What is the clinical evidence from this study?

Study design: Cohort. Population: Refractory dominant cardioinhibitory vasovagal syncope (n=80). Intervention: Cardioneuroablation with extracardiac vagal stimulation (CNA-ECVS) vs. Dual-chamber pacemaker with closed-loop stimulation (CLS-PM). Primary outcome: Syncope-free survival (recurrence of the first syncope episode) (HR 0.45, 95% CI 0.14-1.46, p=0.182).

April 22, 2026Open Access

Cardioneuroablation versus cardiac pacemaker in the management of dominant cardioinhibitory vasovagal syncope: a retrospective cohort study

Key Result

Cardioneuroablation demonstrated comparable syncope-free survival to closed-loop stimulation pacemaker therapy (89.2% vs 79.1%, HR 0.45) in patients over 40 years old with refractory cardioinhibitory vasovagal syncope.

Key Points

This research examines the effectiveness and safety of cardioneuroablation versus cardiac pacemaker in treating refractory vasovagal syncope in older patients.
Conducted a retrospective cohort study from 2018 to 2024 on patients over 40 with refractory cardioinhibitory vasovagal syncope.
Patients were treated with either cardioneuroablation with extracardiac vagal stimulation validation or dual-chamber cardiac pacemaker implantation.
Analyses included Kaplan-Meier survival analysis and Cox proportional hazards models to evaluate syncope recurrence and safety.
During an average follow-up of 3.8 years, 89.2% of patients in the CNA group were syncope-free compared to 79.1% in the CLS-PM group, though statistically not significant (p = 0.363).
Both treatment strategies demonstrated similar recurrence risks and safety profiles, with no major adverse events reported in either group.
Patients in the CNA group had a numerically lower syncope burden (10.8% vs. 20.9%) after treatment, but this difference was not statistically significant.

Study Design

Type

Cohort (n=80)

Multicenter

Structured PICO

Does cardioneuroablation with extracardiac vagal stimulation validation reduce syncope recurrence compared to dual-chamber pacemakers with closed-loop stimulation in patients > 40 years with refractory cardioinhibitory vasovagal syncope?

Population

80 adults > 40 years with refractory dominant cardioinhibitory vasovagal syncope (≥ 2 syncope episodes within the previous 12 months despite non-pharmacological and pharmacological therapy), mean age 58.0 ± 14.6 years, 36.2% male.

Intervention

Cardioneuroablation (CNA) with extracardiac vagal stimulation validation (CNA-ECVS) via endocardial radiofrequency ablation of cardiac ganglionated plexus.

Comparator

Transvenous dual-chamber pacemaker implantation programmed in DDD mode with a Closed-Loop Stimulation (CLS-PM) algorithm.

Outcome

Recurrence of the first syncope episode (syncope-free survival) assessed over the available clinical follow-up.hard clinical

Cardioneuroablation with physiological validation demonstrates comparable efficacy and safety to dual-chamber pacemakers with closed-loop stimulation for preventing syncope recurrence in patients older than 40 years with refractory cardioinhibitory vasovagal syncope.

Main Result

Effect estimate: HR 0.45 (95% CI 0.14-1.46)

Absolute Event Rate: 89.2% vs 79.1%

p-value: p=0.182

Limitations

Observational, retrospective, non-randomized design precluding causal inference
Baseline differences between groups (older age and higher proportion of men in the CLS-PM group)
Low total number of events and high proportion of censored observations reducing statistical power
Reliance on clinical records with potential underreporting
Lack of standardized quality of life and longitudinal autonomic marker assessments
Follow-up duration may be insufficient to fully assess long-term parasympathetic reinnervation

Abstract

Refractory dominant cardioinhibitory vasovagal syncope (VVS) remains a therapeutic challenge in patients older than 40 years. Dual-chamber pacemakers with closed-loop stimulation (CLS-PM) are guideline-supported, while cardioneuroablation (CNA), targeting ganglionated plexus, has emerged as a device-free alternative. Direct comparative data between these strategies are limited. We conducted a retrospective, comparative cohort study including patients > 40 years with refractory cardioinhibitory VVS treated between 2018 and 2024. Patients underwent either CNA with extracardiac vagal stimulation validation (CNA-ECVS) or CLS-PM implantation. The primary outcome was recurrence of the first syncope episode. Secondary outcomes included syncope-free survival, syncope burden (≥ 50% reduction), and safety. Kaplan–Meier analysis and Cox proportional hazards models were applied. Eighty patients were included (37 CNA-ECVS, 43 CLS-PM; mean age 58.0 ± 14.6 years). Patients in the CNA group were younger than those in the CLS-PM group (49.9 ± 10.3 vs. 65.0 ± 14.1 years; p < 0.001). During a mean follow-up of 3.8 years, syncope-free rates were 89.2% in the CNA group and 79.1% in the CLS-PM group (p = 0.363). Syncope-free survival did not differ significantly (log-rank p = 0.168), and recurrence risk was similar between strategies (HR 0.45; 95% CI 0.14–1.46; p = 0.182). Post-procedural syncope burden was numerically lower after CNA (10.8% vs. 20.9%) but without statistical significance. No major adverse events were observed in either group. In patients older than 40 years with refractory cardioinhibitory NCS, CNA with physiological validation and CLS-PM therapy demonstrated comparable efficacy and safety. Both strategies represent viable therapeutic options, warranting confirmation in randomized clinical trials.

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