Renal denervation in patients with heart failure secondary to Chagas' disease: A pilot randomized controlled trial

Abstract

Introduction Chagas disease is one of the most relevant endemic parasitic diseases in Latin America, affecting approximately 6 million people. Overt Chagas heart disease is an ominous condition, occurring in 20–30% of infected individuals, which has besides the persistent myocarditis a peculiar intracardiac ganglionic neuronal depletion and dysautonomy. This study aims to evaluate the safety and feasibility of renal denervation for patients with advanced symptomatic Chagas cardiomyopathy. Methods Open‐label prospective pilot study that randomized patients with Chagas heart disease to either renal denervation or conservative treatment (2:1 ratio). The primary endpoint was the incidence of major adverse events at 9 months, defined as a composite of all‐cause death, myocardial infarction, stroke, need for renal artery invasive treatment, or worsening renal function. Results A total of 17 patients were allocated for renal denervation (n = 11) or conservative treatment (n = 6). Included patients had severe symptomatic heart disease, with markedly depressed left ventricular function (average ejection fraction 26.7 ± 4.9%). For patients randomized to renal denervation, the procedure was performed successfully and uneventfully. After 9 months, the primary endpoint occurred in 36.4% of patients in the renal denervation group and 50.0% in the control arm (p = .6). After 9 months, clinical, laboratory, functional, echocardiographic, and quality of life parameters were similar between groups. Conclusions This pilot study suggests that renal denervation is safe and feasible in patients with Chagas cardiomyopathy, warranting future studies to better evaluate the clinical efficacy of the interventional strategy in improving the prognosis of this high‐risk population.

Device-Based Sympathetic Nerve Regulation for Cardiovascular Diseases

“…Few studies have been conducted on RDN for HF, and the REACH Pilot study was the first to confirm the efficacy of RDN in heart failure with reduced ejection fraction (HFrEF), the study included seven patients with HFrEF receiving standardized pharmacological therapy, 6 months after receiving RDN, the 6-min walking distance (6MWD) increased significantly from baseline (mean difference: 27.1 ± 9.7 m, p = 0.03) ( 82 ). The efficacy of RDN for HFrEF was further confirmed in subsequent clinical studies with larger sample sizes, with several studies showing that RDN could improve ejection fraction (EF), New York Heart Association (NYHA) cardiac function class, and reduced brain natriuretic peptide (BNP) levels ( 10 , 83 , 84 ). A meta-analysis of 5 clinical studies with 177 patients showed that RDN increased EF in patients with HFrEF (weighted mean difference: 6.289%, 95% CI: 1.883–10.695%) ( 85 ), providing a theoretical basis for a large RCT study.…”

“…Although the precise mechanisms of action of sympathetic device modulation are not fully understood, there are research studies to support its value in common CVDs such as hypertension ( 8 ), arrhythmias ( 9 ), and heart failure (HF) ( 10 ) ( Figure 1 ). This article will provide a review of the possible pathophysiological rationale for the application of device-based SN modulation in CVD, the latest clinical research evidence, current controversies, and future perspectives.…”

Perspectiva actual en manejo de Arritmias en Cardiomiopatía Chagásica

“…Después de 9 meses los parámetros clínicos, de laboratorio, funcionales, ecocardiográficos y de calidad de vida fueron similares entre los grupos. El estudio concluyó que la denervación renal es segura y factible en pacientes con miocardiopatía Chagásica (31). Sin embargo, aunque la DSR ha mostrado cierta efectividad, se usa como tratamiento de última línea.…”