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.

AtriCure Europe B 5 Amsterdam The Netherlands

Departement of Cardiac Surgery Center of Cardiovascular Surgery and Transplantation Brno Czech Republic

Departement of Cardiac Surgery Ceske Budejovice Hospital Ceske Budejovice Czech Republic

Departement of Cardiac Surgery Northern General Hospital Sheffield UK

Departement of Cardiac Surgery Schüchtermann Klinik Bad Rothenfelde Germany

Departement of Cardiac Surgery St Antonius Hospital Nieuwegein The Netherlands

Departement of Electrophysiology Center of Cardiovascular Surgery and Transplantation Brno Czech Republic

Departement of Electrophysiology Northern General Hospital Sheffield UK

Departement of Electrophysiology RKH Klinikum Ludwigsburg Ludwigsburg Germany

Departement of Electrophysiology St Antonius Hospital Nieuwegein The Netherlands

Department of Cardiology Ceske Budejovice Hospital Czech Republic

Department of Cardiology Schüchtermann Klinik Bad Rothenfelde Germany

Eberhard Karls University School of Medicine Tuebingen Germany

Faculty of Health and Social Sciences University of South Bohemia in Ceske Budejovice Czech Republic

Faculty of Medicine Masaryk University Brno Czech Republic

Mossakowski Medical Research Institute Polish Academy of Sciences Warsaw Poland

National Medical Institute of the Ministry of Interior and Administration Centre of Postgraduate Medical Education Warsaw Poland

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NCT02695277