Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial.

ABSTRACT

BACKGROUND: Treatment of cardioinhibitory vasovagal syncope (VVS) is difficult. Recently, cardioneuroablation (CNA) has emerged as a new therapeutic option. OBJECTIVES: This study sought to assess the effects of CNA on syncope recurrences in patients with VVS. METHODS: This study was a prospective, open, randomized, controlled, investigator-initiated trial comparing CNA versus optimal nonpharmacologic therapy in patients with cardioinhibitory VVS. Patients were included if they had documented symptomatic cardioinhibitory or mixed VVS and positive atropine test. CNA was performed using radiofrequency ablation of the ganglionated plexi from the left and right atria. Follow-up lasted 2 years. Primary endpoint was time to first syncope recurrence. Secondary endpoints included changes in sinus rhythm and heart rate variability measured in Holter electrocardiography at baseline and 3, 12, and 24 months after CNA, as well as changes in quality of life at baseline and after completion of follow-up. RESULTS: A total of 48 patients (17 male, mean age 38 ± 10 years, 24 in CNA group, 24 in control group) entered the study. The primary endpoint occurred in 2 patients (8%) from the CNA group versus 13 control patients (54%) (P = 0.0004). After CNA the mean sinus rhythm at 24-hour Holter electrocardiography was significantly faster and heart rate variability parameters significantly changed toward parasympathetic withdrawal compared with baseline values. Quality of life significantly improved in the CNA group (30 ± 10 points vs 10 ± 7 points; P = 0.0001), whereas it remained stable in control patients (31 ± 10 points vs 30 ± 10 points; P = 0.5501). CONCLUSIONS: This is the first randomized study documenting efficacy of CNA in patients with cardioinhibitory VVS. Larger studies are needed to confirm these findings. (Cardioneuroablation for Reflex Syncope [ROMAN]; NCT03903744).