Schmidt M.,Klinikum Munich Bogenhausen |
Dorwarth U.,Klinikum Munich Bogenhausen |
Andresen D.,Vivantes Klinikum Am Urban |
Brachmann J.,Klinikum Coburg |
And 7 more authors.
Journal of Cardiovascular Electrophysiology | Year: 2014
German Ablation Registry-Different Energy Sources in AF Ablation Background Catheter ablation is used extensively with curative intention in atrial fibrillation. Radiofrequency ablation has long been a standard of care, while cryoballoon technology has emerged as a feasible approach with promising results. Prospective multicenter registry data referring to both ablation technologies in AF ablation therapy are lacking. Methods Between January 2007 and August 2011, a total of 3,775 consecutive patients with symptomatic paroxysmal AF who underwent PV ablation in their respective centers were enrolled. The cohort was divided into 2 groups according to the ablation energy source used: cryoballoon ablation (group 1, n = 905 [24.0%], median age 63 years, 64.3% men) and RF ablation (group 2, n = 2870 [76.0%], median age 63 years, 62.7% men). Comorbidities and baseline clinical characteristics were similar in both groups. Results Acute success rate was similar in both groups (97.5% in cryo vs 97.6% in RF; P = 0.81). Procedure times were similar, ablation and fluoroscopy times were higher in cryoballoon when compared to RF ablation. Overall complication rate was similar in cryo- (4.6%) and RF-ablation (4.6%; P = 1.0). Phrenic nerve palsy was more often in cryo versus RF ablation (2.1% in cryo vs 0.0% in RF; P < 0.001). Other complications were more common in RF compared to cryoablation (4.6% in RF vs 2.7% in cryo; P < 0.05). Conclusion RF ablation is the most widespread ablation method in Germany, but use of cryoballoon increased significantly. Procedure times were similar, but ablation and fluoroscopy times were longer in cryoballoon ablation. No significant differences were found in terms of acute success and overall complication rate. © 2014 Wiley Periodicals, Inc.
Brignole M.,Arrhythmologic Center |
Moya A.,Hospital Universitario Vall dHebron |
Andresen D.,Vivantes Klinikum Am Urban |
Blanc J.J.,Brest University Hospital Center |
And 7 more authors.
Circulation | Year: 2012
Background-The efficacy of cardiac pacing for prevention of syncopal recurrences in patients with neurally mediated syncope is controversial. We wanted to determine whether pacing therapy reduces syncopal recurrences in patients with severe asystolic neurally mediated syncope. Methods and Results-Double-blind, randomized placebo-controlled study conducted in 29 centers in the Third International Study on Syncope of Uncertain Etiology (ISSUE-3) trial. Patients were 40 years, had experienced 3 syncopal episodes in the previous 2 years. Initially, 511 patients, received an implantable loop recorder; 89 of these had documentation of syncope with 3 s asystole or 6 s asystole without syncope within 12±10 months and met criteria for pacemaker implantation; 77 of 89 patients were randomly assigned to dual-chamber pacing with rate drop response or to sensing only. The data were analyzed on intention-to-treat principle. There was syncope recurrence during follow-up in 27 patients, 19 of whom had been assigned to pacemaker OFF and 8 to pacemaker ON. The 2-year estimated syncope recurrence rate was 57% (95% CI, 40-74) with pacemaker OFF and 25% (95% CI, 13-45) with pacemaker ON (log rank: P=0.039 at the threshold of statistical significance of 0.04). The risk of recurrence was reduced by 57% (95% CI, 4-81). Five patients had procedural complications: lead dislodgment in 4 requiring correction and subclavian vein thrombosis in 1 patient. Conclusions-Dual-chamber permanent pacing is effective in reducing recurrence of syncope in patients 40 years with severe asystolic neurally mediated syncope. The observed 32% absolute and 57% relative reduction in syncope recurrence support this invasive treatment for the relatively benign neurally mediated syncope. Clinical Trial Registration-URL: http://www. clinicaltrials.gov. Unique identifier: NCT00359203. © 2012 American Heart Association, Inc.
Lorch A.,Universitatsklinikum Giessen |
Rick O.,Klinik Reinhardshohe |
Wundisch T.,Universitatsklinikum Giessen |
Hartmann J.-T.,University Hospital of Tuebingen |
And 2 more authors.
Journal of Urology | Year: 2010
Purpose: We assessed the activity of high dose chemotherapy in patients with unresectable late relapse germ cell tumors. Materials and Methods: A total of 35 patients with late relapse were included in a group of 216 treated with high dose chemotherapy as first or subsequent salvage treatment in a prospective, randomized, multicenter phase III trial comparing single vs sequential high dose chemotherapy. Late relapse was defined as unequivocal evidence of relapse more than 2 years after completion of cisplatin based chemotherapy. All patients were considered to have unresectable, progressive, late relapse germ cell tumors. Responders were scheduled for surgical resection of all residual lesions when technically feasible. Results: We identified 4 late relapse groups, including late relapse in 20 of 35 patients (57%) after first line treatment (group 1), in 4 (11%) after first salvage treatment (group 2), in 4 (11%) after initial and after first salvage treatment (group 3), and in 7 (20%) after first line treatment and salvage treatment with rapid progression thereafter who were randomized to a high dose chemotherapy trial (group 4). Median time to late relapse was 4.7 years (range 2.1 to 18.3) in all groups. Resection of all residual lesions could be done in 15 of 35 patients (43%). At a median followup of 5.6 years (range 1.9 to 8.5) 5 of 35 patients (14%) had no progression, resulting in 15% projected progression-free survival. Conclusions: Management for unresectable late relapse germ cell tumors remains controversial. High dose chemotherapy followed by resection of all residual lesions can result in long-term remission in individuals. © 2010 American Urological Association Education and Research, Inc.
Massard C.,University Paris - Sud |
Kramar A.,Center Oscar Lambret |
Beyer J.,Vivantes Klinikum am Urban |
Hartmann J.T.,University of Kiel |
And 5 more authors.
Annals of Oncology | Year: 2013
Background: An early serum tumor marker (TM) decline during chemotherapy was shown to independently predict survival in patients with poor-prognosis disseminated non-seminomatous germ-cell tumors (NSGCTs). The aim of this study was to assess whether a TM decline (TMD) also correlates with the outcome in the salvage setting. Patients and methods: Data regarding 400 patients with progressive or relapsed disseminated NSGCTs after firstline chemotherapy prospectively accrued onto two phase III clinical trials were obtained. Serum alpha-fetoprotein (AFP) and/or human chorionic gonadotropin (hCG) were assessed at baseline and after 6 weeks of chemotherapy. A total of 297 patients, 185 and 112 in the training and validation sets, with initially abnormal TMs for whom a change from baseline could be established were used for this analysis. Results: An unfavorable decline in either AFP or hCG was predictive of progression-free survival (PFS) [hazard ratio, HR = 2.15, (95% CI 1.48-3.11); P < 0.001; 2-year PFS rate: 50% versus 26%] as was the Lorch prognostic score (LPS). In the multivariate analysis, an unfavorable TMD, stratified based on the LPS, was an independent adverse prognostic factor for PFS and OS. Conclusion: An unfavorable TMD during the first 6 weeks after chemotherapy is associated with a poorer outcome in patients with relapsed disseminated NSGCTs. © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Powles T.,St. Bartholomew's Hospital |
Bascoul-Mollevi C.,Biostatistics Unit |
Kramar A.,Center Oscar Lambret |
Lorch A.,University of Marburg |
Beyer J.,Vivantes Klinikum Am Urban
Journal of Cancer Research and Clinical Oncology | Year: 2013
Purpose: To evaluate the impact of age and LDH levels in patients with relapsed seminoma. Methods: Data on the 204 seminoma from the International Prognostic Factor Study Group (IPFSG) were analyzed. All patients experienced unequivocal relapse/progression after at least three cisplatin-based chemotherapy cycles. Age and LDH at relapse were assessed in addition to previously identified prognostic factors for all germ cell tumor patients from the database (J Clin Oncol 28:4906, 2010). Results: The impact of the IPFSG score remained highly significant in multivariate analysis. In addition, LDH ≥1.5 times the upper limit of normal (ULN) was significant in univariate (HR 1.96; CI 1.06-3.61) and multivariate analysis (HR 1.90; CI 1.00-3.62). Age, however, was not significant. Therefore, LDH was incorporated into a modified new IPFSG seminoma score by moving patients to the next unfavorable group for patients with LDH values ≥1.5 × ULN. Three prognostic groups were thus generated, which better subdivided seminoma patients than the original IPFSG score. Progression-free survival at 2 years: "very low risk" (n = 23) 85.7 % (95 % CI 62-95), "low risk" (n = 44) 62.7 % (95 % CI 46-75) and "intermediate risk" (n = 36) 35.1 % (95 % CI 20-51). Overall survival at 3 years: "very low risk" 88.8 % (95 % CI 62-97), "low risk" 71.3 % (95 % CI 55-83) and "intermediate risk" 51.3 % (95 % CI 33-67). Conclusion: The addition of LDH, but not age, improves the impact of the IPFSG prognostic score in seminoma patients relapsing or progressing after cisplatin-based chemotherapy. © 2013 Springer-Verlag Berlin Heidelberg.
Knoll N.,Charité - Medical University of Berlin |
Burkert S.,Charité - Medical University of Berlin |
Scholz U.,University of Bern |
Roigas J.,Vivantes Klinikum am Urban |
Gralla O.,Urologie am Ring
Anxiety, Stress and Coping | Year: 2012
The dual-effects model of social control states that receiving social control leads to better health behavior, but also enhances distress in the control recipient. Associated findings, however, are inconsistent. In this study we investigated the role of relationship satisfaction as a moderator of associations of received spousal control with health behavior and affect. In a study with five waves of assessment spanning two weeks to one year following radical prostatectomy (RP), N=109 married or cohabiting prostate-cancer patients repeatedly reported on their pelvic-floor exercise (PFE) to control postsurgery urinary incontinence and affect as primary outcomes, on received PFE-specific spousal control, relationship satisfaction, and covariates. Findings from two-level hierarchical linear models with repeated assessments nested in individuals suggested significant interactions of received spousal control with relationship satisfaction predicting patients' concurrent PFE and positive affect. Patients who were happy with their relationships seemed to benefit from spousal control regarding regular PFE postsurgery while patients less satisfied with their relationships did not. In addition, the latter reported lower levels of positive affect when receiving much spousal control. Results indicate the utility of the inclusion of relationship satisfaction as a moderator of the dual-effects model of social control. © 2012 Copyright Taylor and Francis Group, LLC.
Raakow R.,Vivantes Klinikum Am Urban |
Jacob D.A.,Center for Minimally Invasive Surgery
Digestive Surgery | Year: 2011
Background: We describe our initial experience performing a single-port (SP) advanced laparoscopic appendectomy in comparison to the conventional port (CP) technique, which uses three ports. Methods: Between June and September 2009, 40 consecutive patients with acute appendicitis underwent laparoscopic appendectomy at Vivantes Klinikum Am Urban, Berlin, Germany. Twenty patients were operated on using the SP technique (SP group), and the data were compared to a control group of 20 patients operated on using the CP technique (CP group) during the same time period. Results: SP surgery was successfully performed on all patients without conversion to CP laparoscopic appendectomy or an open procedure. The mean age was 27.7 ± 8.3 years in the SP group and 31.7 ± 9.3 in the CP group (p = 0.32). Gender (p = 0.352), status of the American Society of Anesthesiologists (p = 0.765) and body mass index (p = 0.971) did not differ significantly between the two groups. The mean operating time was 48.0 ± 13.2 min in the SP group versus 49.0 ± 19.9 min in the CP group (p = 0.694). No patient in the SP group developed surgical complications. No patient in either group developed an incisional hernia or wound infection during the mean follow-up of 98.17 ± 38.56 days. Conclusion: Transumbilical SP appendectomy via a tri-port system with a single incision is a feasible and safe new approach for routine appendectomy. It is easy to perform and good training for more advanced SP surgery. Copyright © 2011 S. Karger AG.
Beyer J.,Vivantes Klinikum Am Urban
Journal of Clinical Oncology | Year: 2010
Purpose: To develop a prognostic model in patients with germ cell tumors (GCT) who experience treatment failure with cisplatin-based first-line chemotherapy. Patients and Methods: Data from 1,984 patients with GCT who progressed after at least three cisplatin-based cycles and were treated with cisplatin-based conventional-dose or carboplatin-based high-dose salvage chemotherapy was retrospectively collected from 38 centers/groups worldwide. One thousand five hundred ninety-four (80%) of 1,984 eligible patients were randomly divided into a training set of 1,067 patients (67%) and a validation set of 527 patients (33%). Seminomas were set aside for posthoc analyses. Primary end point was the 2-year progression-free survival after salvage treatment. Results: Overall, 990 patients (62%) relapsed and 604 patients (38%) remained relapse free. Histology, primary tumor location, response, and progression-free interval after first-line treatment, as well as levels of alpha fetoprotein, human chorionic gonadotrophin, and the presence of liver, bone, or brain metastases at salvage were identified as independent prognostic variables and used to build a prognostic model in the training set. Survival rates in the training and validation set were very similar. The estimated 2-year progression-free survival rates in patients not included in the training set was 75% in very low risk, 51% in low risk, 40% in intermediate risk, 26% in high risk, and only 6% in very high-risk patients. Due to missing values in individual variables, 69 patients could not reliably be classified into one of these categories. Conclusion: Prognostic variables are important in patients with GCT who experienced treatment failure with cisplatin-based first-line chemotherapy and can be used to construct a prognostic model to guide salvage strategies. © 2010 by American Society of Clinical Oncology.
Vaccination with inactivated lactobacilli or heliotherapy can improve the quality-of-life of women with chronic recurrent vulvovaginal candidosis a prospective randomized study [Die Vakzination mit inaktivierten Laktobazillen oder mit Heliotherapie kann die Lebensqualität von Frauen mit chronisch rezidivierender vulvovaginaler Kandidose verbessern Eine prospektive 3-armige randomisierte Studie]
Mendling W.,Vivantes Klinikum Am Urban |
Birkner V.,Praxis fur Gynakologie und Geburtshilfe
Geburtshilfe und Frauenheilkunde | Year: 2011
Objective: All antimycotic therapies for chronic recurrent vulvovaginal candidosis (CRVS) are unsatisfactory as long as there is no immunotherapy. Methods: Three groups of 30 non-pregnant women aged between 18 and 67 years (6 post-menopausal, but with hormone replacement therapy) with CRVC were investigated in 2002 and 2003 by vaginal smear, yeast culture with species determination, the measurement of interleukin (IL) 10, 12, 13 and 16, vaginal and peripheral secretory IgA (sIgA), peripheral T-leucocyte subpopulations, IgM, IgA and IgG prior to treatment, and 612 weeks and 12 months after treatment. All patients answered validated questionnaires about their health (SF-36) and quality-of-life (PLC) and 20 own non-validated questions about their candidosis, sexuality and quality-of-life. Lactobacillus vaccination consisting of 710 9 inactivated lactobacilli of 8 species (Gynatren, Strathmann, Hamburg, Germany) was administered 3 times by intramuscular injection every 2 weeks (group 1). Group 2 had heliotherapy performed according to skin type with suberythematous doses of ultraviolet A and B rays administered 3times per week for 6 weeks (Tancan 8000, Dr.Kern, Driedorf, Germany). Ciclopyroxolamine (100mg) vaginal tablets (Taurus Pharma, Frankfurt, Germany) were given once a day for 6 days to patients in group 3. Results: Clinical signs of CRVC decreased significantly from a mean of 6.3 to 1.5/year in all groups, but vaginal yeast cultures did not. Quality-of-life and health status scores were significantly better after treatment in groups 1 and 2 with a slightly higher improvement in group 1. Peripheral Tlymphocytes were unsignificantly activated inall groups. Vaginal IL-13 as a mediator of allergy decreased significantly in groups 1 and 2 and this decrease correlated with clinical success. Anti-inflammatory IL-10 decreased in all groups but this decrease was not significant. Many patients suffered from symptoms but had negative yeast cultures. Conclusion: Immunomodulation with the injection of a lactobacillus vaccine or heliotherapy and intensive personal care can help to improve the quality-of-life of patients with CRVC. © Georg Thieme Verlag KG Stuttgart New York.
Jacob D.,Vivantes Hospital Spandau |
Raakow R.,Vivantes Klinikum Am Urban
Hepatobiliary and Pancreatic Diseases International | Year: 2011
BACKGROUND: Trans-umbilical single-port laparoscopic cholecystectomy for chronic gallbladder disease is becoming increasingly accepted worldwide. But so far, no reports exist about the challenging single-port surgery for acute cholecystitis. The objective of this study was to describe our experience with single-port cholecystectomy in comparison to the conventional laparoscopic technique. METHODS: Between August 2008 and March 2010, 73 patients with symptomatic gallbladder disease and histopathological signs of acute cholecystitis underwent laparoscopic cholecystectomy at our institution. Thirty-six patients were operated on with the single-port technique (SP group) and the data were compared with a control group of 37 patients who were treated with the multi-port technique (MP group). RESULTS: The mean age in the SP group was 61.5 (range 21-81) years and in the MP group was 60 (range 21-94) (P=0.712). Gender, ASA status and BMI were not significantly different. The number of white blood cells was different before [SP: 9.2 (range 2.8-78.4); MP: 13.2 (range 4.4-28.6); P=0.001] and after the operation [SP: 7.8 (range 3.5-184.8); MP: 11.1 (range 5-20.8); P=0.002]. Mean operating time was 88 (range 34-174) minutes in the SP group vs 94 (range 39-209) minutes in the MP group (P=0.147). Four patients (5%) required conversion to an open procedure (SP: 1; MP: 3; P=0.320). During the followup period of 332 (range 29-570) days in the SP group and 428 (range 111-619) days in the MP group (P=0.044), eleven (15%) patients developed postoperative complications (P=0.745) and two patients in the SP group required reoperation (P=0.154). CONCLUSIONS: Trans-umbilical single-port cholecystectomy for beginning acute cholecystitis is feasible and the complication rate is comparable with the standard multi-port operation. In spite of our good results, these operations are difficult to perform and should only be done in high-volume centers for laparoscopic surgery with experience in single-port surgery. © 2011, Hepatobiliary Pancreat Dis Int.