Abstract
Background
Cardioneuroablation has been emerging as a potential treatment alternative in appropriately selected patients with cardioinhibitory vasovagal syncope (VVS) and functional AV block (AVB). However the majority of available evidence has been derived from retrospective cohort studies performed by experienced operators.
Methods
The Cardioneuroablation for the Management of Patients with Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias (CNA-FWRD) Registry is a multicenter prospective registry with cross-over design evaluating acute and long-term outcomes of VVS and AVB patients treated by conservative therapy and CNA.
Results
The study is a prospective observational registry with cross-over design for analysis of outcomes between a control group (i.e., behavioral and medical therapy only) and intervention group (Cardioneuroablation). Primary and secondary outcomes will only be assessed after enrollment in the registry. The follow-up period will be 3 years after enrollment.
Conclusions
There remains a lack of prospective multicentered data for long-term outcomes comparing conservative therapy to radiofrequency CNA procedures particularly for key outcomes including recurrence of syncope, AV block, durable impact of disruption of the autonomic nervous system, and long-term complications after CNA. The CNA-FWRD registry has the potential to help fill this information gap.
Similar content being viewed by others
References
Brignole M, Moya A, De Lange FJ, et al. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018;39(21):1883–948. https://doi.org/10.1093/EURHEARTJ/EHY037.
Lpidoforos E, Oteriades SS, Ane J, et al. Incidence and prognosis of syncope. 2009;347(12):878–885.https://doi.org/10.1056/NEJMOA012407.
Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: executive summary. Circulation. 2018;138(13). https://doi.org/10.1161/CIR.0000000000000548.
Sutton R. Should we treat severe vasovagal syncope with a pacemaker? J Intern Med. 2017;281(6):554–61. https://doi.org/10.1111/JOIM.12603.
Sutton R, de Jong JSY, Stewart JM, Fedorowski A, de Lange FJ. Pacing in vasovagal syncope: physiology, pacemaker sensors, and recent clinical trials—precise patient selection and measurable benefit. Heart Rhythm. 2020;17(5):821–8. https://doi.org/10.1016/J.HRTHM.2020.01.029.
Pachon MJC, Pachon MEI, Pachon MJC, et al. “Cardioneuroablation” – new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation. EP Europace. 2005;7(1):1–13. https://doi.org/10.1016/J.EUPC.2004.10.003.
Pachon MJC, Pachon MEI, Cunha Pachon MZ, Lobo TJ, Pachon MJC, Santillana PTG. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. EP Europace. 2011;13(9):1231–42. https://doi.org/10.1093/EUROPACE/EUR163.
Pachon MJC, Pachon MEI, Santillana PTG, et al. Simplified method for vagal effect evaluation in cardiac ablation and electrophysiological procedures. JACC: Clinical Electrophysiology. 2015;1(5):451–60. https://doi.org/10.1016/J.JACEP.2015.06.008.
Aksu T, Gopinathannair R, Bozyel S, Yalin K, Gupta D. Cardioneuroablation for treatment of atrioventricular block. Circ Arrhythm Electrophysiol. 2021;14(9):e010018. https://doi.org/10.1161/CIRCEP.121.010018.
Aksu T, Padmanabhan D, Shenthar J, Yalin K, Gautam S, Valappil SP, Banavalikar B, Guler TE, Bozyel S, Tanboga IH, Lakkireddy D, Olshansky RB, Gopinathannair R. The benefit of cardioneuroablation to reduce syncope recurrence in vasovagal syncope patients: a case-control study. J Interv Card Electrophysiol. 2022;63(1):77–86. https://doi.org/10.1007/s10840-020-00938-0.
Piotrowski R, Baran J, Sikorska A, Krynski T, Kulakowski P. Cardioneuroablation for reflex syncope: efficacy and effects on autonomic cardiac regulation-a prospective randomized trial. JACC Clin Electrophysiol. 2023;9(1):85–95. https://doi.org/10.1016/j.jacep.2022.08.011.
Vandenberk B, Lei LY, Ballantyne B, Vickers D, Liang Z, Sheldon RS, Chew DS, Aksu T, Raj SR, Morillo CA. Cardioneuroablation for vasovagal syncope: a systematic review and meta-analysis. Heart Rhythm. 2022;19(11):1804–12. https://doi.org/10.1016/j.hrthm.2022.06.017.
Gopinathannair R, Olshansky B, Turagam MK, Gautam S, Futyma P, Akella K, Tanboga HI, Bozyel S, Yalin K, Padmanabhan D, Shenthar J, Lakkireddy D, Aksu T. Permanent pacing versus cardioneuroablation for cardioinhibitory vasovagal syncope. J Interv Card Electrophysiol. 2022. https://doi.org/10.1007/s10840-022-01456-x.
Sun W, Zheng L, Qiao Y, et al. Catheter ablation as a treatment for vasovagal syncope: long-term outcome of endocardial autonomic modification of the left atrium. J Am Heart Assoc. 2016;5(7). https://doi.org/10.1161/JAHA.116.003471.
Aksu T, De Potter T, John L, Osorio J, Singh D, Alyesh D, Baysal E, Kumar K, Mikaeili J, Dal Forno A, Yalin K, Akdemir B, Woods CE, Salcedo J, Eftekharzadeh M, Akgun T, Sundaram S, Aras D, Tzou WS, Gopinathannair R, Winterfield J, Gupta D, Davila A. Procedural and short-term results of electroanatomic-mapping-guided ganglionated plexus ablation by first-time operators: a multicenter study. J Cardiovasc Electrophysiol. 2022;33(1):117–22. https://doi.org/10.1111/jce.15278.
Pachon-M EI, Pachon-Mateos JC, Higuti C, Santillana-P TG, Lobo T, Pachon C, Pachon-Mateos J, Zerpa J, Ortencio F, Amarante RC, Silva RF, Osório TG. Relation of fractionated atrial potentials with the vagal innervation evaluated by extracardiac vagal stimulation during cardioneuroablation. Circ Arrhythm Electrophysiol. 2020;13(4):e007900. https://doi.org/10.1161/CIRCEP.119.007900.
Aksu T, Yalin K, Mutluer FO, Farhat K, Tanboga HI, Po SS, Stavrakis S. The impact of the clinical diagnosis on the vagal response and heart rate after ganglionated plexus ablation. J Interv Card Electrophysiol. 2022. https://doi.org/10.1007/s10840-022-01270-5.
Esler MD, Krum H, Sobotka PA, et al. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. The Lancet. 2010;376(9756):1903–9. https://doi.org/10.1016/S0140-6736(10)62039-9.
Pappone C, Santinelli V, Manguso F, et al. Pulmonary vein denervation enhances long-term benefit after circumferential ablation for paroxysmal atrial fibrillation. Circulation. 2004;109(3):327–34. https://doi.org/10.1161/01.CIR.0000112641.16340.C7.
Lemola K, Chartier D, Yeh YH, et al. Pulmonary vein region ablation in experimental vagal atrial fibrillation : role of pulmonary veins versus autonomic ganglia. Circulation. 2008;117(4):470–7. https://doi.org/10.1161/CIRCULATIONAHA.107.737023.
Scanavacca M, Pisani CF, Hachul D, et al. Selective atrial vagal denervation guided by evoked vagal reflex to treat patients with paroxysmal atrial fibrillation. Circulation. 2006;114(9):876–85. https://doi.org/10.1161/CIRCULATIONAHA.106.633560.
Krum H. Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension. 2011;57(5):911–7. https://doi.org/10.1161/HYPERTENSIONAHA.110.163014.
Bhatt DL, Kandzari DE, O’Neill WW, et al. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014;370(15):1393–401. https://doi.org/10.1056/NEJMOA1402670/SUPPL_FILE/NEJMOA1402670_DISCLOSURES.PDF.
Weber MA, Kirtane AJ, Weir MR, et al. The Reduce HTN: Reinforce: randomized, sham-controlled trial of bipolar radiofrequency renal denervation for the treatment of hypertension. JACC Cardiovasc Interv. 2020;13(4):461–70. https://doi.org/10.1016/J.JCIN.2019.10.061.
Sun W, Zheng L, Qiao Y, et al. Catheter ablation as a treatment for vasovagal syncope: long-term outcome of endocardial autonomic modification of the left atrium. J Am Heart Assoc. 2016;5(7). https://doi.org/10.1161/JAHA.116.003471
Scanavacca MI, Hachul D. Ganglionated plexi ablation to treat patients with refractory neurally mediated syncope and severe vagal-induced bradycardia. Arq Bras Cardiol. 2019;112(6):709–12. https://doi.org/10.5935/ABC.20190107.
Author information
Authors and Affiliations
Corresponding author
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary Information
Below is the link to the electronic supplementary material.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Aksu, T., Tung, R., De Potter, T. et al. Cardioneuroablation for the management of patients with recurrent vasovagal syncope and symptomatic bradyarrhythmias: the CNA-FWRD Registry. J Interv Card Electrophysiol (2024). https://doi.org/10.1007/s10840-024-01789-9
Received:
Accepted:
Published:
DOI: https://doi.org/10.1007/s10840-024-01789-9