Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes (original) (raw)
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Circulation, 2015
A trial fibrillation (AF), the most common form of cardiac arrhythmia, is associated with a risk of associated complications such as stroke and heart failure, in addition to a higher rate of mortality. 1,2 Sinus rhythm can often be restored with electric cardioversion; however, the rate of AF recurrence is high, even with administration of antiarrhythmic drugs (AADs). 3 In addition to their relatively low efficacy, AADs have the disadvantage of causing adverse events, often leading to discontinuation. 4,5 Catheter ablation is a wellestablished technique for treating paroxysmal AF via pulmonary vein (PV) isolation, with a variety of energy sources used, most commonly radiofrequency (RF) or cryoenergy. 6 RF ablation has been shown to be a highly effective first-or second-line treatment for AF; however, it is associated with more immediate and severe complications compared with drug therapy. 7-10 Incidences of PV stenosis, thromboembolic complications, cardiac perforations with pericardial tamponade, esophageal fistulas, and phrenic nerve palsies (PNPs) have been reported. 7,11 Clinical Perspective on p 1319 The more recently introduced strategy of using a cryoballoon catheter (CB) for PV isolation has produced encouraging results in a number of trials. Neumann et al 12 documented maintained sinus rhythm over a median follow-up period of 12 months in 74% of patients with mainly paroxysmal or persistent AF who underwent the procedure. In a separate longterm study in patients with paroxysmal AF, freedom from AF Background-There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency (RF) and cryoballoon catheter (CB) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. Methods and Results-In a prospective, noninferiority study, 315 patients were randomly assigned to RF (n=159) or CB (n=156) ablation. The primary end point was freedom from atrial arrhythmia with absence of persistent complications. Patients were largely comparable between groups with more vascular disease in the RF group (8.2% versus 2.6% for CB; P=0.028). The primary end point at 12 months was achieved by 70.7% with RF and 73.6% with CB (multiple procedure success), including 31 redo procedures in each group (19.5% of RF versus 19.9% of CB; P=0.933). For the intentionto-treat population, noninferiority of CB was revealed for the predefined inferiority margin (risk difference, 0.029; 95% confidence interval, −0.074 to 0.132; P<0.001). Rates at 6 months were 63.1% and 64.1% for the RF and CB groups (single procedure success), and noninferiority was confirmed (risk difference, 0.010; 95% confidence interval, −0.097 to 0.116; P=0.002). Periprocedural complications for the index procedure were more frequent in the CB group (5.0% RF, 12.2% CB; P=0.022) with a significant difference in phrenic nerve palsies (0% RF, 5.8% CB; P=0.002). Conclusion-This large, prospective, randomized, controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation.
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2015
First-line ablation prior to antiarrhythmic drug (AAD) therapy is an option for symptomatic paroxysmal atrial fibrillation (PAF); however, the optimal ablation technique, radiofrequency (RF), or cryoballoon (CB) has to be determined. The FREEZE Cohort Study compares RF and CB ablation. Treatment-naïve patients were documented in the FREEZEplus Registry. Periprocedural data and outcome were analysed. From 2011 to 2014, a total of 373/4184 (8.9%) patients with PAF naïve to AAD were identified. Pulmonary vein isolation (PVI) was performed with RF (n = 180) or CB (n = 193). In the RF group, patients were older (65 vs. 61 years, P < 0.01) compared with the CB group. The procedure time was significantly shorter and radiation exposure higher in the CB group. Major adverse events occurred in 1.6% (CB) and 3.7% (RF) of patients (P = 0.22). AF/atrial tachycardia (AT) recurrence until discharge was 4.5% (RF) and 8.5% (CB, P = 0.2). Follow-up (FU) ≥12 months was available in 99 (RF) and 107 ...
JACC: Clinical Electrophysiology, 2018
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 AE 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,
Journal of atrial fibrillation, 2019
Aims Pulmonary vein isolation (PVI) can be accomplished using radiofrequency (RF) or second generation cryoballoon (CB2). We aimed to compare the freedom from very late recurrence (VLR) defined as recurrence beyond one year in patients who were AF-free during the first post-procedural year after PVI using CB2 or RF. Methods Consecutive patients who underwent PVI by RF or CB2 ablation between August 2014 and December 2015 were included. The primary endpoint was the occurrence of VLR in follow-up after 12 months. Patients who experienced recurrence between the first 3 to 12 months after PVI and those who did not complete 15-month follow-up time were excluded. Results 139 patients were included: 68 underwent PVI by CB2 and 71 using RF. The global VLR rate was of 22.15%. The freedom from VLR beyond 12-month follow-up was of 84.5% (57 patients) for the CB2 group vs. 71% (50 patients) in the RF group (p=0.037). 15 patients underwent re-ablation (11 of the RF group and 4 of the CB2 group):...
Journal of Cardiovascular Development and Disease
Nowadays, the cryoballoon (CB) constitutes an established alternative to radio frequency (RF) ablation for pulmonary vein isolation (PVI), which offers the possibility to isolate the PVs with a single application. Since the introduction of the second-generation CB, we prospectively collected our data to optimize the procedure on >1000 consecutive patients who underwent CB PVI performed in our center. It is expected that subsequent guidelines will suggest first-line PVI through CB in patients with paroxysmal AF with a class I indication. Indeed, in the long-term follow-up (36 months) of the EARLY-AF trial, CB had a lower incidence of persistent atrial fibrillation episodes compared to the anti-arrhythmic drugs group. We now review the current best practices in an effort to drive consistent outcomes and minimize complications. PV isolation through CB is the most studied single-shot technique for atrial fibrillation ablation, having shown the potential to alter the natural history o...
ARYA Atherosclerosis, 2018
BACKGROUND Atrial fibrillation (AF) is the most common cardiac arrhythmia, and its prevalence increases with advancing age. Pulmonary vein isolation is a standard approach in drug refractory paroxysmal AF which could be performed by cryoballoon ablation (CBA). We tried to evaluate its efficacy and safety in Iranian patients with AF. METHODS From 2015 to 2017, 97 patients with paroxysmal and persistent AF were enrolled in our observational historical cohort study. They were visited 1 and 6 months post-procedure in order to assess the efficacy (recurrence) and safety. Recurrence was defined as 30 seconds of arrhythmia on their 48-hours Holter monitoring. RESULTS Ninety-seven patients enrolled in the study, 64 (66.0%) of them were men, and their mean age was 55 ± 12 years. Hypertension was reported in 41 patients (42.3%), as the most common cardiac risk factor. 71 patients (73.2%) patients with paroxysmal AF and 15 patients (15.5%) with persistent AF underwent the procedure. After 6 mo...
background: There are few data about which is the best technique for the treatment of paroxysmal atrial fibrillation: radiofrequency catheter ablation or cryoballoon ablation. objective: The aim of this study was to compare immediate and long-term outcomes of irrigated radiofrequency ablation with second-generation cryoballoon ablation. Methods: This retrospective, observational, single-center study evaluated 159 consecutive patients with paroxysmal atrial fibrilla-tion undergoing pulmonary vein isolation using radiofrequency or cryoballoon ablation. Patient and procedure characteristics, the immediate success rate and the 12-month outcome were assessed. results: Among a total of 159 patients, 89 underwent cryoballoon ablation and 70 radiofrequency ablation. Mean follow-up was 12 months. There were no significant differences in the population characteristics. The immediate success rate was 97.8% with cry-oballoon ablation versus 97.1% with radiofrequency ablation (p=0.8). Freedom from atrial fibrillation at 12 months after a single procedure was 77.5% with cryoballoon versus 71.4% with radiofrequency (p=0.33) ablation. Cryoballoon ablation was associated with shorter procedure duration compared with radiofrequency ablation (60.19±15 minutes vs. 75.8±31 minutes, respectively; p <0.00001), with shorter left atrial dwell time (45±14 minutes vs. 58±26 minutes; p <0.00001). Fluoroscopy time was significantly higher in the cryoballoon group (18±3.76 minutes vs. 13±2.23 minutes for radiofrequency; p <0.0001). The rate of complications was similar with both procedures (p=0.76). Conclusion: Compared with irrigated radiofrequency ablation, cryoballoon ablation was associated with shorter procedure time and similar rate of complications and freedom from atrial fibrillation at 12 months after a single procedure.
Cryoballoon Ablation for Patients With Paroxysmal Atrial Fibrillation
Circulation Reports, 2020
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in clinical practice and induces cardiac dysfunction and stroke. The development of AF requires a trigger and also an electroanatomic substrate capable of both initiating and perpetuating AF. In the past decade, ectopic beats originating from the pulmonary veins (PV) have been identified as a source of paroxysmal AF. Thus, strategies that target the PV, including the PV antrum, are the cornerstone of most AF ablation procedures. Recently, alternative technologies to radiofrequency catheter ablation for paroxysmal AF such as balloon ablation modalities have been developed. The purpose of this review is to discuss cryoballoon ablation for paroxysmal AF.
Cryoballoon ablation without use of contrast for the treatment of paroxysmal atrial fibrillation
Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) is a well-established method for the treatment of atrial fibrillation (AF). As a rule, cryoenergy delivery is preceded by demonstrating full pulmonary vein (PV) occlusion by injecting contrast. Research on CBA without the use of contrast is sparse. The aim of the study was to determine efficacy and safety of a simplified protocol for CBA performed without demonstrating PV occlusion by venography and compare achieved results with those observed in patients undergoing conventional CBA. Methods This was a dual-centre, prospective, nonrandomized study (NCT04344743). The study cohort consisted of consecutive patients with paroxysmal AF, with 4 separate pulmonary veins (PVs), undergoing a first-time CBA. All ablations were performed using a 28-mm cryoballoon catheter (Arctic Front Advance, Medtronic). In the non-contrast (NC) group CBA was performed using standardized protocol without demonstrating PV occlusion by venography ...
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2017
Cryoballoon ablation (Cryoballoon) has emerged as a new alternative for the treatment of symptomatic drug-refractory atrial fibrillation (AF). Whether the results of Cryoballoon are more reproducible than those of radiofrequency (RF) ablation remains to be proved. A total of 860 consecutive patients undergoing a first ablation procedure for paroxysmal AF (467 treated with RF and 393 treated with Cryoballoon) were selected from a prospective multicentre survey of AF ablation (FrenchAF). Radiofrequency and Cryoballoon were compared regarding mid-term efficacy and safety. During a median follow-up of 14 months (interquartile range 8-23), patients treated with Cryoballoon displayed similar rates of freedom from atrial arrhythmia relapse in centres performing this technique (68-80% at 18 months). However, in centres performing RF, a greater heterogeneity in procedural results was observed (46-79% were free from atrial arrhythmia relapse at 18 months). On multivariate analysis, Cryoballoo...