Background

Cardioneuroablation (CNA) targets the intrinsic cardiac autonomic nervous system ganglionated plexi located in the peri-atrial epicardial fat. There is increasing interest in CNA as a treatment of vasovagal syncope (VVS), despite no randomized clinical trial (RCT) data.

Objective

The purpose of this study was to poll the opinion on CNA) for VVS.

Methods

A REDCap (Research Electronic Data Capture) survey was administered to international physicians treating patients with VVS on their opinion about patient selection criteria, ablation approach, RCT design, and most appropriate end points for CNA procedures.

Results

The survey was completed by 118 physicians; 86% were cardiac electrophysiologists. The majority of respondents (79%) would consider referring a patient with refractory VVS for CNA, and 27% have performed CNA for VVS themselves. Most felt patient selection should require a head-up tilt test with a cardioinhibitory response (67%) and suggest a minimum age of 18 years with a median of 3 (interquartile range 2–5) episodes in the past year. There were differences in patient selection between physicians who have performed CNA themselves and those who have not. The majority felt that the ablation strategy should include both atria (70%) with an anatomical approach in combination with autonomic stimulation (85%). Performing a sham procedure in the control arm was supported by 56% of respondents, providing equipoise in RCT design. The preferred primary outcome was freedom from syncope within 1 year of follow-up.

Conclusion

There is widespread support for well-designed RCTs to confirm the hypothesized clinical benefit of CNA, provide data to guide the risk-benefit equations during patient selection, and appropriately estimate the placebo effect.

中文翻译：

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临床医生对复发性血管迷走性晕厥的心脏神经消融术的需求和看法：一项国际临床医生调查

背景

心脏神经消融术 (CNA) 针对位于心房周围心外膜脂肪中的内在心脏自主神经系统神经节丛。尽管没有随机临床试验 (RCT) 数据，但人们越来越关注 CNA 作为血管迷走性晕厥 (VVS) 的治疗方法。

客观的

本研究的目的是为 VVS 调查关于 CNA 的意见。

方法

对治疗 VVS 患者的国际医生进行了一项 REDCap（研究电子数据采集）调查，以了解他们对患者选择标准、消融方法、RCT 设计和 CNA 程序最合适终点的看法。

结果

该调查由 118 名医生完成；86% 是心脏电生理学家。大多数受访者 (79%) 会考虑将难治性 VVS 患者转诊进行 CNA，27% 自己为 VVS 进行了 CNA。大多数认为患者选择应要求进行具有心脏抑制反应（67%）的平视倾斜测试，并建议在过去一年中，最小年龄为 18 岁，中位数为 3 次（四分位距 2-5）。自己进行过 CNA 的医生和没有进行过 CNA 的医生之间的患者选择存在差异。大多数人认为消融策略应包括心房 (70%) 和解剖方法以及自主神经刺激 (85%)。56% 的受访者支持在控制臂中执行假手术，这在 RCT 设计中提供了平衡。

结论

精心设计的 RCT 得到广泛支持，以确认 CNA 的假设临床益处，提供数据以指导患者选择期间的风险-收益方程，并适当估计安慰剂效应。