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经导管主动脉瓣置换术后的神经系统事件及其预测因素:来自CoreValve试验的报告。

Neurological Events Following Transcatheter Aortic Valve Replacement and Their Predictors: A Report From the CoreValve Trials.

作者信息

Kleiman Neal S, Maini Brijeshwar J, Reardon Michael J, Conte John, Katz Stanley, Rajagopal Vivek, Kauten James, Hartman Alan, McKay Raymond, Hagberg Robert, Huang Jian, Popma Jeffrey

机构信息

From the Houston Methodist DeBakey Heart and Vascular Institute, TX (N.S.K., M.J.R.); Tenet Healthcare Corporation, Delray Beach, FL (B.J.M.); Johns Hopkins University, Baltimore, MD (J.C.); Hofstra North Shore University Hospital, New Hyde Park, NY (S.K., A.H.); Hartford Hospital, CT (R.M., R. H.); Piedmont Heart Institute, Atlanta, GA (V.R., J.K.); Medtronic, Minneapolis, MN (J.H.); and Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.).

出版信息

Circ Cardiovasc Interv. 2016 Sep;9(9). doi: 10.1161/CIRCINTERVENTIONS.115.003551.

DOI:10.1161/CIRCINTERVENTIONS.115.003551
PMID:27601429
Abstract

BACKGROUND

The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread.

METHODS AND RESULTS

Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0-10 days; 4.1% of strokes) and a late phase (11-365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (<21 kg/m(2)), and falls within the past 6 months. Significant procedural predictors were total time in the catheterization laboratory or operating room, delivery catheter in the body time, rapid pacing used during valvuloplasty, and repositioning of the prosthesis. Predictors of stroke between 11 and 365 days were small body surface area, severe aortic calcification, and falls within the past 6 months. There were no significant imaging predictors of early or late stroke.

CONCLUSIONS

Predictors of early stroke after TAVR included clinical and procedural factors; predictors of later stroke were limited to patient but not anatomic characteristics. These findings indicate that further refinement of imaging to identify anatomic factors predisposing to embolization may help improve stroke prediction in patients undergoing TAVR.

CLINICAL TRIAL REGISTRATIONS

URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01240902, NCT01531374.

摘要

背景

经导管主动脉瓣置换术(TAVR)后发生卒中的风险是一个重要问题。随着TAVR的广泛应用,识别卒中的预测因素可能是有助于患者选择和管理的关键因素。

方法和结果

本分析纳入了参加CoreValve美国极高风险和高风险关键试验或持续接入研究并接受自膨胀CoreValve生物假体治疗的患者。TAVR术后1年的卒中发生率为8.4%。对卒中风险率的分析确定了一个早期阶段(0至10天;占卒中的4.1%)和一个晚期阶段(11至365天;占卒中的4.3%)。早期卒中的基线预测因素包括美国国立卫生研究院卒中量表评分>0、既往卒中、既往短暂性脑缺血发作、外周血管疾病、既往未行冠状动脉搭桥手术、心绞痛、低体重指数(<21kg/m²)以及过去6个月内跌倒。重要的手术预测因素包括在导管室或手术室的总时间、输送导管在体内的时间、瓣膜成形术期间使用的快速起搏以及假体的重新定位。11至365天期间卒中的预测因素为小体表面积、严重主动脉钙化以及过去6个月内跌倒。早期或晚期卒中均无显著的影像学预测因素。

结论

TAVR术后早期卒中的预测因素包括临床和手术因素;晚期卒中的预测因素仅限于患者因素而非解剖学特征。这些发现表明,进一步完善影像学检查以识别易导致栓塞的解剖学因素可能有助于改善TAVR患者的卒中预测。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT01240902、NCT01531374。

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