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Introduction: Recently, the wide-band dielectric mapping system Kodex-EPD was introduced. This study reports the first clinical experience using a novel system to guide pulmonary vein isolation (PVI) with radiofrequency (RF) ablation. METHODS AND RESULTS: The study included 20 consecutive patients undergoing de-novo PVI for symptomatic paroxysmal or persistent atrial fibrillation guided by Kodex-EPD. The primary efficacy endpoint was successful PVI. Secondary endpoints included procedural parameters and complications. In all 20 patients (mean age 68 ± 8 years, 12 male patients, paroxysmal fibrillation in 14/20 [70%] patients), PVI was successfully completed. One patient underwent additional cavo-tricuspid isthmus ablation for concomitant typical atrial flutter and one patient required additional ablation of a focal atrial tachycardia. A conventional three-dimensional image of the left atrium as well as the innovative endocardial panoramic view were used to guide catheter manipulation and ablation. Median procedure time was 115 [1st; 3rd quartile 93,75; 140] min and median total fluoroscopy time was 9.9 [9.7; 11.2] min, of which a median of 0.8 [0.6; 0.9] min was required to create left atrial maps. Complete left atrial imaging using Kodex-EPD was achieved within a median of 7.1 [5.7; 8.3] min. Median RF ablation time was 45.1 [34.6; 58.7] min. No major complications were observed., Conclusion: RF ablation PVI guided by Kodex-EPD seems safe and feasible. The system provides effective three-dimensional guidance for PVI., (© 2022 Wiley Periodicals LLC.)

Background: Cryoballoon (CB)-based pulmonary vein isolation (PVI) has proven to be as effective as radiofrequency-based ablation. Different ablation protocols took the individual time-to-isolation (TTI) into account aiming at shorter but equally or even more effective freeze cycles. The current study sought to assess the impact of the TTI on PVI durability in patients undergoing a repeat procedure for recurrence of atrial tachyarrhythmia (ATA)., Methods and Results: In 205 patients with ATA recurrence after previous CB-based PVI, a total of 806 pulmonary veins (PVs) were identified. A total of 126 out of 806 PVs (16%) were previously treated with a TTI-guided ablation (Protocol #1; TTI + 120 s), in 92/806 (11%) PVs TTI was only monitored (m) but fixed freeze cycles were applied (Protocol #2; mTTI) and in 588/806 (73%) a fixed freeze cycle was applied without mTTI. There was no difference in the PV-reconduction rate between the groups (p = .23). The right inferior pulmonary vein (RIPV) showed overall significantly higher reconduction rates compared to the other PVs (RIPV-left inferior PV p < .003, -left superior PV p < .001, -right superior PV p < .013). Twenty-one patients (10%) were demonstrated to have only electrical reconduction of the RIPV, while all other PVs were still electrically isolated., Conclusions: The TTI-based CB ablation protocol did not show significant differences regarding PV-reconduction rates compared to the other ablation protocols., (© 2022 Wiley Periodicals LLC.)

Background: Pulsed-field ablation (PFA) yields a novel ablation technology for atrial fibrillation (AF). PFA lesions promise to be highly durable, however clinical data on lesion characteristics are still limited., Objective: This study sought to investigate PFA lesion creation with ultrahigh-density (UHDx) mapping., Methods: Consecutive AF patients underwent PFA-based pulmonary vein isolation (PVI) using a multispline catheter (Farwave, Farapulse Inc.). Additional ablation, including left atrial posterior wall isolation (LAPWI) and mitral isthmus ablation (MI) were performed in a subset of persistent AF patients. The extent of PFA-lesions and decrease of LA-voltage were assessed with pre- and post PFA UHDx-mapping (Orion™ catheter and Rhythmia™ 3D-mapping system, Boston Scientific)., Results: In 20 patients, acute PVI was achieved in 80/80 PVs, LAPW isolation in 9/9 patients, MI ablation in 2/2 (procedure time: 123 ± 21.6 min, fluoroscopy time: 19.2 ± 5.5 min). UHDx-mapping subsequent to PVI revealed early PV-reconnection in five case (5/80, 6.25%). Gaps were located at the anterior-superior PV ostia and were successfully targeted with additional PFA. Repeat UHDx mapping after PFA revealed a significant decrease of voltage along the PV ostia (1.67 ± 1.36 mV vs. 0.053 ± 0.038 mV, p < .0001) with almost no complex electrogram-fractionation at the lesion border zones. PFA-catheter visualization within the mapping system was feasible in 17/19 (84.9%) patients and adequate in 92.9% of ablation sites., Conclusion: For the first time illustrated by UHDx mapping, PFA creates wide antral circumferential lesions and homogenous LAPW isolation with depression of tissue voltage to a minimum. Although with a low incidence, early PV reconnection can still occur also in the setting of PFA., (© 2022 Wiley Periodicals LLC.)

Background: The current study sought to assess the impact of the intraprocedural heart rhythm (sinus rhythm [SR] vs. atrial fibrillation [AF]) on acute procedural characteristics, durability of pulmonary vein isolation (PVI) and long-term clinical outcomes of cryoballoon (CB) ablation., Methods: A total of 195 patients with symptomatic paroxysmal (n = 136) or persistent AF (n = 59) underwent CB-based PVI. Ablation procedures were either performed in SR (SR group; n = 147) or during AF (AF group; n = 48). Persistent AF was more frequent in the AF group than in the SR group (62% vs. 20%). All other patient baseline characteristics did not differ between the two groups., Results: The nadir temperature during the CB applications was significantly lower in the AF group than in patients in the SR group (-49 [interquartile range, -44; -54]°C vs. -47 [-42; -52]°C, p = 0.002). Median procedure and fluoroscopy times as well as the rate of real-time recordings were not different between the two groups. Repeat ablation for the treatment of atrial arrhythmia recurrence was performed in 60 patients (SR: 44 [30%] patients; AF: 16 [33%] patients), with a trend towards a lower rate of pulmonary vein reconnections in the AF group (p = 0.07). There was no difference in 3-year arrhythmia-free survival (p = 0.8)., Conclusions: Cryoballoon-based PVI during AF results in lower nadir balloon temperatures and a trend towards a higher durability of PVI as compared to procedures performed in SR. The rate of real-time PVI recordings was not affected by the intraprocedural heart rhythm.

In the current guidelines on treatment of atrial fibrillation, cryoballoon-based catheter ablation of atrial fibrillation is recommended in addition to radiofrequency ablation and has become established as a standard procedure in the clinical routine of many centers for index pulmonary vein isolation. A safe, simplified and often durable pulmonary vein isolation can be achieved by a systematic approach. This review article provides a practical guide for all steps of cryoballoon-based pulmonary vein isolation, including preprocedural preparation and postinterventional follow-up. Both cryoballoon systems currently available on the market are considered., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Catheter ablation represents the primary treatment for most arrhythmias. The effectiveness of catheter ablation for the treatment of atrial fibrillation is superior to drug therapy. Therefore, catheter ablation has been established as an increasingly common procedure in clinical routine. In this context, the electrical isolation of the pulmonary veins (PVI) constitutes the cornerstone of the interventional therapy of paroxysmal and persistent atrial fibrillation. This article describes the procedure of pulmonary vein isolation utilizing radiofrequency point-by-point ablation. It shall be a practical guide for the staff in the electrophysiological laboratory. This article continues a series of manuscripts focusing on interventional electrophysiology topics in the course of EP (electrophysiology) training.This article describes the procedure of pulmonary vein isolation utilizing radiofrequency point-by-point ablation. It shall be a practical guide for the staff in the electrophysiological laboratory. This article continues a series of manuscripts dealing with topics of interventional electrophysiology in the course of EP training., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Left atrial (LA) fibrosis is associated with a poor outcome after atrial fibrillation (AF) ablation. This study examined the extent of low-voltage areas in patients with recurrence of atrial tachyarrhythmia (ATA) after CB-based pulmonary vein isolation (PVI).Sixty patients (mean age 67 ± 10 years, n = 32 female; n = 34 paroxysmal AF) who received radiofrequency redo-procedure due to recurrence of ATA within 6 months after CB-based PVI were included. A point-by point 3D-map was performed, and low-voltage sites were delineated based on bipolar voltage < 0.5 mV. The extent of fibrosis was categorized as stage A (0-10% of the LA wall), stage B (10-30%), stage C (30-50%), and stage D (> 50%).The median area of LA low-voltage sites was 28.9 (9; 50.3) cm 2 , corresponding to 17.4 (6; 30.6) % of the LA wall surface. 17/60 (28.3%) patients were categorized as fibrosis stage A, 21/60 (35%) as stage B, 18/60 (30%) as stage C, and 4/60 (6.7%) as stage D. Patient age and LA diameter were associated with more pronounced LA fibrosis; the extent of LA fibrosis was significantly higher in patients with LA tachycardia (LAT) during redo-procedures (P < 0.01), and ablation of linear lesions was more often performed (P < 0.01).In patients after CB2-based PVI, expanded LA tissue fibrosis was associated with the occurrence of LAT and more extensive LA ablation during redo-procedures.

Background: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an established treatment modality for patients suffering from paroxysmal or persistent atrial fibrillation (AF). Recently, the novel fourth-generation cryoballoon (CB4) was introduced which mainly provides a 40% shorter distal tip as compared to the second-generation cryoballoon (CB2). This two-centre analysis sought to assess the primary efficacy of the 28 mm CB4 for PVI and the feasibility of real-time signal recordings from the PVs considering the time-to-isolation (TTI). Methods and results: Eighty-four patients with paroxysmal or short-standing persistent AF underwent CB4-based PVI at two different hospitals. Individual freeze-cycle duration was set at TTI + 120 seconds. No bonus freeze was applied. A total of 331 pulmonary veins (PVs) including five left common PVs were identified and all PVs were successfully isolated. Mean freeze-cycle duration was 165.7 ± 31.5 seconds. The mean minimal CB temperature was -45.6 ± 7.6 °C with a real-time PVI visualisation rate of 78% (67/84 (79.8%) RSPVs, 55/84 (65.5%) RIPVs, 67/79 (84.8%) LSPVs, 66/79 (83.5%) LIPVs and 2/5 (40%) LCPV). Transient phrenic nerve palsy occurred in 2/84 (2.4%) patients during cryo-application along the RSPV. Conclusions: The novel CB4 provides both, a high acute efficacy and a high rate of real time electrical PV-recordings, thus facilitating individual ablation strategies based on TTI.

Atrial fibrillation is a common disease of increasing prevalence. Catheter ablation has evolved into an established therapeutic option that mainly aims to electrically isolate the pulmonary veins from atrial myocardium. The traditional method comprises point-by-point radiofrequency current ablation guided by electroanatomical mapping and has proven to be effective and safe in experienced hands. However, this approach is technically highly demanding and associated with a long learning curve, limiting its widespread utilization. To address these shortcomings, simplified ablation tools for pulmonary vein isolation are needed. In this context, balloon devices promise to ease the procedure by approaching the entire orifice of a targeted pulmonary vein in a single maneuver. This requires less catheter manipulation in the left atrium and often allows ablation of a large volume of tissue with a single application of ablative energy. Two balloon devices-one using cryoenergy, the other laser energy-have already been established in clinical routine and have demonstrated noninferiority when compared with radiofrequency ablation in large randomized trials. More balloon devices are on the verge of being introduced into clinical practice and bear the potential to expand the interventional electrophysiologist's armamentarium when treating atrial fibrillation. The authors review the use of the established balloon devices available for atrial fibrillation ablation and provide a detailed outlook on upcoming balloon technologies, including 3 different balloons utilizing radiofrequency energy as well as a novel cryoballoon., Competing Interests: Author Relationship With Industry Dr. Maurer has received speaker honoraria/travel grants from Abbott, Biosense Webster, Medtronic, and Philips. Dr. Kuck has received consultation fees/honoraria from Boston Scientific, Medtronic, Biosense Webster, Abbott, and Edwards LifeSciences. Dr. Schlüter has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Catheter ablation of atrial fibrillation (AF) in patients with pulmonary lobectomy or pneumectomy is challenging due to anatomical alterations. After lung resection, electrically active pulmonary vein (PV) stumps remain and need to be localized for PV isolation (PVI). The present study aims to describe clinical challenges of PVI in patients with pulmonary lobectomy or pneumectomy., Methods: We performed a retrospective study on 19 patients with previous pulmonary lobectomy or pneumectomy undergoing catheter ablation for AF in three German hospitals., Results: Nineteen patients with paroxysmal, persistent, or longstanding-persistent AF and history of pulmonary lobectomy (n = 11) or pneumectomy (n = 8) were enrolled. Catheter ablation was performed as radiofrequency (RF) ablation using 3D mapping, robotic RF ablation, or by using balloon devices. Decent anatomical changes were observed in patients with lobectomy while cardiac rotation and mediastinal shifting was dominant in patients with pneumectomy. Visualization of all PVs including PV stumps by PV angiography was possible in 10 of 19 patients (52.6%). PV spikes were observed in all identified PV remnants. In nine patients (47.4%), at least one PV remnant could not be identified and electrical isolation was not performed. During 24 months follow-up, patients with incomplete PVI had a significantly shorter arrhythmia-free survival than patients with complete PVI (76.2% [95% Confidence interval (CI) 47.2-100.0%] vs 40.0% [95% CI 5.6-74.1%], P = .043)., Conclusion: In patients with AF and previous lobectomy or pneumectomy, identification and isolation of all PVs are challenging but crucial for ablation success. Additional imaging techniques may be necessary to achieve complete PVI., (© 2020 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Background: Pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB2) for atrial fibrillation (AF) treatment has demonstrated encouraging procedural success rates and mid-term results. However, long-term follow-up data on outcome is sparse. The current study is reporting on five-year clinical outcomes following CB2-based PVI in patients with paroxysmal AF (PAF) and persistent AF (PersAF)., Methods: A total of 139 patients underwent index CB2-based PVI patients (PAF: n = 105, 76% and PersAF: n = 34, 34%) in two electrophysiology centers. Freeze-cycle duration was 240 s. After successful PVI a bonus freeze-cycle of the same duration was applied in the first 71 patients while the bonus-freeze was omitted in 68 following patients. Three patients (2.2%) were lost to follow-up., Results: After a median follow-up duration of 60 months (interquartile range: 46, 72 months) 74/136 (54.4%) patients remained in stable sinus rhythm (PAF: 62/104, 59.6%; PersAF: 15/32, 46.9%). Significant differences were observed concerning 5-year clinical outcome between PAF and PersAF patients (p = 0.0315). After a mean of 1.32 ± 0.6 procedures (2nd and 3rd procedure by radiofrequency ablation) and a median follow-up duration of 60 (37, 68) months 90/136 (66.2%) patients remained in stable sinus rhythm (PAF: 72/104 (69.2%), PersAF: 21/32 (65.6%), p = 0.0276). For the comparison of bonus-freeze vs no-bonus-freeze protocols no differences were observed (53.5% vs 57.4%, p = 0.650)., Conclusions: The five-year single-procedure success rate for CB2-based PVI was 54.4% and increased to 66.2% following repeat RF-based procedures. No differences were detected comparing bonus-freeze and no-bonus-freeze protocols., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: The second-generation cryoballoon (CB2) has demonstrated high procedural efficacy and convincing clinical success rates for pulmonary vein isolation (PVI). Nevertheless, data on the impact of different ablations protocols on durability are limited. The aim was to comparing the durability of PVI following 3 different ablation strategies in patients with recurrence of atrial fibrillation or atrial tachycardia undergoing repeat procedures., Methods and results: In 192 patients, a total of 751 PVs were identified. All PVs were successfully isolated during index PVI. Thirty-one out of 192 (16%) patients were treated with a bonus-freeze protocol (group 1), 67/192 (35%) patients with a no bonus-freeze protocol (group 2), and 94/192 (49%) patients with a time-to-effect-guided protocol (group 3). Persistent PVI was documented in 419/751 (55.8%) PVs, and in 41/192 (21%) patients, all PVs were persistently isolated. The total rate of PV reconnection was not significantly different between the groups (P=0.134) and the comparison of individual PVs revealed no differences (P-values for RSPV: 0.424, RIPV: 0.541, LSPV: 0.788, LIPV: 0.346, LCPV: 0.865). The procedure times were significantly reduced by omitting the bonus-freeze and applying individualized application times (group 1: 123.4±31.5 min, group 2: 112.9±39.8 min, group 3: 86.67±28.4 min, P<0.001)., Conclusions: Comparing 3 common ablation protocols, no differences for durable PVI were detected. Procedure times were significantly reduced by omitting the bonus-freeze cycle and by applying individualized application times.

Aims: The current study sought to assess the impact of the utilized energy source during index ablation on long-term clinical outcomes after repeat ablation of atrial fibrillation (AF). Index ablation procedures were either performed using radiofrequency current (RFC) (RFC group) or cryoballoon (CB) ablation (CB group). Repeat ablation was performed by the use of RFC., Methods: A total of 195 patients (138 RFC group; 57 CB group) with paroxysmal AF were included. All patients had a recurrence of AF following the index ablation procedure. Freedom from AF was estimated with the Kaplan-Meier method., Results: After a 3 years follow-up, the estimated arrhythmia-free survival did not differ between the two groups (RFC group 48% vs CB group 47%, P = .78). During index ablation, procedure times were significantly shorter in the CB group (95 [80, 140] vs 140 [115, 164] minutes, P ≤ .001), whereas fluoroscopy times (16 [11; 22] vs 19 [14; 25] minutes, P = .003), the dose area product (1862 [1203; 2922] vs 3148 [1756; 5888] cGycm 2 , P ≤ .001) and the amount of contrast dye (92 ± 32 vs 123 ± 33 mL, P ≤ .001) were significantly lower in the RFC group. During repeat ablation, procedure times were significantly shorter in patients being initially treated with RFC (115 [85; 145] vs 125 [105; 150] minutes, P = .007). There was a trend towards a higher pulmonary vein reconnection rate in the RFC group without meeting statistical significance (P = .074)., Conclusions: In patients with repeat ablation of AF, index RFC or CB ablation are equally effective in terms of freedom from AF. Although CB ablation results in shorter index procedures times, durations of repeat ablation are significantly longer., (© 2020 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals, Inc.)

Background: The second-generation cryoballoon (CB2) is widely used for pulmonary vein (PV) isolation (PVI) in patients with paroxysmal atrial fibrillation (AF). Recently, the novel fourth-generation CB (CB-Advance PRO) was introduced, incorporating a shortened catheter tip., Hypothesis: The aim of this study was to evaluate the feasibility and acute efficacy of PVI using the CB-Advance PRO., Methods: A total of 200 consecutive patients were analyzed. Hundred patients who underwent PVI due to symptomatic, drug-refractory AF were treated with the CB-Advance PRO (group I) and were included into this multicenter analysis. A group of 100 patients were treated with the CB2 and acted as controls (group II)., Results: In total, 739 of 739 PVs (100%) were successfully isolated. There was a nonsignificant trend in the incidence of online registration of PV signals between both groups (group I: 77.9% vs group II: 71.4%, P = .09). Median time to PVI (time to isolation [TTI]) and mean total freezing time were significantly shorter when using the CB-Advance PRO (group I: 33 [23, 50] vs group II: 40 [26, 60] seconds and group I: 166 ± 29 vs group II: 183 ± 38 seconds, P < .01). In three of 100 (3%) patients of group I and one of 100 (1%) patients of group II, a transient phrenic nerve palsy occurred (P = .62)., Conclusion: The use of the novel CB-Advance PRO is feasible and associated with a significant reduction in mean TTI and mean total freezing time as compared to the CB2., (© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.)

Objectives: This study presents the first report of high-resolution imaging of cardiac anatomy using a novel system., Background: Recently, the wide-band dielectric mapping system Kodex was introduced., Methods: This study included 20 consecutive patients with symptomatic atrial fibrillation or left atrial tachycardia who were scheduled for an ablation procedure and who underwent simultaneous left atrial mapping using the Kodex and CARTO 3 systems. Pulmonary vein angiograms served as a reference to compare the craniocaudal dimensions of the pulmonary vein ostia as depicted by either of the 2 mapping systems., Results: Complete left atrial imaging was achieved within a median [first quartile; third quartile] of 9.7 [7.5; 12.8] min. Median procedure time was 97.5 [90; 112.5] min, and median total fluoroscopy time was 8.2 [5.7; 10.6] min, of which a median of 1.4 [1.1; 2.3] min were used during the creation of the left atrial map. High-resolution representations of left atrial anatomy were successfully created in all patients. Both the Kodex and CARTO measurements correlated well with fluoroscopy measurements, as reflected by Pearson's correlation coefficients (r) of 0.91 and 0.95, respectively. Bland-Altman plots revealed that, on average, Kodex measurements underestimated fluoroscopy measurements by 0.04 mm (95% limits of agreement of -5.72 and 5.64 mm), and CARTO measurements underestimated fluoroscopy measurements by 0.02 mm (95% limits of agreement of -3.61 and 3.57 mm)., Conclusions: Anatomic mapping of the left atrium using Kodex shows the potential to create computed tomography-like images without the need for additional periprocedural imaging., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: We sought to assess (1) clinical outcomes of second-generation cryoballoon (CB) ablation for persistent atrial fibrillation (AF), and (2) the association of baseline and procedural covariates with atrial arrhythmia recurrence (AAR) after ablation., Methods: A total of 135 patients (63 ± 11 years, 96 men [71%]) with persistent AF underwent CB ablation at three experienced electrophysiology centers. Freedom from AAR was estimated with the Kaplan-Meier method. A Cox proportional-hazards model was used to estimate the effects of baseline and procedural covariates on the likelihood of AAR., Results: Freedom from AAR at 6, 12, and 18 months was estimated at 91% (95% confidence interval [CI] 86%-96%), 75% (95% CI, 67%-83%), and 53% (95% CI, 43%-65%), respectively. The presence of an implantable cardiac device (Hazard ratio [HR] 3.09; 95% CI, 1.37-7.00; P = .007), a left atrial (LA) diameter > 50 mm (HR 1.69; 95% CI, 1.02-2.79; P = .043), and absence of antiarrhythmic drug (AAD) therapy before the ablation procedure (HR 3.12; 95% CI, 1.72-5.64; P < .001) were associated with AAR. A trend toward an increased risk of AAR was revealed for women (HR 1.73; 95% CI, 0.96-3.11; P = .069)., Conclusions: CB ablation for persistent AF resulted in freedom from AAR about that reported for RF ablation. The presence of an implantable cardiac device, LA size, and absence of AAD therapy at baseline were associated with the risk of AAR., (© 2019 Wiley Periodicals, Inc.)

Background: Atrial fibrillation (AF) and higher grade mitral valve regurgitation are often associated. For both, there are interventional therapeutic options such as pulmonary vein isolation (PVI) and percutaneous mitral valve repair (PMVR) using MitraClip., Objective: This study investigated the feasibility, safety and clinical outcome of AF ablation in patients with prior PMVR., Methods: This study included patients with symptomatic AF who underwent PVI after prior PMVR at a tertiary care center (14 consecutive patients, group I). A propensity-score matched group of 42 patients (1:3 matching, group II) without prior valve repair acted as controls., Results: Acute PVI was achieved in all patients. No difference was found regarding median procedure time (group I: 125.0 [Q1: 120.0; Q3: 176.3] vs group II: 135.0 [120.0; 177.5] minutes; P = 0.87) and median fluoroscopy duration (group I: 17.2 [12.9; 25.9] vs group II: 18.6 [12.3; 25.9] minutes; P = 0.95). In group I, one patient suffered a postprocedural transient ischemic attack. No further major complications occurred (P = 0.25). No periprocedural interference with the MitraClip was noted. The Kaplan-Meier estimate 18-month overall arrhythmia-free survival after the index procedure including a 3-month blanking period was 64.8% (95% confidence interval [CI] 42.1-99.8%) for the study group and 68.3% (95% CI, 54.6-85.6%) for the control group P = 0.35). A higher percentage of left atrial tachycardias was observed in the study group (67% vs 12% of patients with any arrhythmia recurrence; P = 0.01)., Conclusion: Catheter ablation of AF in patients with prior PMVR is feasible and safe and results in satisfying clinical outcome., (© 2019 Wiley Periodicals, Inc.)

Background: Second-generation cryoballoon (CB2)-based pulmonary vein isolation (PVI) has demonstrated encouraging results in the treatment of atrial fibrillation (AF). This study sought to assess data on the safety, efficacy and clinical success of CB2-based PVI in patients with heart failure (HF) and reduced ejection fraction (HFrEF).Methods and Results:CB2-based PVI was performed in 551 consecutive patients in 3 highly experienced EP centers. Patients with HF and LVEF ≤40% were included (HFrEF group, n=50/551, 9.1%). Data were compared with propensity score-matched patients without HF and preserved left ventricular EF (LVEF) (n=50, control group). The median LVEF was HFrEF: 37% (35, 40) and control: 55% (55, 55), P<0.0001. Major periprocedural complications were registered in 4/50 (8%, HFrEF group) and 3/50 (6%, control group), P=0.695. The 12-month freedom from AF recurrence was 73.1% (95% confidence interval (CI): 61-88, HFrEF group) and 72.6% (95% CI: 61-87, control group), P=0.25. NYHA class decreased from 2.4±0.8 (baseline) to 1.7±0.8 at 12-month follow-up (P<0.0001). LVEF improved from a median of 37% (35, 40) prior to ablation to a median of 55% (40, 55), P<0.0001., Conclusions: CB2-based PVI in patients with HFrEF appeared to be safe, was associated with comparable periprocedural complications and showed promising clinical success rates equal to those for patients with preserved LVEF. NYHA class and LVEF significantly improved at 12-month follow-up.

Background: The prevalence of atrial fibrillation (AF) increases with age. Second-generation cryoballoon (CB2)-based PVI has demonstrated encouraging clinical results in the treatment of paroxysmal (PAF) and persistent atrial fibrillation (PersAF). The objective of this study was to assess data on safety, efficacy and long-term clinical success of CB2-based pulmonary vein isolation (PVI) in patients ≥75 years of age., Methods: CB2-based PVI was performed in 104 patients ≥75 years of age (elderly group) and symptomatic AF (PersAF: n = 44, 42.3%) in three highly experienced German EP centers. The data was compared to propensity score matched patients with age <75 years (n = 104, control group; PersAF: n = 45, 43.3%, p = 0.956)., Results: The median age of the elderly group was 77.5 [75, 80] years while it was 63 [52, 70] years of control group patients (p = 0.0001). The median procedure time was 92.5 [75, 120] minutes (elderly group) and 100 [75, 120] (control group), p = 0.124. Major complications were registered in 7/104 (6.7%) elderly patients and 7/104 (6.7%) control group patients (p = 0.999). Clinical success in terms of freedom from AF recurrence after one-year follow-up was 80% (95% CI: 72-88) and 82% (95% CI: 75-90) and after three-year follow-up 59% (95% CI: 47-74) and 49% (95% CI: 37 64) for the elderly group and the control group, respectively (p = 0.7)., Conclusions: CB2-based PVI in patients ≥75 years of age appears safe, is associated with low procedure times and shows promising clinical success rates equal to patients of the younger population., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Cardiac resynchronization therapy (CRT) is less effective in patients with atrial fibrillation (AF) because of impaired ventricular CRT capture., Objective: We investigated the effects of catheter ablation in patients with AF and previous nonresponse to CRT., Methods: Consecutive patients with AF and CRT nonresponse who underwent catheter ablation for AF were analyzed. CRT nonresponse was defined as one of the following: (1) reduced biventricular capture <95% due to rapidly conducted AF, (2) <1 point improvement in New York Heart Association (NYHA) class after CRT implantation, or (3) insufficient increase in left ventricular ejection fraction (LVEF; ≤5%) after CRT implantation., Results: Thirty-eight patients (8 women [21%]; mean age 68 ± 10 years; LVEF 30% ± 7%, biventricular capture 88.0% [25th, 75th percentile 75.3%, 98.5%]) underwent catheter ablation. One major and 1 minor complication occurred (1 lethal atrioesophageal fistula and 1 hemodynamically nonrelevant pericardial effusion). The Kaplan-Meier estimates for arrhythmia-free survival after single and multiple ablation procedures were 29% (95% confidence interval 16%-51%) and 67% (95% confidence interval 53%-86%) after 24 months. After a median follow-up of 817 days (25th, 75th percentile 179, 1741 days), biventricular capture and LVEF were significantly higher (median [25th, 75th percentile] 99% [96%, 99%], difference 8% [0.2%, 3.75%], P < .0001; mean 32.1% ± 9.1%, difference 2.2% ± 7.1%, P = .0225) and patients had a significantly lower functional NYHA class (28 of 37 patients with improvement of at least 1 point; P < .0001)., Conclusion: Catheter ablation of AF significantly improves CRT response in patients with heart failure and concomitant AF in terms of increased biventricular capture and LVEF and improved functional NYHA class., (Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The second-generation cryoballoon (CB2) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging and reproducible clinical outcome data. The latest- -generation cryoballoon (CB3) incorporates a 40% shorter distal tip, thus allowing for an increased rate of PVI real-time signal recording and facilitating individualized ablation strategies taking the time-to- -effect (TTE) into account. However, whether this characteristic translates into favorable clinical success has not been evaluated yet. Herein was investigated 1-year clinical success after CB3 in comparison to CB2 based-PVI., Methods: One hundred and ten consecutive patients with paroxysmal or short-standing persistent atrial fibrillation (AF) underwent CB2 (n = 55 patients) -or CB3 (n = 55 patients) -based PVI. The freeze-cycle duration was set to TTE + 120 s if TTE could be recorded, otherwise a fixed freeze-cycle duration of 180 s was applied., Results: A total of 217/218 (99%, CB3) and 217/217 (100%, CB2) pulmonary veins (PV) were successfully isolated. The real-time PVI visualization rate was 69.2% (CB3) and 54.8% (CB2; p = 0.0392). The mean freeze-cycle duration was 194 ± 77 s (CB3) and 206 ± 85 s (CB2; p = 0.132), respectively. During a median follow-up of 409 days (interquartile range [IQR] 378-421, CB3) and 432 days (IQR 394-455, CB2) 73.6% (CB3) and 73.1% of patients (CB2) remained in stable sinus rhythm after a single procedure (p = 0.806)., Conclusions: A higher rate of real-time electrical PV recordings was seen using the CB3 as compared to CB2. There was no difference in 1-year clinical follow-up.

Background: Second-generation cryoballoon (CB2)-based pulmonary vein isolation (PVI) has demonstrated encouraging clinical results for the treatment of paroxysmal atrial fibrillation (AF) and persistent AF. However, rhythm follow-up after PVI is mainly based on Holter electrocardiography of limited duration., Objective: The purpose of this study was to assess the real AF burden following CB2-based PVI in patients with implanted cardiac devices., Methods: A total of 670 consecutive patients underwent CB2-based PVI at 3 electrophysiology centers. In 66 patients (9.9%), an implantable cardiac device with continuous monitor function was independently implanted before the procedure (device group). This patient cohort was compared to propensity score-matched patients without cardiac devices (n = 66; control group)., Results: A total of 254 of 258 PVs (98.4%0 in the device group were successfully isolated using only CB2. Postprocedural device interrogation found no device or lead malfunction related to the procedure. Periprocedural complications were registered in 7 of 66 patients (11%) in the device group and in 6 of 66 patients (9%) in the control group (P = .770). Phrenic nerve palsy occurred in 6 of 66 patients (9%) in the device group) and in 2 of 66 patients (3%) in the control group) (P = .274). Clinical success in terms of freedom from AF recurrence after a 1-year follow-up period was 63.8% (95% confidence interval 53-77) in the device group and 77.3% (95% confidence interval 68-88) in the control group (P = .038). In the device group, AF/AT burden decreased from 41.8% ± 35.0% before the procedure to 10.2% ± 22.4% after 1 year (P <.0001)., Conclusion: CB2-PVI seems safe and feasible in patients with an implanted cardiac device. A significantly higher AF/AT burden was seen in patients with an implanted cardiac device compared to a control group., (Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objectives: This study investigated the outcome of wide-area left atrial appendage isolation (WLAAI) and subsequent LAA ligation in patients with recurrent atrial arrhythmias after pulmonary vein isolation (PVI)., Background: LAA isolation and ligation may improve rhythm control and prevent LAA thrombus formation in patients with atrial fibrillation who do not respond to PVI., Methods: Patients (n = 31, mean age: 69.7 ± 7.8 years, 18 men) with arrhythmia recurrence after established PVI undergoing WLAAI with subsequent LAA ligation (LARIAT+ device) were studied. The incidence of arrhythmia recurrence, intracardiac thrombus formation, thromboembolic events, as well as changes in P-wave duration and P-wave dispersion were assessed., Results: All 31 patients underwent successful WLAAI, and successful LAA ligation was performed in 27 patients (87%). Over a median follow-up of 498 (interquartile range: 159 to 791) days, post-ligation arrhythmia recurrence was documented in 8 patients (26%). Kaplan-Meier estimate of 24-month arrhythmia-free survival after WLAAI/ligation was 69.7% (95% confidence interval: 53.9 to 90.1). Following WLAAI, LAA thrombus formation was seen in 11 patients (35.5%), but in no patient after LAA ligation. WLAAI/ligation significantly reduced P-wave duration (from 93 ± 20 ms to 72 ± 20 ms; p = 0.001) and P-wave dispersion (from 63 ± 37 ms to 38 ± 16 ms; p = 0.001)., Conclusions: WLAAI and subsequent LAA ligation in PVI nonresponders led to an estimated freedom from arrhythmia recurrence in 70% of the patients at 24 months. LAA ligation successfully prevented recurrence of cardiac thrombus formation in patients with WLAAI. Significant decreases in P-wave duration and P-wave dispersion occurred with WLAAI/ligation, suggesting favorable electrical remodelling., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: This study aimed to evaluate feasibility and safety as well as 1-year clinical outcome of pulmonary vein isolation (PVI) using a unique radiofrequency ablation catheter ("Thermocool SmartTouch SurroundFlow"; STSF) incorporating both, contact force (CF) sensing technology and enhanced tip irrigation with 56 holes, in one device., Methods: A total of 110 patients suffering from drug-refractory atrial fibrillation underwent wide area circumferential PVI using either the STSF ablation catheter (75 consecutive patients, study group) or a CF catheter with conventional tip irrigation ("Thermocool SmartTouch", 35 consecutive patients, control group). For each ablation lesion, a target CF of ≥ 10-39 g and a force time integral (FTI) of > 400 g s was targeted., Results: Acute PVI was achieved in all patients with target CF obtained in > 85% of ablation points when using either device. Mean procedure time (131.3 ± 33.7 min in the study group vs. 133.0 ± 42.0 min in the control group; p = 0.99), mean fluoroscopy time (14.0 ± 6 vs. 13.5 ± 6.6 min; p = 0.56) and total ablation time were not significantly different (1751.0 ± 394.0 vs. 1604.6 ± 287.8 s; p = 0.2). However, there was a marked reduction in total irrigation fluid delivery by 51.7% (265.52 ± 64.4 vs. 539.6 ± 118.2 ml; p < 0.01). The Kaplan-Meier estimate 12-month arrhythmia-free survival after the index procedure following a 3-month blanking period was 79.9% (95% CI 70.4%, 90.4%) for the study group and 66.7% for the control group (95% CI 50.2%, 88.5%). This finding did not reach statistical significance (p = 0.18). Major complications occurred in 2/75 patients (2.7%; one pericardial tamponade and one transient ischemic attack) in the study group and no patient in the control group (p = 18)., Conclusion: PVI using the STSF catheter is safe and effective and results in beneficial 1-year clinical outcome. The improved tip irrigation leads to a significant reduction in procedural fluid burden.

Aims: Pulmonary vein stenosis or occlusion (PVS/O) following catheter ablation of atrial fibrillation is a rare but potentially severe complication. Treatment options include angioplasty with or without stent implantation, but data on outcome and optimal treatment strategy are limited. We report long-term results after catheter-based treatment of patients with symptomatic PVS/O., Methods and Results: Retrospective analysis was performed in patients undergoing pulmonary vein (PV) angiography for suspected PVS/O. All patients with PVS/O were treated with balloon angioplasty and implantation of a coronary drug-eluting stent (DES) or a peripheral large-diameter bare metal stent (LD-BMS). A total of 25 high-degree PVS/Os in 19 patients were treated. Nine PVs were treated with angioplasty and DES implantation and 16 with angioplasty and LD-BMS implantation. The ostial PV diameter was not different in the DES and LD-BMS groups (10.2 ± 2.5 mm vs. 11.1 ± 1.9 mm, P = 0.34), but the PV/stent diameter ratio was significantly lower in the former (0.43 ± 0.13 vs. 0.82 ± 0.13, P < 0.0001). Angiographic stent restenosis was observed at a median of 539 (interquartile range 99-774) days in 9 of 23 (39%) treated PVs. The restenosis rate in the LD-BMS group was only one-third of that in the DES group [3/14 (21%) vs. 6/9 (67%), respectively; P = 0.08]., Conclusion: The use of LD-BMS for the treatment of PVS/O was associated with an acceptable long-term outcome. Coronary DES implantation resulted in a high rate of restenosis and should therefore not be performed. Larger trials are needed to confirm our findings.

Aims: Second-generation cryoballoon (CB2) based pulmonary vein isolation (PVI) has emerged as an effective treatment option for symptomatic atrial fibrillation (AF). The current study sought to assess the impact of different ablation protocols on the incidence and characteristics of procedural complications in a large patient cohort., Methods and Results: A total of 563 consecutive patients with symptomatic AF who underwent CB2-based ablation between July 2012 and January 2016, were assessed. Three different ablation protocols were applied and characterized by (#1) a bonus-freeze following PVI, (#2) no bonus-freeze after PVI, and (#3) a 'time-to-effect'-guided strategy. Major complications occurred in 30/563 patients (5.3%) with phrenic nerve palsy (PNP) as the most frequent complication occurring in 2.7% of the cases. The overall incidence of complications was significantly lower in patients treated with a 'time-to-effect' guided ablation strategy compared with the other ablation protocols (8.1% [17/211] (protocol #1+#2) vs. 3.7% [13/352] (protocol #3), respectively; P = 0.026). The 'time-to-effect' guided ablation protocol was associated with less applied freeze-cycles and shorter freeze-cycle durations. Additionally, shorter procedure times, radiation exposures and lower volumes of contrast medium needed were assessed for the 'time-to-effect' guided protocol as compared with the other ablation protocols., Conclusion: The overall incidence of complications was 5.3% in our analysis. The most frequent complication was PNP. The use of a time-to-effect guided ablation protocol was associated with a lower incidence of major complications compared with a bonus-freeze and no bonus-freeze protocol.

Background: Visually guided laser balloon (VGLB) ablation allows for pulmonary vein isolation (PVI) under direct endoscopic control. Short- and midterm clinical outcomes are in accordance with results of radiofrequency current (RFC) ablation for the treatment of paroxysmal atrial fibrillation (PAF)., Objective: The current study sought to assess the long-term clinical outcomes of VGLB-based PVI for PAF., Methods: A total of 90 patients [60 ± 10 years; 33 (37%) female, left atrial diameter 42 ± 4 mm] with drug-refractory PAF underwent VGLB ablation. The median duration of PAF until VGLB ablation was 36 (interquartile range 12; 84) months. Follow-up was based on outpatient clinic visits including Holter ECGs and telephone interviews. Repeat ablation due to arrhythmia recurrences was performed using RFC ablation., Results: After a single VGLB procedure, 5-year freedom from arrhythmia recurrence was 51% [95% confidence interval (CI) 39-62%]. Thirty-three patients underwent repeat RFC ablation procedures, resulting in multiple procedure freedom from arrhythmia recurrence of 78% (95% CI 68-88%). Major periprocedural complications occurred in four patients (4%)., Conclusions: VGLB ablation for the treatment of drug-refractory PAF is safe and results in 5-year single and multiple procedure arrhythmia-free survival of 51 and 78%, respectively.

Aims: Procedure times and left atrial dwell times of cryoballoon (CB)-based ablation strategies for atrial fibrillation (AF) are shorter as compared to radiofrequency ablation, yet fluoroscopy times are longer and result in a higher radiation exposure. The objective of this study is to evaluate a modified fluoroscopy protocol aiming at reduction of radiation exposure in CB ablation., Methods and Results: A total of 120 patients with symptomatic AF underwent pulmonary vein isolation (PVI) using the second generation CB and an ablation strategy considering the individual time-to-isolation. The first 60 patients (Group 1) underwent CB-based PVI with conventional fluoroscopy settings. An optimized approach was applied in the following 60 patients (Group 2) by (i) using fluoroscopy instead of filming for verification of pulmonary vein (PV) occlusion after contrast injection, (ii) reducing the frame rate, and (iii) pursuing maximal collimation on the region of interest. A total of 475 PVs were identified and successfully isolated. Median dose area product and fluoroscopy time were significantly shorter in Group 2 as compared to Group 1 [389 (285; 550) cGycm2 vs. 2168 (1355; 3490) cGycm2 (P < 0.0001) and 10 (8; 12) min vs. 14 (11; 19) min (P < 0.0001)]. Additionally, median time-to-isolation of the PVs was significantly shorter in Group 2 [44 (30; 65) s vs. 33 (20; 46) s (P < 0.0001)]., Conclusions: The implementation of an optimized fluoroscopy protocol significantly reduces radiation exposure in CB-based PVI without compromising acute efficacy and safety.

Background: Real-time recording of pulmonary vein isolation (PVI) using a circular mapping catheter has become a key aspect of cryoballoon (CB) ablation. The aim of this study was to investigate the procedural safety, efficacy and rate of real-time pulmonary vein (PV) recording using a novel circular mapping catheter with a 25-mm loop size for CB-based PVI.Methods and Results:A total of 40 patients with symptomatic atrial fibrillation (AF) underwent PVI using a second-generation CB and a novel 25-mm circular mapping catheter. A total of 159 PV were identified and successfully isolated. Real-time PV recording was achieved in 80% of the PV. In 3 right inferior PV the circular mapping catheter had to be exchanged for a stiff guidewire due to insufficient mechanical support. Therefore, acute PVI using exclusively the circular mapping catheter was achieved in 156/159 PV (98%). Mean procedure and fluoroscopy times were 66±21 min and 15±6 min, respectively. Transient phrenic nerve palsy occurred in 1 patient as the only procedural complication., Conclusions: The exclusive use of a novel 25-mm circular mapping catheter for CB ablation of AF results in a real-time PV recording rate of 80% and isolation of 98% of targeted PV.

Background: Circumferential pulmonary vein isolation (CPVI) is increasingly performed for the treatment of symptomatic drug-refractory paroxysmal atrial fibrillation. Long-term data for >10 years after CPVI are sparse. We investigated the long-term clinical outcome and progression of paroxysmal atrial fibrillation after double-lasso and 3-dimensional electroanatomical mapping-guided CPVI., Methods and Results: From 2003 to 2004, 161 patients (mean age: 60±10 years) with symptomatic drug-refractory paroxysmal atrial fibrillation were prospectively enrolled and underwent electroanatomical mapping-guided CPVI. Right-sided and left-sided continuous circular lesions encircling the ipsilateral pulmonary veins were placed with irrigated radiofrequency energy. The procedural end point was the absence of pulmonary vein spikes 30 minutes after CPVI verified by 2 spiral catheters placed within the ipsilateral pulmonary veins (double-lasso technique). Major periprocedural complications occurred in 5 of 161 patients (3.1%). Follow-up was based on outpatient clinic visits, including Holter-ECGs and telephonic interviews. After a single procedure and median follow-up of 129.0 months (interquartile range, 124.7-133.1 months), stable sinus rhythm was present in 53 of 161 (32.9%) patients. Multiprocedural outcome after a mean of 1.73±0.9 procedures and a median follow-up of 123.4 months (interquartile range, 61.0-131.0 months) resulted in stable sinus rhythm in 101 of 161 patients (62.7%). Progression toward persistent atrial fibrillation was observed in 10 of 161 patients (6.2%)., Conclusion: Ten-year single-procedural outcome of CPVI in patients with paroxysmal atrial fibrillation resulted in stable sinus rhythm in 32.9% and in 62.7% of patients after multiple procedures. The progression rate to persistent AF was remarkably low., (© 2018 American Heart Association, Inc.)

Aims: Catheter ablation is an established therapy for symptomatic atrial fibrillation (AF). However, outcome data on catheter ablation for AF in young adults is scarce., Methods and Results: From 2005-2014, 85 consecutive young adults (mean age 31 ± 4 years; 69% men) with symptomatic paroxysmal AF (PAF, n = 52) and persistent (Pers) AF (n = 33) underwent pulmonary vein isolation (PVI) [±ablation of complex fractionated atrial electrograms/linear lesions in PVI non-responders] at our centre. Follow-up was based on outpatient visits including 24-h Holter-ECG at 3, 6 and, 12 months post ablation, and every 12 months thereafter. Recurrence was defined as any AF/atrial tachycardia episode >30s following a 3-month blanking period. Follow-up was available for 74/85 (87%) patients. After a median follow-up of 4.6 years (Q1: 2.6; Q3: 6.6) and a mean of 1.5 ± 0.6 (median 1, range 1-3) ablation procedures 84% [including 13% on previously ineffective antiarrhythmic drugs (AAD)] of patients were in stable SR. Single-procedural 1-year/5-year arrhythmia-free survival was 66% [95% confidence interval (CI): 56-78%]/44% (95% CI: 33-59%), respectively. Structural heart disease [SHD; hazard ratio (HR) 2.79 (95% CI 1.52-5.12), P = 0.001] and obesity [HR 1.10 (95% CI 1.00-1.21) per unit increase in body mass index >27 kg/m2, P = 0.05] independently predicted AF recurrence. Major complications occurred in 6/122 (4.9%) procedures (PV stenosis in 3, cardiac tamponade in 1, stroke in 1, and arterial-venous fistula in 1)., Conclusion: In the majority of very young adults catheter ablation for AF is effective, and associated with an acceptable complication rate. SHD and obesity are predictors for AF recurrence in this population., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions, please email: journals.permissions@oup.com.)

Aims: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an established treatment for symptomatic atrial fibrillation (AF). In the present study, we sought to assess the efficacy and safety of CB-based PVI taking the individual time-to-isolation (TTI) into account., Methods and Results: Sixty consecutive patients with drug-refractory paroxysmal atrial fibrillation [n = 49 (82%)] or short-standing persistent atrial fibrillation [n = 11 (18%)] underwent ablation with a 28-mm second-generation CB. The TTI was assessed by spiral mapping-catheter recordings and subsequently followed by an additional freeze-time of 120 s. No bonus freeze-cycle was applied. If the TTI could not be assessed, a fixed freeze-cycle duration of 240 s was applied and successful PVI confirmed thereafter. Clinical follow-up (FU) included 12-lead ECGs and 24 h Holter-ECGs at 3, 6, and 12 months. A blanking period of 3 months was defined. A total of 239 pulmonary veins (PVs) were identified and successfully isolated. The mean TTI assessed in 170/239 (71%) PVs was 52 ± 32 s. The mean number of CB applications was 1.2 ± 0.5; mean freeze-cycle duration was 192 ± 41 s. Mean procedure and fluoroscopy times were 80 ± 24 min and 16 ± 7 min, respectively. Transient phrenic nerve palsy occurred in one patient (2%). During a mean FU of 405 ± 67 days, 43 patients (72%) remained in stable sinus rhythm., Conclusions: Integrating an individual TTI protocol to CB-based PVI results in shorter freeze-cycle applications in a substantial portion of targeted PVs and an arrhythmia-free survival comparable to conventional ablation protocols. The complication rate is low., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions please email: journals.permissions@oup.com.)

Purpose: The magnetic navigation system (MNS) has shown to be safe and effective for catheter ablation of atrial fibrillation (AF). However, longer procedure duration as compared to manual catheter ablation may limit its widespread use. This study aimed to assess the impact of the newest generation MNS using an optimized mapping and ablation protocol on the efficacy and safety of remote magnetic catheter (RMC)-guided pulmonary vein isolation (PVI)., Methods: This observational study included 52 patients with symptomatic AF who underwent RMC-guided PVI using the second-generation MNS Niobe II (initial 28 patients, group I) or the third-generation MNS Niobe ES in combination with an optimized mapping and ablation protocol (24 patients, group II)., Results: Acute PVI was achieved in 26/28 (93%) patients in group I and 24/24 patients (100%) in group II. Mean procedure time was 263.9 ± 81.9 min in group I and significantly lower in group II (139.7 ± 22.6 min, p < 0.01). Mean fluoroscopy time was 18.8 ± 8.7 min in group I and decreased to 7.9 ± 2.6 in group II (p < 0.01). After a median follow-up of 640.5 days (Q1 460.75; Q3 766.5), 16/24 (67%) patients undergoing RMC-guided PVI in group II remained in stable SR. No periprocedural complications were noted for either group., Conclusions: Use of the third-generation MNS for RMC-guided PVI is safe, effective, and drastically reduced procedure times.

Background: Second-generation cryoballoon (CB2)-based pulmonary vein isolation (PVI) has demonstrated encouraging clinical results in the treatment of paroxysmal (PAF) and persistent atrial fibrillation (PersAF). However, the CB2 features a maximal diameter of 28 mm, and its adaptability to anatomic variations of the pulmonary veins (PVs) might be challenging., Objective: The purpose of this study was to assess the acute efficacy, safety, and long-term clinical results of CB2-based PVI in patients with a left common pulmonary vein (LCPV)., Methods: Six hundred seventy consecutive patients underwent CB2-based PVI in 3 electrophysiology centers. In 74 patients (11%), an LCPV was identified (LCPV group). The data were compared to those from matched patients (n = 74) with normal PV anatomy and comparable baseline characteristics (control group). An antral occlusion of the complete LCPV ostium was feasible in 50% of patients in the LCPV group. If an antral occlusion could not be obtained, a sequential isolation of the first superior and inferior branches was applied., Results: All 74 LCPVs were successfully isolated. A total of 64% patients (LCPV group) and 66% patients (control group) remained in sinus rhythm after mean follow-up of 1.9 ± 0.9 years (P = .820). In 18 of 26 patients (69%) with atrial tachyarrhythmia recurrence, a repeat procedure using radiofrequency energy was performed, and a total of 56% LCPVs were found to be persistently isolated (control group: 61% of left-sided PVs, P = .801)., Conclusion: Patients with an LCPV undergoing CB2-based PVI demonstrate a high acute success rate. Comparable results with regard to clinical success and durability of PVI were shown when comparing patients of the LCPV group and the control group., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Pulmonary vein isolation (PVI) for persistent atrial fibrillation is associated with limited success rates and often requires multiple procedures to maintain stable sinus rhythm. In the prospective and randomized Alster-Lost-AF trial (Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation), we sought to assess, in patients with symptomatic persistent or long-standing persistent atrial fibrillation, the outcomes of initial ablative strategies comprising either stand-alone PVI (PVI-only approach) or a stepwise approach of PVI followed by complex fractionated atrial electrogram ablation and linear ablation (Substrate-modification approach)., Methods and Results: Patients were randomized 1:1 to stand-alone PVI or PVI plus substrate modification. The primary study end point was freedom from recurrence of any atrial tachyarrhythmia, outside a 90-day blanking period, at 12 months. A total of 124 patients were enrolled, with 118 patients included in the analysis (61 in the PVI-only group, 57 in the Substrate-modification group). Atrial tachyarrhythmias recurred in 28 PVI-only group patients and 24 Substrate-modification group patients, for 1-year freedom from tachyarrhythmia recurrence after a single ablation procedure of 54% (95% confidence interval, 43%-68%) in the PVI-only and 57% (95% confidence interval, 46%-72%) in the Substrate-modification group ( P =0.86). Twenty-four patients in the PVI-only group (39%) and 18 in the Substrate-modification group (32%) were without arrhythmia recurrence and off antiarrhythmic drug therapy at the end of the 12-month follow-up., Conclusions: In patients with persistent and long-standing persistent atrial fibrillation, no significant difference was observed in 12-month freedom from atrial tachyarrhythmias between an index ablative approach of stand-alone PVI and a stepwise approach of PVI plus complex fractionated atrial electrogram and linear ablation., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00820625., (© 2017 American Heart Association, Inc.)

Background: Pulmonary vein isolation (PVI) using the 2nd-generation cryoballoon (CB2) for the treatment of atrial fibrillation (AF) has demonstrated encouraging acute and mid-term results. However, follow-up data on outcomes beyond 1 year are sparse. We investigated the 3-year outcome after PVI using the CB2.Methods and Results:100 patients with paroxysmal (PAF, 70/100 [70%] patients) or persistent AF (pAF, 30/100 [30%] patients) underwent CB2-based PVI in 2 experienced centers in Germany. Freeze-cycle duration was 240 s. After successful PVI a bonus freeze-cycle of the same duration was applied in the first 71 patients but was omitted in the following 29 patients. Phrenic nerve palsy occurred in 3 patients (3%); 2 patients were lost to follow-up. After a median follow-up of 38 (29-50) months, 59/98 (60.2%) patients remained in stable sinus rhythm (PAF: 48/70 (69%), pAF: 11/28 (39%) P=0.0084). In 32/39 (77%) patients with arrhythmia recurrence, a second ablation procedure using radiofrequency energy was conducted. Persistent PVI was noted in 76/125 (61%) PVs. After a mean of 1.37±0.6 procedures and a median follow-up of 35 (25-39) months, 77/98 (78.6%) patients remained in stable sinus rhythm (PAF: 56/70 (80%), pAF: 20/28 (71%), P=0.0276)., Conclusions: CB2-based PVI resulted in a 60.2% single-procedure and a 78.6% multiple-procedure success rate after 3 years. Repeat procedures demonstrated a high rate of durable PVI.

Introduction: Atrial fibrillation (AF) is mainly triggered by arrhythmogenic foci originating from atrial myocardial extensions (MEs) into the pulmonary veins (PVs). Aim of the study was to evaluate endocardial voltage maps of PVs as a surrogate parameter for the extent of MEs in subjects with AF through a ultra-high-density mapping system., Methods: Sixty-four bipolar electrograms were recorded simultaneously from the Orion mini-basket catheter placed in 72 PVs of 18 consecutive patients with paroxysmal/persistent AF undergoing PV isolation (PVI). The Rhythmia system in conjunction with the Orion mini-basket catheter was utilized to create a bipolar electro-anatomic reconstruction of the left atrium and PVs., Results: Mean patients' age was 61 ± 10 years, 56% had paroxysmal and 44% persistent AF. Mean endocardial bipolar voltages in the PVs were as follows: 1.06 ± 0.34 mV in right superior PV, 1.14 ± 0.52 mV in right inferior PV, 1.15 ± 0.44 mV in left superior PV and 0.94 ± 0.44 in left inferior PV. PVs had no detectable endocardial signals in 7 out of 72 PVs (9%); a total of 29/72 PVs (40%) revealed a non-uniform arrangement of MEs. The area of MEs was significantly larger in the superior PVs compared to the inferior PVs (9.3 ± 4.7 vs 6.7 ± 4 cm 2 , p = 0.002). No statistical differences in terms of MEs length were found among PVs and according to type of AF., Conclusion: In this pilot study using a ultra-high-resolution electro-anatomical mapping system, endocardial voltage maps of PVs as a surrogate parameter of MEs among patients with AF well correspond to previous data from histopathological studies.

Background: Extensive ablation strategies are currently performed in addition to pulmonary vein isolation (PVI) to improve the clinical outcome of patients with drug-refractory persistent atrial fibrillation (AF). Ablation of complex fractionated atrial electrograms (CFAEs), linear lesions, and/or isolation of the left atrial appendage (LAA) are thought to improve arrhythmia-free survival., Objective: The purpose of this study was to assess the durability of wide-area left atrial appendage isolation (LAAI) achieved by PVI, an anterior line, and a mitral isthmus line., Methods: Seventy-one patients with intentional or incidental LAAI during repeat catheter ablation for treatment of persistent AF were included. The initial ablation strategy was PVI. Additional ablation strategies were performed only if PVI failed to maintain stable sinus rhythm. Durability of LAAI was assessed during a subsequent ablation procedure for arrhythmia recurrences (n = 23) or a subsequent percutaneous LAA closure (n = 48)., Results: LAAI was performed after a mean of 3 ± 1 procedures. Ablation strategies included circumferential PVI in 71 patients (100%), mitral isthmus line in 64 (90%), anterior line in 60 (85%), CFAE in 27 (38%), and roof line in 13 (18%). LAAI occurred after ablation and bidirectional block of LA linear lesions in 63 patients (89%) and during extensive CFAE ablation in 8 patients (11%). After a median of 105 [61;426] days, the LAA remained electrically isolated in 52 of 71 patients (73%)., Conclusion: Wide-area LAAI after extensive catheter ablation for persistent AF is durable in the majority of patients. The potential clinical benefit of LAAI for maintaining stable sinus rhythm requires further investigation., (Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Introduction: Three-dimensional electroanatomical mapping (EAM) is an established tool facilitating catheter ablation. In this context, the novel Rhythmia system sets a new bar in fast high-resolution mapping. The aim of this study was to directly compare point-by-point versus rapid ultra-high-resolution EAM in patients scheduled for ablation of atrial fibrillation (AF) with focus on procedural data, acute success, and midterm clinical outcome., Methods and Results: A total number of 74 consecutive patients (48/74 male) with symptomatic AF were scheduled to undergo pulmonary vein isolation (PVI) using either Carto or Rhythmia. The Carto-guided procedures were performed using point-by-point acquisition according to our routine approach, whereas for Rhythmia, fast anatomical mapping was utilized. Comparing Rhythmia- versus Carto-guided ablation approaches, we observed a significantly longer total mapping time (P = 0.001), longer total fluoroscopy time (P = 0.001), more delivered RF-applications (P = 0.019), and longer total RF-duration (P = 0.002). There was no difference regarding total ablation time (P = 0.707), total procedure duration (P = 0.99), and acute procedural success. During follow-up, 84.8% of patients remained free from any AF/AT-recurrence using Carto versus 88.2% when using Rhythmia (P = 0.53). From Kaplan-Meier analysis, the event rate estimations were 15% versus 13.5%, respectively., Conclusion: The present study reports our first clinical experience using Rhythmia in direct comparison with the established Carto system for AF ablation. Our data clearly demonstrate that Rhythmia was proved to be effective and well applicable but more data will be mandatory before final conclusions can be drawn., (© 2017 Wiley Periodicals, Inc.)

Background: The Rhythmia mapping system was recently launched and allows for rapid ultra-high-resolution electroanatomical mapping. We evaluated the feasibility, acute efficacy and safety of this novel system for ablation of atrial fibrillation (AF) and left atrial (LA) tachycardia (AT)., Methods and Results: A total of 35 consecutive patients (age 64.3 ± 8.6 years, LA diameter 44.4 ± 5.8 mm) underwent catheter ablation for AF and/or AT. All procedures were performed using Rhythmia in conjunction with the Orion mini-basket catheter. Pulmonary vein isolation (PVI) and linear lesions were performed applying radiofrequency (RF) energy. PVI was confirmed by presence of entrance and exit block using the mini-basket catheter. In addition, pacing maneuvers assessed bidirectional conduction block across linear lesions. Procedure duration was 110.3 ± 33 min, fast acquisition mapping (FAM) time was 19 ± 9 min. A mean number of 10165 ± 5904 mapping points were acquired during the initial map and 6379 ± 3191 for a remap. A total number of 31 ± 15 RF applications were delivered within 45 ± 22 min. Total fluoroscopy time was 21 ± 5, 5 ± 2 min were used for FAM. We observed a significant learning curve for mapping duration (p = 0.01). Complications included pericardial tamponade (n = 1), transient air embolism in the right coronary artery (n = 1), and mild groin hematoma (n = 2)., Conclusions: The present study is the largest to describe experience of LA ablation procedures using Rhythmia. PVI was achieved in all patients. Applying this ultra high-resolution electroanatomical mapping system under routine conditions leads to a high level of confidence. More data will be mandatory before final conclusions can be drawn.

Background: Second-generation cryoballoon based pulmonary vein isolation has demonstrated encouraging acute and mid-term clinical outcome. Customarily, a bonus-freeze is applied after successful pulmonary vein isolation., Objective: To compare the long-term clinical outcome and safety profile of a bonus-freeze and a no bonus-freeze protocol., Methods: A total of 120 consecutive patients with paroxysmal [95/120 (79 %)] or persistent atrial fibrillation [25/120 (21 %)] underwent CB2-based PVI. Freeze-cycle duration was 240 s. In the first 60 patients a bonus-freeze was applied after successful PVI (group 1), while in the following 60 patients the bonus-freeze was omitted (group 2)., Results: Procedure and fluoroscopy times were significantly shorter in group 2 [113.8 ± 32 vs 138.2 ± 29 min (p = 0.03) and 19.2 ± 6 vs 24.3 ± 8 min (p = 0.02)]. No differences in procedural complications were found. During a mean follow-up of 849 ± 74 (group 1) and 848 ± 101 days (group 2, p = 0.13) 69 % of patients (group 1) and 67 % of patients (group 2) remained in stable sinus rhythm without any differences between the groups (p = 0.69)., Conclusions: Freedom from atrial fibrillation after second-generation cryoballoon based pulmonary vein isolation and a follow-up of >2 years is comparable when applying a bonus- and a no bonus-freeze protocol, while procedure and fluoroscopy times are significantly shorter when omitting the bonus-freeze. No differences in periprocedural complications were identified.

Background: The second-generation cryoballoon (CB2) has demonstrated superior clinical outcome. Potential procedural complications include esophageal thermal lesions due to excessive esophageal temperature (ET). Safety cut-offs for the ET have previously been published. A safety margin was incorporated due to a delayed esophageal temperature decline even after termination of the CB2 freeze cycle. The extent of these delayed temperature drops requires further systematic evaluation., Methods and Results: The study enrolled 29 patients with paroxysmal or shortstanding persistent AF who underwent CB2-based PVI. Freeze cycle duration was 240 seconds. No bonus freeze was applied after successful PVI. The intraluminal ET was continuously measured via a transorally inserted probe (SensiTherm, St. Jude Medical, Inc.). The CB2 temperature and ET were recorded throughout the procedure using a camera setup. The mean number of freeze cycles per patient was 4.3 ± 2. A total of 147 cryoenergy applications were analyzed. A delayed decline in ET of >0.5 °C was recorded following termination of 23.1% of freeze cycles. The maximum drop in delayed ET was 6.4 °C. Excessive esophageal cooling during the freeze cycle exceeding 8.5 °C/min may result in ET ≤10 °C., Conclusions: Following termination of cryoenergy delivery, the ET may decline an additional 6.4 °C. Proposed ET safety cut-offs during CB2-based PVI need to account for a significant ET drop that may occur even after termination of the individual freeze cycle., (© 2016 Wiley Periodicals, Inc.)

Background: The second-generation cryoballoon (CB2) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome data. The novel third-generation cryoballoon (CB3) incorporates a 40 % shorter distal tip. This design change may translate into an increased rate of PVI real-time signal recording, facilitating an individualized ablation strategy using the time to effect (TTE)., Methods and Results: Thirty consecutive patients with paroxysmal or short-standing persistent atrial fibrillation underwent CB3-based PVI and were compared to 30 patients treated with the CB2. Individual freeze-cycle duration was set to TTE + 120 s for both groups. A total of 118 (CB3) and 119 (CB2) pulmonary veins (PV) were identified and all PVs successfully isolated utilizing the CB3 and CB2, respectively. The real-time PVI visualization rate was 74 % (CB3) and 40 % (CB2; p = 0.001) and the mean freeze-cycle duration 204 ± 88 s (CB3) and 215 ± 90 s (CB2; p = 0.15). Per individual PV, a shorter mean freeze-duration was found for the CB3 and the right superior PVs (188 ± 92 vs. 211 ± 124 s, p = 0.04) and right inferior PVs (192 ± 75 vs. 200 ± 37 s, p = 0.02). No differences were found for the left-sided PVs., Conclusions: A higher rate of real-time electrical PV recordings is seen using the novel CB3 as compared to CB2, which may facilitate an individualized ablation strategy using the TTE.

Aims: The prevalence of atrial fibrillation (AF) increases with age. Catheter ablation is an established treatment option for patients with symptomatic AF. We sought to determine the safety and long-term clinical efficacy of AF ablation in patients ≥75 years., Methods and Results: Patients ≥75 years with symptomatic, drug-refractory AF were included in the study. Circumferential pulmonary vein isolation (PVI) was performed in all patients, extended to ablation of complex fractionated atrial electrograms, and/or linear lesions in PVI non-responders. Retrospective follow-up (FU) was based on routine outpatient clinic visits and regular telephone interviews. A total of 94 patients (54 male, age 78 ± 2 years, and left atrium diameter 46 ± 6 mm) with drug-refractory AF [55/94 (59%) paroxysmal AF (PAF), 29/94 (31%) persistent AF, and 10/94 (11%) long-standing persistent AF] underwent ablation. Follow-up was obtained in 93/94 (99%) patients. Following a single procedure, 35/93 (38%) patients were in stable sinus rhythm (SR; 46% PAF, 31% persistent AF, and 10% long-standing persistent AF) after a mean FU of 37 ± 20 months. After a mean of 1.5 ± 0.6 procedures, 55/93 (59%) patients were ultimately in stable SR (76% PAF, 41% persistent AF, and 20% long-standing persistent AF). In a total of 137 procedures, 8 major (5.8%) and 26 minor (19%) complications occurred., Conclusions: Catheter ablation in patients ≥75 years is associated with a favourable clinical long-term outcome in patients with PAF, while results are less promising in persistent or long-standing persistent patients. The safety profile of AF ablation in patients ≥75 years is comparable with patients of younger age., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Background: Pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB2) in patients with paroxysmal and persistent atrial fibrillation (AF) has demonstrated encouraging acute and mid-term results. Follow-up data on outcome beyond 1-year is lacking. The purpose of this analysis was to investigate the 2-year clinical outcome after CB2-based PVI., Methods: Sixty patients (age 62 ± 11 years) with paroxysmal [45/60 (75%) patients] or short-standing persistent AF [15/60 (25%) patients] underwent 28-mm CB2-based PVI. Freeze-cycle duration was 240 s. After successful PVI, a bonus freeze-cycle of the same duration was applied. Follow-up was based on outpatient clinic visits at 3, 6, 12, 18, and 24 months including 24 h Holter-ECGs and telephone interviews. Recurrence was defined as any symptomatic and/or documented atrial tachyarrhythmia (ATA) episode >30 s following a 3-month blanking period., Results: A total of 231 pulmonary veins (PV) were identified and 230/231 (99.6%) PVs were successfully isolated. Phrenic nerve palsy occurred in 2/60 (3.3%) patients. No other periprocedural complications occurred. Follow-up was available for 59/60 (98%) patients with a mean duration of 838 ± 67 days. A total of 43/59 (73%) patients remained in stable sinus rhythm. In 10/16 (63%) patients with ATA recurrence, a repeat procedure was performed using radiofrequency energy. The overall success rate after a maximum of two ablation procedures and a follow-up period of 838 ± 67 days was 88% (52/59) patients., Conclusions: Patients with paroxysmal or short-persistent AF undergoing PVI using the 28-mm CB2 demonstrated a 73% 2-year single-procedure clinical success rate.

Aims: Studies on the use of the second-generation 28 mm cryoballoon (CB) for the treatment of atrial fibrillation (AF) have reported superior 1-year clinical outcome. Customarily, a bonus freeze cycle is applied after pulmonary vein isolation (PVI). The purpose of the present study was to assess the 1-year clinical outcome following PVI foregoing a bonus freeze cycle., Methods and Results: Patients with drug-refractory paroxysmal AF (PAF) or persistent AF underwent PVI using the second-generation 28 mm CB. The freeze cycle duration was set at 240 s. No bonus freeze cycle was applied. Clinical follow-up (FU) included 12-lead ECGs and 24h-Holter ECGs at 3, 6, and 12 months. A total of 45 patients (age 60 ± 11 years, mean LA diameter 42.1 ± 8.6 mm, n = 38 [84%] PAF) underwent CB-based PVI. Of 177 pulmonary veins (PVs) identified, 176/177 (99%) PVs were successfully isolated. The mean number of CB applications was 1.2 ± 0.4, 1.5 ± 0.8, 1.4 ± 0.7, 1.1 ± 0.3 and 1.7 ± 1.2 for the right superior PVs, right inferior PVs, left superior PVs, left inferior PVs, and left common PVs, respectively. Mean procedure and fluoroscopy times were 113 ± 32 and 19 ± 7 min, respectively. Phrenic nerve palsy occurred in 1/45 (2%) patients. One of 45 (2%) patients was lost to FU. After a mean FU period of 392 ± 58 (267-522) days including a 3-month blanking period, 36 of 44 (82%) patients remained in stable sinus rhythm. Five out of eight patients with arrhythmia recurrence underwent a second procedure. Only those PVs isolated with a single freeze cycle (5/11 PVs, 45%) demonstrated PV reconduction. In contrast, no PV reconnection was found in PVs initially treated with multiple freeze cycles., Conclusions: A 'no-bonus'-freeze protocol for PVI using the second-generation 28 mm CB resulted in an 82% 1-year clinical success rate. A bonus freeze cycle following successful PVI may not be essential to superior clinical outcome., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)