Left atrial roof ablation in patients with persistent atrial fibrillation using the second-generation cryoballoon: benefit or wasted time?

INTRODUCTION: It is unknown whether left atrial (LA) roof ablation combined with pulmonary vein isolation (PVI) using a second-generation cryoballoon provides additional benefit beyond that of PVI alone in patients with persistent atrial fibrillation (AF). The aim of this study was to compare arrhythmia recurrence rates after PVI alone versus PVI plus LA roof ablation. METHODS AND RESULTS: In this observational study, we analyzed 399 symptomatic patients with persistent AF treated with cryoballoon ablation. After univariate and multivariate analyses of the entire cohort, propensity score matching resulted in two groups of 86 patients each: (1) PVI plus LA roof ablation (PVI-plus group) and (2) PVI alone (PVI-only group). The primary endpoint was the first documented > 30-s arrhythmia recurrence after a 3-month blanking period. PVI was successful in all patients. A bidirectional conduction block across the LA roof was verified in 91.9% of patients in the PVI-plus group. During a median mid-term follow-up of 33 months, 21 patients (24.4%) in the PVI-plus group and 37 patients (43.0%) in the PVI-only group (P = 0.01) reached the primary endpoint. Multivariate analysis revealed AF history > 2 years (hazard ratio [HR] = 2.04, P < 0.01), LA area > 21 cm2 (HR = 2.36, P < 0.01), female sex (HR = 1.92, P = 0.02), and LA roof ablation (HR = 0.47, P < 0.01) as significant predictors of outcome. CONCLUSIONS: We observed a significant difference in arrhythmia recurrence rates between the two groups. LA roof ablation is an effective adjuvant treatment option that shows improved outcome compared with PVI alone.

Five-year experience with pulmonary vein isolation using the second-generation cryoballoon for treatment of persistent atrial fibrillation.

INTRODUCTION: We analyzed the procedural experience and clinical outcome after pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) gained over 5 years using the second-generation cryoballoon (CB-Adv). METHODS AND RESULTS: For this retrospective study, we enrolled 281 patients undergoing PVI at our institution between 2012 and 2016. The analyzed period was divided into 5 calendar years. Follow-up data, including Holter electrocardiography recordings, were collected during outpatient clinic visits. The impact of several variables on outcome was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. The median procedure and fluoroscopy times over the years were 90 (72 of 114) and 15 (11 of 21) minutes, respectively. A continuous decline in complication rates and fluoroscopy and procedure times was observed in each subsequent year. During mid-term follow-up (33 [25 of 48] months), 178 (63.3%) patients were AF, atrial flutter, or atrial tachycardia free. Multivariate analysis revealed left atrial area (hazard ratio [HR] = 1.05; P < 0.001), female sex (HR = 2.53; P < 0.001), and common ostium (HR = 1.93; P < 0.001) as significant predictors of outcome. The overall 1-year success rate was 76.2%. A gradual decrease in the 1-year success rate (from 90.5% in 2012 to 67.9% in 2016) was mainly related to a steady increase of left atrial area in the entire cohort with successive years of the study. CONCLUSIONS: PVI using CB-Adv in patients with persistent AF is accompanied by a learning curve and facilitates a satisfactory outcome, followed by the proper selection of patients.

Five-year outcome and predictors of success after second-generation cryoballoon ablation for treatment of symptomatic atrial fibrillation.

INTRODUCTION: Data on long-term outcomes of cryoballoon ablation for treatment of atrial fibrillation (AF) are sparse. Here, we report the first 5-year follow-up results and predictors of outcome for pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB-Adv) in patients with symptomatic AF. METHODS AND RESULTS: For this prospective observational study, we enrolled 178 patients with paroxysmal (132/178 [74.2%] patients) or persistent AF who underwent PVI with CB-Adv at our institution during 2012. Clinical success was defined as freedom from AF, atrial flutter or atrial tachycardia recurrence >30-s following the 3-month blanking period. Follow-up data were collected during outpatient clinic visits and included Holter-ECG recordings. The impacts of several variables on outcome were evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. PVI was sufficient in restoring and maintaining sinus rhythm in 59.0% (n = 105) of patients (paroxysmal AF: 81/132 (61.4%) patients; persistent AF: 24/46 (52.2%) patients, P = 0.20). The median procedure and fluoroscopy times were 126 (interquartile range 114/150) and 20 (16/26) min, respectively. Cox regression analysis showed that left atrial area ≤21 cm2 and the absence of diabetes independently predicted outcome. CONCLUSIONS: Sinus rhythm was maintained in a substantial proportion of patients even 5 years after CB-Adv ablation. Patients with a non-enlarged left atrium without diabetes had the best outcome.

Second-generation cryoballoon ablation as a first-line treatment of symptomatic atrial fibrillation: Two-year outcome and predictors of recurrence after a single procedure.

INTRODUCTION: Antiarrhythmic drug (AAD) therapy of patients with atrial fibrillation (AF) has limitations. We investigated the 2-year outcome and pre-procedural predictors of recurrence for first-line catheter ablation using the second-generation cryoballoon (CB-Adv) in a large cohort of patients with symptomatic AF. METHODS AND RESULTS: For this prospective observational study, we enrolled 457 patients with symptomatic AF (278 paroxysmal, 179 persistent) who had no history of AAD use and who underwent pulmonary vein isolation (PVI) with the CB-Adv at our institution. Follow-up data, including Holter-ECGs, were collected during outpatient clinic visits. The impact of several variables on outcome was evaluated in univariate and multivariate analyses and Cox proportional hazards regression models. Median follow-up duration was 28 (interquartile range 15/42) months. PVI was sufficient in restoring and maintaining sinus rhythm in 79.2% (n=362) of patients. The median procedure and fluoroscopy times were 90 (72/120) and 16 (12/21) min, respectively. Phrenic nerve injury occurred in 16 (3.5%) patients, persisting until hospital discharge in 6 (1.3%) patients; phrenic nerve function recovered in all patients during follow-up. Seven patients developed groin hematomas (1.5%). Cox regression analysis showed that left atrial area >21cm2 independently predicted recurrence. CONCLUSION: This is the first demonstration that PVI with CB-Adv is safe and effective as a first-line treatment of symptomatic AF. Sinus rhythm persisted in 79.2% of patients even 2years after ablation. The success rate was lower in patients with enlarged left atria.

Second-generation cryoballoon ablation for treatment of persistent atrial fibrillation: Three-year outcome and predictors of recurrence after a single procedure.

INTRODUCTION: Data on long-term outcomes of cryoballoon (CB) ablation for treatment of persistent atrial fibrillation (AF) are sparse. Here, we report the first 3-year follow-up results and predictors of success for catheter ablation using the second-generation CB in patients with persistent AF. METHODS AND RESULTS: For this prospective observational study, we enrolled 101 patients ablated with the second-generation CB at our institution. The endpoint was the first documented recurrence (> 30 seconds) of AF, atrial flutter, or atrial tachycardia after a 3-month blanking period. Follow-up data were collected during outpatient clinic visits and included Holter-ECG recordings. The impact of several variables on recurrence was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. After a median follow-up of 37 (31 of 42) months, recurrence was documented in 30 patients (29.7%). The median procedure and fluoroscopy times were 120 (102 of 147) and 20 (16 of 27) minutes, respectively. Phrenic nerve palsy occurred in 2.0% of the patients. Among the 30 patients who experienced recurrence, 16 underwent repeat ablation in radiofrequency technique. Cox regression analysis showed that left atrial area > 21 cm2 and AF history duration > 2 years independently predicted recurrence. CONCLUSIONS: Sinus rhythm was maintained in a substantial proportion of patients even 3 years after CB ablation. Patients with a nonenlarged left atrium and short AF history had the best outcome.

Ice or fire? Comparison of second-generation cryoballoon ablation and radiofrequency ablation in patients with symptomatic persistent atrial fibrillation and an enlarged left atrium.

INTRODUCTION: We aimed to compare arrhythmia recurrence rates after second-generation cryoballoon (CB-Adv) ablation and radiofrequency (RF) ablation in patients with symptomatic persistent atrial fibrillation (AF) and left atrial (LA) enlargement. METHODS AND RESULTS: Persistent AF patients with LA enlargement were compared using a propensity-score-matching algorithm, and 111 patients treated with CB-Adv ablation and 111 patients treated with RF ablation were selected. The primary endpoint was the first documented >30-second arrhythmia recurrence after a 3-month blanking period. Median LA area was comparable between the RF and CB-Adv groups (24.2 vs. 24.0 cm2 , P = 0.49). In addition to pulmonary vein isolation, roof lines (RLs) with bidirectional conduction block were created in 48 patients in the CB-Adv group and 49 patients in the RF group. Midterm outcome after single procedure is characterized by arrhythmia recurrences in 47 patients in the RF group and 32 patients in the CB-Adv group (P = 0.20). There were no differences in the number of AF recurrences in the two groups (38 vs. 32, P = 0.66), but there were more instances of LA tachycardia (LAT) in the RF group than in the CB-Adv group (11 vs. 0, P < 0.01). LAT recurrence in RF patients was associated with RL creation (9 with vs. 2 without, P < 0.01). Among patients in whom a RL was created, arrhythmia-free survival was lower in the RF group than in the CB-Adv group (44.9% vs. 79.2%, P < 0.01). CONCLUSIONS: Arrhythmia recurrence rates in the two groups during midterm follow-up were comparable. RL creation during CB-Adv ablation resulted in acceptable outcomes.

How safe are NOACs compared with phenprocoumon after pulmonary vein isolation with the cryoballoon technique using purse-string suture closure?

INTRODUCTION: The aim of this observational study was to compare the postprocedural incidence of bleeding and thromboembolic complications associated with novel oral anticoagulants (NOACs) with that of interrupted and continuous phenprocoumon after pulmonary vein isolation (PVI) using a purse-string suture (PSS) closure of the puncture site. METHODS AND RESULTS: Consecutive patients who had undergone PVI via cryoballoon ablation were divided into the following groups: (1) interrupted phenprocoumon with heparin bridging (n=101), (2) continuous phenprocoumon targeting an internationally normalized ratio>2 (n=70), and (3) NOACs without bridging that were restarted 2-4h after the procedure (n=185). Protamine was not administered after venous closure with PSS at the end of the procedure. The total complication rate was significantly lower in group 3 than in groups 1 and 2 (1.62% vs. 6.93% vs. 7.14%, p=0.04). The hospital costs were lower and the hospital stay length was significantly shorter (4484±3742 vs. 6082±4044 Euro vs. 4908±2925, p=0.03; 1.94±1.67 vs. 2.70±1.80 vs. 2.19±1.30days, p<0.01). No thromboembolic event occurred. Vascular complications were the most common complications noted (80%). The occurrence of any complication led to a significantly longer hospital stay (5 vs. 2days, p<0.01) and higher costs (10,052±6241 Euro vs. 4747±3447, p<0.01). The vascular complication rate after PSS was independent of intraprocedural heparin dosage and activated clotting time. CONCLUSIONS: NOACs have a lower complication rate and appear to be safer in this setting than phenprocoumon. The hospital costs and hospital stay length after PVI was significantly reduced in patients treated with NOACs compared with phenprocoumon.

Safety and feasibility of percutaneous skin closure using purse-string suture compared with compression bandage after pulmonary vein isolation.

INTRODUCTION: This observational study was designed to analyze the safety and feasibility of percutaneous skin closure using a purse-string suture and compare it with the use of a compression bandage after pulmonary vein isolation. METHODS AND RESULTS: A total of 407 patients undergoing pulmonary vein isolation (217 with radiofrequency and 190 with cryoballoon ablation) were treated with either purse-string sutures or compression bandages. The purse-string suture was applied after ablation before withdrawal of the sheaths. Patients were on bed rest for 6 hours prior to suture removal, which was accomplished 18-24 h after ablation. The compression bandage was applied after sheath withdrawal and was removed after 12 hours of bed rest. We analyzed the occurrence of any vascular or thromboembolic complication as well as hospital costs and hospital stay length after ablation. The incidence of vascular complications after compression bandage was higher than after purse-string suture in the cryoballoon and radiofrequency group (P < 0.05, respectively). The hospital costs were lower and hospital stay was shorter in both radiofrequency (4.921 ± 3.145 vs. 5.802 ± 4.006 Euro; 2.34 ± 1.32 vs. 2.98 ± 1.57 days, P < 0.05) and cryoballoon groups (4.705 ± 3.091 vs. 5.661 ± 3.563 Euro; 2.14 ± 1.37 vs. 2.61 ± 1.55 days, P < 0.05) in patients treated with a purse-string suture. CONCLUSIONS: Percutaneous skin closure with a purse-string suture has the clinical impact to reduce vascular complications, hospital costs, and hospital stay length after pulmonary vein isolation.

The Impact of Left Atrial Surface Area and the Second Generation Cryoballoon on Clinical Outcome of Atrial Fibrillation Cryoablation.

AIMS: In this observational study, we examine the significance of the left atrial (LA) surface area and compare the clinical usage of the Arctic Front Advance (CBA) versus Arctic Front (CB) cryoballoon with the intent to investigate the impact of each in terms of long-term freedom from atrial fibrillation (AF) for patients with nonvalvular AF. METHODS: Pulmonary vein isolation (PVI) was performed while using a cryoballoon ablation catheter in conjunction with an intraluminal circular diagnostic mapping catheter, Achieve. The consecutive patients ablated with CBA were matched with patients previously ablated with CB, using propensity score matching. The primary endpoint of this observational single-center retrospective study was the first observation of electrocardiogram-documented recurrence of atrial arrhythmias lasting >30 seconds. RESULTS: The patient demographic data were similar in the CBA- and CB-group (N = 188 patients each group). In all patients in the CBA-group and in 95% of the patients in the CB group, acute procedural PVI of all veins was achieved with the single usage of a 28-mm cryoballoon. The one-year freedom from atrial arrhythmias was significantly better in the CBA- versus the CB-group of patients, 90% versus 64%, respectively. During 15-month clinical follow-up in CBA group, patients with LA area above 23 cm(2) were more likely to experience recurrence of AF (23%) than patients with LA area below 23 cm(2) (7%). CONCLUSIONS: Comparing one-year outcomes, the CBA is superior to the CB with regards to maintenance of normal sinus rhythm. When using the CBA catheter, an enlarged LA is associated with a higher recurrence of arrhythmia.

Therapy with renin-angiotensin system blockers after pulmonary vein isolation in patients with atrial fibrillation: who is a responder?

AIMS: The data on anti-arrhythmic effect of renin-angiotensin-aldesteron system blockers (RASB) in patients with atrial fibrillation (AF) are controversially discussed. The goal of this analysis was to identify cohort of patients with AF and hypertension, who may have benefit from RASB therapy after pulmonary vein isolation (PVI). METHODS: A total of 284 patients with AF and hypertension (paroxysmal AF [PAF]= 218, male = 185, age = 61 years, left ventricular ejection fraction = 60%, coronary artery disease = 42) considered for PVI were included. The patients with PAF were stratified according to time spent in AF (AF burden) within 3 months prior to admission ( 500 hours). Further patients were divided into two groups: (1) low-burden AF; (2) high-burden AF (PAF and persistent AF). In 195 patients, RASB therapy was administered. A 7-day continuous Holter electrocardiogram was performed after discharge, every 3 months thereafter and by symptoms. RESULTS: Preventive effect of RASB was revealed in whole group (112 out of 195 [57%] vs 36 out of 89 [40%]; P = 0.025) and was more pronounced in patients with low-burden AF (79 out of 112 [71%] receiving RASB vs 27 out of 55 [49%] being on other drugs; P = 0.013). However, efficiency of RASB failed in patients with high-burden AF (33 out of 83 on RASB [40%] vs nine out of 34 on other drugs [27%]; P = 0.328). CONCLUSIONS: Our data suggest that RASB appears to protect against AF recurrences after PVI in patients with low-burden paroxysmal AF. These results should be tested in a prospective study.

Evaluation of atrial fibrillation burden before catheter ablation predicts outcome after pulmonary vein isolation.

BACKGROUND: Paroxysmal atrial fibrillation (PAF) is defined as recurrent AF terminating spontaneously within 7 days. This definition allows the consideration of any AF occurrence lasting < 7 days as paroxysmal, irrespective of the frequency and duration of episodes. The aim of this study was to investigate symptomatic AF burden (AFB) defined as total duration of symptomatic AF episodes within 3 months prior to abalation, for prediction of outcome after pulmonary vein isolation (PVI). METHODS: A total of 320 consecutive patients with symptomatic AF (PAF=244, men=214, age=58 y) were enrolled. AFB in patients with PAF was defined as time spent in AF within 3 months prior to PVI. After the AFB cut-off point was optimized at 500 h, patients with PAF were categorized into 2 groups: Group 1 - patients with AFB< 500 h (n=192), Group 2 - patients with AFB> or = 500 h (n=52). Patients with persistent AF (PersAF, n = 76) comprised control group (Group 3). PVI was performed either with irrigated tip catheter (n=215) or using cryoballoon (n=105). The endpoint of study was first documented recurrence of AF >30 sec. RESULTS: Symptomatic AFB was found to be appropriate for prediction of outcome after PVI. The freedom from AF within 2 years was observed in 69%, 31%, and 43% patients in Group 1, 2 and 3, respectively (Group 1 vs. Group 2, p < .001; Group 1 vs. Group 3, p< .001; Group 2 vs. Group 3, p = 0.46). CONCLUSIONS: Low AFB < 500 h /3 months was associated with better outcome after PVI. Patients with PAF and high AFB should be treated as patients with PersAF.

Usefulness of atrial fibrillation burden as a predictor for success of pulmonary vein isolation.

BACKGROUND: The definition of symptomatic improvement after pulmonary vein isolation (PVI) is controversial. We assessed primarily the usefulness and predictive accuracy (PA) of AF (atrial fibrillation) burden (AFB) within the first 3 months after the procedure as an early predictor for curative success as well as reduction of symptoms. METHODS: We studied 100 pts (62 men, mean age: 54 +/- 9 years, LVEF: 57 +/- 9%, paroxysmal AF, 85, persistent AF, 15) who underwent PVI. RF ablation was used in 63 patients. The combination of cryoablation and RF (Hybrid therapy) was used in the remaining 37 patients, in 19 patients of whom additionally linear lesions were performed. All patients were followed up 3 months after PVI (the blanking period) and every 3 months thereafter. The significance of early recurrence of AF (ERAF) was separately analyzed for RF and for hybrid therapy arm. Quality of life (QoL) was assessed using the physical composite summary score (PCS) and mental composite summary score (MCS). AFB was dichotomized at: 0, 0.5, 1, 6, 12, and 24 hours. RESULTS: ANOVA revealed significant differences between PCS at baseline and after PVI in patients without recurrence and with those with postablation AFB <12 hours. There was no difference between PCS in patients with AFB > or =12 hours within a 3 months interval and PCS at baseline. ERAF occurred in 35% of patients (16 patients, AFB > or =12 hours). Symptomatic ERAF occurred in 29 patients (17 patients AFB > or =12 hours). After the blanking period, documented AF recurrence was found in 50 patients (17 patients, AFB > or =12 hour). Symptomatic late recurrence was found in 47 patients (31 patients with AFB > or =12 hours). Absence of ERAF was revealed to be predictive for long-term success and symptomatic ERAF was found to be predictive for symptomatic AF recurrence (P <0.0001). CONCLUSION: AF recurrence with AFB > or =12 hours within 3 months is associated with a missed improvement of QoL. Symptomatic ERAF predicts recurrence independently of therapy.