Search

ZUSAMMENFASSUNGVorhofflimmern ist die häufigste Herzrhythmusstörung und ist mit einem erhöhten Risiko für Mortalität, Herzinsuffizienz, Schlaganfälle und Demenz assoziiert. Das therapeutische Management des Vorhofflimmerns hat sich in den letzten Jahren in vielfältiger Hinsicht entscheidend verändert. Die frühzeitige Diagnostik und die Einleitung einer gezielten und individualisierten Therapie spielen hierbei eine große Rolle. Die konsequente Behandlung von Risikofaktoren und Begleiterkrankungen sowie die Prävention thrombembolischer Komplikationen rücken in den Vordergrund. Zudem weisen neuste Studienergebnisse auf eine Prognoseverbesserung durch eine frühe Rhythmuskontrolle hin, welche durch antiarrhythmische Medikation oder eine Katheterablation erreicht werden kann. Im folgenden Artikel wird das Therapiemanagement des Vorhofflimmerns mit Fokus auf rhythmuserhaltende Strategien im Kontext der aktuellen Literatur beleuchtet.

The aim of this retrospective cohort study was to investigate associations between depression and anxiety disorder and the risk of COVID-19 severity and mortality in patients treated in large hospitals in Germany.This retrospective study was based on anonymized electronic medical data from 50 public healthcare service hospitals across Germany. Multivariable logistic regression models were used to study associations between depression, anxiety and mechanical ventilation and mortality due to COVID adjusted for age, sex, time of COVID-19 diagnosis, and pre-defined co-diagnoses.Of 28,311 patients diagnosed with COVID-19, 1970 (6.9%) had a diagnosis of depression and 369 (1.3%) had a diagnosis of anxiety disorder prior to contracting COVID-19. While multivariable logistic regression models did not indicate any association between depression diagnosis and the risk of mechanical ventilation, depression was associated with a decreased risk of mortality (OR: 0.71; 95% CI: 0.53-0.94). There was no association between anxiety disorders and risk of mortality, but there was a strong positive association between anxiety disorders and the risk of mechanical ventilation (OR: 2.04; 95% CI: 1.35-3.10).In the present study, depression and anxiety disorder diagnoses were not associated with increased COVID-19 mortality. Anxiety disorder was strongly associated with an increased risk of mechanical ventilation. Further studies are needed to clarify how depression and anxiety disorders may influence COVID-19 severity and mortality.

ZusammenfassungVorhofflimmern ist die weltweit häufigste, anhaltende Herzrhythmusstörung. Trotz des Fortschritts und der Innovationen im Management der betroffenen Patienten bleibt Vorhofflimmern mit einer signifikanten Morbidität und Mortalität, bedingt durch das Auftreten von unter anderem thrombembolischen Ereignissen, Herzinsuffizienz, kardiovaskulären Ereignissen und plötzlichem Herztod, vergesellschaftet. Es konnte kürzlich gezeigt werden, dass eine frühzeitige rhythmuserhaltende Therapie das Risiko für einen Tod durch kardiovaskuläre Ursache, Schlaganfälle und Hospitalisierungen aufgrund von Herzinsuffizienz reduzieren kann. Die Katheterablation von Vorhofflimmern ist zwar effektiver in der Wiederherstellung und Erhaltung von Sinusrhythmus als eine medikamentöse Therapie, aber lediglich in spezifischen Patientengruppen, die von Herzinsuffizienz und Vorhofflimmern betroffen sind, konnte die Ablationsbehandlung mit einer Reduktion der Gesamtmortalität und von Hospitalisierungen assoziiert werden.

Introduction The aim of this study was to investigate electrophysiological findings in patients with arrhythmia recurrence undergoing a repeat ablation procedure using ultra-high-density (UHDx) mapping following an index procedure using either contact-force (CF)-guided radiofrequency current (RFC) pulmonary vein isolation (PVI) or second-generation cryoballoon (CB) PVI for treatment of atrial fibrillation (AF). Methods and results Fifty consecutive patients with recurrence of AF and/or atrial tachycardia (AT) following index CF-RFC PVI (n = 21) or CB PVI (n = 29) were included. A 64-pole mini-basket mapping catheter in combination with an UHDx-mapping system-guided ablation was used. RFC was applied using a catheter tip with three incorporated mini-electrodes. PV reconnection rates were higher after CF-RFC PVI (CF-RFC: 2.5 ± 1.3 PVs vs CB: 1.4 ± 0.9 PVs; P = .0025) and left PVs were more frequently reconnected (CF-RFC: 64% PVs vs CB: 35% PVs; P = .0077). Fractionated signals along the antral index ablation line (FS) were found in 30% of CB-PVI patients (CF-RFC: 9.5% vs CB:30%; P = .098) targeted for ablation. In five cases, FS were a critical part of maintaining consecutive AT. The main AT mechanism found during reablation (n = 45 ATs) was macroreentry (80% [36/45], CF-RFC: 78.9% vs CB: 80.8%; P = 1.0) with a variety of circuits throughout both atria. Conclusion UHDx mapping is sensitive in detecting conduction gaps along the index ablation line. Left PVs are more frequently reconnected after initial CF-RFC PVI. FS are a common finding after CB PVI and can maintain certain forms of ATs. ATs after index PVI are mostly macroreentries with a broad spectrum of entities.

AIMS Catheter contact and local tissue characteristics are relevant information for successful radiofrequency current (RFC)-ablation. Local impedance (LI) has been shown to reflect tissue characteristics and lesion formation during RFC-ablation. Using a novel ablation catheter incorporating three mini-electrodes, we investigated LI in relation to generator impedance (GI) in patients with ventricular tachycardia (VT) and its applicability as an indicator of effective RFC-ablation. METHODS AND RESULTS Baseline impedance, Δimpedance during ablation and drop rate (Δimpedance/time) were analyzed for 625 RFC-applications in 28 patients with recurrent VT undergoing RFC-ablation. LI was lower in scarred (87.0 Ω [79.0-95.0]) compared to healthy myocardium (97.5 Ω ([82.75-111.50]; P = .03) while GI did not differ between scarred and healthy myocardium. ΔLI was higher (18 Ω [9.4-26.0]) for VT-terminating as compared to non-terminating RFC-ablation (ΔLI 13 Ω [8.85-18.0]; P = .03), but did not differ for ΔGI between terminating vs nonterminating RFC-ablation. Correspondingly, LI drop rate was higher for RFC-ablation terminating the VT compared with RFC-ablation not terminating the VT (0.63 Ω/s [0.52-0.76] vs 0.32 Ω [0.20-0.58]; P = .008) while there was no difference for GI drop rate. ΔLI was higher in patients with nonischemic cardiomyopathy vs patients with ischemic cardiomyopathy (16 Ω [11.0-20.0] vs 11.0 Ω [7.85-17.00]; P = .003). CONCLUSION Our findings suggest that LI is a sensitive parameter to guide RFC-ablation in patients with VT. LI indicates differences in tissue characteristics and generally is higher in patients with nonischemic cardiomyopathy. Hence, the etiology of the underlying cardiomyopathy needs to be considered when adopting LI for monitoring catheter ablation of VT.

Background: Acute myocardial injury (AMJ), assessed by elevated levels of cardiac troponin, is associated with fatal outcome in coronavirus disease 2019 (COVID-19). However, the role of acute cardiovascular (CV) events defined by clinical manifestation rather than sole elevations of biomarkers is unclear in hospitalized COVID-19 patients. Objective: The aim of this study was to investigate acute clinically manifest CV events in hospitalized COVID-19 patients. Methods: From 1 March 2020 to 5 January 2021, we conducted a multicenter, prospective, epidemiological cohort study at six hospitals from Hamburg, Germany (a portion of the state-wide 45-center CORONA Germany cohort study) enrolling all hospitalized COVID-19 patients. Primary endpoint was occurrence of a clinically manifest CV-event. Results: In total, 132 CV-events occurred in 92 of 414 (22.2%) patients in the Hamburg-cohort: cardiogenic shock in 10 (2.4%), cardiopulmonary resuscitation in 12 (2.9%), acute coronary syndrome in 11 (2.7%), de-novo arrhythmia in 31 (7.5%), acute heart-failure in 43 (10.3%), myocarditis in 2 (0.5%), pulmonary-embolism in 11 (2.7%), thrombosis in 9 (2.2%) and stroke in 3 (0.7%). In the Hamburg-cohort, mortality was 46% (42/92) for patients with a CV-event and 33% (27/83) for patients with only AMJ without CV-event (OR 1.7, CI: (0.94–3.2), p = 0.077). Mortality was higher in patients with CV-events (Odds ratio(OR): 4.8, 95%-confidence-interval(CI): [2.9–8]). Age (OR 1.1, CI: (0.66–1.86)), atrial fibrillation (AF) on baseline-ECG (OR 3.4, CI: (1.74–6.8)), systolic blood-pressure (OR 0.7, CI: (0.53–0.96)), potassium (OR 1.3, CI: (0.99–1.73)) and C-reactive-protein (1.4, CI (1.04–1.76)) were associated with CV-events. Conclusion: Hospitalized COVID-19 patients with clinical manifestation of acute cardiovascular events show an almost five-fold increased mortality. In this regard, the emergence of arrhythmias is a major determinant.

Since December 2020, the COVID-19 pandemic in Germany was influenced by two new major factors: detection of new virus Variants of Concern (VOC) and the start of the vaccination campaign...

AIMS A novel measure of local impedance (LI) has been found to predict lesion formation during radiofrequency current (RFC) catheter ablation. The aim of this study was to investigate the utility of this novel approach, while comparing LI to the well-established generator impedance (GI). METHODS AND RESULTS In 25 consecutive patients with a history of atrial fibrillation, catheter ablation was guided by a 3D-mapping system measuring LI in addition to GI via an ablation catheter tip with three incorporated mini-electrodes. Local impedance and GI before and during RFC applications were studied. In total, 381 RFC applications were analysed. The baseline LI was higher in high-voltage areas (>0.5 mV; LI: 110.5 ± 13.7 Ω) when compared with intermediate-voltage sites (0.1-0.5 mV; 90.9 ± 10.1 Ω, P < 0.001), low-voltage areas (

Background After one year of the pandemic and hints of seasonal patterns, temporal variations of in-hospital mortality in COVID-19 are widely unknown. Additionally, heterogeneous data regarding clinical indicators predicting disease severity has been published. However, there is a need for a risk stratification model integrating the effects on disease severity and mortality to support clinical decision-making. Methods We conducted a multicenter, observational, prospective, epidemiological cohort study at 45 hospitals in Germany. Until 1 January 2021, all hospitalized SARS CoV-2 positive patients were included. A comprehensive data set was collected in a cohort of seven hospitals. The primary objective was disease severity and prediction of mild, severe, and fatal cases. Ancillary analyses included a temporal analysis of all hospitalized COVID-19 patients for the entire year 2020. Findings A total of 4704 COVID-19 patients were hospitalized with a mortality rate of 19% (890/4704). Rates of mortality, need for ventilation, pneumonia, and respiratory insufficiency showed temporal variations, whereas age had a strong influence on the course of mortality. In cohort conducting analyses, prognostic factors for fatal/severe disease were: age (odds ratio (OR) 1.704, CI:[1.221–2.377]), respiratory rate (OR 1.688, CI:[1.222–2.333]), lactate dehydrogenase (LDH) (OR 1.312, CI:[1.015–1.695]), C-reactive protein (CRP) (OR 2.132, CI:[1.533–2.965]), and creatinine values (OR 2.573, CI:[1.593–4.154]. Conclusions Age, respiratory rate, LDH, CRP, and creatinine at baseline are associated with all cause death, and need for ventilation/ICU treatment in a nationwide series of COVID 19 hospitalized patients. Especially age plays an important prognostic role. In-hospital mortality showed temporal variation during the year 2020, influenced by age. Trial registration number NCT04659187.

Introduction Tailored catheter ablation of atrial tachycardias (ATs) is increasingly recommended as a potentially easy treatment strategy in the era of high-density mapping (HDM). As follow-up data are sparse, we here report outcomes after HDM-guided ablation of ATs in patients with prior catheter ablation or cardiac surgery. Methods and results In 250 consecutive patients (age 66.5 ± 0.7 years, 58% male) with ATs (98% prior catheter ablation, 13% prior cardiac surgery) an HDM-guided catheter ablation was performed with the support of a 64-electrode mini-basket catheter. A total of 354 ATs (1.4 ± 0.1 ATs per patient; mean cycle length 304 ± 4.3 ms; 64% macroreentry, 27% localized reentry, and 9% focal) with acute termination of 95% were targeted in the index procedure. A similar AT as in the index procedure recurred in five patients (2%) after a median follow-up time of 535 days (interquartile range (IQR) 25th-75th percentile: 217-841). Tailored ablation of reentry ATs with freedom from any arrhythmia was obtained in 53% after a single procedure and in 73% after 1.4 ± 0.4 ablation procedures (range: 1-4). A total of 228 patients (91%) were free from any arrhythmia recurrence after 210 days (IQR: 152-494) when including optimal usual care. Conclusions Tailored catheter ablation of ATs guided by HDM has a high acute success rate. The recurrence rate of the index AT is low. In patients with extensive atrial scaring further ablation procedures need to be considered to achieve freedom from any arrhythmia.

Contact force (CF) catheters provide catheter-tissue contact information to improve outcome of pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (PAF). We evaluated different target-CF values for achievement of the additional endpoint of an unexcitable ablation line. A total of 106 patients undergoing PVI were randomized into three groups (G) (G1: target-CF 15 g, G2: target-CF 10 g, G3: CF concealed from operator). The PVI encircling line was divided into predefined sections. Excitable tissue along the PVI-line identified by high output pacing (10 V, 2 ms) was targeted for further ablation. Mean average CF was 17.4 ± 4.7 g (G1) vs. 12.3 ± 6.0 g (G2) vs. 11.1 ± 6.5 g (G 3) (p

Background: Ultra-high density mapping (HDM) is a promising tool in the treatment of patients with complex arrhythmias. In adults with congenital heart disease (CHD), rhythm disorders are among the most common complications but catheter ablation can be challenging due to heterogenous anatomy and complex arrhythmogenic substrates. Here, we describe our initial experience using HDM in conjunction with novel automated annotation algorithms in patients with moderate to great CHD complexity. Methods: We studied a series of consecutive adult patients with moderate to great CHD complexity and an indication for catheter ablation due to symptomatic arrhythmia. HDM was conducted using the Rhythmia™ mapping system and a 64-electrode mini-basket catheter for identification of anatomy, voltage, activation pattern and critical areas of arrhythmia for ablation guidance. To investigate novel advanced mapping strategies, postprocedural signal processing using the Lumipoint™ software was applied. Results: In 19 patients (53±3 years; 53% male), 21 consecutive ablation procedures were conducted. Procedures included ablation of atrial fibrillation (n=7; 33%), atrial tachycardia (n=11; 52%), atrioventricular accessory pathway (n=1; 5%), the atrioventricular node (n=1; 5%) and ventricular arrhythmias (n=4; 19%). A total of 23 supraventricular and 8 ventricular arrhythmias were studied with the generation of 56 complete high density maps (atrial n=43; ventricular n=11, coronary sinus n=2) and an average of 12,043±1,679 mapping points. Multiple arrhythmias were observed in n=7 procedures (33% of procedures; range of arrhythmias detected 2–4). A total range of 1–4 critical areas were defined per procedure and treated within a radiofrequency application time of 16 (interquartile range 12–45) minutes. Postprocedural signal processing using Lumipoint™ allowed rapid annotation of fractionated signals within specific windows of interest. This supported identification of a practical critical isthmus in 20 out of 27 completed atrial and ventricular tachycardia activation maps. Conclusions: Our findings suggest that HDM in conjunction with novel automated annotation algorithms provides detailed insights into arrhythmia mechanisms and might facilitate tailored catheter ablation in patients with moderate to great CHD complexity.

INTRODUCTION Long-term efficacy and safety are uncertain in patients with cardiac implantable electronic devices (CIED) and transvenous leads (TVL) undergoing radiofrequency catheter ablation of atrial fibrillation (AF). Thus, we assessed the outcome of AF ablation in those patients during long-term follow-up using continuous atrial rhythm monitoring (CARM). METHODS AND RESULTS A total of 190 patients (71.3 ± 10.7 years; 108 (56.8% men) were included in this study. At index procedure 81 (42.6%) patients presented with paroxysmal AF and 109 (57.4%) with persistent AF. The ablation strategy included pulmonary vein isolation in all patients and biatrial ablation of complex fractionated electrograms with additional ablation lines, if appropriate. AF recurrences were assessed by CARM- and CIED-related complications by device follow-up. After a mean follow-up of 55.4 ± 38.1 months, freedom of AF was found in 86 (61.4%) and clinical success defined as an AF burden less than or equal to 1% in 101 (72.1%) patients. Freedom of AF was reported in 74.6% and 51.9% (P = 0.006) and clinical success in 89.8% and 59.3% (P

Introduction The need for transesophageal echocardiography (TEE) before catheter ablation of atrial fibrillation (CA-AF) is still being questioned. The aim of this study is to analyze patients’ (pts) risk factors of left atrial appendage thrombus (LAAT) prior to CA-AF in daily clinical practice, according to oral anticoagulation (OAC) strategies recommended by current guidelines. Methods and results All pts scheduled for CA-AF from 01/2015-12/2016 in our center were included and either treated with NOACs (novel-OAC; paused 24-hours pre-ablation) or continuous vitamin K-antagonists (INR 2.0-3.0). All pts received a preprocedural TEE at the day of ablation. Two groups were defined: 1) pts without LAAT, 2) pts with LAAT. The incidence of LAAT was 0.78% (13/1658 pts). No LAAT was detected in pts with a CHA2DS2-VASc score of ≤ 1 (n = 640 pts) irrespective of the underlying AF type. Independent predictors for LAAT are: higher CHA2DS2-VASc scores (odds ratio (OR) 1.54, 95%-confidence interval (CI): 1.07–2.23, P = 0.0019), a history of non-paroxysmal AF (OR 7.96, 95%-CI: 1.52–146.64, P = 0.049), hypertrophic cardiomyopathy (HCM; OR 9.63, 95%-CI: 1.36–43.05, P = 0.007) and a left ventricular ejection fraction (LVEF) < 30% (OR 8.32, 95%-CI: 1.18–36.29, P = 0.011). The type of OAC was not predictive (P = 0.70). Conclusions The incidence of LAAT in pts scheduled for CA-AF is low. Therefore, periprocedural OAC strategies recommended by current guidelines seem feasible. Preprocedural TEE may be dispensed in pts with a CHA2DS2-VASc score ≤ 1. However, a CHA2DS2-VASc score ≥ 2, reduced LVEF, HCM or history of non-paroxysmal AF are independently associated with an increased risk for LAAT. This article is protected by copyright. All rights reserved

Improved Efficacy of Second-Generation CryoballoonBackground The second-generation cryoballoon (CB2) has recently been introduced featuring improved surface cooling. Increased procedural efficacy of pulmonary vein isolation (PVI) when compared to the first-generation balloon (CB1) has been reported. The aim of the study was to investigate the clinical outcome of cryoballoon PVI after 1 year using the CB2 as compared to the CB1. Methods and Results A total of 105 consecutive patients with paroxysmal atrial fibrillation (AF) were studied. Cryoballoon PVI (28 mm) was performed in 50 patients using the CB1, and in 55 patients using the CB2. Patients were scheduled for 72-hour Holter ECG recording at 3, 6, 9, and 12 months and every 6 months thereafter. The study endpoint was defined as recurrent AF or atrial tachycardia >30 seconds documented after a blanking period of 90 days after the procedure. Complete PVI was achieved in 49/50 (98%) and 55/55 (100%) patients in the CB1 and CB2 group, respectively. After a mean follow-up of 416 ± 75 days, 21 (CB1 group) and 10 (CB2 group) patients reached the study endpoint. Kaplan–Meier estimates of arrhythmia-free survival after a single procedure without AAD therapy after 1 year were 63.9% versus 83.6% (P = 0.008) in the CB1 and CB2 group, respectively. Persistent phrenic nerve palsy with delayed healing occurred in 2 (CB1 group) and 3 (CB2 group) patients. Conclusion Clinical outcome of PVI using the CB2 was significantly improved when compared to the CB1.

Aims Recently, a novel second-generation (G2) cryoballoon (CB) was introduced. Comparative analysis of lesion formation in terms of myocardial biomarker release [first-generation CB (G1) vs. G2] has not been studied. To compare myocardial biomarker release using the 28 mm G1 vs. G2 CB. Methods and results In patients (patients) treated with the simplified single big CB (SBCB) strategy for pulmonary vein isolation (PVI), myocardial biomarkers [troponin T (TnT), creatine kinase, lactic dehydrogenase (LDH)] were measured at 12, 24, and 48 h after PVI. Two groups were defined: Group 1 (G1; freezing time: 300 s), Group 2 (G2; freezing time: 240 s). Mean biomarker peak values were compared. To correct for between-group differences in cumulative freezing time, an index calculated as peak biomarker release divided by cumulative freezing time was calculated. Sixty-six CB PVI procedures (G1: 33 patients, G2: 33 patients) were analysed. Pulmonary vein isolation was achieved in all the patients using the simplified SBCB technique only. Mean freezing time (51 ± 10 vs. 33 ± 6 min, P < 0.01) was significantly shorter in G2. All biomarker levels tended to be higher in G2 vs. G1. The indexed biomarkers values were significantly higher in G2: TnT: 18.8 ± 8.5 vs. 32.3 ± 13.6 pg/L/min ( P < 0.01); creatinephosphokinase: 6.7 ± 2.7 vs. 11.7 ± 3.9 U/L/min ( P < 0.01); LDH: 5.2 ± 1.0 vs. 9.1 ± 2.7 U/L/min ( P < 0.01). On a 6-month follow-up (180 days), G2 revealed a significantly higher success rate (20/33 vs. 28/33; P = 0.027). Conclusion Pulmonary vein isolation using the G2 CB increased the myocardial biomarker release index and is linked to a significantly improved 6 months success rate.

Laser- Versus CryoBalloon for PVI Introduction Balloon catheters have been developed to facilitate pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). We sought to compare the safety and efficacy of the cryoballoon (CB) and the laserballoon (LB) in a pilot study. Methods and Results One hundred and forty patients with drug-refractory PAF were prospectively allocated in a 1:1 fashion to undergo a PVI procedure with the 28 mm CB or the LB and were followed for 12 months using 3-day Holter ECG recording. The primary efficacy endpoint was a documented AF recurrence ≥30 seconds between 90 and 365 days after the index ablation. In total, 269 of 270 PVs (99.6%) and 270 of 273 PVs (98.9%) were acutely isolated in the CB and LB group, respectively. Mean procedural time was 136 ± 30 minutes for the CB group and 144 ± 33 minutes for the LB group (P = 0.13). Mean fluoroscopy time was longer in the CB group (21 ± 9 minutes vs 15 ± 6 minutes; P

Asymptomatic Cerebral Lesions in AF Ablation Background Asymptomatic cerebral lesions (ACL) may occur during atrial fibrillation (AF) ablation. We sought to compare the ACL incidence between 3 contemporary technologies: (1) irrigated radiofrequency current (RFC), (2) the single big cryoballoon (CB), and (3) the endoscopic laser-balloon (LB) in a prospective randomized pilot study. Methods and Results Ninety-nine patients were treated in 3 groups. Diffusion weighted MRI was acquired pre- (n = 20) and 24–48 h postablation (n = 99). After ablation, new ACL were detected in 22% of patients without significant differences between groups (RFC 8/33; CB 6/33; LB 8/33; P = 0.8). The presence of hypertension was identified as the only independent predictor of ACL by univariate regression analysis. During LB ablation, more ablation lesions (140 ± 19 vs 119 ± 18; P = 0.007) were applied during longer procedures (166 ± 36 vs 143 ± 32 min; P = 0.05) in patients with ACL. Univariate analysis revealed that a higher number of ablation lesions predicted ACL (P = 0.02). Conclusion In this prospective, randomized, single-center pilot study, ablation technology did not influence the occurrence of ACL during AF ablation.

Pulmonary vein (PV) isolation for ablation of atrial fibrillation is a well-accepted therapy option for high symptomatic patients refractory to antiarrhythmic drugs. Radiofrequency point-by-point ablation is the gold-standard technique; however, in the last two decades, many new technologies have been developed. The endoscopic ablation system makes direct PV ostium visualization possible, despite the large anatomy variation thanks to its compliant balloon. The laser generator delivers precise lesions that in the first clinical studies seem to be durable, with a safety and efficacy profile similar to the other PV isolation techniques. If these early results are confirmed by larger clinical studies, the endoscopic ablation system will offer a new paradigm in ablation of cardiac arrhythmias by directly visualizing the target substrate.

Efficacy of the Novel Cryoballoon Introduction The cryoballoon technology has the potential to isolate a pulmonary vein (PV) with a single energy application. However, using the first-generation cryoballoon (CB-1G) repeated freezing or additional focal ablation is often necessary. The novel second-generation cryoballoon (CB-2G) features a widened zone of optimal cooling comprising the whole frontal hemisphere. The aim of this study was to investigate the impact of the novel design on procedural efficacy of cryoballoon PV isolation (CB-PVI). Methods and Results Single transseptal CB-PVI using an endoluminal spiral mapping catheter was performed in 60 consecutive patients (CB-1G, 28 mm, 300 seconds application time: 30 patients; CB-2G, 28 mm, 240 seconds application time: 30 patients). When compared to the CB-1G, using the CB-2G increased single-shot PVI rate from 51% to 84% (P < 0.001) and decreased procedure duration (128 ± 27 vs 98 ± 30 minutes; P < 0.001), and fluoroscopy exposure time (19.5 ± 7.4 vs 13.4 ± 5.3 min; P = 0.001). Effective CB-2G PVI could be performed with increased real-time PVI visualization rate (49% vs 76%; P < 0.001). Time to PVI (TPVI) was shorter in the CB-2G group (79 ± 60 vs. 52 ± 36 seconds; P = 0.049). Procedure-related complications occurred in 2 patients in the CB-1G group and 1 patient in the CB-2G group. Conclusions The CB-2G significantly improved procedural efficacy compared to the CB-1G and provided reliable TPVI measurement. TPVI may be used to adjust application time and number individually in future studies. Final conclusions regarding the safety profile of the CB-2G requires additional research.

Aims To assess the effects of low-dose (LD) and high-dose (HD) ablation on acute and chronic success in patients with atrial fibrillation (AF). While the concept of visually guided pulmonary vein isolation (PVI) has been established little is known on energy titration using laser ablation. Methods and results In 60 patients with AF, PVI using the endoscopic ablation system (EAS) was performed in two groups. Visually guided ablation was carried out after obtaining optimal tissue contact with 5.5–8.5 W in the LD group and with >8.5 W in the HD group. Acute PVI after a single visually guided circular lesion set was achieved in 89% (HD) and 69% (LD), respectively, ( P = 0.0004). In 70 and 39% of patients all PVs were isolated after a single ablation circle in the HD and LD group, respectively, ( P = 0.009). After gap ablation all PVs were isolated with the EAS. More energy was deployed (6483 ± 1834 vs. 5306 ± 2258 Ws; P ≤ 0.0001) with less applications (31.6 ± 8 vs. 35.2 ± 15 applications per PV; P = 0.03) leading to shorter procedure times (128 ± 17 vs. 154 ± 38 min; P = 0.001). During median follow-up of 311 days (261–346) recurrence rate was 17 and 40% in the HD and LD group, respectively. In both groups one phrenic nerve palsy was observed. Conclusion For the first time, it was demonstrated that high ablation power affects acute and chronic outcomes. High-dose laser balloon ablation allows for an acute PVI rate of 89% solely by visually guided circular ablation and is associated with a chronic success rate of 83% after a single procedure.

Introduction Comparative data of early recurrence rates of atrial fibrillation (ERAF) following second-generation cryoballoon (CB-G2) and radiofrequency current (RFC) ablation for pulmonary vein isolation (PVI) in paroxysmal AF (PAF) are rare. We randomized PAF patients into either PVI with CB-G2 (group 1) or PVI with a combined RFC-approach applying contact force (CF) with the endpoint of unexcitability (group 2) to investigate ERAF. Methods In group 1 ( n = 30), CB-G2-PVI was performed. After CF-PVI in group 2 ( n = 30), bipolar pacing on the ablation line and additional ablation until unexcitability was conducted. Follow-up included 48 h of in-hospital monitoring followed by 5-day Holter ECGs 1, 2, 3, 6, 12 months postablation to evaluate ERAF. Results Acute PVI was reached in 100% of group 2 and in 99% of group 1. Shorter procedure durations (98.0 ± 21.9 vs. 114.3 ± 18.7 min, P < 0.05) but extended fluoroscopy times (15.4 ± 3.9 vs. 10.0 ± 4.3 min, P < 0.05) were found in the CB-G2 group. Ten non-severe complications occurred (6 vs. 4 in group 1 and 2, P = 0.73). In group 2, five patients suffered from ERAF vs. seven patients in group 1 ( P = 0.67). The time until the occurrence of ERAF was shorter in group 2 (1 day (q1–q3: 1−4.5)) when compared with group 1 (22 (q1–q3: 6−54) days, P = 0.025). Conclusion ERAF rates were equal among groups; however, they occurred earlier in the initial phase after RFC ablation when compared with CB-G2. PVI utilizing cryoablation is associated with shorter procedure durations but extended fluoroscopy time while being similarly secure.

The use of non-vitamin K antagonists (NOACs), uninterrupted (uVKA) and interrupted vitamin K antagonists (iVKA) are common periprocedural oral anticoagulation (OAC) strategies for atrial fibrillation (AF) ablation. Comparative data on complication rates resulting from OAC strategies for solely persistent AF (persAF) undergoing ablation are sparse. Thus, we sought to determine the impact of these OAC strategies on complication rates among patients with persAF undergoing catheter ablation.Consecutive patients undergoing persAF ablation were included. Depending on preprocedural OAC, three groups were defined: (1) NOACs (paused 48 h preablation), (2) uVKA, and (3) iVKA with heparin bridging. A combined complication endpoint (CCE) composed of bleeding and thromboembolic events was analyzed.Between 2011 and 2014, 1440 persAF ablation procedures were performed in 1092 patients. NOACs were given in 441 procedures (31 %; rivaroxaban 57 %, dabigatran 33 %, and apixaban 10 %), uVKA in 488 (34 %), and iVKA in 511 (35 %). Adjusted CCE rates were 5.5 % [95 % confidence interval (CI) (3.1-7.8)] in group 1 (NOACs), 7.5 % [95 % CI (5.0-10.1)] in group 2 (uVKA), and 9.9 % [95 % CI (6.6-13.2)] in group 3. Compared to group 1, the combined complication risk was almost twice as high in group 3 [odd's ratio (OR) 1.9, 95 % CI (1.0-3.7), p = 0.049)]. The major complication rate was low (0.9 %). Bleeding complications, driven by minor groin complications, are more frequent than thromboembolic events (n = 112 vs. 1, p 0.0001).Patients undergoing persAF ablation with iVKA anticoagulation have an increased risk of complications compared to NOACs. Major complications, such as thromboembolic events, are generally rare and are exceeded by minor bleedings.

Background: The single big cryoballon technique for pulmonary vein isolation (PVI) has been limited by the need for two transseptal punctures (TP). We therefore investigated feasibility and safety of a simplified approach using a single TP and a novel circumferential mapping catheter (CMC). Methods: Patients underwent 28-mm cryoballoon PVI using a single TP. The CMC (Achieve© Medtronic Inc., Minneapolis, MN, USA) served as (1) guidewire and (2) as a PV mapping tool. Primary endpoint was PVI without switching to a regular guidewire. Secondary endpoints included: (1) PV signal quality during freezing, (2) time to PVI, (3) classification of successful ablation technique, (4) complications, and (5) procedural data. Results: A total of 32 patients (126 PVs) were studied (mean age: 62 ± 11 years, 24 males, left atrium: 40 ± 4 mm). The primary endpoint was achieved in 29/32 patients (91%) and 123/126 PVs (98%) with a procedure and fluoroscopy time of 126 ± 26 minutes and 18.9 ± 7.5 minutes, respectively. Real-time visualization of PVI could be observed in 61/126 (48%) PVs. Time to sustained PVI versus nonsustained PVI was 66 ± 56 seconds versus 129 ± 76 seconds (P < 0.001). One phrenic nerve palsy was observed. After a follow-up of 250 ± 84 days 23/32 patients (72%) remained in sinus rhythm. Conclusion: The “simplified single big cryoballoon” PVI strategy appears to be safe and feasible. However, real-time PV recording was achieved in

The second-generation cryoballoon (CB2) has recently been introduced featuring improved surface cooling. Increased procedural efficacy of pulmonary vein isolation (PVI) when compared to the first-generation balloon (CB1) has been reported. The aim of the study was to investigate the clinical outcome of cryoballoon PVI after 1 year using the CB2 as compared to the CB1.A total of 105 consecutive patients with paroxysmal atrial fibrillation (AF) were studied. Cryoballoon PVI (28 mm) was performed in 50 patients using the CB1, and in 55 patients using the CB2. Patients were scheduled for 72-hour Holter ECG recording at 3, 6, 9, and 12 months and every 6 months thereafter. The study endpoint was defined as recurrent AF or atrial tachycardia30 seconds documented after a blanking period of 90 days after the procedure. Complete PVI was achieved in 49/50 (98%) and 55/55 (100%) patients in the CB1 and CB2 group, respectively. After a mean follow-up of 416 ± 75 days, 21 (CB1 group) and 10 (CB2 group) patients reached the study endpoint. Kaplan-Meier estimates of arrhythmia-free survival after a single procedure without AAD therapy after 1 year were 63.9% versus 83.6% (P = 0.008) in the CB1 and CB2 group, respectively. Persistent phrenic nerve palsy with delayed healing occurred in 2 (CB1 group) and 3 (CB2 group) patients.Clinical outcome of PVI using the CB2 was significantly improved when compared to the CB1.

Balloon catheters have been developed to facilitate pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). We sought to compare the safety and efficacy of the cryoballoon (CB) and the laserballoon (LB) in a pilot study.One hundred and forty patients with drug-refractory PAF were prospectively allocated in a 1:1 fashion to undergo a PVI procedure with the 28 mm CB or the LB and were followed for 12 months using 3-day Holter ECG recording. The primary efficacy endpoint was a documented AF recurrence ≥ 30 seconds between 90 and 365 days after the index ablation. In total, 269 of 270 PVs (99.6%) and 270 of 273 PVs (98.9%) were acutely isolated in the CB and LB group, respectively. Mean procedural time was 136 ± 30 minutes for the CB group and 144 ± 33 minutes for the LB group (P = 0.13). Mean fluoroscopy time was longer in the CB group (21 ± 9 minutes vs 15 ± 6 minutes; P0.001). During 12 months follow-up, 37% of patients in the CB group and 27% in the LB group experienced an AF recurrence (P = 0.18). Phrenic nerve palsies occurred in 5.7% (CB) and 4.2% (LB) of patients, respectively.Balloon catheters are a viable option to safely perform a PVI procedure in patients with drug-refractory PAF. Ninety-nine percent of PVs may be acutely isolated with a single balloon catheter. The AF free survival rate after a single ablation procedure was not statistically different between groups.

Asymptomatic cerebral lesions (ACL) may occur during atrial fibrillation (AF) ablation. We sought to compare the ACL incidence between 3 contemporary technologies: (1) irrigated radiofrequency current (RFC), (2) the single big cryoballoon (CB), and (3) the endoscopic laser-balloon (LB) in a prospective randomized pilot study.Ninety-nine patients were treated in 3 groups. Diffusion weighted MRI was acquired pre- (n = 20) and 24-48 h postablation (n = 99). After ablation, new ACL were detected in 22% of patients without significant differences between groups (RFC 8/33; CB 6/33; LB 8/33; P = 0.8). The presence of hypertension was identified as the only independent predictor of ACL by univariate regression analysis. During LB ablation, more ablation lesions (140 ± 19 vs 119 ± 18; P = 0.007) were applied during longer procedures (166 ± 36 vs 143 ± 32 min; P = 0.05) in patients with ACL. Univariate analysis revealed that a higher number of ablation lesions predicted ACL (P = 0.02).In this prospective, randomized, single-center pilot study, ablation technology did not influence the occurrence of ACL during AF ablation.

Sequential PVI with Laser Balloon. Introduction: Pulmonary vein isolation (PVI) is a challenging procedure most often requiring sophisticated technical aids such as electroanatomical mapping, double transseptal access, and the use of a circular mapping catheter. We sought to develop a PVI strategy solely based on visual guidance with a single ablation device as well as a single transseptal puncture using the endoscopic ablation system (EAS). Methods and Results: In 35 patients with drug-refractory atrial fibrillation (18 male, mean age: 62 ± 9 years) ablation was performed. PVI was achieved in 96 of 137 PVs (70%) purely by visually guided circular ablation. Predictors of acute isolation were the degree of PV occlusion by EAS as well as the number of catheter repositionings but not total ablation energy or the number of laser applications. Conduction gaps were detected at sites with suboptimal occlusion as well as esophageal temperature elevations. Further EAS ablation resulted in a 98% acute isolation rate. Mean procedure and fluoroscopy times were 154 ± 38 minutes and 16 ± 6 minutes, respectively. Between the first and last 12 cases, a reduction in procedure times (175 ± 48 minutes vs 138 ± 26 minutes; P = 0.05) was observed. One pericardial tamponade and 1 right-sided phrenic nerve palsy occurred. During a median follow-up of 266 days (q-q3: 218–389), 27 of 35 patients (77%) remained free of any tachyarrhythmia recurrence off antiarrhythmic drugs. Conclusions: Sequential PVI based solely on endoscopic visual information with a single device and a single transseptal puncture is feasible. Optimal PV occlusion and few controlled repositionings facilitate PVI. (J Cardiovasc Electrophysiol, Vol. 23, pp. 576–582, June 2012)