Author + information
- Received March 26, 2019
- Revision received April 24, 2019
- Accepted April 24, 2019
- Published online July 15, 2019.
- Vivek Y. Reddy, MDa,b,∗ (, )
- Petr Neuzil, MD, PhDa,
- Jacob S. Koruth, MDb@jskoruth,
- Jan Petru, MDa,
- Moritoshi Funosako, MDa,
- Hubert Cochet, MDc,
- Lucie Sediva, MDa,
- Milan Chovanec, MDa,
- Srinivas R. Dukkipati, MDb@SriniDukkipati and
- Pierre Jais, MDc
- aHomolka Hospital, Prague, Czech Republic
- bIcahn School of Medicine at Mount Sinai, New York, New York
- cIHU LIRYC ANR-10-IAHU-04, University of Bordeaux, CHU Bordeaux, Bordeaux, France
- ↵∗Address for correspondence:
Dr. Vivek Y. Reddy, Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, P.O. Box 1030, New York, New York 10029.
Background Catheter ablation of atrial fibrillation using thermal energies such as radiofrequency or cryothermy is associated with indiscriminate tissue destruction. During pulsed field ablation (PFA), subsecond electric fields create microscopic pores in cell membranes—a process called electroporation. Among cell types, cardiomyocytes have among the lowest thresholds to these fields, potentially permitting preferential myocardial ablation.
Objectives The purpose of these 2 trials was to determine whether PFA allows durable pulmonary vein (PV) isolation without damage to collateral structures.
Methods Two trials were conducted to assess the safety and effectiveness of catheter-based PFA in paroxysmal atrial fibrillation. Ablation was performed using proprietary bipolar PFA waveforms: either monophasic with general anesthesia and paralytics to minimize muscle contraction, or biphasic with sedation because there was minimal muscular stimulation. No esophageal protection strategy was used. Invasive electrophysiological mapping was repeated after 3 months to assess the durability of PV isolation.
Results In 81 patients, all PVs were acutely isolated by monophasic (n = 15) or biphasic (n = 66) PFA with ≤3 min elapsed delivery/patient, skin-to-skin procedure time of 92.2 ± 27.4 min, and fluoroscopy time of 13.1 ± 7.6 min. With successive waveform refinement, durability at 3 months improved from 18% to 100% of patients with all PVs isolated. Beyond 1 procedure-related pericardial tamponade, there were no additional primary adverse events over the 120-day median follow-up, including: stroke, phrenic nerve injury, PV stenosis, and esophageal injury. The 12-month Kaplan-Meier estimate of freedom from arrhythmia was 87.4 ± 5.6%.
Conclusions In first-in-human trials, PFA preferentially affected myocardial tissue, allowing facile ultra-rapid PV isolation with excellent durability and chronic safety. (IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation; NCT03700385; and PEFCAT: A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation; NCT03714178)
- atrial fibrillation
- catheter ablation
- esophageal damage
- pulmonary vein isolation
- pulsed field ablation
The trials were supported by the manufacturer of the pulse field ablation system, Farapulse Inc. A scientific grant from the Czech Ministry of Health (DRO NNH 00023884 IG 180504) supported Drs. Neuzil, Petru, Funosako, Sediva, and Chovanec. Dr. Reddy owns stock in Farapulse; and has served as a consultant for Farapulse, Biosense Webster, and Boston Scientific. Dr. Neuzil has received grant support from Farapulse. Dr. Koruth has received grant support from and served as a consultant for Farapulse. Dr. Dukkipati owns stock in Farapulse. Dr. Jais owns stock in Farapulse; and has received honoraria from Farapulse, Biosense Webster, and Boston Scientific. Drs. Reddy and Koruth also have conflicts with other medical companies not related to this paper that are listed in the Online Appendix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Andrea Natale, MD, served as Guest Associate Editor for this paper.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received March 26, 2019.
- Revision received April 24, 2019.
- Accepted April 24, 2019.
- 2019 The Authors