Durable Physiological Changes and Decreased Syncope Burden 12 Months After Unifocal Right-Sided Ablation Under Computed Tomographic Guidance in Patients With Neurally Mediated Syncope or Functional Sinus Node Dysfunction
Philippe Debruyne, Tom Rossenbacker, Luc Janssens, Christine Collienne, Joris Ector, Peter Haemers, Jean‐Benoît le Polain de Waroux, Christine Bazelmans, Tim Boussy, William Wijns
Abstract
Background: Cardioneuromodulation is a cardioneuroablative approach aiming to create adequate vagolysis of the sinoatrial node through partial ablation of the anterior right ganglionated plexus. Methods: We performed an interventional study in patients with recurrent neurally mediated syncope (group A) or functional sinus node dysfunction (group B). Syncope burden, ECG, 24-hour rhythm data, tilt table test, exercise test, and pharmacological challenge with atropine were assessed at baseline and at regular intervals to 12 months. Results: Fifty patients (31 in group A and 19 in group B) underwent cardioneuromodulation. The mean number of syncopes during the previous 12 months was 9.7±18.2. The procedure was associated with a lower rate of syncope (−95%) and presyncope (−95%) at 12 months versus baseline ( P <0.001). Thirty-seven patients remained entirely free of syncope at 12 months, and the syncope-free survival curve remained stable between the 12- and 30-month follow-up. After a mean ablation time of 8±4 minutes, the P-P interval shortened by 247±146 ms ( P <0.001). Basal heart rate (HR) increased by 18% ( P <0.001) and remained stable between 6 and 12 months. At 12 months, the mean HR increased by 12% in the entire cohort ( P <0.001), reached 23% in patients with baseline mean HR <70 beats per minute ( P <0.01), and did not increase in patients with baseline HR >70 beats per minute. Maximum HR during exercise decreased by 10 beats per minute at 1 month ( P <0.001) and was restored at 12 months. Conclusions: Cardioneuromodulation is a safe and fast treatment giving rise to a long-term partial sinus node vagolysis with no apparent short- or long-term safety concerns or undesirable persisting modifications of the intracardiac autonomous nervous system. The impact on vasoplegia is less clear. Cardioneuromodulation is associated with a good clinical outcome in most patients with neurally mediated syncope or functional sinus node dysfunction. These promising data require confirmation in a multicenter randomized trial. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02954666.