BackgroundParavalvular leakage (PVL) and conduction disorders that require permanent pacemaker implantation (PPI) remain clinically relevant challenges after transcatheter aortic valve implantation (TAVI). Computed tomography‐based simulations may predict the risk of significant PVL and PPI.AimsTo evaluate the feasibility and accuracy of preprocedural computer simulation with FEops HEARTguide™ to predict >trace PVL and PPI after TAVI with the self‐expanding supra‐annular ACURATE Neo2 transcatheter heart valve.MethodsProspective multicenter observational study that included consecutive patients undergoing TAVI with an ACURATE Neo2 valve. Computer simulations were performed before the TAVI procedure as part of the preprocedural planning. Follow‐up period for PPI and PVL was 30 days.ResultsSixty‐five patients were included (median age 81 years (25th−75th percentile 77–84.5)). New left bundle branch block occurred in five patients (7.7%) and PPI in two patients (3%). Contact pressure index (CPI) was similar for patients with vs without new conduction disorders. Patients with PPI had numerically higher CPI than those without PPI (median CPI 20.0% (25th−75th percentile 15.0–25.0) vs. 13.0% (25th−75th percentile 5.5–18), p = 0.27). More than trace PVL occurred in 30%. Median PVL was significantly lower in patients with none‐trace PVL (3.2 mL/s [25th−75th percentile 2.2–5.0]), compared to mild PVL (5.2 mL/s [25th−75th percentile 3.2–10.3]) and moderate PVL (12.6 mL/s [25th−75th percentile 3.9–21.3])(p = 0.036). A simulated PVL‐cutoff of 9.65 mL/s identified patients with >trace PVL (AUC 0.70 (95% CI 0.55–0.85), sensitivity 42%, specificity 95%).ConclusionIn our study FEops HEARTguide™ simulations identified patients at risk for >trace PVL with ACURATE Neo2 TAVI but not for PPI.

中文翻译：

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CT 衍生模拟可预测接受 ACURATE Neo2 瓣膜经导管主动脉瓣植入的患者的结果 PRECISE-TAVI B 组试验


背景 经导管主动脉瓣植入 (TAVI) 后，需要植入永久起搏器 (PPI) 的瓣周漏 (PVL) 和传导障碍仍然是临床相关的挑战。基于计算机断层扫描的模拟可以预测显着 PVL 和 PPI 的风险。目的评估使用 FEops HEARTguide™ 进行术前计算机模拟的可行性和准确性，以预测使用自扩张超环形 ACURATE Neo2 经导管心脏进行 TAVI 后>trace PVL 和 PPI方法前瞻性多中心观察研究，包括使用 ACURATE Neo2 瓣膜接受 TAVI 的连续患者。作为术前规划的一部分，在 TAVI 手术之前进行了计算机模拟。 PPI 和 PVL 的随访期为 30 天。 结果 纳入 65 名患者（中位年龄 81 岁（25th−75th 百分位数 77–84.5））。 5 名患者（7.7%）出现新发左束支传导阻滞，2 名患者（3%）出现 PPI。患有新发传导障碍的患者与未患新发传导障碍的患者的接触压力指数（CPI）相似。患有 PPI 的患者的 CPI 在数值上高于未患有 PPI 的患者（中位 CPI 20.0%（25-75 百分位 15.0-25.0）对比 13.0%（25-75 百分位 5.5-18），p = 0.27）。 30%以上发生微量PVL。与轻度 PVL (5.2 mL/s [25th−75th 百分位数 3.2–10.3]) 和中度 PVL 患者相比，无痕 PVL 患者的中位 PVL 显着较低 (3.2 mL/s [25th−75th 百分位数 2.2–5.0]) （12.6 mL/s [25th−75th 百分位数 3.9–21.3]）（p = 0.036）。 9.65 mL/s 的模拟 PVL 截止值确定了具有 >trace PVL 的患者（AUC 0.70 (95% CI 0.55–0.85)，敏感性 42%，特异性 95%）。结论在我们的研究中，FEops HEARTguide™ 模拟通过 ACURATE Neo2 TAVI 确定了存在 >trace PVL 风险的患者，但没有发现 PPI 风险。