RAISE 试验：一种新型装置和首例人体试验。
The RAISE Trial: A Novel Device and First-in-Man Trial.
机构信息
Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, China (W.S., H. Zou, Y.Y., B.L., H. Zhang, J.L., Y. Shen, P.L., T.X., X.C., A.D., M.J., Y.H., Y. Sheng, B.Z., X.K.).
Cardiovascular Device and Technique Engineering Laboratory of Jiangsu Province, Nanjing, China (W.S., X.K.).
出版信息
Circ Heart Fail. 2022 Apr;15(4):e008362. doi: 10.1161/CIRCHEARTFAILURE.121.008362. Epub 2022 Apr 5.
BACKGROUND
Currently, standard medical therapies have limited effects on heart failure with preserved ejection fraction (HFpEF), which impacts on the life quality and survival of patients. This study aimed to evaluate the safety and efficacy of the percutaneous radiofrequency ablation-based interatrial shunting for HFpEF with a novel atrial septostomy device.
METHODS
A preclinical study in 11 normal domestic pigs and the first-in-man study in 10 patients with HFpEF were performed. The major safety events and interatrial shunt performance were evaluated at baseline, 1 month, 3 months, and 6 months post-procedure in both animals and human patients. The clinical functional status was also assessed in the first-in-man study.
RESULTS
Percutaneous radiofrequency ablation-based interatrial shunting therapy was performed successfully both in animals and patients. In the animal study, a left-to-right interatrial shunt was created with a mean defect size of 5.5±2.2 mm without procedure-related safety events. Seven pigs showed the continuous shunting with a mean defect size of 4.1±1.5 mm at 6 months. In the first-in-man study, a median interatrial defect diameter of 5.0 (4.0-6.0) mm was measured immediately. No major safety events including death and thromboembolism were observed. The continuous shunting with the defect size of 4.0 (3.0-4.0) mm could still be observed in 7 patients at 6 months. The clinical status was significantly improved with NT-proBNP (N-terminal pro-B-type natriuretic peptide) reduced by 2149 pg/mL ([95% CI, 204-3301] =0.028), with 6-minute walk distance increased by 88 m ([95% CI, 50-249] =0.008) and with New York Heart Association class improved in 8 patients at 6 months.
CONCLUSIONS
The present results showed that percutaneous radiofrequency ablation-based interatrial shunting was a safe and potentially effective therapy for HFpEF, providing a nonpharmacological and nonimplanted option for HFpEF management.
REGISTRATION
URL: https://www.chictr.org.cn; Unique identifier: ChiCTR1900027664.
背景
目前，标准的医学疗法对射血分数保留的心力衰竭（HFpEF）的效果有限，这影响了患者的生活质量和生存。本研究旨在评估基于经皮射频消融的新型房间隔造口术治疗 HFpEF 的安全性和有效性。
方法
在 11 只正常家猪中进行了临床前研究，并在 10 例 HFpEF 患者中进行了首例人体研究。在动物和人体患者中，在术前、术后 1 个月、3 个月和 6 个月评估主要安全性事件和房间隔分流性能。在首例人体研究中还评估了临床功能状态。
结果
在动物和患者中均成功进行了基于经皮射频消融的房间隔分流治疗。在动物研究中，创建了左向右房间隔分流，平均缺损大小为 5.5±2.2mm，无与程序相关的安全性事件。7 只猪在 6 个月时显示连续分流，平均缺损大小为 4.1±1.5mm。在首例人体研究中，中位房间隔缺损直径为 5.0（4.0-6.0）mm。未观察到包括死亡和血栓栓塞在内的主要安全性事件。7 例患者在 6 个月时仍可观察到缺损大小为 4.0（3.0-4.0）mm 的连续分流。NT-proBNP（氨基末端 B 型利钠肽前体）降低 2149pg/mL（[95%CI，204-3301] =0.028），6 分钟步行距离增加 88m（[95%CI，50-249] =0.008），纽约心脏协会心功能分级改善 8 例患者，临床状况显著改善。
结论
本研究结果表明，基于经皮射频消融的房间隔分流术治疗 HFpEF 是一种安全且有潜在疗效的治疗方法，为 HFpEF 管理提供了一种非药物和非植入的选择。
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