Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation

University Hospital Ostrava

Status: Completed

Conditions: Mitral Valve Disease; Coronary Artery Disease; Atrial Fibrillation; Aortic Valve Disease; Tricuspid Valve Disease

Treatments: Procedure: Concomitant Mapping and Radiofrequency Ablation; Procedure: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03239262

FNO-Cardiosurgery-1

Details and patient eligibility

About

The aim of our study was to investigate, whether enhancement of left atrial cryoablation by ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of surgical treatment of atrial fibrillation in patients with structural heart disease undergoing open-heart surgery.

Full description

The observed patient file consisted of 100 patients, who have undergone a combined open-heart surgery at our department between July 2012 and December 2014. The patients were indicated for the surgical procedure due to structural heart disease, and suffered from paroxysmal, persistent, or long-standing persistent atrial fibrillation. In all cases, left atrial cryoablation was performed in the extent of isolation of pulmonary veins, box lesion, connecting lesion with mitral annulus, amputation of the left atrial appendage and connecting lesion of the appendage base with left pulmonary veins. Furthermore, thirty-five of the patients underwent mapping and radiofrequency ablation of ganglionated plexi, together with decision and ablation of the ligament of Marshall.

Enrollment: 100 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for open-heart surgery (mitral valve disease and/or tricuspidal valve disease and/or aortic valve disease and/or coronary artery disease and/or other)
• Concomitant paroxysmal, persistent, long standing persistent atrial fibrillation
• Signing of the informed consent

Exclusion criteria

• Age below 40 and over 80 years of age
• Left ventricular ejection fraction below 25%
• Left atrium diameter over 60mm
• Permanent atrial fibrillation
• Polymorbidity (Euroscore II over 10)
• Emergency surgery
• Renal insufficiency (creatinine over 200 umol/l)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group GP

Experimental group

Description:

Thirty-five patients (35%) from our population underwent concomitant mapping and radiofrequency ablation of ganglionated plexi (Group GP).

Treatment:

Procedure: Concomitant Mapping and Radiofrequency Ablation

Group LA

Experimental group

Description:

Sixty five patients (65%) in whom no intervention related to ganglionated plexi was performed (Group LA).

Treatment:

Procedure: No intervention