Bradley P Knight1, Paul G Novak2, Robert Sangrigoli3, Jean Champagne4, Marc Dubuc5, Stuart W Adler6, J Thomas Svinarich7, Vidal Essebag8, Robert Hokanson9, Fred Kueffer9, Sandeep K Jain10, Roy M John11, Moussa Mansour12. 1. Northwestern University, Chicago, Illinois. Electronic address: bknight@nm.org. 2. University of British Columbia Royal Jubilee Hospital, Victoria, British Columbia, Canada. 3. Doylestown Cardiology Associates, Doylestown, Pennsylvania. 4. Quebec Heart Institute, Quebec City, Quebec, Canada. 5. Montreal Heart Institute, Montreal, Quebec, Canada. 6. HealthEast Heart Care, St. Paul, Minnesota. 7. Colorado Heart and Vascular, Denver, Colorado. 8. McGill University Health Center, Division of Cardiology, Montreal, Quebec, Canada. 9. Medtronic, Mounds View, Minnesota. 10. University of Pittsburgh, Pittsburgh, Pennsylvania. 11. Vanderbilt University, Nashville, Tennessee. 12. Massachusetts General Hospital, Boston, Massachusetts.
Abstract
OBJECTIVES: STOP AF PAS (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study) 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 was required by the U.S. 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).
OBJECTIVES: STOP AFPAS (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study) 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 AFPAS was required by the U.S. 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 AFPAS]; NCT01456949).
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Authors: Graham Peigh; Jeremiah Wasserlauf; Kelly Vogel; Rachel M Kaplan; Anna Pfenniger; Daniel Marks; Arjun Mehta; Alexandru B Chicos; Rishi Arora; Susan Kim; Albert Lin; Nishant Verma; Kaustubha D Patil; Bradley P Knight; Rod S Passman Journal: J Cardiovasc Electrophysiol Date: 2021-07-05 Impact factor: 2.942