Long-term Results of Bilateral Thoracoscopic Ablation for Stand-alone Atrial Fibrillation

Atrial fibrillation (AFib) represents the most frequent cardiac arrhythmia whose prevalence appears to be increasing in the general population. Furthermore, this arrhythmia determines an increased risk of neurological complications (stroke) and, consequently, of mortality and morbidity.

Currently, the first choice for the treatment of AFib is represented by the use of antiarrhythmic drugs. In patients who do not respond to pharmacological treatment, the ESC 2016 European guidelines recommend the execution of transcatheter ablation (Class I, level of evidence A). However, minimally invasive pulmonary vein isolation surgery (PVI) is recommended for subjects who are not even responsive to transcatheter ablation (Class IIa, Level of Evidence B).

Previous studies have demonstrated good short-term results of thoracoscopic AFib ablation using PVI, with a 1-year freedom from atrial fibrillation recurrence without antiarrhythmic drugs of approximately 64-73%. However, only a few authors have described the medium-long term follow-up outcomes.

The aim of this study is to report the long-term follow-up data of ablation of isolated, predominantly paroxysmal atrial fibrillation performed by isolation of the pulmonary veins by radiofrequency in bilateral thoracoscopy.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Pulmonary veins isoltation in bilateral thoracoscopy

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • Irccs Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent isolated ablation of paroxysmal or persistent AFib with pulmonary veins isolation in bilateral thoracoscopy

Description

Inclusion Criteria:

• Age between 20 and 80 years old;
• Isolated atrial fibrillation (predominantly paroxysmal);
• Patients undergoing ablation of atrial fibrillation (both paroxysmal and persistent) by isolation of the pulmonary veins by radiofrequency in thoracoscopy.

Exclusion Criteria:

• Age under 20 or over 80;
• Previous trauma/deformity of the rib cage limiting the thoracoscopic approach;
• Previous pleurisy or thoracic operations (e.g. lobectomies) conditioning the possible appearance of pleural adhesions limiting the thoracoscopic approach.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	through study completion, a minimum of 6 years
Freedom from AFib	through study completion, a minimum of 6 years

Collaborators and Investigators

• Sponsor: Michele De Bonis

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LTFUP-AFPVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No