CardioneuROablation for reflex syncope: efficacy and effects on autonoMic cArdiac regulatioN. The Roman 1 study

Abstract

Purpose To assess the effects of CNA on syncope recurrences in patients with VVS Methods The Roman 1 study was a prospective, randomized, investigator-initiated trial comparing CNA versus optimal standard therapy in patients with asystolic VVS. Patients were included if they had documented symptomatic cardioinhibitory or mixted spontaneous VVS (at least 3 seconds of asystole), frequent and/or severe symptoms (at least one syncope or 3 presyncopal events during preceding 12 months or very severe syncope in the past, leading to injury) and positive atropine test (>30% increase in sinus rate). CNA was performed using RF ablation of the ganlionated plexi from the left and right atrium. Follow-up lasted 2 years. Primary endpoint was time to first syncope recurrence. One of secondary endpoints were changes in quality of life (QoL) assessed using dedicated questionnaire The Impact of Syncope on Quality-of-Life Questionnaire University of Calgary. Results 48 patients (17 males, mean age 38±10, 24 – CNA group, 24 – control group) entered the study. Baseline demographic and clinical characteristics were similar in both groups. The primary end-point – syncope recurrence, occurred in 2 (8%) patients from the CNA group versus 12 (50%) controls (p=0.00037, see Kaplan-Meier curve). QoL significantly improved in the CNA group (30±10 vs 10±7 points, p=0.0001) whereas remained stable in controls (31±10 vs 30±10 points, p=0.5501). Conclusion(s) This is the first randomized study documenting efficacy of CNA in patients with asystolic VVS. Larger studies are needed to confirm these findings. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Centre of Postgraduate Medical Education

Cardioneuroablation for Drug Refractory Vasovagal Syncope After COVID-19 Infection

“…A recent randomized controlled trial showed that CNA is superior to nonpharmacologic treatments in patients with cardioinhibitory VVS. 7 Both types of VVS (vasodepressor and cardioinhibitory) were shown to respond in the first description of CNA by Pachon et al, 4 and this was supported by a subsequent study by Aksu et al, 5 in which 31 patients with functional or vagally mediated AV block were successfully treated with CNA. Recent data indicate that the clinical benefit of CNA persists more than 2 years after the procedure.…”

“…CNA has emerged as an effective therapeutic alternative that may be superior to traditional measures to prevent VVS. 4 CNA involves identifying sites of cardiac parasympathetic ganglia by empirical anatomical localization, high-frequency stimulation, fractionation mapping, 5 computed tomography, 6 intracardiac echocardiography, 7 or 123 I- meta -iodobenzylguanidine imaging followed by radiofrequency ablation of these sites. GP are commonly located near the ostium of the left and right superior pulmonary veins, the ostium of the right inferior pulmonary vein, the inferior septal portion of the right atrium outside the coronary sinus, and between the distal superior vena cava and proximal aorta.…”

“… 8 A vagal response (eg, decrease in heart rate with high-frequency stimulation) may assist in identifying location of the GP but is not uniformly used. 7 After ablation, an increase in sinus heart rate and decrease of the AH interval is suggestive of successful ablation. 5 Notably, the optimal methods to identify GP, procedural efficacy readouts, assessment methods of vagal input to the heart, and the order and extent of GP ablation are under debate.…”

An assessment of heart rate and blood pressure asymmetry in the diagnosis of vasovagal syncope in females

“…The study of deceleration capacity (which is an HRA index related to the vagal activity) strengthens this conclusion ( Zheng et al, 2020 ; Tu et al, 2022 ). In the case of cardioinhibitory VVS, the patients after cardioneuroablation treatment had lower mean RR and significantly changed HRV parameters toward parasympathetic withdrawal ( Piotrowski et al, 2022 ). However, other research indicates the usefulness of the heart rate Poincaré plot shape analyses in VVS diagnosis ( Yuan et al, 2022 ).…”

Twenty-five years of research on syncope

“… 120 Subsequent case reports and uncontrolled studies reported in Europace 121–127 culminated in a randomized, unblinded study that reported high efficacy after a 2-year follow-up. 128 …”