title: Long-Term Clinical Results of 2 Different Ablation Strategies in Patients With Paroxysmal and Persistent Atrial Fibrillation Substrate modification combined with pulmonary vein isolation improves outcome of catheter ablation in patients with persistent atrial fibrillation: a prospective randomized comparison. Cryoballoon ablation for persistent atrial fibrillation - Large single-center experience. Focal impulse and rotor modulation: Acute procedural observations and extended clinical follow-up. One-year follow-up after irrigated multi-electrode radiofrequency ablation of persistent atrial fibrillation. Pulmonary Vein Isolation Versus Defragmentation: The CHASE-AF Clinical Trial. Circumferential pulmonary vein isolation as index procedure for persistent atrial fibrillation: a comparison between radiofrequency catheter ablation and second-generation cryoballoon ablation. Efficacy of Cryoballoon Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation. Biatrial linear ablation in sustained nonpermanent AF: Results of the substrate modification with ablation and antiarrhythmic drugs in nonpermanent atrial fibrillation (SMAN-PAF) trial. Approaches to catheter ablation for persistent atrial fibrillation. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation.
abstract: Background — Data regarding the long-term efficacy of atrial fibrillation ( AF ) ablation are still lacking . Methods and Results —Two hundred four consecutive patients symptomatic for paroxysmal or persistent/permanent AF were r and omly assigned to 2 different ablation schemes : pulmonary vein isolation ( PVI ) and PVI plus left linear lesions ( LL ) . Primary end point was to assess the maintenance of sinus rhythm ( SR ) after procedures 1 and 2 in the absence of antiarrhythmic drugs in a long-term follow-up of at least 3 years . Paroxysmal AF — With a single procedure at 12-month follow-up , 46 % of patients treated with PVI maintained SR , whereas at 3-year follow-up , 29 % were in SR ; using the “ PVI plus LL ” at the 12-month follow-up , 57 % of patients were in SR , whereas at the 3-year follow-up , 53 % remained in SR . After a second procedure , the long-term overall success rate without antiarrhythmic drugs was 62 % with PVI and 85 % with PVI plus LL . Persistent/Permanent AF — With a single procedure at the 12-month follow-up , 27 % of patients treated with PVI were in SR , whereas at the 3-year follow-up , 19 % maintained SR ; using the PVI plus LL with a single procedure at the 12-month follow-up 45 % of patients were in SR , whereas at the 3-year follow-up , 41 % remained in SR . After a second procedure , the long-term overall success rate without antiarrhythmic drugs was 39 % with PVI and 75 % with PVI plus LL . Conclusions —A long-term follow-up of AF ablation shows that short-term results can not be considered permanent because AF recurrences are still present after the first year especially in patients who have had “ PVI ” strategy .  PVI isolation plus LL is superior to the PVI strategy in maintaining SR without antiarrhythmic drugs after procedures 1 and 2 both in paroxysmal and persistent AF AIMS To investigate the effectiveness of additional substrate modification ( SM ) by left atrial ( LA ) linear lesions as compared with pulmonary vein isolation ( PVI ) alone in patients with persistent atrial fibrillation ( AF ) in a prospect i ve r and omized study . Percutaneous PVI has evolved as an accepted treatment for paroxysmal AF but seemed to be less effective in patients with persistent AF . The benefit of PVI alone and additional linear lesions has not been vali date d in a r and omized study so far . METHODS AND RESULTS Sixty-two patients with persistent AF ( median duration 7 , range 1 - 18 months ) were r and omly assigned to either PVI alone ( n = 30 ) or additional SM ( n = 32 ) consisting of a roof line connecting both left superior and right superior PV and LA isthmus ablation between left inferior PV and mitral annulus . Procedures including SM were performed using a three-dimensional mapping system ( EnSite NavX , St Jude Medical , St Paul , MN , USA ) . Anti-arrhythmic drugs were discontinued within 8 weeks after ablation in both groups . Follow-up included daily trans-telephonic ECG transmitted irrespective of the patient 's symptoms . PVI was successful in 98 % of all targeted veins in both groups . Additional SM did not increase fluoroscopy time ( 72.1+/-18.7 vs. 72.9+/-17.3 min , P=0.92 ) because of the use of three-dimensional navigation in the PVI+SM group . AF recurrences within the first 4 weeks following ablation were more common after PVI alone ( 77 % ) than additional SM ( 44 % , P=0.002 ) . After a follow-up time of 487 ( 429 - 570 ) days , only 20 % of patients undergoing st and alone PVI  remained in sinus rhythm when compared with 69 % following PVI combined with SM ( P=0.0001 ) . Two patients assigned to PVI+SM experienced procedure-related complications ( cardiac tamponade and minor stroke ) which resolved without sequelae . CONCLUSION PVI alone is insufficient in the treatment of persistent AF . However , additional left linear lesions increase the success rate significantly . Early AF-relapses are associated with a negative outcome after PVI alone but not following additional SM 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 BACKGROUND Focal impulse and rotor modulation ( FIRM ) was based on the premise that atrial fibrillation ( AF ) is sustained by rotors that are sufficiently stable to be eliminated by targeted ablation . Early experience reported high success as compared to conventional strategies . OBJECTIVE The purpose of this study was to report on a single-center experience with extended follow-up by using FIRM in a variety of patients with AF . METHODS All FIRM-guided ablation procedures were included . During spontaneous or induced AF , FIRM software constructed phase maps to identify putative AF sources , then targeted for radiofrequency ablation , with adjunctive pulmonary vein isolation ( PVI ) , if needed . All mapped rotors and /or sources were eliminated on the basis of repeated FIRM mapping . RESULTS Of 47 patients , sustained AF was not present or induced in 4 patients who did not undergo FIRM ablation . Of the remaining 43 patients , prior AF was paroxysmal in 9 ( 21 % ) and 72 % had a median of 1 prior PVI . Spontaneous AF ( n = 22 , 52 % ) and induced AF ( n = 21 , 49 % ) were mapped , and all patients had rotors identified ( 1.8 ± 0.8 per patient ; 70 % in the left atrium ) . AF termination occurred in 2 patients ( 5 % ) and none organized to atrial tachycardia . Touch-up redo PVI was also performed in 31 patients ( 72 % ) . At 16.0 ± 10.7 months ( range 1 - 34 months ) , only 9 patients ( 21 % ) were free of recurrent AF ; and only 5 patients ( 12 % ) were free of AF and off antiarrhythmic drugs . CONCLUSION Long-term clinical results after FIRM ablation in this diverse challenging cohort showed poor efficacy . R and omized clinical trials are needed to evaluate the efficacy and clinical utility of the FIRM ablation approach for treating AF AIMS Irrigated multi-electrode ablation ( IMEA ) is a novel tool to perform pulmonary vein isolation ( PVI ) . The aim was to compare IMEA with point-by-point radiofrequency ( RF ) ablation in patients with persistent atrial fibrillation ( AF ) undergoing PVI . METHODS AND RESULTS Forty-nine patients ( age 60 ± 9 years , 82 % male ) were studied . In 24 patients , the IMEA catheter was used in conjunction with an electroanatomic mapping system . Twenty-five patients undergoing RF point-by-point ablation ( RF-PVI ) served as a control group . Validation of PVI based on the IMEA catheter was performed using a st and ard circular mapping catheter . Ninety-two of 94 pulmonary veins ( PVs ) ( 98 % ) were isolated using IMEA alone . Procedure time was 125 ± 23 min in the IMEA group and 127 ± 31 min in the RF-PVI group ( P = 0.79 ) . Fluoroscopy time was 12.2 ( 11 - 16.1 ) min with IMEA compared with 5.2 ( 4.1 - 9.3 ) min in the RF-PVI group ( P < 0.001 ) . Net ablation time was 11.8 ( 10.2 - 15.4 ) min in the IMEA group compared with 33.6 ( 30.3 - 40.1 ) min in the RF-PVI group ( P < 0.001 ) . Of 94 PVs presumed to be isolated after IMEA ablation , validation using a st and ard circular mapping catheter showed persistent PV potentials in 33 PVs ( 35 % ) , requiring additional IMEA ablation . At 12 months , 16 of 24 patients ( 67 % ) in the IMEA group compared with 17 of 25 patients ( 68 % ) in RF-PVI group were free from AF ( P > 0.99 ) . CONCLUSION With similar total procedure duration , IMEA-PVI was associated with shorter net ablation time and longer fluoroscopy time . Irrigated multi-electrode ablation recordings were not sufficient to confirm isolation in 35 % of PVs . Single-procedure efficacy after 12 months was similar between the two groups BACKGROUND Long-term success rates using ablation for persistent atrial fibrillation ( AF ) are disappointing and usually do not exceed 60 % . OBJECTIVES This study sought to compare arrhythmia-free survival between pulmonary vein isolation ( PVI ) and a stepwise approach ( full defrag ) consisting of PVI , ablation of complex fractionated electrograms , and additional linear ablation lines in the setting of atrial tachycardias ( AT ) in patients with persistent AF after PVI . METHODS From November 2010 to February 2013 , 205 patients ( 151 men ; 61.7 ± 10.2 years of age ) underwent de novo ablation for persistent AF . Subsequently , patients were prospect ively r and omized to either PVI alone ( n = 78 ) or full defrag ( n = 75 ) , with 52 patients not r and omized due to AF termination with the original PVI . The primary endpoint was recurrence of any AT after a blanking period of 3 months . RESULTS During the entire study , 241 ablations were performed ( mean : 1.59 in the PVI-alone group , 1.55 in the full-defrag group ) . With the stepwise approach , termination of AF occurred in 45 ( 60 % ) patients . However , arrhythmia-free survival did not differ whether patients underwent single or multiple procedures ( p = 0.468 ) . Procedure duration , fluoroscopy time , and radiofrequency duration were significantly longer in the full-defrag group ( all p < 0.001 ) . CONCLUSIONS A stepwise approach aim ed at AF termination does not seem to provide additional benefit over PVI alone in patients with persistent AF , but it is associated with significantly longer procedural and fluoroscopic duration as well as radiofrequency application time . ( The R and omized Catheter Ablation of Persist End Atrial Fibrillation Study [ CHASE-AF ] ; NCT01580124 ) 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 INTRODUCTION Cryoballoon PVI has emerged as an alternative to radiofrequency PVI for the treatment of paroxysmal AF . The optimal strategy for patients with persistent AF is unclear as data are limited . METHODS We analyzed a prospect i ve registry of consecutive patients with persistent AF who underwent Cryoballoon PVI at a single center between 2011 and 2014 . Patients were assessed for atrial arrhythmia recurrence after a 3-month blanking period at 6 months , 1 year , and 2 years postprocedure . Recurrence was based on typical symptoms , ECG , or event monitor evidence of AF . Kaplan-Meier analysis was used to estimate arrhythmia-free survival . RESULTS Final analysis included 69 patients who underwent Cryoballoon PVI with a mean age 59.4 ± 8.1 years , 85.5 % male , 53.6 % HTN patients , CHA2DS2-VASC score 1.6 ± 1.2 , and LA size 4.5 ± 0.6 cm .  The single procedure atrial arrhythmia recurrence-free rate at 1-year postprocedure after a 3-month blanking period was 59 % and 50 % at a mean follow-up of 607 days . Of the recurrence-free group , 17 % were taking previously ineffective antiarrhythmic medications . In comparing patients with persistent AF duration < 1 year versus > 1 year , there was a trend toward greater AF recurrence-free rates in the < 1 year group ( 66 % vs. 55 % , P = 0.09 ) . CONCLUSION Cryoballoon PVI appears to be an effective initial strategy in treating persistent AF , with an AF recurrence-free rate of 59 % at 1 year BACKGROUND More advanced atrial fibrillation ( AF ) is associated with lower success rates after pulmonary vein isolation ( PVI ) , and the optimal ablation strategy is uncertain . OBJECTIVES To assess the impact of additional linear ablation ( lines ) compared to PVI alone . METHODS In this multicenter r and omized controlled trial , 122 patients ( mean age 61.9 ± 10.5 years ; left atrial diameter 43 ± 6 mm ) with persistent AF ( PeAF ) or sustained ( > 12 hours ) paroxysmal AF ( SusPAF ) with risk factors for atrial substrate were included and followed up for 12 months . Patients were r and omized to  PVI-only or PVI + lines ( left atrial roof line , mitral isthmus line , and tricuspid isthmus line ) group . Holter monitoring was performed at 3 , 6 , and 12 months and according to symptoms . The primary outcome was atrial tachyarrhythmia recurrence lasting ≥30 seconds . RESULTS Baseline characteristics were comparable between groups ; 61 % had PeAF and 39 % SusPAF . Successful PVI was achieved for 98 % of pulmonary veins , and bidirectional block was obtained in 90 % of lines . The primary end point occurred in 38 % of the PVI + lines group and 32 % of the PVI-only group ( P = .50 ) , which was consistent in both PeAF ( 36 % vs 28 % ; P = .45 ) and SusPAF ( 42 % vs 39 % ; P = .86 ) . Compared with the PVI-only group , the PVI + lines group had higher procedure duration ( 209 ± 52 minutes vs 172 ± 44 minutes ; P < .001 ) , ablation time ( 4352 ± 1084 seconds vs 2503 ± 1061 seconds ; P < .001 ) , and radiation exposure ( Dose-area product 3992 ± 6496 Gy·cm(2 ) vs 2106 ± 1679 Gy·cm(2 ) ; P = .03 ) . Quality of life ( disease-specific Atrial Fibrillation Effect on Quality of Life question naire and mental component scale of the Short Form 36 Health Survey ) improved significantly during the study but did not differ between groups . CONCLUSION Adding lines to wide antral PVI in substrate-based AF requires significantly more ablation , increases procedure duration and radiation dose , but provides no additional clinical benefit BACKGROUND Catheter ablation is less successful for persistent atrial fibrillation than for paroxysmal atrial fibrillation . Guidelines suggest that adjuvant substrate modification in addition to pulmonary-vein isolation is required in persistent atrial fibrillation . METHODS We r and omly assigned 589 patients with persistent atrial fibrillation in a 1:4:4 ratio to ablation with pulmonary-vein isolation alone ( 67 patients  ) , pulmonary-vein isolation plus ablation of electrograms showing complex fractionated activity ( 263 patients  ) , or pulmonary-vein isolation plus additional linear ablation across the left atrial roof and mitral valve isthmus ( 259 patients ) . The duration of follow-up was 18 months . The primary end point was freedom from any documented recurrence of atrial fibrillation lasting longer than 30 seconds after a single ablation procedure . RESULTS Procedure time was significantly shorter for pulmonary-vein isolation alone than for the other two procedures ( P<0.001 ) . After 18 months , 59 % of patients assigned to pulmonary-vein isolation alone were free from recurrent atrial fibrillation , as compared with 49 % of patients assigned to pulmonary-vein isolation plus complex electrogram ablation and 46 % of patients assigned to pulmonary-vein isolation plus linear ablation ( P=0.15 ) . There were also no significant differences among the three groups for the secondary end points , including freedom from atrial fibrillation after two ablation procedures and freedom from any atrial arrhythmia . Complications included tamponade ( three patients ) , stroke or transient ischemic attack ( three patients ) , and atrioesophageal fistula ( one patient ) . CONCLUSIONS Among patients with persistent atrial fibrillation , we found no reduction in the rate of recurrent atrial fibrillation when either linear ablation or ablation of complex fractionated electrograms was performed in addition to pulmonary-vein isolation . ( Funded by St. Jude Medical ; Clinical Trials.gov number , NCT01203748 . ) 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 . )
target: A PVI-only strategy in PeAF patients with a low prevalence of structural heart disease using contemporary technology yields excellent outcomes comparable to those for paroxysmal AF ablation
background: BACKGROUND Early studies demonstrated relatively low success rates for pulmonary vein isolation ( PVI ) alone in patients with persistent atrial fibrillation ( PeAF ) .
  However , the advent of new technologies and the observation that additional substrate ablation does not improve outcomes have created a new focus on PVI alone for treatment of PeAF .
  OBJECTIVE The purpose of this study was to systematic ally review the recent medical literature to determine current medium-term outcomes when a PVI-only approach is used for PeAF .