Department of Cardiology, Clinic of Internal Medicine II, Paracelsus Medical University of Salzburg, Salzburg, Austria.
Department of Internal Medicine, Hospital Oberndorf, Teaching Hospital of Paracelsus Medical University Salzburg, Oberndorf, Austria.
Clin Res Cardiol. 2019 Aug;108(8):921-930. doi: 10.1007/s00392-019-01422-0. Epub 2019 Feb 8.
Transcatheter aortic valve replacement (TAVR) has become the mainstay of treatment for aortic stenosis in patients with high surgical risk. Pure aortic regurgitation (PAR) is considered a relative contraindication for TAVR; however, TAVR is increasingly performed in PAR patients with unfavorable risk profile. Herein, we aim to summarize available data on TAVR for PAR with special emphasis on "on-label" versus "off-label" TAVR devices.
Pubmed was searched for studies of patients undergoing TAVR for PAR. Primary outcome was 30 day-mortality. Pooled estimated event rates were calculated. Twelve studies including a total of 640 patients were identified until December 2017. Among these, 208 (33%) patients were treated with devices with CE-mark approval for PAR ("on-label"; JenaValve and J valve). Overall, the procedural success rate was 89.9% (95% CI 81.1-96.1%; I 80%). Major bleeding was reported in 6.4% (95% CI 2.9-10.8%; I 48%). All-cause mortality at 30 days was 10.4% (95% CI 7.1-14.2%; I 20%). Stroke occurred in 2.2% (95% CI 0.9-3.9%; I 0%). A permanent pacemaker was required in 10.7% (95% CI 7.3-14.6%; I 23%). At 30 days after TAVR, ≥ moderate AR post-interventional was observed in 11.5% (95% CI 2.9-23.6%; I 90%). In the "on-label"-group, success rate was 93.0% (95% CI 85.9-98.1%; I 52%). 30-day-mortality was 9.1% (95% CI 3.7-16.0%; I 36%). More than trace AR was present in 2.8% (95% CI 0.1-7.6%; I 0%). Compared to first-generation devices, second-generation devices were associated with significantly lower 30-day-mortality (r = - 0.10; p = 0.02), and significantly higher procedural success rates (r = 0.28; p < 0.001). Compared to other second-generation devices, the use of J valve or JenaValve was not associated with altered mortality (r = 0.04; p = 0.50), rates of > trace residual AR (r = - 0.05; p = 0.65) but with a significantly higher procedural success (r = 0.15; p = 0.042).
Based on this summary of available observational data TAVR for PAR is feasible and safe in patients deemed inoperable. First-generation TAVR devices are associated with inferior outcome and should be avoided. The "on-label" use of PAR-certified TAVR devices is associated with a significantly higher procedural success rate and might be favorable compared to other second-generation devices.
经导管主动脉瓣置换术（TAVR）已成为高危主动脉瓣狭窄患者的主要治疗方法。单纯主动脉瓣反流（PAR）被认为是 TAVR 的相对禁忌证；然而，对于风险状况不佳的 PAR 患者，TAVR 的应用越来越多。在此，我们旨在总结 PAR 行 TAVR 的现有数据，特别强调“适应证内”与“适应证外”TAVR 器械的应用。
在 Pubmed 上检索了 PAR 患者行 TAVR 的研究。主要结局为 30 天死亡率。计算了汇总的估计事件发生率。截至 2017 年 12 月，共确定了 12 项共纳入 640 例患者的研究。其中，208 例（33%）患者使用 CE 标志批准用于 PAR 的器械（“适应证内”；JenaValve 和 J 瓣膜）进行治疗。总体而言，手术成功率为 89.9%（95%CI 81.1-96.1%；I 2=80%）。主要出血发生率为 6.4%（95%CI 2.9-10.8%；I 2=48%）。30 天全因死亡率为 10.4%（95%CI 7.1-14.2%；I 2=20%）。卒中发生率为 2.2%（95%CI 0.9-3.9%；I 2=0%）。需要植入永久性起搏器的比例为 10.7%（95%CI 7.3-14.6%；I 2=23%）。TAVR 后 30 天，观察到≥中度术后 AR 的比例为 11.5%（95%CI 2.9-23.6%；I 2=90%）。在“适应证内”组中，成功率为 93.0%（95%CI 85.9-98.1%；I 2=52%）。30 天死亡率为 9.1%（95%CI 3.7-16.0%；I 2=36%）。>微量 AR 的比例为 2.8%（95%CI 0.1-7.6%；I 2=0%）。与第一代器械相比，第二代器械与显著降低的 30 天死亡率（r=-0.10；p=0.02）和显著更高的手术成功率（r=0.28；p<0.001）相关。与其他第二代器械相比，使用 J 瓣膜或 JenaValve 与死亡率无显著变化（r=0.04；p=0.50）、>微量残余 AR 发生率无显著变化（r=-0.05；p=0.65），但与更高的手术成功率相关（r=0.15；p=0.042）。
基于现有观察性数据的总结，PAR 行 TAVR 对于被认为不能手术的患者是可行且安全的。第一代 TAVR 器械与较差的结果相关，应避免使用。PAR 认证的 TAVR 器械的“适应证内”使用与更高的手术成功率相关，与其他第二代器械相比可能更具优势。
