CardioneuROablation for reflex syncope: efficacy and effects on autonoMic cArdiac regulatioN. The Roman 1 study. (3rd October 2022)

• Record Type: Journal Article
• Authors: Piotrowski, R; Baran, J; Sikorska, A; Krynski, T; Kulakowski, P
• Is Part Of: European heart journal. Volume 43(2022)Supplement 2
• Publication Date: 2022-10-03
• Subjects: Cardiology -- Periodicals; Heart -- Diseases -- Periodicals; 616.12005
• DOI: 10.1093/eurheartj/ehac544.653
• Languages: English
• ISSNs: 0195-668X

Abstract

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