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.

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.

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.

PLAAF score as a novel predictor of long-term outcome after second-generation cryoballoon pulmonary vein isolation.

Aims: Predictors of atrial arrhythmia recurrence have not been described in a long-term follow-up study of patients undergoing pulmonary vein isolation (PVI) using the cryoballoon technique. We aimed to evaluate the efficacy of a second-generation cryoballoon and identify pre-procedural predictors of 3-year outcome after PVI. Methods and results: For this observational cohort study, we enrolled 440 patients ablated at our institution with a second-generation cryoballoon. The endpoint was the first documented recurrence (>30 s) of atrial fibrillation (AF), atrial flutter, or atrial tachycardia after a 3-month blanking period. The impact of several pre-existing variables on clinical outcome was evaluated by univariate and multivariate analyses using the Cox proportional hazards regression model. The PLAAF (persistent AF, left atrial area, abnormal PV anatomy, AF history, female gender) score was defined to predict outcome. After a median follow-up of 36 months (interquartile range 25/75-27/42), the endpoint was achieved in 95 of 440 (21.6%) patients. Cox regression analysis showed that persistent AF, left atrial (LA) area, abnormal PV anatomy, AF history, and female gender independently predicted recurrence. The calculated optimal cut-offs for LA area and AF history were 21 cm2 and 3 years, respectively. Patients with a PLAAF score of 0 showed the best outcome, with an arrhythmia-free survival of 86.7%. Conclusion: PVI using the cryoballoon technique shows acceptable long-term results depending on predictors described by the new PLAAF score, which may facilitate patient selection for PVI.

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 slope of the initial temperature drop predicts acute pulmonary vein isolation using the second-generation cryoballoon.

AIMS: There is no objective, early indicator of occlusion quality, and efficacy of cryoballoon pulmonary vein isolation. As previous experience suggests that the initial cooling rate correlates with these parameters, we investigated the slope of the initial temperature drop as an objective measure. METHODS AND RESULTS: A systematic evaluation of 523 cryoapplications in 105 patients using a serial ROC-AUC analysis was performed. We found the slope of a linear regression of the temperature-time function to be a good predictor (PPV 0.9, specificity 0.72, sensitivity 0.71, and ROC-AUC 0.75) of acute isolation. It also correlated with nadir temperatures (P< 0.001, adjusted R2= 0.43), predicted very low nadir temperatures, and varied according to visual occlusion grades (ANOVA P< 0.001). CONCLUSIONS: About 25 s after freeze initiation, the temperature-time slope predicts important key characteristics of a cryoablation, such as nadir temperature. The slope is the only reported predictor to actually precede acute isolation and thus to support decisions about pull-down manoeuvres or aborting a cryoablation early on. It is also predictive of very low nadir temperatures and phrenic nerve palsy and thus may add to patient safety.

Cryoballoon ablation of persistent atrial fibrillation: feasibility and safety of left atrial roof ablation with generation of conduction block in addition to antral pulmonary vein isolation.

AIMS: Although the generation of linear lesions by ablation improves success rates in patients with persistent atrial fibrillation (AF), the procedure has been considered unsuitable for cryoablation balloon catheter technologies. We developed a technique for linear ablations, using second-generation cryoballoon technology. METHODS AND RESULTS: This was a single-arm, prospective study in 76 patients with persistent AF treated consecutively at our centre. Cryoablation was performed using a 28 mm second-generation cryoballoon. The first cryoenergy application was performed in close proximity to the position during isolation of the left superior pulmonary vein (PV). Sequential overlapping freezes were applied along the left atrial (LA) roof by slight clockwise rotation of the sheath in combination with slight retraction of the sheath and incremental advancement of the cryoballoon, until reaching the original position for right superior PV isolation. The acute endpoint was the creation of a roofline, defined as complete conduction block across the LA roof >120 ms and ascending activation across the posterior LA wall. Acute success in roofline generation was achieved in 88% of patients, applying on average five (median 4-6) freezes with nadir temperature of -40°C (-36 to -44°C). In five patients, conduction block could not be achieved. No phrenic nerve injuries occurred during roofline generation. CONCLUSION: Generation of linear roofline lesions is possible with the second-generation cryoballoon. The technique can be used in combination with PV isolation to treat persistent AF with good acute success rates, short procedure times, and acceptable safety concerns. If validated by further studies, the method would be an appealing alternative to radiofrequency ablation techniques.

Clinical impact of a novel three-dimensional electrocardiographic imaging for non-invasive mapping of ventricular arrhythmias-a prospective randomized trial.

AIMS: ECVUE™ technology, a novel, three-dimensional, non-invasive mapping system, offers a unique arrhythmia characterization and localization. We sought to evaluate the clinical impact of this system in routine clinical mapping and ablation of ventricular arrhythmias (VAs). METHODS AND RESULTS: Patients with monomorphic premature ventricular contractions with or without monomorphic ventricular tachycardia were enrolled prospectively and randomized into two groups: ventricular ectopy localization using either 12-lead electrocardiogram (ECG) algorithms or with ECVUE™, followed by conventional guided ablation. Forty-two patients were enrolled in the study. The ECVUE™ system accurately identified both the chamber and sub-localized the VA origin in 20 of 21 (95.2%) patients. In contrast, using 12-lead ECG algorithms, the chamber was accurately diagnosed in 16 of 21 (76.2%) patients, while the arrhythmia origin in only 8 of 21 (38.1%), (P = 0.001 vs. ECVUE™). Acute success in ablation was achieved in all patients. Regarding the number of radiofrequency-energy applications (in total 2 vs. 4, P = 0.005) in the ECVUE™ arm, ablation was more precise than the ECG group which used standard of care activation and pace mapping-guided ablation. Three months success in ablation was 95.2% for the ECVUE™ and 100% for the ECG group (P = ns). Time to ablation was 35.3 min in the conventional arm and 24.4 min in ECVUE Group, (P = 0.035). The X-ray radiation exposure was 3.21 vs. 0.39 mSv, P = 0.001 for the ECVUE™ group and ECG group. CONCLUSION: ECVUE™ technology offers a clinically useful tool to map VAs with high accuracy and more targeted ablations superior to the body surface ECG but had significantly higher radiation exposure due to computed tomography scan.

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.

Cryoballoon ablation of paroxysmal atrial fibrillation: 5-year outcome after single procedure and predictors of success.

AIMS: Long-term efficacy following cryoballoon (CB) ablation of atrial fibrillation (AF) remains unknown. This study describes 5 years follow-up results and predictors of success of CB ablation in patients with paroxysmal atrial fibrillation (PAF). METHODS AND RESULTS: In total, 163 patients were enrolled with symptomatic, drug refractory PAF. Pulmonary vein isolation (PVI) with CB technique was performed. Primary endpoint of this consecutive single-centre study was first electrocardiogram-documented recurrence of AF, atrial tachycardia or atrial flutter (AFLAT). Five years success rate after single CB ablation was 53%. In 70% of the patients acute complete PVI was achieved with a single 28 mm balloon. The univariate predictors of AFLAT recurrence were (1) size of left atrium, with normalized left atrium (NLA) ≥10.25 [hazard ratios (HR) of 1.81, 95% confidence interval (CI): 1.28-2.56] when compared with NLA <10.25 (35% vs. 53%, P = 0.0001) and (2) renal function, with impaired glomerular filtration rate (GFR) <80 ml/min (HR of 1.26, 95% CI: 1.02-1.57) when compared with GFR ≥80 ml/min (45% vs. 53%, P = 0.041). Normalized left atrium ≥10.25 was the sole independent predictor for outcome (HR 2.11; 95% CI: 1.34-3.31; P = 0.0001). CONCLUSIONS: Sinus rhythm can be maintained in a substantial proportion of patients with PAF even 5 years after circumferential PVI using CB ablation. The rate of decline in freedom from AFLAT was highest within the first 12 months after the index procedure. The patients with enlarged left atrium and/or impaired renal function have lower outcome.

Repeated catheter ablation of atrial fibrillation: how to predict outcome?

BACKGROUND: Pre-procedural predictors (PP) of atrial fibrillation (AF) recurrence (AFR) after repeated catheter ablation of AF (RCAF) are unknown. The aim of this study was identification of PP of outcome after RCAF. METHODS AND RESULTS: In 213 patients (73% male) with drug-refractory AF (47% paroxysmal AF; PAF) RCAF was performed. CHADS2, CHA2DS2-VASc and ALARMEc (AF type, Left Atrium size, Renal insufficiency, MEtabolic syndrome, cardiomyopathy) scores were calculated for each patient. Complete success was defined as no AFR. After RCAF, 125 patients (59%) were free of atrial flutter or atrial tachycardia (AFLAT) on long-term follow-up (FU). The univariate predictors of AFR were: type of AF (non-PAF vs. PAF, P=0.001), normalized left atrium area (NLA ≥10.25 vs. NLA <10.25, P=0.012) and estimated glomerular filtration rate (<68ml/min vs. ≥68ml/min, P=0.048). The independent predictors of AFLAT-free survival after RCAF were non-PAF (P=0.002) and NLA ≥10.25 (P=0.018). Among combined predictors, only ALARMEc score, and neither CHADS2 or CHA2DS2-VASc, predicted outcome after RCAF (P<0.0001). CONCLUSIONS: RCAF results in a moderate success rate on very long-term FU. Lower success was observed in patients with non-PAF and enlarged LA. ALARMEc score allows for clear description of expected outcome after RCAF.

Ipsilateral circumferential radiofrequency ablation of atrial fibrillation with irrigated tip catheter: long-term outcome and pre-procedural predictors.

BACKGROUND: Predictors of long-term outcome of atrial fibrillation (AF) ablation are unknown. The predictors of 5-year follow-up (FU) after single ipsilateral circumferential antrum pulmonary vein isolation (PVI) with irrigated tip catheter were investigated. METHODS AND RESULTS: In 356 patients (74% male) with AF (44% paroxysmal AF [PAF]) PVI was performed. Success was defined as absence of AF, atrial flutter or tachycardia (AFLAT) recurrence. A total of 161 patients (45%) were free of AFLAT. The univariate predictors of AFLAT recurrence were: type of AF (non-PAF vs. PAF, P=0.0001), size of LA (normalized left atrium area [NLA] ≥11.5 vs. NLA <11.5, P=0.0001), renal function (glomerular filtration rate [GFR] <68ml/min vs. GFR ≥68ml/min, P=0.001) and hypertension (HT vs. no HT, P=0.025). The independent predictors of AFLAT-free survival were non-PAF (hazard ratio [HR], 1.67; 95% confidence interval [CI]: 1.23-2.26, P=0.0005), NLA ≥11.5 (HR, 1.40; 95% CI: 1.03-1.90, P=0.007) and GFR <68ml/min (HR, 1.70; 95% CI: 1.21-2.37, P=0.008). CONCLUSIONS: Single PVI results in a moderate success rate in patients with AF during 5-year FU without the use of a 3-D mapping system. Higher success was observed in patients with PAF, non-enlarged LA and good renal function.

Impact of impaired renal function and metabolic syndrome on the recurrence of atrial fibrillation after catheter ablation: a long term follow-up.

BACKGROUND: The goal of this study was to analyze impact of metabolic syndrome (MetS) and impaired renal function on long-term follow-up after catheter ablation of atrial fibrillation (AF). METHODS AND RESULTS: A total of 702 consecutive patients with AF (age = 58 year, history of AF = 5 year, male = 478, paroxysmal atrial fibrillation = 416, coronary artery disease = 62, hypertension = 487) considered for catheter ablation were enrolled in the study. The MetS was diagnosed at admission in 276 patients. The renal function was estimated by glomerular filtration rate (eGFR). Pulmonary vein isolation (PVI) was performed either with cryoballoon technique (n = 260) or circumferential PVI (n = 442) with a 3.5-mm irrigated tip catheter. A 7-day-Holter electrocardiogram was performed at each follow-up visit. Any episode of documented AF after an initial 3-month blanking period was considered as clinical endpoint. Out of 702 patients, 370 (52.7%) were free of AF recurrences at median follow-up of 15 six interquartile range (12.7-42.3) months. The patients with MetS had significantly lower success rate than those without (128/276 (46.4%) vs 242/426 (56.8%), P = 0.006). Among 103 patients with eGFR < 68 mL/min only 35 (34%) were free of recurrences compared with 335/599 (55.9%) in patients with GFR ≥ 68 mL/min (P = 0.001). Both parameters were revealed in multivariate analysis to be independent predictors for outcome after catheter ablation. CONCLUSION: The results of our study clearly demonstrated that outcome after 1st catheter ablation of AF is poor in patients with MetS and/or impaired renal function. This observation has a potential clinical impact for the follow up management of these patients.

Safety and feasibility of a 1 frame-per-second X-ray framerate in cardiac electrophysiology.

BACKGROUND: We investigated the feasibility and safety of a framerate of 1 frame per second ("fps") for fluoroscopy and cine-angiography, to lower radiation exposure for patients and personnel in cardiac electrophysiology ("EP"). METHOD: Analysis of 2521 EP procedures, 899 (36%) with the lowest available conventional framerate (3.75 fps) and 1622 (64%) procedures performed with a framerate lowered further to 1.0 fps (by looping a 1 Hz square pulse to the ECG trigger) performed between 01/2016 and 01/2020. RESULTS: Procedures performed with 1.0 fps had the same acute procedural success rates (p = 0.20) and adverse event rates (p = 0.34) as the 3.75 fps group. There was no difference in total X-ray operation time (p = 0.40). The dose-area-product (DAP) was significantly reduced from 638 to 316 cGy*cm2 (p < < 0.0001) for all procedure types together, and for each subgroup. In a multivariable linear regression model, total X-ray operation time (estimate 38 cGy*cm2 /min) and body mass index (estimate 32 cGy*cm2 / index point) and a framerate of 1.0 fps (-314 cGy*cm2 against 3.75 fps) were independent predictors of a lower DAP (p-value of t-statistic for all << 0.0001). CONCLUSIONS: A framerate of 1.0 fps is safe and feasible in cardiac electrophysiology procedures. It was associated with a significant reduction of radiation exposure for patient and personnel.

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.

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.

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.

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.

Acute success and persistence of bidirectional conduction block in the cavotricuspid isthmus one month post cryocatheter ablation of common atrial flutter.

INTRODUCTION: Cryoablation is successful in the treatment of common atrial flutter. Long-term clinical success is mainly dependent on persistence of bidirectional conduction block (BCB) in the inferior cavotricuspid isthmus (CTI). Only few data on persistence of BCB post cryoablation with the reported technique are available. This prospective study aimed to test efficacy of cryo energy and persistence of BCB in the CTI 1 month post cryoablation. METHODS: Cryoablation of the CTI was performed in 50 consecutive patients (64 +/- 12 years, 40 males) with symptomatic common atrial flutter using a novel 9 Fr 8-mm-tip catheter. BCB in the CTI 30 minutes following the final cryoapplication was the ablation endpoint. Thirty days post ablation, persistence of BCB was controlled by repeat electrophysiological study (EPS). RESULTS: In all patients BCB was achieved with a mean of 9 (IQR 7-17.5) cryo applications and a mean cryo time of 2,378 seconds (IQR 1,680-3,474 seconds). In 5 of 50 patients, common atrial flutter recurred within 1 month post cryoablation. In 30 of 32 recurrence-free patients, persistence of BCB was verified. In 2 patients, resumption of isthmus conduction was detectable. Including relapses, 81.1% of patients (30/37) showed persistence of BCB. No patients reported pain during cryoapplication. No procedural complications were observed. CONCLUSIONS: Cryoablation of the CTI using a large-tip catheter is feasible and safe in the treatment of common atrial flutter. Acute and short-term success rates are comparable to those reported for radiofrequency (RF) ablation. Besides short-term clinical success, the persistence of BCB demonstrates efficacy of the cryoablation technique.