Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence ranging from 5% over 60 years old to 17% after 85 years old. Besides hemodynamical compromises and occurrence of heart failure, stroke remains the most feared complication related to AF with a risk increased by 5-fold. Catheter ablation with the aim of pulmonary veins isolation (PVI) has evolved as a standardized treatment option in paroxysmal AF (PAF), supported by the current guidelines. However, due to advanced electrical and structural remodeling, catheter ablation for persistent AF is rather disappointing with a limited success rate, at least after a single procedure. Due to these shortcomings, minimally invasive thoracoscopic surgical techniques have gained attention with good results in persistent AF patients. Comparison between thoracoscopic surgical ablation and catheter ablation have shown that surgical ablation was associated with higher success rates, less redo procedures but also with higher complication rates. The main issue with surgical ablation is the difficulty to check the ablation lines and pulmonary vein isolation, which are the cornerstones for achieving good long-term results. Hybrid therapy, combining both epicardial surgical and endocardial catheter ablation is expected to be the most effective technique. It would avoid incomplete lesions or incomplete pulmonary vein isolation, and would provide complete lesion set. Hybrid therapy of AF has been compared with mini-invasive surgical ablation of AF, showing a significant higher rate of sinus rhythm achievement in the hybrid therapy group. However, no comparative clinical trials data are currently available in the setting of persistent AF comparing hybrid ablation and conventional catheter ablation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
In the hybrid ablation arm, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure (same operative time). During the endocardial approach, the isolation of the pulmonary veins and the posterior box will be checked and completed if necessary. Then additional ablation will be performed for atrial tachycardia or ongoing persisting atrial fibrillation (AF) according the same lesions setup or stepwise protocol than the conventional arm
In the percutaneous catheter ablation arm, the procedure will be performed according to the current guidelines (pulmonary vein isolation, linear ablation and fragmented potentials ablation if needed, with the achievement of sinus rhythm during the procedure being the optimal endpoint. Any atrial tachycardia will be mapped and ablated as well (DC shock performed otherwise).
Cardiology-rytmology
Paris, France
CHU Toulouse, Hôpital Rangueil
Toulouse, France
Cardiology-rytmology service
Toulouse, France
Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence
occurrence of at least one episode of AF/AT \> 30 seconds in any ECG or Holter tracing (absence or presence)
Time frame: 12 months
AF/AT recurrence or major complication
Percentage of patients developing a recurrence of AF/AT or a major complication (related to the procedure or related to AF/AT)
Time frame: 12 months
Major complication related to the procedure
Percentage of patients developing a major complication related to the procedure
Time frame: 12 months
Major complication related to AF/AT
Percentage of patients developing a major complication related to AF/AT
Time frame: 12 months
Any complication (major or minor)
Percentage of patients developing any complication (major or minor) related to the procedure or related to AF/AT
Time frame: 12 months
Redo-procedure
Percentage of patients requiring a redo-procedure (new ablation in left atrium)
Time frame: 12 months
Cardioversion
Percentage of patients requiring a cardioversion
Time frame: 12 months
Number of hospitalizations
Number of hospitalizations for AF/AT recurrence or complications related to AF/AT or to the procedure
Time frame: 12 months
Duration of the hospitalization
Mean duration of the hospitalization for AF ablation
Time frame: 1 month
Radiation exposure time
Radiation exposure time (expressed in minutes) per patient. In case of redo-ablation during the follow-up, the total exposure time of the two first and the redo procedure will be totalized.
Time frame: 12 months
Radiation exposure dosage
Radiation exposure dosage per patient. In case of redo-ablation during the follow-up, the total exposure dosage of the two first and the redo procedure will be totalized.
Time frame: 12 months
Antiarrhythmic drugs
Percentage of patients requiring class I (flecainide ou propafenone) or III (sotalol ou amiodarone) antiarrhythmic drugs
Time frame: 12 months
Electrophysiological success
Percentage of patients considered as reaching electrophysiological success, i.e. isolation of pulmonary veins and posterior box after epicardial surgical ablation. The validation will be performed during catheter ablation: isolation will be validated if there an entrance block in the posterior wall and in the pulmonary veins.
Time frame: Day 0
Evolution of quality of life
Evolution of quality of life using the Canadian Cardiovascular Society Severity in Atrial Fibrillation (CCS-SAF) scale. Symptom severity, physical and emotional components of quality of life, general well-being, and health care consumption related to AF are evaluated by this scale. The scale ranges from 0 to 4, corresponding to 0=no effect on functional quality of life to 4=a severe effect on life quality.
Time frame: Between baseline to 12 months
ICER
The incremental cost-effectiveness ratio (ICER) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
Time frame: 12 months
ICUR
The incremental Cost-Utility Ratio (ICUR) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
Time frame: 12 months
Production costs
Production costs of the two strategies using the micro-costing approach
Time frame: during the surgical procedure
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