BACKGROUND: Significant aortic stenosis can be effectively treated with transcatheter aortic valve implantation (TAVI) in patients at high or intermediate surgical risk. Predilation is often performed to facilitate TAVI implantation, but its risk-benefit balance with new-generation devices is detabed. We aimed to appraise whether predilation is still needed with new-generation devices for TAVI.
METHODS/MATERIALS: We queried the prospective multicenter RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) Study, comparing patients with vs without predilation receiving Acurate, Evolut, Lotus, Portico, or Sapien3. Baseline, procedural features and early clinical and echocardiographic results were compared with unadjusted and adjusted analyses.
RESULTS: A total of 1409 subjects were included, 1055 (74.9%) receiving predilation, and 354 (25.1%) undergoing direct TAVI. Several baseline and procedural differences were evident at unadjusted analysis between the two groups, including device success, procedural success, contrast volume, procedural time, mean post-procedural gradient, and prevalence of aortic regurgitation 2+ (all p < 0.05). Adjusted analysis showed that only procedural time remained significantly impacted by predilation (average reduction in procedural time with predilation of -12.9 [95% confidence interval -21.0; -4.8] minutes, p = 0.002). Subgroup unadjusted and adjusted analysis showed that predilation was associated with shorter procedural times only when Evolut or Portico devices were used (all p < 0.05). Clinical and echocardiographic follow-up up to 1 month showed similar results irrespective of predilation at both unadjusted and adjusted analysis.
CONCLUSION: TAVI without predilation is not associated with adverse procedural, clinical or echocardiographic results when new-generation devices are used. Predilation may however reduce procedural time with Evolut and Portico devices.