Atrial Fibrillation (AF), Cardiac Surgery
Conditions
Keywords
Atrial firbrillation, Cardiac Surgery, PWI-Box, GeminiS
Brief summary
Atrial Fibrillation (AF) is the most common cardiac arrhythmia worldwide, affecting approximately 2.8% of the population, with prevalence increasing with age. AF is associated with significant morbidity and mortality, accounting for about 25% of ischemic strokes, 10% of cryptogenic strokes, and a 10-40% annual increase in hospital admissions due to heart failure or anticoagulant-related events. About 10% of patients undergoing cardiac surgery have preoperative AF. In 1986, Dr. Cox introduced the MAZE procedure, a surgical technique to isolate AF triggers. Initially involving atrial incisions, it evolved to use radiofrequency lines, significantly reducing morbidity and mortality. The MAZE procedure is now strongly recommended (Class Ia evidence) for concomitant cardiac surgery. However, nearly 85% of eligible patients-especially those undergoing closed-chest cardiac surgery-do not receive this treatment due to technical challenges and limited reproducibility of the Cox-Maze IV technique. Pulmonary Vein Isolation (PVI) with posterior wall isolation (PWI-Box) has emerged as an effective alternative, offering similar outcomes to Cox-Maze IV with fewer adverse effects. Innovative devices like the GeminiS (Medtronic) enable minimally invasive, thoracoscopic PVI-PWI-Box procedures without opening the heart, even off-pump. This approach could expand the use of AF ablation during combined sternotomy surgeries, aligning with clinical guidelines. Primary Objective: Assess the efficacy of PWI-Box using GeminiS combined with other cardiac surgeries via sternotomy. Primary Endpoint: Recurrence rate of paroxysmal or persistent AF (per ESC definition) at 1 year postoperatively, confirmed by 24-hour Holter monitoring.
Interventions
OTHERCollection of study data from patient records
Collection of study data from patient records in the EPICARD national database at the time of surgery, 1 month post-surgery, 12 months post-surgery, 24 months post-surgery and 36 months post-surgery.
Sponsors
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing cardiac surgery via sternotomy * Concomitant use of the PWI box with GeminiS during surgery * Adult patients * Patients with the following characteristics: Preoperative paroxysmal/persistent/permanent AF; Duration of less than 5 years; And left atrium volume \<60 ml/m2 * Informed patient who did not object to the collection of their data for the study
Exclusion criteria
* Unplanned surgery (emergency) * History of cardiac surgery (reoperation) * Pregnant or breastfeeding women * Adults under guardianship, curatorship or judicial protection * Patients with a life expectancy of less than three years * Patients currently taking medication or using an experimental device that clinically interferes with the study's evaluation criteria and results. * Inability to comply with the monitoring schedule. * Contraindication to long-term anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of the PWI box, using GeminiS in combination with other cardiac surgery procedures via sternotomy, at 1 year post-operatively using 24-hour Holter monitoring. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the efficacy of the PWI box using GeminiS in combination with other cardiac surgery procedures via sternotomy at 2 years postoperatively. | 24 months |
| Evaluation of the efficacy of the PWI box using GeminiS in combination with other cardiac surgery procedures via sternotomy at 3 years postoperatively. | 36 months |
| Evaluation of the rate of secondary endocardial ablation of AF. | 12 months |
| Evaluation of clinicals predictive factors for recurrence of AF after MAZE. | 36 months |
| Evaluate the rate of patients on anticoagulant and/or antiarrhythmic therapy after MAZE surgery. | 36 months |
| Assessment of complication rates associated with the technique used during cardiac surgery. | 36 months |
Countries
France
Contacts
CONTACTSponsor
STUDY_DIRECTORCharles-Henri DAVID
Nantes University Hospital
Outcome results
None listed