Best Practice Guide for Cryoballoon Ablation in Atrial Fibrillation: The Compilation Experience of More than 1000 Procedures

Tsiachris, Dimitriοs; Antoniou, Christos‐Konstantinos; Doundoulakis, Ioannis; Manolakou, Panagiota; Sougiannis, Demetrios; Kordalis, Athanasios; Gatzoulis, Konstantinos; Chierchia, Gian‐Battista; Asmundis, Carlo de; Stefanadis, Christodoulos; Tsioufis, Κonstantinos

doi:10.3390/jcdd10020055

Cited by 4 publications

(5 citation statements)

References 87 publications

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“…4 Despite over a decade of use the safety profile of cryoablation remains relatively unchanged. [5][6][7][8][9][10] Recently a novel 28 mm cryoballoon system that operates under markedly lower pressure and maintains constant balloon size during cooling has become available for clinical studies. 11 Additionally, a second generation of this novel cryoballoon that allows inflation and ablation at 2 sizes, 28 or 31 mm, has also become available.…”

Section: Introductionmentioning

confidence: 99%

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One‐year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial

Ellenbogen,

Mittal,

Varma

et al. 2024

Cardiovasc electrophysiol

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IntroductionCryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open‐label, prospective, single‐arm study on the safety and performance of a novel cryoballoon system for treatment of PAF.Methods and ResultsThe study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of one or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow‐up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean ± SD or median (IQR). PVI was performed with a 28 mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60 s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [temporary 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), antiarrhythmic drugs (AAD) were continued or re‐initiated in 26.8% of patients after the 3‐month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31 mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved before discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%.ConclusionsThis novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomies present in patients with PAF. This cryoballoon system proved to be safe and effective for treatment of patients with drug refractory or drug intolerant PAF.

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Section: Introductionmentioning

confidence: 99%

“…Additionally, FIRE and ICE showed that cryoablation has a distinct safety profile compared to RF, shifting primary safety events from heat associated pericarditis/perforation to cold associated phrenic nerve impairment and PV stenosis 4 . Despite over a decade of use the safety profile of cryoablation remains relatively unchanged 5–10 …”

Section: Introductionmentioning

confidence: 99%

One‐year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial

Ellenbogen,

Mittal,

Varma

et al. 2024

Cardiovasc electrophysiol

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“…Medical therapy is the first choice, but its effectiveness in reducing the frequency and symptoms of AF recurrence is limited [3]. Ablation is recommended as a second-line AF treatment therapy when medical treatment is ineffective or not tolerated in patients with paroxysmal or persistent AF [5,11,12]. Radiofrequency (RF) ablation and balloon cryoablation can be used to achieve pulmonary vein isolation [13].…”

Section: Discussionmentioning

confidence: 99%

Results of a 4-Year Follow Up of Patients with Paroxysmal and Persistent Atrial Fibrillation after Cryoablation

Radauskaite,

Račkauskas,

Danilenko

et al. 2023

Medicina

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Background and Objectives: Cryoablation is an established treatment method for atrial fibrillation (AF). We present the long-term results of cryoablation in 94 patients with paroxysmal and persistent AF treated in our center. Materials and Methods: This was an observational, retrospective study of 94 patients who underwent a cryoablation procedure for paroxysmal or persistent AF from 2015 to 2017. The follow up was 51 ± 3 months. The absence of arrhythmia was checked at 6, 12, 24, and 48 months after the procedure with 24 h Holter monitoring. We evaluated echocardiography parameters before and 48 months after cryoablation. The quality of life was assessed by calculating EHRA scores at each visit. Results: The mean history of pre-procedural AF duration was 55.3 ± 8.6 months. Paroxysmal AF was present in 42% of patients and persistent AF in 58%. Comparing the EHRA classes, a statistically significant difference was observed between the score assessed before the procedure and the score after one year, as well as when comparing the rates before the procedure and four years after the procedure (p < 0.000). The recurrence of AF was observed in 22.3% of patients 1 year after the procedure, in 26.6% of patients 2 years after the procedure, and in 34% of patients 4 years after the procedure; 9.3% of them were left in permanent AF. During the observation period, 28% of patients underwent a repeated pulmonary vein isolation procedure, and 6% of patients had a permanent pacemaker implanted. Five hematomas (5%) and one instance of phrenic nerve palsy (1%) were observed during the procedure. Conclusions: The rate of arrhythmia recurrence increased every year after cryoablation. Quality of life improved after the procedure, despite the recurrence of AF. A quarter of patients had to undergo a repeat pulmonary vein isolation procedure.

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“…Cryoballoon or radiofrequency catheter ablation has emerged as a first‐line treatment of AF with high procedural success (>80%) in high‐volume, experienced centers. 77 , 78 , 79 Given the heterogeneity of the substrate of AF, there are 3 main techniques used for AF ablation: pulmonary vein isolation, LA linear isolation, and LA electrophysiological targets. Hypothesizing that the implanted device creates focal, ectopic electric activity, the third approach is probably the most appropriate.…”

Section: Managementmentioning

confidence: 99%

Atrial Fibrillation After Patent Foramen Ovale Closure: Incidence, Pathophysiology, and Management

Apostolos,

Tsiachris,

Drakopoulou

et al. 2024

JAHA

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This comprehensive review explores the incidence, pathophysiology, and management of atrial fibrillation (AF) following percutaneous closure of patent foramen ovale (PFO). Although AF is considered a common adverse event post PFO closure, its incidence, estimated at <5%, varies based on monitoring methods. The review delves into the challenging task of precisely estimating AF incidence, given subclinical AF and diverse diagnostic approaches. Notably, a temporal pattern emerges, with peak incidence around the 14th day after closure and a subsequent decline after the 45th day, mimicking general population AF trends. The pathophysiological mechanisms behind post PFO closure AF remain elusive, with proposed factors including local irritation, device‐related interference, tissue stretch, and nickel hypersensitivity. Management considerations encompass rhythm control, with flecainide showing promise, and anticoagulation tailored to individual risk profiles. The authors advocate for a personalized approach, weighing factors like age, comorbidities, and device characteristics. Notably, postclosure AF is generally considered benign, often resolving spontaneously within 45 days, minimizing thromboembolic risks. Further studies are required to refine understanding and provide evidence‐based guidelines.

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Best Practice Guide for Cryoballoon Ablation in Atrial Fibrillation: The Compilation Experience of More than 1000 Procedures

Cited by 4 publications

References 87 publications

One‐year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial

One‐year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial

Results of a 4-Year Follow Up of Patients with Paroxysmal and Persistent Atrial Fibrillation after Cryoablation

Atrial Fibrillation After Patent Foramen Ovale Closure: Incidence, Pathophysiology, and Management

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