Endovascular Ablation of the Greater Splanchnic Nerve in Heart Failure With Preserved Ejection Fraction: The REBALANCE-HF Randomized Clinical Trial.

IF 14.8 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS JAMA cardiology Pub Date : 2024-10-02 DOI:10.1001/jamacardio.2024.2612

Marat Fudim, Barry A Borlaug, Rajeev C Mohan, Matthew J Price, Peter Fail, Parag Goyal, Scott L Hummel, Teona Zirakashvili, Tamaz Shaburishvili, Ravi B Patel, Vivek Y Reddy, Christopher D Nielsen, Stanley J Chetcuti, Devraj Sukul, Rajiv Gulati, Luke Kim, Keith Benzuly, Sumeet S Mitter, Liviu Klein, Nir Uriel, Ralph S Augostini, John E Blair, Krishna Rocha-Singh, Daniel Burkhoff, Manesh R Patel, Sami I Somo, Sheldon E Litwin, Sanjiv J Shah

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Abstract

Importance: Greater splanchnic nerve ablation may improve hemodynamics in patients with heart failure and preserved ejection fraction (HFpEF).

Objective: To explore the feasibility and safety of endovascular right-sided splanchnic nerve ablation for volume management (SAVM).

Design, setting, and participants: This was a phase 2, double-blind, 1:1, sham-controlled, multicenter, randomized clinical trial conducted at 14 centers in the US and 1 center in the Republic of Georgia. Patients with HFpEF, left ventricular ejection fraction of 40% or greater, and invasively measured peak exercise pulmonary capillary wedge pressure (PCWP) of 25 mm Hg or greater were included. Study data were analyzed from May 2023 to June 2024.

Intervention: SAVM vs sham control procedure.

Main outcomes and measures: The primary efficacy end point was a reduction in legs-up and exercise PCWP at 1 month. The primary safety end point was serious device- or procedure-related adverse events at 1 month. Secondary efficacy end points included HF hospitalizations, changes in exercise function and health status through 12 months, and baseline to 1-month change in resting, legs-up, and 20-W exercise PCWP.

Results: A total of 90 patients (median [range] age, 71 [47-90] years; 58 female [64.4%]) were randomized at 15 centers (44 SAVM vs 46 sham). There were no differences in adverse events between groups. The primary efficacy end point did not differ between SAVM or sham (mean between-group difference in PCWP, -0.03 mm Hg; 95% CI, -2.5 to 2.5 mm Hg; P = .95). There were also no differences in the secondary efficacy end points. There was no difference in the primary safety end point between the treatment (6.8% [3 of 44]) and sham (2.2% [1 of 46]) groups (difference, 4.6%; 95% CI, -6.1% to 15.4%; P = .36). There was no difference in the incidence of orthostatic hypotension between the treatment (11.4% [5 of 44]) and sham (6.5% [3 of 46]) groups (difference, 4.9%; 95% CI, -9.2% to 18.8%; P = .48).

Conclusions and relevance: Results show that SAVM was safe and technically feasible, but it did not reduce exercise PCWP at 1 month or improve clinical outcomes at 12 months in a broad population of patients with HFpEF.

Trial registration: ClinicalTrials.gov Identifier: NCT04592445.

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射血分数保留型心力衰竭患者的大横纹肌神经血管内消融术：REBALANCE-HF 随机临床试验》。

重要性：大脾神经消融术可改善射血分数保留型心力衰竭（HFpEF）患者的血液动力学：探讨血管内右侧脾神经消融术用于容量管理（SAVM）的可行性和安全性：这是一项2期、双盲、1:1、假对照、多中心、随机临床试验，在美国的14个中心和格鲁吉亚共和国的1个中心进行。纳入的患者均患有高频心衰（HFpEF），左心室射血分数大于或等于 40%，有创测得的运动峰值肺毛细血管楔压（PCWP）大于或等于 25 mm Hg。研究数据分析时间为2023年5月至2024年6月：主要结果和测量指标：主要疗效终点是1个月后抬腿和运动PCWP的降低。主要安全性终点为 1 个月时发生的严重器械或手术相关不良事件。次要疗效终点包括心房颤动住院率、12 个月内运动功能和健康状况的变化，以及静息、抬腿和 20 W 运动 PCWP 从基线到 1 个月的变化：共有 90 名患者（中位数[范围]年龄为 71 [47-90] 岁；58 名女性[64.4%]）在 15 个中心接受了随机治疗（44 名 SAVM 对 46 名假体）。各组之间的不良反应没有差异。主要疗效终点在 SAVM 和假体之间没有差异（PCWP 的组间平均差异为 -0.03 mm Hg；95% CI，-2.5 至 2.5 mm Hg；P = .95）。次要疗效终点也无差异。治疗组（6.8% [44 例中的 3 例]）和假治疗组（2.2% [46 例中的 1 例]）在主要安全性终点上没有差异（差异为 4.6%；95% CI，-6.1% 至 15.4%；P = .36）。治疗组（11.4% [44 例中的 5 例]）和假治疗组（6.5% [46 例中的 3 例]）的正性低血压发生率没有差异（差异为 4.9%；95% CI，-9.2% 至 18.8%；P = .48）：研究结果表明，SAVM 是安全的，在技术上也是可行的，但它并不能降低 1 个月时的运动 PCWP，也不能改善 HFpEF 患者 12 个月时的临床预后：试验注册：ClinicalTrials.gov Identifier：试验注册：ClinicalTrials.gov Identifier：NCT04592445。

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来源期刊

JAMA cardiology Medicine-Cardiology and Cardiovascular Medicine

CiteScore

45.80

自引率

1.70%

发文量

264

期刊介绍： JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications. Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program. Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.