Elsevier

Heart Rhythm

Volume 19, Issue 2, February 2022, Pages 197-205
Heart Rhythm

Clinical
Ablation
Quality of life after the initial treatment of atrial fibrillation with cryoablation versus drug therapy

https://doi.org/10.1016/j.hrthm.2021.10.009Get rights and content

Background

The STOP AF First trial recently demonstrated that initial treatment with cryoballoon ablation (CBA) is safe and superior to antiarrhythmic drug (AAD) therapy for preventing atrial arrhythmia recurrence in patients with symptomatic atrial fibrillation (AF).

Objective

The purpose of this study was to evaluate the change in quality of life (QoL) and symptoms after first-line CBA vs AAD therapy.

Methods

Patients with symptomatic AF not previously receiving rhythm control therapy were randomized to AAD (class I or III) or CBA (Arctic Front Advance, Medtronic, Mounds View, MN). QoL was evaluated at baseline and at 6 and 12 months by using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Quality of Life–5 Dimensions questionnaires. A review of AF-associated symptoms was conducted at baseline and at 1, 3, 6, and 12 months.

Results

In total, 203 subjects received either CBA (n = 104 [51.2%]) or AAD therapy (n = 99 [48.8%]). Improvements in the AFEQT summary and subscale scores were significantly larger with CBA than with AAD therapy at 6 and 12 months (P < .02 for all). Clinically meaningful improvement (>5 points) in the AFEQT summary score from baseline to 12 months was observed in 96.0% (100) of patients in the CBA arm vs 72.2% (71) of patients in the AAD arm (P < .001). No significant between-group differences were observed in the change in the European Quality of Life–5 Dimensions index or visual analog scale scores. Overall, 54.4% (57) of the CBA group vs 29.7% (29) of the AAD group reported no AF-specific symptom recurrence after a 90-day blanking period (P = .0005).

Conclusion

First-line CBA vs AAD therapy is associated with larger improvements in AF-specific QoL and a higher rate of symptom resolution.

Introduction

Patients with atrial fibrillation (AF) can experience significant symptoms that lead to anxiety, inhibit activities of daily living,1 and increase health care utilization.2,3 Accordingly, arrhythmia symptom control is an important aspect of AF management. In the absence of definitive evidence that restoring sinus rhythm reduces mortality or stroke in patients with AF, rhythm control is primarily indicated to reduce symptoms that impair quality of life (QoL).4,5 Consequently, it is important to understand the impact of different rhythm control strategies on patient experience and well-being.

Current guidelines and consensus statements suggest that patients pursuing rhythm control therapy should initially be treated with drugs before undergoing catheter ablation.4, 5, 6 However, 3 recent randomized trials demonstrated that initial treatment with cryoballoon catheter ablation (CBA) is superior to antiarrhythmic drug (AAD) therapy for preventing atrial arrhythmia (AA) recurrence in patients with symptomatic paroxysmal AF.7, 8, 9 Moreover, serious procedure-related complications were uncommon, and CBA did not result in a higher rate of serious adverse events as compared with AAD therapy.7, 8, 9 These findings suggest that there may be benefit to first-line CBA in patients who have not been deemed AAD refractory or intolerant. However, the impact of initial treatment with CBA on patient-reported outcome measures has not been as well characterized. The objective of this examination was to evaluate changes in symptoms and QoL with initial “first-line” therapy via CBA vs AAD treatment in the prospective randomized STOP AF First trial.8

Section snippets

Trial design

STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation (STOP AF First; ClinicalTrials.gov identifier NCT03118518) was a prospective, multicenter, randomized (1:1) study evaluating whether CBA is superior to AAD therapy as an initial rhythm control treatment in patients with symptomatic paroxysmal AF. The study was sponsored by Medtronic, who was responsible (with steering committee oversight) for the development of the final protocol and

Patients and treatment characteristics

A total of 203 subjects received either CBA (n = 104) or AAD therapy (n = 99) and were included in the modified intention-to-treat cohort. Overall, 191 of 203 subjects (94.1%) completed 12 months of follow-up. Patient characteristics are presented in Table 1. In total, 7 of 104 subjects (6.7%) in the CBA arm received AAD therapy after the 3-month blanking period. Overall, 34 of the 99 AAD arm subjects (34.3%) had ablation during follow-up, with 17 having between baseline and 6 months and 17

Discussion

In this prospective randomized study, initial rhythm control with either CBA or AAD significantly improved AF-specific and generic QoL measures over 12 months of follow-up. However, larger improvements in AF-specific QoL as assessed by the AFEQT questionnaire were observed with CBA vs AAD treatment, and significantly more patients in the CBA arm had clinically meaningful improvements in the AFEQT summary score. Additionally, initial rhythm control with CBA vs AAD therapy resulted in a larger

Conclusion

In this randomized controlled trial of initial rhythm control with CBA vs AAD therapy, CBA resulted in more patients experiencing symptom resolution. Moreover, larger improvements in AF-specific QoL were observed with CBA vs AAD therapy, and more patients in the CBA group had clinically meaningful improvements in AF-specific QoL. These findings may help guide treatment decisions for patients with symptomatic AF pursuing rhythm control therapy.

Acknowledgments

We acknowledge the invaluable contributions of the trial team, including the trial participants, STOP AF First sites and their dedicated staff, and the Medtronic staff (Jennifer Diouf, Deanna Levenhagen, Jeffrey Cerkvenik, Bob Hokanson, and Hae Lim).

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Funding Sources: The STOP AF FIRST trial was funded by Medtronic.

Disclosures: Dr Wazni is a consultant and speaker for Boston Scientific and Biosense Webster. Dr Dandamudi is a consultant for Medtronic and Abbott and serves on advisory boards for Medtronic, Biotronik, and Abbott. Dr Sood receives research grant support from Medtronic. Dr Hoyt is a speaker and consultant for Abbott and serves on advisory boards for Medtronic. Dr Niebauer serves on a data safety monitoring board for Medtronic. Dr Makati receives research grant support from AtriCure, Boston Scientific, and Medtronic and is a consultant, advisor, and speaker for AtriCure, Boston Scientific, Medtronic, and Abbott. Dr Gauri is a consultant for Medtronic, AtriCure, and iRhythm. Dr Morales is the recipient of a research grant from Medtronic. Ms Pouliot and Dr Kaplon are employed by and stockholders of Medtronic. The rest of the authors report no conflicts of interest.

ClinicalTrials.gov identifier: NCT03118518.

1

A complete list of STOP AF First investigators is provided in the Online Supplemental Appendix.

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