Kapadia Samir, Agarwal Shikhar, Miller D Craig, Webb John G, Mack Michael, Ellis Stephen, Herrmann Howard C, Pichard Augusto D, Tuzcu E Murat, Svensson Lars G, Smith Craig R, Rajeswaran Jeevanantham, Ehrlinger John, Kodali Susheel, Makkar Raj, Thourani Vinod H, Blackstone Eugene H, Leon Martin B
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Circ Cardiovasc Interv. 2016 Sep;9(9). doi: 10.1161/CIRCINTERVENTIONS.115.002981.
Prior studies of stroke and transient ischemic attack (TIA) after transcatheter aortic valve replacement (TAVR) are limited by reporting and follow-up variability. This is a comprehensive analysis of time-related incidence, risk factors, and outcomes of these events.
From April 2007 to February 2012, 2621 patients, aged 84±7.2 years, underwent transfemoral (TF; 1521) or transapical (TA; 1100) TAVR in the PARTNER trial (Placement of Aortic Transcatheter Valves; as-treated), including the continued access registry. Stroke and TIA were identified by protocol and adjudicated by a Clinical Events Committee. Within 30 days of TAVR, 87 (3.3%) patients experienced a stroke (TF 58 [3.8%]; TA 29 [2.7%]; P=0.09), 85% within 1 week. Instantaneous stroke risk peaked on day 2, then fell to a low prolonged risk of 0.8% by 1 to 2 weeks. Within 30 days, 13 (0.50%) patients experienced a TIA (TF 10 [0.67%]; TA 3 [0.27%]; P>0.17). Stroke and TIA were associated with lower 1-year survival than expected (TF 47% after stroke versus 82%, and 64% after TIA versus 83%; TA 53% after stroke versus 80%, and 64% after TIA versus 83%). Risk factors for early stroke after TA-TAVR included more postdilatations, pure aortic stenosis without regurgitation, and possibly more pacing runs, earlier date of procedure, and no dual antiplatelet therapy; high pre-TAVR aortic peak gradient was a risk factor for stroke early after TF-TAVR.
Risk of stroke or TIA is highest early after TAVR and is associated with increased 1-year mortality. Modifications of TAVR, emboli-prevention devices, and better intraprocedural pharmacological protection may mitigate this risk.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
既往关于经导管主动脉瓣置换术（TAVR）后卒中及短暂性脑缺血发作（TIA）的研究受报告及随访差异的限制。本文对这些事件的时间相关发病率、危险因素及转归进行了全面分析。
在2007年4月至2012年2月期间，2621例年龄为84±7.2岁的患者在PARTNER试验（主动脉经导管瓣膜置入；实际治疗）中接受了经股动脉（TF；1521例）或经心尖（TA；1100例）TAVR，包括持续入组登记。卒中及TIA通过方案确定，并由临床事件委员会判定。在TAVR后30天内，87例（3.3%）患者发生卒中（TF组58例[3.8%]；TA组29例[2.7%]；P = 0.09），85%发生在1周内。即刻卒中风险在第2天达到峰值，然后在1至2周时降至0.8%的低水平并持续存在。在30天内，13例（0.50%）患者发生TIA（TF组10例[0.67%]；TA组3例[0.27%]；P>0.17）。卒中和TIA与1年生存率低于预期相关（TF组卒中后为47%，而预期为82%，TIA后为64%，而预期为83%；TA组卒中后为53%，而预期为80%，TIA后为64%，而预期为83%）。TA-TAVR后早期卒中的危险因素包括更多的后扩张、无反流的单纯主动脉瓣狭窄，可能还有更多的起搏次数、手术日期较早以及未接受双联抗血小板治疗；TAVR前较高的主动脉峰值梯度是TF-TAVR后早期卒中的危险因素。
TAVR后早期卒中或TIA风险最高，且与1年死亡率增加相关。对TAVR进行改良、使用栓子预防装置以及更好的术中药物保护可能会降低这种风险。
