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

Tolga Aksu¹, Roderick Tung², Tom De Potter³, Timothy M Markman⁴, Pasquale Santangeli⁵, Jeanne du Fay de Lavallaz⁶, Jeffrey R Winterfield⁷, Tina Baykaner⁸, Daniel Alyesh⁹, Jacqueline E Joza¹⁰, Rakesh Gopinathannair¹¹, Patrick Badertscher⁶, Duc H Do¹², Ayman Hussein⁵, Jose Osorio^{13

14}, Thomas Dewland¹⁵, Alexander Perino⁸, Albert J Rodgers⁸, Christopher DeSimone¹⁶, Alberto Alfie¹⁷, Brett D Atwater¹⁸, David Singh¹⁹, Kapil Kumar²⁰, Jonathan Salcedo²¹, Jason S Bradfield¹², Gaurav Upadhyay²², Nitesh Sood²³, Parikshit S Sharma²⁴, Sandeep Gautam²⁵, Vineet Kumar¹⁸, Alexander Romeno Janner Dal Forno²⁶, Christopher E Woods²⁷, Moshe Rav-Acha²⁸, Chiara Valeriano³, Sunil Kapur²⁹, Andres Enriquez⁴, Sri Sundaram⁹, Michael Glikson²⁸, Edward Gerstenfeld¹⁵, Jonathan Piccini³⁰, Wendy S Tzou³¹, William Sauer²⁹, Andre d'Avila²⁰, Kalyanam Shivkumar¹², Henry D Huang³²

Affiliations

¹ Department of Cardiology, Yeditepe University Hospital, 34100, Istanbul, Turkey.
² The University of Arizona College of Medicine, Banner-University Medical Center, 755 E McDowell Road, Phoenix, AZ, 85006, USA.
³ Department of Cardiology, OLV Hospital, Aalst, Belgium.
⁴ Division of Cardiology, University of Pennsylvania, Hospital of the University of Pennsylvania, Philadelphia, USA.
⁵ Section of Cardiac Pacing and Electrophysiology, Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
⁶ Department of Cardiology, University Hospital Basel, Basel, Switzerland.
⁷ Division of Cardiology, Medical University of South Carolina, Charleston, SC, USA.
⁸ Department of Medicine, Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA.
⁹ South Denver Cardiology Associates, 1000 SouthPark Drive, Littleton, CO, 80120, USA.
¹⁰ McGill University, Montreal, QC, Canada.
¹¹ Kansas City Heart Rhythm Institute, Overland Park, KS, USA.
¹² University of California Los Angeles (UCLA) Cardiac Arrhythmia Center, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.
¹³ Arrhythmia Institute at Grandview, Birmingham, AL, USA.
¹⁴ Heart Rhythm Clinical Research Solutions, Birmingham, AL, USA.
¹⁵ Electrophysiology Section, Division of Cardiology, Department of Internal Medicine, University of California, San Francisco, San Francisco, CA, USA.
¹⁶ Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
¹⁷ Electrophysiology Section, Cardiology Division, Hospital Nacional Profesor Alejandro Posadas, Av. Illia y Marconi S/N 1684, El Palomar, Moron, Province of Buenos Aires, Argentina.
¹⁸ Inova Heart and Vascular Institute, Falls Church, VA, USA.
¹⁹ The Queens Medical Center, Honolulu, HI, USA.
²⁰ Harvard Medical School, Boston, MA, USA.
²¹ Palo Alto Medical Foundation-Sutter Health, Palo Alto, CA, USA.
²² Center for Arrhythmia Care, Section of Cardiology, Pritzker School of Medicine, The University of Chicago Medicine, 5841 S. Maryland Avenue, MC 9024, Chicago, IL, 60637, USA.
²³ Arrhythmia Services, Southcoast Health, Fall River, MA, USA.
²⁴ Department of Cardiology, Rush University Medical Center, Chicago, IL, USA.
²⁵ Department of Cardiac Electrophysiology, University of Missouri-Columbia, Columbia, MO, USA.
²⁶ Serviço de Arritmia e Marcapasso - Hospital SOS Cardio - Florianópolis, Florianópolis, SC, Brazil.
²⁷ Department of Cardiology, California Pacific Medical Center, San Francisco, CA, USA.
²⁸ Jesselson Integrated Heart Center, Shaare Zedek Hospital, 9112102, Jerusalem, Israel.
²⁹ Cardiac Arrhythmia Service, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
³⁰ Duke Clinical Research Institute, Duke University Hospital, Durham, USA.
³¹ Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
³² Department of Cardiology, Rush University Medical Center, Chicago, IL, USA. Henry_d_huang@rush.edu.

PMID: 38499825
PMCID: PMC12064083
DOI: 10.1007/s10840-024-01789-9

Observational Study

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

Tolga Aksu et al. J Interv Card Electrophysiol. 2025 Mar.

. 2025 Mar;68(2):183-191.

doi: 10.1007/s10840-024-01789-9. Epub 2024 Mar 18.

Authors

Affiliations

¹ Department of Cardiology, Yeditepe University Hospital, 34100, Istanbul, Turkey.
² The University of Arizona College of Medicine, Banner-University Medical Center, 755 E McDowell Road, Phoenix, AZ, 85006, USA.
³ Department of Cardiology, OLV Hospital, Aalst, Belgium.
⁴ Division of Cardiology, University of Pennsylvania, Hospital of the University of Pennsylvania, Philadelphia, USA.
⁵ Section of Cardiac Pacing and Electrophysiology, Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
⁶ Department of Cardiology, University Hospital Basel, Basel, Switzerland.
⁷ Division of Cardiology, Medical University of South Carolina, Charleston, SC, USA.
⁸ Department of Medicine, Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA.
⁹ South Denver Cardiology Associates, 1000 SouthPark Drive, Littleton, CO, 80120, USA.
¹⁰ McGill University, Montreal, QC, Canada.
¹¹ Kansas City Heart Rhythm Institute, Overland Park, KS, USA.
¹² University of California Los Angeles (UCLA) Cardiac Arrhythmia Center, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.
¹³ Arrhythmia Institute at Grandview, Birmingham, AL, USA.
¹⁴ Heart Rhythm Clinical Research Solutions, Birmingham, AL, USA.
¹⁵ Electrophysiology Section, Division of Cardiology, Department of Internal Medicine, University of California, San Francisco, San Francisco, CA, USA.
¹⁶ Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
¹⁷ Electrophysiology Section, Cardiology Division, Hospital Nacional Profesor Alejandro Posadas, Av. Illia y Marconi S/N 1684, El Palomar, Moron, Province of Buenos Aires, Argentina.
¹⁸ Inova Heart and Vascular Institute, Falls Church, VA, USA.
¹⁹ The Queens Medical Center, Honolulu, HI, USA.
²⁰ Harvard Medical School, Boston, MA, USA.
²¹ Palo Alto Medical Foundation-Sutter Health, Palo Alto, CA, USA.
²² Center for Arrhythmia Care, Section of Cardiology, Pritzker School of Medicine, The University of Chicago Medicine, 5841 S. Maryland Avenue, MC 9024, Chicago, IL, 60637, USA.
²³ Arrhythmia Services, Southcoast Health, Fall River, MA, USA.
²⁴ Department of Cardiology, Rush University Medical Center, Chicago, IL, USA.
²⁵ Department of Cardiac Electrophysiology, University of Missouri-Columbia, Columbia, MO, USA.
²⁶ Serviço de Arritmia e Marcapasso - Hospital SOS Cardio - Florianópolis, Florianópolis, SC, Brazil.
²⁷ Department of Cardiology, California Pacific Medical Center, San Francisco, CA, USA.
²⁸ Jesselson Integrated Heart Center, Shaare Zedek Hospital, 9112102, Jerusalem, Israel.
²⁹ Cardiac Arrhythmia Service, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
³⁰ Duke Clinical Research Institute, Duke University Hospital, Durham, USA.
³¹ Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
³² Department of Cardiology, Rush University Medical Center, Chicago, IL, USA. Henry_d_huang@rush.edu.

PMID: 38499825
PMCID: PMC12064083
DOI: 10.1007/s10840-024-01789-9

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.

Keywords: AV block; Cardioneuroablation; Ganglionated plexi; Syncope; Vasovagal syncope.

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Figures

**Fig. 1**
Cross-over study design for control and procedure group assignments. Patient 1 does not undergo an ablation and stays in the control group. Patients 2 and 3 undergo successful ablation and switch to the procedure group during the study

**Fig. 2**
Probable location of ganglionic plexi in the left and right atria tagged on 3D mapping system

See this image and copyright information in PMC

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. 10.1093/EURHEARTJ/EHY037. - DOI - PubMed
1. Lpidoforos E, Oteriades SS, Ane J, et al. Incidence and prognosis of syncope. 2009;347(12):878–885. 10.1056/NEJMOA012407. - DOI - PubMed
1. 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). 10.1161/CIR.0000000000000548. - DOI - PubMed
1. Sutton R Should we treat severe vasovagal syncope with a pacemaker? J Intern Med. 2017;281(6):554–61. 10.1111/JOIM.12603. - DOI - PubMed
1. 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. 10.1016/J.HRTHM.2020.01.029. - DOI - PMC - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Miscellaneous