Author + information
- Moussa Mansour, MDa,∗ (, )
- Hugh Calkins, MDb,
- Jose Osorio, MDc,
- Scott J. Pollak, MDd,
- Daniel Melby, MDe,
- Francis E. Marchlinski, MDf,
- Charles A. Athill, MDg,
- Craig Delaughter, MDh,
- Anshul M. Patel, MDi,
- Philip J. Gentlesk, MDj,
- Brian DeVille, MDk,
- Laurent Macle, MDl,
- Kenneth A. Ellenbogen, MDm,
- Srinivas R. Dukkipati, MDn,
- Vivek Y. Reddy, MDn and
- Andrea Natale, MDo
- aMassachusetts General Hospital, Boston, MA
- bJohns Hopkins University, Baltimore, MD
- cArrhythmia Institute at Grandview, Birmingham, AL
- dFlorida Hospital Cardiovascular Institute, Orlando, FL
- eMinneapolis Heart Institute, Minneapolis, MN
- fHospital of the University of Pennsylvania, Philadelphia, PA
- gSan Diego Cardiac Center, San Diego, CA
- hBaylor Scott & White Heart and Vascular Hospital, Fort Worth, TX
- iEmory Saint Joseph’s Hospital, Atlanta, GA
- jSentara Norfolk General Hospital, Norfolk, VA
- kThe Heart Hospital Baylor Plano, Plano, TX
- lMontreal Heart Institute, Montreal, QC, Canada
- mVirginia Commonwealth University, Richmond, VA
- nIcahn School of Medicine at Mount Sinai, New York, NY
- oTexas Cardiac Arrhythmia Research Foundation, Austin, TX
- ↵∗Address for correspondence: Dr. Moussa Mansour, Cardiac Arrhythmia Service, Heart Center, Massachusetts General Hospital 55 Fruit Street, GRB 109 Boston, MA 02114
Background While the safety and effectiveness of catheter ablation of paroxysmal AF is established, there are limited data on outcomes in patients with persistent AF (PsAF). As such, no ablation catheter is currently approved by the FDA for PsAF ablation.
Objectives To evaluate the safety and effectiveness of catheter ablation of PsAF using a porous tip contact force (CF)-sensing catheter.
Methods The prospective, multicenter, nonrandomized PRECEPT study was conducted at 27 sites in the United States and Canada. Enrollment criteria included documented symptomatic PsAF and nonresponse or intolerance to ≥1 antiarrhythmic drug (Class I or III). Individualized treatment approach was used including pulmonary vein isolation (PVI) with ablation of additional targets permitted at investigators’ discretion. To optimize treatment outcomes, a 3-month post-ablation medication adjustment period followed by a 3-month therapy consolidation period were included. Arrhythmia recurrences were stringently monitored by monthly and symptomatic transtelephonic monitoring, electrocardiogram, and Holter, for up to 15 months post-ablation.
Results Of 381 enrolled participants, 348 had the investigational catheter inserted and underwent ablation. The primary adverse event (PAE) rate was 3.8% (14 events in 13 participants). Kaplan Meier analyses estimated the primary effectiveness success rate of 61.7% and clinical success rate of 80.4% at 15 months.
Conclusions The results demonstrate the clinical safety and effectiveness of PsAF ablation using CF-sensing technologies. The PAE was within the expected range and similar to those reported in historical studies of paroxysmal AF ablation.
- atrial arrhythmia
- pulmonary vein isolation
- transtelephonic monitoring
- porous tip catheter
- symptomatic AF
Funding: The study is funded by Biosense Webster, Inc. (Irvine, CA)
Disclosures: Dr. Mansour has served as a consultant for Biosense Webster, Abbott, Medtronic, Boston Scientific, Janssen, Philips, Novartis, and Sentre Heart; has received research grants from Biosense Webster, Abbott, Boston Scientific, Medtronic, Pfizer, Boehringer Ingelheim; and has an equity interest in EPD Solutions, NewPace Ltd, and Affera. Dr. Calkins receives honoraria and consulting fees from Biosense Webster, Medtronic, Abbot, Atricure, and Boston Scientific. Dr. Osorio serves as a consultant and received honorarium and research grants from biosense Webster and Boston scientific. Dr. Pollak receives personal fees from Biosense Webster. Dr. Melby receives honoraria for physician education from Biosense Webster. Dr. Marchlinski serves as a consultant for Abbot, Medtronic, Biosense Webster, and receives honorarium from Biotronik and Boston Scientific. Dr. Athill has received research grant from Biosense Webster, honoraria from Jassen, and is a consultant for Abbot and Boston Scientific. Dr. Delaughter serves as a consultant for Biosense Webster. Dr. Patel has received research grant and personal fees from Biosense Webster. Dr. Gentlesk has no conflict of interests to disclose. Dr. DeVille serves as a consultant and receives honorarium from Biosense Webster, Medtronic, and Boston Scientific. Dr. Macle has received research grants from Biosense Webster and Abbot, and honorarium from Biosense Webster. Dr. Dukkipati receives research grant from Biosense Webster. Dr. Reddy received research grants from and serves as an unpaid consultant to Biosense Webster; other disclosures unrelated to this manuscript are listed in the online
- Received April 22, 2020.
- Revision received April 24, 2020.
- Accepted April 24, 2020.
- 2020 The Authors