AIMS:Cryoballoon (CB) pulmonary vein isolation (PVI) is an accepted ablation strategy for rhythm control in atrial fibrillation (AF). We describe efficacy and safety in a high volume centre with a long experience in the use of the second-generation CB (CB2).METHODS AND RESULTS:Consecutive paroxysmal AF (PAF) or persistent AF (persAF) patients undergoing CB2-PVI were enrolled. Procedural data, efficacy, and safety issues were systematically collected. The 28 mm CB2 was used in combination with an inner lumen spiral catheter, a luminal oesophageal temperature (LET) probe was used with a cut-off of 15°C, the phrenic nerve (PN) monitored during septal PVs ablation. Freeze duration was mainly set at 240 s with a bonus application in case of delayed time-to-isolation (TTI > 75 s). A total of 1017 CB2 procedures were analysed (58% male, 66 ± 12 years old, 70% with PAF). 3964 PVs were identified, 99.8% PVs isolated using solely the 28 mm CB. Mean procedure time was 69 ± 25 min, TTI during the first application was recorded in 77% of PVs after a mean of 48 ± 31 s. We recorded 0.2% cardiac tamponade, 4.8% PN injury (1.6% of PN palsy), and 19% of LET < 15°C. Among 725 patients with follow-up data, 84% with PAF and 75% with persAF were in stable SR at 1 year. Shorter freezing duration and longer TTI were procedural predictors for recurrence.CONCLUSION:Cryoballoon procedures are fast and associated with a benign safety profile. Shorter TTI and longer freeze durations are associated with sinus rhythm during follow-up.

BACKGROUND:Time-to-isolation (TTI) guided second-generation cryoballoon (CB2) ablation has been shown to be effective for pulmonary vein isolation (PVI).OBJECTIVE:The objective of this paper is to compare the safety and clinical outcome of CB2 PVI using the TTI guided 4 minutes vs 3 minutes freeze protocol.METHODS:This was a propensity-matched study based on an institutional database. Symptomatic atrial fibrillation (AF) patients who underwent CB2 PVI and systematic follow-up were consecutively included.RESULTS:A total of 573 patients were identified, of them 214 (107 matched-pairs) symptomatic AF (paroxysmal AF: 61%, persistent AF: 39%) patients (age: 67.7 ± 11.2 years) were analyzed. The baseline characteristics were comparable between the two groups. Procedural time was significantly longer in the 4 minutes group compared to 3 minutes group (67.2 ± 21.8 vs 55.9 ± 16.9 minutes, P < .0001). During a mean follow-up of 2 years, the 4 minutes group was associated with a significantly higher rate of freedom from arrhythmia recurrence compared with the 3 minutes group (66.4% vs 56.1%, P = .009), which was mainly driven by patients with persistent AF. The multivariate regression showed that the 4 minutes freeze was the independent predictor of freedom from arrhythmia recurrence. During the repeat procedure, the 4 minutes group was associated with a significantly higher rate of durable PVI. There was no difference regarding procedural adverse events between the two groups.CONCLUSION:As compared with the 3 minutes freeze, the TTI guided 4 minutes freeze is associated with a significantly higher rate of arrhythmia-free and durable PVI without compromising the safety profile, patients with persistent AF may benefit from the TTI guided 4 minutes freeze more pronouncedly.

BACKGROUND:High-power, short-duration ablation for pulmonary vein isolation (PVI) in the treatment of atrial fibrillation (AF) facilitates the procedure and improve effectiveness; however, esophageal injury remains a safety concern. OBJECTIVE:The purpose of this study was to investigate the role of luminal esophageal temperature (LET) monitoring during high-power ablation for PVI in terms of endoscopic esophageal lesion. METHODS:Patients with symptomatic AF underwent ablation index-guided high-power (AI-HP) PVI (50 W; AI anterior wall/posterior wall: 550/400). In the first consecutive set of patients, an insulated esophageal temperature probe was used for LET monitoring (cutoff LET >39°C) (group A). In the second consecutive set of patients, the probe was not used (group B). All patients were scheduled to undergo esophageal endoscopy 1-3 days after ablation. RESULTS:A total of 120 patients (60 group A; 60 group B) were included in the study (mean age 67.8 years; 64% male). Baseline characteristics and procedural outcomes were similar between the 2 groups. Procedural PVI was achieved in all patients. First-pass PVI rate was 96.6%. Mean procedural radiofrequency (RF) time was 11.5 minutes, mean procedural time was 55.5 minutes, and fluoroscopic time was 5.6 minutes. Mean contact force at the LA posterior wall was 23 g, and mean RF ablation time at the LA posterior wall was 3.2 minutes. Two patients in group A and 1 patient in group B had endoscopic small esophageal lesions (P = .99). No serious procedural adverse events were observed. CONCLUSION:Among patients undergoing AI-HP (50 W) PVI, the incidences of ablation-related endoscopic esophageal lesion in patients with and those without use of a temperature probe for LET monitoring (cutoff 39°C) were comparably low.

OBJECTIVES This study sought to investigate the safety profile of a novel ablation index-guided high-power shortduration (AI-HP) pulmonary vein isolation (PVI) in terms of endoscopic esophageal lesions. BACKGROUND The risk of esophageal injury during PVI is a major concern white ablating the posterior watt for patients with atrial fibrillation. Luminal esophageal temperature (LET) rise during ablation is a surrogate for esophageal lesion development. METHODS A total of 122 consecutive symptomatic atrial fibrillation patients underwent AI-HP PVI (50 W throughout the ablation, AI anterior watt/posterior wall: 550/400). All patients were under LET monitoring (cutoff LET 39 degrees C) during the ablation procedure, and patients with LET rise received esophageal endoscopy examination 1 to 3 days after the ablation. Ablation lesion data of the sites with LET rise were analyzed. RESULTS Procedural PVI success rate was 100%. Per procedure, the mean radiofrequency ablation time, procedural time, and fluoroscopic time were 11.9 +/- 2.7 min, 54.8 +/- 9 min, and 5.5 +/- 1.6 min. The incidence of LET >39 degrees C was 47%, and the mean peak LET was 41.2 +/- 1.8 degrees C. The rate of endoscopic detected lesion was 2 of 57 (3.5%). No perforation or atrial-esophageal fistula was found. The mean contact force, application duration, impedance drop, and AI values at the sites with LET rise were 22.1 +/- 8.9 g, 7 +/- 2.4 s, 9.4 +/- 4.6 Omega, and 419 +/- 44.6. CONCLUSIONS Al-HP (50 W) ablation appears to be a highly efficient ablation technique for PVI. The incidence of esophageal injury during Al-HP PVI seems markedly low. AI-HP ablation targeting AI 400 in combination with multisensor esophageal temperature monitoring for the left atrial posterior wall appears safe and efficient. (C) 2020 by the American College of Cardiology Foundation.

BACKGROUND High-power, short-duration ablation for pulmonary vein isolation (PVI) in the treatment of atrial fibrillation (AF) facilitates the procedure and improve effectiveness; however, esophageal injury remains a safety concern. OBJECTIVE The purpose of this study was to investigate the role of luminal esophageal temperature (LET) monitoring during high-power ablation for PVI in terms of endoscopic esophageal lesion. METHODS Patients with symptomatic AF underwent ablation index-guided high-power (AI-HP) PVI (50 W; AI anterior wall/posterior wall: 550/400). In the first consecutive set of patients, an insulated esophageal temperature probe was used for LET monitoring (cutoff LET >39 degrees C) (group A). In the second consecutive set of patients, the probe was not used (group B). All patients were scheduled to undergo esophageal endoscopy 1-3 days after ablation. RESULTS A total of 120 patients (60 group A; 60 group B) were included in the study (mean age 67.8 years; 64% male). Baseline characteristics and procedural outcomes were similar between the 2 groups. Procedural PVI was achieved in all patients. First-pass PVI rate was 96.6%. Mean procedural radiofrequency (RF) time was 11.5 minutes, mean procedural time was 55.5 minutes, and fluoroscopic time was 5.6 minutes. Mean contact force at the LA posterior wall was 23 g, and mean RF ablation time at the LA posterior wall was 3.2 minutes. Two patients in group A and 1 patient in group B had endoscopic small esophageal lesions (P = .99). No serious procedural adverse events were observed. CONCLUSION Among patients undergoing AI-HP (50 W) PVI, the incidences of ablation-related endoscopic esophageal lesion in patients with and those without use of a temperature probe for LET monitoring (cutoff 39 degrees C) were comparably low.

Abstract Introduction Direct oral anticoagulation (DOAC) therapy represents the standard of care in patients with atrial fibrillation (AF) and increased stroke risk. In a real world setting withholding DOAC medication before elective AF ablation is considered to reduce procedural bleeding risks. The aim of this study was to determine the individual DOAC level prior to the ablation procedure, to identify predisposing factors affecting traceable DOAC levels and to screen for associated severe adverse events. Methods Between September 2016 and March 2019 blood samples were obtained from patients on DOAC before an elective AF ablation. Per institutional standard all patients have been instructed to pause DOAC medication prior ablation for one or two doses depending on the patient profile and type of medication. The time interval between ablation and last DOAC intake was calculated in hours. Patient characteristics, procedural data and in-hospital complications were noted from all patients. Results A total of 1000 patients (60% male, age: 68y, GFR 83.25: BMI: 28, CHADSVASC score 3) undergoing AF ablation were included. Two groups were defined. Group A (n=416, 41.6%): patients treated with “single pill” DOAC (Rivaroxaban (n=288, 28.8%) and Edoxaban (n=128, 12.8%)). Group B (n=584, 58.4%): patients treated with twice a day DOAC (Apixaban (n=505, 50.5%) and Dabigatran (n=79, 7.9%)). The only difference in patient characteristics was an increased prior bleeding history in group B. The DOAC pause was significantly longer in group A (mean 40h) compared to group B (mean 32h), p=0.026. In a total of 217 patients (21.7%) DOAC levels where traceable prior to AF ablation. Traceable DOAC levels were significantly more common in group B (n=144/584, 24.7%) compared to group A (n=73/416, 17.5%). Adverse events occurred in 5.7% of patients (0.4% stroke, 0.3% tamponade, 2.5% hematoma, 1.9% AV-fistel, 0.7% pseudoaneurysma). T-Test analysis showed no significant difference in the occurrence of adverse events between both groups. Conclusion Despite of interrupting DOACs before an elective AF ablation therapeutic substance levels can be detected in >20% of patients. The rate of adverse events was not different between “single pill” vs. twice a day DOAC intake. Funding Acknowledgement Type of funding source: None

We report on an interesting case of resuscitated sudden cardiac death (SDC) in a 51-year-old with hypertension and positive family history for SDC. The patient was resuscitated and an emergency angiogram ruled out coronary artery disease. Cardio-MRT ruled structural disease or infection. Holter and telemetry monitoring revealed premature ventricular complexes and transient ST-changes followed by anginaepisodes in correlation with the use of the nicotine-replacement-spray. The patient was urged to quit smoking and smoking-substitutes. Medical therapy with calcium-channelblocker and a long acting nitrate was administered. One-month follow up reported no arrhythmic or angina events. (C) 2020 Elsevier Inc. All rights reserved.

Background It remains unclear whether left atrial low-voltage area (LALVA) affects atrial tachyarrhythmia recurrence after laser balloon pulmonary vein isolation (PVI) for atrial fibrillation (AF). We prospectively evaluated the outcome of laser balloon PVI in patients with and without LALVA (<= 0.5 mV) together with surface/intracardiac electrophysiological criteria. Methods One hundred consecutive paroxysmal/persistent AF patients underwent laser balloon PVI. The relative extent of LALVA (extent of LALVA/left atrial surface area x 100 [%]: rLALVA), total p-wave duration in lead II (PWD), and time interval from the beginning of p-wave to the local activation in left atrial appendage (TTLAA) were assessed. Patients were divided into patients with LALVA (group A: 23 patients) and those without LALVA (group B: 77 patients). The primary endpoint was freedom from atrial tachyarrhythmia after the blanking periods. Results Complete PVI was achieved in 99/100 (99%) patients. PWD and TTLAA were longer in group A (both, P < 0.001). During 12 months' follow-up, survival free from atrial tachyarrhythmia recurrence was lower in group A (12/23 [52%] patients vs 67/77 [87%] patients, P < 0.001). Multivariate analysis identified rLALVA as the only independent predictor of atrial tachyarrhythmia recurrence. rLALVA correlated with PWD and TTLAA (r = 0.41, P < 0.001 and r = 0.60, P < 0.001, respectively). Receiver operating characteristic curve for rLALVA revealed PWD of 122 ms and TTLAA of 92 ms as the optimal cut-off value. Conclusion LALVA was associated with poorer outcome after laser balloon PVI. Patients may be identified by longer PWD and TTLAA.

Patients with a left atrial appendage thrombus (LAAT) despite oral anticoagulation (OAC) are at high risk of thromboembolism (TE) and a relevant proportion of LAAT do not resolve under continued OAC. Left atrial appendage closure (LAAC) in the presence of LAAT was anecdotally described as a therapeutic option to prevent TE in the patients.

Background The procedural data of pulmonary vein (PV) isolation (PVI) for patients with atrial fibrillation using the second-generation laser balloon (LB2), which became available recently, remains unclear and were evaluated. Methods Thirty consecutive patients (116 PVs) underwent PVI using LB2 (LB2 group) and were matched to 30 patients (116 PVs) treated with the first-generation laser balloon (LB1 group). The left atrial isolated surface area (ISA) (ratio of the total isolated antral surface area excluding PV to the total isolated antral surface area including the posterior wall) was also measured after LB2 PVI. Results PVI was achieved in 103/116 (89%) PVs and 108/116 (93%) PVs in the LB2 and LB1 groups, respectively, after the initial circular ablation (P = 0.360) and in 115/116 (99%) PVs and 116/116 (100%) PVs in the LB2 and LB1 groups, respectively, at the end of the procedure (P = 1.000). PV occlusion grade, categorized by the degree of PV occlusion, was significantly better in the LB2 group than in the LB1 group (P < 0.001). Zero rotational maneuver was applicable in 23/116 (20%) PVs and 8/116 (7%) in the LB2 and LB1 groups, respectively (P = 0.007). There was no significant difference in the procedural time, fluoroscopic time, or complications. The mean ISA after LB2 PVI was 53 +/- 14%. The application number was the only independent predictor of successful PVI after initial circular LB2 ablation (adjusted odds ratio 0.860; 95% confidence interval 0.764-0.968; P = 0.013). Conclusion LB2 displays favorable PV occlusion characteristics and enables more zero rotational maneuvers.

The left atrial appendage (LAA) has been identified as a potential source of atrial fibrillation (AF) and has been described as the “fifth” pulmonary vein (PV). We report our initial experience in LAA isolation (LAAI) using the cryoballoon (CB) and data on durability of CB‐LAAI.

BACKGROUND:Radiofrequency high-power ablation appears to be a novel concept for atrial fibrillation (AF). The ablation index (AI) value has been associated with durability of pulmonary vein isolation (PVI).OBJECTIVES:This study aimed to report the procedural data and initial results of a combined ablation technique using AI-guided high-power (AI-HP; 50 W) ablation for PVI.METHODS:Symptomatic AF patients were consecutively enrolled and underwent wide-area contiguous circumferential PVI. Contact-force catheters were used, ablation power was set to 50 W targeting AI values (550 anterior and 400 posterior). Esophageal temperature was monitored during procedure, all patients underwent postablation esophageal endoscopy.RESULTS:PVI was achieved in all (n = 50, mean age: 68 ± 9 years, female: 60%) patients, rate of first-round PVI was 92%. A total of N = 2105 AI-guided ablation lesions were analyzed. Comparing left anterior wall vs left posterior wall and right anterior wall vs right posterior wall, mean ablation time (s) per lesion was 20.5 ± 8 vs 8.6 ± 3 and 12.2 ± 4 vs 9.3 ± 3; mean contact force (g): 17.1 ± 12 vs 25.4 ± 14 and 33.7 ± 13 vs 21.0 ± 11; mean AI: 547 ± 48 vs 445 ± 55 and 555 ± 56 vs 440 ± 47 (all P < .0001). Procedure and fluoroscopy time (minute) were 55.6 ± 6.6 and 6 ± 1.7, respectively. Only one (2%) patient had a minimal esophageal lesion. During In-hospital and 1-month follow-up no major complications such as death, stroke, tamponade, or atriaesophageal fistula (AE) occurred. Preliminary 6-month follow-up showed 48 of 50 (96%) patients were free from clinical AF/atrial tachycardia recurrence.CONCLUSION:AI-HP (50 W) ablation appears to be a feasible, safe, fast, and effective ablation technique for PVI.

AIMS:Left atrial appendage electrical isolation (LAAI) may improve the rhythm outcome in selected patients with atrial fibrillation (AF). Controversy exists if LAAI is associated with an increased rate of thromboembolic complications. We sought to assess the feasibility, efficacy, and safety of interventional left atrial appendage closure (LAAC) in comparison to oral anticoagulation (OAC) after electrical LAAI.METHODS AND RESULTS:Weeks after index LAAI using the cryoballoon or a linear maze like ablation strategy patients' left atrial appendage was invasively remapped. In case of persistent LAAI, LAAC was performed. Patients who refused invasive remapping continued OAC. The primary endpoint was composed of any stroke or systemic embolism (SE) and the occurrence of intracardiac thrombus. Secondary endpoints included stroke/SE, major bleeding, and all-cause death. Of 166 patients (51% female; mean age 70 ± 8 years; mean CHAD2S2VASc score 3.4 ± 1.8) after LAAI, 94 patients received LAAC (LAAC group) and 72 continued OAC (no LAAC). After LAAC, 83% of patients received dual antiplatelet therapy for 6 weeks and aspirin thereafter. During a mean follow-up of 778 ± 630 days, 5 and 11 primary endpoint events were observed in the LAAC and no LAAC group, respectively [hazard ratio (HR) 0.27, 95% confidence interval (CI) 0.10-0.75; P = 0.010]. The calculated annual thromboembolic event rates were 6.9% (no LAAC) and 2.3% (LAAC), respectively. Left atrial appendage closure significantly reduced the incidence of stroke and SE (HR 0.31, CI 0.1-0.98; P = 0.04).CONCLUSION:After electrical LAAI for rhythm control in AF patients, interventional LAAC was associated with fewer thromboembolic complications when compared with OAC.

AIMS:We aimed to assess the feasibility, efficacy and safety of short-term dual antiplatelet therapy (DAPT) for six weeks after left atrial appendage closure (LAAC).METHODS AND RESULTS:Data of the Cardioangiologisches Centrum Bethanien-LAAC registry were analysed. DAPT (aspirin 100 mg plus clopidogrel 75 mg) was administered until transoesophageal echocardiography (TEE) evaluation six weeks after LAAC. In the absence of significant peri-device flow or device-related thrombus (DRT), the medication was decreased to single antiplatelet therapy (SAPT). Outpatient visits were timed at six-month intervals. The incidences of major bleeding (BARC ≥3) and of thromboembolic events were investigated. A total of 298 patients (76±8 years; 62% male; CHA2DS2-VASc 4.3±1.5; HAS-BLED 3.5±1.0; 61% with history of bleeding) with successful LAAC were included. TEE revealed DRT in 7/298 (2.3%) patients (five at six-week follow-up [FU] 45±10 days after implant, two during a median long-term FU of 731 days). Non-procedure-related bleeding events occurred in 25/298 (8.4%) patients and non-procedure-related thromboembolic events in 11/298 (3.7%) patients. This translated into 3.9 bleeding events/100 patient-years and 1.7 thromboembolic events/100 patient-years, respectively. Procedure-related events consisted of major bleeding in 7/298 (2.3%) patients and stroke in 2/298 (0.7%) patients. Age ≥75 years (OR 3.2; CI: 1.2-8.0; p=0.015) and renal impairment (OR 2.5; CI: 1.1-5.7; p=0.027) were identified as independent predictors for major bleeding after LAAC.CONCLUSIONS:Short-term DAPT for six weeks appears to be a viable alternative for patients after LAAC. Age ≥75 years and renal impairment increase major bleeding events threefold.

Background: The incidence of pulmonary vein stenosis (PVS) after AF ablation following contemporary procedures remains unclear. We compared the incidence of PVS/narrowing (PVS/N) after PV isolation (PVI) for (1) 3-D mapping-guided wide-area encircling irrigated radiofrequency current (RFC) ablation; (2) first-third-generation big cryoballoon (CB1-3) ablation; and (3) laser balloon (LB) ablation. Methods and Results: All patients undergoing a second procedure between January 2012 and November 2016 were subgrouped according to index ablation (PVI): RFC; CB; or LB. PVS/N was classified using PV diameter ratio (second/index procedure) on selective PV angiogram performed before ablation: mild, 25-49%; moderate, 50-74%; or severe, >= 75%. A total of 344 patients (1,362 PV) were analyzed (RFC, n=211; 840 PV; CB1, n=21; 82 PV; CB2,3, n=64; 250 PV; LB, n=48; 190 PV). In the LB group, 45 patients (94%) were treated with dose >= 8.5 W. Second procedures were performed on average 14.9 +/- 14.1 months after the index procedure. Mild PVS/N was observed in 18.4%, 9.5% and 3.6% of PV in the LB, RFC and CB groups, respectively (P<0.01). Moderate PVS was recognized in 2 PV (0.1%; RFC, LB). Severe PVS was never observed, and no PV intervention/surgery was required. Conclusions: The risk for significant PVS is low after RFC/CB. The incidence of mild PVS/N was highest after standard-dose LB ablation and lowest after high-dose CB ablation.

Wide circumferencial ablation Circular ablationEnergy for bilateral isolation(J) 12546.4361249.6516644

OBJECTIVES:The aim of this study was to identify predictors of cardiac tamponade (CT) during atrial fibrillation (AF) ablation using different technologies and strategies.BACKGROUND:The major cause of death during catheter ablation of AF is related to CT. The risk for CT may be linked to different procedural steps (transseptal puncture, catheter manipulation during left atrial and pulmonary vein mapping and ablation).METHODS:All AF ablation procedures undertaken from May 2010 to July 2015 at a single center were included. Two ablation groups were defined: group A, radiofrequency current, and group B, balloon. Group A was divided into groups A1 (pulmonary vein isolation [PVI] only) and A2 (PVI plus additional ablation). In group A, 2 transseptal punctures were performed, followed by wide-area circumferential point-by-point PVI (group A1) within a 3-dimensional left atrial map and complex fractionated atrial electrograms and/or linear lesions (group A2). In group B, 1 transseptal puncture by balloon-based PVI (cryoballoon, laser balloon). All episodes of CT were analyzed.RESULTS:In total, 3,000 AF ablation procedures were performed, 2,125 in group A (group A1, n = 1,559; group A2, n = 566) and 875 in group B (cryoballoon, n = 589; laser balloon, n = 286). The rate of CT was 1.1% (32 of 3,000) and was significantly lower in group B than in group A: 0.1% (1 of 875) versus 1.5% (31 of 2,125) (p = 0.001). The reduced CT risk remained if PVI only (group B vs. group A1) was compared: 0.8% (13 of 1,559) versus 0.1% (1 of 875) (p = 0.024). The greatest CT risk was seen in group A2: 3.2% (18 of 566). Radiofrequency current ablation beyond PVI was a predictor of CT.CONCLUSIONS:The risk for CT in patients undergoing AF ablation at a single high-volume center was decreased with the use of balloon catheters. Extensive radiofrequency current ablation beyond PVI leads to an increased perforation risk.