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Clinical controversy : methodology and indications of cardioneuroablation for reflex syncope

Brignole, Michele ; Aksu, Tolga ; Calò, Leonardo ; Debruyne, Philippe ; Deharo, Jean Claude ; Fanciulli, Alessandra ; Fedorowski, Artur LU orcid ; Kulakowski, Piotr ; Morillo, Carlos and Moya, Angel , et al. (2023) In Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology 25(5). p.1-10
Abstract
In 2005, Pachon et al.1 proposed cardiac vagal denervation to treat neurally mediated syncope. Since then, a metanalysis of observational studies2 and a recent randomized controlled trial (RCT)3 have provided some evidence that cardioneuroablation (CNA) is able to prevent syncope recurrence at least during the first 2 years following the procedure in patients affected by reflex syncope. In brief, the recent metanalysis2 of 14 studies including a total of 465 patients reported an average freedom of syncopal recurrence in 92% of patients (95% confidence interval 88–95%) during follow-up. The only available open RCT3 reported 8% recurrence of syncope in the 24 patients randomized to CNA and 54% recurrence rate in 24 untreated controls (P =... (More)
In 2005, Pachon et al.1 proposed cardiac vagal denervation to treat neurally mediated syncope. Since then, a metanalysis of observational studies2 and a recent randomized controlled trial (RCT)3 have provided some evidence that cardioneuroablation (CNA) is able to prevent syncope recurrence at least during the first 2 years following the procedure in patients affected by reflex syncope. In brief, the recent metanalysis2 of 14 studies including a total of 465 patients reported an average freedom of syncopal recurrence in 92% of patients (95% confidence interval 88–95%) during follow-up. The only available open RCT3 reported 8% recurrence of syncope in the 24 patients randomized to CNA and 54% recurrence rate in 24 untreated controls (P = 0.0004) during 2-year follow-up. In all studies, after the ablation procedure, the patients demonstrated heart rate increase together with reduction of heart rate variability (indicating impaired parasympathetic stimulation of the heart) persisting at least for 2 years. This provides proof-of-concept for the modification of the vagal ganglia activity in the heart.

Given these facts, it is likely that CNA will become increasingly popular among physicians caring for syncope patients in the years to come. Nevertheless, many issues concerning clinical indications, methodology, and long-term results remain unresolved. These issues constitute the background of this manuscript in which leaders in CNA and experts in syncope debated critical issues and aimed to find agreement and, if not possible, to highlight the controversies that could be addressed in future studies. The authors were initially requested to give their evidence-based opinion on several predefined motions. These were merged into a manuscript draft, which was subsequently critically revised by means of two rounds of comments. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
volume
25
issue
5
article number
euad033
pages
1 - 10
publisher
Oxford University Press
external identifiers
  • scopus:85160870300
  • pmid:37021351
ISSN
1532-2092
DOI
10.1093/europace/euad033
language
English
LU publication?
yes
id
8929148e-becc-43f2-8a2c-89f6e32d8a4e
date added to LUP
2023-04-07 18:26:01
date last changed
2024-06-15 01:48:33
@article{8929148e-becc-43f2-8a2c-89f6e32d8a4e,
  abstract     = {{In 2005, Pachon et al.1 proposed cardiac vagal denervation to treat neurally mediated syncope. Since then, a metanalysis of observational studies2 and a recent randomized controlled trial (RCT)3 have provided some evidence that cardioneuroablation (CNA) is able to prevent syncope recurrence at least during the first 2 years following the procedure in patients affected by reflex syncope. In brief, the recent metanalysis2 of 14 studies including a total of 465 patients reported an average freedom of syncopal recurrence in 92% of patients (95% confidence interval 88–95%) during follow-up. The only available open RCT3 reported 8% recurrence of syncope in the 24 patients randomized to CNA and 54% recurrence rate in 24 untreated controls (P = 0.0004) during 2-year follow-up. In all studies, after the ablation procedure, the patients demonstrated heart rate increase together with reduction of heart rate variability (indicating impaired parasympathetic stimulation of the heart) persisting at least for 2 years. This provides proof-of-concept for the modification of the vagal ganglia activity in the heart.<br/><br/>Given these facts, it is likely that CNA will become increasingly popular among physicians caring for syncope patients in the years to come. Nevertheless, many issues concerning clinical indications, methodology, and long-term results remain unresolved. These issues constitute the background of this manuscript in which leaders in CNA and experts in syncope debated critical issues and aimed to find agreement and, if not possible, to highlight the controversies that could be addressed in future studies. The authors were initially requested to give their evidence-based opinion on several predefined motions. These were merged into a manuscript draft, which was subsequently critically revised by means of two rounds of comments.}},
  author       = {{Brignole, Michele and Aksu, Tolga and Calò, Leonardo and Debruyne, Philippe and Deharo, Jean Claude and Fanciulli, Alessandra and Fedorowski, Artur and Kulakowski, Piotr and Morillo, Carlos and Moya, Angel and Olshansky, Brian and Piotrowski, Roman and Stec, Sebastian and Wichterle, Dan}},
  issn         = {{1532-2092}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{1--10}},
  publisher    = {{Oxford University Press}},
  series       = {{Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology}},
  title        = {{Clinical controversy : methodology and indications of cardioneuroablation for reflex syncope}},
  url          = {{http://dx.doi.org/10.1093/europace/euad033}},
  doi          = {{10.1093/europace/euad033}},
  volume       = {{25}},
  year         = {{2023}},
}