Cost-Effectiveness of Radiofrequency Catheter Ablation Compared With Antiarrhythmic Drug Therapy for Paroxysmal Atrial Fibrillation Radiofrequency Catheter Ablation and Antiarrhythmic Drug Therapy: A Prospective, Randomized, 4-Year Follow-Up Trial: The APAF Study 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. Cryoballoon versus radiofrequency catheter ablation for paroxysmal atrial fibrillation. Phased RF ablation in persistent atrial fibrillation. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST): A 2-Center Randomized Clinical Trial Improvements in Symptoms and Quality of Life in Patients With Paroxysmal Atrial Fibrillation Treated With Radiofrequency Catheter Ablation Versus Antiarrhythmic Drugs Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Long-term single procedure efficacy of catheter ablation of atrial fibrillation 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. 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. A Randomized Controlled Trial of the Efficacy and Safety of Electroanatomic Circumferential Pulmonary Vein Ablation Supplemented by Ablation of Complex Fractionated Atrial Electrograms Versus Potential-Guided Pulmonary Vein Antrum Isolation Guided by Intracardiac Ultrasound Results of a Minimally Invasive Surgical Pulmonary Vein Isolation and Ganglionic Plexi Ablation for Atrial Fibrillation: Single-Center Experience With 12-Month Follow-Up Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force–Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study A randomized clinical trial of early invasive intervention for atrial fibrillation (EARLY-AF) - methods and rationale. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. Long-term efficacy and safety of two different rhythm control strategies in elderly patients with symptomatic persistent atrial fibrillation. 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 Catheter Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation: The A4 Study Extensive antiarrhythmic drugs after catheter ablation of persistent atrial fi brillation Antiarrhythmic drug therapy after radiofrequency catheter ablation in patients with atrial fibrillation.
Background —Radiofrequency 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 Results —We 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 prospect ively 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 . Conclusions —RFA 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 Background — Information on comparative outcome between radiofrequency catheter ablation ( RFA ) and antiarrhythmic drugs ( AADs ) > 1 year after r and omization is important for clinical decision-making . Methods and Results — A total of 198 patients ( age , 56±10 years ) with paroxysmal atrial fibrillation were r and omly assigned to RFA ( 99 patients ) or to AADs ( 99 patients ) . We evaluated efficacy of RFA or AADs in a comparable 48-month follow-up period according to intention-to-treat analysis . Cardiac rhythm was assessed with daily transtelephonic transmissions . Quality of life was also analyzed . At 4 years , among the 99 patients first assigned to RFA , the procedure was repeated because of recurrent atrial fibrillation/atrial tachycardia in 27 patients ( 27.3 % ) . Among the 99 patients r and omly assigned to AADs , 87 ( 87.9 % ) crossed over to undergo RFA and 4 years after r and om assignment only 12 ( 12.1 % ) were in sinus rhythm with AAD alone without ablation . Despite the high level of crossovers , at 4 years the intention-to-treat analysis showed that 72.7 % of patients in the ablation arm and 56.5 % of those initially r and omly assigned to AADs were free of recurrent atrial fibrillation/atrial tachycardia ( P=0.017 ) . During the follow-up , 19.2 % of AAD patients progressed to persistent atrial fibrillation before switching to RFA . RFA significantly improved quality of life ( P<0.001 ) , whereas before crossing over to RFA , patients receiving AADs showed poorer quality of life . Except for new left atrial tachycardia , there were no serious complications caused by RFA . Conclusions — With follow-up extended to 4 years after r and omly assigned , ablation remains superior to antiarrhythmic drug in these patients with paroxysmal atrial fibrillation . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00340314 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 ) 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 Persistent and long-st and ing persistent atrial fibrillation ( AF ) often requires extensive and /or repeat radiofrequency ( RF ) ablation procedures . OBJECTIVE The Tailored Treatment of Persistent Atrial Fibrillation ( TTOP-AF ) study assessed the effectiveness and safety of the phased RF system in a r and omized controlled comparison of medical therapy against phased RF ablation for the management of persistent and long-st and ing persistent AF . METHODS Patients who had failed at least 1 antiarrhythmic drug ( AAD ) were r and omized ( 2:1 ) to ablation management ( AM ) or medical management ( MM ) . AM patients were allowed up to 2 ablations . Index and retreatment procedures consisted of pulmonary vein isolation and ablation of complex fractionated atrial electrograms . MM patients received AAD changes and /or cardioversion . The primary end points of the TTOP-AF study included chronic effectiveness and safety at 6 months and acute safety within 7 days of ablation . RESULTS At 6 months , a greater proportion of AM patients achieved effectiveness off AAD ( 77 of 138 [ 55.8 % ] ) compared to MM patients ( 19 of 72 [ 26.4 % ] ) ( P < .0001 ) . Acutely , 92.8 % ( 128/138 ) of the procedures were successful while 12.3 % ( 17/138 ) experienced a serious procedure and /or device-related adverse event . The predefined acute safety end point was not met . The proportion of patients with chronic safety events did not differ significantly between groups . CONCLUSIONS Catheter ablation of persistent/long-st and ing persistent AF with the phased RF ablation system is effective with greater reduction of AF compared with MM . More intense anticoagulation strategies , careful attention to catheter placement relative to the pulmonary vein ostia , and elimination of electrode interaction are expected to reduce the risk of stroke , pulmonary vein stenosis , and asymptomatic cerebral emboli BACKGROUND There are limited data comparing radiofrequency catheter ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation . METHODS We r and omly assigned 294 patients with paroxysmal atrial fibrillation and no history of antiarrhythmic drug use to an initial treatment strategy of either  radiofrequency catheter ablation  ( 146 patients ) or therapy with class IC or class III antiarrhythmic agents ( 148 patients ) . Follow-up included 7-day Holter-monitor recording at 3 , 6 , 12 , 18 , and 24 months . Primary end points were the cumulative and per-visit burden of atrial fibrillation ( i.e. , percentage of time in atrial fibrillation on Holter-monitor recordings ) . Analyses were performed on an intention-to-treat basis . RESULTS There was no significant difference between the ablation and drug-therapy groups in the cumulative burden of atrial fibrillation ( 90th percentile of arrhythmia burden , 13 % and 19 % , respectively ; P=0.10 ) or the burden at 3 , 6 , 12 , or 18 months . At 24 months , the burden of atrial fibrillation was significantly lower in the ablation group than in the drug-therapy group ( 90th percentile , 9 % vs. 18 % ; P=0.007 ) , and more patients in the ablation group were free from any atrial fibrillation ( 85 % vs. 71 % , P=0.004 ) and from symptomatic atrial fibrillation ( 93 % vs. 84 % , P=0.01 ) . One death in the ablation group was due to a procedure-related stroke ; there were three cases of cardiac tamponade in the ablation group . In the drug-therapy group , 54 patients ( 36 % ) underwent supplementary ablation . CONCLUSIONS In comparing radiofrequency ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation , we found no significant difference between the treatment groups in the cumulative burden of atrial fibrillation over a period of 2 years . ( Funded by the Danish Heart Foundation and others ; MANTRA-PAF Clinical Trials.gov number , NCT00133211 . ) Background — Catheter ablation ( CA ) and minimally invasive surgical ablation ( SA ) have become accepted therapy for antiarrhythmic drug – refractory atrial fibrillation . This study describes the first r and omized clinical trial comparing their efficacy and safety during a 12-month follow-up . Methods and Results — One hundred twenty-four patients with antiarrhythmic drug – refractory atrial fibrillation with left atrial dilatation and hypertension ( 42 patients , 33 % ) or failed prior CA ( 82 patients , 67 % ) were r and omized to CA ( 63 patients ) or SA ( 61 patients ) . CA consisted of linear antral pulmonary vein isolation and optional additional lines . SA consisted of bipolar radiofrequency isolation of the bilateral pulmonary vein , ganglionated plexi ablation , and left atrial appendage excision with optional additional lines . Follow-up at 6 and 12 months was performed by ECG and 7-day Holter recording . The primary end point , freedom from left atrial arrhythmia > 30 seconds without antiarrhythmic drugs after 12 months , was 36.5 % for CA and 65.6 % for SA ( P=0.0022 ) . There was no difference in effect for subgroups , which was consistent at both sites . The primary safety end point of significant adverse events during the 12-month follow-up was significantly higher for SA than for CA ( n=21 [ 34.4 % ] versus n=10 [ 15.9 % ] ; P=0.027 ) , driven mainly by procedural complications such as pneumothorax , major bleeding , and the need for pacemaker . In the CA group , 1 patient died at 1 month of subarachnoid hemorrhage . Conclusion — In atrial fibrillation patients with dilated left atrium and hypertension or failed prior atrial fibrillation CA , SA is superior to CA in achieving freedom from left atrial arrhythmias after 12 months of follow-up , although the procedural adverse event rate is significantly higher for SA than for CA . Clinical Trial Registration — URL : http:// clinical trials.gov . Unique identifier : NCT00662701 Background —In patients with paroxysmal atrial fibrillation ( AF ) , catheter ablation maintains sinus rhythm more effectively than antiarrhythmic drugs ( AADs ) , but its effect on symptoms and quality of life ( QOL ) has not been fully characterized . Methods and Results —We evaluated symptoms and QOL in a multicenter , r and omized trial comparing catheter ablation with AADs as second-line treatment for patients with paroxysmal AF . The Short Form (SF)-36 health survey and the AF Symptom Checklist were administered at baseline and 3 , 6 , and 9 months after a blanking or dose-titration period . The primary between-group comparisons were conducted at 3 months because of permitted crossover from AAD to ablation beyond this time . Additional analyses based on subsequent follow-up were performed , including the construction of mixed linear regression models to assess the impact of multiple factors on follow-up QOL scores . At baseline in both the ablation ( n=103 ) and the AAD ( n=56 ) groups , 7 of 8 SF-36 scales were well below population norms , as were the physical ( PCS ) and mental ( MCS ) summary scores . At 3 months , the same 7 SF-36 scales were significantly ( P<0.01 ) higher in the ablation than in the AAD group , as were the PCS ( 52.0±7.8 versus 47.1±10.6 ; P<0.01 ) and MCS ( 52.4±8.1 versus 46.6±9.8 ; P<0.01 ) scores , whereas symptom frequency ( 9.3±9.2 versus 19.0±12.6 ; P<0.001 ) and symptom severity ( 7.7±7.2 versus 16.2±10.0 ; P<0.001 ) were significantly reduced . In multivariable analysis , ablation and recurrent arrhythmias most strongly correlated with QOL changes over time . Conclusions —For second-line therapy of paroxysmal AF , ablation is superior to AAD treatment at improving symptoms and QOL . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00116428 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 Two important limitations of the data regarding the outcomes of catheter ablation of atrial fibrillation ( AF ) are the short-term follow-up used in most published studies and the lack of single-procedure outcomes . Objective The objective was to report the long-term single-procedure outcomes at our center . Material s and methods The patient population was comprised of 200 consecutive patients who underwent ablation ( 133 men ; age 56 ± 11 years ) . Atrial fibrillation was paroxysmal in 92 ( 46 % ) . Success was defined as absence of symptomatic AF , off antiarrhythmic drug ( AAD ) after a single procedure . Results After a follow-up of 26 ± 11 months , the single-procedure long-term success rate was 28 % with an additional 7 % of patients demonstrating improvement . After including repeat procedures in 64 patients , the overall long-term success rate was 41 % with 11 % demonstrating improvement . Further subgroup analysis of 48 paroxysmal AF patients considered to be optimal c and i date s for the procedure , revealed a long-term success rate of 69 % with an additional 4 % demonstrating improvement . A major complication occurred in 7.9 % of patients . Conclusion The results reveal that the long-term single-procedure success rate  of catheter ablation of AF in a cohort of patients with predominantly non-paroxysmal AF is less than 40 % . The inclusion of redo procedures result ed in an improvement in outcomes . A much higher success rate of 69 % was achieved in patients with paroxysmal AF considered to be optimal c and i date s for this procedure . These results make it clear that further advances in the technique of catheter ablation of AF are needed to improve the safety and efficacy of this procedure . In order to be able to compare outcomes of various techniques in differing patient population s , we urge investigators to report long-term single procedure outcomes 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 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 —The study was conducted to compare relative safety and efficacy of pulmonary vein antrum isolation ( PVAI ) using intracardiac echocardiographic guidance and circumferential pulmonary vein ablation ( CPVA ) for atrial fibrillation ( AF ) using radiofrequency energy . Methods and Results —Sixty patients ( 81 % men ; 81 % paroxysmal ; age , 56±8 years ) failing 2±1 antiarrhythmic drugs were r and omly assigned to undergo CPVA ( n=30 ) or PVAI ( n=30 ) at 5 centers between December 2004 and October 2007 .  CPVA patients had circular lesions placed at least 1 cm outside of the veins . Ipsilateral veins were ablated en block with the end point of disappearance of potentials within the circular lesion . Left atrial roof line and mitral isthmus line were ablated without verification of block . For patients in AF postablation or with AF induced with programmed stimulation , complex fractionated electrograms were mapped and ablated to the end point of AF termination or disappearance of complex fractionated electrograms . PVAI did not include complex fractionated electrogram ablation . Esophageal temperature was monitored and kept within 2 ° C of baseline or under 39 ° C . Success was defined as absence of atrial tachyarrhythmias ( AF/AT ) off antiarrhythmic drugs . There was no difference between CPVA and PVAI regarding to baseline variables , catheter used , duration of the procedure , or RF delivery . Fluoroscopy time was longer with PVAI ( 54±17 minutes versus 77±18 minutes , P=0.0001 ) . No significant complications occurred in either arm . PVAI was more likely to achieve control of AF/AT off antiarrhythmic drugs ( 57 % versus 27 % , P=0.02 ) at 2±1 years of follow-up . Conclusions —A single PVAI procedure is more likely to result in freedom from AF/AT off antiarrhythmic drugs than CPVA supplemented by complex fractionated electrogram ablation in select patients Background —The Cox Maze procedure for treatment of medically refractory atrial fibrillation ( AF ) is limited by its complexity and requirement for cardiopulmonary bypass . Long-term follow-up and success using criteria established by the Heart Rhythm Society/European Heart Rhythm Association/European Cardiac Arrhythmia Society consensus statement have not been reported for surgical AF ablation . We describe the results of using a thorascopic approach and radiofrequency energy to perform bilateral pulmonary vein isolation and left atrial ganglionic plexi ablation for treatment of AF . Methods and Results —Forty-five ( 33 paroxysmal ; 12 persistent ) consecutive patients underwent thorascopic bilateral radiofrequency pulmonary vein isolation , ganglionic plexi ablation , ligament of Marshall ablation , and left atrial appendage exclusion by a single surgeon . Forty-three patients were prospect ively followed without antiarrhythmic drugs for a minimum of 1 year with a 30-day continuous event monitor or pacemaker interrogation at 6 and 12 months . Failure was defined as any atrial tachyarrhythmia of > 30 seconds ’ duration occurring > 90 days after surgery . Mean follow-up was 516±181 days ( 202 to 858 days ) . Twenty-eight ( 65 % ) patients had no atrial tachyarrhythmia > 30 seconds by 1 year , and 15 ( 35 % ) patients had atrial tachyarrhythmia recurrences by 1 year . Eight of 15 patients with recurrent AF had catheter ablation result ing in elimination and /or reduction of AF episodes in 7 of 8 patients . Four of 15 patients had AF elimination or reduction with antiarrhythmic drugs alone . Three patients did not benefit from surgery and received rate control only . There were no deaths ; 1 phrenic nerve injury and 2 pleural effusions were the only major complications . Conclusions —The single procedure success at 1-year follow-up for surgical pulmonary vein isolation and ganglionic plexi ablation is 65 % . Atrial tachyarrhythmia recurrences after surgery are usually responsive to catheter ablation and /or antiarrhythmic drugs Background — Contact force ( CF ) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation ablation . This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency ablation catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation . Methods and Results — A total of 300 patients with symptomatic , drug-refractory , paroxysmal atrial fibrillation were enrolled in a prospect i ve , multicenter , r and omized , controlled trial and r and omized to radiofrequency ablation with either a novel CF-sensing catheter or a non-CF catheter ( control ) . The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months . The primary safety end point included device-related serious adverse events . End points were powered to show noninferiority . All pulmonary veins were isolated in both groups . Effectiveness was achieved in 67.8 % and 69.4 % of subjects in the CF and control arms , respectively ( absolute difference , −1.6 % ; lower limit of 1-sided 95 % confidence interval , −10.7 % ; P=0.0073 for noninferiority ) . When the CF arm was stratified into optimal CF ( ≥90 % ablations with ≥10 g ) and nonoptimal CF groups , effectiveness was achieved in 75.9 % versus 58.1 % , respectively ( P=0.018 ) . The primary safety end point occurred in 1.97 % and 1.40 % of CF patients and control subjects , respectively ( absolute difference , 0.57 % ; upper limit of 1-sided 95 % confidence interval , 3.61 % ; P=0.0004 for noninferiority ) . Conclusions — The CF ablation catheter met the primary safety and effectiveness end points . Additionally , optimal CF was associated with improved effectiveness . Clinical Trial Registration — http://www . clinical trials.gov . Unique identifier : NCT01278953 BACKGROUND The ideal management of patients with newly diagnosed symptomatic atrial fibrillation ( AF ) remains unknown . Current practice guidelines recommend a trial of antiarrhythmic drugs ( AAD ) prior to considering an invasive ablation procedure . However , earlier ablation offers an opportunity to halt the progressive patho-anatomical changes associated with AF , as well as impart other important clinical benefits . OBJECTIVE The aim of this study is to determine the optimal initial management strategy for patients with newly diagnosed , symptomatic atrial fibrillation . METHODS / DESIGN The EARLY-AF study ( Clinical Trials.govNCT02825979 ) is a prospect i ve , open label , multicenter , r and omized trial with a blinded assessment of outcomes . A total of 298 patients will be r and omized in a 1:1 fashion to first-line AAD therapy , or first-line cryoballoon-based pulmonary vein isolation .  Patients with symptomatic treatment naïve AF will be included . Arrhythmia outcomes will be assessed by implantable cardiac monitor ( ICM ) . The primary outcome is time to first recurrence of AF , atrial flutter , or atrial tachycardia ( AF/AFL/AT ) between days 91 and 365 following AAD initiation or AF ablation . Secondary outcomes include arrhythmia burden , quality of life , and healthcare utilization . DISCUSSION The EARLY-AF study is a r and omized trial design ed to evaluate the optimal first management approach for patients with AF . We hypothesize that catheter ablation will be superior to drug therapy in prevention of AF recurrence BACKGROUND Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation .  Radiofrequency ablation is the most common method , and cryoballoon ablation is the second most frequently used technology . METHODS We conducted a multicenter , r and omized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation . The primary efficacy end point in a time-to-event analysis was the first documented clinical failure ( recurrence of atrial fibrillation , occurrence of atrial flutter or atrial tachycardia , use of antiarrhythmic drugs , or repeat ablation ) following a 90-day period after the index ablation . The noninferiority margin was prespecified as a hazard ratio of 1.43 . The primary safety end point was a composite of death , cerebrovascular events , or serious treatment-related adverse events . RESULTS A total of 762 patients underwent r and omization ( 378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation ) . The mean duration of follow-up was 1.5 years . The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group ( 1-year Kaplan-Meier event rate estimates , 34.6 % and 35.9 % , respectively ; hazard ratio , 0.96 ; 95 % confidence interval [ CI ] , 0.76 to 1.22 ; P<0.001 for noninferiority ) . The primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group ( 1-year Kaplan-Meier event rate estimates , 10.2 % and 12.8 % , respectively ; hazard ratio , 0.78 ; 95 % CI , 0.52 to 1.18 ; P=0.24 ) . CONCLUSIONS In this r and omized trial , cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation , and there was no significant difference between the two methods with regard to overall safety . ( Funded by Medtronic ; FIRE AND ICE Clinical Trials.gov number , NCT01490814 . ) CONTEXT Antiarrhythmic drugs are commonly used for prevention of recurrent atrial fibrillation ( AF ) despite inconsistent efficacy and frequent adverse effects . Catheter ablation has been proposed as an alternative treatment for paroxysmal AF . OBJECTIVE To determine the efficacy of catheter ablation compared with antiarrhythmic drug therapy ( ADT ) in treating symptomatic paroxysmal AF . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve , multicenter , r and omized ( 2:1 ) , unblinded , Bayesian- design ed study conducted at 19 hospitals of 167 patients who did not respond to at least 1 antiarrhythmic drug and who experienced at least 3 AF episodes within 6 months before r and omization . Enrollment occurred between October 25 , 2004 , and October 11 , 2007 , with the last follow-up on January 19 , 2009 . INTERVENTION Catheter ablation ( n = 106 ) or ADT ( n = 61 ) , with assessment for effectiveness in a comparable 9-month follow-up period . MAIN OUTCOME MEASURES Time to protocol -defined treatment failure . The proportion of patients who experienced major treatment-related adverse events within 30 days of catheter ablation or ADT was also reported . RESULTS At the end of the 9-month effectiveness evaluation period , 66 % of patients in the catheter ablation group remained free from protocol -defined treatment failure compared with 16 % of patients treated with ADT . The hazard ratio of catheter ablation to ADT was 0.30 ( 95 % confidence interval , 0.19 - 0.47 ; P < .001 ) . Major 30-day treatment-related adverse events occurred in 5 of 57 patients ( 8.8 % ) treated with ADT and 5 of 103 patients ( 4.9 % ) treated with catheter ablation .  Mean quality of life scores improved significantly in patients treated by catheter ablation compared with ADT at 3 months ; improvement was maintained during the course of the study . CONCLUSION Among patients with paroxysmal AF who had not responded to at least 1 antiarrhythmic drug , the use of catheter ablation compared with ADT result ed in a longer time to treatment failure during the 9-month follow-up period . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00116428 BACKGROUND We prospect ively compared the efficacy , safety , and quality of life ( QoL ) impact of catheter ablation versus antiarrhythmic drugs ( AAD ) in elderly patients with persistent atrial fibrillation ( AF ) . METHODS AND RESULTS Four hundred and twelve consecutive patients , aged ≥ 70 years , underwent ablation ( Group A , 153 patients ) or AAD ( Group B , 259 patients ) . Study endpoints : treatment failure ( any AF/AT lasting > 30 seconds ) and treatment-related adverse events ( acute when ≤1 month of procedure and long term when > 1 month ) . At a follow-up of 60 ± 17 months , 43 % and 46 % patients in Group B versus 58 % and 76 % in Group A were in sinus rhythm ( SR ) , respectively , after one ( P = 0.003 ) and 2 procedures ( P < 0.001 ) . Fifteen acute adverse events occurred ( 6.7 % in Group A vs 1 % in Group B , P < 0.001 ) , mainly periprocedural cerebral thromboembolism ( 3.3 % in Group A vs 0.7 % in Group B , P = 0.058 ) . Previous TIA/stroke result ed the only independent predictor of periprocedural cerebrovascular accidents ( OR 1.2 , 95%IC 1.1 - 1.3 ) . At follow-up , 74 long-term adverse events occurred ( 7.7 % in Group A vs 23.9 % in Group B , P < 0.001 ) with Group B patients more often experiencing  AAD-related  adverse events ( 12.7 % vs 2.6 % , P < 0.001 ) . Group A and absence of AF/AT recurrences significantly improved QoL scores ( P < 0.001 ) . CONCLUSIONS In elderly persistent AF patients  , catheter ablation is more effective in maintaining SR and in improving QoL  than AAD but is affected by a higher risk of embolic complications , particularly in patients with previous TIA/stroke . Over time , Group A patients more likely discontinued AAD with a reduction of long-term adverse events 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 Background — The mainstay of treatment for atrial fibrillation ( AF ) remains pharmacological ; however , catheter ablation has increasingly been used over the last decade . The relative merits of each strategy have not been extensively studied . Methods and Results — We conducted a r and omized multicenter comparison of these 2 treatment strategies in patients with paroxysmal AF resistant to at least 1 antiarrhythmic drug . The primary end point was absence of recurrent AF between months 3 and 12 , absence of recurrent AF after up to 3 ablation procedures , or changes in antiarrhythmic drugs during the first 3 months . Ablation consisted of pulmonary vein isolation in all cases , whereas additional extrapulmonary vein lesions were at the discretion of the physician . Crossover was permitted at 3 months in case of failure . Echocardiographic data , symptom score , exercise capacity , quality of life , and AF burden were evaluated at 3 , 6 , and 12 months by the supervising committee . Of 149 eligible patients , 112 ( 18 women [ 16 % ] ; age , 51.1±11.1 years ) were enrolled and r and omized to ablation ( n=53 ) or “ new ” antiarrhythmic drugs alone or in combination ( n=59 ) . Crossover from the antiarrhythmic drugs and ablation groups occurred in 37 ( 63 % ) and 5 patients ( 9 % ) , respectively ( P=0.0001 ) . At the 1-year follow-up , 13 of 55 patients ( 23 % ) and 46 of 52 patients ( 89 % ) had no recurrence of AF in the antiarrhythmic drug and ablation groups , respectively ( P<0.0001 ) . Symptom score , exercise capacity , and quality of life were significantly higher in the ablation group . Conclusion — This r and omized multicenter study demonstrates the superiority of catheter ablation over antiarrhythmic drugs in patients with AF with regard to maintenance of sinus rhythm and improvement in symptoms , exercise capacity , and quality of life Objective Whether early rhythm suppression with extensive antiarrhythmic drugs ( AADs ) in persistent atrial fi brillation ( AF ) after catheter ablation decreases arrhythmia recurrence is unknown . We now report the 12-month follow-up data in this prospect i ve and r and omized study . Methods and results 123 consecutive patients with persistent AF undergoing catheter ablation were r and omly divided into an extensive AADs therapy group ( group 1 : 62 patients using both class Ic and III AADs ) or one AAD therapy group ( group 2 : 61 patients using class Ic or III AADs alone ) for the initial 2 months after ablation . Recurrence of atrial tachyarrhythmias ( ATa ) was valuated at both 2 months and 12 months following ablation . During the fi rst 2 months after ablation , less ATa were found in group 1 compared with group 2 ( 17/62 versus 29/61 , P= 0.021 ) . However , there was no diff erence with regard to ATa at 12 months between the groups ( 21/62 versus 22/61 , P= 0.799 ) . ATa at 2 months and left atrial diameter ( LAD ) were the statistically signifi ca nt predictors of ATa during 12-month follow-up . Conclusions While use of extensive AADs within the initial 2 months after persistent AF ablation decreases early ATa , it does not prevent late ATa . Moreover , LAD as well as early ATa is a strong predictor of ATa at 12 months OBJECTIVES The use of antiarrhythmic drugs after ablation is a controversial issue when evaluating the efficacy of atrial fibrillation ( AF ) ablation . This study compares in a prospect i ve and r and omized fashion the impact of an antiarrhythmic drug in preventing AF recurrence after AF ablation . METHODS From February 2004 to May 2005 , 107 consecutive patients ( mean age 57 + /- 10 years , 69 men ) , with paroxysmal ( 60 % ) or persistent ( 40 % ) drug refractory AF , were r and omly assigned to ablation alone ( Group A , 53 patients ) or combined with the best antiarrhythmic therapy , preferably amiodarone ( Group B , 54 patients ) . All patients underwent cavo-tricuspid and left inferior pulmonary vein (PV)-mitral isthmus ablation plus circumferential PV ablation , using a guided electro-anatomical approach . St and ard electrocardiograms ( ECG ) , and ambulatory and transtelephonic ECG monitoring  were used to assess AF recurrences . Recurrences during the first month after ablation were excluded from this analysis . RESULTS At 12 months of follow-up , no significant difference was observed in the rates of AF recurrences between Group A ( 18/53 patients , 34 % ) and Group B ( 16/54 patients , 30 % ) . The percentage of patients with > /= 1 asymptomatic AF episode was higher in Group B than in Group A ( 10/16 patients , 63 % , vs 5/18 patients , 28 % , P = 0.04 ) . CONCLUSIONS Continuing antiarrhythmic drug therapy in patients who undergo catheter ablation for AF did not lower the rate of AF recurrences . Antiarrhythmic drugs increased the proportion of patients with asymptomatic AF episodes
Studies of RFA for treatment of atrial fibrillation report higher efficacy rates than do studies of AAD therapy and a lower rate of complications
BACKGROUND Although radiofrequency catheter ablation ( RFA ) has evolved from an experimental procedure to an important treatment option for atrial fibrillation , the relative safety and efficacy of catheter ablation relative to that of antiarrhythmic drug ( AAD ) therapy has not been established .