Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial

Abstract

BACKGROUND Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation to treat patients with symptomatic drugrefractory atrial fibrillation (AF).OBJECTIVE The purpose of this study was to assess the safety and efficacy of PVI using the cryoballoon catheter to treat patients with persistent AF.METHODS STOP Persistent AF (ClinicalTrials.gov Identifier: NCT03 012841) was a prospective, multicenter, single-arm, Food and Drug Administration-regulated trial designed to evaluate the safety and efficacy of PVI-only cryoballoon ablation for drug-refractory persistent AF (continuous episodes ,6 months). The primary efficacy endpoint was 12-month freedom from 30 seconds of AF, atrial flutter (AFL), or atrial tachycardia (AT) after a 90-day blanking period. The prespecified performance goals were set at .40% and ,13% for the primary efficacy and safety endpoints, respectively. Secondary endpoints assessed quality of life using the AFEQT (Atrial Fibrillation Effect on Quality of Life) and SF (Short Form)-12 questionnaires. RESULTSOf 186 total enrollments, 165 subjects (70% male; age 65 6 9 years; left atrial diameter 4.2 6 0.6 cm; body mass index 31 6 6) were treated at 25 sites in the United States, Canada, and Japan. Total procedural, left atrial dwell, and fluoroscopy times were 121 6 46 minutes, 102 6 41 minutes, and 19 6 16 minutes, respectively. At 12 months, the primary efficacy endpoint was 54.8% (95% confidence [CI] 46.7%-62.1%) freedom from AF, AFL, or AT. There was 1 primary safety event, translating to a rate of 0.6% (95% CI 0.1%-4.4%). AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months postablation (P ,.001). CONCLUSIONThe STOP Persistent AF trial demonstrated cryoballoon ablation to be safe and effective in treating patients with drug-refractory persistent AF characterized by continuous AF episodes ,6 months.

Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real‐world global setting: Results from the Cryo AF Global Registry

“…World‐wide safety of AF ablation has not been published since 2010, in which outcomes after AF ablation performed by radiofrequency ablation catheters were estimated via a voluntary survey 16 . Here, the world‐wide safety profile of cryoballoon ablation procedures conducted according to standard practice at 93 unique global centers (3.4% serious procedure‐ and 1.5% serious device‐related adverse event rate) aligns with smaller, controlled cryoballoon ablation trials and region‐specific observational registries 2‐4,17‐20 . Despite larger LA diameters and generally higher rates of comorbidities in the PsAF cohort compared to the PAF cohort, adverse event rates were similar for both groups treated in this registry.…”

“…Similar to controlled clinical trials, patients with PsAF had baseline characteristics indicative of more advanced AF disease progression and a higher rate of comorbidities than enrolled patients with PAF 3,4 . Regardless of AF classification, standard‐of‐care approaches to treat patients with AF resulted in a consistent and efficient procedure with an average total procedure time of 82 minutes.…”

“…The cryoballoon ablation procedure was conducted according to standard of care at each participating site. This procedure has been described in detail and typical utilization has been published 1‐8 . In brief, transseptal puncture provided access to the left atrium (LA).…”

“…The Arctic Front™ Cardiac Cryoablation System has been widely adopted for the treatment of patients with atrial fibrillation (AF), and local standards of care with the cryoballoon catheter have been established at hospitals worldwide. Well‐controlled clinical trials evaluating cryoballoon ablation have demonstrated the safety and efficacy of pulmonary vein isolation (PVI) when treating patients with either paroxysmal (PAF) or persistent AF (PsAF) who are refractory to antiarrhythmic drugs (AADs) 1‐4 . Recent reports from controlled clinical trials have also demonstrated the safety and efficacy of cryoballoon ablation for treatment of patients prior to AAD failure 5,6 .…”

First experience of POLARx™ versus Arctic Front Advance™: An early technology comparison

“…Since its introduction in 2007, cryoballoon (CB) ablation has emerged as a valid alternative to the point‐to‐point technique with radiofrequency for achieving PVI 3 and this reproducible and rapid technique has become established as a major technique for index procedures in paroxysmal and persistent AF ablation. Indeed, several landmark studies have demonstrated the feasibility, safety, and efficacy of the CB ablation for both paroxysmal and persistent AF 3‐7 . Compared with radiofrequency, the CB technique offers several advantages such as shorter procedure duration, shorter learning curve and a higher degree of reproducibility 8 .…”