Real life outcome of atrial Real life outcome of atrial fibrillation ablationfibrillation ablation

Samir Rafla, FACC, FESC

Professor of Cardiology

Alexandria Univ.

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Methods and Results-—A structured electronic database search of the scientific literature was performed for studies describing outcomes at ≥3 years after AF ablation, with a mean follow-up of ≥ 24 months after the index procedure. The following data were extracted: (1) single-procedure success, (2) multiple-procedure success, and (3) requirement for repeat procedures. Data were extracted from 19 studies, including 6167 patients undergoing AF ablation.

Single procedure freedom from atrial Single procedure freedom from atrial arrhythmia at long-term follow-up was arrhythmia at long-term follow-up was 53.1% 53.1% (95% CI 46.2% to 60.0%) overall, 54.1% (95% CI (95% CI 46.2% to 60.0%) overall, 54.1% (95% CI 44.4% to 63.4%) in paroxysmal AF, and 41.8% 44.4% to 63.4%) in paroxysmal AF, and 41.8% (95% CI 25.2% to 60.5%) in non paroxysmal AF. (95% CI 25.2% to 60.5%) in non paroxysmal AF. Substantial heterogeneity (>50%) wasSubstantial heterogeneity (>50%) was

noted for single-procedure outcomes. With noted for single-procedure outcomes. With multiple procedures, multiple procedures, the long-term success rate the long-term success rate was 79.8% was 79.8% (95% CI 75.0% to 83.8%)(95% CI 75.0% to 83.8%)

overall, with significant heterogeneity (>50%).The overall, with significant heterogeneity (>50%).The average number of procedures per patient was average number of procedures per patient was 1.51 (95% CI 1.36 to 1.67).1.51 (95% CI 1.36 to 1.67).

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ConclusionsConclusions-—Catheter ablation is -—Catheter ablation is an effective and durable long-term an effective and durable long-term therapeutic strategy for some AF patients. therapeutic strategy for some AF patients. Although significant heterogeneity is seen Although significant heterogeneity is seen with single procedures, long-term freedom with single procedures, long-term freedom from atrial arrhythmia can be achieved in from atrial arrhythmia can be achieved in some patients, but multiple procedures some patients, but multiple procedures may be required.(J Am Heart Assoc. may be required.(J Am Heart Assoc. 2013;2:e0045492013;2:e004549

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Single-Procedure Efficacy of Catheter Single-Procedure Efficacy of Catheter Ablation Outcome data Ablation Outcome data

Most studies provided single procedure Most studies provided single procedure success rates, defined as the percentage of success rates, defined as the percentage of patients free of atrial arrhythmia or not patients free of atrial arrhythmia or not requiring a second procedure at 12 months. requiring a second procedure at 12 months.

The pooled overall success rate was The pooled overall success rate was 64.2%64.2% (95% CI 57.5% to 70.3%). The pooled 12-month (95% CI 57.5% to 70.3%). The pooled 12-month success rate for the 11 studies reporting success rate for the 11 studies reporting outcomes for PAF patients was outcomes for PAF patients was 66.6%66.6% (95% CI (95% CI 58.2% to 74.2%), and for the 6 studies 58.2% to 74.2%), and for the 6 studies reporting outcomes for NPAF patients, it was reporting outcomes for NPAF patients, it was 51.9%51.9% (95% CI 33.8% to 69.5%). (95% CI 33.8% to 69.5%). 55

Impact of Multiple ProceduresImpact of Multiple Procedures

Thirteen studies provided outcome data Thirteen studies provided outcome data taking into consideration the impact of taking into consideration the impact of multiple procedures. The overall multiple multiple procedures. The overall multiple procedure long-term success rate was procedure long-term success rate was 79.8%79.8% (95% CI 75.0% to 83.8%) in 13 studies (Figure (95% CI 75.0% to 83.8%) in 13 studies (Figure 3). The overall was >50%, indicating 3). The overall was >50%, indicating significant heterogeneity. The multiple-significant heterogeneity. The multiple-procedure long-term success in PAF was procedure long-term success in PAF was 79.0%79.0% in 8 studies (95% CI 67.6% to 87.1%), in 8 studies (95% CI 67.6% to 87.1%), and that in NPAF was and that in NPAF was 77.8%77.8% in 4 studies in 4 studies (95% CI 68.7% to 84.9%, P=0.9 versus PAF). (95% CI 68.7% to 84.9%, P=0.9 versus PAF).

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Long-term Ablation EfficacyLong-term Ablation Efficacy

Until very recently, few data have been Until very recently, few data have been available on AF ablation outcomes beyond 3 available on AF ablation outcomes beyond 3 years after the index procedure. Both single- years after the index procedure. Both single- and multiple-procedure success rates and multiple-procedure success rates showed relative stability at>3 years after showed relative stability at>3 years after index ablation. Including multiple procedures index ablation. Including multiple procedures 80% of patients in the included studies were 80% of patients in the included studies were free of atrial arrhythmia at long-term follow-free of atrial arrhythmia at long-term follow-up. up.

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Table. Complications of Catheter Table. Complications of Catheter Ablation in the Included StudiesAblation in the Included Studies

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Cryoballoon versus RF Ablation in Paroxysmal Atrial Fibrillation

J Cardiovasc Electrophysiol. 2014;25(1):1-7

German Ablation Registry-Different Energy Sources in AF Ablation: Results Acute success rate was similar in both groups (97.5% in cryo vs 97.6% in RF; P = 0.81). Procedure times were similar, ablation and fluoroscopy times were higher in cryoballoon when compared to RF ablation. Overall complication rate was similar in cryo- (4.6%) and RF-ablation (4.6%; P = 1.0). Phrenic nerve palsy was more often in cryo versus RF ablation (2.1% in cryo vs 0.0% in RF; P < 0.001). Other complications were more common in RF compared to cryoablation (4.6% in RF vs 2.7% in cryo; P < 0.05).

ConclusionConclusion RF ablation is the  RF ablation is the most widespread ablation method in most widespread ablation method in Germany, but use of cryoballoon increased Germany, but use of cryoballoon increased significantly. Procedure times were similar, significantly. Procedure times were similar, but ablation and fluoroscopy times were but ablation and fluoroscopy times were longer in cryoballoon ablation. No significant longer in cryoballoon ablation. No significant differences were found in terms of acute differences were found in terms of acute success and overall complication rate.success and overall complication rate.

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Catheter Ablation vs. Antiarrhythmic Catheter Ablation vs. Antiarrhythmic Drug Treatment of Persistent Atrial FibrillationDrug Treatment of Persistent Atrial Fibrillation

Eur Heart J. 2014;35(8):501-507Eur Heart J. 2014;35(8):501-507

BackgroundBackground Catheter ablation (CA) is a highly  Catheter ablation (CA) is a highly effective therapy for the treatment of paroxysmal effective therapy for the treatment of paroxysmal atrial fibrillation (AF) when compared with atrial fibrillation (AF) when compared with antiarrhythmic drug therapy (ADT). No antiarrhythmic drug therapy (ADT). No randomized studies have compared the two randomized studies have compared the two strategies in persistent AF. The present strategies in persistent AF. The present randomized trial aimed to compare the randomized trial aimed to compare the effectiveness of CA vs. ADT in treating persistent effectiveness of CA vs. ADT in treating persistent AF.AF.

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In total, 146 patients were included In total, 146 patients were included (aged 55 ± 9 years, 77% male). The ADT (aged 55 ± 9 years, 77% male). The ADT group received class Ic (43.8%) or class group received class Ic (43.8%) or class III drugs (56.3%). In an intention-to-treat III drugs (56.3%). In an intention-to-treat analysis, 69 of 98 patients (70.4%) in the analysis, 69 of 98 patients (70.4%) in the CA group and 21 of 48 patients (43.7%) CA group and 21 of 48 patients (43.7%) in the ADT group were free of the in the ADT group were free of the primary endpoint (primary endpoint (PP = 0.002), implying an  = 0.002), implying an absolute risk difference of 26.6% (95% CI absolute risk difference of 26.6% (95% CI 10.0–43.3) in favour of CA.10.0–43.3) in favour of CA.

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The proportion of patients free of The proportion of patients free of any recurrence (>30 s) was higher in the any recurrence (>30 s) was higher in the CA group than in the ADT group (60.2 vs. CA group than in the ADT group (60.2 vs. 29.2%; 29.2%; PP < 0.001) and cardioversion was  < 0.001) and cardioversion was less frequent (34.7 vs. 50%, less frequent (34.7 vs. 50%, respectively; respectively; PP = 0.018). = 0.018).

ConclusionConclusion  Catheter ablation is superior Catheter ablation is superior to medical therapy for the maintenance to medical therapy for the maintenance of sinus rhythm in patients with of sinus rhythm in patients with persistent AF at 12-month follow-up.persistent AF at 12-month follow-up.

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Pacing or Ablation: Which Is Better for Pacing or Ablation: Which Is Better for Paroxysmal Atrial Fibrillation-Related Paroxysmal Atrial Fibrillation-Related Tachycardia-Bradycardia Syndrome?Tachycardia-Bradycardia Syndrome? Pacing Clin Electrophysiol. 2014;37(4):403-411Pacing Clin Electrophysiol. 2014;37(4):403-411

The outcome of AF ablation in patients with paroxysmal The outcome of AF ablation in patients with paroxysmal AF-related tachycardia-bradycardia syndrome was AF-related tachycardia-bradycardia syndrome was compared the efficacy of catheter ablation with compared the efficacy of catheter ablation with permanent pacing plus antiarrhythmic drugs (AADs).permanent pacing plus antiarrhythmic drugs (AADs). ConclusionsConclusions:: In patients with paroxysmal AF-related  In patients with paroxysmal AF-related tachycardia-bradycardia syndrome, AF ablation seems tachycardia-bradycardia syndrome, AF ablation seems to be superior to a strategy of pacing plus AAD. to be superior to a strategy of pacing plus AAD. Pacemaker implantation can be waived in the majority of Pacemaker implantation can be waived in the majority of patients after a successful ablation.patients after a successful ablation.

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Long-term outcome following successful pulmonary Long-term outcome following successful pulmonary vein isolation: pattern and prediction of very late vein isolation: pattern and prediction of very late

recurrence. recurrence. J Cardiovasc Electrophysiol. 2008 Jul;19(7):661-7 2008 Jul;19(7):661-7

RESULTS: RESULTS: During 28 +/- 12 months follow-up, 23 of 264 During 28 +/- 12 months follow-up, 23 of 264 (8.7%) patients had recurrence of AF. The actuarial (8.7%) patients had recurrence of AF. The actuarial recurrence at 2 years post-ablation was 5.8% and recurrence at 2 years post-ablation was 5.8% and increased to 25.5% at 5 years. Compared with long-term increased to 25.5% at 5 years. Compared with long-term responders, more patients with late recurrence had responders, more patients with late recurrence had hypertension and hyperlipidemia. Among 18 patients hypertension and hyperlipidemia. Among 18 patients with recurrent AF necessitating repeat PVI, 15 (83%) with recurrent AF necessitating repeat PVI, 15 (83%) required re-isolation of > 1 PV and 28 of 45 (58%) PVs required re-isolation of > 1 PV and 28 of 45 (58%) PVs showed reconnection. All PVs were re-isolated and five showed reconnection. All PVs were re-isolated and five (28%) patients had additional linear ablation. All 15 (28%) patients had additional linear ablation. All 15 patients became AF-free again.patients became AF-free again.

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Catheter ablation for paroxysmal and Catheter ablation for paroxysmal and persistent atrial fibrillation. persistent atrial fibrillation.

Cochrane Database Syst Rev. 2012 Apr 18;4:CD007101 2012 Apr 18;4:CD007101

Randomised controlled trials (RCTs) A total of 32 RCTs Randomised controlled trials (RCTs) A total of 32 RCTs (3,560 patients) were included. There were no (3,560 patients) were included. There were no differences in mortality (RR, 0.50, 95% CI 0.04 to 5.65), differences in mortality (RR, 0.50, 95% CI 0.04 to 5.65), fatal and non-fatal embolic complication (RR 1.01, 95% fatal and non-fatal embolic complication (RR 1.01, 95% CI 0.18 to 5.68) or death from thrombo-embolic events CI 0.18 to 5.68) or death from thrombo-embolic events (RR 3.04, 95% CI 0.13 to 73.43).Comparisons of (RR 3.04, 95% CI 0.13 to 73.43).Comparisons of different CAs; 25 RCTs compared CA of various kinds. different CAs; 25 RCTs compared CA of various kinds. Circumferential pulmonary vein ablation was better than Circumferential pulmonary vein ablation was better than segmental pulmonary vein ablation in improving segmental pulmonary vein ablation in improving symptoms of AF (p<=0.01) and in reducing the symptoms of AF (p<=0.01) and in reducing the recurrence of AF (p<0.01). recurrence of AF (p<0.01). 1818

Catheter ablation for atrial fibrillationCatheter ablation for atrial fibrillation. . J Am J Am Coll Cardiol Coll Cardiol 2011; 57:160-166.2011; 57:160-166.

Among 100 patients, 175 ablations were performed, with Among 100 patients, 175 ablations were performed, with a median of two procedures performed per patient.  a median of two procedures performed per patient.  When researchers examined recurrences since the last When researchers examined recurrences since the last ablation, the arrhythmia-free survival rate increased, with ablation, the arrhythmia-free survival rate increased, with investigators reporting rates of investigators reporting rates of 87%, 81%, and 63% at 87%, 81%, and 63% at one, two, and five yearsone, two, and five years. Overall, 77 patients were . Overall, 77 patients were arrhythmia-free at one-year follow-up, and 19 of these arrhythmia-free at one-year follow-up, and 19 of these patients presented with a later recurrence. The presence patients presented with a later recurrence. The presence of valvular heart disease and nonischemic dilated of valvular heart disease and nonischemic dilated cardiomyopathy were independent predictors of cardiomyopathy were independent predictors of recurrent atrial fibrillation in multivariate analysis.recurrent atrial fibrillation in multivariate analysis.

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A recent worldwide survey reported A recent worldwide survey reported 8745 8745 patients treated at 181 centres.patients treated at 181 centres.  The numbers per  The numbers per year increased from 18 patients in 1995 to 5050 year increased from 18 patients in 1995 to 5050 in 2002. The majority underwent segmental in 2002. The majority underwent segmental pulmonary vein isolation, pulmonary vein isolation, 27.3%27.3% had more than had more than one procedure, and major complications one procedure, and major complications occurred in occurred in 6.0%6.0%; ; 52%52% became asymptomatic, became asymptomatic, and a further 23.9% were improved by and a further 23.9% were improved by antiarrhythmic drugs. Also of note is the fact that antiarrhythmic drugs. Also of note is the fact that centres which had performed the most centres which had performed the most procedures tended to have the highest success procedures tended to have the highest success rates. rates. Cappato RCappato R, Calkins H, Chen S-A, , Calkins H, Chen S-A, et al.et al. Worldwide survey  Worldwide survey on the methods, efficacy, and safety of catheter ablation for on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation 2005;111:1100–5human atrial fibrillation. Circulation 2005;111:1100–5

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A non-randomised study examining outcome A non-randomised study examining outcome in 589 patients following catheter ablation for in 589 patients following catheter ablation for AF showed improved mortality, morbidity, and AF showed improved mortality, morbidity, and quality of life, compared to 582 medically quality of life, compared to 582 medically treated patients. Indeed, the overall survival of treated patients. Indeed, the overall survival of ablated patients was no different to that of the ablated patients was no different to that of the general population, matched for age and sex.general population, matched for age and sex.  Pappone C, Rosanio S, Augello G, Pappone C, Rosanio S, Augello G, et al.et al. Mortality,  Mortality, morbidity, and quality of life after circumferential morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol 2003;42:185–97term study. J Am Coll Cardiol 2003;42:185–97

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In-Hospital Complications Associated With Catheter In-Hospital Complications Associated With Catheter Ablation of Atrial Fibrillation in the United States Ablation of Atrial Fibrillation in the United States Between 2000 and 2010. Between 2000 and 2010. Analysis of 93 801 Procedures. Analysis of 93 801 Procedures. DeshmukhDeshmukh. Circulation.2013; 128: 2104-2112 . Circulation.2013; 128: 2104-2112

The overall frequency of complications was The overall frequency of complications was 6.29%6.29% with combined cardiac complications (with combined cardiac complications (2.54%2.54%) being ) being the most frequent. Cardiac complications were the most frequent. Cardiac complications were followed by vascular complications (followed by vascular complications (1.53%1.53%), ), respiratory complications (respiratory complications (1.3%1.3%), and neurological ), and neurological complications (complications (1.02%1.02%). The in-hospital ). The in-hospital mortality was mortality was 0.46%0.46%. Annual operator (<25 procedures) and . Annual operator (<25 procedures) and hospital volume (<50 procedures) were significantly hospital volume (<50 procedures) were significantly associated with adverse outcomes. There was a associated with adverse outcomes. There was a small (nonsignificant) rise in overall complication small (nonsignificant) rise in overall complication rates.rates. 2222

Trends in Trends in Complications Complications for AF for AF AblationsAblations

Deshmukh. Deshmukh. Circulation.201Circulation.2013; 128: 2104-3; 128: 2104-21122112

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Complications of AF ablation:Complications of AF ablation:

DeathDeath: Death is an infrequent complication of AF : Death is an infrequent complication of AF catheter ablation. peri-procedural death incidence catheter ablation. peri-procedural death incidence observed in catheter ablation of AF does not differ observed in catheter ablation of AF does not differ from the incidence of peri-procedural death in from the incidence of peri-procedural death in catheter ablation of supraventricular tachycardias. catheter ablation of supraventricular tachycardias. CausesCauses: the need of a transseptal puncture to reach : the need of a transseptal puncture to reach the left atrium and the PV ostia, the handling and the left atrium and the PV ostia, the handling and manipulation of catheters in the left atrium and the manipulation of catheters in the left atrium and the association of radiofrequency-dependent lesions in association of radiofrequency-dependent lesions in the left atrium with very high levels of the left atrium with very high levels of anticoagulation.anticoagulation.

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Cardiac tamponade Cardiac tamponade (both acute (both acute and/or late) has demonstrated to be the most and/or late) has demonstrated to be the most common fatal complication leading to common fatal complication leading to cardiac arrest during or after AF catheter cardiac arrest during or after AF catheter ablation, followed by development of atrio-ablation, followed by development of atrio-oesophageal fistulas. Ischaemic brain or oesophageal fistulas. Ischaemic brain or cardiac insults are the third most frequent cardiac insults are the third most frequent causes of death followed by extrapericardial causes of death followed by extrapericardial bleedings related to subclavian or PV bleedings related to subclavian or PV perforation and by post-operative massive perforation and by post-operative massive pneumonia refractory to antibiotics. pneumonia refractory to antibiotics.

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Atrio-oesophageal fistula Atrio-oesophageal fistula is a very is a very rare complication of AF catheter ablation. rare complication of AF catheter ablation. this complication is the most dreadful and this complication is the most dreadful and lethal among all the others related to AF lethal among all the others related to AF catheter ablation. catheter ablation.

Haemorrhagic ComplicationsHaemorrhagic Complications

Haemorrhagic complications include major Haemorrhagic complications include major and minor bleedings. Cardiac tamponade and minor bleedings. Cardiac tamponade has to be considered a major bleeding and is has to be considered a major bleeding and is by far the most common major complication by far the most common major complication of AF catheter ablation. of AF catheter ablation.

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Thromboembolic EventsThromboembolic Events

The introduction of open-irrigated catheters The introduction of open-irrigated catheters and the use of early and aggressive and the use of early and aggressive heparinization have reduced significantly heparinization have reduced significantly the risk of cerebrovascular events related the risk of cerebrovascular events related to the procedure.to the procedure.

Pulmonary Vein StenosisPulmonary Vein Stenosis: Occurring in 1–: Occurring in 1–3% of cases.3% of cases.

Phrenic nerve injury Phrenic nerve injury occurred in 0.48% of occurred in 0.48% of cases.cases.

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Left atrial tachycardias or left atrial flutters Left atrial tachycardias or left atrial flutters are the most common 'electrophysiological' are the most common 'electrophysiological' complications of AF catheter ablation. complications of AF catheter ablation. Occurring in up to Occurring in up to 31%31% of patients of patients undergoing this procedure, these undergoing this procedure, these arrhythmias are often more symptomatic arrhythmias are often more symptomatic than AF itself because they are often than AF itself because they are often associated with high regular ventricular associated with high regular ventricular response.response.

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Schematic of common lesion sets employed in AF ablation

Figure . Strategies for Rhythm Control in Patients with Figure . Strategies for Rhythm Control in Patients with Paroxysmal and Persistent AF Paroxysmal and Persistent AF

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*Catheter ablation is only recommended as first-line therapy for patients with paroxysmal AF (Class IIa recommendation). †Drugs are listed alphabetically. ‡Depending on patient preference when performed in experienced centers. §Not recommended with severe LVH (wall thickness >1.5 cm). ║Should be used with caution in patients at risk for torsades de pointes ventricular tachycardia. ¶Should be combined with AV nodal blocking agents.