Efficacy and safety of hybrid epicardial and endocardial ablation versus endocardial ablation in patients with persistent and longstanding persistent atrial fibrillation: a randomised, controlled trial

Nicolas Doll; Timo Weimar; Dariusz A Kosior; Alan Bulava; Ales Mokracek; Gerold Mönnig; Jonathan Sahu; Steven Hunter; Maurits Wijffels; Bart van Putte; Norman Rüb; Petr Nemec; Tomas Ostrizek; Piotr Suwalski

doi:10.1016/j.eclinm.2023.102052

Efficacy and safety of hybrid epicardial and endocardial ablation versus endocardial ablation in patients with persistent and longstanding persistent atrial fibrillation: a randomised, controlled trial

EClinicalMedicine. 2023 Jun 22:61:102052. doi: 10.1016/j.eclinm.2023.102052. eCollection 2023 Jul.

Authors

Nicolas Doll¹, Timo Weimar², Dariusz A Kosior^{3

4}, Alan Bulava⁵, Ales Mokracek⁵, Gerold Mönnig¹, Jonathan Sahu⁶, Steven Hunter⁶, Maurits Wijffels⁷, Bart van Putte⁷, Norman Rüb⁸, Petr Nemec⁹, Tomas Ostrizek⁹, Piotr Suwalski¹⁰

Affiliations

¹ Schüchtermann-Klinik, Bad Rothenfelde, Germany.
² Eberhard Karls University School of Medicine, Tuebingen, Germany.
³ Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.
⁴ Mossakowski Medical Research Institute, Polish Academy of Sciences, Warsaw, Poland.
⁵ Ceske Budejovice Hospital, Ceske Budejovice, Czech Republic and Faculty of Health and Social Sciences, University of South Bohemia in Ceske Budejovice, Czech Republic.
⁶ Northern General Hospital, Sheffield, UK.
⁷ St Antonius Hospital, Nieuwegein, Netherlands.
⁸ RKH Klinikum Ludwigsburg, Ludwigsburg, Germany.
⁹ Center of Cardiovascular Surgery and Transplantation, Brno, Czech Republic.
¹⁰ National Medical Institute of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland.

Abstract

Background: Endocardial catheter ablation (CA) has limited long-term benefit for persistent and longstanding persistent atrial fibrillation (PersAF/LSPAF). We hypothesized hybrid epicardial-endocardial ablation (HA) would have superior effectiveness compared to CA, including repeat (rCA), in PersAF/LSPAF.

Methods: CEASE-AF (NCT02695277) is a prospective, multi-center, randomized controlled trial. Nine hospitals in Poland, Czech Republic, Germany, United Kingdom, and the Netherlands enrolled eligible participants with symptomatic, drug refractory PersAF and left atrial diameter (LAD) > 4.0 cm or LSPAF. Randomization was 2:1 to HA or CA by an independent statistician and stratified by site. Treatment assignments were masked to the core rhythm monitoring laboratory. For HA, pulmonary veins (PV) and left posterior atrial wall were isolated with thoracoscopic epicardial ablation including left atrial appendage exclusion. Endocardial touch-up ablation was performed 91-180 days post-index procedure. For CA, endocardial PV isolation and optional substrate ablation were performed. rCA was permitted between days 91-180. Primary effectiveness was freedom from AF/atrial flutter/atrial tachycardia >30-s through 12-months absent class I/III anti-arrhythmic drugs except those not exceeding previously failed doses. It was assessed in the modified intention-to-treat (mITT) population who had the index procedure and follow-up data. Major complications were assessed in the ITT population who had the index procedure. Thirty-six month follow-up continues.

Findings: Enrollment began November 20, 2015 and ended May 22, 2020. In 154 ITT patients (102 HA; 52 CA), 75% were male, mean age was 60.7 ± 7.9 years, mean LAD was 4.7 ± 0.4 cm, and 81% had PersAF. Primary effectiveness was 71.6% (68/95) in HA versus 39.2% (20/51) in CA (absolute benefit increase: 32.4% [95% CI 14.3%-48.0%], p < 0.001). Major complications through 30-days after index procedures plus 30-days after second stage/rCA were similar (HA: 7.8% [8/102] versus CA: 5.8% [3/52], p = 0.75).

Interpretation: HA had superior effectiveness compared to CA/rCA in PersAF/LSPAF without significant procedural risk increase.

Funding: AtriCure, Inc.

Keywords: Atrial fibrillation; Catheter ablation; Endocardial ablation; Epicardial ablation; Hybrid ablation; Left atrial appendage; Longstanding persistent atrial fibrillation; Persistent atrial fibrillation; Randomized controlled trial.