BACKGROUND:Early recurrence of atrial tachyarrhythmias (ERAT) within 3 months of thermal ablation for atrial fibrillation (AF) is common and often considered transient. Pulsed field ablation (PFA) is a nonthermal energy source in which ERAT is not well described. OBJECTIVE:The purpose of this study was to analyze ERAT in patients with AF undergoing PFA in the Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF) trial. METHODS:This analysis included 154 (52.4%) paroxysmal AF and 140 (47.6%) persistent AF who had ≥10 rhythm assessments during the 90-day blanking period. ERAT was defined as any instance of ≥30 seconds of AF, atrial flutter, or atrial tachycardia on transtelephonic monitoring (weekly and symptomatic) or ≥10 seconds on electrocardiography (at 3 months), both within 90 days. Late recurrence of atrial tachyarrhythmias (LRAT) was defined as observed atrial tachyarrhythmias between 90 days and 12 months. RESULTS:The overall prevalence of ERAT was 27.1% in patients with paroxysmal AF and 31.6% in patients with persistent AF. In patients with ERAT, 73% had ERAT onset within the first month of the procedure. The presence of ERAT was associated with LRAT in patients with paroxysmal AF (hazard ratio 6.4; 95% confidence interval 3.6-11.3) and patients with persistent AF (hazard ratio 3.8; 95% confidence interval 2.2-6.6). Yet, in 29.4% of patients with paroxysmal AF and 34.3% of patients with persistent AF with ERAT, LRAT was not observed. LRAT was positively correlated with the number of ERAT observations. CONCLUSION:ERAT after PFA predicted LRAT in patients with paroxysmal and persistent AF. However, the concept of a blanking period after PFA is still valid, as approximately one-third of patients with ERAT did not continue to have LRAT during follow-up and may not need reablation.

Background With advancements in technology and ablation techniques, catheter ablation for the treatment of atrial fibrillation (AF) has become safer with time. In the past, standard-of-care recommended overnight stay for outpatient procedures. As safety has improved and procedure times have shortened, some centers have allowed for same-day discharge. We report the results of a multi-center, randomized clinical trial investigating the safety of same-day discharge post-cryoballoon ablation. Methods Patients with paroxysmal atrial fibrillation underwent pulmonary vein isolation (PVI) with the Medtronic Arctic Advance cryoballoon at 3 US centers. Six hours after the procedure, patients were randomized to either stay overnight or be discharged same day. Results A total of 49 patients were enrolled. Two patients were withdrawn prior to randomization. One patient chose to withdraw after randomization. Of the 22 patients randomized to same-day discharge and the 23 patients randomized the overnight stay, no significant adverse outcomes were reported in either group. Occurrence of adverse events did not differ significantly between the two groups. Procedure time and fluoroscopy time did not significantly differ between groups. Conclusions This is the first randomized trial examining the safety of same-day discharge post-cryoballoon ablation. Based on our results, same-day discharge following cryoballoon ablation for paroxysmal AF is a safe option following uncomplicated ablation for PVI. Operators should use their discretion in selecting patients for same-day discharge.

Ms. Paskman and Ms. Hammond are employees of Abbott. The other authors report no conflicts of interest for the published content. Address correspondence to: Robert Sangrigoli, MD. Email: rsangrigoli@dh.org. A 49-year-old woman with multiple documented episodes of narrow QRS complex tachycardia underwent electrophysiology study at our hospital. Baseline ventricular pacing demonstrated eccentric retrograde coronary sinus activation consistent with a left lateral accessory pathway (Figure 1A). Orthodromic tachycardia using a left lateral accessory pathway was repeatedly induced.

The STOP Persistent AF trial demonstrated that pulmonary vein isolation (PVI) by cryoablation was safe and effective for the treatment of patients with persistent atrial fibrillation (PsAF). To evaluate freedom from symptomatic atrial arrhythmia recurrence and corresponding patient quality of life after cryoablation for PsAF. The STOP Persistent AF trial was a prospective study that evaluated the safety and efficacy of PVI via cryoballoon ablation (Arctic Front Advance, Medtronic, Inc.) for the treatment of patients with PsAF (<6 mo episode duration) enrolled at 25 sites in the US, Canada, and Japan. The primary efficacy endpoint was freedom from ≥30 sec AF/AFL/AT recurrence, reablation, AAD increase or initiation at 12-mo excluding a 3-mo blanking period. Symptoms were documented at the time of 24 h Holters at 6 and 12 mo and weekly/symptomatic transtelephonic monitoring. Freedom from ≥30 sec symptomatic AF/AFL/AT recurrence after the blanking period was evaluated. Quality of life (AFEQT) was compared between patients with and without a symptomatic recurrence at 12 mo. A total of 165 patients (65±9 years, 70.3% male, LAD 4.2±0.6 mm, AF onset 2.5±4.8 years) were included. Freedom from all primary efficacy failures was 54.8% (95% CI: 46.7-62.1%), and freedom from symptomatic AF/AFL/AT recurrence was 71.1% (95% CI: 63.4 - 77.5%) at 12-months. Asymptomatic recurrence accounted for 36.1% of efficacy failures in the trial. Overall, the mean AFEQT score increased from 63.7 at baseline to 89.5 at 12 mo (25.8 point increase; p<0.001). The AFEQT score improved more in patients without an efficacy failure vs subjects with symptomatic arrhythmia recurrence (31.2% vs 17.1%, p<0.001). The 12 mo improvement in AFEQT for subjects with asymptomatic recurrence (25.0%) was not significantly different from either the symptomatic recurrence or treatment success group (17.1% and 31.2%, respectively; p>0.05). A high rate of freedom from symptomatic arrhythmia recurrence evaluated with weekly monitoring and significant improvements in quality of life were observed after cryoablation for PsAF.

Introduction: With advancements in technology and techniques, catheter ablation for the treatment of atrial fibrillation (AF) has become safer with time. Historically, standard-of-care recommended overnight stay after procedure. With improved safety and shorter procedure times, some centers have allowed for same-day discharge (SDD). We report the results of a multi-center, randomized clinical trial investigating the safety of SDD after cryoballoon (CB) ablation of paroxysmal AF. Methods: Patients underwent pulmonary vein isolation (PVI) with the Medtronic Arctic Advance TM cryoballoon at 3 experienced U.S. centers. Six hours after procedure, patients were randomized to either stay overnight or be discharged same-day after meeting study inclusion criteria. Results: A total of 51 patients were enrolled. Two were determined to be screen-fails following ablation of extra-pulmonary foci. Final analysis encompassed the 46 patients who completed randomization and follow-up, with 23 randomized to each group. No significant adverse outcomes were reported in either group, defined as major cardiovascular or cerebrovascular events. Occurrence of any adverse events, including arrhythmia recurrence, vascular complication, ventricular arrhythmia, syncope, pacemaker implant, pulmonary vein stenosis, and persistent phrenic nerve palsy, did not differ significantly between the two groups (p=1.0). Four patients had symptomatic and/or documented recurrence of atrial arrhythmia, three of which were in the same-day discharge group. Two patients developed cough post-operatively, one from each group. One patient from the next-day discharge cohort was diagnosed with pneumonia >2 weeks post-procedure. No patients from either group required emergency room visits due to delayed procedural-related complications. Conclusions: This is the first randomized trial to our knowledge examining the safety of SDD post CB ablation. Based on our results, SDD following CB ablation is a safe option following uncomplicated ablation for PVI. Operators should use their discretion in selecting patients for SDD.

BACKGROUND Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation to treat patients with symptomatic drug-refractory 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: NCT03012841) 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. RESULTS Of 186 total enrollments, 165 subjects (70% male; age 65 +/- 9 years; left atrial diameter 4.2 +/- 0.6 cm; body mass index 31 +/- 6) were treated at 25 sites in the United States, Canada, and Japan. Total procedural, left atrial dwell, and fluoroscopy times were 121 +/- 46 minutes, 102 +/- 41 minutes, and 19 +/- 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). CONCLUSION The 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.

Current guidelines recommend pulmonary vein isolation (PVI) as the cornerstone of atrial fibrillation (AF) ablation, including persistent AF (PerAF). Multiple examinations support cryoablation for paroxysmal AF, however, there are limited evaluations in PerAF patients. The STOP PERSISTENT AF study

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) (C) 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.

BACKGROUND:Pulmonary vein isolation by catheter ablation is a class IA indication for the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation (PAF). Quality of life (QoL) has been identified as a clinically meaningful endpoint but has not been comprehensively evaluated to date.OBJECTIVE:The purpose of this study was to evaluate the effects of cryoballoon ablation on long-term QoL.METHODS:As part of the STOP-AF Post-Approval Study, QoL was assessed using the Short Form-12 Health Survey (SF-12) along with evaluation of arrhythmia-related symptoms through 36 months. A multivariate linear mixed effects regression was used to determine the association between atrial fibrillation symptoms and QoL scores, and univariate linear regressions were used to assess predictors of 36-month change in QoL scores.RESULTS:Three hundred thirty-five subjects fully completed SF-12 forms at baseline, with 319, 308, 291, and 278 subjects completing surveys at the subsequent follow-up visits. Both physical and mental composite scores increased significantly from baseline (P <.001), and all arrhythmia symptoms significantly decreased from baseline (P <.001), with 62.0% of subjects reporting no symptoms at 6 months compared to 5.7% at baseline (P <.001). Presence of dyspnea and fatigue at baseline were univariate predictors of physical QoL improvement (P = .045 and 0.0497, respectively), whereas each year of age and each year of PAF duration were predictors of a decrease in mental QoL (P = .014 and .04, respectively).CONCLUSION:Cryoballoon ablation for treatment of PAF results in a significant, and sustained, QoL improvement. The observed improvement in physical and mental health likely may be mediated by a reduction in symptom and arrhythmia burden.

Introduction: This analysis evaluates clinical predictors of arrhythmia recurrence in patients with drug-refractory recurrent symptomatic paroxysmal AF who have undergone ablation using the second ...

Background: Cryoballoon ablation has been effective in treating atrial fibrillation (AF) with high rate of pulmonary vein isolation (PVI). Repeat ablation for failed prior cryoballoon PVI may revea...

Purpose: The purpose of this interim analysis was to determine the impact of cryoballoon ablation, using the second generation cryoballoon, on AF symptoms and quality of life (QOL) at 12 months post-ablation in patients with drug-refractory recurrent symptomatic paroxysmal AF. Methods: The STOP-AF Post Approval Study (PAS) is a prospective, multi-center, non-randomized, single-arm, unblinded, condition of approval study, designed to provide long-term safety and efficacy data for cryoballoon ablation. A total of 402 patients at 39 sites from the United States and Canada are participating in the study. Changes in arrhythmic symptoms and QOL (using the SF-12 Health Survey) are assessed at baseline, 6 months, 12 months, and annually thereafter. Results: At the time of this interim analysis, 304 patients (67% male; 60 ± 10 years of age; with AF onset 4.7 ± 5.6 years prior to baseline) treated with the second generation cryoballoon for drug-refractory, recurrent symptomatic paroxysmal AF completed symptom evaluations at both baseline and 12 months. At 12 months post-ablation, there was a 56% reduction in arrhythmic symptoms. This symptomatic improvement was confirmed by significant improvement in SF-12 scores in patients reporting QOL at 12 months post-ablation. The SF-12 mean physical component score improved from 45.3 to 50.1 (p < 0.01) and the mental component scores improved from 49.4 to 53.0 (p < 0.01). Arrhythmia-related symptom reduction was statistically significant (p < 0.01) 12 months post-ablation for all patient symptoms: dizziness (35.5% to 6.3%), palpitations (74.0% to 25.0%), rapid heartbeat (39.5% to 9.2%), dyspnea (41.1% to 8.2%), fatigue (57.2% to 7.9%), and syncope (5.3% to 0.0%). Conclusions: Patients treated with the second generation cryoballoon demonstrated a significant improvement in arrhythmia related symptoms and QOL from baseline to 12 months post-ablation.

Purpose: The purpose of this interim analysis was to report the safety and 12 month efficacy from the largest prospective multi-center trial evaluating cryoballoon ablation using the second generation cryoballoon (CB2) in the United States and Canada. Methods: The STOP-AF post approval study is a prospective, multi-center, non-randomized study designed to provide long-term safety and efficacy data for cryoballoon ablation. Safety data is presented on the final enrolled cohort of patients treated with CB2 (n = 345). Freedom from atrial fibrillation (AF) and symptomatic atrial flutter (AFL) / tachycardia (AT) is presented for patients who had a minimum of 12 months follow-up at the time of this interim analysis (n = 338). Kaplan-Meier estimate was utilized for calculating the primary endpoint. Documented AF lasting longer than 30 seconds and/or a repeat ablation after the 90-day blanking period were considered treatment failures. Results: Upon completion of enrollment, 345 patients were treated with CB2 for drug-refractory, recurrent symptomatic paroxysmal AF. Acute pulmonary vein isolation (PVI) was achieved in 99.4% (343/345) of patients. Of the 345 patients, 338 (98%) had a minimum of 12-months follow-up (mean follow-up 17 ± 7 months). Freedom from AF at 12 months was 82.8% (95% CI: 78.2% to 86.5%) and freedom from AF and symptomatic AFL/AT was 80.0% (95% CI: 75.3% to 84.0%). Phrenic nerve injury (PNI) was unresolved at hospital discharge in 11 patients (3.2%). PNI resolved in 8/11 patients (mean time to resolution = 125 days) and was still present after 12 months in 3 patients (0.9%). Other major events included: cerebrovascular accident (0.3%), PV stenosis (0.6%), pericardial effusion (0.6%), tamponade (0.3%), and hemoptysis (0.9%). No device or procedure related deaths occurred. Conclusions: PVI using the CB2 is a highly effective treatment for patients with drug-refractory recurrent symptomatic paroxysmal AF. This analysis reports freedom from AF of 82.8%, and freedom from all atrial arrhythmias of 80.0% at 12 months. PNI ongoing beyond 12 months is observed in less than 1% of patients.