Hybrid ablation of atrial fibrillation: A unilateral left-sided thoracoscopic approach

BACKGROUND: Hybrid ablation (HA) of atrial fibrillation (AF) combines minimally invasive thoracoscopic epicardial ablation with transvenous endocardial electrophysiologic validation and touch-up of incomplete epicardial lesions if needed. While studies have reported on a bilateral thoracoscopic HA approach, data on a unilateral left-sided approach are scarce. AIM: To evaluate the efficacy and safety of a unilateral left-sided thoracoscopic approach. METHODS: Retrospective analysis of a prospectively gathered cohort of all consecutive patients undergoing a unilateral left-sided HA for AF between 2015 and 2018 in the Maastricht University Medical Centre. RESULTS: One-hundred nineteen patients were analyzed (mean age 64 ± 8, 28% female, mean body mass index 28 ± 4 kg/m2 , median CHA2 DS2 -VASc Score 2 [1-3], [longstanding]-persistent AF 71%, previous catheter ablation 44%). In all patients, a unilateral left-sided HA consisting of pulmonary vein (PV) isolation, posterior left atrial (LA) wall isolation, and LA appendage exclusion was attempted. Epicardial (n = 59) and/or endocardial validation (n = 81) was performed and endocardial touch-up was performed in 33 patients. Major peri-operative complications occurred in 5% of all patients. After 12 and 24 months, the probability of being free from supraventricular tachyarrhythmia recurrence was 80% [73-87] and 67% [58-76], respectively, when allowing antiarrhythmic drugs. CONCLUSION: Unilateral left-sided hybrid AF ablation is an efficacious and safe approach to treat patients with paroxysmal and (longstanding) persistent AF. Future studies should compare a unilateral with a bilateral approach to determine whether a left-sided approach is as efficacious as a bilateral approach and allows for less complications

Unilateral Left-sided Thoracoscopic Ablation of Atrial Fibrillation Concomitant to Minimally Invasive Bypass Grafting of the Left Anterior Descending Artery

OBJECTIVES: Thoracoscopic ablation for atrial fibrillation (AF) and minimally invasive direct coronary artery bypass (MIDCAB) with robot-assisted left internal mammary artery (LIMA) harvesting may represent a safe and effective alternative to more invasive surgical approaches via sternotomy. The aim of our study was to describe the feasibility, safety and efficacy of a unilateral left-sided thoracoscopic AF ablation and concomitant MIDCAB surgery. METHODS: Retrospective analysis of a prospectively gathered cohort was performed of all consecutive patients with AF and at least a critical left anterior descending artery (LAD) stenosis that underwent unilateral left-sided thoracoscopic AF ablation and concomitant off-pump MIDCAB surgery in the Maastricht University Medical Centre between 2017 and 2021. RESULTS: Twenty-three patients were included [age 69 years (standard deviation = 8), paroxysmal AF 61%, left atrial volume index 42 ml/m(2) (standard deviation = 11)]. Unilateral left-sided thoracoscopic isolation of the left (n = 23) and right (n = 22) pulmonary veins and box (n = 21) by radiofrequency ablation was succeeded by epicardial validation of exit- and entrance block (n = 22). All patients received robot-assisted LIMA harvesting and off-pump LIMA-LAD anastomosis through a left mini-thoracotomy. The perioperative complications consisted of one bleeding of the thoracotomy wound and one aborted myocardial infarction not requiring intervention. The mean duration of hospital stay was 6 days (standard deviation = 2). After discharge, cardiac hospital readmission occurred in 4 patients (AF n = 1; pleural- and pericardial effusion n = 2, myocardial infarction requiring the percutaneous intervention of the LIMA-LAD n = 1) within 1 year. After 12 months, 17/21 (81%) patients were in sinus rhythm when allowing anti-arrhythmic drugs. Finally, the left atrial ejection fraction improved postoperatively [26% (standard deviation = 11) to 38% (standard deviation = 7), P = 0.01]. CONCLUSIONS: In this initial feasibility and early safety study, unilateral left-sided thoracoscopic AF ablation and concomitant MIDCAB for LIMA-LAD grafting is a feasible, safe and efficacious for patients with AF and a critical LAD stenosis

COMPARE LAAO: Rationale and design of the randomized controlled trial "COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible

Background: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking. Study objectives: To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications. Study design: This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands. The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use

COMPARE LAAO: Rationale and design of the randomized controlled trial “COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy”

Background: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking. Study objectives: To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications. Study design: This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands. The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use