Background

Approximately one-third of patients with symptomatic severe aortic valve stenosis who are scheduled for transcatheter aortic valve implantation (TAVI) have some degree of cognitive impairment. TAVI may have negative cognitive effects due to periprocedural micro-emboli inducing cerebral infarction. On the contrary, TAVI may also have positive cognitive effects due to increases in cardiac output and cerebral blood flow (CBF). However, studies that systematically assess these effects are scarce. Therefore, the main aim of this study is to assess cerebral and cognitive outcomes in patients with severe aortic valve stenosis undergoing TAVI.

Study design

In the prospective CAPITA (CArdiac OutPut, Cerebral Blood Flow and Cognition In Patients With Severe Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Implantation) study, cerebral and cognitive outcomes are assessed in patients undergoing TAVI. One day before and 3 months after TAVI, patients will undergo echocardiography (cardiac output, valve function), brain magnetic resonance imaging (CBF, structural lesions) and extensive neuropsychological assessment. To assess longer-term effects of TAVI, patients will again undergo echocardiography and neuropsychological assessment 1 year after the procedure. The co-primary outcome measures are change in CBF (in ml/100 g per min) and change in global cognitive functioning (Z-score) between baseline and 3‑month follow-up. Secondary objectives include change in cardiac output, white matter hyperintensities and other structural brain lesions. (ClinicalTrials.gov identifier NCT05481008)

Conclusion

The CAPITA study is the first study designed to systematically assess positive and negative cerebral and cognitive outcomes after TAVI. We hypothesise that TAVI improves cardiac output, CBF and cognitive functioning.

中文翻译：

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接受经导管主动脉瓣植入术的严重主动脉瓣狭窄患者的心输出量、脑血流量和认知：CAPITA 研究的设计和原理

背景

计划接受经导管主动脉瓣植入术 (TAVI) 的有症状的严重主动脉瓣狭窄患者中，大约三分之一存在一定程度的认知障碍。由于围手术期微栓塞诱发脑梗塞，TAVI 可能会对认知产生负面影响。相反，TAVI 还可能因心输出量和脑血流量 (CBF) 的增加而产生积极的认知作用。然而，系统评估这些影响的研究很少。因此，本研究的主要目的是评估接受 TAVI 的严重主动脉瓣狭窄患者的大脑和认知结果。

学习规划

在前瞻性 CAPITA（经导管主动脉瓣植入术中严重主动脉瓣狭窄患者的CA心脏输出、脑血流和认知）研究中，评估了接受 TAVI 的患者的脑部和认知结果。TAVI 前一天和术后 3 个月，患者将接受超声心动图（心输出量、瓣膜功能）、脑磁共振成像（CBF、结构性病变）和广泛的神经心理学评估。为了评估 TAVI 的长期效果，患者将在手术后 1 年后再次接受超声心动图和神经心理学评估。共同主要结局指标是基线和 3 个月随访期间 CBF 的变化（以毫升/100 克/分钟为单位）和总体认知功能（Z 评分）的变化。次要目标包括心输出量、白质高信号和其他结构性脑损伤的变化。（ClinicalTrials.gov 标识符 NCT05481008）

结论

CAPITA 研究是第一项旨在系统评估 TAVI 后积极和消极的大脑和认知结果的研究。我们假设 TAVI 可以改善心输出量、CBF 和认知功能。