Giordano Arturo, Corcione Nicola, Ferraro Paolo, Morello Alberto, Conte Sirio, Bedogni Francesco, Testa Luca, Iadanza Alessandro, Sardella Gennaro, Mancone Massimo, Tomai Fabrizio, De Persio Giovanni, Attisano Tiziana, Pepe Martino, Frati Giacomo, Biondi-Zoccai Giuseppe
Unità Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castel Volturno, Italy.
Unità Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castel Volturno, Italy; Unità Operativa di Emodinamica, Casa di Salute Santa Lucia, San Giuseppe Vesuviano, Italy.
Cardiovasc Revasc Med. 2019 Dec;20(12):1096-1099. doi: 10.1016/j.carrev.2019.01.017. Epub 2019 Jan 23.
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.
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.
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.
对于手术风险高或中等的患者，经导管主动脉瓣植入术（TAVI）可有效治疗严重主动脉瓣狭窄。预扩张常被用于促进TAVI植入，但新一代器械的预扩张风险效益平衡仍有待确定。我们旨在评估新一代TAVI器械是否仍需要预扩张。
方法/材料：我们查询了前瞻性多中心RISPEVA（意大利经皮主动脉瓣植入注册研究），比较接受预扩张和未接受预扩张的患者使用Acurate、Evolut、Lotus、Portico或Sapien3器械的情况。对基线、手术特征以及早期临床和超声心动图结果进行了未调整和调整分析。
共纳入1409名受试者，1055名（74.9%）接受预扩张，354名（25.1%）接受直接TAVI。两组在未调整分析时有几个基线和手术差异明显，包括器械成功率、手术成功率、造影剂用量、手术时间、术后平均压差以及2级以上主动脉反流发生率（均p<0.05）。调整分析显示，只有手术时间仍受预扩张的显著影响（预扩张使手术时间平均减少-12.9[95%置信区间-21.0；-4.8]分钟，p=0.002）。亚组未调整和调整分析显示，仅在使用Evolut或Portico器械时，预扩张与较短的手术时间相关（均p<0.05）。长达1个月的临床和超声心动图随访显示，无论是否进行预扩张，在未调整和调整分析中结果相似。
使用新一代器械时，不进行预扩张的TAVI与不良手术、临床或超声心动图结果无关。然而，预扩张可能会减少使用Evolut和Portico器械时的手术时间。
