First Randomized Study on Cardioneuroablation Shows Promise

Reflex vasovagal syncope (VVS) is the most common cause of transient loss of consciousness.1 Despite its benign course, many patients experience recurrent syncope, significantly affecting their quality of life. 2 Guideline-directed therapy for VVS include lifestyle modifications, increased salt and water intake, counterpressure maneuvers, drug therapy, or a combination of these. Some may benefit from a pacemaker. However, despite guideline-directed therapies, up to 20% of patients suffer from refractory vasovagal syncope.2

Cardioneuroablation has emerged as a promising therapy for patients with refractory vasovagal syncope. In this catheter-based procedure, radiofrequency ablation is done to ganglionated plexi around the right atrium and left atrium. This procedure aims to diminish vagal tone in patients with VVS as the ganglionic plexi are predominantly composed of parasympathetic fibers.3

In the first randomized study (ROMAN Trial) documenting the efficacy of cardioneuroablation in vasovagal syncope, Dr. Piotrowski et al showed that cardioneuroablation was associated with significantly decreased first syncope recurrence and improved quality of life measures compared to optimal nonpharmacological therapy in patients with cardioinhibitory VVS. The findings of this trial were presented in the European Society of Cardiology Congress 2022 and published in the Journal of American College of Cardiology EP.3

In this prospective randomized trial, 48 adults (mean age of 38 years old, with an average of 10 syncopal episodes in the past) with severe cardioinhibitory VVS were randomized between cardioneuroablation and guideline-directed medical therapy. After a 2-year follow-up, the primary endpoint of first syncope recurrence occurred in 2 patients (8%) in the cardioneuroablation group versus 13 in the controls (54%) (p=0.0004). The quality-of-life scores improved in the cardioneuroablation group post-treatment whereas it only remained stable in control patients. There were no procedural complications in the patients that underwent cardioneuroablation.

Dr. Carlos Morillo, Professor in the Department of Cardiac Sciences at the Libin Cardiovascular Institute, University of Calgary, comments, “The ROMAN trial is the first randomized control trial of cardioneuroablation in patients with VVS. The results are promising but caution should be exerted as this was not necessarily a refractory population. Most patients did not receive goal-directed medical therapy and the control group underwent a myriad of non-pharmacological measures. Previous studies such as VPS1, showed similar effectiveness with dual chamber (DDD) pacing when compared to non-pharmacological measures. However, when VPS II2 was conducted and all patients received a pacemaker, no difference was observed regardless of whether the pacemaker was on or off.”

He adds, “In summary, this is a promising study. However, previous pacing studies have demonstrated a large expectation and placebo effects when interventional procedures are compared against non-pharmacological measures. Future trials should include a sham procedure in a truly refractory VVS population that primarily has a cardioinhibitory response.”

References. 

  1. Brignole M, Moya A, de Lange FJ, et al, ESC Scientific Document Group. 2018 ESC guidelines for the diagnosis and management of syncope. Eur Heart J. 2018;39(21):1883–1948.
  2. Vandenberk B, Lei LY, Ballantyne B, et al. Cardioneuroablation for vasovagal syncope: A systematic review and meta-analysis. Heart Rhythm. 2022 Jun 16:S1547-5271(22)02088-4. doi: 10.1016/j.hrthm.2022.06.017. Epub ahead of print. PMID: 35716859.
  3. Piotrowski R, Baran J, Sikorska A, et al. Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2022 Aug 28:S2405-500X(22)00680-6. doi: 10.1016/j.jacep.2022.08.011. Epub ahead of print. PMID: 36114133.
  4. Benditt DG, Petersen M, Lurie KG, Sutton R. Cardiac pacing for the prevention of recurrent vasovagal syncope. Ann Intern Med.1995;122:204-209.
  5. Connolly SJ, Sheldon R, Thorpe KE, et al. Pacemaker Therapy for Prevention of Syncope in Patients With Recurrent Severe Vasovagal Syncope: Second Vasovagal Pacemaker Study (VPS II): A Randomized Trial. JAMA.2003;289(17):2224–2229. doi:10.1001/jama.289.17.2224