Alpaslan A.,Augusta Hospital and Catholic Hospital Group |
Wintermark M.,Stanford University |
Pinter L.,Lukas Hospital |
Macdonald S.,Silk Road Medical |
And 2 more authors.
Journal of Endovascular Therapy | Year: 2017
Purpose: To report a study evaluating the safety and efficacy of stenting via direct carotid access with flow reversal using the ENROUTE Transcarotid Neuroprotection System. Methods: Between March 2009 and June 2012, 75 patients (mean age 72.6 years; 45 men) underwent carotid artery stenting with the ENROUTE System; the majority of patients (63, 84%) were asymptomatic. The primary safety endpoint was the composite of major stroke, myocardial infarction, or death at 30 days. Efficacy outcomes included acute device success, procedure success, and tolerance to flow reversal. Fifty-six (74.7%) patients underwent diffusion-weighted magnetic resonance imaging (DW-MRI) before and after the procedure to assess the development of new ischemic brain lesions. Results: Acute device and procedure success were achieved in 68 (90.6%) patients. The reverse flow circuit was established in 71 (94.6%) patients; only 5 patients demonstrated transient intolerance to flow reversal that did not interfere with completion of the procedure. The mean time on flow reversal was 19.1 minutes. In the DW-MRI substudy, 10 (17.9%) of 56 patients had ipsilateral new white lesions with a mean volume of 0.17 mL. At 30 days, no major stroke, myocardial infarction, or death occurred; 1 patient had experienced a minor stroke that was adjudicated as not related to either the device or procedure. Conclusion: Results of the PROOF study demonstrate the safety and efficacy of transcarotid revascularization with the ENROUTE Transcarotid Neuroprotection System. © The Author(s) 2016.
Barski D.,Lukas Hospital |
Deng D.Y.,University of California at San Francisco
BioMed Research International | Year: 2015
Purpose. To evaluate the surgical treatment concepts for the complications related to the implantation of mesh material for urogynecological indications. Materials and Methods. A review of the current literature on PubMed was performed. Results. Only retrospective studies were detected. The rate of mesh-related complications is about 15-25% and mesh erosion is up to 10% for POP and SUI repair. Mesh explantation is necessary in about 1-2% of patients due to complications. The initial approach appears to be an early surgical treatment with partial or complete mesh resection. Vaginal and endoscopic access for mesh resection is favored. Prior to recurrent surgeries, a careful examination and planning for the operation strategy are crucial. Conclusions. The data on the management of mesh complication is scarce. Revisions should be performed by an experienced surgeon and a proper follow-up with prospective documentation is essential for a good outcome. © 2015 D. Barski and D. Y. Deng.
News Article | March 31, 2016
Cybercriminals have found a new, soft target for mass extortion schemes. Since February, at least a dozen hospitals have been affected by ransomware—malware that encrypts a victim's files until they pay a hefty bounty. Some of the victims have had to resort to using pen-and-paper and diverting emergency services to other hospitals while they try to regain control of their systems. Judging by interviews with researchers working alongside the FBI on an active investigation into a related case, as well as others who have found serious issues with the security of hospitals and medical devices, the ransomware problem facing the healthcare sector may be set to get worse. “We made a decision very quickly to shut down our systems,” Ann Nickels, a spokesperson for MedStar Health, told Motherboard in a phone call. MedStar is a non-profit network that runs 10 hospitals in the Baltimore and Washington area and was attacked with malware earlier this week. As of Wednesday, computers in at least four associated hospitals remained offline. Nickels refused to say whether the attack involved ransomware, but staff at MedStar facilitates have reportedly seen pop-ups on their computers demanding around $19,000 in bitcoin. MedStar, it seems, is just the latest suspected victim of ransomware in a months-long campaign targeting the healthcare sector. On February 5, the Hollywood Presbyterian Medical Center in Los Angeles was hit and eventually coughed up just under $17,000 to hackers in order to decrypt its files. At least two facilities in Germany were targeted around the same time, and a handful of computers at the Ottawa Hospital were infected in March. The Methodist Hospital in Henderson, Kentucky was targeted shortly after. “Methodist Hospital is currently working in an Internal State of Emergency due to a Computer Virus that has limited our use of electronic web based services,” the hospital said in a statement at the time. The damage to many of these hospitals has been debilitating. Doctors pushed high-risk surgeries to later dates, records had to be faxed or hand-delivered, and written notes then had to be entered back into computers once everything was up and running again. Even if certain systems weren’t infected with malware, some hospitals still pulled the plug as a precaution, seriously affecting productivity. “For security reasons we turned off all computers immediately,” Dr. Andreas Kremer, a spokesperson for Lukas Hospital in Neuss, Germany, told Motherboard. “Working through our 700 computers is still ongoing, meanwhile many work stations got completely new hardware and the old devices were disposed [of] appropriately.” Near the start of the attack, the hospital had to cut down its emergency services for a few days, “because providing emergency care needs a fast system and we could not provide that,” Kremer continued. When asked how many computers MedStar uses, Nickels said, “We haven't even tried to provide that number, but it's affected our entire system.” “We detected an intrusion in our servers, and immediately acted to shut down our systems, and keep it from spreading elsewhere,” she continued. “Our large system server. Not a single PC.” Although Nickels would not specify what kind of malware had infected MedStar's system, the fact that it targeted a server suggests it could have been Samsam, a new form of ransomware that is spreading like wildfire, and not just in hospitals. Ransom notes reportedly found on MedStar computers also resemble those from Samsam. Samsam’s most interesting innovation is that it requires no human interaction from the target in order to start cutting off files. Typically with ransomware, a victim’s machine might be infected by a malicious email attachment or a malware-laden advert. But Samsam doesn't target humans. It targets servers. “Samsam is innovative, in that it actually decided to target server vulnerabilities,” Craig Williams, senior technical leader from research group Talos, which is part of cybersecurity company Cisco, told Motherboard in a phone call. Talos has been researching Samsam and is actively working with the FBI on a criminal investigation into its use. Although Williams wouldn't name specific hospitals, he said Talos had received numerous reports from the healthcare industry about Samsam-related attacks. The Samsam ransomware is so worrying that the FBI has published a direct call to the private sector, urgently asking for assistance in combating it. In February, the FBI's Cyber Division distributed an industry alert about MSIL/Samas.A, other names used to label the Samsam ransomware. “In a new scheme, cyber criminals attempt to infect whole networks with ransomware and use persistent access to locate and delete network backups,” it read, and gave the usual advice of creating offline backups of data so as to thwart the criminals' extortion attempts. A month later, however, the FBI issued another alert, this time much more urgent. “WE NEED YOUR HELP!” the document, obtained by Motherboard and originally reported by Reuters, reads. “If you find any of these indicators on your networks, or have related information, please contact FBI CYWATCH immediately.” Screenshot of part of the FBI alert Samsam works by first exploiting vulnerabilities in JBoss application servers by using an open source, publicly available penetration testing tool called JexBoss. “They literally have copied the exploits out of [JexBoss],” Williams said. From here, the hackers can move through the network onto other machines and encrypt their files. “These attackers have done their reconnaissance,” Williams added. “They've scanned the internet for this particular set of JBoss vulnerabilities, and set up a set of servers they wanted to attack, relatively simultaneously.” Williams said the Samsam attackers appear to be new to the ransomware game, pointing to how their extortion price has steadily increased over the months, indicating that the attackers are still trying to figure out how much money they can squeeze from victims. Williams added that the Samsam attackers have also targeted other industries, such as gaming and construction, since December. According to him, Samsam has raked in around $115,000 as of earlier this month, but has since seen a significant increase in successful extortions. On Wednesday, Williams also said his team had found tens of thousands of servers vulnerable to the issues the Samsam attackers were leveraging, but it wasn't immediately clear if all the servers were exploitable. Fortunately, at least when it comes to the Samsam ransomware, there is a very easy solution. “Patch your servers. Backup your data. Done,” Williams said. “This isn't one of those situations where they need to educate every user.” Since the malware doesn't rely on a human mistakenly downloading it, one gullible click won’t cause an infection. That's only the case with Samsam though—mitigating more traditionally delivered ransomware would still need hospital staff to be vigilant. It is not clear how many of the recent hospital cases can be directly linked to Samsam. “For the other types of ransomware targeting hospitals, I don't think they're related,” Williams said. “I think it's a simple copycat thing.” At least one of the attacks in Germany, for example, reportedly started from a malicious email attachment; Kremer from the Lukas Hospital told Motherboard their investigation was still ongoing. Even if the FBI and industry does start to get a grip on Samsam, the way some medical networks are designed means the ransomware threat facing hospitals may get even worse, and problems aren't likely to be addressed any time soon. Sergey Lozhkin, a senior researcher at Kaspersky Lab said this is because “in lots of cases medical equipment is not isolated from the local office network.” Last month, he detailed the results of his penetration test of a Moscow hospital. Among other issues, Lozhkin discovered a login portal for a CT scan machine on the open internet, and once inside the hospital's local network, he found a control panel for an MRI machine that was not password protected. “If somehow ransomware gets inside the hospital, it could spread through the internal network” and manage to get onto medical devices, Lozhkin said. After all, medical devices are often, at bottom, just computers, with some running the same operating system as office desktops such as Windows XP. Security of these devices has largely been an afterthought, with efficiency naturally pegged as the highest priority. Ultimately, there's only really one way to help ward off ransomware attacks: not paying the hackers. “The FBI does not condone payment of ransom, as payment of extortion monies may encourage continued criminal activity, lead to other victimizations, or be used to facilitate serious crimes,” an FBI official told Motherboard. “The problem is, as long as people continue to pay that ransom, not only are they funding the development of future versions of ransomware that are going to become even more insidious, but they're also encouraging other malware authors to move towards ransomware,” Williams said. “Until users start backing up their hard drive, and not paying the ransom, this is only going to continue to be a problem.”
Engelmann G.,Lukas Hospital |
Hoffmann G.F.,University of Heidelberg |
Grulich-Henn J.,University of Heidelberg |
Teufel U.,University of Heidelberg
Hepatitis Monthly | Year: 2014
Background: Elevated aminotransferases serve as surrogate markers of non-alcoholic fatty liver disease, a feature commonly associated with the metabolic syndrome. Studies on the prevalence of fatty liver disease in obese children comprise small patient samples or focus on those patients with liver enzyme elevation. Objectives: We have prospectively analyzed liver enzymes in all overweight and obese children coming to our tertiary care centre. Patients and Methods: In a prospective study 224 healthy, overweight or obese children aged 1 - 12 years were examined. Body Mass Index-Standard Deviation Score, alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl-transpeptidase were measured. Results: Elevated alanine aminotransferase was observed in 29% of children. 26 % of obese and 30 % of overweight children had liver enzyme elevations. Obese children had significantly higher alanine aminotransferase levels than overweight children (0.9 vs. 0.7 times the Upper Limit of Normal; P = 0.04). Conclusions: Elevation of liver enzymes appears in 29 % obese children in a tertiary care centre. Absolute alanine aminotransferase levels are significantly higher in obese than in overweight children. Even obese children with normal liver enzymes show signs of fatty liver disease as demonstrated by liver enzymes at the upper limit of normal. © 2014, Kowsar Corp.
Gerullis H.,Lukas Hospital |
Gerullis H.,University of Duisburg - Essen |
Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine
Drugs of Today | Year: 2011
Vinflunine is a novel third-generation bifluorinated semisynthetic vinca alkaloid that has been shown to have activity against a variety of solid tumor types including advanced transitional cell carcinoma of the urothelium. In contrast to other vinca alkaloids, vinflunine shows superior antitumor activity and an excellent safety profile. Vinflunine interacts with tubulin and has a lower affinity to tubulin; it has a high intracellular accumulation rate and therefore significant effects on microtubule dynamics. A large, phase III trial comparing vinflunine with best supportive care versus best supportive care alone showed an improvement in overall survival in the vinflunine arm in preplanned secondary analyses. In addition, the drug has shown a moderate adverse event profile in the phase II and III trials. In September 2009, vinflunine was approved as a second-line treatment for patients with urothelial carcinoma resistant to first-line platinum-containing chemotherapy by the European Medicines Agency. Copyright © 2011 Prous Science, S.A.U. or its licensors. All rights reserved.
Gerullis H.,Lukas Hospital |
Gerullis H.,University of Duisburg - Essen |
Bergmann L.,Goethe University Frankfurt |
Maute L.,Goethe University Frankfurt |
And 4 more authors.
Medical Oncology | Year: 2010
Targeted agents sunitinib and temsirolimus are effective in advanced renal cell carcinoma. Treatment algorithms for single-agent use have been proposed in order to optimize timing and type of therapy. The aim of this study was to investigate the tolerability and adverse event profile of patients who received sunitinib and temsirolimus in sequence. We performed a retrospective analysis of patients with advanced renal cell carcinoma who received temsirolimus after disease progression under sunitinib therapy. Dosages of both drugs were in accordance with the recommendations given by the respective manufacturers. Temsirolimus was provided before its official approval within a compassionate use program. Adverse event assessment followed the National Cancer Institute Common Toxicity Criteria. Thirteen patients receiving temsirolimus after progression under sunitinib were identified. Overall treatment time with targeted drugs (sunitinib/temsirolimus) was 34.8 (17-78) weeks, treatment with sunitinib was 28.6 (12-72), and with temsirolimus 6.2 (2-16) weeks, respectively, whereas mean therapy interruption time between both approaches was 4.4 (2-12) weeks. Under sunitinib, we observed 52 transient adverse events, 49 (94.2%) were of grade I/II, whereas 3 (5.8%) were of grade III. Under temsirolimus 36 adverse events, only grade I/II in nature were remarked. Sequential use of temsirolimus after progression under sunitinib seems to be feasible and results in a predictable, medically manageable side effect profile. Further evaluation is necessary to define the oncological validity of this sequencing approach. © 2009 Humana Press Inc.
Gerullis H.,Lukas Hospital |
Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine |
Eimer C.,Lukas Hospital |
Ecke T.H.,HELIOS Hospital |
And 4 more authors.
Anti-Cancer Drugs | Year: 2013
The role of pazopanib in the second-line setting of refractory metastatic transitional cell carcinoma of the urothelium has not been defined clearly. The aim of this phase I/II trial was to assess the safety, tolerability, and efficacy of combining pazopanib and vinflunine in patients with metastatic transitional cell carcinoma of the urothelium after failure of first-line platinum-containing therapy. From May 2011 to December 2011, five patients were enrolled in this trial. Pazopanib was the investigated compound; four levels were planned (200, 400, 600, and 800 mg/day). Vinflunine was dosed at 280 mg/m for the first dose and 320 mg/m every 3 weeks thereafter. After the definition of a tolerated dose for the combined therapy, a subsequent phase II study was planned. At the starting level, pazopanib 200 mg/day, dose-limiting toxicities were observed in two of five patients. One patient experienced grade 4 febrile neutropenia, which led to treatment discontinuation. A second patient showed grade 3 hepatobiliary disorder with an increase in γ-glutamyltransferase. The study was interrupted at dose level 1 for safety reasons. The initially planned phase II study was therefore not carried out. This phase I study showed that combined therapy of daily pazopanib (200 mg) and vinflunine (280/320 mg/m) every 3 weeks is poorly tolerated in patients with refractory advanced urothelial cancer. © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Wlodzimirow K.A.,University of Amsterdam |
Abu-Hanna A.,University of Amsterdam |
Royakkers A.A.N.M.,Zaans Medical Center |
Spronk P.E.,Lukas Hospital |
And 4 more authors.
Nephron - Clinical Practice | Year: 2014
Aims: To evaluate the performance of fractional excretion of urea (FeU) for differentiating transient (T) from persistent (P) acute kidney injury (AKI) and to assess performance of FeU in predicting AKI in patients admitted to the ICU. Methods: We performed secondary analysis of a multicenter prospective observational cohort study on the predictive performance of biological markers for AKI in critically ill patients. AKI was diagnosed according to RIFLE staging. Results: Of 150 patients, 51 and 41 patients were classified as having T-AKI and P-AKI, respectively. The diagnostic performance for FeU to discriminate T-AKI from P-AKI on the day of AKI was poor (AUC-ROC = 0.61; 95% CI: 0.49-0.73). The diagnostic performance of FeU to predict AKI 1 and 2 days prior to AKI was poor as well (AUC-ROC = 0.61; 95% CI: 0.47-0.74, and 0.58; 95% CI: 0.43-0.73, respectively). Conclusions: FeU does not seem to be helpful in differentiating T- from P-AKI in critically ill patients and it is a poor predictor of AKI. © 2014 S. Karger AG, Basel.
Barski D.,Lukas Hospital |
Georgas E.,Lukas Hospital |
Gerullis H.,Lukas Hospital |
Ecke T.,Helios Hospital
Central European Journal of Urology | Year: 2014
Introduction Penile carcinoma has an incidence of 4,000 cases in Europe. The therapy and prognosis depend decisively on the lymph node status. Lymph node metastases are detected in 23-65% cases depending on the histopathological pattern. Due to improved diagnostic methods an early detection of tumor stage is possible. Multimodal therapeutic concepts can offer curability for a subset of patients, even those suffering from advanced disease. Material and methods Current data on penile cancer based on a selective review of the literature by PubMed and the EAU guidelines 2009. Results Invasive diagnostic tools, such as fine-needle biopsy (FNB) and dynamic sentinel node biopsy (DSNB), improved the diagnosis of lymph node status considerably and reduced the morbidity in specialized centers. The application of 18F-FDG-PET/CT for metastases detection needs further evaluation due to inconsistent results. Inguinal lymphadenectomy is the therapeutic standard in case of metastases proof. It was possible to reduce the complications due to the new modified operation techniques. Patients with extended lymph node and distant metastases have a poor prognosis. Different systemic polychemotherapy regimes are applied currently and are associated with poor outcome (response rates <50%) and high morbidity. Neoadjuvant chemotherapy is recommended in patients with unresectable and relapsing lymph node metastases. Conclusions Currently, inconsistent therapy regimens are applied for metastatic penile cancer. Standardization is urgently needed through the development of high-quality studies and long-term registers in order to lower the morbidity and increase the efficiency of diagnosis and therapy.
Gerullis H.,Lukas Hospital
Journal of the Egyptian Society of Parasitology | Year: 2010
Bladder cancer is controllable when adequately diagnosed and treated according to current recommendations. Radical cystectomy with urinary diversion is the standard therapy for muscle invasive tumors. In patients unfit or unwilling to get radical surgery, external beam or combined chemo-radiotherapy display alternative treatment options and can be safely performed. Every therapy implies the patient's disposition to cooperate. Case presentation: This case report describes the clinical course over 31 months after initial diagnosis of a 56-years-old Caucasian, white man with an initial pT1G3 urothelial carcinoma of the bladder. The patient denied early radical cystectomy, radio-chemotherapy and almost all alternative treatment possibilities. He finally died 31 months after initial verification of the disease.