bluuebunny/crossref_metadata_2025 huggingface dataset:
Velocities, Shear Stresses and Blood Damage Potential of the Leakage Jets of the Medtronic Parallel™ Bileaflet Valve
Authors: Zimmer R. , Steegers A. , Paul R. , Affeld K. , Reul H.
Published: March 2018

Even nowadays, the essential problem of mechanical heart valve prostheses is the risk of thromboembolic events mainly caused by unnatural hemodynamics, e.g. just a few years ago the Medtronic Parallel™ (MP) showed unsatisfactory clinical results caused by thrombi (1).

Therefore, in vitro investigations of the whole leakage jets were performed at the MP in mitral position by means of a pulse duplicator using a two channel laser Doppler anemometer. From the measured data, mean velocity profiles and the distribution of Reynolds shear stresses, as a function of the location within the jet, were calculated. From this data the potential of blood damage is evaluated computing a Blood Damage Index (BDI) of hemolysis and platelet damage.

Four regurgitant free jets right above the hinges were observed during systole at the inflow side of the MP. The peak velocities at the origin of the jets were in the order of 1.6 - 2.1 m/s. Two jets experienced maximum turbulent shear stresses around 100 N/m2 within this area. The BDI for platelets of the MP is around ten times higher than the BDI of the St.-Jude-Medical.

The study shows that besides the flow structure within the hinges of a mechanical heart valve, the whole regurgitant jet has a large blood damage potential. This potential is measurable, respectively calculable and seems to be (on account of it's support of the clinical outcome) one piece of the puzzle that explains the negative trials of the MP. (Int J Artif Organs 2000; 23: 41–8)
Extracorporeal Photochemotherapy after Cardiac Transplantation: A New Therapeutic Approach to Allograft Rejection
Authors: Dall'Amico R. , Montini G. , Murer L. , Andreetta B. , Zacchello G. , Gambino A. , Feltrin G. , Caforio A. , Tursi V. , Livi U.
Published: March 2018

Photopheresis (ECP) is a new immunomodulatory therapy in which recipient lymphocytes are treated extracorporeally with 8-methoxypsoralen and ultraviolet light. The treatment seems to induce an inhibition of both humoral and cellular rejection after transplantation.

Objective

Since recurrent rejection (RR) continues to be a severe complication after heart transplantation (HTx) and the immunosuppressive regimes used for the treatment are often associated with increased morbidity and mortality, we investigated whether ECP could have a beneficial effect on the number and severity of rejection episodes.

Methods

Eleven HTX recipients (5 M and 6 F, mean age 48.5 yrs) with RR were enrolled in the study. ECP was performed at weekly intervals during the 1st month, at 2 week intervals during the 2nd and 3rd month, and then monthly for another 3 months.

Results

The fraction of biopsies (EMB) with a grade 0/1A rejection increased during ECP from 46% to 72% while the EMB showing a 3A/3B rejection decreased from 42% to 18%. It is also noteworthy that out of the 78 EMB performed during ECP only one showed a 3B rejection in comparison with 13 out of 110 EMB in the pre-ECP period. Six rejection relapses were observed in a total follow-up of 60 months, two of them occurring during the tapering of oral steroid. Four relapses were reversed by ECP, one by IV steroids and the last by methotrexate after the failure of both IV steroids and ECP. The mean doses of immunosuppressive drugs resulted lower after 6 months of ECP: steroids were reduced from 13 to 8.25 mg/day, cyclosporine from 375 to 285 mg/day, azathioprine from 55 to 35 mg/day.

Conclusions

ECP is a well tolerated treatment. Its administration allows better RR control and significant reduction in immunosuppressive therapy. (Int J Artif Organs 2000; 23: 49–54)
Anca in Dialysis Patients: A Role for Bioincompatibility?
Authors: Andreini B. , Panichi V. , Cirami C. , Migliori M. , DE Pietro S. , Taccola D. , Aloisi M. , Antonelli A. , Giusti R. , Rindi P. , Buoncristiani U. , Giovannini L. , Palla R.
Published: March 2018

Background

Anti-neutrophil cytoplasmic autoantibodies (ANCA) have been described in patients suffering from systemic vasculitis such as Wegener granulomatosis, microscopic polyangiitis, Churg-Strauss syndrome and other pathological conditions. In this paper we report a greater incidence of ANCA in hemodialysis patients as compared to peritoneal dialysis patients, predialytic uremic patients and non-renal patients; a possible role for dialysis bioincompatibility in ANCA generation was also investigated.

Methods

A total of 335 uremics in substitutive treatment (176 in hemodialytic treatment and 159 in peritoneal dialysis) were examined for ANCA positivity. A total of 189 patients with advanced renal failure in conservative treatment and 100 healthy subjects were used as control. The dialysis techniques were standard hemodialysis (n = 119), low volume hemodiafiltration (n = 26) and hemofiltration (n = 31). ANCA positivity was examined by immunofluorescence (IF): diffuse finely granular staining was considered as classical positive reaction (C-ANCA) and P-ANCA was diagnosed if a perinuclear staining was observed. EIA for proteinase-3 (anti PR-3) and myeloperoxidase-antibodies (anti-MPO) were also performed.

Results

In non-renal patients and in patients with pre-dialytic renal insufficiency none were found ANCA positive. In peritoneal dialysis patients all but one were ANCA negative with IF, with all EIA test resulting negative. In hemodialytic patients, a positive IF test was found in 26 (14.7%) for P-ANCA and in 5 (2.8%) for C-ANCA; using the EIA test 23 (13%) patients were positive for MPO and 12 (6.8%) for PR-3.

Conclusions

No correlation with age, primary renal diseases, dialytic age, dialysis membrane materials was found; regarding the different extracorporeal dialytic techniques a higher incidence (p < 0.02) was detected in patients undergoing HDF. Backfiltration of contaminated dialysate may induce ANCA via an increased cytokine generation. (Int J Artif Organs 2000; 23: 97–103)
Blood Profile during and after Hemoglobin Substitute Administration
Authors: Mueller X. M. , Tevaearai H. T. , Gardaz J. P. , Jegger D. , von Segesser L. K.
Published: March 2018

The in vivo effects of Diaspirin Crosslinked Hemoglobin (DCLHb, Baxter Healthcare Corp.) on hematology and biochemistry are unknown. This study includes 6 calves (71.2±1.3 kg). In each animal a total of 2 litres of blood was exchanged for the same amount of hydroxylethyl starch (Haes, Fresenius) (n=3) or DCLHb (n=3), which is equivalent to 28cc/kg of blood substitute, over a period of 5 hours. The animals were allowed to survive 7 days. Blood samples were taken hourly during the perfusion protocol, at postoperative day (POD) 1, 2 and 7. ANOVA test was used for repeated measurements. Blood cell profiles were similar in both groups. Peak methemoglobinemia was 4.2% in the DCLHb group. Osmolarity was significantly higher in the DCLHb group with the greatest difference at POD 1 and 2. Postmortem analysis of the major organs did not show any sign of hemoglobin deposit in the DCLHb group. In the given setup DCLHb can be administered in a large quantity with good hematological tolerance and without any deposits in major organs. A prolonged plasma expander effect was observed. (Int J Artif Organs 2000; 23: 119–24)
The Impact of Equations on Calculation of Lean Body Mass by Bioelectrical Impedance Analysis in RDT Patients
Authors: Oe B. , De Fijter C.W.H. , Geers A.B.M. , Vos P.F. , Donker A.J.M. , De Vries P.M.J.M.
Published: March 2018

Several equations are available to derive lean body mass (LBM) from bioelectrical impedance analysis (BIA). The purpose of this study was to investigate in dialysis patients the impact of the equation used on the outcome of LBM assessment. To avoid dyshydration as a confounder, vena cava diameter measurement was used to assess normohydration in the 21 patients studied. Five equations were compared.

In a previously published study to assess total body water using antipyrine as a gold standard, Deurenberg's formula was advocated to be used in the estimation of LBM by BIA. Therefore, this formula was used as a basis for comparison with the other four equations.

One equation gave results comparable to those obtained by Deurenberg's formula. Despite high correlations and agreement according to Bland and Altman analysis, the other three equations showed a significant difference with Deurenberg-derived LBM. Thus, the equation used has a major impact on the outcome of LBM estimations. (Int J Artif Organs 2000; 23: 168–72)
The Effect of Hemodialysis and Acetate-Free Biofiltration on Anemia
Authors: Eiselt J. , Racek J. , Opatrnyjr K.
Published: March 2018

The authors monitored, for a period of 12 months, anemia-, nutrition-, and free radical-related parameters and the rHuEPO dose required to maintain target hemoglobin (Hb) in 20 patients with chronic renal failure. Ten patients each were randomized for treatment by either acetate-free biofiltration (AFB) or low-flux hemodialysis (HD). At baseline, Hb levels were 102±2 (AFB) vs. 98±2 g/L (HD) (not significant difference, NS), the rHuEPO dose was 4050±976 vs. 5100±1538 IU/week (NS). Compared with baseline and with HD, lower rHuEPO doses were required during AFB at months 8, 9, 10 and 11, and 12 when they were 2100±510 (AFB) vs. 6000±1153 (HD), p=0.008. Prealbumin, transferrin and cholinesterase levels rose in the AFB group. Kt/V, albumin, transferrin saturation, aluminium, bicarbonate in serum, superoxide dismutase and glutathione peroxidase in erythrocytes, and malondialdehyde and antioxidant capacity in plasma did not differ between the AFB and HD groups. In terms of anemia control, AFB using an AN69 membrane was found to be more advantageous than low-flux HD, AFB improves some nutritional parameters. The compared methods do not differ in their effect on lipid peroxidation and the antioxidant system. (Int J Artif Organs 2000; 23: 173–80)
Intraindividual Comparison of the Impact of two Selective Apheresis Methods (DALI and HELP) on the Coagulation System
Authors: Julius U. , Siegert G. , Gromeier S.
Published: March 2018

We performed an intraindividual comparison of the effect on the coagulation system of two selective apheresis procedures: Direct Adsorption of Lipoproteins (DALI) and Heparin-induced Lipoprotein Fibrinogen Precipitation (HELP). Six patients suffering from heterozygous familial hypercholesterolemia have been treated with 2 sessions of each procedure. Anticoagulation was carried out according to usual recommendations. Blood samples were taken before, immediately after and on the second day after the sessions. We assessed global coagulation tests (prothrombin time, activated partial thromboplastin time), fibrinogen, prothrombin fragment F 1 + 2 and a variety of factors (Factors II, V, VII, XIII, IX, X, XI, XII, XIIa; von Willebrand Factor; collagen-binding activity, prekallikrein, high-molecular weight kininogen) and antagonists (antithrombin III, protein S activity, free protein S). In fact, all parameters measured have been influenced by the apheresis treatment. Fibrinogen is lowered more by HELP, which also has a more definite impact on factors belonging to the prothrombin complex (II, VII, X). In contrast, the major effects of the DALI system have been seen on the intrinsic pathway of the coagulation system (IX, XI, prekallikrein, high-molecular-weight kininogen). With both systems, no increases in activated Factor XII or in prothrombin fragment F1 + 2 have been observed. These data provide a solid basis for individual adaptations of anticoagulant doses.
Sleep Disorders in Peritoneal and Haemodialysis Patients as Assessed by a Self-Administered Questionnaire
Authors: De Vecchi A. , Finazzi S. , Padalino R. , Santagostino T. , Bottaro E. , Roma E. , Bossi R.
Published: March 2018

Sleep disorders have been reported as a frequent problem in dialysis patients. However, only one paper has compared the prevalence and possible causes of this complication in peritoneal (PD) and haemodialysis (HD) patients.

We surveyed 84 PD and 87 HD patients about disordered sleep using a self-administered questionnaire. Forty-nine percent of PD and 56% of HD patients reported problems sleeping. These problems were rated as severe by 29 PD and 22 HD patients. Type of disturbances involved delayed sleeping (13 PD and 32 HD, p< 0.005), interrupted sleep (32 PD and 44 HD) and early morning awakening (25 PD and 37 HD). The number of hours of sleep varied widely among patients: it was 5 and 21 minutes in PD patients with sleep disorders and 7 and 37 min in PD pts without such problems. No statistically significant relationship was evidenced between sleep disorders and age, sex, body weight, obesity, duration of dialysis, dialysis dose, self-assessed sadness, anxiety, worry, pain, pruritus, dyspnoea, restless leg syndrome, use of cigarettes, caffeine, or sleeping pills. In conclusion, sleep disorders are a frequent problem in both PD and HD patients. Apparently the relationship with demographics, dialysis dose, lifestyle and personality traits is poor. The possible role of other causes should be investigated.
Effects of Anion Exchange Resin as Phosphate Binder on Serum Phosphate and Ipth Levels in Normal Rats
Authors: Inoue H. , Kagoshima M. , Kaibara K.
Published: March 2018

In order to investigate the characteristics of anion exchange resins that may safely and effectively bind dietary phosphate in digestive tract, phosphate binding experiments were carried out in vitro and in vivo with normal rats by comparing anion exchange resins, PAA-B (which has the same chemical structure as Sevelamer® HCl) and Dowe 1x8, with CaCO3. In in vitro phosphate binding experiments, PAA-B bound 32.3% less phosphate than CaCO3 at pH 7. In the rat dietary phosphorus excretion experiments, PAA-B, Dowex 1x8, and CaCO3 increased fecal phosphorus excretion by 62.7, 32.3, and 84.0%, respectively. Famotidine significantly reduced the phosphate binding of CaCO3. When phosphate solution was orally adiministered, PAA-B depressed serum phosphorus augmentations immediately after administration and thereafter effectively depressed serum iPTH. This suggests that anion exchange resins with most primary and secondary amino type anion exchange groups, have bright prospects in the treatment of hyperphosphatemia. (Int J Artif Organs 2000; 23: 243–9)
Alumina Femoral Head Fracture: An in Vitro Study
Authors: Affatato S. , Ghisolfi E. , Cacciari G.L. , Toni A.
Published: March 2018

A fracture of a ceramic femoral head is reported in this study. Fractures of ceramic femoral heads are uncommon and reports on this complication are rare. After 3 million cycles, on a twelve station hip simulator that tested alumina femoral head against polyethylene acetabular cup, fracture of the ceramic ball was observed. The retrieved specimen consisted of three large ceramic fragments from the same ceramic femoral head, a polyethylene acetabular cup and a stainless steel jig. Careful and detailed examination of the removed components was made. The fracture of the ceramic ball resulted in damage to the metal taper of the jig component which was fixed into the simulator.
Development of a Special Catheterbag to Enable Artificial Organ Evaluation in Conscious, Unrestrained Pigs: Technical Note
Authors: Unger J.K. , Gerlach J.C. , Juhr N.C. , Rossaint R.
Published: March 2018

Pigs are widely used as models for a variety of human diseases, because many of their physiological functions closely resemble those of humans. However, information on instrumentation techniques is still scarce. In particular, experiments in conscious pigs focused on extracorporeal circuits are connected to a variety of methodical problems with respect to the handling of the animals. Usually, pigs are placed in restraint-slings during the application of an extracorporeal system. However, this method of restraint may lead to excessive mental distress even in trained animals. The latter might influence the results and certainly affects principles of animal welfare. Our own experiences with instrumented, conscious, but unrestrained dogs encouraged us to modify methods used for the fixation of in-dwelling central venous catheters in dogs with special regard to the species specific behaviour and phenotype of pigs. A cord retractable leash (CRL) was used for maintaining a safe distance between the animal and the outer ends of the catheters. To prevent dehiscences of the required fixation sutures a new catheter bag (CB) was designed to counteract tension forces caused by the CRL's spring-mechanism. The combination of both the CRL and CB enabled us to conduct safe experiments with conscious, unrestrained pigs. We alleviated the mental distress these animals were exposed to in comparison to former methods based on restraint of the animals.
The Ovariectomised Sheep as a Model for Testing Biomaterials and Prosthetic Devices in Osteopenic Bone: A Preliminary Study on Iliac Crest Biopsies
Authors: Fini M. , Pierini G. , Giavaresi G. , Biagini G. , Belmonte M. Mattioli , Aldini N. Nicoli , Rocca M. , Martini L. , Giardino R.
Published: March 2018

A histomorphometric and ultrastructural evaluation on sheep iliac bone was performed. Six sheep were ovariectomised (OVX Group) and 6 were left intact (Sham-aged, Control Group). An iliac crest biopsy was performed randomly in 6 animals at the beginning of the study, then, in all the animals, after 12 and 24 months. A significant decrease in trabecular bone volume, trabecular thickness (p<0.0005) and cell volume (p<0.005) was observed in OVX animals. A modest decrease in trabecular number and osteoid thickness together with an increase in trabecular separation were observed in OVX animals at 12 and 24 months. The osteoid volume showed a significant difference (p<0.05) between the groups. In OVX animals, at 12 months, Scanning Electron Microscopy revealed an enlargement of the trabecular space and a progressive replacement of bone matrix with adipose tissue. These signs were accentuated at 24 months.

In conclusion, OVX sheep showed a loss of trabecular bone starting at 12 months after ovariectomy. The developed osteopenic state may be considered as a useful tool when doing research on biomaterial osteointegration. (Int J Artif Organs 2000; 23: 275–81)
Troponins in Renal Dysfunction
Authors: Martin G.
Published: March 2018

“I have yet to see any problem, however complicated, which, when you looked at it in the right way, did not become still more complicated.”

Poul (William) Anderson
Trillium™ Biopassive Surface: A New Biocompatible Treatment for Extracorporeal Circulation Circuits
Authors: Cazzaniga A. , Ranucci M. , Isgrò G. , Soro G. , De Benedetti D. , Corradi R. , Gardinali M.
Published: March 2018

139 patients undergoing cardiac surgery were included in a prospective, randomized trial. Patients were randomly allocated to receive cardiopulmonary bypass (CPB) with Trillium™ Biopassive Surface (TBS Group) coated oxygenators or conventional circuits (control group).

112 patients were studied with respect to postoperative biochemical profile; a subgroup of 27 patients was studied with respect to perioperative complement (C3a) activation.

Patients in the TBS group demonstrated a significantly lower white blood cell count at the end of the operation (p=0.036) and a significantly higher platelet count the day after the operation (p=0.023) when compared to the control group. C3a was significantly higher (p=0.02) in the TBS group after 30 minutes of CPB, but the C3a increase after protamine administration was significantly less pronounced in the TBS group vs. the control group.

Further studies involving platelet and leukocyte activation are required to better elucidate the action of this new coating in the setting of routine CPB.
Evaluation of Microparticle Leakage during DALI LDL Adsorption in a Simulated Clinical Setting
Authors: Heinemann O. , Bosch T.
Published: March 2018

The aim of the present study was to investigate microparticle (Mp) leakage during simulated LDL-hemoperfusion using 12 DALI 750 adsorbers and the original DALI hardware under conditions strictly comparable to the clinical situation. Thus, the sessions were divided into 4 sections, i.e. priming and preparation of the adsorber followed by treatment (6–7 L at a flow rate of 60 ml/min) and reinfusion. As Mp counts can be performed only in clear, cell-free media, blood was replaced by normal saline in sections 2–4 of the simulated sessions.

Mp counts were analysed for ≥ 2, ≥ 5, ≥ 10 and ≥ 25 μm particle sizes in the efferent line post adsorber using a standard light blockage method. As there are no official thresholds for particle release in extracorporeal circuits, the limits for infusion of large fluid volumes of 500, 100 (80), 25 and 5 (3) Mp/ml according to the Europäische Arzneimittelbuch, the British and American Pharmacopoeias were used. Mean particle counts for the sections 3 and 4 in which the patient is connected to the efferent line were 19, 7, 2 and 0 Mp/ml and amounted to < 10% of the above mentioned limits. Modifications of the standard simulation procedure by inserting additional pump stops or using different flow rates during the treatment phase slightly increased Mp leakage, but never exceeded the prescribed limits. In summary, no undue particle release could be detected during simulations of the clinical DALI LDL-adsorption procedure.
Aachen-Keratoprosthesis as Temporary Implant. Case Report on First Clinical Application
Authors: Kompa S. , Langefeld S. , Kirchhof B. , Brenman K. , Schrage N.
Published: March 2018

Background

The Aachen-Keratoprosthesis was designed to serve as a permanent keratoprosthesis, modeling natural corneal physical properties as closely as possible. Prior to permanent application in patients, keratoprostheses are commonly tested in animal models to assess biochemical and biomechanical compatibility. However, immune and inflammatory responses acquired through animal experimentation are difficult to extrapolate in order to develop a predictable and generalized outcome in humans. Therefore, this preliminary report includes results following a temporary implantation of the Aachen-Keratoprosthesis in a patient during vitreoretinal surgery to assess the long-term prospect of application as a permanent artificial cornea.

Patient and Methods

A 43 year old man presented with a ruptured right eye resulting in an opaque cornea and retinal detachment. A soft silicone rubber keratoprosthesis, the Aachen-Keratoprosthesis, was temporarily implanted. Subretinal membranes were removed and the total retinal detachment was reattached. Liquid perfluorocarbon and silicone oil were used. The temporary keratoprosthesis was replaced by a 7 mm corneal graft after completion of surgery.

Results

The Aachen-Keratoprosthesis was securely positioned into the trephined hole. It allowed complete visualisation of vitreous, retina and thus controlled manipulations in the vitreous cavity up to the extreme periphery. Leakage across the trephination-prosthesis interface was minimal. Conclusion: We report the first temporary application of an innovative keratoprosthesis. Its flexibility and good optical qualities allow visualisation and control of intraoperative procedures. This temporary pilot study of the Aachen KPro encourages further investigation of the Aachen KPro as a permanent replacement for a diseased cornea.
Clinical Characterisation of Polysulfone LS Membrane for Renal Replacement Therapy
Authors: Hoenich N.A.
Published: March 2018

The solute transport characteristics and biocompatibility of a new polysulfone membrane (Polysulfone LS, Fresenius Medical Care, Bad Homburg, Germany) has been established and compared for two different sizes of dialyser (1.3 and 1.8 m2). The in vivo small molecular clearance of the two sizes of dialyser showed an overlap in performance. Neutropenia was slight and independent of the membrane area as were changes in C5ades Arg. The membrane induced neutrophil degranulation characterised by the release of elestase α1 inhibitor complex with time averaged values over 180 minutes related to membrane area (p=0.010). Heparin activity during dialysis with the membrane was within the therapeutic range necessary for anticoagulation (0.3–1.0 IU/ml), but despite this an increase in thrombin antithrombin III levels during treatment was noted. Polysulfone LS extends the range of polysulfone membranes available for clinical use and its performance is such that it may be considered as a membrane for the treatment of patients awaiting a transplant, or in whom use of the high flux therapies may be inappropriate.
Development of a Hybrid Artificial Liver using a Polyurethane Foam/Hepatocyte-Spheroid Packed-Bed Module
Authors: Ijima H. , Nakazawa K. , Koyama S. , Kaneko M. , Matsushita T. , Gion T. , Shirabe K. , Shimada M. , Takenaka K. , Sugimachi K. , Funatsu K.
Published: March 2018

Primary dog hepatocytes spontaneously formed spheroids in the pores of polyurethane foam (PUF) within 1–2 days of stationary culture. The spheroids, about 100–150 μm in diameter, partly attached to the surface and immobilized inside these pores.

The lidocaine disappearance rate decreased to about 4 μg/105 viable cells/day for 10 days, while in the PUF/spheroid culture the rate was maintained at almost the initial level of 8 μg/105 viable cells/day for 10 days. Then, two scales of PUF packed-bed modules were designed. A small module (PUF volume; 14.5 cm3) was used for in vitro culture to investigate optimum culture conditions, and a large module (PUF volume; 300 cm3) was designed for dog experiments. Hepatocytes inoculated in these modules also formed spheroids and maintained almost the same activity of albumin secretion rate (111 μg/cm3 PUF/day in the small module and 87.7 μg/cm3 PUF/day in the large module). These results indicate that the PUF packed-bed module containing hepatocyte-spheroids is promising as a hybrid artificial liver
Quantitative and Qualitative Evaluation of Blood Salvaged after Extracorporeal Circulation (ECC) in Paediatric Heart Surgery
Authors: Calza G. , Zannini L. , Lerzo F. , Nitti P. , Mangraviti S. , Perutelli P. , Porlezza M.
Published: March 2018

The salvaging of ECC circuit priming blood is essential for reducing the morbidity related to homologous blood transfusions and the importance of this technique is inversely proportionate to the age and weight of the child. In infants, the washing and centrifugation of blood not only drastically reduce the risk of contracting blood-transmitted diseases and cut management costs, but are also of considerable hemodynamic importance, producing a rapid normalization of the patient's hematocrit and hemoglobin and balancing the O2 consumption/demand ratio. The marketing of miniaturized salvaging devices with 55 ml bowls by Dideco has made possible the recovery of small quantities of blood, so as to normalise the hematic crisis and permit the application of total hemodilution in low-weight patients. The salvaged blood shows an average hematocrit of 52.7±9.7% (max 68.1%) and an average hemoglobin of 17.6±2.9 g/dl (max 20.7 g/dl), and maintains its structural components, osmotic resistance, concentration of intraerythrocytic hemoglobin and mean corpuscular hemoglobin all intact. Washing with isoosmotic and isoionic hydroelectrolytic solutions normalizes the ionic situation in the post-operative period and activated blood salvaging after Extracorporeal Circulation. The use of solutions without nutritional substances results however in a considerable fall in the number of enzymes in the intraerythrocytic metabolic glucide chain (G6PDH: −40.7±14.3% p<0.001), (PK: −23.8±20.5% p<0.03). This drop may be responsible for erythrocytic morphological alterations (echinocytic change) and probably for the release of hemoglobin from the red blood cells.

Washing with isoionic, isoosmotic solutions containing G5% and adenine could, at least in theory, improve the quality of the salvaged blood, by normalizing the morphology and the volume of the RBC and by increasing the hematocrit.
Origin and Appearance of HITS Induced by Prosthetic Heart Valves: An in vitro Study
Authors: Potthast K. , Erdönmez G. , Schnelke C. , Sellin L. , Sliwka U. , Schöndube F. , Eichler M. , Reul H.
Published: March 2018

Patients with mechanical heart valve prostheses show significantly enhanced numbers of HITS detected by transcranial Doppler ultrasound. In order to assess the origin of HITS formation, an in vitro study was set out to quantify valve induced microemboli for mechanical and bioprosthetic valves under various circulatory conditions by means of Ultrasound-Doppler-Sonography. At the same time the influence of CO2 partial pressure on HITS rate vas investigated. It can be summarised that for mechanical heart valve prostheses a strong correlation exists between left ventricular dp/dtmax and the detected HITS rates. It was also demonstrated that a bioprosthesis generates significantly less HITS than a mechanical valve. The origin of HITS is gaseous since the tests were carried out using a cell-free filtered water-glycerol test fluid. The HITS rate could be increased by increasing the amount of dissolved gas within the test fluid. The results support the hypothesis that cavitation is the key factor in the appearance of gaseous microemboli at heart valve prostheses.
Design and in vitro Testing of a Voice-Producing Element for Laryngectomized Patients
Authors: De Vries M.P. , Van Der Plaats A. , Van Der Torn M. , Mahieu H.F. , Schutte H.K. , Verkerke G.J.
Published: March 2018

A voice-producing element has been developed to improve speech quality after laryngectomy. The design process started with the formulation of a list of requirements. The lip principle has the best potential for fulfilling the requirements. A numerical model was made to find the optimal geometry of an element based on the lip principle. Extensive in vitro tests were performed to check all requirements. For this a test set-up with realistic acoustic and aerodynamic properties was developed. Results show that the protruding lip length dominates fundamental frequency, cross-sectional area dominates flow resistance and relation between flow and fundamental frequency. Most requirements have been fullfilled; both for males and females a potentially good functioning prototype could be selected.

Clinical experiments will be performed to confirm the quality of the voice-producing prosthesis.
Blood Flow around Hollow Fibers
Authors: Dierickx P.W.T. , De Wachter D. , Verdonck P.R.
Published: March 2018

In an artificial lung, blood is oxygenated and flows around a bundle of hollow fibers while gas flows inside the fiber. The objective of this study is to understand the hydrodynamics of three different fiber banks (inline square IS, staggered square SS and equilateral triangle ET) and to investigate the influence of both a Newtonian and non-Newtonian Casson viscosity model on the flow field. A two-dimensional finite element model for permanent, isothermal, laminar blood flow perpendicular to hollow fibers is used. All fibers are assumed identical, straight and parallel. Porosity ranges from 0.4 to 0.6 and Reynolds number varies from 1 to 60. For a given Re, ET generates less resistance than SS, the latter being comparable with IS. A lower porosity increases resistance. Non-Newtonian viscosity affects velocity patterns only at low Re (<0.5) and higher porosity (>0.5). Resistance at low Re is significantly elevated in the fiber banks due to an overall increase in viscosity. This model makes it possible to study the influence of geometry and viscosity on hydrodynamics in fiber banks and may aid in the optimization of hollow fiber artificial lung design.
A Physical Model of the Human Systemic Arterial Tree
Authors: Ferrari G. , Nicoletti A. , De Lazzari C. , Clemente F. , Tosti G. , Guaragno M. , Mimmo R. , Ambrosi D. , Górczyńaska K.
Published: March 2018

A physical model of the human arterial tree has been developed to be used in a computer controlled mock circulatory system (MCS). Its aim is to represent systemic arterial tree properties and extend the capacity of the MCS to intraortic balloon pump (IABP) testing. The main problem was to model the aorta simply and to accurately reproduce aortic impedance and related flow and pressure waveforms at different sections. The model is composed of eight segments; lumped parameter models are used for its peripheral loads.

After the numerical simulation, the physical model was reproduced as a silicon rubber tapered tube. This rubber was chosen for its stability over time and the acceptable behaviour of its Young's modulus (Ey =22.23 gf·mm–2) with different loads and in comparison with data from the literature (Ey ≈ 20.4 gf·mm–2). The properties of each segment of the aorta were defined in terms of compliance, resistance and inertance as a function of length, radius and thickness. The variable thickness was obtained using positive and negative molds. Total static compliance of the aorta model is about 1.125·10–3 g–1cm4·sec2 (1.5 cm3·mmHg–1). Measurements were performed both on numerical and physical models (in open and closed loop configuration). Data reported show pressure and flow waveforms along with input impedance modulus and phase. The results are in good agreement with data from the literature.
Stability of Urea and Creatinine in Spent Hemodialysate
Authors: Cheng Y.L. , Shek C.C. , Tsang D.N.C. , Li C.S. , Lentino J.R. , Daugirdas J.T. , Kjellstrand C.M. , Ing T. S.
Published: March 2018

Urea and creatinine levels in spent hemodialysates showed only small declines in spite of incubation at 37° C for 36 hours. In the determination of dialysate-side solute removal, it would seem prudent to keep spent dialysate cold during collection to retard bacterial breakdown of these waste products.
Modeling and Control of a Magnetic Bearing System for the Magnetically Suspended Centrifugal Blood Pump
Authors: Kim H. , Kim H.C.
Published: March 2018

We have developed a centrifugal blood pump with a magnetically suspended impeller to reduce the hemolysis level for long-term use. The main advance we have made was simplifying the traditional 5 axes controlled magnetic bearing system, since the total device should ultimately be small enough to implant into a human body. A simplified magnetic bearing system with only 3 actively controlled axes was designed to levitate the impeller. The state equations of the magnetic bearing plant were established using Lagrange's methods, and using the results, a linear quadratic optimal controller was designed to regulate the position of the impeller. Flow rate and differential pressure of 5L/min and 300mmHg, respectively at a motor speed of 2750 rpm was achieved from a mock circulation setup. These results show satisfactory performance as a cardiopulmonary bypass device. The lowering of pumping efficiency as the clearance between the impeller and pump housing increased was negligible. Thus for power efficiency, the smallest gap not leading to a hemolysis level rise can be determined as a feasible operation clearance.
In Vivo and in Vitro Experience with the PUCA-II, a Single-Valved Pulsatile Catheter-Pump
Authors: Mihaylov D. , Rakhorst G. , Van Der Plaats A. , Van Loon J. P. , Hummel M.M. , Elstrodt J. , Verkerke G.J.
Published: March 2018

The Pulsatile Catheter (PUCA) pump is a trans-arterial pulsatile ventricular assist device that can be used for short-term left ventricular support. The separate inflow and outflow valves in the first version of the device (PUCA-I) were replaced by a single inflow/outflow valve in the latest PUCA pump version (PUCA-II). The new combined valve was tested during in vitro (mock circulation) and in vivo experiments for valve leakage, flow resistance, and thrombus formation. During the in vitro experiments a maximum valve leakage of 6% during ejection and 21% during aspiration was found. The maximum flow resistance coefficient (K) was 4. The animal experiments demonstrated that the PUCA-II could be positioned within a few minutes into the left ventricle without X-ray guidance and without using a vascular graft. Thrombi were not found in the combined valve after total pump time of 3 hours, which proved the good washout of the valve. Initial experiments to position the pump in the right ventricle through the pulmonary artery were successful and contributed to the development of a new application for the device.
Stem Cell Collection using the Dideco Excel Continuous Flow Blood Cell Separator: Parameters for Optimal Stem Cell Collection Timing
Authors: Lai M. , Menichella G. , Pierelli L. , Serafini R. , Rumi C. , Sica S. , Candido A. , Leone G.
Published: March 2018

This study evaluates stem cell collection procedures performed with the Dideco Excel blood cell separator, with particular attention given to yields and separator collection efficiencies. Patients’ blood precounts and yield parameters related to the harvest capacity of the collection system were investigated. Fifty-five collection procedures were analyzed in 32 patients suffering from hematological malignancies and solid tumors and mobilized with chemotherapy plus G-CSF. The median blood volume processed in each procedure was 15.8 liters (12–19.750), with a blood flow rate of 70 ml/min. Patients had the following median blood precount value: NC 7.81×109/L, CD34+ cells 49.08×103/ml. Leukapheresis procedures gave the following yields: NC 14.95×109, MNC 10.83×109, CD34+ cells 4.37×106; yields/kg, NC 0.21×109kg, MNC 0.15×109/kg CD34+ cells 4.26×106/kg. Procedures show the following collection efficiencies: NC 10.79%, MNC 29.06%, CD34+ 42.33%, PLT 26.5%. The RBC (red blood cell) contamination of the product was (median value) 20.9 ml for each procedure, and for platelets 1.76×1011 per procedure. The CD34+ cell precounts strongly correlated with the CD34+ yields/kg (r=0.82. p=0.000). Furthermore the NC and MNC precounts correlated with the CD34+ yields/kg but only the MNC precount correlation is notable (r=0.57, p=0.000). The logistic regression analysis shows that CD34+ (p=0.008) but not NC (po=0.14), MNC (p=0.09), or PLT (p=0.53) precounts significantly influenced the collection of a sufficient dose of CD34+ cells for transplantation (≥ 2.5×106/kg). Eleven of the thirty-two patients have been transplanted till now, and all had a prompt and lasting trilineage engraftment NC >1×109/L on day 12 (10–17). Our data show that the collection system analyzed in this report is able to collect large amounts of progenitor cells, harvesting ≥2.5×106/kg CD34+ cells with a single procedure in 68.8% of patients and assuring complete recovery after stem cell transplantation.
Artificial Trachea and Long Term follow-up in Carinal Reconstruction in Dogs
Authors: Nakamura T. , Teramachi M. , Sekine T. , Kawanami R. , Fukuda S. , Yoshitani M. , Toba T. , Ueda H. , Hori Y. , Inoue M. , Shigeno K. , Taka T. Nakahara , Liu Y. , Tamura N. , Shimizu Y.
Published: March 2018

We have already reported “del” successful carinal reconstruction of the trachea with an observation period of 1 – 2 years. In this study, we evaluate the long-term safety and efficacy of the reconstruction after 5-years of follow-up.

The Y-shaped Marlex® mesh tube was reinforced with a polypropylene spiral and coated with atelocollagen made from porcine skin. The prosthesis was 60 mm long with an outer diameter of 18 mm. Replacement of the tracheobronchial bifurcation was preformed through a right thoracotomy in a beagle dog. Bronchoscopical examination and sampling of the tracheal epithelium was performed periodically to check the function of cilia.

The implanted prothesis was promptly infiltrated by the surrounding connective tissue and completely incorporated by the host trachea and bronchus. Bronchoscopically, sufficient epithelization was confirmed from the upper to the lower site of anastomosis. After 5 years neither stenosis nor dehiscence was observed. In spite of there being mesh-exposure at the luminal surface, the dog had no clinical symptoms until sacrifice for pathological examination. The bent frequency of the cilia was maintained within the normal range, indicating “del” functional recovery of the regenerating airway.

Our tracheal prosthesis is promising for clinical “del” repair of the tracheobronchial bifurcation.
Numerical Simulation of the Influence of a Left Ventricular Assist Device on the Cardiovascular System
Authors: Verkerke G.J. , Geertsema A.A. , Mihaylov D. , Blanksma P.K. , Rakhorst G.
Published: March 2018

The PUCA (pulsatile catheter) pump is a left ventricular assist device (LVAD) capable of unloading the left ventricle (LV) and improving coronary flow by providing a counterpulsation effect. It consists of an extracorporeal located membrane pump, coupled to a transarterial catheter that enters the body via a superficial artery and ends in the LV. Blood is aspirated from the LV and pumped in the ascending aorta through the same catheter guided by a valve system. Timing and frequency of the PUCA pump influence its efficacy. To study the influence of several pump parameters a numerical model of the device and the circulatory system has been developed. Results of animal experiments were used to validate the model.

Optimization studies resulted in a pump configuration with a stroke volume of 50 cc and pump:heart frequency mode of 1:2 that starts ejection at the beginning of diastole.
Three Dimensional Culture Upregulates Extracellular Matrix Protein Expression in Human Liver Cell Lines - a Step towards Mimicking the Liver in Vivo?
Authors: Selden C. , Khalil M. , Hodgson H.
Published: March 2018

Extracellular matrix (ECM) in the liver affects the phenotype of both hepatocytes and non-parenchymal cells. To be able to mimic in vivo liver function for extracorporeal hepatic support using human cell lines, a necessary step is to upregulate the function normally seen in monolayer culture. 3-D spheroid colonies were formed by culturing single HepG2 cells encapsulated in alginate beads. ECM expression in these cultures was compared to monolayer Hep G2 cultures. The following ECM proteins were detected immunohistochemically:- collagens I, III, V and VI, the glycoproteins fibronectin, tenascin and vitronectin, and the basement membrane protein laminin. In 3-D cultures, all proteins except tenascin were strongly expressed, as compared with weak or undetectable expression in monolayer cultures, even with 10-fold increases in the antibody concentration used. In conclusion, we have demonstrated that the 3-D environment created by alginate encapsulation of cell lines leads to cell behaviour mimicking that in vivo.
Medical Technology Assessment: The use of the Analytic Hierarchy process as a Tool for Multidisciplinary Evaluation of Medical Devices
Authors: Marjan Hummel J.M. , Van Rossum W. , Verkerke G.J. , Rakhorst G.
Published: March 2018

Most types of medical technology assessment are performed only after the technology has been developed. Consequently, they have only minor effects on changes in clinical practice. Our study introduces a new method of constructive medical technology assessment that can change the development and diffusion of a medical device to improve its later clinical effectiveness. The method, based on Saaty's Analytic Hierarchy Process, quantitatively supports discussions between various parties involved in technological development and diffusion. We applied this method in comparing a new blood pump with two competitors based on technical, medical and social requirements. These discussions changed the evaluators’ perspectives, reduced diasagreements, and ended in a reliable evaluation of the pump's performance. On the basis of these results, adaptations were derived which improved the design and diffusion of the blood pump. This application shows the adequate potential of our method to steer technological development and diffusion of artificial organs.
Biomaterials in Spinal Fixation. An Experimental Animal Study to Improve the Performance
Authors: Rocca M. , Fini M. , Greggi T. , Parisini P. , Carpi A. , Giardino R.
Published: March 2018

Different pedicle screws were biomechanically and morphologically studied and compared through the use of an animal model to determine their efficacy and resistance in spinal fixation. The principal objective was to compare biomechanical and histomorphological aspects of HA-coated screws to uncoated ones.

Fourty-eight cylindrical transpedicular self-tapping screws divided into three groups of sixteen each were employed; Group A: stainless steel screws; Group B: titanium screws; Group C: HA-coated titanium screws. The screws were implanted bilaterally and randomly into the L3, L4, and L5 pedicles of eight adult mongrel sheep. The final insertion torque was measured in all the implants. After one and four months, upon euthanization, four samples per group were extracted from the surrounding bone and the screw extraction torque was measured. The remaining samples were examined and processed for histological and histomorphological evaluations.

No differences were observed at one month among the extraction torque of the three groups. After four months the only significance between insertion and extraction values was for the HA group, i.e. p=0.001. Comparing the extraction torque values of the three groups after four months of healing, the HA-coated group showed a greater than twofold increase (p<0.0005). No differences were observed at one month among the percentages of bone-implant contact in the three groups. After four months the percentage was significant only for the C group (p<0.0005). At four months a correlation was found between the morphological and the biomechanical data of group C (p<0.0005).

The use of hydroxyapatite-coated screws could act as an effective method to improve the bone-implant interface, thus obtaining a strong fixation of the implant independently of the arthrodesis achieved with bone graft.
Therapeutic Apheresis in Children: Experience in a Pediatric Dialysis Center
Authors: De Palo T. , Giordano M. , Bellantuono R. , Colella V. , Troise D. , Palumbo F. , Caringella D.A.
Published: March 2018

The use of apheretic procedures in pediatric patients has always been restricted by technical difficulties and the low incidence of diseases requiring this kind of treatment. The aim of the present study was to describe the solutions adopted to solve technical difficulties related to priming, vascular access and monitoring and then to evaluate clinical results.

Between 1982 and 2000, 51 consecutive children (28 male, 23 female) with a mean age of 4.9 ± 4.8 years (3 months – 14.8 years) and a mean weight of 19.7 ± 12.8 kg (5 – 52 kg), with renal and/or extra-renal diseases requiring apheretic procedures were selected for the study. The overall number of procedures performed were: 226 plasma-exchange (PE), 6 LDL-apheresis (LDL-A) and 8 protein A immunoadsorption (IAPA) sessions.

Our therapeutic protocol involves hematic flux of 20 – 100 ml/min and ultrafiltration of 5–20 ml/min. In each 70–95 minute session we exchanged plasmatic volume with fresh frozen plasma or with a solution of 6% albumin in lactated Ringer's, using heparin (10–20 UI/kg/h). We used Paired Filtration Dialysis Monitor in PE and LDL-A; Citem 10 in IAPA. As plasma separator, we used a filter made of polypropylene, 0.2 m2 surface, 30 ml priming (Hemaplex BT 900).

Hemolytic uremic syndrome was the most commonly treated disease (18/51 cases) with good results in 10/18 cases. We recorded, good results in vasculitis as well, in one girl with focal glomerulosclerosis in transplanted kidney and rapid improvement in all children with Guillaine-Barré Syndrome. PE treatment was effective in metabolic disorders such as tirosynemia and familiar hypercolesterolemia. Only 4/12 patients with acute liver failure due to viral hepatitis recovered. We had poor results in the remaining eight cases.

Complications were rare and no viral infection was found in any patient. Our data show that it is possible to use these procedures in pediatric patients even though clinical indications and real effectiveness still need to be cleared up.