Pulmonary vein narrowing after pulsed field versus thermal ablation

Author:

Mansour Moussa1ORCID,Gerstenfeld Edward P2,Patel Chinmay3ORCID,Natale Andrea45ORCID,Whang William6,Cuoco Frank A7,Mountantonakis Stavros E8,Gibson Douglas N9ORCID,Harding John D10,Holland Scott K11ORCID,Achyutha Anitha B12,Schneider Christopher W12ORCID,Mugglin Andrew S13ORCID,Albrecht Elizabeth M14,Stein Kenneth M14,Lehmann John W15,Reddy Vivek Y6ORCID

Affiliation:

1. Massachusetts General Hospital , GRB 815, 55 Fruit Street , Boston, MA, USA

2. Section of Cardiac Electrophysiology, University of California San Francisco , San Francisco, CA, USA

3. Heart and Vascular Institute, University of Pittsburgh Medical Center Pinnacle, Harrisburg, PA, USA

4. Texas Cardiac Arrhythmia Institute, St. David’s Medical Center , Austin, TX, USA

5. Case Western Reserve University , Cleveland, OH, USA

6. Helmsley Electrophysiology Center, Mount Sinai Fuster Heart Hospital , New York, NY, USA

7. Trident Medical Center , Charleston, SC, USA

8. Lenox Hill Hospital, Northwell Health , New York City, NY, USA

9. Scripps Clinic and Prebys Cardiovascular Institute , San Diego, CA, USA

10. Doylestown Hospital , Doylestown, PA, USA

11. Medpace Core Laboratories , Cincinnati, OH, USA

12. Department of Electrophysiology, Boston Scientific Corporation , Menlo Park, CA, USA

13. Paradigm Biostatistics LLC , Anoka, MN, USA

14. Department of Electrophysiology, Boston Scientific Corporation , St. Paul, MN, USA

15. Lehmann Consulting , Naples, FL, USA

Abstract

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.

Funder

Farapulse Boston Scientific

Publisher

Oxford University Press (OUP)

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