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119 result(s) for "Lindner, Dirk"
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Venous thromboembolism and intracranial hemorrhage in patients undergoing glioblastoma surgery
In the perioperative management of patients with glioblastoma (GBM), physicians face the question of whether and when to administer prophylactic or therapeutic anticoagulation (AC). In this study, we investigate the effects of the timing of postoperative heparinization on thromboembolic events (TE) and postoperative hemorrhage (bleeding, PH) as well as the interactions between the two in the context of an underlying intracerebral malignancy. For this retrospective data analysis, 222 patients who underwent surgery for grade IV glioblastoma, IDH-wildtype (2016 CNS WHO) between 01/01/2014 and 31/12/2019 were included. We followed up for 12 months. We assessed various biographical and clinical data for risk factors and focused on the connection between timepoint of AC and adverse events. Subgroup analyses were performed for pulmonary artery embolism (PE), deep vein thrombosis, and postoperative intracranial hemorrhage (PH) that either required surgical intervention or was controlled radiologically only. Statistical analysis was performed using Mann–Whitney U-Test, Chi-square test, Fisher’s exact test and univariate binomial logistic regression. p values below 0.05 were considered statistically significant. There was no significant association between prophylactic AC within 24 h and more frequent major bleeding ( p  = 0.350). AC in patients who developed major bleeding was regularly postponed by the physician/surgeon upon detection of the re-bleeding; therefore, patients with PH were anticoagulated significantly later ( p  = 0.034). The timing of anticoagulant administration did not differ significantly between patients who experienced a thromboembolic event and those who did not ( p  = 0.634). There was considerable overlap between the groups. Three of the six patients (50%) with PE had to be lysed or therapeutically anticoagulated and thereafter developed major bleeding ( p  < 0.001). Patients who experienced TE were more likely to die during hospitalization than those with major bleeding ( p  = 0.022 vs. p  = 1.00). Prophylactic AC within 24 h after surgery does not result in more frequent bleeding. Our data suggests that postoperative intracranial hemorrhage is not caused by prophylactic AC but rather is a surgical complication or the result of antithrombotic therapy. However, thromboembolic events worsen patient outcomes far more than postoperative bleeding. The fact that bleeding may occur as a complication of life-saving lysis therapy in the setting of a thromboembolic event should be included in this cost–benefit consideration.
Development of 3D printed patient-specific skull implants based on 3d surface scans
Sometimes cranioplasty is necessary to reconstruct skull bone defects after a neurosurgical operation. If an autologous bone is unavailable, alloplastic materials are used. The standard technical approach for the fabrication of cranial implants is based on 3D imaging by computed tomography using the defect and the contralateral site. A new approach uses 3D surface scans, which accurately replicate the curvature of the removed bone flap. For this purpose, the removed bone flap is scanned intraoperatively and digitized accordingly. When using a design procedure developed for this purpose creating a patient-specific implant for each bone flap shape in short time is possible. The designed skull implants have complex free-form surfaces analogous to the curvature of the skull, which is why additive manufacturing is the ideal manufacturing technology here. In this study, we will describe the intraoperative procedure for the acquisition of scanned data and its further processing up to the creation of the implant.
Perioperative anticoagulation in patients with intracranial meningioma: No increased risk of intracranial hemorrhage?
Anticoagulation (AC) is a critical topic in perioperative and post-bleeding management. Nevertheless, there is a lack of data about the safe, judicious use of prophylactic and therapeutic anticoagulation with regard to risk factors and the cause and modality of brain tissue damage as well as unfavorable outcomes such as postoperative hemorrhage (PH) and thromboembolic events (TE) in neurosurgical patients. We therefore present retrospective data on perioperative anticoagulation in meningioma surgery. Data of 286 patients undergoing meningioma surgery between 2006 and 2018 were analyzed. We followed up on anticoagulation management, doses and time points of first application, laboratory values, and adverse events such as PH and TE. Pre-existing medication and hemostatic conditions were evaluated. The time course of patients was measured as overall survival, readmission within 30 days after surgery, as well as Glasgow Outcome Scale (GOS) and modified Rankin Scale (mRS). Statistical analysis was performed using multivariate regression. We carried out AC with Fraxiparin and, starting in 2015, Tinzaparin in weight-adapted recommended prophylactic doses. Delayed (216 ± 228h) AC was associated with a significantly increased rate of TE (p = 0.026). Early (29 ± 21.9h) prophylactic AC, on the other hand, did not increase the risk of PH. We identified additional risk factors for PH, such as blood pressure maxima, steroid treatment, and increased white blood cell count. Patients' outcome was affected more adversely by TE than PH (+3 points in modified Rankin Scale in TE vs. +1 point in PH, p = 0.001). Early prophylactic AC is not associated with an increased rate of PH. The risks of TE seem to outweigh those of PH. Early postoperative prophylactic AC in patients undergoing intracranial meningioma resection should be considered.
Final results from the vedolizumab extended access program multinational study demonstrate long-term treatment persistence and safety
Long-term treatment of inflammatory bowel disease with vedolizumab is safe, effective, and well-tolerated by patients Why was the study done? When harmful bacteria are swallowed with food, immune cells move to the gut to clear the bacteria, which causes inflammation. This natural process is exacerbated in individuals with inflammatory bowel disease (IBD), who may be diagnosed with either ulcerative colitis (UC) or Crohn’s disease (CD). Vedolizumab (VDZ) is an approved treatment for UC and CD that limits immune cells moving to the gut, preventing inflammation. This study aimed to enhance our current understanding about VDZ’s long-term safety and effectiveness. What did the researchers do? In this study, researchers used data from 331 patients with UC or CD over approximately 6.5 years. The researchers measured how long patients took less frequent doses of VDZ without interruption and without relapse of IBD symptoms. Instances where VDZ treatment frequency had to be increased to remain effective as well as the frequency of medical complications (for example: side effects or hospitalization) were also examined. What did the researchers find? The study found that 98% of patients with UC and 95% with CD received VDZ for at least 6 continuous months without disease relapse. Patients with UC or CD continued taking VDZ for 3.5 or 3.6 years, respectively, on average. A minority (9%) of patients with UC or CD needed to increase how often they took VDZ to control their symptoms. Only 1% of patients in the study experienced VDZ-related medical complications during the study period. Why are the findings significant? These results show that patients who have taken VDZ for a long time previously and then later reduce their treatment frequency rarely need to increase how often they take VDZ again, and that this reduction rarely causes medical problems. This adds to the body of evidence showing that VDZ is a safe and effective treatment for patients with IBD.
Vedolizumab clinical decision support tool predicts clinically relevant targets in patients with Crohn’s disease
Vedolizumab clinical decision support tool to predict improvements in symptoms and quality of life in people living with Crohn’s disease Crohn’s disease is a long-term condition that causes inflammation in the digestive tract. This can lead to symptoms such as abdominal pain and diarrhea. People with Crohn’s disease often report that they have a lower quality of life than those without Crohn’s disease. Vedolizumab is a medicine used to treat adults with moderate to severe Crohn’s disease. It works by reducing inflammation by targeting the immune system in the gut. The aim of this study was to find out if a decision support tool could help predict which people were likely to have improvements in symptoms and quality of life if they were treated with vedolizumab. The Vedolizumab Clinical Decision Support Tool (VDZ-CDST) uses information on baseline characteristics such as history of bowel surgery, previous treatments, disease history and levels of certain biomarkers. The VDZ-CDST classifies people as having a low, intermediate or high likelihood of vedolizumab keeping Crohn’s disease under control. This study used information on 1189 people taking part in three clinical trials to see how well the VDZ-CDST predicted long-term improvements in symptoms and quality of life. People in the high likelihood group had the quickest and best improvements in symptoms after one year of vedolizumab treatment. People in the intermediate likelihood group had better improvements than those in the low likelihood group. This group had lower improvements in comparison with the high likelihood group, but greater improvements in comparison with the low likelihood group. The greatest improvements in quality of life were in people in the high likelihood group. These results suggest that clinicians could use the VDZ-CDST to identify which people with Crohn’s disease are most likely to respond to the therapy and have long-term improvements in symptoms and quality of life when treated with vedolizumab. This is one of the first examples of grouping patients with IBD based on how they are likely to respond to future treatment.
Flow diversion beyond the circle of Willis: endovascular aneurysm treatment in peripheral cerebral arteries employing a novel low-profile flow diverting stent
BackgroundFlow diversion (FD) has emerged as superior minimally invasive therapy for cerebral aneurysms. However, aneurysms of small peripheral vessel segments have not yet been adequately treatable. More specifically, currently established devices necessitate large microcatheters which impede atraumatic maneuvering. The Silk Vista Baby (SVB), a novel flow diverter, offers the as yet unique feature of deliverability via a 0.017 inch microcatheter. This study reports our first experience with the SVB in challenging intracranial vessels employing a vessel-specific tailored microcatheter strategy.Materials and methods25 patients (27 aneurysms) were prospectively included. A total of 30 SVBs were employed, predominantly targeting demanding aneurysms of the anterior communicating artery complex. The efficacy of the FD was assessed using two-dimensional vector-based perfusion and conventional digital subtraction angiography (DSA) after implantation and at the first follow-up at 3 months. The first follow-up was available in 22 patients.ResultsAll devices were implanted without technical or clinical complications. Eleven treatments were performed using the recommended Headway 17. In 14 interventions the even more maneuverable Excelsior SL10 was used, which was previously tried and tested for safety ’in vitro’ as an alternative delivery system. Aneurysmal influx was strongly reduced after implantation. All parent vessels remained patent. 17/27 aneurysms were completely occluded at first follow-up (∼2.7 months), 6/27 aneurysms showed decreased influx or delayed washout and one remained unchanged. In three cases follow-up DSAs are remaining.ConclusionsSVB provides enhanced controllability in vulnerable segments beyond the circle of Willis. Smaller variants (2.25 mm and 2.75 mm) can safely be implanted via the superiorly navigable Excelsior SL10. Hence, the SVB represents the next evolutionary step in minimally invasive treatment of cerebral aneurysms.
Hydroxyethyl starch for volume expansion after subarachnoid haemorrhage and renal function: Results of a retrospective analysis
Hydroxyethyl starch (HES) was part of \"triple-H\" therapy for prophylaxis and therapy of vasospasm in patients with subarachnoid haemorrhage (SAH). The European Medicines Agency restricted the use of HES in 2013 due to an increase of renal failure in critically ill patients receiving HES compared to crystalloid fluids. The occurrence of renal insufficiency in patients with SAH due to HES is still uncertain. The purpose of our study was to evaluate whether there was an association with renal impairment in patients receiving HES after subarachnoid haemorrhage. Medical records of all non-traumatic SAH patients treated at the Departments of Anaesthesiology and Neurosurgery, University Hospital of Leipzig, Germany, between January 2009 and December 2014 were analysed. Patients received either HES 6% and/or 10% (HES group, n = 183) or exclusively crystalloids for fluid therapy (Crystalloid group, n = 93). Primary outcome was the incidence of acute kidney injury. The study groups had similar characteristics except for initial SAPS scores, incidence of vasospasm and ICU length of stay. Patients receiving HES fulfilled significantly more often SIRS (systemic inflammatory response syndrome) criteria. 24.6% (45/183) of the patients in the HES group had acute kidney injury (KDIGO 1-3) at any time during their ICU stay compared to 26.9% (25/93) in the crystalloid group (p = 0.679). Only few patients needed renal replacement therapy with no significant difference between groups (Crystalloid group: 4.3%; HES group: 2.2%; p = 0.322). The incidence of vasospasm was increased in the HES group when compared to the crystalloid group (33.9% vs. 17.2%; p = 0.004). In the presented series of patients with non-traumatic SAH we found no significant association between HES therapy and the incidence of acute kidney injury. Treatment without HES did not worsen patient outcome.
Magnetic Resonance Enterography Assessment of Transmural Healing with Vedolizumab in Moderate to Severe Crohn’s Disease: Feasibility in the VERSIFY Phase 3 Clinical Trial
The VERSIFY phase 3 trial in patients with Crohn's disease (CD) treated with vedolizumab was the first to include a substudy that used a standardized magnetic resonance enterography (MRE) protocol to assess features of transmural inflammation (bowel edema and wall thickness) and extramural disease activity (enlarged lymph nodes). Patients received intravenous vedolizumab (300 mg) at weeks 0 (baseline), 2, and 6, and then every 8 weeks for 26 or 52 weeks. Post hoc analyses included a subpopulation with a Magnetic Resonance Index of Activity score of ≥7 in at least one bowel segment at baseline and at least one postbaseline MRE assessment. Changes in transmural inflammation, including intramural bowel edema and wall thickness, were evaluated. Patient-level and segment-level analyses were performed. MRE images were evaluated in 27 patients with 83 evaluable bowel segments at baseline and week 26, and 13 patients with 38 evaluable segments at baseline, week 26, and week 52. At baseline, all patients had bowel wall edema and wall thickness of >3 mm in at least one bowel segment. The proportion of patients with edema decreased at weeks 26 (17/27 [63.0%]) and 52 (4/13 [30.8%]) and the proportion with bowel wall thickness of >3 mm decreased at weeks 26 (25/27 [92.6%]) and 52 (10/13 [76.9%]). In patients with CD treated with vedolizumab for 26 and 52 weeks, the number of patients, and bowel segments, with MRE-detected transmural inflammation was reduced. These results highlight the impact of vedolizumab on components of transmural inflammation in CD and demonstrate that using MRE in CD multicenter clinical trials is feasible. ClinicalTrials.gov NCT02425111, April 23, 2015, http://www.clinicaltrials.gov NCT02425111; EU Clinical Trials Register EudraCT 2014-003509-13, https://www.clinicaltrialsregister.eu.