ImportanceTranscatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated.ObjectiveTo explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR.Design, Setting, and ParticipantsThis post hoc analysis of a prospective, postmarket, randomized clinical trial evaluating TAVR performed with or without the CEP took place at 51 hospitals in the US, Europe, and Australia from February 2020 to January 2022. Patients with symptomatic aortic stenosis treated with transfemoral TAVR were included. Randomization was stratified according to center, operative risk, and intended TAVR valve type. Patients were excluded if the left common carotid or brachiocephalic artery had greater than 70% stenosis or if the anatomy precluded placement of the CEP device. Data for this post hoc study were analyzed from August to October 2024.InterventionTAVR with or without CEP.Main Outcomes and MeasuresThe primary end point was the rate of all stroke events at hospital discharge or 72 hours post-TAVR, whichever came first. Neurological examinations were performed at baseline and postprocedure to identify stroke, disabling stroke, and other neurological outcomes.ResultsThe Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial enrolled and randomized 3000 patients (1803 [60.1%] male; mean [SD] age, 78.9 [7.8] years): 1833 in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587). Patients in the US cohort were younger, more predominantly male, had a lower prevalence of atrial fibrillation, and had a higher prevalence of bicuspid aortic valve, diabetes, and peripheral vascular disease compared with the OUS cohort. In the main trial, the incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group, and there was no interaction by geographic region. In this post hoc analysis, patients treated with CEP in the US cohort exhibited a 50% relative risk reduction for overall stroke and a 73% relative risk reduction for disabling stroke compared to TAVR alone; a treatment effect on stroke risk reduction was not observed in the OUS cohort.Conclusion and RelevanceThe PROTECTED TAVR trial could not show that the use of CEP had a significant effect on the incidence of periprocedural stroke during TAVR. Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort. These findings are hypothesis generating, and further research is needed to determine if regional differences in patient characteristics or procedural practices affect CEP efficacy.Trial RegistrationClinicalTrials.gov Identifier: NCT04149535

中文翻译：

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按地理区域划分的脑栓塞保护


重要性经导管主动脉瓣置换术 （TAVR） 是许多严重症状性主动脉瓣狭窄患者的既定治疗选择;然而，手术过程中脱落的碎屑会导致栓塞性中风。Sentinel 脑栓塞保护 （CEP） 装置被批准用于在 TAVR 期间捕获和去除栓塞物质，但其疗效一直存在争议。目的探讨接受 CEP 使用与接受 TAVR.Design CEP 的患者、环境和参与者中风结局关联的区域差异这项前瞻性、上市后、随机临床试验的事后分析评估了 TAVR 在有或没有 CEP 的情况下进行，于 2020 年 2 月至 2022 年 1 月在美国、欧洲和澳大利亚的 51 家医院进行。纳入经股动脉 TAVR 治疗的症状性主动脉瓣狭窄患者。根据中心、手术风险和预期的 TAVR 瓣膜类型对随机分组。如果左颈总动脉或头臂动脉狭窄大于 70%，或者解剖结构排除了 CEP 装置的放置，则患者被排除在外。这项事后研究的数据是在 2024 年 8 月至 10 月期间分析的。主要结局和测量主要终点是出院时或 TAVR 后 72 小时的所有卒中事件发生率，以先到者为准。在基线和术后进行神经系统检查，以确定中风、致残性中风和其他神经系统结局。结果经导管主动脉瓣置换术期间哨兵卒中保护 （PROTECTED TAVR） 试验入组并随机分配了 3000 名患者 （1803 [60.1%] 男性;平均 [SD] 年龄，78.9 [7.8] 岁）：美国队列中有 1833 名患者（单独使用 TAVR：919，TAVR 伴 CEP：914）和美国以外 （OUS） 队列中有 1167 名患者（单独使用 TAVR：580，TAVR 伴 CEP：587）。与 OUS 队列相比，美国队列中的患者更年轻，以男性为主，心房颤动的患病率较低，二叶式主动脉瓣、糖尿病和外周血管疾病的患病率更高。在主要试验中，CEP 组和对照组之间 TAVR 后 72 小时内或出院前的卒中发生率没有显著差异，并且没有地理区域的相互作用。在这项事后分析中，与单独使用 TAVR 相比，美国队列中接受 CEP 治疗的患者总体卒中的相对风险降低 50%，致残性卒中的相对风险降低 73%;在 OUS 队列中未观察到对降低卒中风险的治疗效果。结论和相关性PROTECTED TAVR 试验不能显示使用 CEP 对 TAVR 期间围手术期卒中的发生率有显著影响。尽管按地理区域没有显着的交互作用，但这项探索性事后分析表明，美国队列中有更大减少中风的趋势，但在 OUS 队列中没有。这些发现是假设产生的，需要进一步的研究来确定患者特征或手术实践的地区差异是否会影响 CEP 疗效。试验注册临床试验。gov 标识符： NCT04149535