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中危患者经导管主动脉瓣置换术与外科主动脉瓣置换术后的神经系统并发症。

Neurological Complications After Transcatheter Versus Surgical Aortic Valve Replacement in Intermediate-Risk Patients.

机构信息

Department of Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands.

Departments of Cardiology and Cardiovascular Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.

出版信息

J Am Coll Cardiol. 2018 Oct 30;72(18):2109-2119. doi: 10.1016/j.jacc.2018.07.093.

Abstract

BACKGROUND

Neurological events after aortic valve interventions are associated with increased mortality and morbidity. Transcatheter aortic valve replacement (TAVR) is increasingly offered for lower-risk patients with severe aortic stenosis, previously considered candidates for surgical aortic valve replacement (SAVR). Differences in post-procedural neurological events have important implications in treatment allocation.

OBJECTIVES

The authors sought to analyze the neurological events in the randomized SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial.

METHODS

Patients with severe, symptomatic aortic stenosis at intermediate surgical risk were randomized 1:1 to TAVR or SAVR. The rates of neurological events and quality of life were analyzed at 30 days, and 6 and 12 months post-procedure in a modified intention-to-treat population (mean age 79.8 ± 6.2 years; N = 1,660).

RESULTS

The rates of early (30-day) stroke and post-procedural encephalopathy were higher after SAVR versus TAVR (5.4% vs. 3.3%; p = 0.031; and 7.8% vs. 1.6%; p < 0.001, respectively). At 12 months, the rate of stroke was not different between SAVR and TAVR (6.9% vs. 5.2%; p = 0.136). Early stroke and early encephalopathy resulted in an elevated mortality at 12 months in both treatment groups. Quality of life after an early stroke was significantly lower in SAVR versus TAVR patients at 30 days and was similar at 6 and 12 months.

CONCLUSIONS

The early stroke rate was lower after TAVR than SAVR. In patients with early strokes, QOL improved earlier after TAVR. At 12-month follow-up, stroke rates and QOL were not different between TAVR and SAVR patients. (Surgical Replacement and Transcatheter Aortic Valve Implantation [SURTAVI]; NCT01586910).

摘要

背景

主动脉瓣介入治疗后的神经系统事件与死亡率和发病率的增加有关。经导管主动脉瓣置换术(TAVR)越来越多地用于严重主动脉瓣狭窄的低危患者,这些患者以前被认为是主动脉瓣置换术(SAVR)的候选者。术后神经系统事件的差异在治疗分配中具有重要意义。

目的

作者分析了随机 SURTAVI(外科置换和经导管主动脉瓣植入)试验中的神经系统事件。

方法

中危外科风险的严重、有症状的主动脉瓣狭窄患者以 1:1 的比例随机分为 TAVR 或 SAVR 组。在改良意向治疗人群(平均年龄 79.8±6.2 岁;N=1660)中,在术后 30 天、6 个月和 12 个月时分析神经系统事件和生活质量。

结果

SAVR 组的早期(30 天)卒中发生率和术后脑病发生率高于 TAVR 组(5.4%比 3.3%;p=0.031;7.8%比 1.6%;p<0.001)。在 12 个月时,SAVR 组和 TAVR 组的卒中发生率无差异(6.9%比 5.2%;p=0.136)。两组在治疗后 12 个月时早期卒中导致的死亡率均升高。在 SAVR 组和 TAVR 组中,早期卒中后 30 天的生活质量明显降低,而在 6 个月和 12 个月时则相似。

结论

TAVR 术后的早期卒中发生率低于 SAVR。在早期发生卒中的患者中,TAVR 后的 QOL 更早改善。在 12 个月随访时,TAVR 组和 SAVR 组的卒中发生率和 QOL 无差异。(SURTAVI;NCT01586910)。

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