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Background: The European rivaroxaban post-authorization safety study evaluated bleeding risk among patients initiated on rivaroxaban or vitamin K antagonists for the treatment and secondary prevention of venous thromboembolism in routine clinical practice. Methods: Cohorts were created using electronic healthcare databases from the UK, the Netherlands, Germany and Sweden. Patients with a first prescription of rivaroxaban or vitamin K antagonist during the period from December 2011 (in the UK, January 2012) to December 2017 (in Germany, December 2016) for venous thromboembolism indication, with no record of atrial fibrillation or recent cancer history, were observed until the occurrence of each safety outcome (hospitalization for intracranial, gastrointestinal, urogenital or other bleeding), death or study end (December 2018; in Germany, December 2017). Crude incidence rates of each outcome per 100 person-years were computed. Results: Overall, 44 737 rivaroxaban and 45 842 vitamin K antagonist patients were enrolled, mean age, 59.9–63.8 years. Incidence rates were similar between rivaroxaban and vitamin K antagonist users with some exceptions, including higher incidence rates for gastrointestinal bleeding in rivaroxaban users than in vitamin K antagonist users. Among rivaroxaban users, mortality and bleeding risk generally increased with age, renal impairment and diabetes. Conclusions: This study provides further data from routine clinical practice that broadly support safety profile of rivaroxaban for VTE indication and complement findings from previous randomized clinical trials. [ABSTRACT FROM AUTHOR]

Purpose: Psychiatric disorders and cancer are both common, and comorbidity has detrimental impacts on cancer outcomes. Previous studies focus on affective disorders which arise after cancer diagnosis, not on the impact of psychiatric disorders on cancer risk. We investigate the association between psychiatric disorders and subsequent gastrointestinal cancer in a large cohort in Germany. Methods: This case–control study used secondary data (electronic medical records) from the national IQVIA Disease Analyzer database. We evaluated the association between previous psychiatric diagnosis in 44,582 matched patients with and without gastrointestinal (GI) cancer. Regression analyses were stratified by psychiatric diagnosis and adjusted by chronic comorbidities and previous psychiatric treatments. Results: No association between any previous psychiatric disease and GI cancers was found (OR = 0.98 (0.95–1.02 95%CL, p = 0.39). Previous psychosomatic disorder and GI cancer showed a significant negative association (OR: 0.86, 0.81–0.90 95%CL, p < 0.0001). No association was found between previous diagnosis with depression or PTSD and GI cancer. These results remained consistent when including previous psychiatric treatments in the regression analyses. Conclusion: Psychiatric disease was not associated with GI cancer risk. Further investigation into the pathways linking psychiatric disease and cancer needs to be conducted, taking into consideration psychiatric treatments administered, to enhance our understanding of the relationship between these two common and devastating diseases. [ABSTRACT FROM AUTHOR]

Purpose: Although participation in multidisciplinary tumor boards (MTBs) is an obligatory quality criterion for certification, there is scarce evidence, whether MTB recommendations are consistent with consensus guidelines and whether they are followed in clinical practice. Reasons of guideline and tumor board deviations are poorly understood so far. Methods: MTB's recommendations from the weekly MTB for gastrointestinal cancers at the University Cancer Center Leipzig/Germany (UCCL) in 2020 were analyzed for their adherence to therapy recommendations as stated in National German guidelines and implementation within an observation period of 3 months. To assess adherence, an objective classification system was developed assigning a degree of guideline and tumor board adherence to each MTB case. For cases with deviations, underlying causes and influencing factors were investigated and categorized. Results: 76% of MTBs were fully adherent to guidelines, with 16% showing deviations, mainly due to study inclusions and patient comorbidities. Guideline adherence in 8% of case discussions could not be determined, especially because there was no underlying guideline recommendation for the specific topic. Full implementation of the MTBs treatment recommendation occurred in 64% of all cases, while 21% showed deviations with primarily reasons of comorbidities and differing patient wishes. Significantly lower guideline and tumor board adherences were demonstrated in patients with reduced performance status (ECOG-PS ≥ 2) and for palliative intended therapy (p = 0.002/0.007). Conclusions: The assessment of guideline deviations and adherence to MTB decisions by a systematic and objective quality assessment tool could become a meaningful quality criterion for cancer centers in Germany. [ABSTRACT FROM AUTHOR]

Aims/Objectives: Patients with bleeding disorders are a rare and complex population in catheter ablation (CA) procedures. The most common types of bleeding disorders are von Willebrand disease (VWD) and hemophilia A (HA). Patients with VWD or HA tend to have a higher risk of bleeding complications compared to other patients. There is a lack of data concerning peri- and postinterventional coagulation treatment. We sought to assess the optimal management of patients with VWD and HA referred for catheter ablation procedures. Methods and Results: In this study, we analyzed patients with VWD or HA undergoing CA procedures at two centers in Germany and Switzerland between 2016 and 2021. Clotting factors were administered in conjunction with hemostaseological recommendations. CA was performed as per the institutional standard. During the procedure, unfractionated heparin (UFH) was given intravenously with respect to the activated clotting time (ACT). Primary endpoints included the feasibility of the procedure, bleeding complications, and thromboembolic events during the procedure. Secondary endpoints included bleeding complications and thromboembolic events up to one year after catheter ablation. A total of seven patients (three VWD Type I, one VWD Type IIa, three HA) underwent 10 catheter ablation procedures (pulmonary vein isolation (PVI): two × radiofrequency (RF), one × laser balloon (LB), one × cryoballoon (CB); PVI + cavotricuspid isthmus (CTI): one × RF; PVI + left atrial appendage isolation (LAAI): one × RF; Premature ventricular contraction (PVC): three × RF; Atrioventricular nodal reentrant tachycardia (AVNRT): one × RF). VWD patients received 2000–3000 IE Wilate i.v. 30 to 45 min prior to ablation. Patients with HA received 2000–3000 IE factor VIII before the procedure. All patients undergoing PVI received UFH (cumulative dose 9000–18,000 IE) with a target ACT of >300 s. All patients after PVI were started on oral anticoagulation (OAC) 12 h after ablation. Two patients received aspirin (acetylsalicylic acid; ASA) for 4 weeks after the ablation of left-sided PVCs. No anticoagulation was prescribed after slow pathway modulation in a case with AVNRT. No bleeding complications or thromboembolic events were reported. During a follow-up of one year, one case of gastrointestinal bleeding occurred following OAC withdrawal after LAA occlusion. Conclusions: After the substitution of clotting factors, catheter ablation in patients with VWD and HA seems to be safe and feasible. [ABSTRACT FROM AUTHOR]

Simple Summary: We identified a panel of co-diagnosis occurring at higher or lower frequencies in CRC patients compared to matched controls without CRC. Such data might help optimizing CRC screening and improving the clinical management of CRC patients. Background: The prognosis of colorectal cancer (CRC) patients is determined to a decisive extent by comorbidities. On the other hand, anti-cancer treatments for CRC are associated with relevant toxicities and may therefore cause additional comorbidities. Methods: This retrospective cohort study assessed the prevalence of various diseases in patients 12 months before and 12 months after an initial diagnosis of colorectal cancer (ICD-10: C18, C20) in 1274 general practices in Germany between January 2000 and December 2018. The study is based on the Disease Analyzer database (IQVIA), which contains drug prescriptions, diagnoses, and basic medical and demographic data. Patients with and without CRC were matched by sex, age, and index year. Results: We identified several diagnoses with a significantly higher prevalence among CRC patients 12 months prior to the index date compared to controls. These diagnoses included gastrointestinal hemorrhage, hemorrhoids, perianal venous thrombosis, and abdominal and pelvic pain, as well as functional intestinal disorders. In contrast, the prevalence of lipid metabolism disorder, depression, hypertension, coronary heart disease, or acute bronchitis was significantly lower in CRC cases. After diagnosis of CRC, we found a significantly higher prevalence of anemia, polyneuropathies, functional intestinal disorders, and chronic kidney disease among CRC patients compared to the control group, while the prevalence of acute upper respiratory infections of multiple and unspecified sites and acute bronchitis was significantly lower in CRC patients compared to non-CRC patients. Conclusions: In the present study, we identified a variety of diseases occurring at higher or lower frequencies in CRC patients compared to matched controls without CRC. This might help to select patients for early CRC screening and improve the clinical management of CRC patients. [ABSTRACT FROM AUTHOR]

It has been shown that endocardial occlusion of the left atrial appendage (LAA) is equally effective in preventing embolic events compared to oral anticoagulation in patients with nonvalvular atrial fibrillation. An 82‐year‐old female patient was admitted for LAA occlusion for repetitive GI bleeding. She had high CHADSVASC Score and HASBLED with long persistent atrial fibrillation with many comorbities. The preprocedural transesophageal echo revealed a great mass in the left atrium (Picture 1). Cardiac surgery was denied, we performed an epicardial only ligation for closing the LAA. For this approach we performed an epicardial puncture and contrast injection within the pericardial space to delineate the LAA. An epicardial wire with a suction mechanism at its distal end was attached to the anterior lobe of the LAA. Using this epicardial wire the snare could be advanced over the appendage and closed down. Complete exclusion of the LAA was achieved. There were no procedural complications and the patient is doing well after 3 months. [ABSTRACT FROM AUTHOR]

Venous thromboembolism (VTE) constitute a major global burden of disease. Current international guidelines recommend treatment with anticoagulant therapy after VTE for a duration of at least 3 months. Since anticoagulation also imposes an increased risk for bleeding events, the individual risk has to be evaluated to determine adequate treatment plans. The nationwide German inpatient sample of the years 2005–2017 was used for this analysis. Hospitalized VTE patients were stratified according to Kuijer risk class and the performance of the Kuijer score was evaluated to predict adverse in-hospital events. Overall, 1,204,895 VTE patients were treated between 2005 and 2017 in Germany and were included in the present study (839,143 patients had deep venous thrombosis and/or thrombophlebitis and 669,881 patients pulmonary embolism). According to Kuijer risk class stratification, in total, 176,723 (14.7%) of the hospitalized VTE patients were classified as low risk, 914,964 (75.9%) as intermediate risk and 113,208 (9.4%) as high risk. A higher Kuijer risk class was predictive for in-hospital death (odds ratio [OR] 1.99 [95% confidence interval (CI) 1.96–2.02], P < 0.001), major adverse cardiovascular and cerebrovascular events (MACCE, OR 1.90 [95%CI 1.87–1.93], P < 0.001), intracerebral bleeding (OR 1.28 [95%CI 1.14–1.44], P < 0.001), gastrointestinal bleeding (OR 1.56 [95%CI 1.48–1.64], P < 0.001) as well as necessity of transfusion of blood constituents (OR 2.94 [95%CI 2.88–3.00], P < 0.001) independently of important comorbidities. The Kuijer score is an important risk stratification tool to predict individual risk regarding in-hospital outcomes comprising major bleeding events such as intracerebral bleeding and necessity of transfusion of blood constituents, but also in-hospital mortality and MACCE in VTE patients. • Kuijer score is an important risk stratification tool to predict different outcomes in VTE patients. • Kuijer score revealed a good predictive performance for major bleeding events in VTE. • In addition, Kuijer score was also predictive for in-hospital mortality and MACCE in VTE. [ABSTRACT FROM AUTHOR]

Background: Upper gastrointestinal bleeding (UGIB) is a leading cause of morbidity and is associated with a 2 % - 17 % mortality rate in the UK and USA. Bleeding peptic ulcers account for 50 % of UGIB cases. Endoscopic intervention in a timely manner can improve outcomes. Hemostatic spray is an endoscopic hemostatic powder for GI bleeding. This multicenter registry was created to collect data prospectively on the immediate endoscopic hemostasis of GI bleeding in patients with peptic ulcer disease when hemostatic spray is applied as endoscopic monotherapy, dual therapy, or rescue therapy.Methods: Data were collected prospectively (January 2016 - March 2019) from 14 centers in the UK, France, Germany, and the USA. The application of hemostatic spray was decided upon at the endoscopist's discretion.Results: 202 patients with UGIB secondary to peptic ulcers were recruited. Immediate hemostasis was achieved in 178/202 patients (88 %), 26/154 (17 %) experienced rebleeding, 21/175 (12 %) died within 7 days, and 38/175 (22 %) died within 30 days (all-cause mortality). Combination therapy of hemostatic spray with other endoscopic modalities had an associated lower 30-day mortality (16 %, P < 0.05) compared with monotherapy or rescue therapy. There were high immediate hemostasis rates across all peptic ulcer disease Forrest classifications.Conclusions: This is the largest case series of outcomes of peptic ulcer bleeding treated with hemostatic spray, with high immediate hemostasis rates for bleeding peptic ulcers. [ABSTRACT FROM AUTHOR]

Importance: Blood transfusion is one of the most frequently used therapies worldwide and is associated with benefits, risks, and costs.Objective: To develop a set of evidence-based recommendations for patient blood management (PBM) and for research.Evidence Review: The scientific committee developed 17 Population/Intervention/Comparison/Outcome (PICO) questions for red blood cell (RBC) transfusion in adult patients in 3 areas: preoperative anemia (3 questions), RBC transfusion thresholds (11 questions), and implementation of PBM programs (3 questions). These questions guided the literature search in 4 biomedical databases (MEDLINE, EMBASE, Cochrane Library, Transfusion Evidence Library), searched from inception to January 2018. Meta-analyses were conducted with the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology and the Evidence-to-Decision framework by 3 panels including clinical and scientific experts, nurses, patient representatives, and methodologists, to develop clinical recommendations during a consensus conference in Frankfurt/Main, Germany, in April 2018.Findings: From 17 607 literature citations associated with the 17 PICO questions, 145 studies, including 63 randomized clinical trials with 23 143 patients and 82 observational studies with more than 4 million patients, were analyzed. For preoperative anemia, 4 clinical and 3 research recommendations were developed, including the strong recommendation to detect and manage anemia sufficiently early before major elective surgery. For RBC transfusion thresholds, 4 clinical and 6 research recommendations were developed, including 2 strong clinical recommendations for critically ill but clinically stable intensive care patients with or without septic shock (recommended threshold for RBC transfusion, hemoglobin concentration <7 g/dL) as well as for patients undergoing cardiac surgery (recommended threshold for RBC transfusion, hemoglobin concentration <7.5 g/dL). For implementation of PBM programs, 2 clinical and 3 research recommendations were developed, including recommendations to implement comprehensive PBM programs and to use electronic decision support systems (both conditional recommendations) to improve appropriate RBC utilization.Conclusions and Relevance: The 2018 PBM International Consensus Conference defined the current status of the PBM evidence base for practice and research purposes and established 10 clinical recommendations and 12 research recommendations for preoperative anemia, RBC transfusion thresholds for adults, and implementation of PBM programs. The relative paucity of strong evidence to answer many of the PICO questions supports the need for additional research and an international consensus for accepted definitions and hemoglobin thresholds, as well as clinically meaningful end points for multicenter trials. [ABSTRACT FROM AUTHOR]

Abstract: Background: Despite the prevalence of internal hemorrhoid disease (HD), there are few pharmacologic options. Iferanserin, a selective serotonin receptor antagonist, is being studied for use in the treatment of HD. Objective: This Phase IIb study evaluated the efficacy and tolerability of 10-mg twice-daily iferanserin intra-anal ointment for the cessation of bleeding and other symptoms associated with internal HD. Methods: This randomized, double-blind, placebo-controlled study was conducted at 5 sites in Germany. Outpatients with Goligher grade I, II, and/or III hemorrhoids and bleeding were randomly assigned to receive iferanserin ointment 10 mg or inactive vehicle (placebo) BID for 14 days. During treatment, patients rated the severity of HD symptoms daily on a 10-point scale using a diary form. At enrollment and study end, physicians recorded the frequency and intensity of HD symptoms, adverse events, and results from blood and urine analyses on clinical-report forms. Results: Of the 121 patients enrolled in the study, 118 were evaluable for tolerability and 111 for efficacy. The mean age of the tolerability population was 52.7 years, 78.9% were male, and all were white. The 2 groups had similar HD symptoms at baseline, but overall, patients in the placebo group had numerically higher grades of HD than did patients in the iferanserin group. Compared with placebo, iferanserin was associated with significantly lower patient-reported severity ratings of daily bleeding and itching, beginning at day 1 for bleeding and at day 2 for itching (P < 0.05), but not with reduced ratings for severity of other HD symptoms, including pain, tenderness, difficulty with defecation, fullness, throbbing, and gas. In the physician assessments, iferanserin was associated with significantly reduced bleeding frequency by day 14 compared with placebo (P < 0.05). Adverse events were mild and infrequent, with no significant differences in prevalences between the 2 treatment groups and no clinically significant changes in laboratory values in any patient. Conclusion: Compared with placebo, intra-anal iferanserin was associated with significantly reduced patient-reported severity of bleeding and itching and physician-assessed bleeding frequency in these patients presenting with grade I, II, and/or III internal hemorrhoids and bleeding at 5 sites in Germany. ClinicalTrials.gov identifier: 01483833. [Copyright &y& Elsevier]

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Introduction: The aim of the study was to evaluate the safety and feasibility of stapled transanal procedures performed by a 36 mm stapling device, the so-called TST36 stapler. Methods: From September 2013 to June 2014 a prospective observational study was carried out by 8 proctology centers in Germany. The Cleveland Clinic Incontinence Score (CCIS) for incontinence and the Altomare ODS score were determined preoperatively. Follow-up examinations were performed after 14 days, one month and 6 months, at this time both scores were reevaluated. Results: 110 consecutive patients (71 women, 39 men) with a mean age of 59.7 years (±13.8 years) were included in the study. The eight participating institutes entered 3 to 31 patients each into the study. The indication for surgery was an advanced hemorrhoidal disease in 55 patients and ODS with rectal intussusception or rectocele in 55 patients. Mechanical problems with stapler introduction occurred in 22 cases (20%) and a partial stapleline dehiscence in 4 cases (3.6%). Additional stitches for bleeding from stapleline were necessary in 86 patients (78.2%). Reintervention was necessary for bleeding 7 times (6.3%). Severe complications during follow-up were stapleline dehiscence in one case and recurrent hemorrhoidal prolapse in 5 cases (4.5%). Altomare ODS score and CCIS improved significantly after surgery. Conclusions: Despite a notable complication rate during surgery and the postoperative period, the TST36 can be considered as an effective tool for low rectal stapling for anorectal prolapse causing hemorrhoids or obstructed defecation. [ABSTRACT FROM AUTHOR]

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Presents an update on the administration of the painkiller Toradol from Syntex as of 1995. Temporary suspension of the drug in Germany; Components of the drug; Association of the drug with a number of cases of serious gastrointestinal bleeding.