Durable effectiveness and safety of hybrid ablation versus catheter ablation: 2-year results from the randomized...

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.

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.

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].

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).

NCT02695277.