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Randomized Controlled Trial
. 2025 Jul 1;67(7):ezaf146.
doi: 10.1093/ejcts/ezaf146.

Durable effectiveness and safety of hybrid ablation versus catheter ablation: 2-year results from the randomized CEASE-AF trial†

Nicolas Doll  1 , Timo Weimar  2 , Dariusz A Kosior  3   4 , Alan Bulava  5   6 , Ales Mokracek  6   7 , Gerold Mönnig  8 , Jonathan Sahu  9 , Steven Hunter  10 , Maurits Wijffels  11 , Bart van Putte  12 , Norman Rüb  13 , Petr Nemec  14   15 , Tomas Ostrizek  16 , Erik Fransen  17 , Piotr Suwalski  3
Affiliations
Randomized Controlled Trial

Durable effectiveness and safety of hybrid ablation versus catheter ablation: 2-year results from the randomized CEASE-AF trial†

Nicolas Doll et al. Eur J Cardiothorac Surg. .

Abstract

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.

Keywords: Atrial fibrillation; Catheter ablation; Hybrid ablation; Left atrial appendage; Surgical ablation.

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Figures

None
Graphical abstract
Figure 1:
Figure 1:
CONSORT diagram for CEASE-AF over the 24-month follow-up period. AAD: anti-arrhythmic; AE/SAE: adverse event/serious adverse event; CHA2DS2VASc: Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, prior Stroke or TIA or thromboembolism (doubled), Vascular score; ECG: electrocardiogram; ITT: intention to treat; LAAE: left atrial appendage exclusion; mITT: modified intention to treat; PVI: pulmonary vein isolation; T0: index procedure plus 6 months; TEE: transesophageal echocardiography.
Figure 2:
Figure 2:
Freedom from atrial fibrillation, atrial flutter and atrial tachycardia off anti-arrhythmic drugs except those previously failed at doses not exceeding those previously failed, unless otherwise indicated, through 24 months in the hybrid and catheter ablation arms. AAD: anti-arrhythmic; AF: atrial fibrillation; CI: confidence interval.
Figure 3:
Figure 3:
Cumulative major complications over 24 months in the intention-to-treat population.
See this image and copyright information in PMC

References

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