bluuebunny/crossref_metadata_2025_split huggingface dataset:
Accreditation and Certification
Authors: Setti Bassanini M.C. 
Published: March 2018

In Italy the debate has focused on three different assessment systems: accreditamento autorizzativo (regulatory accreditation), accreditamento di eccellenza (excellence accreditation), and certification. Regulatory accreditation verifies the conformance to a set of quality standards that entitle an organisation to the status of belonging to the NHS. Excellence accreditation attempts to maintain incremental improvement of the quality of services. Certification is a means by which an indipendent third party declares that a determined product or process conforms to the ISO 9000 set of standards; the main objective of certification is to increase the “credibility” of a company on the market in order to orient and at the same time assure customers. Certification loses meaning in a regulated market, as the Italian NHS, in which there is a distinction between the consumer and the paying body. Regulatory accreditation should be deeply rooted in regional planning; the recognition of accredited organisations should be the result of a demonstrated capacity to co-operate in achieving the goals of regional planning and not of conformance to organisational standards. Regional experiences of regulating accreditation show a high level of contamination between systems for quality assessment. The large number of standards proposed seemed to be redundand with respect to the aims that should be pursued by a regulating accreditation system. The furthering of quality in the NHS requires a complex system of quality assessment within which a plurality of subjects, each with different interests, work together to determine the final result by each one setting up procedures consistent with its own particular problems: the institutions set up regulatory accreditation and the professions develop excellence accreditation in their individual professional associations. What is important is to establish relationships across the various levels so as to give the whole system cohesion and consistency.
Medical Knowledge, Quality of Life and Accreditation of Quality in Health Care the Perspective of the Clinical Nephrologist
Authors: Zoccali C. 
Published: March 2018

The problem of Quality has three dimensions: the dimension of quality of life (the patients, perspective), the dimension of quality of medical knowledge and of the appropriate use of medical technology (i.e. the “evidence based” medical approach to clinical decision making) and the dimension of accreditation of health care providers. The problem of keeping clinicians well updated is a difficult one but there are solutions. The medical literature can be selectively but thoroughly analysed and on the basis of high quality studies specific recommendations (i.e. guidelines) can be produced. Scientific societies are now making major efforts to produce high quality guidelines for the treatment of patients with chronic renal failure and for those on chronic dialysis. The DOQI and the Standards Document by the Renal Association offer first class examples of how scientific knowledge can be translated into clear practice guidelines. As far as the dimension of quality of medical knowledge is concerned, there is now increasing evidence that the taking into full account of quality of life issues such as those regarding the physical, psychic and social dimensions of health improves substantially patient's satisfaction and the patient-doctor relationship. Quality of life considerations are now fully considered when evaluating the efficacy erythropoietin in the treatment of uraemic anemia. If we accept the perspective that health care organisations should aim at excellence, the performance of a given provider can be evaluated on the basis of various indicators and its performance made transparent to the potential users. The internet has become the most accessible source of such kind of information and it can be easily forecasted that the performances of all major hospitals and health care organisations will soon be in the public domain.
Haemodynamic Changes in Patients Undergoing High-Risk PTCA under Protection of Transfemoral Heart-Lung Machine Support with Centrifugal Pumps
Authors: Waldenberger F.R. , Borges A. , Schubel J. , Baumann G. , Konertz W. 
Published: March 2018

Patients with a high risk for myocardial revascularization by cardiological or surgical means can be supported during high-risk PTCA with mechanical circulatory support (supp HR-PTCA). Between November 1994 and June 1997 we performed 28 supp HR-PTCA's under protection of a heart-lung machine (HLM) with femoro - femoral cannulation under regional anesthesia. We approached 2.8±1.5 stenoses and 1.7±0.6 vessels per patient. Primary success rate was 95 percent of the treated vessels. During unloading, pulmonary artery mean pressure fell to 42±29% of the starting value. and LVEDP was decreased to 36±42%. Mechanical unloading also resulted in a significant reduction of left ventricular volumes (unloaded LVEDVI and LVESVI represent 76.8% and 76.6% of pre-unloaded values, respectively, p<0,05). All patients except one survived the procedure and could be discharged from the hospital. Femoro-femoral cardio-pulmonary bypass under regional anesthesia provides sufficient protection for high risk PTCA procedures and enables high risk patients to benefit from coronary revascularization.
Effects of Dialysis Membrane Nature on Intradialytic Phagocytizing Activity
Authors: Colì L. , Tumietto F. , De Pascalis A. , La Manna G. , Zanchelli F. , Isola E. , Perna C. , Raimondi C. , De Sanctis L.B. , Marseglia C.D. , Costigliola P. , Stefoni S. 
Published: March 2018

Blood-membrane contact in the extracorporeal circuit affects the activation of many biological systems. Among these, phagocytizing activity has been reported to be influenced by the nature of the hemodialysis membrane used, whether cellulosic or synthetic. This work reports on an ex-vivo, comparative test between cellulosics and synthetics concerning the effects of blood-membrane contact on the polymorphonucleate and monocyte phagocytizing function, both during and after the hemodialysis session. By means of flow cytometry, we evaluated the capacity for phagosoma formation and oxidative burst both in polymorphonucleates and monocytes. Ten hemodialysis patients were included in the study. Six separate dialysis procedures for each patient were considered, one per dialyzer (3 cellulosic and 3 synthetic membranes). Tests were performed at 15', 60', 210’ and 4 hours after the session end. Comparative evaluation was made according to Student's t test. Polymorphonucleate phagocytosis and oxidative burst activation were globally more marked for synthetic than cellulosic membranes, tending to level out in the post-dialysis. This result could be affected by their functional exhaustion following pulmonary sequestration. Monocyte intradialytic phagocytosis and oxidative burst proved more activated by cellulosic membrane. All differences tended to vanish in the post-dialysis.
Physiological Saline is not a Biocompatible Peritoneal Dialysis Solution
Authors: Wang T. , Heimbürger O. , Qureshi A. Rashid , Waniewski J. , Bergström J. , Lindholm B. 
Published: March 2018

We have previously demonstrated that daily exposure to dialysis fluid results in significantly increased peritoneal lymphatic flow. In this study, we investigated if daily intraperitoneal infusion of saline (isotonic, glucose free) could cause similar changes. Methods Sixteen male SD rats received daily infusion (i.p) of 20 ml saline for ten days (Saline group). Twenty-four hours after the last infusion, a 4 hour dwell study using 25 ml 3.86% glucose dialysis solution with frequent dialysate and blood sampling was done in each rat as well as in rats which did not receive daily infusion (Control, n=8). Radiolabeled human albumin (RISA) was added to the solution as an intraperitoneal volume marker. Radioactivity, glucose, urea, sodium, and potassium were measured for each sample. In a separate study, the RISA absorption to peritoneal tissue was also determined. Results The net ultrafiltration was significantly decreased in the daily infusion group (p<0.05). However, the apparent volume at 3 minutes of the dwell was markedly increased; this was due to a significant increase in the RISA binding (1.5–12.0% in the Saline group vs. 0.45–1.12% in the Control group) to peritoneal tissues as assessed by measurement of RISA recovery at 3 min of the dwell. This resulted in a significant overestimation both of the intraperitoneal volume (IPV) at 3 min and the (apparent) fluid absorption rate (as estimated by the transport of RISA out of peritoneal cavity): 0.087±0.026 ml/min in the Saline group vs. 0.052±0.007 ml/min in the Control group, p<0.001. The direct lymphatic flow as estimated by the clearance of RISA to plasma (which should not be affected by the RISA binding) also increased markedly (0.021±0.005 ml/min in the Saline group vs. 0.008±0.001 ml/min in the control group). There was no significant difference in the D/P values for small solutes (urea, sodium, potassium, urate) and D/D0 for glucose between the two groups. Conclusions 1) Daily infusion of physiological saline into peritoneal cavity may increase the peritoneal lymphatic flow; 2) The significant (apparent) increase in IPV shortly after infusion may suggest increased RISA binding to peritoneal tissues (which may be related to the damage of the tissues, and results in overestimation of the peritoneal fluid absorption rate); 3) Saline is not a biocompatible peritoneal dialysis solution, and should therefore not be used as a control or flush solution.
Mathematical Modeling of Solute Kinetics and Body Fluid Changes during Profiled Hemodialysis
Authors: Ursino M. , Colì L. , Brighenti C. , De Pascalis A. , Chiari L. , Dalmastri V. , La Manna G. , Mosconi G. , Avanzolini G. , Stefoni S. 
Published: March 2018

A mathematical model of solute kinetics oriented to improve hemodialysis treatment is presented. It includes a two-compartment description of the main solutes (K+, Na+, Cl–, urea, HCO–3, H+, CO2), acid-base equilibrium through two buffer systems (bicarbonate and non-carbonic buffers) and a three-compartment model of body fluids (plasma, interstitial and intracellular). The main model parameters can be individually assigned a priori, on the basis of body weight and plasma concentration values measured before beginning the session. Model predictions are compared with clinical data obtained during 11 different hemodialysis sessions performed on six patients with profiled sodium concentration in the dialysate and profiled ultrafiltration rate. In all cases, the agreement between the time pattern of model solute concentrations in plasma and clinical data turns out fairly good as to urea, sodium, chloride and potassium kinetics. Finally, the time patterns of plasma bicarbonate concentration and pH can be reproduced fairly well with the model, provided CO2 concentration remains constant. Only in two sessions, blood volume was directly measured in the patient, and in both cases the agreement with model predictions was good. In conclusion, the model allows a priori computation of the amount of sodium removed during hemodialysis, and may enable the prediction of plasma volume changes and plasma osmolarity changes induced by a given sodium concentration profile in the dialysate and by a given ultrafiltration profile. Hence, it can be used to improve the dialysis session taking the characteristics of individual patients into account, in order to minimize intradialytic imbalances (such as hypotension or disequilibrium syndrome).
Surface Characterization of Polymers for Medical Devices
Authors: Werner C. , Jacobasch H.-J. 
Published: March 2018

A survey is given on analytical techniques currently applied to the surface characterization of biomedical polymers. The techniques include spectroscopies, thermodynamic and electrochemical measurements and microscopies, respectively. To illustrate the motivation for surface analysis, the hypotheses on the correlations between surface parameters and hemocompatibility of polymers are briefly examined. The applications of the examined methods are illustrated by a number of examples. These examples include the characterization of cellulose membranes (low-flux hemodialysis membranes) by streaming potential measurements and by inverse contact angle measurements. The use of surface spectroscopies (ATR-FTIR and XPS) is demonstrated by considering the optimization of surface modification procedures of vascular prostheses made from poly(tetrafluoroethylene). Furthermore, the characterization of water-swollen cellulose membranes by scanning force microscopy is shown. Finally, the extended application of physico-chemical surface analysis to the investigation of protein adsorption is considered. An example deals with in situ spectroscopic ellipsometry used to study the adsorption of fibrinogen onto a plasma-deposited hydrophobic fluoropolymer and onto poly(ethyleneoxide)-grafted fluoropolymer, respectively.
Push-pull Sorbent-Based Pheresis Treatment in an Experimental Canine Endotoxemia Model: Preliminary Report
Authors: Peter A.T. , Ash S.R. , Steczko J. , Turek J.J. , Blake D.E. , Carr D.J. , Knab W.R. , Bosley R.H. 
Published: March 2018

The Biologic-DTPF System™ (DTPF), an extracorporeal blood treatment device with potential to treat sepsis, was tested in a preliminary study using a canine endotoxemia model. Six dogs were used and they formed four treatment groups, as control group (n=1) and three groups based on the type of sorbent present in the plasma filter (PF) system: sham treatment with no sorbent (n=1), charcoal as sorbent (n=2), and charcoal/silica as sorbent (“silica” group, n=2). Cardiodynamic data were recorded before treatment and every 30 minutes, and blood samples were collected to determine blood chemistry and to detect the levels of endotoxin and selected plasma cytokines: interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor (TNF). The dogs were given Escherichia coli endotoxin (2 mg/kg) as an intravenous drip (extended over a period of 30 minutes). Thirty minutes after the end of infusion all animals except the control were treated with the DTPF system for four hours. To determine the effect of treatment, data collected at one hour from the initiation of treatment until the end of treatment were compared between control and treated dogs. The endotoxin levels in the control dog were higher (P < 0.05) than other groups. The control dog had lower levels of TNF than other groups. The control dog had similar levels of IL-1 (P > 0.05) and higher levels (P < 0.05) at 4 hours into treatment compared to other groups. The control dog had similar levels of IL-6 as other groups (P > 0.05). In the control dog, the mean arterial pressure (MAP) fell and then remained low but stable at 1–4 hours. The charcoal group had lower MAP than the control dog at 1–4 hours (P < 0.05). The silica group had higher MAP levels similar to the control dog. After treatment, the control dog had higher (P < 0.05) values of hematocrit, hemoglobin, calcium, potassium, and albumin compared to the treated groups. As expected for a system removing plasma during sepsis, the DTPF System had some adverse effects on the physiologic status of the dogs, especially when loaded with charcoal sorbent only. The findings of the present study suggest that the filters are capable of eliminating endotoxin and there is some evidence of cytokine removal. Although the charcoal dogs did poorly, addition of silica to the sorbent offset any negative effects. Further work is underway to improve the efficiency of the system, primarily, to enhance the capacity of the sorbents for cytokines. A more realistic canine sepsis model with mortality after several days (the Escherichia coli- infected intraperitoneal clot) will also be considered in future studies.
A Simple Method for Emax Trend Evaluation: In Vitro and in Vivo Results
Authors: Ferrari G.F. , Mimmo R. , Mercogliano D. , De Lazzari C. , Menichetti A. , Di Natale M. , Tosti G. , Tritapepe L. , Clemente F. , Giardino R. 
Published: March 2018

The aim of this study is the evaluation of end systolic ventricular elastance trend (as a measure of heart contractility) by hemodynamic variables available in intensive care units or during heart surgery: heart rate, cardiac output, left atrial, mean and diastolic arterial pressure. Its basic assumption is the description of ejection as the interaction between variable left ventricular and arterial compliances (reciprocal of the corresponding elastances) connected in parallel. As pressure is the same in each compliance at systole beginning and ending, ventricular elastance can be estimated by assuming that energy variation is the same on both compliances. The algorithm has been tested on a numerical simulator of the circulatory system and on six sheep at basal conditions and during drug infusion. Correlation function in numerical simulation, between true and computed ventricular elastance (range 0.45÷5 mm Hg-cm-3), yields 0.985. In vivo comparison between computed ventricular elastance trend and ventricular dp/dt trend yields a correlation function ranging between 0.87 and 0.99. The result of the algorithm cannot be assumed to be Emax value. However, it can be considered a contractility index as it closely follows any change in dp/dt. It can be computed by simple calculations and needs no variables other than those usually measured in intensive care. It allows the extrapolation of useful information for evaluating the trend in heart contractility and for setting up a control strategy for mechanical or pharmacological assistance during heart recovery.
Hip Prothesis: An in Vitro Wear Protocol Based on a Comparison between Gravimetric and Profilometric Analysis
Authors: Affatato S. , Tagliati M. , Toni A. 
Published: March 2018

Ultra high molecular weight polyethylene acetabular cups were analysed by means of a shadowgraph method (using a profile projector) to measure linear wear. The results were compared with those of previous wear tests performed on a hip joint simulator. Twelve polyethylene acetabular cups were analysed. The specimens were evaluated visually for evidence of polyethylene wear. Examination of the polyethylene inner surface did not reveal evidence of surface failure such as delamination, fatigue cracks or scratches. Volumetric wear was calculated using a formula based on dimensional change due to the penetration of the femoral head in the acetabular cup. It was found to be of the same order of magnitude as the wear obtained in in vitro experimental tests.
Autotransfusion with Predeposit-Haemodilution and Perioperative Blood Salvage: 20 Years of Experience
Authors: Borghi B. , Fanelli G. , Celleno D. ,   Rizzoli Study Group on Orthopaedic Anaesthesia, IRCSS Rizzoli Orthopaedic Institutes, Bologna, Caroli G.C. , Pignotti E. , Montebugnoli M. , De Simone N. , Righi U. , Bugamelli S. , Laguardia AM. , Cataldi F. , Feoli MA. , Bonfatti Paini M. , Bombardini T. , Lorenzini L. , Castellazzi L. , Baroncini S. 
Published: March 2018

Background Through a prospective study, we evaluated the efficacy of an integrated autotransfusion regimen comprised of predeposit-hemodiluition and intra and post-operative blood salvage in major orthopaedic surgery. Methods We examined the records of 2303 consecutive patients (1524 females and 779 males, mean age 62.7, standard deviation 11 years (range 16–90 yrs), pre-operative haemoglobin (Hb) concentration 13.5 (SD 1.4) (range 6.7–19.3) g/dl undergong total hip arthroplasty (THA 1582 patients), THA after the removal of internal fixation devices (RFD+THA, 25 patients), total knee arthroplasty (TKA, 347 patients), revision surgery of the hip (HR, cup+stem revision, 248 patients; cup revision 64 patients; stem revision 23 patients) and total knee revision (TKR 14 patients). We estimated that the number of predonations (MSBOS - maximum surgery blood order schedule) was 2 units for THA, TKA and TKR, and 3 units for partial or total hip revision and for total hip arthroplasty with fixation removal. Results It was possible to obtain the MSBOS in 2070 patients (89.8%). Homologous red blood cell (HRBC) transfusion were carried out in 184 patients (8%). We found that the need to use HRBC was significantly associated with failure to meet the number of MSBOS, female sex, lower pre-operative Hb concentration, use of calcium heparin for antithrombosis prophylaxis, more extensive surgery, a higher ASA rating and co-existing diseases such as coronary artery disease. Conclusions Cooperation among anaesthesis, transfusionists and surgeons in the application of an integrated autotransfusion regimen enabled us to treat 92% of our patients with only autotransfusion.
The Enabler Cannula Pump: A Novel Circulatory Support System
Authors: Nishimura Y. , Meyns B. , Ozaki S. , Racz R. , Dohmen P. , Flameng W. 
Published: March 2018

Background The enabler circulatory support system is a catheter pump which expels blood from the left or right ventricular cavity and provides pulsatile flow in the ascending aorta or pulmonary artery. It is driven by a bedside installed pulsatile driving console. The device can easily be implanted by a minimal invasive approach, similar to the Hemopump. Purpose To demonstrate the hemodynamic performance of this new intracardiac support system. Methods In a series of 9 sheep, hemodynamic evolutions were recorded in various conditions of myocardial contractility (the non-failing, the moderately failing and the severely failing heart). Heart failure was induced by injection of microspheres in the coronary arteries. Results Introduction of the cannula through the aortic valve was feasible in all cases. Pump flow by the enabler was gradually increased to a maximum of 3.5 L/min. Diastolic (and mean) aortic blood pressure is significantly increased in the non-failing and moderately failing condition (counterpulsation mode). In heart failure, cardiac output is significantly increased by the pump (p<0.0001). A drop in left atrial pressure (indicating unloading) is achieved in all conditions but reaches significant levels only during heart failure (p=0.0068). Conclusions This new circulatory support system contributes to stabilization of the circulation in the presence of cardiac unloading. In heart failure it actually supports the circulation by increasing cardiac output and perfusion pressure.
In Vitro and in Vivo Assessment of Bone-Implant Interface: A Comparative Study
Authors: De Benedittis A. , Mattioli-Belmonte M. , Krajewski A. , Fini M. , Ravaglioli A. , Giardino R. , Biagini G. 
Published: March 2018

The present in vitro and in vivo comparison of three bioactive (HA, AP40, RKKP) and three bioinert (Ti6-Al4-V, Al2O3, ZrO2) materials was undertaken to identify which of them provide(s) the most suitable coating for prostheses implanted in patients with altered metabolic status. The experimental design included in vitro tests with human osteoblasts and morphological observations by scanning electron microscopy. For the in vivo evaluation, the materials were implanted in the femoral condyle of ovariectomised and intact female rats, and two months after surgery an X-ray microanalytical study was performed. The in vitro study showed good biocompatibility with all materials. Microanalysis evidenced a similar behaviour with all materials except the two biological glasses. The differences in Ca and P content observed between intact and ovariectomised rats can be explained by the intrinsic capability of biological glasses to undergo surface modifications in the presence of alterations of the bone metabolism. Thus, their use seems to be indicated in recipients with osteoporotic pathologies.