Does cryoballoon ablation affect the symptom severity of atrial fibrillation? Insights from 12-months continuous cardiac monitoring.

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Most data on asymptomatic atrial fibrillation (AF) recurrence following catheter ablation primarily derive from studies on radiofrequency ablation (RFA). Our previous study with a small sample size revealed no significant difference in AF freedom rates detected via patient history, ECG, Holter monitoring, and continuous cardiac monitoring in the cryoballoon ablation (CBA) group. This study aims to evaluate alterations in AF symptoms following pulmonary vein (PV) CBA using implantable loop recorders (ILR) and patient-reported data. A total of 145 patients with highly symptomatic AF (EHRA score ≥ 2b) were consecutively enrolled and underwent primary PV CBA with simultaneous ILR implantation. Follow-up visits occurred at 3-, 6-, and 12-months post-ablation. Data were collected from patients' symptom logs, ILR readings, and clinical events at each visit. Clinical efficacy was defined as the absence of AF recurrence based on patients' symptom logs, while absolute efficacy was defined as the absence of AF detected by ILR. ILR detection served as the reference standard, and detection via patient symptom log was considered the test method. The absolute efficacy was 57,2% (n = 83). All cases of AF relapse were also reported by patients in their symptom logs. Agreement between patient-reported data and ILR data was substantial, with a κ statistic value of 0.98. The agreement between patient-reported data and ILR data showed a κ statistic value of 0.98. CBA using second-generation cryoballoon does not significantly alter AF symptom perception in highly symptomatic patients. Cardiac rhythm in these patients might be effectively monitored through symptom logs, ECGs, or Holter monitoring. ClinicalTrials.gov NCT03587181, SubstrateAF study, first posted date July 16, 2018.

ReferencesShowing 10 of 18 papers
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Radiofrequency versus Cryoballoon Ablation of Atrial Fibrillation: An Evaluation Using ECG, Holter Monitoring, and Implantable Loop Recorders to Monitor Absolute and Clinical Effectiveness
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Perception of Atrial Fibrillation Before and After Radiofrequency Catheter Ablation
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Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation
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Cryoballoon pulmonary vein isolation temporarily modulates the intrinsic cardiac autonomic nervous system
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Quantification of the cryoablation zone demarcated by pre- and postprocedural electroanatomic mapping in patients with atrial fibrillation using the 28-mm second-generation cryoballoon
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  • Heart Rhythm
  • David N Kenigsberg + 4 more

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2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC.
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Comparative analysis of three-year efficacy of catheter ablation of atrial fibrillation using the Ablation Index module and the second-generation cryoballoon
  • Sep 5, 2025
  • Journal of Arrhythmology
  • S N Azizov + 4 more

Aim. To compare immediate and long-term outcomes of catheter-based atrial fibrillation (AF) treatment following pulmonary vein (PV) cryoballoon ablation (CBA) using the second-generation cryoballoon and PV radiofrequency ablation (RFA) performed on the navigation system using the contact force-sensing catheter with the AI module.Methods. The study included 199 patients referred for PV isolation between 2018 and 2021. Patients were divided into two groups: the study group (n=110) underwent PV isolation via RFA using the catheter with the AI module; the control group (n=89) underwent PV CBA using the second-generation cryoballoon. The follow-up period was limited to 36 months, with a mean follow-up of 27.9 ± 14.2 months.Results. The three-year efficacy of CBA and RFA using the AI module was comparable (freedom from atrial tachy­ arrhythmias: RFA group 0.61±0.05, CBA group 0.62±0.05 (Log-Rank test, p = 0.896)), with similar complication rates and profiles (3.6% (n=4) vs. 4.5% (n=4), p=0.759). The AF recurrence rate during the blanking period was significantly lower in the RFA group using the AI module (1.8% (n=2) vs. 9.0% (n=8) in the CBA group, p=0.045). Procedure duration was significantly shorter in the cryoablation group (RFA 92.7±20.9 min, CBA 83.9±19.6 min, p=0.005). The need for repeat intervention was comparable between groups (RFA 21.8% (n=24), CBA 30.3% (n=27), p=0.171).Conclusion. Comparative analysis of the three-year efficacy of radiofrequency antral pulmonary vein isolation using the catheter with the “Ablation Index” (AI) module demonstrated results comparable to ablation with the secondgeneration cryoballoon. Furthermore, during the blanking period, the RFA group showed a statistically significant reduction in AF recurrence compared to the CBA group.

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Comparison of fluoroscopy use between cryoballoon and radiofrequency catheter ablation for paroxysmal atrial fibrillation
  • Apr 28, 2018
  • Ni Suo + 11 more

Objective This study aims to compare the fluoroscopy use between cryoballoon ablation (CBA) and radiofrequency ablation (RFA) for the treatment of paroxysmal atrial fibrillation (PAF) . Method The study was designed as a single-centered prospective cohort protocol. 43 continuous patients (RFA, 21, CBA, 22) were alternatively enrolled. The fluoroscopy equipment and parameter setting was same for the two groups. Detailed information about the fluoroscopy use including time and dose usage was recorded for every major step. Procedure time, acute pulmonary vein isolation (PVI) rates and complications were also recorded. Results No significant differences on baseline characteristics were observed between the two groups. The fluoroscopy time for CBA group was longer than RFA group [RFA (10.0±4.5) min vs. CBA (14.9±3.4) min, P<0.001] . The fluoroscopy dose was substantially higher in CBA group compared with RFA group for total procedure [RFA, (59.6±34.9) mGy vs.CBA, (189.2±85.4) mGy, P<0.001] , and more prominent in left atrial dwell period [CBA, (179.2±23.1) mGy vs. RFA, (41.6±23.1) mGy, P<0.001] . The differences of fluoroscopy dose among 4 pulmonary veins (PVs) in CBA group did not achieve statistical significance left superior pulmonary vein (LSPV) 39.4±22.4 mGy, left inferior pulmonary vein (LIPV) 32.9±24.9 mGy, right inferior pulmonary vein (RIPV) 19.8±12.5 mGy, right superior pulmonary vein (RSPV) 29.6±17.0 mGy; P=0.155) . The total procedure time [RFA, (96.0±20.8) min, vs. CBA, (100.4±15.7) min, P=0.451] , acute PVI successful rate (100% in both groups) and acute phase complication rate (RFA, 0%; CBA, 4.5%, P=1.000) were similar between RFA and CBA group. Conclusion In this study, both the fluoroscopy time and fluoroscopy dose were higher in CBA group compared with that in RFA group, especially in left atrium dwell period. The fluoroscopy dose might represent the actual fluoroscopy exposure better than fluoroscopy time during procedure. Key words: Atrial fibrillation; Radiofrequency ablation; Cryoballoon ablation

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Detection of atrial fibrillation in patients with embolic stroke of undetermined source by prolonged monitoring with implantable loop recorders.
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Recently, the clinical entity embolic stroke of undetermined source (ESUS) has been defined for patients with ischemic strokes, where neither a cardioembolic nor a non-cardiac source can be detected. These patients may suffer from asymptomatic atrial fibrillation (AF), terminating spontaneously and thus eluding detection. Implantable loop recorders (ILR) with automatic AF detection algorithms can detect short-lasting, subclinical AF. The aim of this study was to prospectively assess and predict AF detection in patients with ESUS using ILR with daily remote interrogation. Patients with acute ESUS received an ILR, were seen every 6 months and additionally interrogated their ILR daily using remote monitoring. The incidence of AF detection was assessed and parameters which might predict AF detection (clinical and from magnetic resonance tomography) were analysed. ILR implantation was performed in 123 patients on average 20 days after stroke. During a mean follow-up of 12.7±5.5 months, AF was documented and manually confirmed in 29 of 123 patients (23.6 %). First AF detection occurred on average after 3.6±3.4 months of monitoring. Patients with AF were on average older, had a higher CHA2DS2-VASc score and more often cerebral microangiopathy. In conclusion, AF can be documented in approximately 25 % of patients with the diagnosis of ESUS after careful work-up within a year of monitoring by an ILR and daily remote interrogation. This had important therapeutic consequences (initiation of anticoagulation for secondary stroke prevention) in these patients.

  • Research Article
  • Cite Count Icon 18
  • 10.1155/2018/3629384
Radiofrequency versus Cryoballoon Ablation of Atrial Fibrillation: An Evaluation Using ECG, Holter Monitoring, and Implantable Loop Recorders to Monitor Absolute and Clinical Effectiveness
  • Jan 1, 2018
  • BioMed Research International
  • Karapet Davtyan + 8 more

Introduction While several studies have compared the radiofrequency current (RFC) and cryoablation for the treatment of patients with atrial fibrillation (AF), no study has monitored the long-term outcomes with the usage of implantable loop recorders (ILRs). Methods We enrolled 89 consecutive patients with nonvalvular paroxysmal AF (N = 44 for RFC and N = 45 for cryoballoon). The primary efficacy end point was the assessment of effectiveness for each group (RFC versus cryoballoon) when examining freedom from arrhythmia by monitoring with ECG, Holter, and implantable loop recoder (ILR). The primary safety end point compared rates of adverse events between both groups. The secondary efficacy end point examined the duration of the postablation blanking period from ILR retrieved data. Results The mean age of the study population was 56.6 ± 10.2 years, and the follow-up duration was 12 months. There were no differences in baseline patient characteristics between groups. At 12 months, the absolute effectiveness (measured by ILR) was 65.9% in the RFC group and 51.1% in the cryoballoon group (OR = 1.85; 95% CI: 0.79–4.35; p = 0.157), and the clinical effectiveness (measured by ECG and Holter) was 81.8% in the RFC group and 55.6% in the cryoballoon group (OR = 3.6; 95% CI: 1.37–9.46; p = 0.008). There was no difference in safety between both groups. Asymptomatic episodes were significantly more present in the RFC group as measured by ILRs (p < 0.010). In cryoballoon group, arrhythmia episodes were recorded equally irrespective of the follow-up method (i.e., ECG and Holter versus ILR (p > 0.010)). The blanking period does not seem to be as important in cryoballoon as compared to RFC. Conclusion RFC and cryoballoon ablation had similar absolute effectiveness at 12 months. ECG and Holter were effective when assessing the efficacy of the cryoballoon ablation; however, in the RFC group, ILR was necessary to accurately assess long-term efficacy.

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Will Smartphone Applications Replace the Insertable Cardiac Monitor in the Detection of Atrial Fibrillation? The First Comparison in a Case Report of a Cryptogenic Stroke Patient
  • Mar 23, 2022
  • Frontiers in Cardiovascular Medicine
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Background and CaseThis case report exemplifies the clinical application of non-invasive photoplethysmography (PPG)-based rhythm monitoring in the awakening mobile health (mHealth) era to detect symptomatic and asymptomatic paroxysmal atrial fibrillation (AF) in a cryptogenic stroke patient. Despite extensive diagnostic workup, the etiology remains unknown in one out of three ischemic strokes (i.e., cryptogenic stroke). Prolonged cardiac monitoring can reveal asymptomatic atrial fibrillation in up to one-third of this population. This case report describes a cryptogenic stroke patient who received prolonged cardiac monitoring with an insertable cardiac monitor (ICM) as standard of care. In the context of a clinical study, the patient simultaneously monitored his heart rhythm with a PPG-based smartphone application. AF was detected simultaneously on both the ICM and smartphone application after three days of monitoring. Similar AF burden was detected during follow-up (five episodes, median duration of 28 and 34 h on ICM and mHealth, respectively, p = 0.5). The detection prompted the initiation of oral anticoagulation and AF catheter ablation procedure.ConclusionThis is the first report of the cryptogenic stroke patient in whom PPG-based mHealth was able to detect occurrence and burden of the symptomatic and asymptomatic paroxysmal AF episodes with similar precision as ICM. It accentuates the potential role of PPG-based mHealth in prolonged cardiac rhythm monitoring in cryptogenic stroke patients.

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  • Aug 6, 2019
  • HeartRhythm Case Reports
  • Zack Dale + 1 more

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  • Cite Count Icon 15
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Localization of gaps during redo ablations of paroxysmal atrial fibrillation: Preferential patterns depending on the choice of cryoballoon ablation or radiofrequency ablation for the initial procedure
  • Sep 28, 2016
  • Archives of Cardiovascular Diseases
  • Vincent Galand + 8 more

Localization of gaps during redo ablations of paroxysmal atrial fibrillation: Preferential patterns depending on the choice of cryoballoon ablation or radiofrequency ablation for the initial procedure

  • Discussion
  • Cite Count Icon 5
  • 10.1016/s0140-6736(21)01785-2
High-intensity atrial fibrillation screening to prevent stroke
  • Aug 29, 2021
  • The Lancet
  • Ben Freedman + 1 more

High-intensity atrial fibrillation screening to prevent stroke

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  • Cite Count Icon 24
  • 10.1007/s10840-016-0220-8
Comparison of catheter ablation for paroxysmal atrial fibrillation between cryoballoon and radiofrequency: a meta-analysis.
  • Jan 7, 2017
  • Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing
  • Chao-Feng Chen + 5 more

The present systematic review and meta-analysis aimed to assess and compare the safety and efficacy of radiofrequency (RF) and cryoballoon (CB) ablation for paroxysmal atrial fibrillation (PAF). RF and CB ablation are two frequently used methods for pulmonary vein isolation in PAF, but which is a better choice for PAF remains uncertain. A systematic review was conducted in Medline, PubMed, Embase, and Cochrane Library. All trials comparing RF and CB ablation were screened and included if the inclusion criteria were met. A total of 38 eligible studies, 9 prospective randomized or randomized controlled trials (RCTs), and 29 non- RCTs were identified, adding up to 15,496 patients. Pool analyses indicated that CB ablation was more beneficial in terms of procedural time [standard mean difference = -0.58; 95% confidence interval (CI), -0.85 to -0.30], complications without phrenic nerve injury (PNI) [odds ratio (OR) = 0.79; 95% CI, 0.67-0.93; I 2 = 16%], and recrudescence (OR = 0.83; 95% CI, 0.70-0.97; I 2 = 63%) for PAF; however, the total complications of CB was higher than RF. The subgroup analysis found that, compared with non-contact force radiofrequency (non-CF-RF), both first-generation cryoballoon (CB1) and second-generation cryoballoon (CB2) ablation could reduce complications with PNI, procedural time, and recrudescence. However, the safety and efficacy of CB2 was similar to those of CF-RF. Available overall and subgroup data suggested that both CB1 and CB2 were more beneficial than RF ablation, and the main advantages were reflected in comparing them with non-CF-RF. However, CF-RF and CB2 showed similar clinical benefits.

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  • 10.1016/j.hrthm.2014.03.016
Asymptomatic persistent atrial fibrillation and outcome: Results of the RACE study
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Asymptomatic persistent atrial fibrillation and outcome: Results of the RACE study

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VP122 Cryoballoon Versus Radiofrequency Ablation For Atrial Fibrillation
  • Jan 1, 2017
  • International Journal of Technology Assessment in Health Care
  • Gongru Wang + 4 more

INTRODUCTION:Pulmonary vein isolation (PVI) is a new effective treatment for atrial fibrillation (AF) (1). The standard of care for ablation methods using radiofrequency (RF) is time-consuming and technically challenging (2), and restricted to a few specialized centers, which causes the limited availability of ablation therapy (3). Therefore, cryoballoon (CB) ablation has been developed to shorten and simplify the procedure. The objective of this systematic literature review and meta-analysis was to compare the effectiveness of cryoballoon ablation (CBA) with radiofrequency ablation (RFA) for the treatment of AF.METHODS:We searched the Cochrane Library and PubMed from 2009 to October 2016 to screen the eligible literature according to the inclusion and exclusion criteria. The effectiveness measures were the acute pulmonary vein (PV) isolation rate, procedure time, complications and the proportion of patients free from AF (follow-up &gt; 3 months). Meta-analysis and descriptive statistics were used in this study.RESULTS:A total of seventeen articles with 5,806 cases (2,288 from CBA group, 3,518 from RFA group) from seven different countries were reviewed and analyzed. Pooled analyses indicated that CBA was more beneficial in terms of procedural time (Standard mean difference, SMD = -.501; 95%CI: -.893– -.109; P&lt;.05) for RFA; but the acute PV isolation rate (Odds ratio, OR = .06; 95 percent Confidence Interval, CI: .03–.13; P &lt; .05) in RFA was higher than for CBA; also, after median follow-up of 14 months (range 9–28 months), the proportion of patients free from AF (OR = .965; 95 percent CI:.859—1.085; P = .554) and the total complication rates (OR = .937; 95 percent CI:.753–1.167; P = .562) were not significantly different between CBA and RFA.In the four randomized controlled trials (RCTs) of the seventeen studies, the proportion of patients free from AF (OR = .951; 95 percent CI:.752–1.202; P = .672) and the complications (OR = 1.521; 95 percent CI:.570–4.058; P = .402) were not significantly different between CBA and RFA.CONCLUSIONS:Overall, compared with RFA for the treatment of patients with AF, CBA had similar clinical effectiveness on the proportion of people free from AF and the number of complications, and yet greater improvement in total procedure time referred for CBA and higher acute PVI rate referred for RFA.

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Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation
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Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation

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