Second-generation cryoballoon ablation as a first-line treatment of symptomatic atrial fibrillation: Two-year outcome and predictors of recurrence after a single procedure

Akkaya, Ersan; Berkowitsch, Alexander; Zaltsberg, Sergej; Greiß, Harald; Hamm, Christian W.; Sperzel, Johannes; Neumann, Thomas; Kuniss, Malte

doi:10.1016/j.ijcard.2017.11.011

Cited by 19 publications

(18 citation statements)

References 23 publications

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“…Our data are consistent with the results of observational studies involving patients who had not previously received treatment for rhythm control, in which a high percentage was found to have no recurrent atrial arrhythmia following CBA. 28,29 The results of this analysis support the current expert consensus recommending the use of CA as the first-line treatment for paroxysmal AF, with a class IIa indication. 10,30 Three RCTs have previously compared RFA and AAD as first-line treatment for symptomatic AF.…”

Section: Bias Assessment and Evidence Classificationsupporting

confidence: 68%

Meta‐analysis of cryoballoon ablation versus antiarrhythmic drugs as initial therapy for symptomatic atrial fibrillation

Mao

Feng

Huang

et al. 2021

Clinical Cardiology

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Background: The optimal first-line approach for patients with symptomatic atrial fibrillation (AF) remains unclear. We compared the efficacy and safety of cryoballoon ablation (CBA) and antiarrhythmic drugs (AADs) in the initial management of symptomatic AF.Hypothesis: CBA is superior to AAD as initial therapy for symptomatic AF.Methods: We searched the EMBASE, PubMed, and Cochrane Library databases for randomized controlled trials (RCTs) that compared CBA with AAD as first-line treatment for AF from the date of database establishment until March 18, 2021. The risk ratio (RR) with a 95% confidence interval (CI) was used as a measure of treatment effect.Results: Three RCTs that enrolled 724 patients in total were included in this metaanalysis. Majority of the patients were relatively young and had paroxysmal AF. CBA was associated with a significant reduction in the recurrence of atrial arrhythmia compared with AAD therapy, with low heterogeneity (RR, 0.59; 95% CI, 0.49-0.71; p < .00001; I 2 = 0%). There was a significant difference in the rate of symptomatic atrial arrhythmia recurrence (RR, 0.44; 95% CI, 0.29-0.65; p < .0001; I 2 = 0%); however, the rate of serious adverse events was similar between the two treatment groups (RR: 1.18; 95% CI: 0.71-1.97, p = .53; I 2 = 0%). Transient phrenic nerve palsy occurred in four patients after the CBA procedure. Conclusion:The current meta-analysis suggests that CBA is more effective than AAD as initial therapy in patients with symptomatic paroxysmal AF. Serious iatrogenic adverse events are uncommon in CBAs.

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Section: Bias Assessment and Evidence Classificationsupporting

confidence: 68%

Meta‐analysis of cryoballoon ablation versus antiarrhythmic drugs as initial therapy for symptomatic atrial fibrillation

Mao

Feng

Huang

et al. 2021

Clinical Cardiology

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“…In these studies, freedom from arrhythmia recurrence ranged from 71% to 89% over a follow-up period of 12–28 months. 13 , 14 , 21 More recently, two randomized studies (EARLY-AF 10 and STOP AF First 11 ) have specifically evaluated cryoballoon CA vs. AAD therapy as a first-line treatment strategy in patients with symptomatic AF. Similar to the present investigation, both studies demonstrated that cryoballoon CA was superior to AAD therapy for preventing AA recurrence over 12 months.…”

Section: Discussionmentioning

confidence: 99%

Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation

et al. 2021

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Aims Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF). Methods and results A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001). Conclusions Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy.

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“…As cryoablation has recently been introduced in patients with paroxysmal AF, this procedure may allow a simpler approach to electrically isolate the pulmonary vein (PV) from the left atrium (LA) to prevent recurrent AF. Short-to-midterm studies employing cryoballoons have shown recurrence rates after ablation ranging from 67 to 83.6% for patients with drug-refractory paroxysmal AF (3 –5). The reason for AF relapse is not completely understood but is related to restored PV conduction (6,7).…”

Section: Introductionmentioning

confidence: 99%

Pulmonary vein parameters are similar or better predictors than left atrial diameter for paroxysmal atrial fibrillation after cryoablation

Guo

Liu

et al. 2019

Braz J Med Biol Res

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Left atrial diameter (LAD) has been considered an independent risk factor for atrial fibrillation (AF) relapse after pulmonary vein isolation (PVI). However, whether LAD or other factors are more predictive of late recurrence in patients with paroxysmal AF remains unclear. We aimed to evaluate the value of pulmonary vein (PV) parameters for predicting AF relapse 1 year after patients underwent cryoablation for paroxysmal AF. Ninety-seven patients with paroxysmal AF who underwent PVI successfully were included. PV parameters were measured through computed tomography scans prior to PVI. A total of 28 patients had recurrence of AF at one-year follow-up. The impact of several variables on recurrence was evaluated in multivariate analyses. LAD and the time from first diagnosis of AF to ablation maintained its significance in predicting the relapse of AF after relevant adjustments in multivariate analysis. When major diameter of right inferior pulmonary vein (RIPV) (net reclassification improvement (NRI) 0.179, CI=0.031–0.326, P<0.05) and cross-sectional area (CSA) of RIPV (NRI: 0.122, CI=0.004–0.240, P<0.05) entered the AF risk model separately, the added predictive capacity was large. The accuracy of the two parameters in predicting recurrence of AF were not inferior (AUC: 0.665 and 0.659, respectively) to echocardiographic LAD (AUC: 0.663). The inclusion of either RIPV major diameter or CSA of RIPV in the model increased the C-index (0.766 and 0.758, respectively). We concluded that major diameter of RIPV had predictive capacity similar to or even better than that of LAD for predicting AF relapse after cryoablation PVI.

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Second-generation cryoballoon ablation as a first-line treatment of symptomatic atrial fibrillation: Two-year outcome and predictors of recurrence after a single procedure

Cited by 19 publications

References 23 publications

Meta‐analysis of cryoballoon ablation versus antiarrhythmic drugs as initial therapy for symptomatic atrial fibrillation

Meta‐analysis of cryoballoon ablation versus antiarrhythmic drugs as initial therapy for symptomatic atrial fibrillation

Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation

Pulmonary vein parameters are similar or better predictors than left atrial diameter for paroxysmal atrial fibrillation after cryoablation

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