Skip to main content
Log in

Cardioneuroablation for the management of patients with recurrent vasovagal syncope and symptomatic bradyarrhythmias: the CNA-FWRD Registry

  • CLINICAL TRIAL STUDY DESIGN
  • Published:
Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others

References 

  1. 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.

    Article  PubMed  Google Scholar 

  2. Lpidoforos E, Oteriades SS, Ane J, et al. Incidence and prognosis of syncope. 2009;347(12):878–885.https://doi.org/10.1056/NEJMOA012407.

  3. 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.

  4. 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.

    Article  CAS  PubMed  Google Scholar 

  5. 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.

    Article  PubMed  PubMed Central  Google Scholar 

  6. 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.

    Article  MathSciNet  Google Scholar 

  7. 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.

    Article  Google Scholar 

  8. 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.

    Article  PubMed  Google Scholar 

  9. 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.

    Article  CAS  PubMed  Google Scholar 

  10. 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.

    Article  PubMed  Google Scholar 

  11. 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.

    Article  PubMed  Google Scholar 

  12. 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.

    Article  PubMed  Google Scholar 

  13. 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.

    Article  PubMed  Google Scholar 

  14. 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.

  15. 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.

    Article  PubMed  Google Scholar 

  16. 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.

    Article  PubMed  Google Scholar 

  17. 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.

    Article  PubMed  PubMed Central  Google Scholar 

  18. 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.

    Article  Google Scholar 

  19. 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.

    Article  PubMed  Google Scholar 

  20. 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.

    Article  PubMed  Google Scholar 

  21. 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.

    Article  PubMed  Google Scholar 

  22. 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.

    Article  CAS  Google Scholar 

  23. 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.

    Article  CAS  PubMed  Google Scholar 

  24. 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.

    Article  PubMed  Google Scholar 

  25. 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

  26. 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.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Henry D. Huang.

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.

Supplementary file1 (DOCX 36 KB)

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.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

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

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s10840-024-01789-9

Keywords

Navigation