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

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.