Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation

Pomeranian Medical University Szczecin

Status: Completed

Conditions: Vagal Nerve Stimulation; Autonomic Nervous System; Catheter Ablation

Treatments: Procedure: cryoballoon-based pulmonary veins isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT04896424

KB-0012/91/10/15

Details and patient eligibility

About

The investigators sought to evaluate the incidence and influence of vagal response observed during cryoballoon-based pulmonary vein isolation on the cardiac autonomic nervous system (CANS) and ablation outcomes in paroxysmal atrial fibrillation cohort. 296 patients were treated with a 28-mm second-generation cryoballoon (Arctic Front Advance, Medtronic). Preprocedural pulmonary veins anatomy and their ostial dimensions were acquired with a computed tomography. 74 patients without structural heart disease and with no concomitant diseases were chosen for a detailed CANS assessment with heart rate variability analysis. All patients were screened over a 2-year post-ablation period.

Full description

An interplay between left atrial (LA) ganglionated plexi (GP), a part of the intrinsic cardiac autonomic nervous system (CANS), and pulmonary veins (PVs) is considered to be an important mechanism related with the initiation and maintenance of atrial fibrillation (AF). Therefore additional GP ablation has been reported with better ablation outcomes when added to RF-based PV isolation (PVI). A cryoballoon ablation (CBA) is an anatomically based approach which allows PVI that is highly safe and efficacious. The extension of the scar created by the cryoballoon frequently extends beyond the PV orifice in the acute and chronic post-ablation phase creating a set of lesions that are near the LA-GP area and inadvertent damage. A marked vagal response (VR) observed during CBA is considered a marker for the CANS modification. However, changes in the autonomic tone were independently noted from the presence of VR in several studies. Moreover, it is not clear if these changes are transient or long-lasting, and it has been shown that the presence of VR increases ablation success although with conflicting results. In previous studies assessing the influence of CBA on the autonomic balance, CANS modulation was appraised with different surrogates, a small number of individuals were usually recruited and both paroxysmal and persistent AF populations were included. Therefore, the investigators sought to evaluate the incidence of VR observed during CBA-based PVI, its impact on CANS assessed with widely accepted heart rate variability (HRV) analysis, and in relation to ablation outcomes in a large paroxysmal AF (PAF) cohort.

Enrollment: 296 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of paroxysmal atrial fibrillation

Exclusion criteria

• Previous atrial fibrillation ablation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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296 participants in 1 patient group

Cryoballoon-based pulmonary veins isolation cohort

Other group

Description:

Patients treated with a 28-mm second-generation cryoballoon (Arctic Front Advance, Medtronic) for paroxysmal atrial fibrillation and screened over a 2-year post-ablation period.

Treatment:

Procedure: cryoballoon-based pulmonary veins isolation