Department of Cardiology, University of Cologne Heart Center, Cologne, Germany.
Department of Cardiac Surgery, Medical University Innsbruck, Innsbruck, Austria.
BMC Cardiovasc Disord. 2019 Jul 19;19(1):172. doi: 10.1186/s12872-019-1151-y.
To evaluate the outcomes of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) in a real-world setting through a patient-level meta-analysis.
The meta-analysis included patients of three European multicenter, prospective, observational registry studies that compared outcomes after Edwards SAPIEN 3 or XT TAVI with (n = 339) or without (n = 355) BAV. Unadjusted and adjusted pooled odds ratios (with 95% confidence intervals) were calculated for procedural and 30-day outcomes.
Median procedural time was shorter in the non-BAV group than in the BAV group (73 versus 93 min, p = 0.001), as was median fluoroscopy time (7 versus 11 min, p = 0.001). Post-delivery balloon dilation (15.5% versus 22.4%, p = 0.02) and catecholamine use (9.0% vs. 17.9%; p = 0.016) was required less often in the non-BAV group than in the BAV group with the difference becoming insignificant after multiple adjustment. There was a reduced risk for periprocedural atrioventricular block during the intervention (1.4% versus 4.1%, p = 0.035) which was non-significant after adjustment. The rate of moderate/severe paravalvular regurgitation post-TAVI was 0.6% in the no-BAV group versus 2.7% in the BAV group. There were no between-group differences in the risk of death, stroke or other adverse clinical outcomes at day 30.
This patient-level meta-analysis of real-world data indicates that TAVI performed without BAV is advantageous as it has an adequate device success rate, reduced procedure time and no adverse effects on short-term clinical outcomes.
通过患者水平的荟萃分析，评估真实世界环境中不经球囊主动脉瓣成形术（BAV）的经导管主动脉瓣植入术（TAVI）的结果。
该荟萃分析纳入了三项比较经爱德华兹 SAPIEN 3 或 XT TAVI 后有（n=339）或无（n=355）BAV 患者结局的欧洲多中心前瞻性观察性注册研究中的患者。计算了手术和 30 天结局的未调整和调整后合并比值比（95%置信区间）。
无 BAV 组的手术时间中位数（73 分钟比 93 分钟，p=0.001）和透视时间中位数（7 分钟比 11 分钟，p=0.001）均短于 BAV 组。无 BAV 组的球囊后扩张（15.5%比 22.4%，p=0.02）和儿茶酚胺使用率（9.0%比 17.9%，p=0.016）较低，在进行多次调整后差异无统计学意义。术中房室传导阻滞的风险降低（1.4%比 4.1%，p=0.035），但调整后无统计学意义。无 BAV 组术后 TAVI 时中度/重度瓣周反流的发生率为 0.6%，而 BAV 组为 2.7%。两组在 30 天死亡、卒中和其他不良临床结局的风险无差异。
这项真实世界数据的患者水平荟萃分析表明，不进行 BAV 的 TAVI 具有优势，因为它具有足够的器械成功率，缩短了手术时间，且对短期临床结局无不良影响。
