TY - JOUR
T1 - Positive Clinical Benefit on Patient Care, Quality of Life, and Symptoms After Contact Force-Guided Radiofrequency Ablation in Persistent Atrial Fibrillation
T2 - Analyses From the PRECEPT Prospective Multicenter Study
AU - Natale, Andrea
AU - Calkins, Hugh
AU - Osorio, Jose
AU - Pollak, Scott J.
AU - Melby, Daniel
AU - Marchlinski, Francis E.
AU - Athill, Charles A.
AU - Delaughter, Craig
AU - Patel, Anshul M.
AU - Gentlesk, Philip J.
AU - Deville, Brian
AU - MacLe, Laurent
AU - Ellenbogen, Kenneth A.
AU - Dukkipati, Srinivas R.
AU - Reddy, Vivek Y.
AU - Mansour, Moussa
N1 - Funding Information:
We wish to express our appreciation to all the Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PRECEPT) trial investigators. The PRECEPT study was sponsored by Biosense Webster, Inc. We wish to thank the following individuals for their efforts in execution of the trial, statistical analysis, medical writing, and providing valuable input/contribution to the development of the manuscript: Robert Stagg, Reecha Sharma, Lee Ming Boo, Christina Kaneko, Bharat Kumar Janapala, Lingqiao Zhang, Tiffany Tan, and Me-dErgy HealthGroup. The authors retained full control of the manuscript content.
Funding Information:
The study is funded by Biosense Webster, Inc (Irvine, CA).
Publisher Copyright:
© 2021 Lippincott Williams and Wilkins. All rights reserved.
PY - 2021/1/1
Y1 - 2021/1/1
N2 - Background: There is limited evidence on the long-term clinical benefits of catheter ablation in patients with persistent atrial fibrillation. Methods: PRECEPT was a prospective, multicenter, single-arm Food and Drug Administration-regulated investigational device exemption clinical study. Patients were followed up to 15 months after ablation. Outcomes included use of antiarrhythmic drugs, rate of cardioversions and cardiovascular hospitalization, Atrial Fibrillation Effect on Quality-of-Life score, and Canadian Cardiovascular Society Severity of Atrial Fibrillation score. Results: A total of 333 enrolled persistent atrial fibrillation patients underwent ablation. The cardioversion rate decreased by 83% at the 9- to 15-month follow-up. Antiarrhythmic drug utilization decreased by 69% at 12 to 15 months post-ablation. The Kaplan-Meier estimate of freedom from cardiovascular hospitalization was 84.2% (95% CI, 80.2%-88.2%) at 15 months. Consistent improvements in mean Atrial Fibrillation Effect on Quality-of-Life composite (+50.0) were seen at 6 months, sustained at 15 months, and exceeded the minimum clinically important difference. Improvements in Atrial Fibrillation Effect on Quality-of-Life scores were significantly better among participants without documented atrial arrhythmia recurrences. By Canadian Cardiovascular Society Severity of Atrial Fibrillation symptom classification, >80% of patients were asymptomatic (class 0) at 15 months post-ablation compared with only 0.7% at baseline. Conclusions: Contact force-guided radiofrequency ablation of persistent atrial fibrillation was associated with a significant decrease in antiarrhythmic drug use, cardioversion rate, and hospitalization. Clinically meaningful improvements in quality of life were observed in all patients. The majority of the patients (>80%) were asymptomatic at 15 months post-ablation. The positive clinical impact of improved quality of life and reduced health care utilization may help with shared decision-making in persistent atrial fibrillation treatment. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02817776.
AB - Background: There is limited evidence on the long-term clinical benefits of catheter ablation in patients with persistent atrial fibrillation. Methods: PRECEPT was a prospective, multicenter, single-arm Food and Drug Administration-regulated investigational device exemption clinical study. Patients were followed up to 15 months after ablation. Outcomes included use of antiarrhythmic drugs, rate of cardioversions and cardiovascular hospitalization, Atrial Fibrillation Effect on Quality-of-Life score, and Canadian Cardiovascular Society Severity of Atrial Fibrillation score. Results: A total of 333 enrolled persistent atrial fibrillation patients underwent ablation. The cardioversion rate decreased by 83% at the 9- to 15-month follow-up. Antiarrhythmic drug utilization decreased by 69% at 12 to 15 months post-ablation. The Kaplan-Meier estimate of freedom from cardiovascular hospitalization was 84.2% (95% CI, 80.2%-88.2%) at 15 months. Consistent improvements in mean Atrial Fibrillation Effect on Quality-of-Life composite (+50.0) were seen at 6 months, sustained at 15 months, and exceeded the minimum clinically important difference. Improvements in Atrial Fibrillation Effect on Quality-of-Life scores were significantly better among participants without documented atrial arrhythmia recurrences. By Canadian Cardiovascular Society Severity of Atrial Fibrillation symptom classification, >80% of patients were asymptomatic (class 0) at 15 months post-ablation compared with only 0.7% at baseline. Conclusions: Contact force-guided radiofrequency ablation of persistent atrial fibrillation was associated with a significant decrease in antiarrhythmic drug use, cardioversion rate, and hospitalization. Clinically meaningful improvements in quality of life were observed in all patients. The majority of the patients (>80%) were asymptomatic at 15 months post-ablation. The positive clinical impact of improved quality of life and reduced health care utilization may help with shared decision-making in persistent atrial fibrillation treatment. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02817776.
KW - AFEQT
KW - health care utilization
KW - persistent atrial fibrillation
KW - quality of life
KW - radiofrequency ablation
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U2 - 10.1161/CIRCEP.120.008867
DO - 10.1161/CIRCEP.120.008867
M3 - Article
C2 - 33290093
AN - SCOPUS:85100279837
SN - 1941-3149
VL - 14
SP - E008867
JO - Circulation: Arrhythmia and Electrophysiology
JF - Circulation: Arrhythmia and Electrophysiology
IS - 1
ER -