rates of valve migration and residual AR, although 1-year mortality did not differ significantly between device groups. Further prospective studies with longer follow-up are needed to assess valve durability and long-term clinical outcomes.PROSPERO registration number CRD 42024611296.