Permanent pacing versus cardioneuroablation for cardioinhibitory vasovagal syncope.

ABSTRACT

BACKGROUND: We compared the efficacy and safety of cardioneuroablation (CNA) vs. permanent pacing (PM) for recurrent cardioinhibitory vasovagal syncope (CI-VVS). METHODS: One hundred sixty-two patients (CNA = 61, PM = 101), age 36 + 11 years) with syncope frequency of 6.7 ± 3.9/year were included in this multicenter study. All patients with CNA were provided by a single center, while patients with PM were provided by 4 other centers. In the CNA arm, an electroanatomic mapping guided approach was used to detect and ablate ganglionated plexus sites. Dual chamber rate drop response (RDR) or close loop stimulation (CLS) transvenous and leadless pacemakers were implanted using standard technique. The primary endpoint was freedom from syncope. RESULTS: Of 101 patients in the PM group, 39 received dual-chamber pacemaker implants with the CLS algorithm, 38 received dual-chamber pacemakers with the RDR algorithm, and 24 received a leadless pacemaker. At 1-year follow-up, 97% and 89% in the CNA and PM group met the primary endpoint (adjusted HR = 0.27, 95% CI 0.06-1.24, p = 0.09). No significant differences in adverse events were noted between groups. There was no significant association between age (HR1.01, 95% CI 0.96-1.06, p = 0.655), sex (HR1.15, 95% CI 0.38-3.51, p = 0.809), and syncope frequency in the past year (HR1.10, 95% CI 0.97-1.25, p = 0.122) and the primary outcome in univariable analyses. CONCLUSIONS: After adjustment for patient characteristics, the medium-term syncope recurrence risk of CI-VVS patients who underwent CNA was similar to that of a population of patients undergoing pacemaker implantation with a similar safety profile.