AIMS: Stand-alone minimal invasive epicardial and hybrid atrial fibrillation ablation (EHAFA) has evolved to a recognized treatment option in challenging patients. The EHAFA registry was initiated to describe the applied diagnostic and therapeutic approaches used in routine practice for these procedures, as well as the outcomes in terms of rhythm, symptoms, and complications. METHODS AND RESULTS: Between January 2016 and March 2018, patients who underwent an EHAFA procedure for all types of atrial fibrillation (AF) were consecutively enrolled in the international, prospective, observational EHAFA registry. Follow-up occurred after 1 year. A total of 468 patients were enrolled from 17 centres in 10 countries. Stand-alone ablation (n = 464) was performed epicardially in 47% (n = 220) or as epi-/endocardial hybrid in 53% (n = 244). The predominate type of AF was non-paroxysmal in 74% (n = 342), and 36% (n = 166) of patients had failed previous catheter ablation. The main lesion sets applied consisted of pulmonary vein isolation (99%, n = 460) and isolation of the left atrial (LA) posterior wall (82%, n = 383). In 82% (n = 382), the LA appendage was managed. The overall in-hospital major complication rate was 8.2% (n = 38/464). Freedom from atrial arrhythmias > 30 s with and without antiarrhythmic drug usage was 79% and 64% (n = 279/353, n = 223/351, respectively). The EHRA score at follow-up was clearly reduced compared to preoperatively (EHRA I: 72%, n = 233/325, vs. 3%, n = 14/464). CONCLUSION: This international registry revealed good rhythm control efficacy for epicardial and hybrid AF ablation in patients with advanced AF, leading to improvement in AF-related symptoms. However, a certain associated complication rate needs to be considered.
- Klíčová slova
- Atrial fibrillation, Epicardial ablation, Hybrid ablation, Registry, Surgical ablation,
- MeSH
- časové faktory MeSH
- fibrilace síní * chirurgie patofyziologie diagnóza MeSH
- katetrizační ablace * metody škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- perikard * chirurgie MeSH
- prospektivní studie MeSH
- recidiva MeSH
- registrace MeSH
- senioři MeSH
- venae pulmonales * chirurgie patofyziologie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- Geografické názvy
- Evropa MeSH
OBJECTIVES: The CEASE-AF trial demonstrated that epicardial-endocardial hybrid ablation (HA) had superior effectiveness compared to endocardial catheter ablation (CA) for non-paroxysmal atrial fibrillation (AF), without significantly increasing major complications during a 12-month period. Most contemporary AF ablation trials have not evaluated durability beyond 12 months. Therefore, 24-month effectiveness and safety of HA and CA are compared. METHODS: CEASE-AF is a prospective, multicentre, randomized trial. Patients 18-75 years of age with symptomatic, drug refractory persistent AF and left atrial diameter >4.0 cm or long-standing persistent AF were randomized 2:1 to HA (posterior wall and pulmonary vein isolation with left atrial appendage exclusion) or CA (pulmonary vein isolation). Secondary effectiveness was freedom from AF/atrial flutter/atrial tachycardia off class I/III anti-arrhythmic drugs except for those who previously failed at doses not exceeding those previously failed through a 24-month follow-up period. Major complications and reinterventions were evaluated. RESULTS: The intention-to-treat population was 102 patients with HA and 52 patients with CA. Seventy-five percent were male, 80.5% had persistent AF and 19.5% had long-standing persistent AF, with a mean age of 60.7 ± 7.9 years. Effectiveness for 24 months was 66.3% (63/95) with HA and 33.3% (17/51) with CA [absolute difference 33.0% (95% confidence interval 14.3%, 48.3%; P < 0.001)]. Major complication rates were 10.8% (11/102) with HA and 9.6% (5/52) with CA (P = 1.0), and fewer patients had reinterventions after HA than CA [18.9% (18/95) vs 52.9% (27/51), P < 0.001]. CONCLUSIONS: CEASE-AF demonstrated that the 32.4% absolute benefit of HA over CA for 12 months was durable for 24 months at 33% with continued similar safety rates and fewer reinterventions after HA (funded by AtriCure, Inc.; NCT02695277). CLINICALTRIALS.GOV REGISTRATION: NCT02695277.
- Klíčová slova
- Atrial fibrillation, Catheter ablation, Hybrid ablation, Left atrial appendage, Surgical ablation,
- MeSH
- dospělí MeSH
- endokard chirurgie MeSH
- fibrilace síní * chirurgie MeSH
- katetrizační ablace * metody škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- prospektivní studie MeSH
- senioři MeSH
- venae pulmonales chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
AIMS: Data on the hybrid atrial fibrillation (AF) treatment are lacking in patients with structural heart disease undergoing concomitant CryoMaze procedures. The aim was to assess whether the timely pre-emptive catheter ablation would achieve higher freedom from AF or atrial tachycardia (AT) and be associated with better clinical outcomes than surgical ablation alone. METHODS AND RESULTS: The trial investigated patients with non-paroxysmal AF undergoing coronary artery bypass grafting and/or valve repair/replacement with mandatory concomitant CryoMaze procedure who were randomly assigned to undergo either radiofrequency catheter ablation [Hybrid Group (HG)] or no further treatment (Surgery Group). The primary efficacy endpoint was the first recurrence of AF/AT without class I or III antiarrhythmic drugs as assessed by implantable cardiac monitors. The primary clinical endpoint was a composite of hospitalization for arrhythmia recurrence, worsening of heart failure, cardioembolic event, or major bleeding. We analysed 113 and 116 patients in the Hybrid and Surgery Groups, respectively, with a median follow-up of 715 (IQR: 528-1072) days. The primary efficacy endpoint was significantly reduced in the HG [41.1% vs. 67.4%, hazard ratio (HR) = 0.38, 95% confidence interval (CI): 0.26-0.57, P < 0.001] as well as the primary clinical endpoint (19.9% vs. 40.1%, HR = 0.51, 95% CI: 0.29-0.86, P = 0.012). The trial groups did not differ in all-cause mortality (10.6% vs. 8.6%, HR = 1.17, 95%CI: 0.51-2.71, P = 0.71). The major complications of catheter ablation were infrequent (1.9%). CONCLUSION: Pre-emptively performed catheter ablation after the CryoMaze procedure was safe and associated with higher freedom from AF/AT and improved clinical outcomes.
- Klíčová slova
- Atrial fibrillation, Catheter ablation, Concomitant atrial fibrillation ablation, Hybrid ablation, Maze procedure,
- MeSH
- antiarytmika terapeutické užití MeSH
- fibrilace síní * diagnóza chirurgie farmakoterapie MeSH
- katetrizační ablace * škodlivé účinky metody MeSH
- krvácení MeSH
- lidé MeSH
- recidiva MeSH
- supraventrikulární tachykardie * chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- antiarytmika MeSH