Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project

Tondo, Claudio; Iacopino, Saverio; Pieragnoli, Paolo; Molon, Giulio; Verlato, Roberto; Curnis, Antonio; Landolina, Maurizio; Allocca, Giuseppe; Arena, Giuseppe; Fassini, Gaetano; Sciarra, Luigi; Luzi, Mario; Manfrin, Massimiliano; Padeletti, Luigi

doi:10.1016/j.hrthm.2017.10.038

Cited by 76 publications

(87 citation statements)

References 14 publications

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“…Takarada et al reported an AF‐free survival without AADs after a single procedure was 71.5% in paroxysmal AF patients at a mean 38.0 ± 7.4 months follow‐up. Furthermore, in the multicenter Italian Clinical Service 1STOP project, Tondo et al reported that the AF‐free survival was 63.9% at 12 months and 51.5% at 18 months in 486 nonparoxysmal AF patients. Furthermore, Akkaya et al reported a 67.9% ATa‐free success rate in 102 persistent AF patients with a 5‐year follow‐up.…”

Section: Discussionmentioning

confidence: 99%

Long‐term outcomes of pulmonary vein isolation using second‐generation cryoballoon during atrial fibrillation ablation

Canpolat

Koçyiğit²,

Yalçın

et al. 2019

Pacing Clinical Electrophis

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Background: Currently available second-generation cryoballoon (CB2) is accepted as an effective and safe tool for pulmonary vein isolation (PVI). Although much more data exist about 1-year outcomes of CB2 ablation, data on long-term outcomes are scarce. Objective:We aimed to assess the long-term outcomes of PVI using CB2 in a large-scale symptomatic atrial fibrillation (AF) population at our tertiary referral center. Methods:In this nonrandomized prospective observational study, a total of 486 patients with paroxysmal (71%) or persistent (29%) AF who underwent index PVI using CB2 at our hospital between January 2013 and June 2017 were enrolled. Atrial tachyarrhythmia (ATa)-free survival was defined as the absence of AF, atrial flutter, or atrial tachycardia recurrence ≥30 s following a 3 months blanking period. Predictors of recurrence were evaluated by univariate and multivariate Cox proportional hazards regression models. Results:Acute procedural success rate was 99.8% (1898( /1902. Mean procedural and fluoroscopy time were 64.9 ± 9.2 and 12.1 ± 2.6, respectively. At median 39 (interquartile range: 26-56) months follow-up, ATa-free survival was 78.6% after a single procedure (280/345 [81.2%] for paroxysmal AF vs. 102/141 [72.3%] for persistent AF, P = .019) and 84.4% after a mean 1.48 ± 0.42 ablations. Cox regression analysis showed that left atrium diameter, duration of AF history, and early ATa recurrence were found as the independent predictors of late recurrence.Phrenic nerve palsy was observed in 17 (3.5%) patients. Conclusions:CB2-based PVI is effective to maintain sinus rhythm in a significant proportion of paroxysmal and persistent AF patients with an acceptable complication rate at long-term follow-up. K E Y W O R D S atrial fibrillation, complication, cryoballoon, recurrence 1 INTRODUCTION As pulmonary vein (PV) isolation (PVI) is accepted as the cornerstone of all atrial fibrillation (AF) ablation procedures, recent expert consen-sus document recommends to isolate PVs at first either using point-bypoint radiofrequency (RF) or cryoballoon (CB) ablation in all patients, including paroxysmal and nonparoxysmal AF. 1 CB technology has been shown to be as effective as RF technique for AF ablation. 2 910

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Section: Discussionmentioning

confidence: 99%

Long‐term outcomes of pulmonary vein isolation using second‐generation cryoballoon during atrial fibrillation ablation

Canpolat

Koçyiğit²,

Yalçın

et al. 2019

Pacing Clinical Electrophis

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“…Patients with AF who had undergone CB‐PVI (using CB‐1, −2, −3, or −4) in 47 Italian institutions from April 2012 to April 2019 were prospectively followed through in‐hospital visits according to each center's clinical practice through the framework of the Italian ClinicalService and 1STOP project . In brief, the project (Clinical Trial Registration: NCT01007474) is a prospective examination of CB ablations conducted in Italian cardiology centers.…”

Section: Methodsmentioning

confidence: 99%

“…Consequently, we examined patients that were treated for AF using the CB‐1 vs CB‐2 vs CB‐3 vs CB‐4. These four cohorts were compared in a real‐world multicenter examination of procedural safety and efficacy utilizing a retrospective review of data held within the 1STOP Italian registry project …”

Section: Introductionmentioning

confidence: 99%

A comparison of acute procedural outcomes within four generations of cryoballoon catheters utilized in the real‐world multicenter experience of 1STOP

Iacopino

Pieragnoli

Arena

et al. 2019

Cardiovasc electrophysiol

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Introduction Four generations of the cryoballoon (CB) catheter were retrospectively evaluated in a real‐world examination of patients with atrial fibrillation (AF). Methods and Results Four hundred eighty patients (27% female and 60 ± 10 years) suffering from AF, underwent pulmonary vein (PV) ablation with one‐of‐four generations of the CB catheter. The total cohort was divided into four groups of patients: 120 with first‐generation (CB‐1); 120 with second‐generation (CB‐2); 120 with third‐generation (CB‐3); and 120 with fourth‐generation (CB‐4). Equal group sizes were achieved by examining the last 120 patients treated in each cohort, attempting to minimize the effect of a learning curve between the generations of CB catheter. Baseline clinical and patient characteristics were similar between the four cohorts, excepting age and the number of tested antiarrhythmic drugs. Procedure, fluoroscopy, and left atrial dwell times were significantly lower in the CB‐4 cohort compared to previous generations of the CB catheters, while the acute procedural success rate was comparable across all catheter groups (>99%). Total acute procedural complications were low (2.5%), and acute complications were comparable within the CB‐2, CB‐3, and CB‐4 groups (0.8% reported in each cohort). The rate of time‐to‐isolation (TTI) visualization increased with later generations of the CB catheters. Conclusions The novel CB‐4 achieved significantly faster procedural ablation times in comparison to the previous generations, while still maintaining a low rate of acute complications. Also, the rate of TTI visualization was observed to be higher with the CB‐4 catheter. Further long‐term evaluation is necessary, including an assessment of AF recurrence and PV reconnection(s).

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“…In particular, among all the different therapeutic options in the setting of patients with drug‐refractory paroxysmal AF, PVI by CB‐A has proven to be noninferior to PVI performed by RF ablation in terms of both efficacy and safety . Subsequently, also in the context of persistent and long‐standing persistent AF, CB‐A has demonstrated to be safe and effective. The overall comparability of these two different techniques, after being addressed by the FIRE and ICE trial, was recently confirmed by an observational cluster cohort study by Hoffmann et al, who showed no difference between CB‐A and RF ablation in terms of atrial arrhythmia recurrence and, furthermore, significantly less rehospitalization due to re‐ablations and adverse events during follow‐up after CB‐A.…”

Section: Discussionmentioning

confidence: 99%

“…1 In particular, among all the different therapeutic options in the setting of patients with drug-refractory paroxysmal AF, PVI by CB-A has proven to be noninferior to PVI performed by RF ablation in terms of both efficacy and safety. 19,20 Subsequently, also in the context of persistent 21,22 and long-standing persistent 22 AF, CB-A has demonstrated to be safe and effective.…”

Section: Discussionmentioning

confidence: 99%

Conversion of atrial fibrillation to sinus rhythm during cryoballoon ablation: A favorable and not unusual phenomenon during second‐generation cryoballoon pulmonary vein isolation

Maj

Borio

Osório

et al. 2020

Journal of Arrhythmia

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Background The prevalence and the clinical impact of conversion of atrial fibrillation (AF) to sinus rhythm (SR) during cryoballoon ablation (CB‐A) are unknown. Objective The purpose of this study was to evaluate the prevalence of restoration of SR during CB‐A and the clinical impact of this phenomenon. Methods Between January 2012 and September 2018, all patients who experienced conversion of AF to SR during CB‐A were included. This group was subsequently matched for gender, age, type of AF, diagnosis‐to‐ablation time, and left atrial size with patients who underwent CB‐A and did not experienced conversion of AF to SR. After discharge, patients were scheduled for follow‐up visits at 1, 3, 6, and 12 months and 24 hours Holter recordings were obtained at each follow‐up visit. All documented AF episodes of >30 seconds were considered as recurrence. A 3 month post‐procedural blanking period (BP) was applied. Results A total of 1559 patients underwent pulmonary veins isolation by CB‐A between January 2012 and September 2018; among them, 58 patients (3.7%) experienced restoration of SR during CB‐A. In total, 53 patients (41 males [77.3%], mean age 61.4 ± 13.3 years) were included in the case group. During CB‐A, restoration of SR occurred more frequently during right‐side PVs applications (right inferior pulmonary vein 39.6%, right superior pulmonary vein 30.2%). If considering a BP, at 2 year follow‐up, freedom from recurrences was 86.5% in the case group and 68.0% in the control group (P = .036). Conclusion Conversion of AF to SR is a favorable and relatively frequent phenomenon during cryoballoon pulmonary vein isolation ablation.

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Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project

Cited by 76 publications

References 14 publications

Long‐term outcomes of pulmonary vein isolation using second‐generation cryoballoon during atrial fibrillation ablation

Long‐term outcomes of pulmonary vein isolation using second‐generation cryoballoon during atrial fibrillation ablation

A comparison of acute procedural outcomes within four generations of cryoballoon catheters utilized in the real‐world multicenter experience of 1STOP

Conversion of atrial fibrillation to sinus rhythm during cryoballoon ablation: A favorable and not unusual phenomenon during second‐generation cryoballoon pulmonary vein isolation

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