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Stefan G Spitzer,1 Laszlo Karolyi,1 Thomas Weinmann,1 Frank Scharfe,1 Carola Rämmler,1 Tobias Otto,1 Friedrich Jung,2 Clemens T Kadalie11Praxisklinik Herz und Gefäße, Akademische Lehrpraxisklinik der TU Dresden, Dresden, Germany; 2Saarland University, Homburg, Saar, GermanyPurpose: To provide data on acute and long-term outcomes from pulmonary vein isolation with the pulmonary vein ablation catheter (PVAC) in patients with paroxysmal or persistent atrial fibrillation (AF).Methods: This was a single-center, retrospective, nonrandomized, case control study. Patients with documented symptomatic paroxysmal or persistent AF were treated with PVAC or with point-by-point radiofrequency ablation guided by the NavX™ mapping system. All follow-up visits were conducted in our center at 1 month, 3 months, and 6 months, and then at 6-month intervals. Electrocardiography and 24-hour Holter monitoring were performed at each follow-up visit. The endpoints included procedure times, acute and 24-month outcomes, and complications.Results: Of the 539 patients that were enrolled consecutively, 388 were ablated using PVAC and 151 using radiofrequency ablation. More patients with paroxysmal AF were treated with PVAC than with radiofrequency ablation. Acute success rates were >99% with both methods. Procedure duration and fluoroscopy times were significantly (P

Aim: This study sought to quantify the healthcare costs of multivessel disease (MVD) and determine the prevalence and incidence of recurrent major adverse cardiovascular events (MACE) in high-risk patients diagnosed with MVD following an acute myocardial infarction (MI)., Methods: This retrospective study utilized German claims data (AOK PLUS), between 01/01/2010 and 31/12/2020. Patients were included if they (1) had an inpatient diagnosis of an MI between 01/01/2012 and 31/12/2019 (index date), (2) were ≥ 18 years of age at date of MI diagnosis, and (3) had diabetes or met two of the following criteria: ≥ 65 years old, prior MI, peripheral arterial disease. MACE was defined as (1) MI, (2) stroke, or (3) death with a cardiovascular diagnosis within 30 days prior. To measure the burden of MVD, patients were identified during the index hospitalization by presence of MVD. Healthcare resource use and costs were compared after adjustment based on propensity score matching (PSM)., Results: A total of 5158 patients with evidence for MVD were included in the main analysis. 31.17% experienced a MACE within 365 days following the incident MI. After PSM adjustment, 33.22% of the MVD cohort experienced a MACE versus 36.48% of non-MVD patients. MVD patients had a higher rate of recurrent MI (14.22% vs. 9.81%). Additionally, public healthcare costs were about €4 million higher in the total MVD cohort than in the non-MVD cohort in the first year after an MI (€47,896,012.32 vs. €43,718,713.75, respectively), reflecting the MVD cohort's higher use of the public healthcare system. More MVD patients were prescribed guideline-recommended medication (61.4% vs. 46.0%)., Conclusion: This study found that presence of MVD contributed to higher rates of recurrent MI. Patients with MVD experienced higher rates of recurrent MI despite a higher proportion of patients receiving guideline-directed medication therapy compared to non-MVD patients. Conversely, there was a higher mortality rate observed in the non-MVD cohort., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: Since the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR-AF II), there has been a trend toward pulmonary vein isolation (PVI)-only ablation strategies for persistent atrial fibrillation (PeAF). Electrographic flow (EGF) mapping can identify active sources of atrial fibrillation (AF) and estimate the electrographic flow consistency (EGFC) of wavefront propagation through substrate, revealing functional AF mechanisms., Objective: We sought to examine the success of a PVI-only ablation strategy for a redo PeAF/longstanding PeAF population., Methods: Electrographic Flow-Guided Ablation in Redo Patients With Persistent Atrial Fibrillation (FLOW-AF [NCT04473963]) prospectively enrolled patients with nonparoxysmal AF undergoing redo ablation at 4 centers. One-minute EGF recordings using 64-pole basket catheters were obtained both pre-PVI and post-PVI following a 20-minute wait and confirmation of electrical isolation of veins. Patients with EGF-identified sources were randomized 1:1 to EGF-guided source ablation vs PVI-only. Patients with no sources were not randomized and mostly received PVI only., Results: Study of 85 patients enrolled 24 with EGF-identified sources randomized to PVI only and 23 with no sources receiving PVI only. Of these 47 patients, those with sources (Group 2) had different clinical characteristics including older age and higher CHA 2 DS 2 -VASc scores compared with those with no sources (Group 1). After PVI only, Group 1 had 70% (16 of 23) freedom from recurrent AF (FFAF) within 1 year vs Group 2 with 35% (8 of 23), P = .018. In addition, patients with high electrographic flow consistency (EGFC) indicative of healthy or normal substrate had 67% (10 of 15) FFAF vs 45% (14 of 31) in those with low EGFC suggestive of abnormal substrate, P = .011., Conclusion: Success rates in no-sources patients receiving PVI only are better than in those with sources randomized to PVI only. For the clinically heterogenous population of patients with PeAF, the presence of EGF-identified sources matters clinically, and PVI only will not be enough for all patients., Competing Interests: Disclosures Dr Verma is consultant and owns equity in Cortex, Inc; is consultant for Adagio Medical and Mediumics; has received research grants from Bayer Inc, Biosense Webster, Medtronic, and Boston Scientific. Dr Castellano is an employee of Cortex, Inc, with equity interest. Dr Kong is a former employee of Cortex, Inc, with equity interest and relevant patent holdings. Dr Neuzil has received support from a Scientific Grant by Ministry of Health, Czech Republic, DRO (NNH, IG 180504) and travel grants from Cortex, Inc. Dr Szili-Torok has served as consultant for Biotronik and has received institutional grants from Biotronik, Abbott NL, Biosense Webster, Acutus Medical Inc, Stereotaxis, and Catheter Precision. Dr Spitzer has received honoraria for lectures from Amgen, AstraZeneca, Biotronik, Daiichi Sankyo, and Edwards Medtronic and has participated in clinical trials for Boston Scientific, LifeTech, and Vanguard. Dr Rillig has served as consultant for Medtronic, KODEX-EPD, Biosense Webster, and Boston Scientific and has received travel grants and lecture fees from Cortex, Inc, Medtronic, CardioFocus, Biosense Webster, Abbott, Boehringer Ingelheim, Philips KODEX-EPD, Bayer Inc, Novartis, LifeTech, and Boston Scientific. Dr Reddy has served as consultant and owns equity in Cortex, Inc, Acutus Medical, Affera-Medtronic, Anumana, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, Laminar, LuxMed, Medlumics, Middlepeak, NuVera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, and Valcare; has served as consultant for Abbott, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Philips, and Pulse Biosciences; and owns equity in DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and VizaraMed., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: For the treatment of the symptoms of post-COVID-19 syndrome, no causal therapy is currently widely recommended according to evidence-based criteria. The overarching goal of the intervention study over a 3-year period (Q1-2021-Q4-2023) was to evaluate the changes in the key symptoms of fatigue and sensorimotor instability through individualized stress-controlled training therapy and through intensified cognitive behavioral therapy., Material and Methods: In the 3‑year period 407 vaccinated nucleocapsid positive patients were treated at the Post-COVID-19 Center Lausitz (Senftenberg). In 78 (around 19%) fatigue/immunometabolic depression and sensorimotor instability were identified as the leading syndromes. The evaluation of the individualized stress-controlled training therapy was based on the specific post-COVID-19 syndrome and motor fatigue parameters. The secondary psychosomatic syndrome was assessed using cognitive fatigue parameters and cognitive behavioral therapy instruments. The investigation of -parameters influencing behavior took place in Q2-2023-Q4-2023 with a guide-supported qualitative interview among the participants., Results: The post-COVID-19 key symptoms "fatigue," "sensorimotor instability," "neuropsychiatric symptoms," "cardiac/autonomic dysfunction," and "pain" improved significantly in the overall cohort and in the gender-specific analysis. A deterioration occurred in "secondary psychosomatic symptoms". A therapeutic effect was demonstrated for all motor fatigue parameters for the entire cohort using the Cohen's d value. An intensification of cognitive behavioral therapy achieved positive effects through an increasing development of the patients' own activity and their self-control using persuasion and gamification., (© 2024. The Author(s).)

Background: Electrographic flow (EGF) mapping enables full spatiotemporal reconstruction of organized wavefront propagation to identify extrapulmonary vein sources of atrial fibrillation (AF)., Objectives: FLOW-AF (A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW [EGF] Algorithm Technology [Ablamap Software] to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation) was multicenter, randomized controlled study of EGF mapping to: 1) stratify a nonparoxysmal AF population undergoing redo ablation; 2) guide ablation of these extrapulmonary vein AF sources; and 3) improve AF recurrence outcomes., Methods: FLOW-AF enrolled persistent atrial fibrillation (PerAF)/long-standing PerAF patients undergoing redo ablation at 4 centers. One-minute EGF maps were recorded from standardized biatrial basket positions. Patients with source activity ≥26.5% were randomized 1:1 to PVI + EGF-guided ablation vs PVI only; patients without sources ≥26.5% threshold were not randomized. Follow-up and electrocardiographic monitoring occurred at 3, 6, and 12 months., Results: We enrolled 85 patients (age 65.6 ± 9.3 years, 37% female, 24% long-standing PerAF). Thirty-four (40%) patients had no sources greater than threshold; at least 1 source greater than threshold was present in 46 (60%) (EGF-guided ablation, n = 22; control group, n = 26). Patients with sources were older (68.2 vs 62.6 years; P = 0.005) with higher CHA 2 DS 2 -VASc scores (2.8 vs 1.9; P = 0.001). The freedom from safety events was 97.2%, and 95% of EGF-identified sources were successfully ablated. In randomized patients, AF-free survival at 12 months was 68% for EGF-guided ablation vs 17% for the control group (P = 0.042); freedom from AF/atrial tachycardia/atrial flutter at 12 months was 51% vs 14% (P = 0.103), respectively., Conclusions: In nonparoxysmal AF patients undergoing redo ablation, EGF mapping identified AF sources in 60% of patients, and could be successfully ablated in 95%. Compared with PVI alone, PVI + source ablation improved AF-free survival by 51% on an absolute basis. (FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology [A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW (EGF) Algorithm Technology (Ablamap Software) to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation]; NCT04473963)., Competing Interests: Funding Support and Author Disclosures This study was funded by Ablacon, Inc. Drs Petru, Funasako, and Neuzil were supported by a Scientific Grant by the Ministry of Health Czech Republic, DRO (NNH, IG 180504). Dr Reddy has served as a consultant for and owns equity in Ablacon; unrelated to this manuscript, has served as a consultant for and owns equity in Acutus Medical, Affera-Medtronic, Anumana, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, Laminar, LuxMed, Medlumics, Middlepeak, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, and Valcare; unrelated to this work, has served as a consultant for Abbott, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Philips, and Pulse Biosciences; and owns equity in DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. Dr Szili-Torok has served as a consultant, served as an advisor, or has had a speaker contract for product development with Ablacon Inc, Acutus Medical Inc, and Stereotaxis; and his institution, Erasmus Medical Center, has received institutional grants from Ablacon, Abbott NL, Biosense Webster, Acutus Medical Inc, Stereotaxis, and Catheter Precision. Dr Dinshaw has received speaker fees and travel grants from Abbott; and speaker fees from Daiichi Sankyo. Dr Rillig has received research and travel grants from Ablacon; travel grants from Abbott; speaker fees and travel grants from Biosense Webster; and speaker and consultant fees and travel grants from Medtronic. Dr Spitzer has received lecture grants from Abbott, Biotronik, Edwards, and Medtronic; served on the advisory board and received travel grants from Medtronic; and received research grants from Ablacon, Medtronic, and Lifetech Scientific. Dr Kong is an employee of and owns equity in Ablacon. Dr Neuzil has received grant funding from Ablacon. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Electrographic flow (EGF) mapping enables the dynamic detection of functional or active atrial fibrillation (AF) sources outside the pulmonary veins (PVs), and the presence or absence of these sources offers a novel framework for classifying and treating persistent AF patients based on the underlying pathophysiology of their AF disease., Objective: The primary objective of the FLOW-AF trial is to evaluate the reliability of the EGF algorithm technology (Ablamap software) to identify AF sources and guide ablation therapy in patients with persistent AF., Methods: The FLOW-AF trial (NCT04473963) is a prospective, multicenter, randomized clinical study in which patients with persistent or long-standing persistent AF who have failed prior PV isolation (PVI) undergo EGF mapping after confirmation of intact PVI. In total, 85 patients will be enrolled and stratified based on the presence or absence of EGF-identified sources. Patients with an EGF-identified source above the predetermined activity threshold of ≥26.5% will be randomized in a 1:1 fashion to PVI only vs PVI + ablation of EGF-identified extra-PV sources of AF., Results: The primary safety endpoint is freedom from serious adverse events related to the procedure through 7 days following the randomization procedure; and the primary effectiveness endpoint is the successful elimination of significant sources of excitation with the target parameter the activity of the leading source., Conclusions: The FLOW-AF trial is a randomized study designed to evaluate the ability of the EGF mapping algorithm to identify patients with active extra-PV AF sources., (© 2023 Published by Elsevier Inc. on behalf of Heart Rhythm Society.)

Aims: REDO-FIRM evaluated safety and effectiveness of conventional vs. focal impulse and rotor modulation (FIRM)-guided ablation of recurrent persistent or paroxysmal atrial fibrillation (AF) after an initial AF ablation procedure., Methods and Results: This prospective, multicentre, randomized study included patients with a single prior AF ablation, but with recurrent AF and reconnected pulmonary veins (PVs). Conventional ablation generally included PV re-isolation; however, additional ablation was permitted per physician discretion. In the FIRM arm, beyond PV re-isolation, basket catheter-based FIRM mapping created dynamic animations of putative rotors, which were targeted for ablation. Between May 2016 and July 2019, 269 subjects were randomized, with 243 subjects completing 12-month follow-up. Ablation beyond re-pulmonary vein isolation, the FIRM vs. Conventional arms did not differ significantly: cavo-tricuspid isthmus -9.0% vs. 15.3%, caval vein isolation -1.5% vs. 0.8%, non-PV trigger -2.2% vs. 3.8%, other -11.9% vs. 13.0%. Single procedure 12-month freedom from AF/atrial tachycardia/atrial flutter-recurrence was 63.3% (76/120) vs. 59.0% (72/122) in the FIRM and Conventional arms (P = 0.3503). Efficacy was similar in the paroxysmal and persistent AF subgroups (P = 0.22 and P = 0.48). The 10-day and 12-month safety endpoints were achieved in 93.3% vs. 93.8% (P = 0.89) and 88.4% vs. 93.4% (P = 0.22) in the FIRM and Conventional arms, respectively., Conclusions: In REDO-FIRM, as compared to standard ablation, FIRM-guided ablation did not provide additional efficacy in redo ablation procedures, but FIRM-guided ablation was equally safe. Additional studies are necessary to identify any potential population able to benefit from FIRM-guided ablation., Competing Interests: Conflict of interest: S.G.S. received speaker’s honoraria and or honoraria for advisory board activities from Medtronic, Abbott, Daiichi Sankyo, Edwards, AstraZeneca, BayerVital, Bristol Myer Sqibb and Boeringer Ingelheim, and participated in clinical trials with Abbott, Medtronic and Ablacon. J.M.M. received speaker’s honoraria and honoraria for training support from Medtronic, Boston Scientific, Biotronik and Biosense Webster, is consultant of Biosense-Webster and MediLynx, and received speaker’s honoraria from Abbott as well as Royalties vom Elsevier, Inc. P.S. is member of advisora board of Abbott, Biosense-Webster, Boston Scientific and Medtronic. V.Y.R. reports being an unpaid consultant to Abbott Inc; in addition, he has disclosures unrelated to this manuscript, which are detailed in the Supplementary material online, appendix. D.W. stated the following disclosures: Abbott: Research (modest), ACC Foundation: consulting (modest), Atricure: Research (modest), Biosense Webster: Research (modest), consulting (modest), Boston Scientific: Research (modest), consulting (modest). The other authors report no conflicts of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Various randomized multicenter studies have shown that percutaneous left atrial appendage closure (LAAC) is not inferior in stroke prevention compared to vitamin K antagonists (VKA) and can be performed safely and effectively., Aims: The prospective multicenter ORIGINAL registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure) investigated the efficiency and safety of LAAC with Watchman or Amulet device in a real word setting. A special focus was put on the influence of LAAC frequency on periprocedural efficiency and safety., Methods and Results: The total of 482 consecutive patients (Abbott Amulet N = 93 and Boston Scientific Watchman N = 389) were included in the periinterventional analyses. After 6 weeks, 353 patients completed the first follow-up including transoesophageal echocardiography (TEE) (73.2%). Successful LAAC could be performed in more than 94%. The complication rate does not significantly differ between device types (p = 0.92) according to Fischer test and comprised 2.2% in the Amulet and 2.3% in the Watchman group. The kind of device and the frequency of LAAC per study center had no influence on the success and complication rates. Device related thrombus could be revealed more frequently in the Watchman group (4.5%) than in the Amulet group (1.4%) but this difference is still not significant in Fisher test (p = 0.14). Same conclusion can be made about residual leakage 1.1% versus 0% [not significant in Fisher test (p = 0.26)]. Dual antiplatelet therapy followed the intervention in 64% and 22% of patients were discharged under a combination of an anticoagulant (VKA/DOAC/Heparin) and one antiplatelet agent., Conclusions: The ORIGINAL registry supports the thesis from large, randomized trials that LAAC can be performed with a very high procedural success rate in the everyday clinical routine irrespective of the used LAA device (Watchman or Amulet). The postprocedural antithrombotic strategy differs widely among the participating centers. Trial registration Name of the registry: "saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure", Trial registration number: DRKS00023803; Date of registration: 15/12/2020 'Retrospectively registered'; URL of trial registry record: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023803 ., (© 2022. The Author(s).)

Aim: To compare patient characteristics, safety and efficacy of catheter ablation of supraventricular tachycardia (SVT) in patients with and without structural heart disease (SHD) enrolled in the German ablation registry., Methods and Results: From January 2007 until January 2010, a total of 12,536 patients (37.2% with known SHD) were enrolled and followed for at least one year. Patients with SHD more often underwent ablation for atrial flutter (45.8% vs. 20.9%, p < 0.001), whereas patients without SHD more often underwent ablation for atrioventricular nodal reentrant tachycardia (30.2% vs. 11.8%, p < 0.001) or atrioventricular reentrant tachycardia (9.1% vs. 1.6%, p < 0.001). Atrial fibrillation catheter ablation procedures were performed in a similar proportion of patients with and without SHD (38.1% vs. 36.9%, p = 0.21). Overall, periprocedural success rate was high in both groups. Death, myocardial infarction or stroke occurred in 0.2% and 0.1% of patients with and without SHD (p = 0.066). Major non-fatal complications prior to discharge were rare and did not differ significantly between patients with and without SHD (0.5% vs. 0.4%, p = 0.34). Kaplan-Meier mortality estimate at 1 year demonstrated a significant mortality increase in patients with SHD (2.6% versus 0.7%; p < 0.001)., Conclusion: Patients with and without SHD undergoing SVT ablation exhibit similar success rates and low major complication rates, despite disadvantageous baseline characteristics in SHD patients. These data highlight the safety and efficacy of SVT ablation in patients with and without SHD. Nevertheless Kaplan-Meier mortality estimates at 1 year demonstrate a significant mortality increase in patients with SHD, highlighting the importance of treating the underlying condition and reliable anticoagulation if indicated., (© 2021. The Author(s).)

Background: Registry data add important information to randomized controlled trials (RCT) on real-life aspects of implantable cardioverter-defibrillator (ICD) patients with and without cardiac resynchronization therapy (CRT-D). This analysis of the prospectively conducted German Device Registry aims at comparing mortality rates, comorbidities, complication rates to results from RCT., Methods: The German Device registry (DEVICE) prospectively collected data on ICD and CRT-D first implantations from 50 German centres. Demographic data, details on cardiac disease, electrocardiogram (ECG), medication, and data about procedure, complications, and hospital stay were stored in electronic case report forms. One year after device implantation patients were contacted for follow-up., Results: DEVICE included n = 4384 first ICD/CRT-D implantations (29.3% CRT-D devices). We found a strong adherence to guidelines with over 90% of patients being on ß-blocker and ACE-inhibitor medication and adequate QRS width in the majority of CRT-D patients. Patients receiving a CRT-D were older (67.6 ± 11.0 years vs. 63.9 ± 13.4 years, p < .001) and had lower ejection fractions (mean 25% vs. 30%, p < .001) compared to ICD patients. Dilated cardiomyopathy was the predominant underlying heart disease in CRT-D (53.3%), coronary artery disease in ICD patients (64.7%). Compared to RCT our DEVICE patients had more comorbidities (17.9% chronic kidney disease [CKD]) and higher 1-year mortality rates (10.7% ICD group, 12.3% CRT group). In multivariate analysis, CKD patients had an almost 2-fold higher risk of 1-year mortality., Conclusion: Despite relevant limitations of registry data, DEVICE highlights important differences between RCT and real-world registry data and the impact of comorbidities on mortality of ICD and CRT-D recipients., (© 2022 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Aims: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become increasingly safe and effective with the evolution of single-tip ablation catheters aided by contact force sensing (ST-CF) and single-shot devices such as the second-generation pulmonary vein ablation catheter (PVAC) Gold multi-electrode array. The multicentre randomized GOLD FORCE trial was conducted to evaluate non-inferiority of safety and efficacy of PVAC Gold PVI compared to ST-CF ablation for paroxysmal AF., Methods and Results: The primary efficacy endpoint documented AF recurrence ≥30 s was assessed by time-to-first-event analysis after a 90-day blanking period using repeated 7-day Holters. Secondary endpoints include acute success and procedural characteristics. Safety endpoints included procedural complications, stroke/transient ischaemic attack (TIA), tamponade, bleeding, and access site complications. Two hundred and eight patients underwent randomization and PVI (103 assigned to PVAC Gold, 105 to ST-CF). Acute success rates were 95% and 97% for PVAC Gold and ST-CF, respectively. At 12 months, AF recurrence was observed in 46.6% of the PVAC Gold group and in 26.2% of the ST-CF group [absolute efficacy difference 20.4% (95% confidence interval, CI 7.5-33.2%), hazard ratio 2.05 (95% CI 1.28-3.29), P = 0.003]. PVAC Gold had significantly shorter procedure and ablation times. Complication rates were 5.7% and 4.9% for PVAC Gold and ST-CF, respectively (P = 0.782)., Conclusion: In this multicentre randomized clinical trial, ablation with ST-CF and PVAC Gold ablation catheters non-inferiority for efficacy was not met. AF recurrence was significantly more frequent in the PVAC Gold group compared to single-tip contact force group. Both groups had similarly low rates of adverse events. PVAC Gold ablation had significantly shorter procedure and ablation times., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Background: Patients receiving implantable-cardioverter-defibrillators (ICD) in clinical practice are often older or younger than in clinical trials. Whether older patients benefit from ICD-therapy in a similar way as younger patients is under debate. The objective of this study was to provide real-world data regarding outcomes with respect to age in a large cohort in the German Device Registry., Methods: Within the registry data from 50 German centers were collected between January 2007 and February 2014., Results: Our analysis included 3239 ICD patients representing a group of young (28%; group I: < 58 years), intermediate aged (50%; group II: 58-74 years), and elderly patients (22%; group III: 75-92 years). Intergroup comparison of all groups was performed followed by individual comparison vs. group II serving as age-reference group. Procedure-related complications did not differ between all groups. Analysis of the primary endpoint, 1-year all-cause mortality, revealed an increased mortality in the elderly and a decreased mortality in the young cohort vs. the reference group II (group I 2.1%, group II 6.2%, group III 13.2%; p < 0.001). While all-cause rehospitalizations did not differ, we observed a difference in reported device revisions showing more device revisions required in younger patients (group I 8.9%, group II 6.8%, group III 4.0%; p = 0.001)., Conclusions: One-year mortality was doubled in elderly ICD patients probably due to non-cardiac causes. These results further underpin the need for re-evaluating the primary prevention ICD indication in octo- and nonagenarians. Young patients show lower mortality rates but seem to bear higher risk of device-related complications, which highlights the need for improved measures to reduce device-related complications in the young., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

Aims: Despite lacking supporting randomized trials, cardiac glycosides (CGs) are widely used in heart failure and/or atrial fibrillation. Moreover, several pro- and retrospective studies and registry-data have recently raised serious concerns in terms of efficacy and safety of CGs in this field. We have therefore examined the association between CGs and clinical outcome of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization (CRT-ICD) patients of the large German DEVICE registry., Methods and Results: Between 2007 and 2014, 3782 ICD and 1529 CRT-ICD patients were enrolled in the German DEVICE registry. Those two groups were analyzed independently according to medication with or without CGs. After adjustment for patient characteristics, CGs were not significantly associated with increased one-year mortality (HR 1.27, 95%-CI 0.91-1.76, p = 0.162), major adverse cardiac and cerebrovascular events (OR 1.36, 95%-CI 0.98-1.89, p = 0.063), ICD-shocks (OR 1.29, 95%-CI 0.95-1.74, p = 0.104) or the need for rehospitalization in ICD patients at one-year-follow-up. Similar findings were obtained in CRT-ICD patients. Regarding possible determinants for glycoside treatment, atrial fibrillation at enrollment was found to be most strongly associated with the prescription of glycosides in ICD (adjusted OR 3.25, 95%-CI 2.63-4.02) and CRT-ICD patients (adjusted OR 3.17, 95%-CI 2.39-4.19)., Conclusion: Overall harmful effects of CGs in ICD- and CRT-ICD patients could not be confirmed in DEVICE. Further large and randomized-controlled trials that investigate dose-dependent effects of CGs in addition to contemporary therapy of heart failure and atrial fibrillation are needed., (Copyright © 2021. Published by Elsevier B.V.)

Background: The impact of structural heart disease (SHD) on safety and efficacy of catheter ablation of cavo-tricuspid isthmus-dependent atrial flutter (AFLU) is unclear. In addition, recent data suggest a higher complication rate of AFLU ablation compared to the more complex atrial fibrillation (AF) ablation procedure., Methods and Results: Within our prospective multicenter registry, 3526 consecutive patients underwent AFLU ablation at 49 German electrophysiological centers from 2007 to 2010. For the present analysis, the patients were divided into a group with SHD (n = 2164 [61.4%]; median age 69 years; 78.5% male) and a group without SHD (n = 1362 [38.6%]; 65 years; 70.3% male). In our study, SHD mainly encompasses coronary artery disease (52.6%), left ventricular ejection fraction ≤ 50% (47.6%), and hypertensive heart disease (28.0%). The primary ablation success (97%) and the incidence of major (0.2%) or moderate (1.2%) complications did not differ significantly between the two groups (P = 1.0 and 0.87, respectively). Vascular access site complications (0.6%), AV block III° (0.2%), and bleeding (≥ BARC II: 0.2%) were most common. After a median 562 days of follow-up, we observed a 2.92-fold higher one-year mortality (P < 0.0001) in patients with SHD. Patients' satisfaction with the ablation therapy (72.0% satisfied) was close to the overall subjective tachyarrhythmia-free rate (70.7%)., Conclusions: The present analysis demonstrates that ablation of cavo-tricuspid isthmus dependent AFLU in patients with SHD has a comparable, excellent risk-benefit profile in our large "real-world" registry. Mortality rates expectedly are higher in patients with SHD and AFLU compared to patients without SHD. CLINICALTRIALS.GOV: NCT01197638, http://clinicaltrials.gov/ct2/show/NCT01197638.

Background: Ablation of recurrent atrial fibrillation (AF) is common. Studies indicate that AF recurrence is primarily due to pulmonary vein (PV) re-conduction. This retrospective analysis characterized and evaluated recurrent AF patients using focal impulse and rotor mapping (FIRM) plus PV re-isolation, with follow up at 3, 6, 12, and 24 months after the repeat ablation., Methods and Results: Patients (consecutive, n = 100) underwent FIRM-guided ablation followed by conventional PV re-isolation for recurrent AF treatment. All FIRM patients had failed one or more conventional ablation procedures (1.4 ± 0.08) for paroxysmal (14%), persistent (15%), and long-standing persistent (71%) AF. Stable rotors were identified in 97/100 patients: 60% in the right atrium (RA) and 82% in left atrium (LA) (mean 1.5 ± 0.8 and 2.1 ± 1.2 per patient, respectively). No correlation was noted between the previous number of ablations, AF duration, or LA diameter to the number of rotors (R 2  = 0.0039, R 2  = 0.0017, and R 2  = 0.006, respectively). In this limited observation, only 22% of identified rotors were associated with proximity to low voltage areas. The 12- and 24-month arrhythmia free rate was 93% (13/14) and 92% (12/13) for paroxysmal AF, 60% (9/15) and 47% (7/15) for persistent AF, and 70% (48/69) and 64% (43/67) for long-standing persistent AF, respectively, after a single FIRM procedure and re-isolation of the veins., Conclusions: The data show a benefit for FIRM-guided ablation in recurrent AF at 12 months. No correlation was found between rotors and tissue characterization, AF duration, or previous number of ablations, suggesting that rotors may play an independent role in maintaining recurrent AF after prior failed ablation.

In an international comparison, Germany is in the top group for health care. Not only since the economic burdens of the corona pandemic, however, has there been agreement of the necessity of exploiting the considerable efficiency and effectiveness reserves that also exist in this area. Particularly in the interface area between outpatient and inpatient care, increasingly divergent development paths are beeing discusssed. Despite scientific findings to the contrary, integrative cooperative structures threaten to fall behind.

Background: Hypertension (HTN) constitutes a risk factor for the development of atrial fibrillation (AF), as well as for thromboembolic and bleeding events. We analysed the outcome after catheter ablation of AF in HTN in a cohort from the prospective multicenter German Ablation Registry., Methods: Between 03/2008 and 01/2010, 626 patients undergoing AF-ablation were analysed. Patients diagnosed with HTN ( n = 386) were compared with patients without HTN ( n = 240) with respect to baseline, procedural and long-term outcome parameters., Results: Patients with HTN were older and more often presented with persistent forms of AF and cardiac comorbidities. Major and moderate in-hospital complications were low. At long-term follow-up, major cardiovascular events were rare in both groups. Rates of AF-recurrence, freedom from antiarrhythmic medication and repeat ablation were not statistically different between groups. Most patients reported improvement of symptoms and satisfaction with the treatment. However, patients with HTN more frequently complained of dyspnea of New York Heart Association (NYHA) class ≥ II and angina. They were more often rehospitalized, particularly when persistent AF had been diagnosed., Conclusion: Catheter ablation of AF is associated with low complication rates and favorable arrhythmia-related results in patients with HTN. Residual clinical symptoms may be due to cardiac comorbidities and require additional attention in this important subgroup of AF-patients.

Background: In atrioventricular nodal reentrant tachycardia (AVNRT), catheter ablation is considered as first-line therapy. Despite high success rates, some patients present with arrhythmia recurrence or develop other types of arrhythmias over time., Objective: To assess the incidence of symptomatic arrhythmias after initially successful AVNRT ablation and to analyze their clinical implications in a real-world cohort., Methods: We included 2,795 patients from the German Ablation Registry undergoing first ablation of AVNRT between 01/2007 and 01/2010. In patients alive at long-term follow-up, patient-specific characteristics and long-term follow-up data were compared between patients with (group A) and without (group B) any symptomatic arrhythmia during follow-up., Results: Symptomatic arrhythmias occurred in 17.2% of patients during a mean follow-up of 678 days after AVNRT ablation. The patients with symptomatic arrhythmias were more often female and suffered from structural heart disease. Arrhythmia occurrence was clinically relevant regarding symptoms and patient satisfaction. Serious adverse events including stroke, transient ischemic attack, pacemaker implantation, as well as continued use of antiarrhythmic medication occurred more often in group A. A second ablation procedure was performed in 26% of symptomatic patients to optimize the symptomatic outcome, whereas cardiovascular events or patient satisfaction were not further improved., Conclusion: During long-term follow-up, one out of six patients experienced symptomatic arrhythmias after AVNRT ablation, associated with an increase of serious adverse events. A subset of patients required medical or interventional antiarrhythmic therapy, possibly attributable to the co-existence of other arrhythmias. Screening for arrhythmic and cardiac co-morbidity before and after ablation may support comprehensive therapy planning and outcome.

Background: In patients with high risk for sudden cardiac death the implantation of a defibrillator is an established treatment. However the benefits and risks for patients in accordance to the number of the leads are not clear. Even in the current guidelines a recommendation to this question is missing. We analyzed advantage and disadvantages of single-chamber implantable cardioverter defibrillators (VVI-ICD) versus dual-chamber implantable cardioverter defibrillators (DDD-ICD) in the prospective German Device Registry., Methods: The data of 2240 patients who underwent ICD implantation in 45 German Centers between January 2007 and March 2011 were included in a prospective device registry (VVI: n = 1629, male = 1358, EF = 34% ± 13%; DDD: n = 611, male = 491, EF = 35% ± 14%)., Results: The in-hospital complications were significantly higher in the DDD-ICD group with higher revision/device complication rates (3.0% vs. 1.2%; p = 0.003) but also higher mortality rate (1.0% vs. 0.1%; p < 0.001). Regarding the adjusted data at 1-year follow-up DDD-ICD caused more device revisions, but no difference in rehospitalization and mortality., Conclusion: It is still unclear whether DDD-ICD may be beneficial for patients with preserved sinus and atrioventricular nodal function. Our data show that the decision of the operator to choose a DDD-ICD in these patients must be taken very carefully. By choosing a DDD-ICD the patient is exposed to a significantly higher periprocedural complication rate and higher in-hospital mortality. In absence of relevant bradycardias implantation of a DDD-ICD is not justified.

Aims: Diabetes mellitus (DM) has a negative impact on prognosis in patients with heart failure (HF). The role impact of DM in HF patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices might differ and remains unclear. The aim of our study was to investigate the impact of DM on periprocedural complications and clinical outcome in HF patients undergoing ICD or CRT implantation., Methods and Results: Within the German Device Registry, data from 50 German centres were collected between January 2007 and February 2014. A retrospective analysis of n = 5329 patients undergoing ICD implantation was conducted. Patients' characteristics, procedural data, periprocedural complications, and post-procedural clinical outcome, including a composite clinical endpoint of all-cause mortality, stroke, and myocardial infarction (MACCE), were analysed. Subgroup analysis were performed for ICD and CRT implantations. Median follow-up was 15.7 (12.9; 20.0) and 16.2 (12.8; 21.2) months in DM and non-DM patients. Of 5329 patients enrolled, n = 1448 (27.2%) had a diagnosis of DM. Within the cohort, 94% of DM and 90% of non-DM patients had a diagnosis of HF. Patients with DM were older, had higher body mass index, and higher rate of cardiovascular comorbidities compared with non-DM patients. Unadjusted and adjusted analyses revealed similar all-over intrahospital periprocedural complication rates in both groups (4.1% vs 3.9%). Unadjusted Kaplan-Meier survival analysis showed higher all-cause mortality after 1 year (9.0% vs 6.3%; log-rank P = 0.001) with higher MACCE rates (10.0% vs 7.3%; P < 0.001) in the DM group versus non-DM patients. After multivariable adjustment for relevant covariates, the association of DM to MACCE disappeared [HR 1.11 (0.89-1.38)]. Because chronic kidney disease (CKD) was clearly associated with increased 1 year MACCE after multivariate adjustment [odds ratio (OR) 2.11 (1.68-2.64)], a subgroup analysis was performed showing a strong trend towards more perioperative complications in DM patients with CKD [OR 2.16 (0.9-5.21)], while no effect of DM was observed in patients without CKD [OR 0.73 (0.42-1.28)]., Conclusions: The overall risk of periprocedural complications and short-term (1 year) clinical outcome in patients with DM and HF undergoing ICD or CRT defibrillator (CRT-D) implantation was not increased. In contrast, CKD was associated with an increased risk of 1 year MACCE in HF patients undergoing ICD/CRT-D implantation., (© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)

Low-grade B-cell lymphoma with immunoglobulin ( IG ) and interferon regulatory factor 4 ( IRF4 ) gene rearrangement is extremely rare, with only 4 cases being previously reported. In this article, we report one additional case that arises from the skull and review the literature. The patient was a 69-year-old man who presented with recurrent and disabling vertigo and was found to have a 5.0 × 1.7 cm lesion within the left posterior parietal bone. Histological examination revealed a bone lesion with diffuse lymphoid infiltrate comprising of mostly small lymphocytes with scant cytoplasm, slightly irregular nuclei and inconspicuous nucleoli, and scattered larger cells resembling prolymphocytes and paraimmunoblasts. Immunohistochemical studies showed that the neoplastic cells were positive for CD20, CD79a, PAX5, CD23, CD43, BCL-2, BCL-6, MUM-1, LEF-1, and IgM and negative for CD5, CD10, cyclinD1, SOX11, and IgD. Flow cytometric analysis identified CD5 negative and CD10 negative monoclonal B cells with lambda light chain restriction. Fluorescence in situ hybridization analysis revealed del(13q) abnormality, but was negative for IGH/BCL2, IGH/CCND1 , and BIRC3/MALT1 translocations. Next-generation sequencing identified IGK-IRF4 rearrangement and BRD4 E1113 del abnormalities. Given a low clinical stage (IE) of the disease, the patient did not receive additional treatments and was free of disease at 1 year after the diagnosis.

Background: Implantable cardioverter- defibrillator (ICD) therapy is established for the prevention of sudden cardiac death (SCD) in different entities. However, data from large patient cohorts with electrical heart disease are rare. Therefore, we investigated these patients as well as patients with hypertrophic cardiomyopathy by analyzing registry data from a multi-center 'real-life' registry., Methods: The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5450 patients receiving device implantations in 50 German centers. The present analysis of DEVICE focussed on patients with electrical heart disease or HCM who received an ICD for primary or secondary prevention., Results: 174 patients with HCM and 112 patients with electrical heart disease (long-QT syndrome, Brugada syndrome and arrhythmogenic right ventricular cardiomyopathy) were compared with 5164 other ICD patients. Median follow-up was 17.0 months. Patients in the control group were significantly older. Of note, overall mortality after 1 year was 1.8% in HCM patients, 6.6% in patients with electrical heart disease and 7.3% in the control group. Patients in the control group presented significantly more severe comorbidities. In contrast to HCM patients and the control group where primary prevention was the major indication for ICD implantation, 77.5% of patients with electrical heart disease received an ICD for secondary prevention. The number of surgical revisions was higher in patients with electrical heart disease., Conclusion: Data from the present registry display a surprisingly high mortality in patients with electrical heart disease equivalent to the control group. A high proportion of patients who received an ICD for secondary prevention may be regarded as a major determinant for these results, while severe comorbidities such as diabetes, hypertension, and renal failure are major determinants for mortality in the control cohort.

Background: Aged patients are underrepresented in clinical trials on catheter ablation of atrial fibrillation (AF). In addition, results of outcomes after repeat ablation in the elderly are lacking. We report the results of first repeat AF ablation procedures of aged patients from a real-world multicenter prospective registry., Methods: Patients undergoing second AF ablation included in the prospective, multicenter German Ablation Registry were divided in two groups (age > 70 years (group 1) and age ≤ 70 years (group 2)) and analyzed for procedural characteristics and clinical follow-up., Results: 738 patients were analyzed (108 patients in group 1, 630 patients in group 2). Significantly more aged patients had structural heart disease (56 patients (51.9%) vs. 203 patients (32.2%), p < 0.001). The majority of the patients underwent repeat pulmonary vein isolation (101 patients (93.5%) vs. 593 patients (94.1%), p = 0.98). More aged patients underwent ablation of left atrial linear lesions (78.1% vs. 57.3% of all linear lesions, p = 0.027). There was no difference in the occurrence of peri-procedural complications (7 patients (6.5%) vs. 24 patients (3.8%), p = 0.30). Recurrence of atrial arrhythmias was documented in 45/105 (42.9%) and 252/603 (41.8%) patients with available follow-up in groups 1 and 2 after a median of 447 (400; 532) and 473 (411; 544) days (p = 0.84). A comparable amount of patients were asymptomatic or reported symptom improvement after repeat ablation in both groups (80% (80/100) in group 1 and 77% (446/576) in group 2; p = 0.57)., Conclusion: Repeat ablation for AF in elderly patients can be performed with safety and efficacy comparable to younger patients.

Background: Digitalis glycosides are employed for rate control of atrial fibrillation. Recent studies suggested potential harmful effects of digitalis monotherapy and combination with antiarrhythmic drugs. The aim of the present study was to assess the prevalence and potential impact of digitalis therapy on outcome in patients undergoing catheter ablation of supraventricular arrhythmias., Methods and Results: The German Ablation Registry is a nationwide, prospective registry with a 1-year follow-up investigating 12,566 patients receiving catheter ablations of supraventricular arrhythmias in 52 German centres. The present analysis focussed on pharmacotherapy in 8608 patients undergoing catheter ablation of atrial tachycardia, atrial fibrillation, or atrial flutter. Patients receiving digitalis therapy (n = 417) were older and presented a significantly increased prevalence of comorbidities including coronary artery disease, heart failure, diabetes, and pulmonary disease. One-year mortality was significantly higher in digitalis-treated patients (4.7% vs. 1.3%, p < 0.001), most strikingly in patients undergoing ablation of atrial flutter. This effect was maintained after adjustment for important risk factors. Similar results were obtained for as the combined endpoint of death, myocardial infarction, stroke and major bleeding (6.6% vs. 2.7%, p < 0.001), and non-fatal rehospitalisations (54.1% vs. 45.1%, p = 0.001)., Conclusion: In the present study of patients undergoing catheter ablation of supraventricular arrhythmias, an association of digitalis therapy with increased mortality and an increased rate of other severe adverse events were observed. The results from this 'real-life' registry are consistent with previously published studies. However, whether digitalis therapy promotes a poorer prognosis or may just serve as a marker for this aspect cannot be thoroughly interpreted.

Background: We aimed to compare patient characteristics and outcome of patients who had either undergone pulmonary vein isolation (PVI) or AV-node ablation (AVN) to control AF-related symptoms., Methods: From the German Ablation Registry, we analyzed data of 4444 patients (95%) who had undergone PVI and 234 patients (5%) with AVN., Results: AVN patients were on average 10 years older than PVI patients (71 ± 10 vs. 61 ± 10 years, p < 0.001) with 33% aged > 75 years. AVN patients had significantly more cardiovascular comorbidities (diabetes 21% vs. 8%, renal insufficiency 24% vs. 3%, underlying heart disease 80% vs. 36%, severely reduced left ventricular function 28% vs. 1%, all p < 0.001). Significantly more PVI patients had paroxysmal AF (63% vs. 18%, p < 0.001), and more AVN patients had long-standing persistent AF (44% vs. 7%, p < 0.001). At 1-year follow-up, mortality in the AVN group was much higher (Kaplan-Meier estimates 9.8% vs. 0.5%). 20% of PVI patients had undergone another ablation vs. 3% AVN patients (p < 0.001). Symptomatic improvement was equally achieved in about 80%. Re-hospitalization for cardiovascular reasons occurred significantly more often in PVI vs. AVN patients (31% vs. 18%, p < 0.001)., Conclusion: In the large German Ablation Registry, AVN ablation was performed much less frequently than PVI for symptomatic treatment of AF and typically in older patients with more comorbidity. Symptomatic improvement was similar in both groups. Hospitalizations for cardiovascular reasons were lower in AVN patients despite older age and more cardiovascular comorbidities. 20% of PVI patients had undergone at least one re-ablation.

Hodgkin/Reed-Sternberg (HRS) cells of classical Hodgkin lymphoma (CHL) are of B-cell origin. In a small number of CHL cases, the tumor cells can express T-cell antigens. CD8 expression in this setting is extremely rare. We identified 5 cases of CHL with aberrant CD8 expression from our database. The patients included 3 men and 2 women with a median age of 33 years (range = 20-59 years). All the patients initially presented with lymphadenopathy and variable number of RS cells. Two cases were classified as mixed cellularity type that showed prominent vascular proliferation mimicking peripheral T-cell lymphoma. Two cases represented nodular sclerosis type. The tumor cells in all cases were positive for CD8 and negative for CD2, CD3, CD4, and CD7 and carried germline T-cell receptor genes. Molecular studies revealed T-cell receptor genes to be in germline configuration in 4 cases with available information. Given the morphologic overlap with peripheral T-cell lymphoma and the rarity of this type of CHL, identifying more cases will help our better understanding of this entity.

Catheter ablation has become the most common therapy in patients with atrial fibrillation (AF). However, despite significant advances in technology and operators' experience, ablation outcomes remain suboptimal, especially in patients with persistent AF. Focal impulse and rotor modulation (FIRM) represents a new technology for mapping and ablation of patient-specific AF sources. This approach is based on the concept of localized sources, which can be understood as organized rotational waves or focal impulses driving disorganized AF. Several studies, mainly single-center case series, have shown an incremental benefit in long-term outcome when adding FIRM-guided ablation to conventional pulmonary vein isolation (PVI). Therefore, the results of ongoing multicenter randomized trials are needed to support this data.

Objective: To compare the real-world effectiveness and safety of non-vitamin-K-antagonist oral anticoagulant (NOAC) treatment in atrial fibrillation (AF) patients with a vitamin-K-antagonist (VKA)-based treatment., Methods: This was a retrospective analysis of an anonymized claims dataset from 3 German health insurance funds covering the period from January 01, 2010 to June 30, 2014, with a minimum observation time of 12 months. All continuously insured patients with at least 2 outpatient AF diagnoses and/or 1 inpatient respective diagnosis who received at least 1 outpatient prescription of a NOAC or VKA were included., Outcomes and Measures: Death, ischemic strokes (IS), non-specified strokes, transient ischemic attacks (TIAs), myocardial infarctions (MIs), arterial embolism (AE), hemorrhagic strokes, severe bleedings, and composite outcomes. Main comparisons were done based on propensity score-matched (PSM) cohorts. Results were reported as incidence rate ratios and hazard ratios (HRs)., Results: We assigned 37,439 AF patients to each PSM cohort (NOAC cohort: mean age 78.2 years, mean CHA 2 DS 2 VASc score 2.96, mean follow-up 348.5 days; VKA cohort: mean age 78.2 years, mean CHA 2 DS 2 VASc 2.95, mean follow-up 365.5 days). NOAC exposure was associated with significantly higher incidence rate ratios; 95% CI/HRs; 95% CI for the following outcomes: death (1.22; 1.17-1.28/1.22; 1.17-1.28), IS (1.90; 1.69-2.15/1.92; 1.69-2.19), non-specified strokes (2.04; 1.16-3.70/1.93; 1.13-3.32), TIAs (1.52; 1.29-1.79/1.44; 1.21-1.70), MIs (1.26; 1.10-1.15/1.31; 1.13-1.52), AE (1.75; 1.32-2.32/1.81; 1.36-2.34) and severe bleeding (1.92; 1.71-2.15/1.95; 1.74-2.20). Multivariable Cox regression analyses and additional sensitivity analysis, including analysis of PSM-matched NOAC/VKA treatment-naive patients, only confirmed the above results. The study was documented under clinicaltrials.gov (NCT02657616)., Conclusion and Relevance: A VKA therapy seems to be more effective and safer than a NOAC therapy in a real-world cohort of German AF patients., Competing Interests: Disclosure UM received modest honoraria from several pharmaceutical companies. SGS received modest honoraria from BMS/Pfizer and Bayer Vital, and modest research grant support from BMS/Pfizer and Daiichi Sankyo. SM and AG participated in this study as staff members of IPAM. AP and AS do not have any conflicts of interest except those potentially related to their employer, AOK Baden-Württemberg and AOK Bayern, respectively. The authors report no other conflicts of interest in this work.

Primary central nervous system T-cell lymphoma (PCNSTCL) is rare, accounting for 2% of CNS lymphomas. We report the first case of PCNSTCL with aberrant expression of CD20 and CD79a in an 81-year-old man with a left periventricular brain mass. A biopsy revealed dense lymphoid infiltrate consisting of medium-sized cells in a background of gliosis and many histiocytes. The lymphoid cells were positive for CD2, CD3, CD7, CD8, T-cell intracellular antigen-1, granzyme B, CD20, and CD79a and negative for CD4, CD5, PAX-5, OCT-2, BOB-1, human herpes virus-8, and Epstein-Barr virus-encoded small RNAs. Molecular studies revealed clonal TCR-β and TCR-γ gene rearrangements and negative immunoglobulin gene rearrangements. The patient was treated with chemotherapy (vincristine and methotrexate) and rituximab, but he died 1 month after the diagnosis. This is a unique case that emphasizes the use of a multimodal approach, including a broad immunohistochemical panel and molecular studies in lineage determination for lymphomas with ambiguous phenotype.

Background: There is a lack of procedural and follow-up data on pulmonary vein isolation (PVI) with the second-generation pulmonary vein ablation catheter® (PVAC Gold) in patients with atrial fibrillation (AF). This study provides data on PVI procedures and 1-year follow-up results with PVAC Gold in patients with AF treated in clinical practice., Methods and Results: Three hundred and eighty four patients with documented symptomatic paroxysmal (n=198) or persistent (n=186) AF were included in a non-randomized prospectively designed database. Patients were enrolled consecutively at 2 high-volume centers. Procedural as well as 1year follow-up data were systematically analyzed. Average procedure times±standard deviations were 94±23min and 97±23min, respectively, in patients with paroxysmal and persistent AF. Average fluoroscopy times were 14.7±5.4min and 15.2±5.6min and total application times 18.1±5.0min and 18.8±5.2min, respectively, in the 2 patient cohorts. At 12months, 70.7% (70/99) and 61.9% (70/113) of patients with paroxysmal and persistent AF, respectively, were free from AF. Four early complications occurred. In the group with persistent AF, 1 posterior cerebral infarction occurred 2days after the procedure during initiation of anticoagulation. There was no phrenic nerve palsy or esophageal injury associated with the procedures. No thromboembolic events were recorded during follow-up., Conclusions: In patients with paroxysmal or persistent AF, second generation multi-electrode-phased radiofrequency ablation delivers favorable mid-term PVI success rates with few procedure-related or follow-up complications., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Aims: To analyse the long-term safety of implantable cardioverter defibrillators (ICDs) in patients discharged within 24 h or after 2- 5-day hospitalization, respectively, after complication-free implantation, in circumstances of actual care., Methods and Results: Patients in the multicentre, nationwide German DEVICE registry were contacted 12-15 months after their first ICD implantation or device replacement. Data were collected on complications, potential arrhythmic events, syncope, resuscitation, ablation procedures, cardiac events, hospitalizations, heart failure status, change of medication, and quality of life. Of 2356 patients from 43 centres, 527 patients were discharged within 24 h and 1829 were hospitalized routinely for >24 h after complication-free implantations. The disease profiles and rates of co-morbidities were similar at baseline for both cohorts. During between 384 and 543 days of follow-up, there were no significant differences between the groups in terms of complications, hospitalizations, or quality of life. One-year rates of death were 4.5% in patients discharged early compared with 7.2% in hospitalized patients (hazard ratio 0.65; 95% confidence interval 0.42-1.02; P = 0.052). Rates of major adverse cardiovascular events or defibrillator events were not higher in patients discharged after 24 h. In both groups, a high rate of patients declared that they would opt for the procedure again in the same situation., Conclusion: Data from a large-scale registry reflecting current day-to-day practice in Germany suggest that most patients can be discharged safely within 24 h of successful ICD implantation if there are no procedure-related events. Follow-up data up to 1.5 years after implantation did not raise long-term safety concerns., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Aims: To analyse outcomes of supraventricular tachycardia (SVT) ablations performed within a prospective German Ablation Quality Registry., Methods and Results: Data from 12 566 patients who underwent catheter ablation of SVT between January 2007 and January 2010 to treat atrial fibrillation (AFIB, 37.2% of procedures), atrial flutter (AFL, 29.9%), atrioventricular nodal re-entrant tachycardia (AVNRT, 23.2%), atrioventricular re-entrant tachycardia (6.3%), and focal atrial tachycardia (AT, 3.4%) were prospectively collected. Patients were followed for at least 1 year. The periprocedural success rate was 96.3%, ranging from 84.3% (focal AT) to 98.9% (AVNRT). Kaplan-Meier mortality estimate at 1 year was 1.4% overall, and as high as 2.6% in the AFL group and 2.8% in the focal AT group. Recurrence of ablated or another symptomatic SVT was observed in 3783 (32.6%) of patients, ranging from 17.2% (AVNRT) to 45.6% (AFIB). Repeat ablation was performed in 12.0% of patients. After 1 year, 74.1% of survivors perceived ablation therapy as successful, 15.7% as partly successful, and 9.6% as unsuccessful. Even in those patients with arrhythmia recurrence, 76.0% perceived ablation as successful or partly successful and 89.6% would still undergo repeat ablation in the same institution., Conclusion: Ablation therapy for SVT is a safe procedure bringing symptomatic improvement and satisfaction to three quarters of patients after 1 year. Even in patients with arrhythmia recurrence, a high satisfaction level and adherence to the ablating institution could be documented. Strikingly high mortality and stroke rates in follow-up were observed in AFL patients, who apparently need consistent long-term anticoagulation and more medical attention., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)

Introduction: Despite a rising demand for catheter ablation (CA) of atrial fibrillation (AF) in an elderly population, complication and success rates are not fully elucidated. We sought to compare complication rates of CA of AF in patients ≥75 versus <75 years of age., Methods and Results: Patients with symptomatic, drug-refractory AF were prospectively enrolled from January 2007 to 2010 in this multicenter study. A total of 4,449 patients, group 1 ≥75 years and group 2 <75 years (n = 227, age 77.3 ± 2.2 vs. 59.7 ± 9.8 years, 52.0% vs. n = 4,222, 68.9% male, CHA 2 DS 2 -VASc-Score 3.7 ± 1.0 vs. 1.7 ± 1.2; P < 0.001, respectively), with paroxysmal AF (59.9% in group 1 vs. 63.3% in group 2, P = 0.30), and persistent AF (34.8% in group 1 vs. 29.4% in group 2, P = 0.082) underwent CA of AF. A centralized follow-up was obtained in 4,347 patients by the Institute for Myocardial Infarction Research (IHF, Ludwigshafen). There was a significant difference between periprocedural stroke rates in the elderly versus the younger cohort (1.3% vs. 0.1%, P < 0.01). In-hospital severe nonfatal complications did not differ significantly between the groups (4.4% vs. 2.7%, P = 0.14). Other procedure-related, in-hospital complications were not significantly different. After a mean follow-up of 472 ± 99 days (group 1) and 477 ± 94 days (group 2), no differences were found in complication rates., Conclusion: CA of AF in patients ≥75 years is associated with higher in-hospital stroke rates. In a 1-year follow-up, complication rates do not differ between the groups., (© 2016 Wiley Periodicals, Inc.)

Introduction: A patient-tailored ablation approach focused on the elimination of both pulmonary vein triggers as well as substrate drivers may result in favorable outcomes in recurrent persistent AF patients., Objective: We evaluated the long-term outcomes of rotor ablation combined with conventional pulmonary vein isolation (PVI) in patients with recurrent nonparoxysmal AF., Methods: Fifty-eight consecutive patients underwent FIRM-guided rotor ablation followed by conventional PVI for the treatment of recurrent nonparoxysmal AF. A software algorithm was used to display rotational activity at rotor sites by creating propagation maps from unipolar electrograms recorded using a 64-electrode basket catheter. These rotor sites were targeted for ablation, followed by conventional PVI., Results: All patients had nonparoxysmal AF (83% longstanding persistent) and a previously failed conventional ablation procedure. Stable rotors were identified in all patients (mean of 3.0 ± 1.6 per patient), with 55.2% having right atrial rotors and 96.6% left atrial rotors, respectively. Complications occurred in 5.2% of patients, none related to the FIRM procedure. The median follow-up was 12 months. At 6 and 12 months of follow-up, 73.2% and 76.9% of patients remained free from AF/AT, respectively. Excluding 2 patients who underwent a successful redo ablation procedure/electrical cardioversion, at 12 months of follow-up, 69.2% were free from any AF/AT and 73.1% were free from AF after a single FIRM-guided ablation procedure., Conclusion: A high degree of success was observed in this cohort of primarily longstanding persistent AF patients treated for recurrent AF with FIRM-guided rotor ablation. Prospective randomized controlled trials are needed., (© 2016 Wiley Periodicals, Inc.)

Aim: The aim of this study was to analyze the radiation usage in patients undergoing pulmonary vein isolation (PVI) in Germany and to evaluate the possibility to reduce radiation dose., Methods and Results: A total of 6617 patients with atrial fibrillation (AF) from the German ablation registry and the FREEZEplus registry (control group), who underwent first PVI between 2007 and 2014, were analyzed. In the second step, the effect of optimized conventional fluoroscopy and optimized 3D mapping use was evaluated in 526 consecutive patients with AF who underwent first PVI at the Klinikum Ludwigshafen (optimized group) between 2007 and 2014. In the control group, the median dose area product (DAP) for PVI was 34 Gy cm(2), and the median DAP rate was 1.3 Gy cm(2)/min. The DAP decreased from 37 to 28 Gy cm(2), whereas the DAP rate increased from 1.3 to 1.6 Gy cm(2)/min between 2007 and 2014. In the optimized group, optimized radiation application and use of 3D mapping resulted in a continuous decrease in the DAP from 67 to 2 Gy cm(2) and DAP rate from 1.0 to 0.2 Gy cm(2)/min., Conclusion: Currently, the median radiation exposure during PVI in Germany is 28 Gy cm(2). Optimized fluoroscopy by simple means can safely reduce the radiation dose to about 2 Gy cm(2) or even lower when using 3D mapping. Before introducing novel expensive technologies for radiation reduction optimizing of the conventional fluoroscopy is mandatory.

Background: Stratification of patients with atrial fibrillation (AF) according to mechanistic and prognostic criteria may optimize the effectiveness and safety of catheter ablation. In women, AF is associated with more severe symptoms and worse prognosis., Objective: We sought to assess sex-related differences in catheter ablation procedures and outcome in a large cohort of patients with AF., Methods: A total of 3652 patients (1198 women [33%]; 2454 men [67%]) included in the German Ablation Registry were analyzed. Periprocedural parameters and outcome at 12-month follow-up were compared between male and female patients., Results: Women were older at the time of ablation (women: 63.6 years; men: 59.1 years; P < .0001) and exhibited a higher prevalence of paroxysmal AF (women: 72%; men: 61%; P < .0001). They were less often affected by cardiovascular disease and reduced left ventricular function. Energy application duration and overall procedure duration were shorter in women. Conversely, the rate of major inhospital complications was increased in female patients (1.9% vs 0.8%; P = .023) and mainly driven by major bleeding events. At follow-up, women experienced higher AF recurrence rates (women: 50%; men: 45%; P = .017) and more often received oral medication for rhythm and rate control. In addition, the rate of pacemaker implantation was higher in the female cohort. Women more frequently reported femoral access site complications (women: 6%; men: 3%; P < .001). Overall, male patients were more often free from AF-related symptoms and satisfied with the treatment., Conclusion: Catheter ablation of AF was associated with a distinct sex-related outcome and complication profile that requires consideration in clinical practice., (Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objectives: Acquired somatic mutation Janus kinase 2 (JAK2) V617F is associated with various myeloproliferative neoplasms (MPN). Allele-specific real-time polymerase chain reaction has been widely adopted to detect mutation; however, the utility of low positive results is not well understood. The aim of this study is to investigate the clinical significance of low positivity of JAK2 V617F., Materials and Methods: Retrospective analysis was performed for JAK2 V617F mutation tests performed using JAK2 MutaQuant kit (Ipsogen) in molecular laboratories at 2 major academic medical centers between 2010 and 2012. Cases with low positive JAK2 V617F, defined as 0.2% to 5% mutant allele, were documented. Chart review was performed for the clinical correlation., Results: A total of 1697 JAK2 V617F tests was performed. Forty-five cases (2.65%) yielded a low JAK2 V617F positivity (average 1.45%), the majority of which (n=26, 62%) had <1%. Eight cases had a history of MPN. The remaining cases were related to reactive conditions without a clonal disease. Our data indicate that a low positivity of JAK2 V617F can be seen in MPN as well as reactive conditions., Conclusions: An interpretation of JAK2 V617F status should not be performed simply following some arbitrary cutoff. Any low positivity of JAK2 V617F should be reported and a correlation with clinical information is warranted for proper interpretation.

Objectives: Objective of the present study was to compare VARC-2 access and bleeding complications of a complete percutaneous versus a surgical cut-down approach for transfemoral TAVI "in a real world-all comers" setting., Background: The ideal approach for transfemoral TAVI is still part of a lively debate. Until today, for none of the available techniques superiority could be demonstrated. The present study adds a considerable number of patients to the available experience., Methods: The study included 334 consecutive patients, including 199 patients in the percutaneous and 135 patients in the cut-down group. Mean patient's age was 81.4 ± 4.6. Calculated logistic EuroSCORE correlated an intermediate to high surgical risk (17.8% ± 12.3%). Primary study endpoints were vascular access site as well as bleeding complications according the actual VARC-2 criteria., Results: Mean procedure time was significantly shorter in the cut-down group (69 ± 19 min vs. 91 ± 22 min; P < 0.01). Overall rate of VARC-2 access complications were significantly more frequent in the percutaneous group (n = 41/199; 20.6% vs. n = 11/135; 8.1%; P = 0.04); the incidence of major complications did not differ significantly (P = 0.19). VARC-2 bleeding complications were more frequent in the percutaneous group as well (18.1% vs. 4.4%; P = 0.029). Hospital stay differed not significantly (P = 0.214). Hospital mortality was 3.5% in the percutaneous group and 1.5% in the cut-down group (P = n.s.)., Conclusion: Surgical cut-down provided a convenient and controlled access, resulting in less access and bleeding complications. Nontheless, major access complication differed not significantly. Both approaches must be seen as complementary techniques. A portfolio containing both techniques is the exclusive way to provide a tailor-made and patient-orientated approach. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Background: Diabetes mellitus (DM) is an independent risk factor for cardiovascular disease and arrhythmias. Procedural data and complication rates in patients with DM undergoing catheter ablation for atrial arrhythmias are unknown., Methods: The German Ablation Registry has been designed as a multi-center prospective registry. Between January 2007 and January 2010 data from ablation of right atrial flutter (AFlut) and atrial fibrillation (AF) were collected from 51 German centres. Patients with DM and without DM were compared., Results: We included 8175 patients who underwent catheter ablation of AFlut or AF. Patients with DM (n=944) were older and presented significantly more severe comorbidities. Major periprocedural complications did not significantly differ between patients with and without DM for both ablation of AFlut and AF. Kaplan-Meier survival analysis for 366days of follow-up, showed a significant increase of MACCE for DM patients as compared to controls after AFlut [6.1% vs. 3.4%(p=0.002)], but not after AF ablation [1.2% vs. 0.9%(p=0.59)]. Ablation of AFlut led to a comparable reduction of palpitations and NYHA class in both patient groups. AF ablation reduced palpitations and NYHA class in patients without DM, while patients with DM reported no improvement of NYHA class despite a reduction of palpitations., Conclusion: As compared to non-DM, patients with DM show no increased periprocedural risk and no increased arrhythmia recurrence after ablation of AFlut or AF. As expected patients with DM exhibit more comorbidities and an increased ongoing mortality after atrial flutter ablation presumably caused by the higher age of this group as compared to controls., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)