Radiofrequency Versus Cryoballoon Catheter Ablation for Paroxysmal Atrial Fibrillation: Durability of Pulmonary Vein Isolation and Effect on Atrial Fibrillation Burden: The RACE-AF Randomized Controlled Trial.
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SUBMITTER: Sorensen SK
PROVIDER: S-EPMC8136462 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background Cryoballoon ablation was established as an effective and safe modality to achieve pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (PAF). However, its role in persistent atrial fibrillation (PersAF) remains unclear. Objective This study aimed to evaluate the efficacy and safety of cryoballoon PVI in PAF and PersAF comparing conventional radiofrequency catheter ablation (RFCA). Methods Two hundred patients undergoing cryoballoon ablation for symptomatic AF were consecutively enrolled in this retrospective study. For comparison, 210 patients undergoing RFCA in the same period were included. The primary outcome was a recurrence of any atrial tachyarrhythmias (ATas) after the index ablation. 12-lead ECG and 24-hour Holter monitoring were obtained at 1,3,6 and 9–12 months. Results PVI by cryoablation alone was achieved in 197 patients (98.5%). ATas-free survival at 12 months post-ablation was 72.7% in the cryoablation and 80.6% in the RFCA group (P = 0.123), respectively. The cryoablation showed comparable efficacy maintaining sinus rhythm compared with RFCA in PAF (P = 0.539), whereas in PersAF, ATas-free survival was significantly lower in cryoablation (P = 0.039). PV reconnection was observed in the majority of patients (14/16, 87.5%) who receive redo RFCA. Complications were encountered in 10 patients, including femoral arteriovenous fistula (n = 1), transient phrenic nerve palsy (n = 8), and minimal amount pericardial effusion (n = 1). Conclusion The efficacy of cryoballoon PVI is comparable with conventional RFCA in PAF, whereas PVI alone using cryoballoon may not be insufficient to maintaining sinus rhythm in PersAF. The safety of cryoballlon PVI is tolerable.
| S-EPMC9328506 | biostudies-literature
Project description:AimsTo 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 resultsProspective 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.ConclusionsThe 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 registrationClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.
| S-EPMC6735953 | 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:Pulmonary veins (PVs) are a major source of ectopic beats that initiate AF. PV isolation from the left atrium is an effective therapy for the majority of paroxysmal AF. However, investigators have reported that ectopy originating from non-PV areas can also initiate AF. Patients with recurrent AF after persistent PV isolation highlight the need to identify non-PV ectopy. Furthermore, adding non-PV ablation after multiple AF ablation procedures leads to lower AF recurrence and a higher AF cure rate. These findings suggest that non-PV ectopy is important in both the initiation and recurrence of AF. This article summarises current knowledge about the electrophysiological characteristics of non-PV AF, suitable mapping and ablation strategies, and the safety and efficacy of catheter ablation of AF initiated by ectopic foci originating from non-PV areas.
| S-EPMC6304799 | biostudies-other
Project description:BackgroundModulation of the cardiac autonomic nervous system by pulmonary vein isolation (PVI) influences the sinoatrial nodal rate. Little is known about the causes, maintenance and prognostic value of this phenomenon. We set out to explore the effects of cryoballoon PVI (cryo-PVI) on sinus rate and its significance for clinical outcome.Methods and resultsWe evaluated 110 patients with paroxysmal atrial fibrillation (AF), who underwent PVI using a second-generation 28 mm cryoballoon by pre-, peri- and postprocedural heart rate acquisition and analysis of clinical outcome. Ninety-one patients could be included in postinterventional follow-up, indicating that cryo-PVI resulted in a significant rise of sinus rate by 16.5% (+ 9.8 ± 0.9 beats/min, p < 0.001) 1 day post procedure compared to preprocedural acquisition. This effect was more pronounced in patients with initial sinus bradycardia (< 60 beats/min.) compared to patients with faster heart rate. Increase of rate was primarily driven by ablation of the right superior pulmonary vein and for a subset of patients, in whom this could be assessed, persisted ≥ 1 year after the procedure. AF recurrence was neither predicted by the magnitude of the initial rate, nor by the extent of rate change, but postprocedural sinus bradycardia was associated with higher recurrence of AF in the year post PVI.ConclusionsCryo-PVI causes a significant rise of sinus rate that is more pronounced in subjects with previous sinus bradycardia. Patient follow-up indicates persistence of this effect and suggests an increased risk of AF recurrence in patients with postprocedural bradycardia.
| S-EPMC7806555 | biostudies-literature
Project description:AimsThe current challenge in atrial fibrillation (AF) treatment is to develop effective, efficient, and safe ablation strategies. This randomized controlled trial assesses the medium-term efficacy of duty-cycled radiofrequency ablation via the circular pulmonary vein ablation catheter (PVAC) vs. conventional electro-anatomically guided wide-area circumferential ablation (WACA).Methods and resultsOne hundred and eighty-eight patients (mean age 62 ± 12 years, 116 M : 72 F) with paroxysmal AF were prospectively randomized to PVAC or WACA strategies and sequentially followed for 12 months. The primary endpoint was freedom from symptomatic or documented >30 s AF off medications for 7 days at 12 months post-procedure. One hundred and eighty-three patients completed 12 m follow-up. Ninety-four patients underwent PVAC PV isolation with 372 of 376 pulmonary veins (PVs) successfully isolated and all PVs isolated in 92 WACA patients. Three WACA and no PVAC patients developed tamponade. Fifty-six percent of WACA and 60% of PVAC patients were free of AF at 12 months post-procedure (P = ns) with a significant attrition rate from 77 to 78%, respectively, at 6 months. The mean procedure (140 ± 43 vs. 167 ± 42 min, P<0.0001), fluoroscopy (35 ± 16 vs. 42 ± 20 min, P<0.05) times were significantly shorter for PVAC than for WACA. Two patients developed strokes within 72 h of the procedure in the PVAC group, one possibly related directly to PVAC ablation in a high-risk patient and none in the WACA group (P = ns). Two of the 47 patients in the PVAC group who underwent repeat ablation had sub-clinical mild PV stenoses of 25-50% and 1 WACA patient developed delayed severe PV stenosis requiring venoplasty.ConclusionThe pulmonary vein ablation catheter is equivalent in efficacy to WACA with reduced procedural and fluoroscopy times. However, there is a risk of thrombo-embolic and pulmonary stenosis complications which needs to be addressed and prospectively monitored.Clinicaltrialsgov identifierNCT00678340.
| S-EPMC4114331 | biostudies-literature
Project description:BackgroundPrevious studies have shown inconsistent results in clinical effectiveness between cryoballoon ablation (CBA) and radiofrequency ablation (RFA), and cost assessment between the procedures is important. The aim of this study was to evaluate the clinical effectiveness and cost-effectiveness between the procedures in patients with paroxysmal atrial fibrillation (AF) refractory to antiarrhythmic drug therapy.MethodsA systematic review and meta-analysis were performed. The primary outcome for the meta-analysis was long-term AF recurrence. Following the results of the meta-analysis, the cost-effectiveness of CBA versus RFA in Japan was assessed.ResultsThe meta-analysis included 12 randomized controlled trials and six propensity-score matching cohort studies. AF recurrence was slightly lower in patients referred for CBA than for RFA, with an integrated risk ratio of 0.93 (95% confidence interval: 0.81-1.07) and an integrated hazard ratio of 0.96 (95% confidence interval: 0.77-1.19), but no significant difference was found. A cost-minimization analysis was conducted to compare the medical costs of CBA versus RFA because there was no significant difference in the risk of AF recurrence between the procedures. The estimated costs for CBA and RFA were JPY 4 858 544 (USD 32 390) and JPY 4 505 255 (USD 30 035), respectively, with cost savings for RFA of JPY 353 289 (USD 2355).ConclusionOur meta-analysis suggests that CBA provides comparable benefits with regard to AF recurrence compared with RFA, as shown in previous studies. Although the choice of treatment should be based on patient and treatment characteristics, RFA was shown that it might be cost saving as compared to CBA.
| S-EPMC11317739 | biostudies-literature
Project description:This article reviews methods for lesion set assessment during radiofrequency catheter ablation for atrial fibrillation (AF). Pulmonary vein isolation (PVI) is the foundation for AF ablation, but PV reconnection can lead to treatment failure. Testing for entrance block can help confirm PVI, although complex electrograms that consist of both near- and far-field potentials may make assessment of entrance block challenging. Differential pacing maneuvers can help appropriately identify PV potentials. After entrance block has been achieved, pacing within the PVs to demonstrate capture of PV musculature with exit block may also help to confirm completeness of lesion sets for PVI. Employing a waiting period of at least 30 min or administering adenosine or isoproterenol can reveal dormant conduction, warranting adjunctive ablation. Additional techniques to confirm durable PVI include testing the ablation lines for excitability with high amplitude pacing, and automated waveform analysis of local electrogram morphology. Newer techniques like real-time magnetic resonance imaging and acoustic radiation force impulse elastography may have a role in testing the completeness of lesion sets in the future.
| S-EPMC7252765 | biostudies-literature
Project description:BackgroundRadiofrequency catheter ablation (RFA) has emerged as an important treatment strategy for atrial fibrillation (AF). The potential cost-effectiveness of RFA for AF, relative to antiarrhythmic drug (AAD) therapy, has not been fully explored from a US perspective.Methods and resultsWe constructed a Markov disease simulation model for a hypothetical cohort of patients with drug-refractory paroxysmal AF, treated either with RFA with/without AAD or AAD alone. Costs and quality-adjusted life-years were projected over 5 years. Model inputs were drawn from published clinical trial and registry data, from new registry and trial data analysis, and from data prospectively collected from patients with AF treated with RFA at our institution. We assumed no benefit from ablation on stroke, heart failure or death, but did estimate changes in quality-adjusted life expectancy using data from several AF cohorts. In the base case scenario, cumulative costs with the RFA and AAD strategies were $26,584 and $19,898, respectively. Over 5 years, quality-adjusted life expectancy was 3.51 quality-adjusted life-years with RFA versus 3.38 for the AAD group. The incremental cost-effectiveness ratio for RFA versus AAD was thus $51,431 per quality-adjusted life-year. Model results were most sensitive to time horizon, the relative utility weights of successful ablation versus unsuccessful drug therapy, and to the cost of an ablation procedure.ConclusionsRFA with/without AAD for symptomatic, drug-refractory paroxysmal AF appears to be reasonably cost-effective compared with AAD therapy alone from the perspective of the US health care system, based on improved quality of life and avoidance of future health care costs.
| S-EPMC2760061 | 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