Cryoballoon versus radiofrequency for pulmonary vein re-isolation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation. Cryoballoon versus radiofrequency catheter ablation for paroxysmal atrial fibrillation. Long-term comparison of cryoballoon and radiofrequency ablation of paroxysmal atrial fibrillation: a propensity score matched analysis. Circumferential pulmonary vein isolation with the cryoballoon technique results from a prospective 3-center study. Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation Rationale and Design of FIRE AND ICE: A multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction. Cryoballoon ablation for persistent atrial fibrillation - Large single-center experience. Randomised clinical trial of cryoballoon versus irrigated radio frequency catheter ablation for atrial fibrillation—the effect of double short versus standard exposure cryoablation duration during pulmonary vein isolation (CIRCA-DOSE): methods and rationale Two-Year Follow-Up after Contact Force Sensing Radiofrequency Catheter and Second-Generation Cryoballoon Ablation for Paroxysmal Atrial Fibrillation: A Comparative Single Centre Study Ablation of atrial fibrillation with cryoballoon or duty-cycled radiofrequency pulmonary vein ablation catheter: a randomized controlled study comparing the clinical outcome and safety; the AF-COR study. Pulmonary venous isolation by antral ablation with a large cryoballoon for treatment of paroxysmal and persistent atrial fibrillation: medium-term outcomes and non-randomised comparison with pulmonary venous isolation by radiofrequency ablation Circumferential pulmonary vein isolation as index procedure for persistent atrial fibrillation: a comparison between radiofrequency catheter ablation and second-generation cryoballoon ablation. The COR trial: a randomized study with continuous rhythm monitoring to compare the efficacy of cryoenergy and radiofrequency for pulmonary vein isolation. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Radiofrequency catheter ablation maintains its efficacy better than antiarrhythmic medication in patients with paroxysmal atrial fibrillation: On-treatment analysis of the randomized controlled MANTRA-PAF trial.
AIM Catheter ablation of paroxysmal atrial fibrillation ( PAF ) is associated with an important risk of early and late recurrence , necessitating repeat ablation procedures . The aim of this prospect i ve r and omized patient-blind study was to compare the efficacy and safety of cryoballoon ( Cryo ) versus radiofrequency ( RF ) ablation of PAF after failed initial RF ablation procedure . METHODS Patients with a history of symptomatic PAF after a previous failed first RF ablation procedure were eligible for this study . Patients were r and omized to Cryo or RF redo ablation . The primary endpoint of the study was recurrence of atrial tachyarrhythmia , including AF and left atrial flutter/tachycardia , after a second ablation procedure at 1 year of follow-up . All patients were implanted with a cardiac monitor ( Reveal XT , Medtronic ) to continuously track the cardiac rhythm . Patients with an AF burden ( AF% ) ≤ 0.5 % were considered AF-free ( Responders ) , while those with an AF% > 0.5 % were classified as patients with AF recurrences ( non-Responders ) . RESULTS Eighty patients with AF recurrences after a first RF pulmonary vein isolation ( PVI ) were r and omized to Cryo ( N = 40 ) or to RF ( N = 40 ) . Electrical potentials were recorded in 77 mapped PVs ( 1.9 ± 0.8 per patient ) in Cryo Group and 72 PVs ( 1.7 ± 0.8 per patient ) in RF Group ( P = 0.62 ) , all of which were targeted . In Cryo group , 68 ( 88 % ) of the 77 PVs were re-isolated using only Cryo technique ; the remaining 9 PVs were re-isolated using RF . In RF group , all 72 PVs were successfully re-isolated ( P = 0.003 vs Cryo ) . By intention-to-treat , 23 ( 58 % ) RF patients were AF-free vs 17 ( 43 % ) Cryo patients on no antiarrhythmic drugs at 1 year ( P = 0.06 ) . Three patients had temporary phrenic nerve paralysis in the Cryo group ; the RF group had no complications . Of the 29 patients who had only Cryo PVI without any RF ablation , 11 ( 38 % ) were AF-free vs 20 ( 59 % ) of the 34 patients who had RF only ( P = 0.021 ) . CONCLUSION When patients require a redo pulmonary vein isolation ablation procedure for recurrent PAF , RF appears to be the preferred energy source relative to Cryo BACKGROUND Catheter ablation is an established treatment for atrial fibrillation ( AF ) .  Cryoballoon ablation ( CBA ) has emerged as an alternative to radiofrequency ablation ( RFA ) . However , there are few data comparing these modalities for treatment of paroxysmal AF ( pAF ) in the U.S. POPULATION The purpose of this study was to compare procedural times , safety , and efficacy of CBA against RFA . METHODS A single-center prospect i ve cohort study evaluated patients who underwent catheter ablation for pAF using CBA or RFA between January 1 , 2010 and October 31 , 2013 . Patients with prior ablation and those without rhythm follow-up for at least 3 months were excluded . The primary end point was freedom from AF , atrial flutter , and atrial tachycardia ( FFAF ) > 30 seconds after a 3-month blanking period without requirement for antiarrhythmic drugs . We also compared rates of successful pulmonary vein isolation ( PVI ) , fluoroscopy and procedure times , and major complication rates . RESULTS A total of 201 patients were included ( CBA = 101 , RFA = 100 ) . The rate of successful PVI was 99.3 % in CBA versus 97.4 % in RFA ( P = 0.08 ) . Procedure times were shorter with CBA ( 192.9 ± 44.0 minutes vs 283.7 ± 78.0 minutes , P < 0.001 ) as well as total fluoroscopy times ( 46.0 ± 22.4 minutes vs 73.0 ± 30.1 minutes , P < 0.001 ) . Overall complication rates were equivalent ; however , fewer cardiac perforations occurred with CBA ( 0 % vs 4 % , P = 0.042 ) . The 1-year FFAF rates were 60.3 % for CBA and 61.1 % for RFA ( log rank P = 0.93 ) . CONCLUSION CBA was associated with equivalent 1-year FFAF rate as RFA for pAF . Procedure and fluoroscopy times were shorter for CBA and fewer cardiac perforations occurred BACKGROUND Although radiofrequency ( RF ) and cryoballoon ( CB ) based technologies for pulmonary vein isolation ( PVI ) have both individually been demonstrated to be effective and safe for the treatment of paroxysmal AF , head-to-head comparisons are lacking . The purpose of this study was to compare the outcome of cryoballoon versus radiofrequency ablation in patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation . METHODS Out of a prospect i ve registry of 327 patients undergoing PVI , 208 patients ( age 58±11 years , ejection fraction 59±6 % , left atrial size 39±6 mm ) with paroxysmal AF were identified . The presented data set was obtained by 1:1 propensity score matching and contained 142 patients undergoing CB-PVI or RF-PVI in conjunction with a 3D mapping system , respectively . We compared single procedure efficacy of the two methods using a Cox proportional hazards model . RESULTS After a mean follow-up of 28 months and a single procedure , AF recurred in 37 of 71 ( 52 % ) in the CB-PVI group and in 31 of 71 patients ( 44 % ) in the RF-PVI group ( HR [ 95 % CI]=1.19 [ 0.74 , 1.92 ] , p=0.48 ) . Recurrence of AF for PVI using solely the CB was observed in 23 of 51 ( 45 % ) patients and in 23 of 51 ( 45 % ) patients in the corresponding RF-PVI group ( HR [ 95 % CI]=0.93 [ 0.52 , 1.66 ] , p=0.81 ) . Complication rate was not different between the groups . CONCLUSION A propensity score matched comparison between CB-PVI and RF-PVI using a 3D-mapping system for AF ablation showed similar long-term success rates OBJECTIVES The purpose of this study was to investigate the efficacy safety of the novel cryoballoon device ( A rct ic Front , Cryocath , Quebec , Canada ) . BACKGROUND Antral pulmonary vein ( PV ) ablation with radiofrequency energy is widely used as a strategy for catheter ablation of paroxysmal atrial fibrillation ( PAF ) . A novel double lumen cryoballoon catheter was design ed for circumferential pulmonary vein isolation ( PVI ) with the cryoablation technique . METHODS We consecutively enrolled 346 patients with symptomatic , drug refractory paroxysmal ( n = 293 ) or persistent ( n = 53 ) atrial fibrillation ( AF ) . In all patients , PVI of all targeted PVs was the therapeutic aim . The primary end points of this nonr and omized study were : 1 ) acute isolation rate of targeted PV ; and 2 ) first electrocardiogram-documented recurrence of AF . The secondary end point was occurrence of PV stenosis or atrio-esophageal fistula . RESULTS The 1,360 of 1,403 PVs ( 97 % ) were targeted with balloons or balloons in combination with the use of Freezor Max ( Cryocath ) . We found that ablation with the cryoballoon result ed in maintenance of sinus rhythm in 74 % of patients with PAF and 42 % of patients with persistent AF . No PV narrowing occurred . The most frequent complication was right phrenic nerve palsy observed during cryoballoon ablation at the right superior PV . CONCLUSIONS Pulmonary vein isolation with a new cryoballoon technique is feasible . Sinus rhythm can be maintained in the majority of patients with PAF by circumferential PVI using a cryoballoon ablation system . Cryoablation was less effective in patients with persistent AF than in patients with PAF Background 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 . Methods FreezeAF was a r and omised 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 . Results Of the 315 patients that were r and omised 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 . Conclusion 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 . Trial registration Clinical Trials.gov Identifier : NCT00774566 ; first registered October 16 , 2008 ; first patient included October 20 , 2008 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 ) 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 BACKGROUND Atrial fibrillation ( AF ) is the most common sustained cardiac arrhythmia imposing substantial morbidity and mortality . Catheter-based pulmonary vein isolation ( PVI ) using radiofrequency current ( RFC ) has become a st and ard treatment for drug-resistant and symptomatic paroxysmal AF ( PAF ) . In recent years , the cryoballoon-based technique is increasingly used as a promising alternative with a short learning curve . METHODS The FIRE AND ICE trial is a prospect i ve , r and omized , controlled , open , blinded outcome assessment , noninferiority trial comparing cryoballoon- , and RFC-based PVI .  Patients with drug-resistant PAF will be r and omized in a 1:1 matrix in multiple European centers . The primary hypothesis is that cryoballoon ablation is not inferior to RFC ablation using 3-dimensional mapping with respect to clinical efficacy . The primary endpoint is defined as the time to first documented clinical failure , including : ( 1 ) recurrence of AF ; ( 2 ) atrial flutter or atrial tachycardia ; ( 3 ) prescription of class I or III antiarrhythmic drugs ; or ( 4 ) re-ablation , whichever comes first , following a blanking period of 3 months after the index ablation procedure . The primary safety endpoint is a composite of death , stroke/transient ischemic attack , cardiac arrhythmias ( apart from AF recurrence ) causally related to the therapeutic intervention , and procedure-related serious adverse events . CONCLUSION The FIRE AND ICE trial compares 2 different technologies to perform catheter ablation of PAF with respect to efficacy and safety . It aims at providing objective data to guide selection and usage of ablation catheters in the treatment of AF BACKGROUND Different catheter ablation ( CA ) strategies have been established in the treatment of persistent atrial fibrillation ( persAF ) .  Pulmonary vein isolation ( PVI ) only might be an option for the initial ablation procedure . There is a paucity of outcome data on second-generation cryoballoon ( CBG2 ) PVI in persAF . METHODS Patients with symptomatic drug-refractory persAF who underwent initial CA of AF  were prospect ively enrolled and PVI was performed with CBG2 . The primary composite endpoint was freedom from AF , atrial tachycardia , or related symptoms after a 3-month blanking period . The secondary endpoint referred to periprocedural complications . RESULTS One hundred seventy-three consecutive patients ( 64±10 years , 29 % female ) with symptomatic drug-refractory persAF were identified . Acute PVI was achieved in 100 % of pulmonary veins with the CB technique . The left atrial procedure time was 112±30min . Major complications occurred in 1.7 % ( 3 of 173 patients ) including two phrenic nerve palsies ( 1 % ) , which resolved until discharge , and one pericardial effusion ( 0.6 % ) . Follow-up ≥12 months was completed for 157 of 173 patients ( 91 % ) . Median follow-up was 14 months . At 12 months , the primary composite endpoint was achieved in 129 of 157 patients ( 82 % ) . However , 22 of 129 patients at risk ( 17 % ) were still on antiarrhythmic drugs . A relapse during the blanking period was identified as the only independent predictor for AF recurrence . CONCLUSION PVI using the second-generation cryoballoon is a reasonable treatment option for patients with symptomatic drug-refractory persAF with a favorable rate of freedom from AF and a low complication rate Introduction Pulmonary vein isolation ( PVI ) is an effective therapy for paroxysmal atrial fibrillation ( AF ) , but it has limitations . The two most significant recent advances have centred on the integration of real-time quantitative assessment of catheter contact force into focal radio frequency ( RF ) ablation catheters and the development of dedicated ablation tools capable of achieving PVI with a single ablation lesion ( A rct ic Front cryoballoon , Medtronic , Minneapolis , MN , USA ) . Although each of these holds promise for improving the clinical success of catheter ablation of AF , there has not been a rigorous comparison of these advanced ablation technologies . Moreover , the optimal duration of cryoablation ( freezing time ) has not been determined . Methods and analysis Patients undergoing an initial PVI procedure for paroxysmal AF will be recruited . Patients will be r and omised 1:1:1 between contact-force irrigated RF ablation , short duration cryoballoon ablation ( 2 min applications ) and st and ard duration cryoballoon ablation ( 4 min applications ) . The primary outcome is time to first documented AF recurrence on implantable loop recorder . With a sample size of 111 per group and a two-sided 0.025 significance level ( to account for the two main comparisons ) , the study will have 80 % power ( using a log-rank test ) to detect a difference of 20 % between contact force RF catheter ablation and either of the two cryoballoon ablation groups . Factoring in a 4 % loss to follow-up , 116 patients per group should be r and omised and followed for a year ( total study population of 348 ) . Ethics and dissemination The study was approved by the University of British Columbia Office of Research ( Services ) Ethics Clinical Research Ethics Board . Results of the study will be su bmi tted for publication in a peer- review ed journal . Trial registration number NCT01913522 ; Pre- Background . There are little comparative data on catheter ablation of paroxysmal atrial fibrillation ( AF ) using the contact force radiofrequency ( CF-RF ) catheter versus the second-generation cryoballoon ( CB2 ) . Methods and results . This is a single center , retrospective , nonr and omized study of 98 patients with symptomatic , drug-refractory paroxysmal AF who underwent their first PVI ablation using either the CB2 ( n = 40 ) or CF-RF ( n = 58 ) . The mean age was 60 years with 63 % men , a mean LA size of 42 mm . The procedure duration ( 74 ± 17 versus 120 ± 49 minutes p < 0.05 ) was shorter for CB2 group ; the fluoroscopy time ( 14 ± 17 versus 16 ± 5 minutes , p = 0.45 ) was similar . Complete PVI was achieved in 96 % of patients with RF-CF and 98 % with CB2 . Phrenic nerve palsies ( 2 transient and 1 persistent ) occurred exclusively in the CB2 group and 1 severe , nonlethal complication ( pericardial tamponade ) occurred in the CF-RF group . At 24-month follow-up , the success rate , defined as freedom from AF/atrial tachycardia ( AT ) after a single procedure without antiarrhythmic drug , was comparable in CF-RF group and CB2 group ( 65.5 % versus 67 % , resp . , log rank p = 0.54 ) . Conclusion . Both the CB2 and the RF-CF ablation appeared safe ; the success rate at 2 years was comparable between both technologies AIMS The urge to facilitate the atrial fibrillation ( AF ) ablation procedure has led to the development of new ablation catheters specifically design ed as ' one-shot tools ' for pulmonary vein isolation ( PVI ) . The purpose of this study was to compare the efficacy , safety , and procedure times for two such catheters using different energy sources . METHODS AND RESULTS One hundred and ten patients , referred for ablation of paroxysmal or persistent AF , were r and omized to treatment with either the cryoballoon or the circular multipolar duty-cycled radiofrequency-based pulmonary vein ablation catheter ( PVAC ) .  Complete PVI was achieved in 98 vs. 93 % patients in the cryoballoon and PVAC group , respectively , with complication rates of 8 vs. 2 % ( P = 0.2 ) . Complete freedom from AF , without antiarrhythmic drugs , after one single ablation procedure was seen in 46 % in the cryoballoon vs. 34 % after 12 months ( P = 0.2 ) . Procedure times were comparable , but fluoroscopy time was shorter for the cryoballoon ( 32 ± 16 min ) than for the PVAC procedures ( 47 ± 17 min ) ( P < 0.001 ) . A significant improvement of quality of life ( QoL ) and arrhythmia-related symptoms was seen in both groups after ablation . CONCLUSION Both catheters proved comparably effective and safe in achieving acute PVI , apart from the shorter fluoroscopy times achieved with the cryoballoon . At follow-up , there was no statistically significant difference between the groups regarding freedom from AF and clinical success . The QoL increased to the same levels as for the general Swedish population in both groups Background To prevent  atrial fibrillation ( AF ) recurrence after catheter ablation , pulmonary venous isolation ( PVI ) at an antral level is more effective than segmental ostial ablation . Cryoablation around the pulmonary venous ( PV ) ostia for AF therapy is potentially safer compared to radiofrequency ablation ( RFA ) . The aim of this study was to investigate the efficacy of a strategy using a large cryoablation balloon to perform antral cryoablation with ‘ touch-up ’ ostial cryoablation for PVI in patients with paroxysmal and persistent AF . Methods Paroxysmal and persistent AF patients undergoing their first left atrial ablation were recruited . After cryoballoon therapy , each PV was assessed for isolation and if necessary , treated with focal ostial cryoablation until PVI was achieved . Follow-up with Holter monitoring was performed . Clinical outcomes of the cryoablation protocol were compared , with consecutive patients undergoing PVI by RFA . Results 124 consecutive patients underwent cryoablation . 77 % of paroxysmal and 48 % of persistent AF subjects were free from AF at 12 months after a single procedure . Over the same time period , 53 consecutive paroxysmal AF subjects underwent PVI with RFA and at 12 months , 72 % were free from AF at 12 months ( p = NS ) . There were too few persistent AF subjects ( n=8 ) undergoing solely PVI by RFA as a comparison group . Procedural and fluoroscopic times during cryoablation were significantly shorter than RFA . Conclusions PV isolation can be achieved in less than 2 h by a simple cryoablation protocol with excellent results after a single intervention , particularly for paroxysmal AF 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 Results from r and omized trials design ed to compare cryoenergy with radiofrequency for pulmonary vein ( PV ) isolation are lacking . OBJECTIVE To compare the efficacy of a simplified strategy for PV cryoablation ( group C ) vs PV isolation with open-irrigated radiofrequency catheters ( group R ) . METHODS Fifty patients with paroxysmal atrial fibrillation ( AF ) and 4 independent PVs received a Reveal XT implantable cardiac monitor and were r and omized to group C or group R. In group C , PV ablation was done with a single A rct ic Front balloon ( 23 or 28 mm ) per patient and two 300-second applications per PV . No further applications were delivered to close residual conduction gaps . In group R , bidirectional PV conduction block was pursued with Lasso and Navistar ThermoCool catheters and the CARTO system . The primary end point was the proportion of patients remaining free from AF recurrences ≥2 minutes without taking antiarrhythmic drugs 12 months after ablation . RESULTS The primary end point was met by 12 ( 48 % ) patients in group C and 25 ( 68 % ) patients in group R ( odds ratio 0.43 ; P = .05 ) . This difference disappeared after adjustment for acute procedural outcome . In patients for whom all 4 PVs were blocked at the end of the procedure , there was no difference between group C and group R in the primary end point ( 67 % vs 68 % ; P = .94 ) . CONCLUSIONS The efficacy of the simplified strategy for PV cryoablation tested in this study is inferior to PV isolation using open-irrigated radiofrequency catheters with electrophysiological and electroanatomical guidance . Complete PV conduction block is critical to the success of AF ablation BACKGROUND Catheter ablation is important for treatment of paroxysmal atrial fibrillation ( PAF ) . Limited animal and human studies suggest a correlation between electrode-tissue contact and radiofrequency lesion generation . OBJECTIVES The study sought to assess the safety and effectiveness of an irrigated , contact force (CF)-sensing catheter in the treatment of drug refractory symptomatic PAF . METHODS A prospect i ve , multicenter , nonr and omized study was conducted . Enrollment criteria included : ≥3 symptomatic episodes of PAF within 6 months of enrollment and failure of ≥1 antiarrhythmic drug ( Class I to IV ) . Ablation included pulmonary vein isolation with confirmed entrance block as procedural endpoint . RESULTS A total of 172 patients were enrolled at 21 sites , where 161 patients had a study catheter inserted and 160 patients underwent radiofrequency application . Procedural-related serious adverse events occurring within 7 days of the procedure included tamponade ( n = 4 ) , pericarditis ( n = 3 ) , heart block ( n = 1 , prior to radiofrequency application ) , and vascular access complications ( n = 4 ) . By Kaplan-Meier analyses , 12-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 72.5 % . The average CF per procedure was 17.9 ± 9.4 g. When the CF employed was between investigator selected working ranges ≥80 % of the time during therapy , outcomes were 4.25 times more likely to be successful ( p = 0.0054 ; 95 % confidence interval : 1.53 to 11.79 ) . CONCLUSIONS The SMART-AF trial demonstrated that this irrigated CF-sensing catheter is safe and effective for the treatment of drug refractory symptomatic PAF , with no unanticipated device-related adverse events . The increased percent of time within investigator-targeted CF ranges correlates with increased freedom from arrhythmia recurrence . Stable CF during radiofrequency application increases the likelihood of 12-month success . ( THERMOCOOL ® SMARTTOUCH ® Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation ; NCT01385202 ) BACKGROUND The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation ( MANTRA-PAF ) is a r and omized trial comparing radiofrequency catheter ablation ( RFA ) to antiarrhythmic drugs ( AADs ) as first-line treatment of paroxysmal atrial fibrillation ( PAF ) . In order to eliminate the clouding effect of crossover we performed an on-treatment analysis of the data . METHODS AND RESULTS Patients ( n=294 ) were divided into three groups : those receiving only the assigned therapy ( RFA and AAD groups ) and those receiving both therapies ( crossover group ) . The primary end points were AF burden in 7-day Holter recordings at 3 , 6 , 12 , 18 , and 24 months and cumulative AF burden in all recordings . At 24 months , AF burden was significantly lower in the RFA ( n=110 ) than in the AAD ( n=92 ) and the crossover ( n=84 ) groups ( 90th percentile 1 % vs. 10 % vs. 16 % , P=0.007 ) , and more patients were free from any AF ( 89 % vs. 73 % vs. 74 % , P=0.006 ) . In the RFA , AAD and the crossover groups 63 % , 59 % and 21 % ( P<0.001 ) of the patients had no AF episodes in any Holter recording , respectively . Quality of life improved significantly in all groups . There were no differences in serious adverse events between the RFA , AAD and crossover groups ( 19 % vs. 8 % vs. 23 % ) ( P=0.10 ) . CONCLUSIONS In the treatment of antiarrhythmic therapy naïve patients with PAF long-term efficacy of RFA was superior to AAD therapy . Thus , it is reasonable to offer RFA as first-line treatment for highly symptomatic patients who accept the risks of the procedure and are aware of frequent need for reablation(s )
Conclusion Our systemic review and meta- analysis revealed further evidence that cryoballoon ablation is an equally effective alternative procedure to the st and ard radiofrequency treatment with a slightly , non-significant higher freedom from AF 1 year after the ablation and a shorter procedure time
Objective The aim of this study was to evaluate the clinical efficacy and safety outcomes of the treatment with cryoballoon ( CB ) compared to the treatment with traditional irrigated radiofrequency ablation ( RF ) for pulmonary vein isolation ( PVI ) in patients with paroxysmal atrial fibrillation ( pAF ) and refractory to antiarrhythmic drug therapy ( AAD ) .