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Randomized Controlled Trial
. 2024 Feb 1;26(2):euae038.
doi: 10.1093/europace/euae038.

Pulmonary vein narrowing after pulsed field versus thermal ablation

Moussa Mansour  1 , Edward P Gerstenfeld  2 , Chinmay Patel  3 , Andrea Natale  4   5 , William Whang  6 , Frank A Cuoco  7 , Stavros E Mountantonakis  8 , Douglas N Gibson  9 , John D Harding  10 , Scott K Holland  11 , Anitha B Achyutha  12 , Christopher W Schneider  12 , Andrew S Mugglin  13 , Elizabeth M Albrecht  14 , Kenneth M Stein  14 , John W Lehmann  15 , Vivek Y Reddy  6
Affiliations
Randomized Controlled Trial

Pulmonary vein narrowing after pulsed field versus thermal ablation

Moussa Mansour et al. Europace. .

Abstract

Aims: When it occurs, pulmonary vein (PV) stenosis after atrial fibrillation (AF) ablation is associated with significant morbidity. Even mild-to-moderate PV narrowing may have long-term implications. Unlike thermal ablation energies, such as radiofrequency (RF) or cryothermy, pulsed field ablation (PFA) is a non-thermal modality associated with less fibrotic proliferation. Herein, we compared the effects of PFA vs. thermal ablation on PV narrowing after AF ablation.

Methods and results: ADVENT was a multi-centre, randomized, single-blind study comparing PFA (pentaspline catheter) with thermal ablation-force-sensing RF or cryoballoon (CB)-to treat drug-refractory paroxysmal AF. Pulmonary vein diameter and aggregate cross-sectional area were obtained by baseline and 3-month imaging. The pre-specified, formally tested, secondary safety endpoint compared a measure of PV narrowing between PFA vs. thermal groups, with superiority defined by posterior probability > 0.975. Among subjects randomized to PFA (n = 305) or thermal ablation (n = 302), 259 PFA and 255 thermal ablation (137 RF and 118 CB) subjects had complete baseline and 3-month PV imaging. No subject had significant (≥70%) PV stenosis. Change in aggregate PV cross-sectional area was less with PFA (-0.9%) than thermal ablation (-12%, posterior probability > 0.999)-primarily driven by the RF sub-cohort (-19.5%) vs. CB sub-cohort (-3.3%). Almost half of all PFA PV diameters did not decrease, but the majority (80%) of RF PVs decreased, regardless of PV anatomic location.

Conclusion: In this first randomized comparison of PFA vs. thermal ablation, PFA resulted in less PV narrowing-thereby underscoring the qualitatively differential and favourable impact of PFA on PV tissue.

Keywords: Atrial fibrillation; Pulmonary vein stenosis; Pulsed field ablation; Randomized controlled trial.

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Conflict of interest statement

Conflict of interest: M.M. is a consultant for Boston Scientific, Biosense Webster, Abbott, Medtronic, Siemens Novartis, Janssen, Boehringer Ingelheim, Pfizer, and SentreHEART/AtriCure and has equity in EPD-Philips (divested), and NewPace Ltd. E.P.G. is a consultant to Farapulse Inc and serves as an unpaid consultant to Boston Scientific Inc and scientific advisory board to Biosense Webster and Adagio Medical, has research support from Biosense-Webster, Adagio Medical, and Abbott, has lecture honoraria from Medtronic, Boston Scientific Inc and Abbott. C.P. is a consultant for Boston Scientific. A.N. is a consultant for Abbott, Baylis, Biotronik, Biosense Webster, Boston Scientific, and Medtronic. W.W. has no relevant disclosures. F.A.C. is a consultant to Boston Scientific and Biosense Webster. S.E.M. is a consultant to Medtronic and Boston Scientific Inc, has research support from Medtronic, Biotronik, Abbott, and CVRx, and has lecture honoraria from Biosense Webster, Medtronic, Boston Scientific Inc, Zoll, and Abbott. D.N.G. is a consultant to Abbott, Baylis, Biotronik, Biosense Webster, Boston Scientific, and Medtronic. J.D.H. has no relevant disclosures. S.K.H. is an employee of Medpace Core Laboratories. C.W.S., A.B.A., E.M.A., and K.M.S. are employees of Boston Scientific. A.S.M. is a consultant to Farapulse Inc and serves as a consultant to Boston Scientific Inc; unrelated to this manuscript, he has also provided statistical consulting and/or Data Safety Monitoring Board services for AtriCure, Abbott, Biosense Webster, and Medtronic. J.W.L. is a consultant to and received equity from Farapulse Inc (now divested) and serves as a consultant to Boston Scientific Inc. V.Y.R. is a Farapulse-Boston Scientific Inc: grant support, consultant, equity (now divested); and unrelated to this manuscript, V.Y.R. also serves as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, Anumana, APN Health, AquaHeart, AtaCor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, MedLumics, Middlepeak, NeuTrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; unrelated to this work, V.Y.R. has served as a consultant for Abbott, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Cairdac, CardioFocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, and Pulse Biosciences and has equity in DRS Vascular, Manual Surgical Sciences, NewPace, Nyra Medical, SureCor, and VizaraMed.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Example cardiac CT measurements showing the short and long diameter measurements (A) and images reconstructed in 3D renderings to show pre-procedural and 90-day pulmonary vein dimensions for a patient treated with PFA (B, C) and thermal (RF) ablation (D, E). P, posterior; PFA, pulsed field ablation; RF, radiofrequency; S, superior.
Figure 2
Figure 2
Patient flow chart (only the four main PVs were included in this analysis). CBA, cryoballoon ablation; PAF, paroxsymal atrial fibrillation; PFA, pulsed field ablation; PV, pulmonary vein; RFA, radiofrequency ablation.
Figure 3
Figure 3
(A) Percentage change in pulmonary vein dimensions following PVI by ablation modality. (B) Categorization of pulmonary vein diameter changes. PFA, pulsed field ablation; PV, pulmonary vein; RFA, radiofrequency.
Figure 4
Figure 4
Pulmonary vein diameter changes categorized per patient. PFA, pulsed field ablation; PV, pulmonary vein; RFA, radiofrequency.
Figure 5
Figure 5
Absolute and per cent change in aggregate pulmonary vein cross-sectional area by ablation modality from baseline to 3-month follow-up. PFA, pulsed field ablation; PV, pulmonary vein; RFA, radiofrequency.
See this image and copyright information in PMC

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