Medico-economic study of the management of hepatocellular carcinoma by chemo-embolization.

PURPOSE: This study has two aims. The first is to compare conventional lipiodol chemo-embolization (Trans Arterial Chemo-Embolization - TACE) to one using pre-loaded particles (Trans Arterial Chemo-Embolisation-Drug Eluted Bead - TACE-DEB) using a cost minimization study. The second is to define the fundable nature of TACE-DEB and the conditions under which it is cost-effective. MATERIALS AND METHODS: Retrospective study of patients treated by chemo-embolization (n=31: TACE; n=32: TACE-DEB) during the year 2010. The cost minimization study was conducted from the hospital perspective. Direct medical costs were calculated and compared using the readjusted ENCC (National Studies of Costs by Common Methodology) method. The affordability of the two techniques and definition of a cost-effective hypothesis (break-even point) were also established. RESULTS: All DRGs combined, lengths of stay (TACE: 4.90 ± 3.36; TACE-DEB: 5.03 ± 3.36) does not change significantly. An average upper mean cost for TACE-DEB is described (TACE: 2869.05 €; TACE-DEB: 3960.10 €). The affordability calculations in the study show that, overall, TACE-DEB can be funded regardless of DRG. A ratio of 1.3 procedures using the conventional (TACE) method would enable TACE-DEB procedures to be funded. CONCLUSION: This medico-economic analysis demonstrates that the TACE-DEB procedure is fundable.

[Cost-effectiveness analysis of vacuum-assisted closure in the surgical wound bed preparation of soft tissue injuries]. / Evaluation coût-efficacité de la thérapie par pression négative dans la préparation chirurgicale des pertes de substance cutanée.

This work proposes, from the point of view of the University Hospital Center of Nantes (acute care), a cost-effectiveness assessment of negative pressure wound therapy (NPWT), in comparison with moist wound therapy, in the surgical preparation of cutaneous defects requiring reconstructive surgery. This retrospective study was realized after data collection from patient files with hospitalization for the management of open-leg fractures with a view to reconstructive surgery by graft or flap (Cauchoix II or III). Effectiveness criteria, after debridement and NWPT initiation, was the time period required for preparing the wound for definitive reconstructive surgery closure by flap or graft. NWPT is compared, over the same 2000 to 2006 period, to the only existing therapeutic alternative, that is to say moist wound therapy. Only direct costs in relation with consumed resources dedicated to each medical strategy were taken into account. A Mann-Whitney U nonparametric test and boostrap technique have been used for statistical and sensitivity analysis. Twenty-five patients were recruited for the two medical strategies. Wound preparation time is significantly shorter for patient treated with NPWT (p=0.026 Mann-Whitney U-test) and is equal to 20 days less on average for time period required for preparing the wound for reconstructive surgery. Hospitalization costs is very significantly lower for patients being treated with NPWT (p=0.02). In absolute value, this cost is reduced on the average by 6000 euro per patient (i.e. by more than 60%). The incremental cost-effectiveness ratio is of the order of 164 euro per day of wound preparation for surgery gained.

[Biomaterials for reconstruction and bone substitution in otorhinolaryngology and head and neck surgery]. / Biomatériaux de reconstruction et de comblement osseux en ORL et chirurgie cervicofaciale.

INTRODUCTION: Position of medical devices has increased for last 30 years in otorhinolaryngology. Legal directive of use, main indications and perspectives are presented. RESULTS AND DISCUSSION: Biomaterials are medical devices planned for tissue reconstruction or substitution. The approval labelling are planned in Europe by the European Community certification (marquage CE) and overseen by a postmarket medical device safety (matériovigilance), that are completely independent from the Food and Drug Administration certification. Indications of biomaterials are likely competitive to those of autografts; their advantage is to limit the morbidity due to autograft harvesting. Benefits are aesthetics, functional or complementary. Main indications are presented in otology, rhinology, face traumatology, laryngology, anti-aging surgery, implants and epithesis. Research fields are scanned (increased therapeutic properties, drug delivery systems, tissue engineering...). CONCLUSION: Biomaterials are increasingly implanted in ENT surgery. The surgical success of their use require a strict legal label and well-defined indications.

Neointimal hyperplasia after stenting in a human mammary artery organ culture.

Although the use of stents has limited the incidence of restenosis, in-stent restenosis remains an important problem. In-stent restenosis is the result of a healing process that induced neointimal hyperplasia through mechanisms that are still not understood. The aim of this study was to analyze the histological consequences of the healing process following stent implantation. Internal mammary arteries from atheroslerotic patients undergoing coronary artery bypass surgery were stented and maintained in culture for 0-28 days. Stent implantation after predilatation induced an extensive loss of endothelial cells whereas direct stenting preserved endothelium between the struts. Morphometric analysis shows that stent placement induced neointimal thickening. Smooth muscle alpha-actin labeling indicates that neo-intimal formation was mainly due to proliferation and migration of smooth muscle cells. Smooth muscle cell proliferation, assessed by MIB-1 staining, was maximal at day 14 after stent insertion. Human mammary artery organ culture thus provides valuable information on histological consequences of stent implantation with or without predilatation regarding endothelial cell disappearance and neointimal hyperplasia. These data also demonstrate that neointimal thickening induced by stent implantation comprises an intrinsic component resulting from the vessel wall response to stent insertion and suggest that blood factors could play an amplifying but not necessary role.

Injectable bone substitute using a hydrophilic polymer.

We studied a new injectable biomaterial for bone and dental surgery consisting of a hydrophilic polymer as matrix and bioactive calcium phosphate (CaP) ceramics as fillers. This material is composed of complex fluids whose flow is determined by the laws of rheology. We investigated the macromolecular effects on this composite in a tube. The stability of the polymer and the mixture is essential to the production of a ready-to-use injectable biomaterial. These flow properties are necessary to obtain CaP bioactivity in a dental canal or bone defect during percutaneous surgery. Macromolecules provide spaces between CaP ceramic granules and facilitate the role of the biological agents of bone substitution.

In vitro influence of apatite-granule-specific area on human growth hormone loading and release.

Although calcium phosphate biomaterials often are used as drug delivery systems (DDS) at bone sites, the conditions affecting the loading of the therapeutic agent (TA) have not been well documented. A human growth hormone (hGH) adsorption method was used in this study to investigate the influence of the formulated apatite (AP)-specific area on loading and release. AP powders were formulated with a 200-500 microm granulometry and various specific areas. Two milligrams of hGH in solution were deposited for 24 h at 37 degrees C on 100 mg of AP with different specific areas. The amount of hGH loaded was determined by immunoradiometric assay (IRMA) and eluted stain bioassay (ESTA) using Nb2 lymphoma rat cells. Although loading was not greatly influenced by a specific area between 3 and 25 m2/g, dependency was noted for higher specific areas. Human GH release was measured by IRMA and ESTA over a 33-day period, with half-time release between 25 and 79 h. Comparison of IRMA and ESTA measurements for the hGH amounts loaded showed that hGH biologic activity was conserved. Results indicate that it is feasible to control the quantity of TA loading on AP by modifying specific areas for in vivo applications.

In vitro evaluation of a new injectable calcium phosphate material.

The purpose of this study was to develop an injectable bone substitute (IBS) for percutaneous orthopedic surgery. The multiphasic material used was composed of a 2% aqueous solution of methylhydroxypropylcellulose (MHPC) and biphasic calcium phosphate (BCP, 60% hydroxyapatite and 40% beta-tricalcium phosphate) in which MHPC served as the carrier for 80-200 microm of BCP granules. The best BCP/polymer ratio was determined by the rheological properties and higher BCP content of the material. Steam sterilization was more effective than gamma irradiation in maintaining the stability of the mixture and conserving its physiochemical and mechanical properties. The in vitro biocompatibility of the composite was checked by direct-contact cytotoxicity and cell-proliferation assays. A preliminary in vivo test was performed in the rabbit using intraosseous implantations in the femoral epiphysis. Histological analysis was done after 1, 2, 4, and 10 weeks. Bone ingrowth into the IBS, in close association with BCP granules, was observed after 1 week and increased regularly from the surface inward at 2, 4, and 10 weeks. At the same time, smaller BCP granules (less than 80 microns in diameter) were degraded and resorbed. This injectable biomaterial proved suitable for cavity filling. The water solubility and viscosity of the polymer allow cells to recolonize, with in situ bonding of the mineral phase.