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.

Center of Cardiovascular Surgery and Transplantation Brno Czech Republic

Central Clinical Hospital of the Ministry of Interior and Administration Warsaw Poland

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

Eberhard Karls University School of Medicine Tuebingen Germany

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

Northern General Hospital Sheffield UK

RKH Klinikum Ludwigsburg Ludwigsburg Germany

Schüchtermann Klinik Bad Rothenfelde Germany

St Antonius Hospital Nieuwegein Netherlands

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Benjamin E.J., Wolf P.A., D'Agostino R.B., Silbershatz H., Kannel W.B., Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998;98:946–952. PubMed

Blackshear J.L., Odell J.A. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61:755–759. PubMed

Chugh S.S., Havmoeller R., Narayanan K., et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation. 2014;129:837–847. PubMed PMC

Hindricks G., Potpara T., Dagres N., et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): the Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021;42:373–498. PubMed

Calkins H., Hindricks G., Cappato R., et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017;14:e275–e444. PubMed PMC

Thiyagarajah A., Kadhim K., Lau D.H., et al. Feasibility, safety, and efficacy of posterior wall isolation during atrial fibrillation ablation: a systematic review and meta-analysis. Circ Arrhythm Electrophysiol. 2019;12 PubMed

Bai R., Di Biase L., Mohanty P., et al. Proven isolation of the pulmonary vein antrum with or without left atrial posterior wall isolation in patients with persistent atrial fibrillation. Heart Rhythm. 2016;13:132–140. PubMed

Markman T.M., Hyman M.C., Kumareswaran R., et al. Durability of posterior wall isolation after catheter ablation among patients with recurrent atrial fibrillation. Heart Rhythm. 2020;17:1740–1744. PubMed

Pothineni N.V.K., Lin A., Frankel D.S., et al. Impact of left atrial posterior wall isolation on arrhythmia outcomes in patients with atrial fibrillation undergoing repeat ablation. Heart Rhythm O2. 2021;2:489–497. PubMed PMC

Tilz R.R., Rillig A., Thum A.M., et al. Catheter ablation of long-standing persistent atrial fibrillation: 5-year outcomes of the Hamburg sequential ablation strategy. J Am Coll Cardiol. 2012;60:1921–1929. PubMed

Darby A.E. Recurrent atrial fibrillation after catheter ablation: considerations for repeat ablation and strategies to optimize success. J Atr Fibrillation. 2016;9:1427. PubMed PMC

Shah S., Barakat A.F., Saliba W.I., et al. Recurrent atrial fibrillation after initial long-term ablation success. Circ Arrhythm Electrophysiol. 2018;11 PubMed

Al-Hijji M.A., Deshmukh A.J., Yao X., et al. Trends and predictors of repeat catheter ablation for atrial fibrillation. Am Heart J. 2016;171:48–55. PubMed

Verma A., Jiang C.Y., Betts T.R., et al. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015;372:1812–1822. PubMed

Mansour M., Calkins H., Osorio J., et al. Persistent atrial fibrillation ablation with contact force-sensing catheter: the prospective multicenter PRECEPT trial. JACC Clin Electrophysiol. 2020;6:958–969. PubMed

Su W.W., Reddy V.Y., Bhasin K., et al. Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: results from the multicenter STOP persistent AF trial. Heart Rhythm. 2020;17:1841–1847. PubMed

Varzaly J.A., Lau D.H., Chapman D., Edwards J., Worthington M., Sanders P. Hybrid ablation for atrial fibrillation: a systematic review and meta-analysis. JTCVS Open. 2021;7:141–154. PubMed PMC

DeLurgio D.B., Crossen K.J., Gill J., et al. Hybrid convergent procedure for the treatment of persistent and long-standing persistent atrial fibrillation: results of CONVERGE clinical trial. Circ Arrhythm Electrophysiol. 2020;13 PubMed

Shrestha S., Plasseraud K.M., Makati K., et al. Hybrid convergent ablation for atrial fibrillation: a systematic review and meta-analysis. Heart Rhythm O2. 2022;3:396–404. PubMed PMC

Summary of safety and effectiveness data (SSED) - THERMOCOOL SMARTTOUCH SF Bi-directional navigation catheter; THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation catheter. https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030031S100B.pdf2020 Available from:

Deshmukh A., Patel N.J., Pant S., et al. In-hospital complications associated with catheter ablation of atrial fibrillation in the United States between 2000 and 2010: analysis of 93 801 procedures. Circulation. 2013;128:2104–2112. PubMed

Gharaviri A., Bidar E., Potse M., et al. Epicardial fibrosis explains increased endo-epicardial dissociation and epicardial breakthroughs in human atrial fibrillation. Front Physiol. 2020;11:68. PubMed PMC

Lim H.S., Hocini M., Dubois R., et al. Complexity and distribution of drivers in relation to duration of persistent atrial fibrillation. J Am Coll Cardiol. 2017;69:1257–1269. PubMed

Voeller R.K., Bailey M.S., Zierer A., et al. Isolating the entire posterior left atrium improves surgical outcomes after the Cox maze procedure. J Thorac Cardiovasc Surg. 2008;135:870–877. PubMed

Kistler P.M., Chieng D., Sugumar H., et al. Effect of catheter ablation using pulmonary vein isolation with vs without posterior left atrial wall isolation on atrial arrhythmia recurrence in patients with persistent atrial fibrillation: the CAPLA randomized clinical trial. JAMA. 2023;329:127–135. PubMed PMC

Valderrabano M., Peterson L.E., Swarup V., et al. Effect of catheter ablation with vein of marshall ethanol infusion vs catheter ablation alone on persistent atrial fibrillation: the VENUS randomized clinical trial. JAMA. 2020;324:1620–1628. PubMed PMC

Lo M., Nair D., Mansour M., et al. Contact force catheter ablation for the treatment of persistent atrial fibrillation: results from the PERSIST-END study. J Cardiovasc Electrophysiol. 2022;34(2):279–290. PubMed

van der Heijden C.A.J., Weberndorfer V., Vroomen M., et al. Hybrid ablation versus repeated catheter ablation in persistent atrial fibrillation: a randomized controlled trial. JACC Clin Electrophysiol. 2023 doi: 10.1016/j.jacep.2022.12.011. PubMed DOI

Sequential hybrid ablation vs. surgical CryoMaze alone for treatment of atrial fibrillation: results of multicentre randomized controlled trial