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Coburg, Germany

Zylla M.M.,University of Heidelberg | Brachmann J.,Hospital Coburg | Lewalter T.,Isar Heart Center Munich | Hoffmann E.,Heart Center Munich Bogenhausen | And 7 more authors.
Journal of Electrocardiology | Year: 2016

Aims This investigation addresses procedural characteristics of catheter ablation in patients with atrial fibrillation (AF) and sinus bradycardia. Methods From the prospective, multi-center German Ablation Registry 1073 patients with sinus rhythm at the time of AF ablation were divided into two groups according to heart rate at start of procedure (A, < 60 beats per minute (bpm), n = 197; B, 60-99 bpm, n = 876). Results Acute procedural success was high (≥ 98%) and similar between groups. Procedure duration and energy application time were increased in group A (180 min vs. 155 min and 2561 s vs. 1879 s, respectively). Major complications were more frequent in group A (2.2% vs. 0.5%), and a greater proportion of these patients was discharged under antiarrhythmic medication (64% vs. 52%). Conclusion Catheter ablation of AF with concomitant sinus bradycardia is associated with high procedural efficacy, longer procedure- and energy application durations, and a slightly elevated complication rate. © 2016 Elsevier Inc. All rights reserved. Source

Kuhnt T.,University of Rostock | Sandner A.,Martin Luther University of Halle Wittenberg | Wendt T.,Friedrich - Schiller University of Jena | Engenhart-Cabillic R.,University of Marburg | And 7 more authors.
Annals of Oncology | Year: 2010

Background: Cetuximab is active in the treatment of squamous cell carcinoma of the head and neck (SCCHN), enhancing both radiotherapy and chemotherapy effects. This phase I study was designed to investigate the safety and tolerability of combining weekly cisplatin treatment with cetuximab and hyperfractionated-accelerated radiotherapy (HART) for locally advanced SCCHN. Patients and methods: Patients with unresectable stage III or IVA/B SCCHN were treated with cetuximab, 400 mg/m2 initial dose on day -7 of HART, followed by 250 mg/m2 weekly during the administration of HART, which started with 2.0 Gy/day (5 days/week) for 3 weeks followed by 1.4 Gy/twice-daily (Monday to Friday) for another 3 weeks, resulting in a total dose of 70.6 Gy. Cisplatin was administered weekly starting on the first day of radiotherapy until week 6. Cisplatin was dose escalated of four dose levels from 20 to 40 mg/m2 using a classical 3 + 3 dose escalation algorithm. Results: Eighteen patients were enrolled. Sixteen patients were eligible for toxicity, and 15 for response. No maximum tolerated dose was reached for cisplatin. One of six patients of dose level 4 had grade 4 neutropenia. This patient died 1 week after the end of the study treatment. The most common types of grade 3+ adverse events were mucositis (9 of 16 patients), in-field dermatitis (6 of 16 patients) and neutropenia (4 of 16 patients). Cetuximab-related hypersensitivity was observed in 1 out of 18 patients. Six weeks after the end of the study treatment, 5 complete responses, 8 partial responses and 1 progressive disease (at distant sites) were documented in a total of 15 patients (objective response rate 87%). Conclusions: The combination of cisplatin with cetuximab and HART is active, well tolerated and merits additional investigation. The recommended weekly dose of cisplatin for phase II studies is 40 mg/m2. © The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source

Hoffmann B.A.,University of Hamburg | Kuck K.-H.,Asklepios Hospital St. Georg | Andresen D.,Vivantes Hospital | Spitzer S.G.,Praxisklinik Herz und Gefasse | And 11 more authors.
Journal of Cardiovascular Electrophysiology | Year: 2014

Acute Complication Rate in AF Ablation Introduction Catheter ablation (CA) has emerged as a widespread therapeutic option in the treatment of atrial fibrillation (AF). Currently, no safety data with regard to the impact of the underlying structural heart diseases (SHD) are available. We sought to assess the risk for acute and long-term complications during CA of AF in relation to underlying SHD. Methods and Results We included 6,211 patients in a prospective registry undergoing CA of AF in 41 nationwide centers. All patients were divided into 4 groups according to the underlying heart disease: No SHD (69.4%), hypertensive heart disease (HHD) (12.0%), coronary artery disease (CAD) (15.1%), and cardiomyopathy (CM) (3.6%). In univariate analysis, patients with HHD had an overall complication rate of 7.28%, whereas patients without an SHD had a significantly lower rate of 6.01% (P < 0.01). Multivariate analysis revealed that HHD (adjusted odds ratio [OR]: 1.97 [95% confidence interval (CI): 1.02-3.83], P = 0.0442) and age (years; OR: 1.04 [95% CI: 1.01-1.07], P = 0.0155) were independent predictors of severe, nonfatal complications and death. Other SHD including CAD (OR: 1.48 (0.73-3.00), P = 0.2797) and CM (OR: 2.37 [0.70-7.99], P = 0.1630) failed to reach statistical significance. Male sex was protective (OR: 0.47 [95% CI: 0.27-0.81], P = 0.0062). Conclusion In general, CA of AF has a low number of severe complications. In our prospective registry HHD emerged as an independent predictor of severe, nonfatal complications during AF ablation but other SHD including CAD and CM did not. The influence of HHD on the complication rate should be considered in patient selection. © 2013 Wiley Periodicals, Inc. Source

Nuhrich J.M.,University of Hamburg | Kuck K.-H.,Asklepios Hospital St. Georg | Andresen D.,Vivantes Hospital | Steven D.,University of Hamburg | And 10 more authors.
Clinical Research in Cardiology | Year: 2015

Aims: Atrial fibrillation (AF) is the most common cause of ischemic stroke. Recent data suggest that AF patients after successful ablation have the same risk for thromboembolic events (TE) as patients without AF. Despite current guideline recommendations it is still under debate if oral anticoagulation (OAC) can be safely discontinued after ablation. We analyzed follow-up (FU) after ablation of paroxysmal AF (PAF) in a high- (previous stroke; group 1) and a low-risk group (no previous stroke; group 2) based on data from the German Ablation Registry to reveal real-life prescription behavior. Methods: Overall 29 centers in Germany participated by performing AF-ablation. Between April 2008 and April 2011, 83 patients in group 1 and 377 patients in group 2 with a first ablation of PAF were included in the registry. Results: Mean CHA2DS2-VASc-Score was 4.2 ± 1.4 (group 1) vs. 1.6 ± 1.2 (group 2) (p < 0.0001). No peri-interventional TE was observed. Arrhythmia recurrence was seen in 47.4 vs. 48.4 % (p = 0.79) during a median FU of 489 (453–782) days, resulting in a repeat procedure in 20.0 vs. 20.7 % (p = 0.88), respectively. OAC was discontinued in 38.6 % in group 1 vs. 66.3 % in group 2 (p < 0.0001) during FU. TE during FU occurred more often in group 1 than in group 2 (4.3 vs. 0.3 %, p < 0.05). Conclusion: Even in patients with previous stroke, OAC was frequently discontinued during FU after PAF ablation in this observational study. However, TE occurred significantly more frequent in these high-risk patients. These data argue against OAC discontinuation after ablation in patients with previous stroke. © 2014, Springer-Verlag Berlin Heidelberg. Source

Hoffmann B.A.,University of Hamburg | Brachmann J.,Hospital Coburg | Andresen D.,Vivantes Hospital | Eckardt L.,University of Munster | And 10 more authors.
Heart Rhythm | Year: 2011

Background: Catheter ablation (CA) is considered the treatment of choice for patients with atrioventricular nodal reentrant tachycardia (AVNRT). However, there is a tendency to avoid CA in the elderly because of a presumed increased risk of periprocedural atrioventricular (AV) nodal block. Objective: The purpose of this prospective registry was to assess age-related differences in the efficacy and safety of CA within a large population with AVNRT. Methods: A total of 3,234 consecutive patients from 48 German trial centers who underwent CA of AVNRT between March 2007 and May 2010 were enrolled in this study. The cohort was divided into three age groups: <50 years (group 1, n = 1,268 [39.2%]; median age = 40 [30.0-45.0] years, 74.1% women), 50-75 years old (group 2, n = 1,707 [52.8%]; 63.0 [58.0-69.0] years, 63.0% women), and > 75 years old (group 3, n = 259 [8.0%]; 79.0 [77.0-82.0] years, 50.6% women). Results: CA was performed with radiofrequency current (RFC) in 97.7% and cryoablation technology in 2.3% of all cases. No differences were observed among the three groups with regard to primary CA success rate (98.7% vs. 98.8 % vs. 98.5%; P = .92) and overall procedure duration (75.0 minutes [50.0-105.0]; P = .93). Hemodynamically stable pericardial effusion occurred in five group 2 (0.3%) and two group 3 (0.8%) patients but in none of the group 1 (P <.05) patients. Complete AV block requiring permanent pacemaker implantation occurred in two patients in group 1 (0.2%) and six patients in group 2 (0.4%) but none in group 3 (P = 0.41). During a median follow-up period of 511.5 days (396.0-771.0), AVNRT recurrence occurred in 5.7% of all patients. Patients >75 years (group 3) had a significantly longer hospital stay (3.0 days [2.0-5.0]) compared with group 1 (2.0 days [1.0-2.0]) or group 2 (2.0 days [1.0-3.0]) patients (P <.0001). Conclusion: CA of AVNRT is highly effective and safe and does not pose an increased risk for complete AV block in patients over 75 years of age, despite a higher prevalence of structural heart disease. Antiarrhythmic drug therapy is often ineffective in this age group; thus, CA for AVNRT should be considered the preferred treatment even in elderly patients. © 2011 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved. Source

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