Author + information
- Received July 17, 2018
- Revision received October 30, 2018
- Accepted November 1, 2018
- Published online January 8, 2019.
- Bradley P. Knight, MDa,∗ (, )
- Paul G. Novak, MDb,
- Robert Sangrigoli, MDc,
- Jean Champagne, MDd,
- Marc Dubuc, MDe,
- Stuart W. Adler, MDf,
- J. Thomas Svinarich, MDg,
- Vidal Essebag, MD, PhDh,
- Robert Hokanson, BAi,
- Fred Kueffer, MSi,
- Sandeep K. Jain, MDj,
- Roy M. John, MD, PhDk,
- Moussa Mansour, MDl,
- STOP AF PAS Investigators
- aNorthwestern University, Chicago, Illinois
- bUniversity of British Columbia Royal Jubilee Hospital, Victoria, British Columbia, Canada
- cDoylestown Cardiology Associates, Doylestown, Pennsylvania
- dQuebec Heart Institute, Quebec City, Quebec, Canada
- eMontreal Heart Institute, Montreal, Quebec, Canada
- fHealthEast Heart Care, St. Paul, Minnesota
- gColorado Heart and Vascular, Denver, Colorado
- hMcGill University Health Center, Division of Cardiology, Montreal, Quebec, Canada
- iMedtronic, Mounds View, Minnesota
- jUniversity of Pittsburgh, Pittsburgh, Pennsylvania
- kVanderbilt University, Nashville, Tennessee
- lMassachusetts General Hospital, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. Bradley P. Knight, Department of Cardiology, Northwestern University, Feinberg School of Medicine, 251 East Huron Street, Feinberg 8-503E, Chicago, Illinois 60611.
Objectives STOP AF PAS is the first prospective, multicenter, 3-year study in North America to assess long-term safety and effectiveness of the cryoballoon for treatment of patients with drug-refractory symptomatic pAF.
Background The STOP AF PAS (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study) was required by the US Food and Drug Administration at the time of approval of the first-generation cryoballoon for the treatment of paroxysmal atrial fibrillation (pAF). The second-generation cryoballoon (CB2) was commercially released shortly after this trial was initiated.
Methods The study was nonrandomized. Enrollment was completed with 344 eligible patients undergoing pulmonary vein isolation (PVI) using the CB2. Procedure-related safety and freedom from AF and symptomatic atrial flutter/atrial tachycardia through 3 years were determined. Documented atrial arrhythmias ≥30 s were considered treatment failures.
Results Acute PVI was achieved in 99.3% (1,341 of 1,350) of veins. Mean follow-up was 34 ± 7 months. The rate of major complications was 5.8%, including a 3.2% rate of phrenic nerve injury, which resolved in all but 1 patient by 36 months. At 36 months, 11.7% of patients were prescribed antiarrhythmic agents, inclusive of “pill-in-the-pocket” administration. Freedom from AF was 81.6% at 12 months, 73.8% at 24 months, and 68.1% at 36 months. Freedom from AF and symptomatic atrial flutter/atrial tachycardia was 79.0% at 12 months, 70.8% at 24 months, and 64.1% at 36 months. Freedom from a repeat ablation procedure was 80.9% at 36 months.
Conclusions PVI using the CB2 was an effective treatment for patients with pAF, with freedom from all atrial arrhythmias of 64% at 36 months. (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study [STOP AF PAS]; NCT01456949.)
This analysis was a Medtronic-sponsored, US Food and Drug Administration–required condition of approval study. The institutions of employment for all authors have received compensation from Medtronic to participate as investigators in the study; there were no personal fees provided to the investigators for manuscript development. Dr. Knight has received consulting fees/honoraria, Speakers Bureau honoraria, research grants, and fellowship support from Medtronic. Dr. Sangrigoli, has received consulting fees/honoraria and Speakers Bureau honoraria from Medtronic. Dr. Essebag has received consulting fees/honoraria from Medtronic. Dr. Adler has received consulting fees/honoraria and fellowship support from Medtronic. Dr. Dubuc has received consulting fees/honoraria, Speakers Bureau honoraria, and research grants from Medtronic. Dr. Adler has received consulting fees/honoraria from Medtronic. Dr. Jain has received research grants and consulting fees from Medtronic. Dr. Svinarich has received consulting fees/honoraria from Medtronic. Dr. John has received consulting fees/honoraria from Medtronic. Mr. Hokanson and Mr. Kueffer are employees of Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received July 17, 2018.
- Revision received October 30, 2018.
- Accepted November 1, 2018.
- 2018 American College of Cardiology Foundation