(Press-News.org) Amsterdam, Netherlands – 27 Aug 2023: Pulsed field ablation (PFA) is as effective and safe as conventional thermal ablation for the treatment of paroxysmal atrial fibrillation (AF), according to late breaking research presented in a Hot Line session today at ESC Congress 2023.1
ESC guidelines recommend catheter ablation after failure of drug therapy in patients with paroxysmal AF.2 Conventional ablation technology uses thermal energy (either heat/radiofrequency energy or cold/cryothermal energy) to ablate the tissue. Unlike thermal ablation, PFA uses high energy electrical pulses to destroy tissue by a process called electroporation. Preclinical and clinical studies have demonstrated that PFA seems to preferentially ablate the heart tissue, with minimal or no damage to surrounding structures such as the oesophagus and phrenic nerve, as well as no pulmonary vein stenosis – all complications that can occur with conventional thermal ablation.3-6
ADVENT was the first randomised controlled trial comparing PFA to conventional ablation (either radiofrequency or cryothermal ablation).7 The trial is intended to inform Food and Drug Administration (FDA) approval of the PFA catheter in the US. The study enrolled patients with drug-resistant, symptomatic paroxysmal AF. One to three roll-in patients were permitted at each site to ensure experience using the PFA catheter. The remaining patients were randomised in a 1:1 ratio to PFA or conventional thermal ablation. At the beginning of the trial, approximately 50% of centres were assigned to radiofrequency energy for the control group and the remaining centres were assigned to cryothermal energy for the control group. Patients were followed for 12 months with weekly electrocardiogram transmissions and 72-hour Holter assessments at six and 12 months.
A total of 687 patients underwent ablation by 65 operators at 30 centres in the US. The initial roll-in phase included 80 patients; the remaining 607 patients were randomised to PFA (305 patients) or conventional thermal ablation (302 patients, of which 167 received radiofrequency ablation and 135 received cryoablation). The average age of randomised participants was 62 years and approximately 35% were female.
The primary efficacy endpoint was the success rate, defined as acute success and chronic success (one-year freedom from recurrent atrial arrhythmias, antiarrhythmic drug use, and cardioversion or repeat ablation). The success rate was 73.3% and 71.3% in the PFA and thermal groups, respectively, and met the prespecified criteria for noninferiority (between-group difference, 2.0%; 95% Bayesian credible interval [BCI], -5.2 to 9.2%; posterior probability of noninferiority >0.999). The secondary efficacy endpoint was the same as the primary efficacy endpoint, but tested for superiority: this did not meet the criteria for superiority (posterior probability of superiority 0.708).
The primary safety endpoint was a composite of serious adverse events related to use of an ablation catheter or the procedure itself and occurring within seven days, as well as pulmonary vein stenosis or oesophageal fistula occurring at any time during the 12-month follow up. This endpoint occurred in 2.1% and 1.5% patients in the PFA and thermal groups, respectively, and met the prespecified criteria for noninferiority (between-group difference, 0.6%; 95% BCI, -1.5 to 2.8%; posterior probability of noninferiority >0.999). The secondary safety endpoint was the change in pulmonary vein dimension (i.e., any stenosis or narrowing) from baseline to day 90. The reductions in vein cross-sectional area were 3.3% and 19.5% in the PFA and thermal groups, respectively, which met the prespecified criteria for superiority of PFA (posterior probability of superiority >0.999).
Principal investigator Professor Vivek Reddy of the Icahn School of Medicine at Mount Sinai, New York, US said: “The ADVENT trial showed that PFA is as effective and safe as conventional thermal ablation to treat paroxysmal AF. Procedure times were faster for PFA than thermal ablation, but there was more X-ray exposure with PFA.”
ENDS
Notes to editors
Authors: ESC Press Office
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Funding: Farapulse-Boston Scientific (the manufacturer of the pulsed field ablation catheter technology).
Disclosures: Professor Reddy received grant support and served as a consultant to Farapulse-Boston Scientific Inc; he had also received equity from Farapulse, but this has been divested, so he has no residual equity conflict. Unrelated to this manuscript, he has a number of disclosures with other companies that manufacture other types of catheter ablation devices.
References and notes
1ADVENT will be discussed during Hot Line 5 on Sunday 27 August at 11:15 to 12:15 CEST in room Amsterdam.
2Hindricks 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). Eur Heart J. 2020;42:373-498.
3Koruth JS, Kuroki K, Iwasawa J, et al. Endocardial ventricular pulsed field ablation: a proof-of-concept preclinical evaluation. Europace. 2020;22:434–439.
4Koruth JS, Kuroki K, Kawamura I, et al. Pulsed field ablation versus radiofrequency ablation: esophageal injury in a novel porcine model. Circ Arrhythm Electrophysiol. 2020;13:e008303.
5Reddy VY, Dukkipati SR, Neuzil P, et al. Pulsed field ablation of paroxysmal atrial fibrillation: 1-year outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021;7:614–627.
6Cochet H, Nakatani Y, Sridi-Cheniti S, et al. Pulsed field ablation selectively spares the oesophagus during pulmonary vein isolation for atrial fibrillation. Europace. 2021;23:1391–1399.
7Reddy VY, Lehmann JW, Gerstenfeld EP, et al. A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design. Heart Rhythm O2. 2023;4:317-328.
About ESC Congress 2023
It is the world’s largest gathering of cardiovascular professionals, disseminating ground-breaking science both onsite in Amsterdam and online – from 25 to 28 August. Explore the scientific programme. More information is available from the ESC Press Office at press@escardio.org.
About the European Society of Cardiology
The European Society of Cardiology brings together health care professionals from more than 150 countries, working to advance cardiovascular medicine and help people lead longer, healthier lives.
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Pulsed field ablation is noninferior to thermal ablation in paroxysmal atrial fibrillation
2023-08-28
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