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Ablation of atrial fibrillation in the context of obesity can be challenging. We sought to evaluate the role of cryoballoon pulmonary vein isolation (CB-PVI) in obese patients with symptomatic atrial fibrillation (AF).Patients with a BMI ≥ 25 kg/m600 patients were included (59% male; 66 ± 11 years old); 337, 149, and 114 were assigned to G1, G2, and G3, respectively. Acute procedural success was recorded in 99.7% of patients. Procedural and fluoroscopy time were comparable but the radiation dose was significantly higher in G3. Procedural complications were 3% in G1, 5.4% in G2, and 8.8% in G3 (p = .01). The overall freedom from AF after 1-year was 77%. G3 had a significantly worse 1-year success rate compared to G1 and G2 (G3: 66.5% vs. G1: 78.4%; p = .015 and vs. G2: 82.5%; p = .008) with reduced 1-year success in paroxysmal AF (G1: 84.0%; G2: 86.3%; and G3: 69.6%) but not in persistent AF (G1: 68.7%; G2: 77.4%; and G3: 62.1%). G3 showed similar success rates irrespective of AF form (PAF: 69.6% vs. persAF 62.1%; p = .501).Cryoballoon ablation in obese patients can be effective with an acceptable safety profile, 77% of patients were in stable SR at 1 year. Severe obese patients (BMI ≥ 35) showed reduced procedural safety and 1-year success rate. In association with life style modification, CB ablation may represent a strategy to enhance rhythm control in the context of obesity.

BACKGROUND: The cryoballoon represents the gold standard single-shot device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Single-shot pulsed field PVI ablation (nonthermal, cardiac tissue selective) has recently entered the arena. We sought to compare procedural data and long-term outcome of both techniques. METHODS: Consecutive AF patients who underwent pulsed field ablation (PFA) and cryoballoon-based PVI were enrolled. Cryoballoon PVI was performed using the second-generation 28-mm cryoballoon; PFA was performed using a 31/35-mm pentaspline catheter. Success was defined as no recurrence of atrial tachyarrhythmia after a 3-month blanking period. RESULTS: Four hundred patients were included (56.5% men; 60.8% paroxysmal AF; age, 70 [interquartile range, 59–77] years), 200 in each group (cryoballoon and PFA), and baseline characteristics did not differ. Acute PVI was achieved in 100% of PFA and in 98% (196/200) of cryoballoon patients ( P =0.123; 4 touch-up ablations). Median procedure time was significantly shorter in PFA (34.5 [29–40] minutes) versus cryoballoon (50 [45–60] minutes; P P =0.1), driven by a higher rate of phrenic nerve palsies using cryoballoon. The 1-year success rates in paroxysmal AF (cryoballoon, 83.1%; PFA, 80.3%; P =0.724) and persistent AF (cryoballoon, 71%; PFA, 66.8%; P =0.629) were similar for both techniques. CONCLUSIONS: PFA compared with cryoballoon PVI shows a similar procedural efficacy but is associated with shorter procedure time and no phrenic nerve palsies. Importantly, 12-month clinical success rates are favorable but not different between both groups.

Aims A novel irrigated radiofrequency (RF) balloon (RFB) for pulmonary vein (PV) isolation (PVI) was released in selected centres. We pooled the procedural data on efficacy and safety of RFB-PVI from two high volume German centres. Methods and results Consecutive patients with RFB procedures were enrolled. A 3D electroanatomical left atrial map guided the RFB navigation. Every RF delivery lasted 60 s, and duration was automatically reduced to 20 s for electrodes facing the posterior wall. Procedural data and post-procedural endoscopy data ( Conclusion The RFB showed a high efficacy allowing for fast PVI procedures, and 60% of PVs could be isolated at the first application. Most safety events were recorded during the learning phase. An oesophageal temperature monitoring is suggested: oesophageal lesions were detected in 8% of patients.

Catheter ablation is a widely used, effective and safe treatment for AF. Pulsed field ablation (PFA), as a novel energy source for cardiac ablation, has been shown to be tissue selective and is expected to decrease damage to non-cardiac tissue while providing high efficacy in pulmonary vein isolation. The FARAPULSE ablation system (Boston Scientific) follows the idea of single-shot ablation and is the first device approved for clinical use in Europe. Since its approval, multiple high-volume centres have performed increasing numbers of PFA procedures in patients with AF and have published their experiences. This review summarises the current clinical experience regarding the use of PFA for AF using the FARAPULSE system. It provides an overview of its efficacy and safety.

Background Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist and share an increased risk of thromboembolic events. CKD concomitantly contributes to several pathophysiological changes predisposing towards a pro-haemorrhagic state. Objective To evaluate the impact of kidney function on peri-procedural complications and clinical outcomes in AF patients undergoing left atrial appendage occlusion (LAAO) with a Watchman device. Methods 2124 consecutive AF patients undergoing Watchman implantation at 8 different centers were categorized into CKD stage 1+2 (n=1089), CKD stage 3 (n=796), CKD stage 4 (n=170), CKD stage 5 (n=69) based on the estimated glomerular filtration rate at baseline. The primary efficacy endpoint included a composite of cardiovascular (CV) mortality, stroke, transient ischemic attack, peripheral thromboembolism (TE), and major bleeding. Results A non-significant higher incidence of major peri-procedural adverse events (1.7% vs. 2.3% vs. 4.1% vs. 4.3%) was observed with worsening baseline kidney function (p=0.14). The mean follow-up period was 13 ± 7 months [2226 patient-years (PY)]. In comparison to CKD stage 1+2 as a reference, the incidence of the primary endpoint was significantly higher in CKD stage 3 (log-rank p-value= 0.04), CKD stage 4 (log-rank p-value= 0.01), and CKD stage 5 (log-rank p-value= 0.001). A non-significant increase in event rates for stroke/TIA and clinically relevant bleeding was observed among the four groups. LAAO led to a TE risk reduction of 72%, 66%, 62%, and 41% in each group. The relative risk reduction in the incidence of major bleeding was 58%, 44%, 51%, and 52%, respectively. Conclusion Patients with moderate-to-severe CKD had a higher incidence of the primary composite endpoint. The relative risk reduction in the incidence of TE and major bleeding was consistent across CKD groups, irrespective of the very different risk profiles at baseline.

Background The second- and third-generation endoscopic ablation systems (EAS2 and EAS3) have been launched in recent years. We aimed to assess the lesion durability as well as gap localization using the multigenerational novel technologies in patients with recurrent atrial fibrillation (AF). Methods Consecutive patients who underwent second ablation for recurrent AF following the initial pulmonary vein isolation (PVI) with EAS2 or EAS3 were retrospectively investigated. The persistent durability of PVI, gap localization at the second procedure, and procedural/anatomical features of durable PVI were analyzed. Results Among 225 patients treated with EAS3 (N = 125) and EAS2 (N = 100), 34 patients (EAS3: 13 patients, 50 PVs, EAS2: 21 patients, 82 PVs) underwent a second procedure because of recurrent AF mean 11.9 ± 9.3 months after the initial procedure. Persistent isolation of all four PVs was recorded in 6 (46.2%) patients in EAS3 group and 4 (19.1%) patients in EAS2 group (p = 0.130). Ninety-one out of 132 (68.9%) PVs were persistently isolated with a higher rate in EAS3 group (82.0% vs. EAS2 group: 61.0%, p = 0.0113). A total of 45 gaps were recorded in 41 PVs. Right superior PV (RSPV) was the predominantly common reconnected vein (15 gaps, 14 PVs) irrespective of generations (EAS3: 4 gaps in 3 PVs and EAS2: 12 gaps in 11 PVs). Logistic multivariate regression analysis revealed ablation without reduced energy dose (5.5–7 W) as an independent predictor of durable PVI [adjusted OR: 3.70, 95% CI (1.408–10.003)], p = 0.008]. Conclusion The technical innovation resulted in a higher lesion durability in EAS3-guided PVI in patients with recurrent AF. The most common gap location was found at RSPV in successor EASs. Ablation without reduced energy was a predictor of durable PVI in successor EASs.

Background Pulsed field ablation (PFA) is a new feasible and safe method for the ablative treatment of cardiac arrhythmias, such as atrial fibrillation (AF). Through the use of electric fields, it causes pore-like openings in the cell’s wall, leading to cell death. The most appealing characteristic of this new technique is its selectivity for cardiomyocytes and consequently its low risk of collateral damage to extracardiac tissues. We present three cases of a PFA-induced transient phrenic nerve (PN) injury documented during pulmonary vein isolation (PVI). Case summaries Three patients aged 55–81 years underwent PFA for symptomatic AF. Cases 1 and 3 were affected by paroxysmal AF without evidence of structural heart disease. Case 2 had persistent AF and ischaemic cardiomyopathy with preserved ejection fraction. We observed a transient right hemidiaphragm palsy during the delivery of impulses in the right superior pulmonary vein (Cases 1 and 2) and in the right inferior pulmonary vein (Case 3). The palsy lasted Discussion Transient PN dysfunction can be observed following PFA in AF ablation. According to our initial experience, a full recovery of the PN function can be expected within seconds. We hypothesize a hyperpolarization of neuronal cells or a depletion of acetylcholine in the motoric endplate to explain this event. Further studies are required to understand the exact pathophysiological mechanism.

AimsPulsed-field ablation (PFA) can offer a novel perspective for atrial fibrillation (AF) ablation. We aimed to characterize the incidence of pulmonary vein (PV) reconnection, types of recurrent atrial tachyarrhythmia (ATa) and lesion quality after PFA-guided PV isolation (PVI).Methods and resultsPatients undergoing second ablation for recurrent ATa following the initial PVI using the pentaspline PFA catheter were investigated. The rate of PV reconnection, the features of recurrent ATa, and the amount of isolated posterior wall (PW) surface area (ISAPW%) (ratio of the isolated- to total surface area on PW) were analyzed.ResultsAmong 360 patients treated with PFA, 25 patients (paroxysmal AF, n = 19) with 99 PVs underwent a second procedure 6.1 ± 4.0 months after the initial procedure. The rate of PV reconnection was 9.1% (9 PVs). Patients presented with atrial tachycardia (AT) (n = 16), AF (n = 8) and typical atrial flutter (n = 1). The mechanism of all but one AT was macro-reentry. The critical isthmus was found to be linked to the initial lesion set at the left atrial (LA) PW in eight patients and linked to pre-existing substrate at the LA anterior wall in four patients. One AT had a focal origin at the septum. In three patients, AT were unmappable. Mean ISAPW% was 72.7 ± 19.0%.ConclusionWe revealed a remarkable low reconnection rate with a large antral lesion at the PW after pentaspline PFA catheter-guided PVI. However, macro-reentrant AT with a critical isthmus at the LAPW linked to the PVI lesion set was commonly observed.

Background: Pulsed field ablation represents an energy source specific for ablation of cardiac arrhythmias including atrial fibrillation. The aim of the study was to describe the adoption and the process of streamlining procedures with a new ablation technology. Methods: All-comer atrial fibrillation patients (n=191; mean age 69±12 years) underwent catheter ablation with a pulsed field ablation ablation device exclusively using analog-sedation. In the validation phase (n=25), device electrogram quality was compared with a circular mapping catheter to assess pulmonary vein isolation and esophageal temperature monitoring was used. In the streamline phase (n=166), a single-catheter approach was implemented. Postprocedural cerebral magnetic resonance imaging was performed in 53 patients. In 52 patients, esophageal endoscopy was performed at day 1 after the procedure. Follow-up was performed using 72 hours Holter ECGs. Results: On a pulmonary vein basis, pulmonary vein isolation rate was 100% including a single shot isolation rate of 99.5%. The electrogram information of the pulsed field ablation catheter and the circular mapping catheter were 100% congruent. Neither esophageal temperature rises nor esophageal thermal injury were observed. Two minor strokes occurred, presumable due to air embolism during catheter exchanges through the large bore sheath (13.8 F ID). In the streamline phase, reduced procedure times (46±14 versus 38±13 minutes, P =0.004), no further strokes and a low incidence of silent cerebral injury (10/53 patients; 19%) were noted. During short-term follow-up, 17/191 patients (9%) had a atrial tachyarrhythmia recurrence. Conclusions: The pulsed field ablation device allows for simple and safe simple single shot pulmonary vein isolation using standard sedation protocols. Procedural speed and efficacy are remarkable and streamlining measures have added safety.

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.

We report a case of an incessant atrial tachycardia from the right atrial appendage that was effectively treated with pulsed field ablation after two failed radio frequency ablation attempts.

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

BACKGROUND The endoscopic ablation system (EAS) is an established ablation device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). The novel X3 EAS is now equipped with a contiguous circumferential ablation mode (RAPID mode). AIM To determine the feasibility of single-shot fashioned ablation using X3. METHODS Consecutive patients who underwent AF ablation using X3 were enrolled. We assessed the acute procedural data focusing on "Single-sweep PVI" defined as successful PVI with a single RAPID mode energy application, and on "first-pass isolation" defined as successful PVI after initial circular lesion set. RESULTS One hundred AF patients (56% male, age: 68 ± 10 years, 66% paroxysmal AF) were analyzed. A total of 379 of 383 PVs (99%) were isolated with X3. Single-sweep PVI and first-pass-isolation were achieved in 214 PVs (56%) and in 362 PVs (95%), respectively. Single-sweep PVI rates varied across PVs with higher rates at the superior PVs (61.2% vs. inferior PVs: 49.5%, p = .0239) and at PVs with maximal ostial diameter 24 mm: 36.8%, p = .0151). The mean total procedure and fluoroscopy times were 43.0 ± 10 and 4.0 ± 2 min, respectively. In none of the patients an acute thromboembolic event (stroke or transient ischemic attack) or a pericardial effusion/tamponade occurred. A single transient phrenic nerve palsy was observed. CONCLUSION The new X3 EAS allows for single-shot fashioned ablation in terms of single-sweep PVI in half or more of PVs. The new RAPID ablation mode leads to an improved rate of first-pass isolation associated with very short procedure times without compromising safety.

Funding Acknowledgements Type of funding sources: None. Background A novel irrigated RF balloon (RFB) for pulmonary vein isolation (PVI) was recently released in selected centers . It is a 28 mm open irrigated balloon with 10 unipolar electrodes on its surface to deploy a circular ostial lesion set around the PVs. An inner lumen spiral catheter allows for real time PVI visualization during the ablation. Methods Data from consecutive RFB procedures were collected and analysed. After a single transseptal puncture and selective PV angiograms a 3D map of the left atrium was acquired. Sequential PVI was performed using the RFB: each application lasted 60 seconds, the posterior electrodes were identified to stop the energy delivery after 20 seconds. Real time to isolation data were acquired. A 3D bipolar remap was finally performed to observe the level of isolation. A temperature probe was used to monitor the local esophageal temperature (LET) with a cut off of 39°C. Acute procedural data and complication were collected. Endoscopy was scheduled the day after procedure. Results Data from 10 consecutive RFB procedures were analyzed: 6/10 patients were male, 67 ± 9 years old, 8/10 with history of paroxysmal AF. A total of 36 PVs were targeted and isolated with the RFB, with a mean of 7,3 ± 4,0 applications per patient and 2,0 ± 1,2 applications per PV. First pass "single shot" isolation was achieved in 22/36 (61%), time to isolation during the first application was observed in 29/36 (80%) PVs, but an acute reconnection was observed in 10/29 (35%) isolated PVs. Mean time to sustained isolation was 13 ± 5 sec., mean time to non-sustained isolation was significantly longer (29 ± 17 sec; p = 0,001). Procedure time was 57 ± 16 min., left atrial dwell time 50 ± 14 min, ablation phase time 29 ± 14 min and fluoroscopy time was 10 ± 4 minutes. An esophageal temperature above 39°C was recorded in 2/36 PVs. No phrenic nerve palsy was recorded. 7/10 patients underwent endoscopy and no thermal lesions were detected. No other complications were recorded. Conclusion The novel irrigated RFB seems to allow an effective, safe and fast pulmonary vein isolation. More studies are needed to optimize energy dosing to possibly increase the rate of durable single shot PVI.

Background: Pulmonary vein isolation (PVI) represents the cornerstone in atrial fibrillation ablation. Cryoballoon and laserballoon catheters have emerged as promising devices but lack randomized comparisons. Therefore, we sought to compare efficacy and safety comparing both balloons in patients with persistent and paroxysmal atrial fibrillation (AF). Methods: Symptomatic AF patients (n=200) were prospectively randomized (1:1) to receive either cryoballoon or laserballoon PVI (cryoballoon: n=100: 50 paroxysmal atrial fibrillation + 50 persistent AF versus laserballoon: n=100: 50 paroxysmal atrial fibrillation + 50 persistent AF). All antiarrhythmic drugs were stopped after ablation. Follow-up included 3-day Holter-ECG recordings and office visits at 3, 6, and 12 months. Primary efficacy end point was defined as freedom from atrial tachyarrhythmia between 90 and 365 days after a single ablation. Secondary end points included procedural parameters and periprocedural complications. Results: Patient baseline parameters were not different between both groups. In all (n=200) complete PVI was obtained and the entire follow-up accomplished. Balloon only PVI was obtained in 98% (cryoballoon) versus 95% (laserballoon) requiring focal touch-up in 2 and 5 patients, respectively. Procedure but not fluoroscopy time was significantly shorter in the cryoballoon group (50.9±21.0 versus 96.0±20.4 minutes; P P =0.083). Overall, the primary end point of no atrial tachyarrhythmia recurrence was met in 79% (cryoballoon: 80.0% versus laserballoon: 78.0%, P =ns). No death, atrio-esophageal fistula, tamponade, or vascular laceration requiring surgery occurred. In the cryoballoon group, 8 transient but no persistent phrenic nerve palsy were noted compared with 2 persistent phrenic nerve palsy and one transient ischemic attack in the laserballoon group. Conclusions: Both balloon technologies represent highly effective and safe tools for PVI resulting in similar favorable rhythm outcome after 12 months. Use of the cryoballoon is associated with significantly shorter procedure but not fluoroscopy time.

Background The impact of body mass index (BMI) on atrial fibrillation (AF) ablation using cryoballoon (CB) has been seldom reported. Purpose To evaluate the impact of BMI on procedural data as well as the clinical efficacy and safety character of using CB. Methods Symptomatic AF patients (paroxysmal / persistent AF) with BMI ≥25 who underwent CB based pulmonary vein isolation (PVI) were enrolled. CB PVI was performed using the second generation CB (CB 2, 28mm), with 4min based freeze protocol and bonus freeze delivery in case of time-to-isolation (TTI) >75 sec. All procedures were performed under conscious sedation. Procedural endpoint was electrical pulmonary vein isolation. Clinical success was defined as no recurrence of AF/atrial tachycardia (AT). Results Data from 600 consecutive patients were collected. Three groups defined: BMI 25–29 (Group 1, G1 n=337); BMI 30–34 (Group 2, G2 n=149); BMI ≥35 (Group 3, G3 n=114). Patients in Group 3 were younger (G1: 67±11 y; G2: 68±10y G3 62±11y; p Among 2342 Targeted PVs, 2332 (99,6%) were isolated using solely the CB (G2: one procedure was abolished due to failed aortic puncture during transseptal access; G3: one PVI was not completed due to PNP; 6 touch up RF ablation in G1 and 2 in G3). Procedure time (G1:58,45 min; G2: 60,44 min; G3 63,19 min) and fluoroscopy time (G1: 9,3 min; G2: 9,5 G3: 10,6 min) were comparable among the groups. PN Injury was the main recorded complication: 20/600 (2,6%) patients with a transient PN palsy (PNP) and 6/600 (1%) with a persistent PNP. No sedation related complication was recorded. Follow up survival curve analysis after one year revealed a favorable follow up in G1 (78,4%) and G2 (82,5%) compared to G3 (66,5%) (G1 Vs G3 p: 0,002 G2 vs G3 p=0,008, G1 vs G2 p=0,47). The influence of BMI on the follow up was confirmed in the subgroup of patients with paroxysmal AF but not in patients presenting persistent AF. Conclusions Cryoballoon ablation in obese patients is feasible and associated with a relatively low complication rate. BMI plays a role in predicting recurrences especially in patients presenting with paroxysmal AF. Funding Acknowledgement Type of funding source: None

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

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 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