title: Telemonitoring in heart failure patients treated by cardiac resynchronisation therapy with defibrillator (CRT-D): the TELECART Study. Contemporary management of patients undergoing atrial fibrillation ablation: in-hospital and 1-year follow-up findings from the ESC-EHRA atrial fibrillation ablation long-term registry Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. Acute and Long-Term Outcomes of Catheter Ablation of Atrial Fibrillation Using the Second-Generation Cryoballoon versus Open-Irrigated Radiofrequency: A Multicenter Experience. Long-term outcomes after cryoballoon pulmonary vein isolation: results from a prospective study in 605 patients. Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation Second‐generation cryoballoon ablation for treatment of persistent atrial fibrillation: Three‐year outcome and predictors of recurrence after a single procedure Circumferential pulmonary vein isolation as index procedure for persistent atrial fibrillation: a comparison between radiofrequency catheter ablation and second-generation cryoballoon ablation. Cryoballoon versus RF ablation in paroxysmal atrial fibrillation: results from the German Ablation Registry. Differences of two cryoballoon generations: insights from the prospective multicentre, multinational FREEZE Cohort Substudy. Phrenic nerve paralysis during cryoballoon ablation for atrial fibrillation: a comparison between the first- and second-generation balloon. Effects of Alpha Lipoic Acid on Multiple Cytokines and Biomarkers and Recurrence of Atrial Fibrillation Within 1 Year of Catheter Ablation.
abstract: AIM Telemonitoring ( TM ) is a safe and efficient monitoring system for internal cardioverter defibrillator device ( ICD ) recipients . TM has been used to track info on the clinical status of heart failure patients treated by ICD and /or cardiac resynchronisation therapy defibrillator ( CRT-D ) .  The aim of this study was to investigate the impact of TM on clinical outcomes in a population of CRT-D patients with heart failure . METHODS In a multicentre , r and omised study , patients with chronic heart failure , New York Heart Association ( NYHA ) functional class II or III , left bundle branch block , severe left ventricle ejection fraction reduction ( LVEF < 35 % ) have been identified and screened . RESULTS One hundred and ninety-one patients have been r and omised to receive either a CRT-D with TM or a CRT-D with traditional ambulatory monitoring ( control group ) and completed the 12-month study follow-up . Primary endpoints were all cause death , cardiac death and hospital admission for heart failure . Secondary endpoints were atrial fibrillation , sustained episodes , non-sustained and self terminated ventricular tachyarrhythmia , sustained ventricular tachycardia , and ventricular fibrillation , ICD shocks and percentage of CRT-D responder patients . Univariate analysis identified the following factors predicting hospitalisation : TM , age , chronic kidney disease , hypercholesterolaemia , LVEF and NYHA class . At multivariate analysis , TM was the only factor predicting heart failure hospitalisation ( hazard ratio 0.6 , 0.42 - 0.79 , 95 % CI , p = 0.002 ) , without affecting overall mortality and cardiac deaths events . CONCLUSIONS Taken together , our data indicate the importance of TM in predicting heart failure hospitalisation in patients treated with Aims The ESC-EHRA Atrial Fibrillation Ablation Long-Term registry is a prospect i ve , multinational study that aims at providing an accurate picture of contemporary real-world ablation for atrial fibrillation ( AFib ) and its outcome . Methods and results A total of 104 centres in 27 European countries participated and were asked to enrol 20–50 consecutive patients scheduled for first and re-do AFib ablation .  Pre-procedural , procedural and 1-year follow-up data were captured on a web-based electronic case record form . Overall , 3630 patients were included , of which 3593 underwent an AFib ablation ( 98.9 % ) . Median age was 59 years and 32.4 % patients had lone atrial fibrillation .  Pulmonary vein isolation was attempted in 98.8 % of patients and achieved in 95–97 % . AFib-related symptoms were present in 97 % . In-hospital complications occurred in 7.8 % and one patient died due to an atrioesophageal fistula . One-year follow-up was performed in 3180 ( 88.6 % ) at a median of 12.4 months ( 11.9–13.4 ) after ablation : 52.8 % by clinical visit , 44.2 % by telephone contact and 3.0 % by contact with the general practitioner . At 12-months , the success rate with or without antiarrhythmic drugs ( AADs ) was 73.6 % . A significant portion ( 46 % ) was still on AADs . Late complications included 14 additional deaths ( 4 cardiac , 4 vascular , 6 other causes ) and 333 ( 10.7 % ) other complications . Conclusion AFib ablation in clinical practice is mostly performed in symptomatic , relatively young and otherwise healthy patients . Overall success rate is satisfactory , but complication rate remains considerable and a significant portion of patients remain on AADs . Monitoring after ablation shows wide variations . Antithrombotic treatment after ablation shows insufficient guideline -adherence Abstract Aims The primary safety and efficacy endpoints of the r and omized FIRE AND ICE trial have recently demonstrated non-inferiority of cryoballoon vs. radiofrequency current ( RFC ) catheter ablation in patients with drug-refractory symptomatic paroxysmal atrial fibrillation ( AF ) . The aim of the current study was to assess outcome parameters that are important for the daily clinical management of patients using key secondary analyses . Specifically , re interventions , rehospitalizations , and quality -of-life were examined in this r and omized trial of cryoballoon vs. RFC catheter ablation . Methods and results Patients ( 374 subjects in the cryoballoon group and 376 subjects in the RFC group ) were evaluated in the modified intention-to-treat cohort . After the index ablation , log-rank testing over 1000 days of follow-up demonstrated that there were statistically significant differences in favour of cryoballoon ablation with respect to repeat ablations ( 11.8 % cryoballoon vs. 17.6 % RFC ; P = 0.03 ) , direct-current cardioversions ( 3.2 % cryoballoon vs. 6.4 % RFC ; P = 0.04 ) , all-cause rehospitalizations ( 32.6 % cryoballoon vs. 41.5 % RFC ; P = 0.01 ) , and cardiovascular rehospitalizations ( 23.8 % cryoballoon vs. 35.9 % RFC ; P < 0.01 ) . There were no statistical differences between groups in the quality -of-life surveys ( both mental and physical ) as measured by the Short Form-12 health survey and the EuroQol five-dimension question naire . There was an improvement in both mental and physical quality -of-life in all patients that began at 6 months after the index ablation and was maintained throughout the 30 months of follow-up . Conclusion Patients treated with cryoballoon as opposed to RFC ablation had significantly fewer repeat ablations , direct-current cardioversions , all-cause rehospitalizations , and cardiovascular rehospitalizations during follow-up . Both patient groups improved in quality -of-life scores after AF ablation . Clinical trial registration Clinical Trials.gov identifier : NCT01490814 OBJECTIVES This study sought to assess the safety and effectiveness of a novel cryoballoon ablation technology design ed to achieve single-delivery pulmonary vein ( PV ) isolation . BACKGROUND St and ard radiofrequency ablation is effective in eliminating atrial fibrillation ( AF ) but requires multiple lesion delivery at the risk of significant complications . METHODS Patients with documented symptomatic paroxysmal AF and previously failed therapy with ≥ 1 membrane active antiarrhythmic drug underwent 2:1 r and omization to either cryoballoon ablation ( n = 163 ) or drug therapy ( n = 82 ) . A 90-day blanking period allowed for optimization of antiarrhythmic drug therapy and reablation if necessary . Effectiveness of the cryoablation procedure versus drug therapy was determined at 12 months . RESULTS Patients had highly symptomatic AF ( 78 % paroxysmal , 22 % early persistent ) and experienced failure of at least one antiarrhythmic drug . Cryoablation produced acute isolation of three or more PVs in 98.2 % and all four PVs in 97.6 % of patients . PVs isolation was achieved with the balloon catheter alone in 83 % . At 12 months , treatment success was 69.9 % ( 114 of 163 ) of cryoblation patients compared with 7.3 % of antiarrhythmic drug patients ( absolute difference , 62.6 % [ p < 0.001 ] ) . Sixty-five ( 79 % ) drug-treated patients crossed over to cryoablation during 12 months of study follow-up due to recurrent , symptomatic AF , constituting drug treatment failure . There were 7 of the result ing 228 cryoablated patients ( 3.1 % ) with a > 75 % reduction in PV area during 12 months of follow-up . Twenty-nine of 259 procedures ( 11.2 % ) were associated with phrenic nerve palsy as determined by radiographic screening ; 25 of these had resolved by 12 months . Cryoablation patients had significantly improved symptoms at 12 months . CONCLUSIONS The STOP AF trial demonstrated that cryoballoon ablation is a safe and effective alternative to antiarrhythmic medication for the treatment of patients with symptomatic paroxysmal AF , for whom at least one antiarrhythmic drug has failed , with risks within accepted st and ards for ablation therapy . ( A Clinical Study of the A rct ic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [ Stop AF ] ; NCT00523978 ) INTRODUCTION There are limited comparative data on catheter ablation of atrial fibrillation ( CAAF ) using the second-generation cryoballoon ( CB-2 ) versus point-by-point radiofrequency ( RF ) . This study examines the acute/long-term CAAF outcomes using these 2 strategies . METHODS AND RESULTS In this multicenter , retrospective , nonr and omized analysis , procedural and clinical outcomes of 1,196 patients ( 76 % with paroxysmal AF ) undergoing CAAF using CB-2 ( n = 773 ) and open-irrigated , non-force sensing RF ( n = 423 ) were evaluated . Pulmonary vein isolation was achieved in 98 % with CB-2 and 99 % with RF ( P = 0.168 ) . CB-2 was associated with shorter ablation time ( 40 ± 14 min vs. 66 ± 26 min ; P < 0.001 ) and procedure time ( 145 ± 49 minutes vs. 188 ± 42 minutes ; P < 0.001 ) , but greater fluoroscopic utilization ( 29 ± 13 minutes vs. 23 ± 14 minutes ; P < 0.001 ) . While transient ( 7.6 % vs. 0 % ; P < 0.001 ) and persistent ( 1.2 % vs. 0 % ; P = 0.026 ) phrenic nerve palsy occurred exclusively with CB-2 , other adverse event rates were similar between CB-2 ( 1.6 % ) and RF ( 2.6 % ) ; P = 0.207 . However , freedom from AF/atrial flutter/tachycardia at 12 months following a single procedure without antiarrhythmic therapy was greater with CB-2 ( 76.6 % ) versus RF ( 60.4 % ) ; P < 0.001 . While this difference was evident in patients with paroxysmal AF ( P < 0.001 ) , it did not reach significance in those with persistent AF ( P = 0.089 ) . Additionally , CB-2 was associated with reduced long-term need for antiarrhythmic therapy ( 16.7 % vs. 22.0 % ; P = 0.024 ) and repeat ablations ( 14.6 % vs. 24.1 % ; P < 0.001 ) . CONCLUSION In this multicenter , retrospective , nonr and omized study , CAAF using CB-2 coupled with RF as occasionally required was associated with greater freedom from atrial arrhythmias at 12 months following a single procedure without antiarrhythmic therapy when compared to open-irrigated , non-force sensing RF , alone OBJECTIVES The purpose of this study was to investigate long-term outcomes of freedom from atrial fibrillation ( AF ) after pulmonary vein ( PV ) isolation using cryoballoon ablation with balloon-size selection based on individual PV diameters . BACKGROUND Data are lacking on long-term outcomes from cryoablation and on the most effective balloon size . METHODS This was a prospect i ve observational study involving 605 consecutively enrolled patients with symptomatic paroxysmal AF ( n = 579 ) or persistent AF .  Cryoballoon size was based on magnetic resonance imaging and /or conventional angiograms . Patients were followed up every 3 months during the first year after discharge and every 6 months in the second year . After 24 months , follow-up was on an outpatient basis with documented AF episodes recorded . RESULTS The PV isolation was achieved without touch-up in 91.1 % of patients , using the smaller balloon in 26.7 % , the larger balloon in 25.6 % , and both balloons in 47.7 % of patients . Follow-up data for > 12 months ( median 30 months ; interquartile range 18 to 48 months ) were available for 451 patients , 278 ( 61.6 % ) of whom were free of AF recurrence with no need for repeat procedures after the 3-month blanking period . Rates of freedom from AF after 1 , 2 , and 3 repeat procedures ( using cryoballoon or radiofrequency ablation with similar success rates ) were 74.9 % , 76.2 % , and 76.9 % , respectively . Use of the smaller balloons or both balloons produced the highest rates of long-term freedom from AF . Phrenic nerve palsy occurred in 12 patients ( 2 % ) , resolving within 3 to 9 months . CONCLUSIONS Rates of long-term freedom from AF after cryoballoon ablation are similar to those reported for radiofrequency ablation . A choice between balloons may improve outcomes Background — There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency ( RF ) and cryoballoon catheter ( CB ) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation . Methods and Results — In a prospect i ve , noninferiority study , 315 patients were r and omly assigned to RF ( n=159 ) or CB ( n=156 ) ablation . The primary end point was freedom from atrial arrhythmia with absence of persistent complications . Patients were largely comparable between groups with more vascular disease in the RF group ( 8.2 % versus 2.6 % for CB ; P=0.028 ) . The primary end point at 12 months was achieved by 70.7 % with RF and 73.6 % with CB ( multiple procedure success ) , including 31 redo procedures in each group ( 19.5 % of RF versus 19.9 % of CB ; P=0.933 ) . For the intention-to-treat population , noninferiority of CB was revealed for the predefined inferiority margin ( risk difference , 0.029 ; 95 % confidence interval , −0.074 to 0.132 ; P<0.001 ) . Rates at 6 months were 63.1 % and 64.1 % for the RF and CB groups ( single procedure success ) , and noninferiority was confirmed ( risk difference , 0.010 ; 95 % confidence interval , −0.097 to 0.116 ; P=0.002 ) . Periprocedural complications for the index procedure were more frequent in the CB group ( 5.0 % RF , 12.2 % CB ; P=0.022 ) with a significant difference in phrenic nerve palsies ( 0 % RF , 5.8 % CB ; P=0.002 ) . Conclusion — This large , prospect i ve , r and omized , controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00774566 INTRODUCTION Data on long-term outcomes of cryoballoon ( CB ) ablation for treatment of persistent atrial fibrillation ( AF ) are sparse . Here , we report the first 3-year follow-up results and predictors of success for catheter ablation using the second-generation CB in patients with persistent AF . METHODS AND RESULTS For this prospect i ve observational study , we enrolled 101 patients ablated with the second-generation CB at our institution . The endpoint was the first documented recurrence ( > 30 seconds ) of AF , atrial flutter , or atrial tachycardia after a 3-month blanking period . Follow-up data were collected during outpatient clinic visits and included Holter-ECG recordings . The impact of several variables on recurrence was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models . After a median follow-up of 37 ( 31 of 42 ) months , recurrence was documented in 30 patients ( 29.7 % ) . The median procedure and fluoroscopy times were 120 ( 102 of 147 ) and 20 ( 16 of 27 ) minutes , respectively . Phrenic nerve palsy occurred in 2.0 % of the patients . Among the 30 patients who experienced recurrence , 16 underwent repeat ablation in radiofrequency technique . Cox regression analysis showed that left atrial area > 21 cm2 and AF history duration > 2 years independently predicted recurrence . CONCLUSIONS Sinus rhythm was maintained in a substantial proportion of patients even 3 years after CB ablation . Patients with a nonenlarged left atrium and short AF history had the best outcome AIMS To assess the 1 year efficacy of pulmonary vein isolation ( PVI ) as index procedure for persistent atrial fibrillation ( PersAF ) comparing conventional radiofrequency irrigated-tip catheter ablation ( RFCA ) using contact-force technology and ablation using the second-generation cryoballoon ( CB-AdvA ) . METHODS AND RESULTS One hundred consecutive patients ( 74 male , 74 % ; mean age 62.4 ± 9.6 years ) with drug-refractory PersAF undergoing PVI using RFCA and CB-AdvA were enrolled . Follow-up was based on outpatient clinic visits including Holter-electrocardiograms . Recurrence of atrial tachyarrhythmias ( ATas ) was defined as a symptomatic or documented episode > 30 s. Among 100 patients , 50 underwent RFCA whereas 50 CB-AdvA.  Mean procedure and fluoroscopy times were 90.5 ± 41.7 vs. 140.2 ± 46.9 min and 14.5 ± 6.6 vs. 19.8 ± 6.8 min in the CB-Adv and in the RFCA group , respectively ( P < 0.01 ) . At 1 year follow-up , after a 3 months blanking period ( BP ) , freedom from ATas off-drugs after a single procedure was 60 % ( 28/50 patients ) in the CB-Adv and 56 % ( 27/50 patients ) in the RFCA group ( P = 0.71 ) . Multivariate analysis demonstrated that PersAF duration ( P = 0.01 ) and relapses during BP ( P = 0.02 ) were independent predictors of ATa recurrences following the index procedure . CONCLUSION Freedom from ATas following PersAF ablation with RFCA and CB-Adv is comparable at 1 year follow-up after a single procedure . Ablation with the CB-Adv is associated with shorter procedure time and radiation exposure as compared with RFCA . Atrial tachyarrhythmias occurrence during BP and longer time of PersAF seem to be significant predictors of arrhythmia recurrences after the index procedure BACKGROUND Catheter ablation is used extensively with curative intention in atrial fibrillation .  Radiofrequency ablation has long been a st and ard of care , while cryoballoon technology has emerged as a feasible approach with promising results . Prospect i ve multicenter registry data referring to both ablation technologies in AF ablation therapy are lacking . METHODS Between January 2007 and August 2011 , a total of 3,775 consecutive patients with symptomatic paroxysmal AF who underwent PV ablation in their respective centers were enrolled . The cohort was divided into 2 groups according to the ablation energy source used : cryoballoon ablation ( group 1 , n = 905 [ 24.0 % ] , median age 63 years , 64.3 % men ) and RF ablation ( group 2 , n = 2870 [ 76.0 % ] , median age 63 years , 62.7 % men ) . Comorbidities and baseline clinical characteristics were similar in both groups . RESULTS Acute success rate was similar in both groups ( 97.5 % in cryo vs 97.6 % in RF ; P = 0.81 ) . Procedure times were similar , ablation and fluoroscopy times were higher in cryoballoon when compared to RF ablation .  Overall complication rate was similar in cryo- ( 4.6 % ) and RF-ablation ( 4.6 % ; P = 1.0 ) . Phrenic nerve palsy was more often in cryo versus RF ablation ( 2.1 % in cryo vs 0.0 % in RF ; P < 0.001 ) . Other complications were more common in RF compared to cryoablation ( 4.6 % in RF vs 2.7 % in cryo ; P < 0.05 ) . CONCLUSION RF ablation is the most widespread ablation method in Germany , but use of cryoballoon increased significantly . Procedure times were similar , but ablation and fluoroscopy times were longer in cryoballoon ablation . No significant differences were found in terms of acute success and overall complication rate AIMS Cryoballoon ( CB ) ablation with the second-generation cryoballoon ( CBG2 ) seems to be more effective than its predecessor [ first-generation cryoballoon ( CBG1 ) ] , but phrenic nerve palsies were observed more frequently . The aim of this study was to compare the safety and efficacy of CBG1 and CBG2 in a sub study of the prospect i ve multicentre , multinational FREEZE Cohort Study . METHODS AND RESULTS Periprocedural data were analysed , and a total of 532 patients with paroxysmal atrial fibrillation ( AF ) were examined ( n = 224 for CBG1 and n = 308 for CBG2 ) . Procedure time decreased significantly from 149 to 130 min when comparing CBG1 with CBG2 ( P < 0.0001 ) , and pulmonary vein isolation ( PVI ) was achieved in 97.8 and 97.6 % of PVs with CBG1 and CBG2 ( P = 0.77 ) , respectively . The need for dual-balloon usage within a procedure dropped ( 20.1 vs. 9.0 % , P < 0.001 ) , and the fluoroscopy time was reduced when operating the CBG2 .  Atrial fibrillation recurrence rates until discharge were similar ( 5.0 vs. 5.8 % , P = 0.69 ) . Comparable low rates of major complications were observed with both CBs , and there was a non-significant trend for more phrenic nerve palsies . CONCLUSION Second-generation cryoballoon demonstrated a high rate of acute PVI in a significant faster procedure , which also utilized less radiation exposure and less dual-balloon usage during an average procedure . The safety profile remains favourable with a non-significant trend for more phrenic nerve palsies . If the enhancements lead to a higher clinical benefit has to be determined . The 1-year outcome data from the ongoing FREEZE Cohort Study comparing radiofrequency and CB ablation will shed some light on that issue . CLINICAL TRIALS GOV IDENTIFIER NCT01360008 BACKGROUND Phrenic nerve palsy ( PNP ) is the most frequently observed complication during  cryoballoon ablation ( CB ; A rct ic Front , Medtronic , MN ) occurring in roughly 7%-9 % of the cases . The new second-generation cryoballoon ablation A rct ic Front Advance ( CB-A ) ( A rct ic Front ) has recently been launched in the market . OBJECTIVE To evaluate the incidence of right PNP with the new CB-A in comparison with the first-generation balloon in a series of consecutive patients that underwent pulmonary vein isolation with this modality . METHODS The study was design ed as an observational study with a prospect i ve follow-up . In total , 121 consecutive patients were included : 80 patients with the CB ( group 1 ) and 41 with the CB-A ( group 2 ) . RESULTS Mean procedural times , fluoroscopic times , and time to pulmonary vein isolation documented by real-time recordings were significantly lower in group 2 ( P ≤ .05 ) . The occurrence of PNP was significantly higher in group 2 ( 6.25 % [ 5 of 80 ] in group 1 vs 19.5 % [ 8 of 41 ] in group 2 ; P = .033 ) . At 7 months , PNP persisted in 1 ( 2.5 % ) patient in the CB-A group . CONCLUSIONS Right PNP seems to occur in a significantly larger number of patients with the second-generation CB-A. However , this complication is reversible in nearly all cases on short-term follow-up . More refined phrenic nerve monitoring during right-sided pulmonary vein ablation and less vigorous wedging maneuvers in the pulmonary vein ostia might significantly reduce the occurrence of this complication Catheter ablation ( CA ) is a procedure commonly used to restore sinus rhythm in patients with atrial fibrillation ( AF ) . However , AF recurrence after CA remains a relevant clinical issue . We tested the effects of an oral antioxidant treatment ( alpha lipoic acid [ ALA ] ) on AF recurrence post-CA . Patients with paroxysmal AF have been enrolled in a r and omized , prospect i ve , double-blind , controlled placebo trial . After CA , patients have been r and omly assigned to receive ALA oral supplementation ( ALA group ) or placebo ( control group ) and evaluated at baseline and after a 12-month follow-up : 73 patients completed the 12-month follow-up  ( ALA : 33 and control : 40 ) . No significant difference has been detected between the 2 groups at baseline . Strikingly , 1 year after CA , ALA therapy significantly reduced serum markers of inflammation . However , there was no significant difference in AF recurrence events at follow-up comparing ALA with placebo group . Multivariate analysis revealed that the only independent prognostic risk factor for AF recurrence after CA is age . In conclusion , ALA therapy reduces serum levels of common markers of inflammation in ablated patients . Nevertheless , ALA does not prevent AF recurrence after an ablative treatment
target: No death or myocardial infa rct ion was reported .
  CONCLUSION ' PVI-plus ' involving 2G-CB seems to be safe and effective for treating PerAF
background: BACKGROUND Growing evidence suggests that second-generation cryoballoon ablation ( 2G-CB ) is effective in patients with persistent atrial fibrillation ( PerAF ) .
  The cornerstone of atrial fibrillation ( AF ) ablation is pulmonary vein isolation ( PVI ) .
  The purpose of this study was to summarize the available data on the safety and mid-term ( ≥ 12 months ) effectiveness of a ' PVI-only ' strategy vs. a ' PVI-plus ' strategy using 2G-CB in patients with PerAF .