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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.

Visually guided laser balloon (LB) catheter has been an established modality dedicated for pulmonary vein (PV) isolation in patients with atrial fibrillation. The newly updated version of this novel device has technically evolved recent years.This review will summarize the contemporary technical evolution of LB catheter. Available efficacy outcomes and the historical change of ablation style will be evaluated. Furthermore, the future perspectives for clinical practice are discussed.The initial LB ablation system provided comparable clinical results in PV isolation with other technologies, but with a unique strategical concept enabling the direct visualization of the tissue to cauterize. With multigenerational development, the LB catheter has been equipped with more compliant balloon for favorable PV occlusion and a robotically motor driven continuous ablation mode (RAPID mode). These technical innovations changed the concept of the ablation strategy using LB catheter as 'point-by-point' into 'single-shot' fashion. The remaining tasks are further improvements such as equipping with real-time recording system of intracardiac electrogram, durable structured balloon and the instrument for visualizing the cauterization area in a 360-degree panoramic view, which includes potential possibilities to develop this novel device to the more optimal device for PV isolation.

BACKGROUND: Major bleeding (MB) events are independent predictors of mortality after cardiac interventional procedures. The clinical relevance of MB following left atrial appendage occlusion (LAAO) remains unclear.AIMS: This study aimed to investigate the incidence and clinical impact of MB after LAAO in a real-world population at high risk for bleeding and contraindicated to anticoagulation.METHODS: The two-year results of the Amplatzer Amulet Observational Post-Market Study were analysed. An independent committee adjudicated MBs according to the Bleeding Academic Research Consortium scale. Cox proportional hazards regression identified variables associated with MB events and mortality.RESULTS: The MB rate was 7.2%/year, with a rate of 10.1%/year during year one, decreasing to 4.0%/year over year two. The most common bleeding location was gastrointestinal, accounting for 48% of MBs. Pre-LAAO MB was associated with an increased risk for post-LAAO MB (HR 2.34, 95% CI: 1.37-3.99). The occurrence of post-LAAO MB was associated with increased mortality (37.3% vs 12.7%; pCONCLUSIONS: In real-world patients at high bleeding risk, MB following LAAO was not uncommon and associated with a significant increase in mortality, without increasing the risk of stroke. ClinicalTrials.gov Identifier: NCT02447081. https://clinicaltrials.gov/ct2/show/NCT02447081.

ZUSAMMENFASSUNGBedauerlicherweise existieren bisher keine randomisierten Studiendaten hinsichtlich des Stellenwerts eines Vorhofohrverschlusssystems (LAAC: „left atrial appendage closure“) im Vergleich zu oralen Antikoagulanzien (OAK) bei CKD-Patienten (CKD: „chronic kidney disease“). Eine derartige Studie (WATCH AFIB in CKD) wurde wegen geringer Rekrutierungszahlen eingestellt. Aus den im Beitrag angesprochenen Beobachtungsstudien kann allerdings eine gute Sicherheit und Effektivität der Therapie abgeleitet werden. In Anbetracht der unzureichenden Evidenz sollte bei VHF Patienten (VHF: Vorhofflimmern) mit CKD bis zu einer glomerulären Filtrationsrate (GFR) von 30 ml/min/1,73 m2 primär eine NOAK-Therapie (NOAK: neue OAK) verordnet werden. Im Falle von Blutungen kann dann gemäß Leitlinienempfehlung eine LAAC alternativ angeboten werden. Im Falle von Patienten mit dialysepflichtiger CKD muss eine individuelle Entscheidung getroffen werden, ob und wie eine Thromboembolieprophylaxe durchgeführt werden soll.

Aims Catheter ablation (CA) is recommended for patients with atrial fibrillation (AF) after failure of antiarrhythmic drugs (AADs). The role of CA as ‘initial therapy’ for AF is to be determined. Methods and results Following PRISMA guideline an up-to-date pooled analysis of randomized data comparing ablation vs. AADs as first-line therapy for symptomatic AF was performed. The primary outcome was recurrence of atrial tachyarrhythmia. The secondary outcomes were improvement in quality-of-life (QoL) and major adverse events. A total of 997 patients from five randomized trials were enrolled (mean age 57.4 years, 68.6% male patients, 98% paroxysmal AF, mean follow-up 1.4 years). The baseline characteristics were similar between the ablation and AADs group. Overall pooled analysis showed that, as compared with AADs, CA as first-line therapy was associated with significantly higher freedom from arrhythmia recurrence (69% vs. 48%, odds ratio: 0.36, 95% confidence interval: 0.27–0.48, P Conclusions Catheter ablation as ‘initial therapy’ was superior to AADs in maintenance of sinus rhythm and improving QoL for patients with symptomatic paroxysmal AF, without increasing risk of serious adverse events.

Aims Anticoagulation for atrial fibrillation patients with liver disease represents a clinical dilemma. We sought to evaluate the efficacy/safety of different anticoagulation, i.e. vitamin K antagonist (VKA) and non-VKA oral anticoagulants (NOACs) in such patient group. Methods and results This was a pooled-analysis enrolling up-to-date clinical data. Two subsets: subset A (VKA vs. Non-Anticoagulation) and subset B (NOACs vs. VKA) were pre-specified. The study outcomes were ischaemic stroke (IS)/thromboembolism (TE), major bleeding (MB), intracranial bleeding (ICB), gastrointestinal bleeding (GIB), and all-cause mortality. A total of 20 042 patients’ data were analysed (subset A: N = 10 275, subset B: N = 9767). Overall mean age: 71 ± 11 years, mean CHA2DS2-VASc score: 4.0 ± 1.8, mean HAS-BLED score: 3.6 ± 1.2. The majority of the patients had Child-Pugh category (A-B). As compared with Non-Anticoagulation, VKA seemed to reduce the risk of IS/TE [odds ratio (OR): 0.60, P = 0.05], but heighten the risk of all-bleeding events including MB (OR: 2.81, P = 0.01), ICB (OR: 1.60, P = 0.01), and GIB (OR: 3.32, P = 0.01). When compared with VKA, NOACs had similar efficacy in reducing the risk of IS/TE (OR: 0.82, P = 0.64), significantly lower risk of MB (OR: 0.54, P = 0.0003) and ICB (OR: 0.35, P Conclusions VKA appears to reduce the risk of IS/TE but increase all-bleeding events. NOACs have similar effect in reducing the risk of IS/TE and have significantly lower risk of MB and ICB as compared with VKA. NOACs seem to be associated with better clinical outcome than VKA in patients with mild–moderate liver disease.

Die Katheterablation ventrikularer Tachykardien (VT) stellt fur viele Patienten mit und ohne strukturelle Herzerkrankung eine effektive Therapieoption dar. Bei Patienten ohne strukturelle Herzerkrankung (idiopathische VT oder ventrikulare Extrasystolen [VES]) erfolgt die Indikationsstellung ublicherweise symptombezogen. Die Ablation asymptomatischer VES erscheint nur zur Wiederherstellung einer eingeschrankten Ventrikelfunktion gerechtfertigt. Bisher konnte keine Studie einen Mortalitatsvorteil durch die VT-Ablation demonstrieren, allerdings zeigt sich je nach zugrunde liegender kardialer Pathologie in unterschiedlichem Ausmas eine Reduktion von VT-Rezidiven. Die Indikation zur Ablation von VT bei ischamischer Kardiomyopathie basiert auf mehreren randomisierten Studien, wohingegen die Indikationsempfehlungen zur Ablation bei nichtischamischer VT auf Daten aus Expertenzentren basieren. Eine Klasse-I-Empfehlung zur Katheterablation gibt es unabhangig von der kardialen Pathologie fur Patienten mit rezidivierenden VTs trotz chronischer antiarrhythmischer Therapie sowie im elektrischen Sturm. Bei Patienten mit nichtischamischer Kardiomyopathie ist haufig ein epikardiales Vorgehen notwendig. In diesen Fallen konnen das VT-EKG und die prainterventionelle Bildgebung hilfreich sein. Das intraprozedurale Vorgehen zur Ablation von VTs bei struktureller Herzerkrankung kann auf einer Identifikation von VT-Kanalen mittels prainterventioneller Bildgebung sowie intraprozeduralem Mapping mit einem elektroanatomischen Mappingsystem basieren, zunehmend wird ein High-Density-Mapping angewendet. Entscheidend erscheint die notwendig hohe Expertise der Untersucher und des durchfuhrenden Teams zur Versorgung von Patienten mit VTs. Das Einbinden eines multidisziplinaren Teams in der Betreuung von VT-Patienten erscheint insbesondere auch zur optimierten Therapie der Grunderkrankung sinnvoll. Fur die Versorgungsstruktur in Deutschland ist die Einbindung einer rhythmologischen Expertise fur die differenzierte Versorgung von Patienten mit VTs notwendig. Die epikardiale Ablation von VTs sollte sinnvollerweise in Zentren mit einer dokumentierten Erfahrung von mindestens 75 Ablationen ventrikularer Arrhythmien sowie allen Voraussetzungen fur ein effektives und sicheres Management dieser komplex kranken Patienten erfolgen.

We present a case of ventricular fibrillation triggered by a premature ventricular complex. During ablation from the left coronary cusp, the ablation catheter dislodged inside left main coronary artery, thus resulting in cardiac arrest. We immediately performed angioplasty and stent implantation, and the procedure was accomplished with a guiding catheter left inside the vessel. (Level of Difficulty: Intermediate.), Graphical abstract

OBJECTIVES: This study sought to report early experience with the new-generation Watchman FLX device (Boston Scientific, Marlborough, Massachusetts).BACKGROUND: The new-generation Watchman FLX features a reduced height, improved anchoring and fabric coverage, and a closed distal end. These design modifications aim to simplify implantation, allow full recapture and repositioning, and reduce peridevice leak and device-related thrombosis.METHODS: A total of 165 patients undergoing left atrial appendage (LAA) occlusion (LAAO) with Watchman FLX were enrolled in a prospective, multicenter registry at 12 centers participating in the European limited market release program.RESULTS: Mean age was 75.4 ± 8.9 years, and CHA2DS2-VASc score 4.4 ± 1.4. A total of 128 patients (77.6%) had a history of major bleeding, including previous intracranial hemorrhage in 55 cases (33.3%). LAA landing zone minimal and maximal mean diameters were 19.1 ± 3.6 mm and 22.3 ± 3.7 mm, and 24.2% of LAA were considered complex by dimensions. Technical success was achieved in all patients. Successful implantation at first attempt was achieved in 129 cases (78.2%), and a second device was required in 6 cases (3.6%). Procedure-related complications occurred in 3 patients (1.8%): 2 access-related (1.2%) and 1 pericardial effusion (0.6%). No peri-procedural strokes, deaths, or device embolizations occurred. Forty-nine patients (29.7%) were discharged with single antiplatelet therapy, 105 (63.6%) on dual antiplatelet, and 11 (6.7%) on anticoagulation. Imaging follow-up displayed just 1 peridevice leak ≥5 mm and 7 cases of device-related thrombosis (4.7%). During a median follow-up of 55 days (interquartile range: 45 to 148 days), there were 6 hemorrhagic complications (4.8%), 1 patient (0.8%) had an ischemic stroke, and 1 (0.8%) died. No late device embolizations occurred.CONCLUSIONS: LAAO with the Watchman FLX is safe and effective in a wide range of LAA morphologies, with a low procedural complication rate, high degree of LAA sealing, and favorable short-term efficacy.

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.

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 short-duration (AI-HP) pulmonary vein isolation (PVI) in terms of endoscopic esop...

Die Rhythmologie hat sich zu einer breiten, spannenden und herausfordernden Subdisziplin der modernen Kardiologie entwickelt. Die beruflichen Moglichkeiten, die sich als Rhythmologin oder Rhythmologe auftun, sind vielfaltig und bieten verschiedenste Karriereziele. Der vorliegende Artikel soll jungen Kardiologinnen und Kardiologen zeigen, wie die unterschiedlichen Endstrecken aussehen konnen, wenn sie sich heute fur die Rhythmologie entscheiden. Anhand personlicher Berichte zum eigenen Karriereweg von funf erfahrenen Rhythmologinnen und Rhythmologen soll exemplarisch gezeigt werden, welche Entscheidungen, Unterstutzungen und Hurden und es auf diesen Wegen von der Niederlassung bis zur Universitatsprofessur gab. Dieser Artikel soll jungen Kardiologinnen und Kardiologen, die den Weg in die Rhythmologie ins Auge fassen, Hilfestellungen bei der Planung ihrer Karriere bieten.

Maze‐like linear substrate modification in atrial fibrillation patients nonresponders to pulmonary vein isolation represents a feasible technique to gain left atrial appendage electrical isolation even in the presence of a Watchman occluder device.

Background The potentiator ivacaftor (VX-770) has been approved for therapy of 38 cystic fibrosis (CF) mutations (∼10% of the patient population) associated with a gating defect of the CF transmembrane conductance regulator (CFTR). Despite the success of VX-770 treatment of patients carrying at least one allele of the most common gating mutation G551D-CFTR, some lung function decline and P. aeruginosa colonization persist. This study aims at identifying potentiator combinations that can considerably enhance the limited channel activity of a panel of CFTR gating mutants over monotherapy. Methods The functional response of 13 CFTR mutants to single potentiators or systematic potentiator combinations was determined in the human bronchial epithelial cell line CFBE41o- and a subset of them was confirmed in primary human nasal epithelia (HNE). Results In six out of thirteen CFTR missense mutants the fractional plasma membrane (PM) activity, a surrogate measure of CFTR channel gating, reached only ∼10–50% of WT channel activity upon VX-770 treatment, indicating incomplete gating correction. Combinatorial potentiator profiling and cluster analysis of mutant responses to 24 diverse investigational potentiators identified several compound pairs that improved the gating activity of R352Q-, S549R-, S549N-, G551D-, and G1244E-CFTR to ∼70–120% of the WT. Similarly, the potentiator combinations were able to confer WT-like function to G551D-CFTR in patient-derived human nasal epithelia. Conclusion This study suggests that half of CF patients with missense mutations approved for VX-770 administration, could benefit from the development of dual potentiator therapy.

Please verify if "pigtail guided" should be "pigtail catheter-guided": Recent design changes for left atrial appendage (LAA) closure devices have led to significant improvement by facilitating the procedural workflow (no need for pigtail guided LAA intubation), moving the workspace from distal LAA to the landing zone (closed distal end design), and improving device stability (different anchor design). The availability of different device types (plug vs disc-lobe design) offers an option to tailor a device type to a patient's anatomy; thereby, sealing results have improved substantially. The issue of device-related thrombus has not been resolved and deserves future research, with the goal of eliminating postprocedural antithrombotic medication without increasing risk for stroke.

Type-2 diabetes mellitus (DM) is associated with an increased risk of atrial fibrillation (AF). It is unclear whether DM is a risk factor for arrhythmia recurrence following catheter ablation of AF. We performed a nonrandomised, observational study in 7 high-volume European centres. A total of 2,504 patients who underwent catheter ablation of AF were included, and procedural outcomes were compared among patients with or without DM. Patients with DM (234) accounted for 9.3% of the sample, and were significantly older, had a higher BMI and suffered more frequently from persistent AF. Arrhythmia relapses at 12 months after AF ablation occurred more frequently in the DM group (32.0% vs 25.3%, p = 0.031). After adjusting for type of AF (i.e., paroxysmal vs persistent), during a median follow-up of 17 ± 16 months, atrial arrhythmia free-survival was lower in the diabetics with persistent AF (log-rank p = 0.003), and comparable for paroxysmal AF (log-rank p = 0.554). These results were confirmed in a propensity-matched analysis, and DM was also an independent predictor of AF recurrence on the multivariate analysis (hazard ratio 1.39; 95% confidence interval 95%1.07 to 1.88; p = 0.016). There was no significant difference in the rate of periprocedural complications among DM and non-DM patients (3.8% vs 6.3%, p = 0.128). Efficacy and safety of cryoballoon ablation were comparable to radiofrequency ablation in both DM and no-DM groups. In conclusion, catheter ablation of AF appears to be safe in patients with DM. However, DM is associated with higher rate of atrial arrhythmia relapse, particularly for patients with persistent AF.

Resumen Introduccion y objetivos Los pacientes ancianos con fibrilacion auricular estan en mayor riesgo de eventos cardioembolicos y hemorragia mayor que los mas jovenes. El cierre de la orejuela izquierda (COI) podria ser una opcion atractiva para estos pacientes, pero hay pocos datos sobre los resultados del COI de pacientes de 85 o mas anos. El objetivo del presente estudio es evaluar la seguridad y la eficacia del COI de pacientes de 85 o mas anos. Metodos Se analizo a 1.025 pacientes incluidos en el registro EWOLUTION que se habian sometido al COI, se identifico a 84 de edad ≥ 85 anos y se los comparo con el grupo de menos edad. Resultados Los pacientes de 85 o mas anos tenian mayores riesgos estimados de accidente cerebrovascular y de hemorragias que los pacientes mas jovenes (edad ≥ 85 frente a Conclusiones El COI de los pacientes de edad ≥ 85 anos es seguro y eficaz a pesar del alto riesgo de eventos embolicos y hemorragicos de estos pacientes. El COI puede ser una alternativa razonable a la anticoagulacion oral para estos pacientes.

Background The new second- and third-generation endoscopic ablation systems (EAS 2 and EAS 3) have been launched in recent years. We aimed to assess the index lesion durability as well as gap localization using the multigenerational novel technologies in patients with recurrent atrial fibrillation (AF). Methods Consecutive patients who underwent the second ablation for recurrent AF following the initial pulmonary vein isolation (PVI) with EAS 2 or EAS 3 were investigated. The persistent durability of PVI and gap localization at the second procedure were analyzed using spiral mapping catheter and three-dimensional mapping system. Results A total of 34 patients (EAS3: N=13, 50 PVs, EAS2: N=21, 82 PVs) were enrolled. Repeat procedure was performed mean 11.9±9.3 months after the initial procedure. Persistent durable isolation of all four PVs was recorded in 6 (46.2%) patients in EAS3 and 4 (19.1%) patients in EAS2 (P=0.130). Ninety-one out of 132 (68.9%) PVs were persistently isolated with a higher rate in EAS3 (EAS3: 82.0% vs. EAS2: 61.0%, P=0.0113). A total of 45 gaps were recorded in 41 PVs, of which right superior PV (RSPV) was the predominantly common reconnected vein (15 gaps in 14 PVs) irrespective of generation difference (EAS 3: 4 gaps in 3 PVs and EAS 2: 12 gaps in 11 PVs). Anterior-segment of RSPV was the most common gap distribution (EAS 3: 2 gaps and EAS 2: 6 gaps). Logistic multivariate regression analysis revealed high-dose (≥8.5W) only ablation as an independent predictor of durable PVI (adjusted OR: 3.70, 95% CI [1.408 - 10.003], P=0.008) Conclusion The multigenerational technical innovation resulted in a higher index lesion durability in EAS3 guided PVI in patients with recurrent AF. The specific gap patterns frequent at RSPV, especially at the anterior-superior segment, and the feasibility of high-dose ablation were confirmed in successor EASs. Funding Acknowledgement Type of funding sources: None.

Background The high cooling power and ultra-low temperature cryoablation (ULTC) catheter called “Adagio” has been recently launched. A combination of a newly exploited cryogen and interchangeable stylet enables flexible and continuous lesion creation applicable not only for atrial fibrillation (AF) but also for other tachyarrhythmia by optimizing catheter shape. The exclusive esophageal warming balloon in order to preserve esophageal temperature is encouraged to prevent the potential risk of esophageal complication during procedure. Aim To assess the initial clinical data on pulmonary vein (PV) isolation for patients with AF using the novel ULTC catheter. Methods Consecutive patients who underwent AF ablation using ULTC in our center were enrolled. We assessed the acute procedural data focusing on procedural feasibility and safety comprising “first-pass isolation” defined as successful PV isolation after the initial application. Results A total of 16 AF patients (53% male, age 67 years, 59% paroxysmal AF) were analyzed. Sixty-six out of 67 PVs (98.5%) were isolated with ULTC. The mean number of applications per PV was 2.3 1.1. Touch-up catheter was needed in one case at left inferior PV. The mean total procedure and fluoroscopy times were 79±30 and 14±7 mins, respectively. First-pass isolation was achieved in 34 PVs (50.7%) varying across PVs from left superior PV (43.8%) to right superior PV (58.8%). In none of the patients an acute thromboembolic event (stroke or transient ischemic attack), a pericardial effusion/tamponade and postprocedural esophageal complication occurred. A single transient phrenic nerve weakening was observed at right superior PV. Conclusion Sequential PV isolation using the novel ULTC catheter was achieved feasibly without compromising safety. First-pass isolation was accomplished about in a half of PVs. Funding Acknowledgement Type of funding sources: None.

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.

Background: Percutaneous LAAO represents an alternative for stroke prevention in patients not tolerating anticoagulation. While women are at higher risk of complications during percutaneous coronary or valvular interventions, the impact of gender on LAAO outcomes is not well characterized. The current study assessed potential gender-related differences in procedural and long-term outcomes following left atrial appendage occlusion (LAAO). Methods: 1088 AF patients were enrolled in the prospective, multicenter, Amplatzer™ Amulet™ Observational Study and followed for 2 years with scheduled adverse event assessments. The prespecified primary outcome was ischemic stroke, systemic embolism or cardiovascular (CV) death at 2 years. We also compared the rate of procedural success, device-related thrombus (DRT) and major bleeding between genders. Results: 702 men and 386 women underwent LAAO. Implant successwas high, and similar between men and women (98.9 vs 99.5%, p = 0.58). Similarly, no difference was observed in the primary outcome (12.0 vs 12.5%, p = 0.82). Compared to the CHA2DS2-VASc predicted rate, we observed a numerically greater absolute risk reduction of ischemic stroke in women (from 7.6 to 2.1%/year) than men (from 6.2 to 2.2%/year). DRT through 2 years was similar between groups (1.6%, p = 0.96). We found no significant gender difference in terms of periprocedural or long-term (7.1 vs 7.6%/year) major bleeding. Conclusions: In this large group of patients undergoing LAAO using the Amplatzer™ Amulet™ device we found no significant gender difference in terms of procedural or long-term clinical outcomes. Similarly to oral anticoagulation, device-based LAA occlusion renders AF-related stroke risk similar in women and men. Clinical trial registration: Clinicaltrials.gov Identifier: NCT02447081. https://clinicaltrials.gov/ct2/show/NCT02447081.

Background Cryoballoon ablation is an established procedure for atrial fibrillation (AF). Patients who had previous pulmonary surgery undergoing pulmonary vein isolation (PVI) were seldom reported. Case presentation We describe an AF ablation using the novel short-tip third-generation cryoballoon in a patient with resected pulmonary vein. All pulmonary veins were successfully isolated without complication. The short-tip third-generation cryoballoon shows advantageous profile in PVI for AF patients with previous pulmonary surgery. Conclusions This report indicates that for AF patient who had previous resected PV surgery, the short-tip CB 3 provides an ideal device option for real-time PVI.

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

Aims The optimal treatment for patients with atrial fibrillation (AF) and heart failure (HF) has been a subject of debate for years. We aimed to evaluate the efficacy and safety of rhythm control strategy in patients with AF complicated with HF regarding hard clinical endpoints. Methods and results Up-to-date randomized data comparing rhythm control using antiarrhythmic drugs (AADs) vs. rate control (Subset A) or rhythm control using catheter ablation vs. medical therapy (Subset B) in AF and HF patients were pooled. The primary outcomes were all-cause mortality, re-hospitalization, stroke, and thromboembolic events. A total of 11 studies involving 3598 patients were enrolled (Subset A: 2486; Subset B: 1112). As compared with medical rate control, the AADs rhythm control was associated with similar all-cause mortality [odds ratio (OR): 0.96, P = 0.65], significantly higher rate of re-hospitalization (OR: 1.25, P = 0.01), and similar rate of stroke and thromboembolic events (OR: 0.91, P = 0.76,); however, as compared with medical therapy, catheter ablation rhythm control was associated with significantly lower all-cause mortality (OR: 0.51, P = 0.0003), reduced re-hospitalization rate (OR: 0.44, P = 0.003), similar rate of stroke events (OR: 0.59, P = 0.27), greater improvement in left ventricular ejection fraction [weighted mean difference (WMD): 6.8%, P = 0.0004], lower arrhythmia recurrence (29.6% vs. 80.1%, OR: 0.04, P Conclusion Catheter ablation as rhythm control strategy substantially improves survival rate, reduces re-hospitalization, increases the maintenance rate of sinus rhythm, contributes to preserve cardiac function, and improves quality of life for AF patients complicated with HF.

INTRODUCTION: Catheter ablation of atrial fibrillation (AF) has been recently shown to have an impact on the outcome of patients with heart failure and reduced LV ejection fraction (LVEF). We aimed to assess patients with reduced LVEF referred to catheter ablation of AF, and the efficacy and safety of this procedure compared with healthier patients. METHODS: 2083 consecutive procedures of catheter ablation of AF in six centers were divided into two groups on the basis of LVEF (≤ vs >35%) and comparisons were performed regarding procedural safety and efficacy. RESULTS: Only 51 (2.4%) of patients had low LVEF. Complication rate was comparable: 8.0% vs 6.9% (P = .760). Low LVEF patients are more frequently in persistent AF at the time of the procedure, have a higher degree of left atrial dilation, and higher CHA2 DS2 VASc score. The rate of atrial arrhythmia relapse post-blanking period in the first 12 months was higher in the low LVEF group: 58.0% vs 37.6% (P

AimsLeft 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 resultsWeeks 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).ConclusionAfter electrical LAAI for rhythm control in AF patients, interventional LAAC was associated with fewer thromboembolic complications when compared with OAC.

OBJECTIVES: This study sought to report the incidence, characteristics, and clinical impact of device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the AMPLATZER Amulet device (Abbott, Plymouth, Minnesota).BACKGROUND: DRT is a potential serious complication of LAAO, but the incidence and clinical impact of DRTs in a real-world setting are not well characterized.METHODS: A total of 1,088 patients were enrolled in a multicenter prospective study and followed for 1 year. All events were adjudicated by an independent committee, including the presence of DRT. Patients with DRT were reviewed for suboptimal device implantation and characterization of DRT formation. Multiple Cox regression was performed to identify predictors of DRT formation.RESULTS: Device implantation was successful in 1,078 (99%) patients, with 1-year follow-up completed in 96.3% of patients. A total of 18 DRTs occurred in 17 patients (1.7%/year), as a second DRT developed following complete resolution of an initial DRT in 1 patient. The left upper pulmonary vein ridge was not covered by the Amulet disc in 82% of DRT patients, indicating suboptimal implantation, with most thrombus developing in the untrabeculated area of the LAA ostium between the pulmonary vein ridge and the upper edge of the disc. Three (18%) DRT patients had an ischemic stroke, all within 3 months of DRT diagnosis. Patients with a DRT were at a greater risk for ischemic stroke or transient ischemic attack compared with non-DRT patients (hazard ratio: 5.27; 95% confidence interval: 1.58 to 17.55; p = 0.007). Larger LAA orifice width was a predictor of DRT formation (hazard ratio: 1.09; 95% confidence interval: 1.00 to 1.19; p = 0.04).CONCLUSIONS: Following LAAO with the AMPLATZER Amulet device, DRT was observed infrequently. Although the presence of DRT was associated with an increased rate of ischemic stroke or transient ischemic attack as compared with patients without DRT, the large majority of DRT patients (82%) did not experience any ischemic neurologic events.

Durable pulmonary vein isolation (PVI) is the goal of atrial fibrillation (AF) ablation. The endoscopic ablation system (EAS) is associated with a high rate of persistent PVI. The aim of this study was to analyze the incidence and pattern of conduction gaps in patients with arrhythmia recurrence after an EAS-guided PVI. Repeat ablations after an EAS-guided PVI were analyzed. After PV angiograms, PV reconnection was assessed. Radiofrequency ablation was delivered at the earliest pulmonary vein (PV) activation site (gap) with the goal of PV re-isolation. First, the incidence of reconnected PVs per patient was assessed. Second, the gap pattern according to the individual PV quadrant was analyzed. Fifty-nine out of 373 (16%) patients underwent a second procedure after index EAS. PV reconnection was observed in 71/230 (31%) PVs without statistically significant differences between individual PVs. A higher incidence of gaps was found for right PVs (49 vs. 27; p 0.0006). The carina between the superior and inferior PV presented a low incidence of gaps (18 vs. 56, p

Objectives This study sought to evaluate the durability of pulmonary vein isolation (PVI) after 2 different freeze durations by using time-to-effect guided (ICE-T) second generation cryoballoon (CB2) ablation strategy in patients with atrial fibrillation (AF) undergoing repeat procedure. Background CB2 represents a powerful technology for PVI. Recently, the ICE-T CB2 ablation strategy targeting a 240-s single freeze demonstrated fast and efficient PVI. To further optimize safety and efficacy, a shortened 3-min freeze duration has been suggested, but PVI durability remains unclear. Methods Between May 1, 2013 and December 31, 2017, all CB2 ablations followed the ICE-T concept (target freeze: 240 s or 180 s). Patients undergoing a second procedure for arrhythmia recurrence were analyzed. Two groups were defined based on the index freeze duration (group A: 240 s vs. group B: 180 s). In all repeat procedures a 3-dimensional left-atrial map was obtained. Durability of PVI and localization of conduction gaps were compared. Results Of 788 total patients, 106 (13%) underwent a second procedure (group A: 80 of 604 vs. group B: 26 of 184) after a mean of 377 days. There was no difference regarding PV occlusion and time-to-isolation in the index procedure between the 2 groups. No major complications occurred. During the second procedure, significantly more patients demonstrated durable isolation of all PV in group A (61% vs. 35%; p = 0.02) along with a significantly increased rate of PVI durability (88% vs. 69%, per vein; p Conclusions The ICE-T ablation strategy is associated with a high rate of durable PVI in patients with arrhythmia recurrence. Target freeze duration of 240 s versus 180 s is associated with significantly increased lesion durability, particularly at left-sided PV, without increasing complications.

Background 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. Methods Patients treated with a CB-LAAI were retrospectively identified. Six weeks after electrical LAAI, patients were scheduled for staged percutaneous LAA closure. During the second procedure, a subset of patients underwent invasive remapping of the LAA. Results A total of 32 patients (21 males, 68 ± 10 years old) were treated with CB-LAAI. Acute LAAI was achieved in 29 of 32 (91%) patients: single-shot LAAI was observed in 18 of 32 (56%) patients. Acute procedural sustained LAAI was related with a significantly shorter time to LAAI (sustained LAAI: 84 ± 50 s vs nonsustained LAAI: 166 ± 76 s, P = 0.004). Mean procedure and fluoroscopy time were 61 ± 29 and 8 ± 6 min, respectively. One left-sided phrenic nerve palsy occurred. In 25 of 32 (78%) patients, a second procedure for percutaneous LAA closure device implantation was performed. In 22 patients, persistency of LAAI was tested: durable LAAI was documented in 16/22 patients (73%). Conclusion In the present report, CB LAA isolation followed by staged LAA closure appeared to be safe and feasible but more data are required. Time to LAAI played a role in predicting acute sustained LAAI rate. CB LAA ablation leads to 73% of durable LAA isolation.

Die technische Weiterentwicklung der Behandlung bradykarder Herzrhythmusstorungen hat dazu gefuhrt, dass heute uber die Leistengefase Transkatheter-Schrittmacher (TPS) eingebracht werden konnen. Diese werden im rechten Ventrikel verankert und beinhalten sowohl die Sonde als auch das Aggregat mit elektronischen Bauteilen und Batterie. Die Systeme sind derzeit lediglich fur einen Einsatz im VVI (R)-Modus geeignet. Die Implantation erfolgt analog zu anderen Transkatheter-Verfahren uber einen venosen Leistenzugang. Die Batterielaufzeit dieser MRT-fahigen Systeme wird mit etwa 10 Jahren angegeben. Die TPS-Implantation geht nach den bislang vorliegenden Daten mit einer hohen Erfolgs- und geringen Komplikationsrate einher. Fur interventionell tatige Kardiologen/Elektrophysiologen scheint die effektive und sichere TPS-Implantation unter Anleitung zugig erlernbar zu sein. Die bisherigen Register und Studien zeigen, dass Infektionen, implantationsbedingte Komplikationen und v. a. Perikardtamponaden auch im Vergleich zu konventionellen Systemen selten auftreten und erfolgreich behandelt werden konnen.

Introduction Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. Methods and Results The REDUCE‐TE Pilot was a prospective multicenter, single‐arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold‐tip, externally irrigated ablation catheter. After ablation, cerebral diffusion‐weighted MRI and a postablation follow‐up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA2DS 2‐VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3‐16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow‐up. Conclusions Ablation of AF using a novel gold‐tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.

INTRODUCTION Disturbance of sympathetic and vagal nervous system participates in the pathogenesis of hypertension and atrial fibrillation (AF). Renal denervation (RDN) can modulate autonomic nervous activity and reduce blood pressure (BP) in hypertensive patients. We aimed to evaluate the effect of RDN combined with pulmonary vein isolation (PVI) in patients with AF and hypertension. METHODS Clinical trials including randomized data comparing PVI plus RDN vs PVI alone were enrolled. Primary outcome was incidence of AF recurrence after procedure. RESULTS A total of 387 patients, of them 252 were randomized and were enrolled. Mean age was 57 ± 10 years, 71% were male, and mean left ventricular ejection fraction was 57.4% ± 6.9%. Follow-up for randomized data was 12 months. Overall comparison for primary outcome showed that PVI + RDN was associated with significantly lower AF recurrence as compared with PVI alone (35.8% vs 55.4%, P

Introduction Pulmonary vein isolation (PVI) is the cornerstone ablation strategy for treatment of atrial fibrillation (AF). Ablation outside the PVs is sometimes needed particularly in persistent or longstanding AF. This study reported left atrial appendage isolation (LAAI) using cryoballoon (CB) focusing on technical data and short-term clinical follow-up. Methods and results Patients with recurrent persistent AF after multiple AF procedures were enrolled. LAAI was performed using the second generation CB guided by compound motor action potential (CMAP) and 240 seconds plus bonus freeze (ICE-B) protocol. Ten patients were included, median age was 69.5 (56-73) years, CHA2 DS 2 -VASc score was 3 (1.8-4), LA diameter was 44 (38.8-46.5) mm. All patients had a mean of three AF procedures before the LAAI procedure. All patients were under successful CMAP guidance. During the CB LAAI procedure, the median time to LAA isolation was 100 (76-270) seconds, minimal freeze temperature was -50 (-57 to -47)°C. A "pull-down (or pull-away)" CB maneuver was performed in all patients. Median fluoroscopic time was 4.8 (3.4-6.8) minutes and acute LAAI success rate was 100%. No phrenic nerve injury or other major complications were observed. At 6-week follow-up, remapping of the LAA showed durable isolation of all PVs (100%), all patients were scheduled for LAA occlusion. Six-month follow-up showed that 80% of patients were free from AF/AT recurrence. Conclusion CMAP plus ICE-B guided LAAI using cryo-technology appears feasible and safe, results in durable LAAI, and shows promising clinical results in patients with recurrent persistent AF.

ObjectivesThe association between obesity and atrial fibrillation (AF) is well-established. We aimed to evaluate the impact of index body mass index (BMI) on AF recurrence at 12 months following catheter ablation using propensity-weighted analysis. In addition, periprocedural complications and fluoroscopy details were examined to assess overall safety in relationship to increasing BMI ranges.MethodsBaseline, periprocedural and follow-up data were collected on consecutive patients scheduled for AF ablation. There were no specific exclusion criteria. Patients were categorised according to baseline BMI in order to assess the outcomes for each category.ResultsAmong 3333 patients, 728 (21.8%) were classified as normal (BMI 2), 1537 (46.1%) as overweight (BMI 25.5–29.0 kg/m2) and 1068 (32.0%) as obese (BMI ≥30.0 kg/m2). Procedural duration and radiation dose were higher for overweight and obese patients compared with those with a normal BMI (p=0.002 and p2led to a 1.2-fold increased likelihood of experiencing recurrent AF at 12-months follow-up as compared with overweight patients (HR 1.223; 95% CI 1.047 to 1.429; p=0.011), while no significant correlation was found between overweight and normal BMI groups (HR 0.954; 95% CI 0.798 to 1.140; p=0.605) and obese versus normal BMI (HR 1.16; 95% CI 0.965 to 1.412; p=0.112).ConclusionsPatients with a baseline BMI ≥30 kg/m2have a higher recurrence rate of AF following catheter ablation and therefore lifestyle modification to target obesity preprocedure should be considered in these patients.

Transcatheter left atrial appendage occlusion (LAAO) is non-inferior to vitamin K antagonists (VKAs) in preventing thromboembolic events in atrial fibrillation (AF). Non-vitamin K antagonists (NOACs) have an improved safety profile over VKAs, however, evidence regarding their effect on cardiovascular and neurological outcomes relative to LAAO is limited. Up-to-date randomized trials or propensity-score-matched data comparing LAAO vs. NOACs in high-risk patients with AF were pooled in our study. A total of 2849 AF patients (LAAO: 1368, NOACs: 1481, mean age: 75 ± 7.5 yrs, 63.5% male) were enrolled. The mean CHA2DS2-VASc score was 4.3 ± 1.7, and the mean HAS-BLED score was 3.4 ± 1.2. The baseline characteristics were comparable between the two groups. In the LAAO group, the success rate of device implantation was 98.8%. During a mean follow-up of 2 years, as compared with NOACs, LAAO was associated with a significant reduction of ISTH major bleeding (p = 0.0002). There were no significant differences in terms of ischemic stroke (p = 0.61), ischemic stroke/thromboembolism (p = 0.63), ISTH major and clinically relevant minor bleeding (p = 0.73), cardiovascular death (p = 0.63), and all-cause mortality (p = 0.71). There was a trend toward reduction of combined major cardiovascular and neurological endpoints in the LAAO group (OR: 0.84, 95% CI: 0.64–1.11, p = 0.12). In conclusion, for high-risk AF patients, LAAO is associated with a significant reduction of ISTH major bleeding without increased ischemic events, as compared to “contemporary NOACs”. The present data show the superior role of LAAO over NOACs among high-risk AF patients in terms of reduction of major bleeding, however, more randomized controlled trials are warranted.

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-sweep 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 PVI with a single energy application using RAPID mode to complete the circular lesion set, and on “first-pass isolation” defined as successful visually guided 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 isolation and first-pass-isolation were achieved in 214 PVs (56%) and in 362 PVs (95%), respectively. Single-sweep isolation rates varied across PVs with higher rates at the superior PVs (61.2% vs. inferior PVs:49.5%, P=0.0239) and at PVs with maximal ostial diameter 24mm: 36.8%, P=0.0151). The mean total procedure and fluoroscopy times were 43.0±10 and 4.0±2 mins, 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-sweep PVI in 56% 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.

BACKGROUND Recently a double 120 s freeze cryoballoon (CB) pulmonary vein isolation (PVI) protocol proved to be non inferior to a double 240 s freeze protocol in terms of atrial fibrillation (AF) recurrences. We hypothesized that this approach could also result in an increased procedure safety. METHODS Eighty consecutive patients treated with a double 120 s freeze protocol (Group CB120) were compared with 80 previous consecutive patients treated with a single 240 s freeze protocol (Group CB240). Procedures were performed with a temperature probe to monitor the luminal esophageal temperature (LET), using a cut off for cryoenergy interruption of 15°C. During ablation at the septal pulmonary veins (PVs), the phrenic nerve (PN) function was monitored by pacing. RESULTS In CB120 and CB240 the rate of single shot isolation was similar in all PVs. Time to isolation was not different between the two groups. Mean minimal esophageal temperature was lower in LSPV and LIPV of the CB240 group. A total of 4/80 patients (5%) of the CB120 group experienced a PN injury, but no persistent form was recorded; 11/80 patients (14%) of the CB240 group experienced a PN injury, three in a persistent form (p = .10). A LET

Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): CardioFocus Background The endoscopic ablation system (EAS) is an established ablation device for pulmonary vein isolation (PVI) in patients with paroxysmal and persistent atrial fibrillation (AF). In randomized studies, however, point-by-point laser ablation resulted in longer procedure times. The novel X3 EAS is now equipped with a motor driven laser generator that sweeps the diode laser beam around the individual PV ostium at a pre-defined speed (2.25°/sec) thus allowing for contiguous circumferential ablation (RAPID mode). Purpose To determine the feasibility of single sweep ablation using the new X3 EAS. Methods Consecutive AF patients were enrolled. After single transseptal puncture selective PV angiographies were performed. A 3D enabled circular mapping catheter was used to record PV potentials and to create a 3D map of the left atrium. Then, the transseptal sheath was exchanged for the 12F EAS delivery sheath. The EAS was inflated to obtain optimal circumferential contact to the PV ostium. Before ablation, the laser generator was retracted to ensure optimal contact behind the catheter shaft (blind spot). Ideally, RAPID mode ablation was employed at 13-15W. In case of esophageal heating >39°C or suboptimal tissue exposure point-by-point ablation (5.5-12W for 20-30 secs) was used instead. During ablation at the septal PVs phrenic nerve pacing was performed via a diagnostic catheter in the superior vena cava. Single sweep ablation was defined as one single RAPID energy application per PV to complete the singular, circular lesion set. PV conduction was re-assessed after all PVs had been treated. In case of residual PV conduction, gap mapping followed by EAS guided ablation was performed. If EAS failed to achieve complete PVI, touch up ablation was allowed at the discretion of the operator. Hemostasis was achieved by means of a figure of 8 suture. Procedure time was defined as initial groin puncture to groin closure. Follow-up included office visits at 3, 6 and 12 months including 72 h Holter monitoring. Results One-hundred AF patients (56% male, mean age 6810 years, 66% PAF) with normal LV ejection fraction (mean 60 ± 10%) and normal LA size (41 ± 6mm) underwent X3 EAS ablation. Of 382 PVs 378 (99%) were isolated with the X3 EAS. In 214 PVs (56%) single sweep isolation was achieved. First pass isolation and RAPID mode only PVI was achieved in 362 (95%) and 357 (94%), respectively. Single sweep isolation rates varied across PVs from 46% at LIPV to 64% at RSPV. The mean total procedure and fluoroscopy times were 43 ± 10 and 4 ± 2 mins, respectively. Safety data and the complete follow-up will be reported. Conclusion The new X3 EAS equipped with a motor driven laser generator allows for single sweep PVI in 56% of PVs. Almost all PVs (94%) may be isolated with RAPID mode only leading to a very high first pass isolation rate. Altogether, this leads to substantially faster procedure times compared to the predecessor EAS.

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.

Funding Acknowledgements Type of funding sources: None. Objectives To evaluate the feasibility, procedural data, and lesion characteristics of anterior line (AL) and roof line (RL) ablation by using ablation index (AI) guided high-power(50W) among patients with recurrent atrial fibrillation (AF) or atrial tachycardia (AT) after pulmonary vein isolation (PVI). Methods 35 consecutive patients with macro-reentrant left atrial tachycardia (LAT) or substrate at LA anterior wall or roof after previous PVI were enrolled. Ablation power was set to 50W, targeting AI 500 for AL and 400 for RL. First-pass conduction block (FPB) was evaluated. The AL was arbitrarily divided into 3(caudal, middle and cranial) segments to analyze the location of conduction gaps in non-FPB patients. Results A total of 32 AL and 17 RL were deployed and FPB was achieved in 24 (75%) and 14 (82%) of them respectively. In non-FPB group, the most frequent gap location along the AL was the middle third. Final block of AL was achieved in 97%, and block of RL was achieved in 100%. The RF ablation time was short (2,9 ± 0,8 min for AL and 46,2 ± 15,6 sec for RL). For AL, female gender was significantly more frequent in FPB than in non-FPB patients(p 0,028); patients with non-FPB were associated with significantly longer RF time as compared to patients with FPB (204 ± 47 sec vs 161 ± 41 sec; p = 0,02). No procedural complications occurred. Conclusion AI guided high-power(50W) ablation appears to be a feasible, effective and fast technique for AL and RL ablation.

Objective: Epicardial access is sometimes required to effectively treat ventricular arrhythmias, but it can be associated with increased risk of procedural complications needing surgical intervention. The present study aimed to evaluate the feasibility and safety of epicardial mapping/ablation in experienced center without onsite cardiac surgery. Methods: Patients who had drug-refractory, recurrent ventricular arrhythmias were scheduled for catheter ablation. All surgeons had at least fifty pericardial puncture experiences. Epicardial puncture and perioperative anticoagulation were carried out based on institutional protocol. Phrenic nerve was mapped by 3-D mapping system. Coronary anatomy was delineated by coronary angiography. Results: A total of 44 patients (63.3 years, male 86.4%) received epicardial access. Of them 7 (15.9%) were scheduled for PVC ablation, 37 (84.1%) for VT ablation (ICM: 25%, NICM: 59.1%). Mean LVEF was 41.3%. Acute ablation success rate was 35 (79.5%). Procedural adverse events included: pericardial effusion occurred in 3 (6.8%) patients who all well treated with pericardial drainage; and pericardial tamponade in 1 (2.3%) patient requiring transfer to surgical intervention. No death, stroke, phrenic nerves palsy, or coronary artery injury were observed. Median hospitalization was 4 (3-6) days. Univariable analysis and ROC curve showed that patients’ age was a significant predictor of epicardial procedural complication (area under curve (AUC): 0.813, P=0.041). Conclusions: Guided by a tailored procedural protocol, the majority of the epicardial access related complications can be treated conservatively without needing onsite surgery. Older age is a risk factor associated with epicardial access related complications.

Backgrounds: Left atrial appendage (LAA) isolation (LAAI) has been described as an adjunctive ablation strategy for patients with recurrent atrial fibrillation (AF). Objectives: We compared the clinical impact of persistent LAAI durability between radiofrequency catheter (RF)-guided wide-area LAAI and cryoballoon (CB)-guided ostial LAAI. Methods: Consecutive patients who underwent RF- or CB-guided LAAI were retrospectively analyzed. RF-guided LAAI was performed by combining anterior, roof and mitral isthmus linear ablation. CB-guided LAAI was performed by LAA ostial ablation. After LAAI, patients underwent invasive re-mapping study. LAA closure was performed if persistent durability was confirmed. Procedural data, LAAI durability and ATa recurrence were assessed. Results: A total of 260 patients (RF:n=201, CB:n=59) undergoing LAAI were identified out of 7630 AF ablation procedures. Acute rate of procedural LAAI was significantly higher in CB group (RF: 82.6% vs. CB: 94.9%, P=0.02) and associated with a lower rate of pericardial effusion (RF: 7.5% vs. CB: 0%, P=0.03). Six-week durable LAAI was similar between two groups (RF: 78.1% vs. CB: 66.0%, P=0.103). One-year freedom from ATa recurrence was higher in the patients with durable LAAI after RF-guided wide-area LAAI irrespective of arrhythmia types (overall; RF:76.3% vs. CB:56.7%, P=0.0017, only AF; RF:81.3% vs. CB:57.5%, P=0.0013, respectively). Multivariate analysis revealed that RF-guided LAAI was a predictor of freedom from ATa recurrence (HR: 0.41, 95%CI: 0.221–0.766, P=0.0056). Conclusions: Acute LAAI can be more readily and safely achieved by CB-guided ostial ablation. In patients with confirmed LAAI, however, the freedom from ATa recurrence was higher after a RF-guided wide-area isolation.

Objective To evaluate the safety and efficacy of percutaneous left atrial appendage occlusion (LAAO) using conscious sedation (CS). Background Several percutaneous structural heart disease interventions are safely and efficiently performed using CS instead of general anaesthesia (GA). This concept has not been evaluated in a large multicenter cohort of patients undergoing LAAO. Methods Patients from the prospective, global Amplatzer Amulet Occluder Observational Study were divided into two groups (GA vs CS). Baseline information, periprocedural and postprocedural efficacy and complications, as well as outcomes through 7 days post implant were compared. Results Patients undergoing transesophageal-guided implants were categorised by GA (n=607, 64%) or CS (n=342, 36%) usage. Mean age was 75 years in both groups. LAAO technical success was achieved in 99% of both groups. The procedure duration (GA: 35±22 min vs CS: 27±19 min, p Conclusions In a large global study, LAAO with the Amplatzer Amulet occluder is safe and feasible using CS. Procedure duration and total amount of contrast were less with CS than GA cases. Trial registration number NCT02447081; Results.

Background: The HeartLight endoscopic ablation system has proven similar efficacy as radiofrequency guided pulmonary vein (PV) isolation in prospective randomized studies though longer procedure times were reported. Recently, the option of a new ablation mode (RAPID) was added, during which the laser arc generator is swept around the PV antrum by an integrated motor drive at a predefined speed for continuous ablation. We sought to determine the performance of the new endoscopic ablation system (X3). Methods: The study was prospective, 2-center, and historically controlled (comparison to pivotal HeartLight study). The primary end point was ablation time (time from insertion of the X3 catheter to the end of the last 30-minute wait period). Transtelephonic monitoring was performed from 90 days to 12 months after ablation. Results: A total of 60 patients were enrolled at 2 centers. Except one, all PVs were treated with RAPID mode. Acute PV isolation was achieved in 225/228 of these PVs (98.7%). The ablation time was significantly shorter with X3 than in the HeartLight study (77.3±25.8 versus 173.8±46.6 min; P P P Conclusions: The novel X3 generation endoscopic ablation system allows for rapid PV isolation by continuous lesion deployment. This was associated with a significant reduction in ablation and procedure times while maintaining the safety and chronic effectiveness in comparison to historical controls. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03470636.

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.

Objectives To evaluate the feasibility, procedural data, and lesion characteristics of the anterior line (AL) and roofline (RL) ablation by using ablation index (AI)-guided high power (50 W) among patients with recurrent atrial fibrillation (AF) or atrial tachycardia (AT) after pulmonary vein isolation (PVI). Methods Data from 35 consecutive patients with macro-reentrant left atrial tachycardia or substrate at the left atrium anterior wall or roof after previous PVI were collected. Ablation power was set to 50 W, targeting AI 500 for AL and 400 for RL. The first-pass conduction block (FPB) was evaluated. The AL was arbitrarily divided into three (caudal, middle, and cranial) segments to analyze the location of conduction gaps in non-FPB patients. Results A total of 32 AL and 17 RL were deployed and FPB was achieved in 24 (75%) and 14 (82%) of them, respectively. In the non-FPB group, the most frequent gap location along the AL was the middle third. The final block of AL was achieved in 97%, and the block of RL was achieved in 100%. The radiofrequency (RF) ablation time was short (2.9 ± 0.8 min for AL and 46.2 ± 15.6 s for RL). For AL, the female gender was significantly more frequent in FPB than in non-FPB patients (p = .028); patients with non-FPB were associated with significantly longer RF time as compared to patients with FPB (204 ± 47 s vs. 161 ± 41 s; p = .02). No procedural complications occurred. Conclusion AI-guided high-power (50 W) ablation appears to be a feasible, effective, and fast technique for AL and RL ablation.