Cerebral Embolic Protection by Geographic Region

IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Raj R. Makkar, Aakriti Gupta, Thomas E. Waggoner, Samuel Horr, Juhana Karha, Lowell Satler, Robert C. Stoler, Jorge Alvarez, Rahul Sakhuja, Lee MacDonald, Rodrigo Modolo, Martin B. Leon, Axel Linke, Samir R. Kapadia
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引用次数: 0

Abstract

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
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方案,但手术过程中脱落的碎片可能导致栓塞性中风。设计、设置和参与者2020年2月至2022年1月期间,美国、欧洲和澳大利亚的51家医院开展了一项前瞻性、上市后随机临床试验,对使用或不使用CEP进行的TAVR进行了评估。试验纳入了接受经股动脉 TAVR 治疗的无症状主动脉瓣狭窄患者。根据中心、手术风险和预定的TAVR瓣膜类型进行分层随机化。如果左侧颈总动脉或肱动脉狭窄超过70%,或解剖结构不允许放置CEP装置,则排除患者。主要结果和测量指标主要终点是出院时或TAVR术后72小时(以先到者为准)所有卒中事件的发生率。结果经导管主动脉瓣置换术(PROTECTED TAVR)期间哨兵卒中保护试验招募并随机分配了 3000 名患者(1803 名 [60.1%] 男性;平均 [SD] 年龄 78.9 [7.8] 岁):美国队列中有 1833 名患者(单纯 TAVR:919 名,TAVR 联合 CEP:914 名),美国以外队列中有 1167 名患者(单纯 TAVR:580 名,TAVR 联合 CEP:587 名)。与美国以外队列相比,美国队列的患者更年轻,男性占多数,心房颤动发病率较低,主动脉瓣二尖瓣、糖尿病和外周血管疾病发病率较高。在主要试验中,TAVR 术后 72 小时内或出院前中风的发生率在 CEP 组和对照组之间没有显著差异,也没有因地理区域而产生交互作用。在这项事后分析中,与单纯 TAVR 相比,美国队列中接受 CEP 治疗的患者总体中风的相对风险降低了 50%,致残性中风的相对风险降低了 73%;在美国本土队列中未观察到治疗对降低中风风险的影响。虽然地理区域之间没有明显的交互作用,但这一探索性事后分析表明,美国队列有更大程度减少卒中的趋势,而其他国家队列则没有。这些发现是假设性的,还需要进一步研究以确定患者特征或手术方法的地区差异是否会影响 CEP 的疗效:NCT04149535
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来源期刊
JAMA cardiology
JAMA cardiology Medicine-Cardiology and Cardiovascular Medicine
CiteScore
45.80
自引率
1.70%
发文量
264
期刊介绍: JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications. Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program. Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.
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