Bagur Rodrigo, Kwok Chun Shing, Nombela-Franco Luis, Ludman Peter F, de Belder Mark A, Sponga Sandro, Gunning Mark, Nolan James, Diamantouros Pantelis, Teefy Patrick J, Kiaii Bob, Chu Michael W A, Mamas Mamas A
Division of Cardiology, Department of Medicine, London Health Sciences Centre, Western University, London, Ontario, Canada Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada
Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, United Kingdom Keele Cardiovascular Research Group, Institute of Science and Technology in Medicine and Primary Care, Keele University, Stoke-on-Trent, Staffordshire, United Kingdom.
J Am Heart Assoc. 2016 Jun 13;5(6):e003191. doi: 10.1161/JAHA.115.003191.
Preimplantation balloon aortic valvuloplasty (BAV) is considered a routine procedure during transcatheter aortic valve implantation (TAVI) to facilitate prosthesis implantation and expansion; however, it has been speculated that fewer embolic events and/or less hemodynamic instability may occur if TAVI is performed without preimplantation BAV. The aim of this study was to systematically review the clinical outcomes associated with TAVI undertaken without preimplantation BAV.
We conducted a search of Medline and Embase to identify studies that evaluated patients who underwent TAVI with or without preimplantation BAV for predilation. Pooled analysis and random-effects meta-analyses were used to estimate the rate and risk of adverse outcomes. Sixteen studies involving 1395 patients (674 with and 721 without preimplantation BAV) fulfilled the inclusion criteria. Crude device success was achieved in 94% (1311 of 1395), and 30-day all-cause mortality occurred in 6% (72 of 1282) of patients. Meta-analyses evaluating outcomes of strategies with and without preimplantation BAV showed no statistically significant differences in terms of mortality (relative risk [RR] 0.61, 95% CI 0.32-1.14, P=0.12), safety composite end point (RR 0.85, 95% CI 0.62-1.18, P=0.34), moderate to severe paravalvular leaks (RR 0.68, 95% CI 0.23-1.99, P=0.48), need for postdilation (RR 0.86, 95% CI 0.66-1.13, P=0.58), stroke and/or transient ischemic attack (RR 0.72, 95% CI 0.30-1.71, P=0.45), and permanent pacemaker implantation (RR 0.80, 95% CI 0.49-1.30, P=0.37).
Our analysis suggests that TAVI procedures with or without preimplantation BAV were associated with similar outcomes for a number of clinically relevant end points. Further studies including a large number of patients are needed to ascertain the impact of TAVI without preimplantation BAV as a standard practice.
植入前球囊主动脉瓣成形术（BAV）被认为是经导管主动脉瓣植入术（TAVI）过程中的常规操作，以利于假体植入和扩张；然而，有人推测，如果在没有植入前BAV的情况下进行TAVI，可能会发生更少的栓塞事件和/或更少的血流动力学不稳定。本研究的目的是系统评价不进行植入前BAV的TAVI的临床结局。
我们检索了Medline和Embase，以确定评估接受或未接受植入前BAV进行预扩张的TAVI患者的研究。采用汇总分析和随机效应荟萃分析来估计不良结局的发生率和风险。16项研究纳入1395例患者（674例接受植入前BAV，721例未接受植入前BAV），符合纳入标准。总体器械成功率为94%（1395例中的1311例），30天全因死亡率为6%（1282例中的72例）。评估有或没有植入前BAV策略结局的荟萃分析显示，在死亡率（相对风险[RR]0.61，95%CI 0.32 - 1.14，P = 0.12）、安全性复合终点（RR 0.85，95%CI 0.62 - 1.18，P = 0.34）、中至重度瓣周漏（RR 0.68，95%CI 0.23 - 1.99，P = 0.48）、需要进行后扩张（RR 0.86，95%CI 0.66 - 1.13，P = 0.58）、中风和/或短暂性脑缺血发作（RR 0.72，95%CI 0.30 - 1.71，P = 0.45）以及永久起搏器植入（RR 0.80，95%CI 0.49 - 1.30，P = 0.37）方面，均无统计学显著差异。
我们的分析表明，无论有无植入前BAV，TAVI在一些临床相关终点方面的结局相似。需要开展包括大量患者的进一步研究，以确定不进行植入前BAV的TAVI作为标准操作的影响。
