Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective

The European Journal of Health Economics - The transferability of the EU joint clinical assessment (JCA) reports for pharmaceuticals for the German benefit assessment was evaluated by...     

Detection of periodontal microorganisms in coronary atheromatous plaque specimens of myocardial infarction patients: A systematic review and meta-analysis

BackgroundMicrobial translocation from inflamed periodontal pockets into coronary atheroma via systemic circulation is one of the proposed pathways that links periodontitis and myocardial infarction (MI). The purpose of this systematic review is to determine the reported prevalence of periodontal microorganisms in coronary atheroma and/or aspirated clot samples collected from MI patients with periodontal disease.MethodologyThe “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” (PRISMA) guidelines were followed. Six databases were systematically searched using Medical Subject Headings/Index and Entree terms. After a thorough screening, fourteen publications spanning over ten years (2007–2017) were eligible for this systematic review and meta-analysis.ResultsOut of 14 included studies, 12 reported presence of periodontal bacterial DNA in coronary atherosclerotic plaque specimens. Overall, Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans were the most frequently detected periodontal bacterial species. Meta-analysis revealed that the prevalence of P. gingivalis was significantly higher than A. actinomycetemcomitans in coronary atheromatous plaque samples. Apart from periodontal microbes, DNA from a variety of other microbes e.g. Pseudomonas fluorescens, Streptococcus species, Chlamydia pneumoniae were also recovered from the collected samples.ConclusionConsistent detection of periodontal bacterial DNA in coronary atheroma suggests their systemic dissemination from periodontal sites. It should further be investigated whether they are merely bystanders or induce any structural changes within coronary arterial walls.     

Basal inhibin B and the testosterone response to human chorionic gonadotropin correlate in prepubertal boys

During childhood, the quiescent phase of testicular activity, the hCG stimulation test is widely used to evaluate testicular function. Inhibin B, a gonadal peptide regulating FSH secretion, is an established marker of Sertoli cell function and spermatogenesis in adults. In contrast to the other hormones of the hypothalamo-pituitary-gonadal axis, inhibin B is also secreted in detectable amounts during childhood. The aim of this study was to determine whether basal inhibin B levels are able to predict prepubertal testicular function, so as to avoid a stimulation test. Inhibin B and testosterone before and after hCG stimulation were measured in 54 male children with various testicular disorders by an immunoassay specific for inhibin B. Basal inhibin B was compared to the testosterone increase after hCG. Inhibin B and the hCG-induced testosterone increment correlated strongly (r = 0.84; P<0.0001). Patients with anorchia were clearly distinguishable from those with abdominal testes, having undetectable (inhibin B, <15 pg/mL) respective normal inhibin B levels for age. Inhibin B and the testosterone response to hCG were low in boys with testicular damage (delayed diagnosis of cryptorchidism; after testicular torsion) and in patients with gonadal dysgenesis, but were normal or increased in children with androgen insensitivity syndrome. We conclude that basal inhibin B predicts the testosterone response to hCG in boys and therefore gives reliable information about both the presence and function of the testes. The diagnostic procedure in cryptorchidism may be reduced to a single inhibin B measurement. Furthermore, inhibin B levels show specific alterations in patients with sexual ambiguity, adding a valuable diagnostic tool to the complex differential diagnosis of male pseudohermaphroditism.     

Comparative study of the corrosion behavior of peripheral stents in an accelerated corrosion model: experimental in vitro study of 28 metallic vascular endoprostheses

PURPOSE

Clinical cases of stent-fractures show that corrosion behavior might play a role in these fractures. Implanted in vivo, especially in combination with other implanted foreign materials, these metallic products are exposed to special conditions, which can cause a process of corrosion. Here, we aimed to test the corrosion potential of stents made of different materials in an in vitro setting.

METHODS

A total of 28 peripheral stents of different materials (nitinol, cobalt-chromium-nickel, tantalum, V4A) and surface treatments (electropolish, mechanical polish, no polish) were tested in vitro. Corrosion was accelerated by applying a constant voltage of 3.5 V and amperage of 1.16 mA in 0.9% NaCl.

RESULTS

Nitinol stents showed the lowest susceptibility to corrosion and the longest period without damage. The Memotherm II^® (BARD Angiomed^®) was the only stent that showed neither macroscopic nor microscopic damages. The worst performing material was cobalt-chromium-nickel, which showed corrosion damages about ten times earlier compared to nitinol. Considering the reasons for termination of the test, nitinol stents primarily showed length deficits, while V4A and tantalum stents showed fractures. Cobalt-chromium-nickel stents had multiple fractures or a complete lysis in equal proportions. When placed in direct contact, nitinol stents showed best corrosion resistance, regardless of what material they were combined with. In terms of polishing treatments, electropolished stents performed the best, mechanical-polished stents and those without polishing treatment followed.

CONCLUSION

The analysis of corrosion behavior may be useful to select the right stent fulfilling the individual needs of the patient within a large number of different stents.Congenital stenosis or volume decreasing processes due to accumulation of tissues or by outside pressures are the most common indications for vascular interventional therapies. After the initial “cardiac catheterization” by Forssmann et al. (1) in 1929, percutaneous interventional techniques for treatment of vasoconstricting processes was continued constantly, whereby the use of permanent mechanical stents has gained an increasingly important role.Stents used in clinical practice should fulfill certain conditions to achieve an un-problematic application as well as an optimal result. The following properties apply to this ideal: good biocompatibility, low shortening, high-density in X-ray, high patency rates, low thrombogenicity, rapid endothelialization without excessive intimal hyperplasia, high flexibility and longitudinal elasticity, sufficient pressure stability at high centrifugal force, technical ability to secure application and exact positioning, and good expansion ratio for safe percutaneous application also with larger prostheses (2, 3). With the approval of stents for clinical use in 1986, the use of stents in peripheral vessels was also practiced on human patients. Palmaz et al. (4) published the first results of the clinical use in 1988 in one of the first multicenter trials on the use of stents in stenosed atherosclerotic iliac arteries. After the successful development of Palmaz^® stents and Wallstents^® as prototypes of balloon-expandable and self-expanding stents, a variety of new stents have been developed.The stents used today are made of different materials. These include nickel titanium alloys (nitinol), surgical stainless steel (V4A), tantalum, and cobalt compounds. Implanted in the human body, especially in combination with other implanted foreign materials, these metallic products are exposed to special conditions causing a process of corrosion. The higher the ionic conductivity of a liquid is, the faster the reaction. For this reason, liquids that contain a high proportion of electrolytes, such as blood with its high proportion of NaCl, cause much faster corrosion of materials (5).We aimed to perform a comparative study regarding the corrosion behavior of peripheral stents, to reffect the behavior of implanted stents in patients and contribute to find a safer indication in the selection of vascular prostheses. Likewise, we tested the hypothesis that the polishing process influences their corrosion behavior.     

Tiling resolution array comparative genomic hybridization analysis of a fibrosarcoma of bone

Fibrosarcoma of bone is a rare malignant tumor accounting for less than 5% of all primary malignant bone neoplasms. There is very limited knowledge regarding the molecular genetics of this tumor, and there are no cytogenetic data available. In the present study, a fibrosarcoma deriving from the left iliac bone of a 10-year-old girl was characterized using cytogenetics, fluorescence in situ hybridization (FISH), and whole genome tiling resolution array comparative genomic hybridization (CGH). Cytogenetic and FISH analyses revealed a ring chromosome 6 as the sole acquired aberration, a finding corroborated by array CGH. The ring formation, however, did not result in any gain of genetic material. Nor did the breakpoints in 6p25 and 6q14 seem to affect any known gene loci in such a way that the ring formation could have resulted in the creation of a fusion gene or in the exchange of regulatory sequences. Thus, a reasonable interpretation of the pathogenetic significance of the ring formation would be that it resulted in the loss of one or more putative tumor suppressor gene loci distal to the two breakpoints.