Outcomes of Cryoballoon Ablation in High- and Low-Volume Atrial Fibrillation Ablation Centres: A Russian Pilot Survey.
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ABSTRACT: Purpose
The results of cryoballoon ablation (CBA) procedure have been mainly derived from studies conducted in experienced atrial fibrillation (AF) ablation centres. Here, we report on CBA efficacy and complications resulting from real practice of this procedure at both high- and low-volume centres.Methods
Among 62 Russian centres performing AF ablation, 15 (24%) used CBA technology for pulmonary vein isolation. The centres were asked to provide a detailed description of all CBA procedures performed and complications, if encountered.Results
Thirteen sites completed interviews on all CBAs in their centres (>95% of CBAs in Russia). Six sites were high-volume AF ablation (>100 AF cases/year) centres, and 7 were low-volume AF ablation. There was no statistical difference in arrhythmia-free rates between high- and low-volume centres (64.6 versus 60.8% at 6 months). Major complications developed in 1.5% of patients and were equally distributed between high- and low-volume centres. Minor procedure-related events were encountered in 8% of patients and were more prevalent in high-volume centres. Total event and vascular access site event rates were higher in women than in men.Conclusions
CBA has an acceptable efficacy profile in real practice. In less experienced AF ablation centres, the major complication rate is equal to that in high-volume centres.
SUBMITTER: Mikhaylov EN
PROVIDER: S-EPMC4659951 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveAtrial fibrillation (AF) recurrence occurs in approximately 25% of the patients undergoing cryoballoon ablation (CBA), leading to repeated ablations and complications. Left atrial (LA) dilation has been proposed as a predictor of AF recurrence. However, LA strain is a surrogate marker of LA mechanical dysfunction, which might appear before the enlargement of the LA. The purpose of this study was to evaluate the additional predictive value of LA function assessed using strain echocardiography for AF recurrence after CBA.Methods172 consecutive patients (62.2 ± 12.2 years, 61% male) were prospectively analyzed. Echocardiography was performed before CBA. Blanking period was defined as the first three months post-ablation. The primary endpoint was AF recurrence after the blanking period.Results50 (29%) patients had AF recurrence. In the overall study population, peak atrial longitudinal strain (PALS) ≤ 17% had the highest incremental predictive value for AF recurrence (HR = 9.45, 95%CI: 3.17-28.13, p < 0.001). In patients with non-dilated LA, PALS≤17% remained an independent predictor of AF recurrence (HR = 5.39, 95%CI: 1.66-17.52, p = 0.005).ConclusionsThis study showed that LA function assessed by PALS provided an additional predictive value for AF recurrence after CBA, over LA enlargement. In patients with non-dilated LA, PALS also predicted AF recurrence. These findings emphasize the added value of LA strain, suggesting that it should be implemented in the systematic evaluation of AF patients before CBA.
| S-EPMC8604362 | biostudies-literature
Project description:AbstractAtrial fibrillation is considered to be the most common arrhythmia in the clinic, and it gradually increases with age. In recent years, there has been increasing evidence that atrial fibrillation may exacerbate the progression of cognitive dysfunction. The current guidelines recommend ablation for drug-refractory atrial fibrillation.We aimed to prospectively analyze changes in cognitive function in patients with atrial fibrillation following treatment using different ablation methods.A total of 139 patients, with non-valvular atrial fibrillation, were included in the study. The patients were divided into the drug therapy (n = 41) and catheter ablation (n = 98) groups, with the catheter ablation group further subdivided into radiofrequency ablation (n = 68) and cryoballoon (CY) ablation (n = 30). We evaluated cognitive function at baseline, 3- and 12-months follow-up using the Telephone Interview for Cognitive Status-modified (TICS-m) test, then analyzed differences in cognitive function between the drug therapy and catheter ablation groups, to reveal the effect of the different ablation methods.We observed a significantly higher TICS-m score (39.56 ± 3.198) in the catheter ablation group at 12-month follow-up (P < .001), than the drug treatment group was. Additionally, we found no statistically significant differences in TICS-m scores between the radiofrequency ablation and CY groups at 3- and 12-month postoperatively (P > .05), although the two subgroups showed statistically significant cognitive function (P < .001).Overall, these findings indicated that radiofrequency and CY ablation improve cognitive function in patients with atrial fibrillation.
| S-EPMC8360464 | biostudies-literature
Project description:BackgroundCatheter ablation is increasingly being performed worldwide for atrial fibrillation (AF). However, there are concerns of lower success rates and higher complications of AF ablations performed in low-volume centers. Thus, we sought to evaluate the safety and efficacy of AF catheter ablation in a low-volume center using contemporary technologies.Methods and results71 consecutive patients (50 paroxysmal AF [pAF] vs 21 persistent AF) who underwent first catheter ablation were studied. Primary outcome was AF recurrence rate. Secondary outcomes included periprocedural complications, hospitalization for symptomatic tachy-arrhythmias post-ablation and number of repeat ablations. Mean age of our cohort was 59.1 ± 9.7 years, of which 56 (78.9%) were males. 1-year AF recurrence was 19.5% in pAF and 23.8% in persistent AF (p = 0.694). Ablation in persistent AF group required longer procedural (197.76 ± 48.60 min [pAF] vs 238.67 ± 70.50 min [persistent AF], p = 0.006) and ablation duration (35.08 ± 15.84 min [pAF] vs 52.65 ± 28.46 min [persistent AF], p = 0.001). There were no significant differences in secondary outcomes. Major periprocedural complication rate was 2.8%.Subset analysis on (i) cryoablation vs radiofrequency, (ii) Ensite vs CARTO navigational system and (iii) circular vs high density mapping catheter did not yield significant differences in primary or secondary outcomes.ConclusionsThe AF ablation complication and recurrence free rates in both paroxysmal and persistent AF at one year were comparable to high-volume centers. Long-term follow up is needed. In addition, first AF catheter ablation in a low-volume center is realistic with comparable efficacy and safety outcomes to high-volume centers using contemporary ablation technologies.
| S-EPMC7591346 | biostudies-literature
Project description:AIMS:To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF). METHODS AND RESULTS:Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was 'atrial arrhythmia recurrence', secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P?=?0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P?<?0.001). Follow-up duration was 441 (CBA) and 511?days (RFA) (P?<?0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70-1.04; P?=?0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64-0.99; P?=?0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26-1.10; P?=?0.088). Re-ablations (adjHR 0.46, 95% CI 0.34-0.61; P?<?0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48-0.88; P?=?0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations. CONCLUSIONS:The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF. TRIAL REGISTRATION:ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.
| S-EPMC6735953 | biostudies-literature
Project description:IntroductionAblation Index, also known as VISITAG SURPOINT™, is a novel lesion-quality marker that improves outcomes in radiofrequency (RF) catheter ablation of atrial fibrillation (AF). There is no direct evidence on the comparative effectiveness of RF ablation with Ablation Index and cryoballoon (CB). The objective of the present study was to conduct a matching-adjusted indirect comparison (MAIC) using individual patient-level data (IPD) to compare the effectiveness of RF ablation with Ablation Index to that of CB on recurrence of atrial arrhythmias 12 months after catheter ablation in patients with paroxysmal AF (PAF).MethodsIndividual patient-level data for RF ablation with Ablation Index were obtained from two studies: Solimene et al. [J Interv Card Electrophysiol 54(1):9-15, 2019] and Hussein et al. [J Cardiovasc Electrophysiol 28(9):1037-1047, 2017]. Comparable CB studies identified from a systematic literature review were pooled. Prognostic variables for adjustment were ranked a priori by several practicing electrophysiologists. In the absence of a common treatment arm between the Ablation Index and CB studies, an unanchored MAIC was conducted. Primary analysis compared the Solimene et al. study to pooled CB studies. A secondary analysis compared pooled RF ablation with Ablation Index studies to pooled CB studies. Several scenario and sensitivity analyses were conducted.ResultsPrimary analyses showed statistically significant reductions in the rate of arrhythmia recurrence with RF ablation with Ablation Index compared to CB in unmatched, unadjusted (HR 0.50, 95% CI 0.27-0.95) and matched (0.42, 0.21-0.86) analyses. Greater reductions in the rate of arrhythmia recurrence that favored RF ablation with Ablation Index were observed after matching and adjusting for age (0.41, 0.20-0.85), age and left ventricular ejection fraction (0.37, 0.16-0.88), and age, sex, and left ventricular ejection fraction (0.30, 0.13-0.71). Secondary and sensitivity analyses showed similar reductions.ConclusionsRadiofrequency ablation with Ablation Index was associated with reductions in recurrence of atrial arrhythmias at 12 months compared to CB in unmatched and unadjusted, matched, and matched and adjusted comparisons.
| S-EPMC7004430 | biostudies-literature
Project description:Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF.FreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF. Procedural success for the long-term follow-up (30 months) was defined as freedom from AF with an absence of persistent complications.Of the 315 patients that were randomised and received catheter ablation, 292 (92.7%) completed the 30-month follow-up (147 in the RF group and 145 in the CB group). The baseline characteristics of the RF and CB groups were similar. Single-procedure success was achieved by 40% of patients in the RF group and 42% of the CB group (p < 0.001 for non-inferiority). When including re-do procedures in the analysis, the multiple procedure success rate was 72% in the RF group and 76% in the CB group.The data provide long-term evidence that CB ablation is non-inferior to RF ablation, with high proportions of patients reporting freedom from AF 30 months after the index procedure.ClinicalTrials.gov Identifier: NCT00774566 ; first registered October 16, 2008; first patient included October 20, 2008.
| S-EPMC5445510 | biostudies-literature
Project description:AimsTreatment 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 resultsA 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).ConclusionsCryoballoon 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.
| S-EPMC8286851 | biostudies-literature
Project description:Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia (Calkins H, et al. 2012). There are various methods to treat AF of which Ablation is one of the most effective. We aimed to assess the cost-utility of Cryoballoon ablation (CBA) compared to Radiofrequency ablation (RFA) to treat patients with paroxysmal AF in Iran. A cost-utility analysis was done using a decision-analytic model based on a lifetime Markov structure which was drawn considering the nature of interventions and the natural progress of the disease. Costs data were extracted from medical records of 47 patients of Shahid Rajaie Cardiovascular Medical Center in Tehran in 2019. Parameters and variables such as transition probabilities, risks related to side effects, mortality rates, and utility values were extracted from the available evidence. Deterministic and probabilistic sensitivity analysis was also done. TreeAge pro-2020 software was used in all stages of analysis. In the base case analysis, the CBA strategy was associated with higher cost and effectiveness than RFA, and the incremental cost-effectiveness ratio was $11,223 per Quality-adjusted life year (QALY), which compared to Iran's GDP per capita as Willingness to pay threshold, CBA was not cost-effective. On the other hand, considering twice the GDP per capita as a threshold, CBA was cost-effective. Probabilistic sensitivity analysis confirmed the findings of base case analysis, showed that RFA was cost-effective and the probability of cost-effectiveness was 59%. One-way sensitivity analysis showed that the results of the study have the highest sensitivity to changes in the RFA cost variable. Results of sensitivity analysis showed that the cost-effectiveness results were not robust and are sensitive to changes in variables changes. Primary results showed that CBA compared to RFA is not cost-effective in the treatment of AF considering one GDP per capita. But the sensitivity analysis results showed considerable sensitivity to changes of the ablation costs variable.
| S-EPMC9258804 | biostudies-literature
Project description:BackgroundThe 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.HypothesisCBA is superior to AAD as initial therapy for symptomatic AF.MethodsWe 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.ResultsThree RCTs that enrolled 724 patients in total were included in this meta-analysis. 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; I2 = 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; I2 = 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; I2 = 0%). Transient phrenic nerve palsy occurred in four patients after the CBA procedure.ConclusionThe 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.
| S-EPMC8495081 | biostudies-literature
Project description:AimsAtrial fibrillation (AF) and heart failure (HF) are the most common cardiac diseases and often coexist leading to increased mortality and morbidity compared with AF patients without HF. As shown previously, AF ablation using radio frequency (RF) in HF patients leads to a reduction of AF burden, an increase of left ventricular ejection fraction (LVEF) and consequently to reduced hospitalization and mortality. Previous AF ablation studies on HF patients have been liberal about additional targets beyond pulmonary vein isolation (PVI). Thus, the aim of this study was to assess systematically the impact of a straightforward PVI-only strategy on LVEF, NYHA functional class, and cardiovascular hospitalization rate in HF patients.Methods and resultsOut of 414 consecutive patients undergoing PVI, only with the cryoballoon 113 patients with reduced LVEF [mean: 38.4 ± 10.8%, reduced ejection fraction (rEF) group] and 301 patients with normal LVEF (>55%) at baseline were identified [normal ejection fraction (nEF) group]. Remarkably, even though freedom from arrhythmia recurrence after 1 year was significantly lower in the rEF group (64.9%) compared with the nEF group (71.2%, P = 0.036), mean LVEF improved from 38.4 ± 10.8% to 52.5 ± 17.2% (P < 0.001) after cryoballoon ablation in the rEF group. Accordingly, HF-related symptoms as well as hospitalization rate declined significantly in the rEF group during follow-up compared with baseline.ConclusionsThe results of the present study suggest that catheter ablation restricted to a straightforward PVI-only strategy using the cryoballoon leads to improved left ventricular ejection fraction as well as improvement of NYHA functional class and increased freedom from cardiovascular rehospitalization.
| S-EPMC7524096 | biostudies-literature