Department of Cardiology, Cardiovascular Institute, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands.
The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Catheter Cardiovasc Interv. 2024 Nov;104(5):1044-1051. doi: 10.1002/ccd.31194. Epub 2024 Aug 28.
Paravalvular 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.
To 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.
Prospective 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.
Sixty-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%).
In our study FEops HEARTguide™ simulations identified patients at risk for >trace PVL with ACURATE Neo2 TAVI but not for PPI.
经导管主动脉瓣置换术（TAVI）后，瓣周漏（PVL）和需要植入永久性起搏器（PPI）的传导障碍仍然是临床上的一个挑战。基于计算机断层扫描的模拟可能预测发生严重 PVL 和 PPI 的风险。
评估使用 FEops HEARTguide™进行术前计算机模拟预测自膨式瓣环上 ACURATE Neo2 经导管心脏瓣膜 TAVI 后 >微量 PVL 和 PPI 的可行性和准确性。
前瞻性多中心观察性研究，纳入了接受 ACURATE Neo2 瓣膜 TAVI 的连续患者。计算机模拟作为术前规划的一部分，在 TAVI 术前进行。PPI 和 PVL 的随访时间为 30 天。
共纳入 65 例患者（中位年龄 81 岁（25 至 75 百分位数为 77 至 84.5））。5 例患者出现新发左束支传导阻滞（7.7%），2 例患者出现 PPI（3%）。有新传导障碍的患者与无新传导障碍的患者的接触压力指数（CPI）相似。有 PPI 的患者的 CPI 数值高于无 PPI 的患者（中位数 CPI 20.0%（25 至 75 百分位数 15.0 至 25.0）vs. 13.0%（25 至 75 百分位数 5.5 至 18），p=0.27）。30%的患者发生微量以上的 PVL。无微量 PVL 的患者的中位 PVL 明显低于轻度 PVL（5.2 毫升/秒（25 至 75 百分位数 3.2 至 10.3））和中度 PVL（12.6 毫升/秒（25 至 75 百分位数 3.9 至 21.3））（p=0.036）。模拟 PVL 截断值为 9.65 毫升/秒，可识别出 ACURATE Neo2 TAVI 后发生 >微量 PVL 的患者（AUC 为 0.70（95%CI 为 0.55-0.85），敏感性为 42%，特异性为 95%）。
在我们的研究中，FEops HEARTguide™模拟可识别出接受 ACURATE Neo2 TAVI 治疗的患者发生微量以上 PVL 的风险，但无法识别发生 PPI 的风险。
