Effectiveness and handling characteristics of a three-layer polymer dura substitute: a prospective multicenter clinical study

OBJECT: The goal of this study was to assess the effectiveness and handling characteristics of a dura substitute composed of two outer layers of expanded polytetrafluoroethylene (PTFE) and a middle layer consisting of an elastomeric fluoropolymer. METHODS: In a prospective multicenter study, the dura substitute was implanted using a standard technique in 119 patients undergoing cranial or spinal surgery requiring duraplasty. Intraoperative assessments of the dura patch consisted of testing for cerebrospinal fluid (CSF) leakage employing the Valsalva maneuver and a surgeon's standard evaluation of the handling characteristics of the device. Postoperative assessments conducted during a mean follow-up time of 15.7 months (range 0.3-45.6 months) consisted of physical examinations, routine computed tomography (CT) or magnetic resonance (MR) imaging studies, and histological studies of any removed dura patches. The mean age of the 119 patients was 40 years (range < 1-81 years). The dura substitute was implanted cranially in 102 patients and spinally in 17. Intraoperative assessment including the Valsalva maneuver led to application of additional sutures in 17 patients. Handling features were rated very good to excellent. Postoperative clinical evaluation resulted in 79 excellent and 18 good results. Imaging studies (MR imaging studies in 69 patients and CT studies in 34 patients) showed no adhesions in 87 patients and minimal adhesions in seven patients (the dura was not visualized in nine patients). Postoperative complications occurred in 12 patients. There were six cases of CSF leakage, three cases of extradural hematoma, one case of arachnoid fibrosis after decompression of a Chiari malformation Type I, and two cases of infection. Eight (7%) of these complications were potentially related to the dura patch. CONCLUSIONS: In a large, multicenter clinical study of the use of an expanded-PTFE-containing dura substitute, the device was found to be easy to handle and implant. No serious dura patch-related intraoperative adverse events were observed. Postoperatively, there were no major sealing problems or long-term complications. In two cases the patch had to be removed due to fibrosis and infection. The three-layer polymer dura substitute appears to be safe and effective in minimizing CSF leakage and adhesion formation, and its use avoids any risk of prion disease transmission.     

Nosocomial transmission of hepatitis B virus associated with endomyocardial biopsy

OBJECTIVES: A high prevalence of chronic hepatitis B has been previously reported in heart transplant recipients in our center. Nosocomial transmission of hepatitis B has been therefore suggested. The aim of the present study was to investigate an outbreak of hepatitis B infection in heart transplant recipients and to to look for nosocomial acquisition of hepatitis B in these patients. METHODS: In a retrospective case-control study, review of transvenous endomyocardial biopsy (TEB) procedure, line probe assay and DNA sequencing for characterization of the outbreak isolate genotypes were performed in order to assess the possible risk of nosocomial transmission of hepatitis B in the setting of heart transplantation. Case was defined as a patient negative for HBsAg before heart transplantation and positive after. Controls were matched with cases by date of transplantation and time-interval of HBV infection occurrence in the cases patients. RESULTS: Transmission of HBV was associated with the number of HBsAg positive patients undergoing TEB the same day and in the same ward (OR=1.17, per additional encounter; 95%CI=1.01-1.37, P=0.02) and with the total number of TEB undergone after a HBsAg positive patient (OR=1.43 for additional encounter, 95%CI=0.97-2.1, P=0.056) but not with the number of biopsies. The virological study identified eight different strains. No common devices nor gloves, drapes, or medical solution were shared among patients during TEB. One staff member, but no surgeon, was HBsAg positive. No further case occurred after implementation of control measures. CONCLUSIONS: Patient-to-patient transmission during TEB sessions was demonstrated by the virological and the case-control studies. This transmission occurred without evidence of blood contact through vials or devices. There is strong evidence that this transmission may be due to the spread of infective blood droplets on the environmental surfaces and the material during the TEB procedure.     

Infliximab plus azathioprine for steroid-dependent Crohn's disease patients: a randomized placebo-controlled trial

BACKGROUND & AIMS: The aim of this study was to evaluate the usefulness of short-term infliximab combined with azathioprine (AZA) or 6-mercaptopurine (6-MP) in steroid-dependent Crohn's disease patients. METHODS: Patients with active disease despite prednisone given for more than 6 months were eligible and were stratified as follows: the failure stratum consisted of patients receiving AZA/6-MP at a stable dose for more than 6 months, and the naive stratum consisted of patients not treated previously with AZA/6-MP. Patients were randomized to infliximab 5 mg/kg or placebo at weeks 0, 2, and 6. All patients were treated with AZA/6-MP maintained at a stable dose throughout the 52 weeks of the study. The primary end point was remission off steroids at week 24. RESULTS: Among the 113 enrolled patients (55 in the failure stratum), 57 were assigned to infliximab. At week 24, the success rate (intent-to-treat analysis) was higher in the infliximab group than in the placebo group (57% vs 29%; P = .003); at weeks 12 and 52, the corresponding rates were 75% vs 38% (P < .001) and 40% vs 22% (P = .04), respectively. In each stratum, the success rate was significantly higher in the infliximab group at weeks 12 and 24, and a trend was found at week 52. In the failure stratum, only 27% of the patients in the infliximab group were still in remission off steroids, compared with 52% in the naive stratum. Steroid resistance was less common and the cumulative dose of prednisone was lower in the infliximab group. CONCLUSIONS: Infliximab plus AZA/6-MP is more effective than AZA/6-MP alone in steroid-dependent Crohn's disease patients.     

Assessment of atorvastatin effectiveness on serum PSA level in hypercholesterolemic males

The previous large retrospective studies demonstrated that treatment with Statins reduces both the incidence of prostate cancer by 50% and serum Prostate Specific Antigen (PSA) level up to 40%. However the main problem in those studies was the absence of control groups of men with hypercholesterolemia without Statin treatment. We performed a small prospective controlled clinical trial to assess the influence of the treatment with Atorvastatin on serum PSA in men with hypercholesterolemia referred to our educational and treatment center from October 2007 to March 2008. In this study, among the newly diagnosed males with hypercholesterolemia (LDL > 130 mg/dl), 40 patients with LDL more than 190 mg/dl were selected as a case group and were treated with Atorvastatin (20 mg/day). Among the same population and in the same period, another 40 patients with LDL between 130 and 190 mg/dl were selected as first control group and were treated only with low fat diet. Another 40 patients with normal serum cholesterol and without any treatment were selected as second control group. The lipid profile and serum PSA level of patients of all groups were tested at the first and third months after the therapy. After completion of data, the mean serum lipids and PSA level were measured in both visits and compared with each other by paired t-test. Also the mean PSA change in two visits between three groups was compared by ANOVA and Tukey HSD test. There was not any significant difference in mean baseline PSA between hypercholesterolemic and normocholesterolemic patients (P=0.547). In case group, mean PSA and LDL was reduced by 14.1% (P=0.0001) and 30% (P=0.0001) respectively by second visit. In first control group, mean PSA was not changed significantly (P=0.337), whereas mean LDL in this group was reduced by 9.6% (P= 0.0001). Similarly in the second control group mean PSA was not changed significantly (P=0.309) by second visit. In addition, mean change of PSA in case group was compared with first and second control groups that was significantly different (P=0.0001) whereas mean change of PSA between two control groups was not significantly different (P=0.615). The results of this study showed that: 1) Short term treatment with Atorvastatin can reduce serum PSA level, and 2) This reduction is more likely to be due to direct effect and is not related to lowering serum cholesterol levels. Thus, if results of this study are confirmed by large prospective randomized clinical trials with longer follow up period, it will be possible that Atorvastatin could be used in long term as a safe chemoprophylactic agent against prostate cancer in high risk patients.     

Complete remission of gastric Burkitt＇s lymphoma after eradication of Helicobacter pylori

Burkitt’s lymphoma is a highly aggressive non-Hodgkin lymphoma, often presenting in extra-nodal sites. It generally has a poor spontaneous outcome and needs aggressive treatment with systemic and intrathecal chemotherapy. Occurrence at the gastric site is rare. We report the case of a 39-year old woman who presented with a prominent ulcerated lesion of the antrum corresponding histologically to a Burkitt’s lymphoma associated with Helicobacter pylori (H pylori) infection. Interphase fluorescence in situ hybridization (FISH) demonstrated c-MYC gene rearrangement in tumour cells without BCL2 or BCL6 gene translocations. Ulcer healing and tumour regression with a complete histological response were obtained 8 wk after H pylori eradication. In spite of this complete remission, taking into account the high risk of recurrence, the patient received systemic and intrathecal chemotherapy. Two years later, the patient remained in complete remission. This is the first report of a gastric Burkitt’s lymphoma responding to H pylori eradication. These findings raise the question of the potential role of H pylori in the pathogenesis of some gastric Burkitt’s lymphomas, and show the importance of searching for and eradicating the bacteria in combination with conventional chemotherapy regimens.