Innovative Approaches to 3D Printing of PA12 Forearm Orthoses: A Comprehensive Analysis of Mechanical Properties and Production Efficiency.

This research paper aims to explore the mechanical characteristics of polyamide PA12 (PA12) as a 3D material printed utilizing Selective Laser Sintering (SLS) and HP MultiJet Fusion (HP MJF) technologies in order to design and manufacture forearm orthoses. The study assessed the flowability of the materials used and compared the mechanical performance of PA12 with each other using tensile, flexure, and impact tests in five different fabrication orientations: X, Y, Z, tilted 45° XZ, and tilted 45° YZ. The results of the study provide, firstly-the data for testing the quality of the applied polyamide powder blend and, secondly-the data for the design of the orthosis geometry from the aspect of its strength parameters and the safety of construction. The mechanical parameters of SLS specimens had less variation than MJF specimens in a given orientation. The difference in tensile strength between the 3D printing technologies tested was 1.8%, and flexural strength was 4.7%. A process analysis of the forearm orthoses revealed that the HP MJF 5200 system had a higher weekly production capacity than the EOS P396 in a production variance based on obtaining maximum strength parameters and a variance based on maximizing economic efficiency. The results suggest that medical device manufacturers can use additive manufacturing technologies to produce prototypes and small-batch parts for medical applications. This paper pioneers using 3D printing technology with Powder Bed Fusion (PBF) methods in designing and manufacturing forearm orthoses as a low- to medium-volume product. The applied solution addresses the problem of medical device manufacturers with regard to the analysis of production costs and mechanical properties when using 3D printing for certified medical devices.

Influence of Antibacterial Coating and Mechanical and Chemical Treatment on the Surface Properties of PA12 Parts Manufactured with SLS and MJF Techniques in the Context of Medical Applications.

Additive manufacturing (AM) is a rapidly growing branch of manufacturing techniques used, among others, in the medical industry. New machines and materials and additional processing methods are improved or developed. Due to the dynamic development of post-processing and its relative novelty, it has not yet been widely described in the literature. This study focuses on the surface topography (parameters Sa, Sz, Sdq, Sds, Str, Sdr) of biocompatible polyamide 12 (PA12) samples made by selective laser sintering (SLS) and multi jet fusion (MJF). The surfaces of the samples were modified by commercial methods: four types of smoothing treatments (two mechanical and two chemical), and two antibacterial coatings. The smoothing treatment decreased the values of all analyzed topography parameters. On average, the Sa of the SLS samples was 33% higher than that of the MJF samples. After mechanical treatment, Sa decreased by 42% and after chemical treatment by 80%. The reduction in Sdq and Sdr is reflected in a higher surface gloss. One antibacterial coating did not significantly modify the surface topography. The other coating had a smoothing effect on the surface. The results of the study can help in the development of manufacturing methodologies for parts made of PA12, e.g., in the medical industry.

Manufacturing Polymer Model of Anatomical Structures with Increased Accuracy Using CAx and AM Systems for Planning Orthopedic Procedures.

Currently, medicine uses typical industrial structure techniques, including reverse engineering, data processing, 3D-CAD modeling, 3D printing, and coordinate measurement techniques. Taking this into account, one can notice the applications of procedures used in the aviation or automotive industries based on the structure of Industry 4.0 in the planning of operations and the production of medical models with high geometric accuracy. The procedure presented in the publication shortens the processing time of tomographic data and increases the reconstruction accuracy within the hip and knee joints. The procedure allows for the partial removal of metallic artifacts from the diagnostic image. Additionally, numerical models of anatomical structures, implants, and bone cement were developed in more detail by averaging the values of local segmentation thresholds. Before the model manufacturing process, additional tests of the PLA material were conducted in terms of its strength and thermal properties. Their goal was to select the appropriate type of PLA material for manufacturing models of anatomical structures. The numerical models were divided into parts before being manufactured using the Fused Filament Fabrication technique. The use of the modifier made it possible to change the density, type of filling, number of counters, and the type of supporting structure. These treatments allowed us to reduce costs and production time and increase the accuracy of the printout. The accuracy of the manufactured model geometry was verified using the MCA-II measuring arm with the MMDx100 laser head and surface roughness using a 3D Talyscan 150 profilometer. Using the procedure, a decrease in geometric deviations and amplitude parameters of the surface roughness were noticed. The models based on the presented approach allowed for detailed and meticulous treatment planning.

Characterisation of Selected Materials in Medical Applications.

Tissue engineering is an interdisciplinary field of science that has developed very intensively in recent years. The first part of this review describes materials with medical and dental applications from the following groups: metals, polymers, ceramics, and composites. Both positive and negative sides of their application are presented from the point of view of medical application and mechanical properties. A variety of techniques for the manufacture of biomedical components are presented in this review. The main focus of this work is on additive manufacturing and 3D printing, as these modern techniques have been evaluated to be the best methods for the manufacture of medical and dental devices. The second part presents devices for skull bone reconstruction. The materials from which they are made and the possibilities offered by 3D printing in this field are also described. The last part concerns dental transitional implants (scaffolds) for guided bone regeneration, focusing on polylactide-hydroxyapatite nanocomposite due to its unique properties. This section summarises the current knowledge of scaffolds, focusing on the material, mechanical and biological requirements, the effects of these devices on the human body, and their great potential for applications.

Study on the Incorporation of Oat and Yeast ß-Glucan into Shortbread Biscuits as a Basis for Designing Healthier and High Quality Food Products.

According to international health and food organizations and authorities, people should limit fat intake since fat is the most caloric component of food and it is often a source of unsafe saturated fatty acids (FA) and trans isomers. The greatest health benefits come from replacing shorts with dietary fiber molecules. The aim of the study was to determine the possibility of reducing shortening content, which has an undesirable profile of FA, by addition of ß-glucan molecules in shortbread biscuits. The effect of oat and yeast ß-glucan supplementation on physical and sensory quality of products with reduced fat content (max 15%) were studied. It was shown that the substitution of shortening by ß-glucan in shortbread biscuits is possible to a limited extent. Reduction in product energy value (up to 36 kcal/100 g) and content of undesirable FA (maximum 2.1 g/100 g) and increased of ß-glucan content, regardless of the type, caused deterioration of biscuits quality and affected changes during storage. The substitution of shortening by ß-glucan in food is a good way to improve nutritional value by increasing the amount of dietary fiber molecules, reducing calories, and amount of SFA in diets.

Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product.

The work mainly focused on a validation of the method for determining the content of salicylic acid and individual unknown impurities in new pharmaceutical product-tablets containing: 75, 100 or 150 mg of acetylsalicylic acid and glycine in the amount of 40 mg for each dosage. The separation of the components was carried out by means of HPLC, using a Waters Symmetry C18 column (4.6 × 250 mm, 5 µm) as the stationary phase. The mobile phase consisted of a mixture of 85% orthophosphoric acid, acetonitrile and purified water (2:400:600 V/V/V). Detection was carried out at a wavelength of 237 nm, with a constant flow rate of 1.0 ml min-1. In order to verify the method, linearity, precision (repeatability and reproducibility), accuracy, specificity, range, robustness, system precision, stability of the test and standard solution, limit of quantification and forced degradation were determined. Validation tests were performed in accordance with ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines. The method was validated successfully. It was confirmed that the method in a tested range of 0.005-0.40% salicylic acid with respect to acetylsalicylic acid content is linear, precise and accurate.

Procedure Increasing the Accuracy of Modelling and the Manufacturing of Surgical Templates with the Use of 3D Printing Techniques, Applied in Planning the Procedures of Reconstruction of the Mandible.

The application of anatomical models and surgical templates in maxillofacial surgery allows, among other benefits, the increase of precision and the shortening of the operation time. Insufficiently precise anastomosis of the broken parts of the mandible may adversely affect the functioning of this organ. Applying the modern mechanical engineering methods, including computer-aided design methods (CAD), reverse engineering (RE), and rapid prototyping (RP), a procedure used to shorten the data processing time and increase the accuracy of modelling anatomical structures and the surgical templates with the use of 3D printing techniques was developed. The basis for developing and testing this procedure was the medical imaging data DICOM of patients treated at the Maxillofacial Surgery Clinic of the Fryderyk Chopin Provincial Clinical Hospital in Rzeszów. The patients were operated on because of malignant tumours of the floor of the oral cavity and the necrosis of the mandibular corpus, requiring an extensive resection of the soft tissues and resection of the mandible. Familiarity with and the implementation of the developed procedure allowed doctors to plan the operation precisely and prepare the surgical templates and tools in terms of the expected accuracy of the procedures. The models obtained based on this procedure shortened the operation time and increased the accuracy of performance, which accelerated the patient's rehabilitation in the further course of events.

Recruiting, training and managing a sensory panel in odor nuisance testing.

A growing level of environmental awareness in societies has led to an increased interest in the odor nuisance. Residents' complaints have ultimately revealed the need to develop adequate research methods that would ensure objective measurements, thus shedding more light on this complex problem. One of the possible ways to conduct an objective odor assessment is to use a sensory panel in the tests. This paper presents the procedure for selecting and training the sensory analysis team especially for the purposes of odor nuisance testing. Several useful suggestions for conducting studies that involve a sensory panel are also provided. This in turn can prove a useful tool, supplementing the EN 13725 standard within the scope of building and convening a sensory panel. In this paper a performance comparison of two sensory panels is also discussed: one that received a basic training of 20h, solely based on the guidelines of the EN 13725 standard and another, whose members completed an extended training of 60h, based on the standards and guidelines used in the field of sensory analysis. It has been shown that acquiring more knowledge and developing certain competences in the field of sensory analysis may contribute to an increase in the overall and individual precision of determinations as adequate sensory training improves the panel's performance.

Estimating the Accuracy of Mandible Anatomical Models Manufactured Using Material Extrusion Methods.

The development of new solutions in craniofacial surgery brings the need to increase the accuracy of 3D printing models. The accuracy of the manufactured models is most often verified using optical coordinate measuring systems. However, so far, no decision has been taken regarding which type of system would allow for a reliable estimation of the geometrical accuracy of the anatomical models. Three types of optical measurement systems (Atos III Triple Scan, articulated arm (MCA-II) with a laser head (MMD × 100), and Benchtop CT160Xi) were used to verify the accuracy of 12 polymer anatomical models of the left side of the mandible. The models were manufactured using fused deposition modeling (FDM), melted and extruded modeling (MEM), and fused filament fabrication (FFF) techniques. The obtained results indicate that the Atos III Triple Scan allows for the most accurate estimation of errors in model manufacturing. Using the FDM technique obtained the best accuracy in models manufactured (0.008 ± 0.118 mm for ABS0-M30 and 0.016 ± 0.178 mm for PC-10 material). A very similar value of the standard deviation of PLA and PET material was observed (about 0.180 mm). The worst results were observed in the MEM technique (0.012 mm ± 0.308 mm). The knowledge regarding the precisely evaluated errors in manufactured models within the mandibular area will help in the controlled preparation of templates regarding the expected accuracy of surgical operations.

An Analysis of Polymer Gear Wear in a Spur Gear Train Made Using FDM and FFF Methods Based on Tooth Surface Topography Assessment.

This article focuses on wear tests of spur gears made with the use of additive manufacturing techniques from thermoplastic materials. The following additive manufacturing techniques were employed in this study: Melted and Extruded Modelling (FDM) and Fused Filament Fabrication (FFF). The study analysed gears made from ABS M-30 (Acrylonitrile Butadiene Styrene), ULTEM 9085 (PEI Polyetherimide) and PEEK (Polyetheretherketone), and the selection of these materials reflects their hierarchy in terms of economical application and strength parameters. A test rig designed by the authors was used to determine the fatigue life of polymer gears. Gear trains were tested under load in order to measure wear in polymer gears manufactured using FDM and FFF techniques. In order to understand the mechanism behind gear wear, further tests were performed on a P40 coordinate measuring machine (CMM) and a TalyScan 150 scanning instrument. The results of the gear tests made under load allow us to conclude that PEEK is resistant to wear and gear train operating temperature. Its initial topography undergoes slight changes in comparison to ABS M-30 and Ultem 9085. The biggest wear was reported for gears made from Ultem 9085. The hardness of the material decreased due to the loaded gear train's operating temperature.

The Quality of Emulsions with New Synthetized Lipids Stabilized by Xanthan Gum.

The study investigated the quality of emulsions containing rabbit fat modified with vegetable oil. The modification of the fat and introducing it as a fatty base into the emulsion was dictated by consumer preferences. Emulsion systems containing various fatty bases and viscosity modifier contents were evaluated in the terms of their stability (by means of Turbiscan test), texture properties, color, and viscosity. Moreover, the emulsions were assessed by a sensory panel in the context of the intensity of the following parameters: color, fragrance, consistency, greasiness, and hydration. The same characteristics were also subject to consumer evaluation. The results of the sensory assessment showed the sensory panel attributed higher scores to consistency and skin hydration to the emulsions formed with modified fats; these systems were more appreciated by consumers as well. The results confirmed a major role of sensory determinations in the development of new emulsion products. They also provide knowledge on modifications to product characteristics that would lead to the best possible quality and consumer acceptance. This research has also reaffirmed that looking for new fats among waste fats is becoming a solution to finding new fatty bases for emulsions. The natural origin of these components, and thus their agreeability with the human body, appear noteworthy as well. Enrichment with unsaturated fatty acids is an added advantage of the enzymatic modification of rabbit fat with pumpkin seed oil and can be applied not only for food but also for skin applications.

Identifying the location of odour nuisance emitters using spatial GIS analyses.

The primary objective of the article was to establish the location of odour emitters with the use of spatial GIS analyses. The odour emitter location analysis based on measurements was carried out using QGIS software tools. The algorithm of the procedure was developed by analysing vector elements, including simulated odour streaks (in the form of wedge buffer surfaces) and a regular grid of points needed to determine the presence of a given buffer in a given location. Statistical analysis was performed in ArcGIS software. The detailed aim of the conducted study was to analyse the nuisance of odours from the measurement data on the basis of IDW interpolation and the arrangement of buildings. An innovative element of the developed analysis is the application of the inversed method of fragrance streak propagation. Identifying a streak from the measuring point towards the blowing wind is very likely to determine the approximate location of the odour emitter measured. The described method should provide better results at the location of emitters than the above mentioned methods using interpolation, because of taking into account wind direction and speed. In addition, it is a method that can be applied over a large open area where methods based on simulation and particle propagation would not be efficient or highly impossible to apply due to extensive and complex analysis. It was necessary to conduct field studies in order to meet the main goal, which resulted in sensory evaluation of the intensity of odour nuisance in an urbanised area. Odour concentration tests using field olfactometry with NasalRanger olfactometer were taken.

An Analysis of the Casting Polymer Mold Wear Manufactured Using PolyJet Method Based on the Measurement of the Surface Topography.

An important factor having an impact on the condition of machine parts is their surface topography. For instance, in the production of a molded element in casting or injection molding processes, the surface topography of the molding cavity has a significant impact on the surface condition of the product. An analysis of the wear of a mold made with the PolyJet technique was performed in this work, and we examined the surface topography using the stylus method after casting a wax model of the turbine blade. The surface topographies showed a gradual degradation of the mold cavity surface. After the manufacture of 40 castings, there was a significant deformation of the microstructure of the mold cavity. The maximum height value (Sz) parameter had the most dynamic change from 18.980 to 27.920 µm. Its growth dynamics are mainly influenced by maximum peak height (Sp) rather than the maximum pit height (Sv) parameter. In the case of the root mean square height (Sq) and arithmetic mean height (Sa), their gradual increases can be seen from 2.578 to 3.599 µm and from 2.038 to 2.746 µm. In the case of the value of the skewness (Ssk) parameter, a small positive skew was observed. As for the kurtosis (Sku) values, the distributions are clearly leptokurtic.

Assessing the Radiological Density and Accuracy of Mandible Polymer Anatomical Structures Manufactured Using 3D Printing Technologies.

Nowadays, 3D printing technologies are among the rapidly developing technologies applied to manufacture even the most geometrically complex models, however no techniques dominate in the area of craniofacial applications. This study included 12 different anatomical structures of the mandible, which were obtained during the process of reconstructing data from the Siemens Somatom Sensation Open 40 system. The manufacturing process used for the 12 structures involved the use of 8 3D printers and 12 different polymer materials. Verification of the accuracy and radiological density was performed with the CT160Xi Benchtop tomography system. The most accurate results were obtained in the case of models manufactured using the following materials: E-Model (Standard Deviation (SD) = 0.145 mm), FullCure 830 (SD = 0.188 mm), VeroClear (SD = 0.128 mm), Digital ABS-Ivory (SD = 0.117 mm), and E-Partial (SD = 0.129 mm). In the case of radiological density, ABS-M30 was similar to spongious bone, PC-10 was similar to the liver, and Polylactic acid (PLA) and Polyethylene terephthalate (PET) were similar to the spleen. Acrylic resin materials were able to imitate the pancreas, kidney, brain, and heart. The presented results constitute valuable guidelines that may improve currently used radiological phantoms and may provide support to surgeons in the process of performing more precise treatments within the mandible area.

Improved accuracy of mandible geometry reconstruction at the stage of data processing and modeling.

The article presents a comparative study of influence of the Lanczos resampling filter on improving the accuracy of reconstruction of mandible geometries. The research was performed on eight different patients. Digital Imaging and Communications in Medicine data were obtained on the Siemens Somatom Sensation Open 40 scanner. At the stage of reconstruction, the same parameters were utilized, while only slice thickness was changed. Modeling with voxel dimensions of 0.4 mm × 0.4 mm × 1.5 mm was chosen as the gold standard over the modeling approach comprising voxel dimensions of 0.4 mm × 0.4 mm × 3.0 mm and improved using the Lanczos resampling filter. The influence of the Lanczos resampling filter on the accuracy of reconstruction of mandible geometry is very similar for the eight presented patients. The average results show a distribution with a positive skew and kurtosis. The value of skewness is 0.713 and kurtosis is 4.221 for the model without Lanczos filtering applied. When the Lanczos filtering is applied the value of skewness is 0.542 and kurtosis is 4.313. Based on 95% confidence, changes in layer thickness from 1.5 mm to 3 mm generated errors reconstructing the geometry of the mandible at the value of 0.153 mm ± 1.209 mm. In models improved using the Lanczos resampling filter, the errors generated in reconstructing the geometry of the mandible were minimized at the value of 0.160 mm ± 1.007 mm. The presented research highlights new opportunities to improve the accuracy of reconstruction geometry of the mandible at the stage of data processing.

The influence of change in slice thickness on the accuracy of reconstruction of cranium geometry.

The article presents a comparative study of change in slice thickness on the accuracy of reconstruction of cranium geometry. Research was performed on 10 different patients. Digital Imaging and Communications in Medicine data were obtained on the Siemens Somatom Sensation Open 40 scanner. At the stage of reconstruction, the same parameters were utilized, while only slice thickness was changed. Modeling with voxel dimensions of 0.4 mm × 0.4 mm × 2.4 mm was chosen as the gold standard over the modeling approach comprising voxel dimensions of 0.4 mm × 0.4 mm × 4.8 mm. The influence of layer thickness on the accuracy of cranium geometry is very similar for the 10 presented patients. The average results show a distribution with a positive skew and kurtosis. The value of skewness is 0.284 (small asymmetry) and kurtosis is 3.746 (a distribution more peaked). Based on 95% confidence, the changes in layer thickness from 2.4 to 4.8 mm generated errors reconstructing the geometry of the cranium by 0.516 mm ± 1.345 mm. The presented research highlights new opportunities to control deviations at the stage of data processing and modeling geometry of the cranium.

Access to selected diagnostic procedures in the management of heart failure patients in Poland - POLKARD 2005.

BACKGROUND: Polish heart failure surveys from 1999 and 2005 indicated that non-invasive and invasive diagnostic procedures in heart failure patients are underused, mostly due to limited availability. AIM: To assess the access to procedures used for the diagnosis and treatment of heart failure in randomly selected outpatient clinics and hospital wards in Poland. METHODS: The study was undertaken in 2005, as a part of the National Project of Prevention and Treatment of Cardiovascular Diseases - POLKARD. The data on non-interventional and interventional procedures were collected from 400 primary care units, 396 secondary outpatient clinics and 259 hospitals, and included cardiology or internal medicine departments. Additionally, the last five patients with diagnosed heart failures were identified, who visited outpatient clinics or were discharged from the hospitals, and their medical records of diagnostic procedures were analysed. RESULTS: Echocardiography was not available in approximately 10% of hospital wards and 13-37% of outpatient clinics, both primary and secondary. Generally, the waiting time for echocardiography in Poland varied from region to region. A one-month waiting time was declared by more than 50% of secondary outpatient clinics and only 11-18% of primary care units, regardless of the community size. On the first day of hospital admission, echocardiography was performed in approximately 10% of patients of internal medicine wards and up to 36% of patients in cardiology departments. The assessment of B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) was generally performed only in a few hospitals, usually in cardiology departments. In primary care units, it was practically not available. Percutaneous coronary interventions, pacemaker or cardioverter-defibrillator implantations were available in approximately 20% of city hospitals, 30-40% of province hospitals, and 60-70% of clinical wards of medical universities. CONCLUSIONS: These data show limited availability of echocardiography in primary care units. It is necessary to continue actions for better accessibility and frequency of performing interventional procedures in patients with heart failure in Poland.

[Primary percutaneous coronary interventions in acute myocardial infraction with ST-segment elevation. Experience in a heart catheterization unit without surgical backup]. / Pierwotna angioplastyka wiencowa w swiezym zawale serca. Doswiadczenia pracowni odleglej od osrodka kardiochirurgicznego.

BACKGROUND: Primary percutaneous coronary intervention (PCI) in patients (pts) with ST-segment elevation myocardial infarction is regarded as treatment superior to thrombolysis. Coronary stents and GP IIb/IIIa receptor inhibitors improved safety and clinical outcome of interventional procedures. Safety of primary PCI procedure in catheterisation laboratories which do not have on-site surgical backup is still under evaluation. METHODS: In a cohort of 249 consecutive patients we analysed short and long-term clinical outcome of primary PCI performed in catheterisation laboratory which is located several kilometres from a cardiac surgery department, with an effective transfer time < 30 minutes. RESULTS: Coronary stents were implanted in 43% pts. GP IIb/IIIa receptor inhibitors were used in 54.2% pts. Cardiogenic shock on admission was diagnosed in 7.2% pts. Intra-aortic balloon counterpulsation usage was necessary in 6.4% pts. In-hospital mortality was 6% (3.5% in non-shock pts). In two pts (0.8%) during hospitalization repeat PCI was performed--in one case due to reinfarction. No urgent cardiosurgery intervention was necessary. Mortality and myocardial infarction rate after hospital discharge during 6 month follow up was 2.4% and 2.8% respectively. In 4% pts repeated PCI was performed due to restensosis. Cumulative event free survival was 84%. CONCLUSION: Primary PCI procedure for acute myocardial infarction seems to be feasible and safe in catheterisation laboratories without on-site surgical backup provided usage of stents, GPIIb/IIIa receptor inhibitors and intraaortic balloon counterpulsation and cooperation with a nearby cardiosurgery department with short transfer time.

[Coronary flow reserve in acute myocardial infarction in a patient treated with primary venous angioplasty. Case report]. / Rezerwa wiencowa w ostrym okresie zwalu serca u chorej leczonej pierwotna angioplastyka wiencowa. Opis przypadku.

Residual stenosis, dissection and/or microvascular damage have been proposed as mechanisms of impaired flow after primary angioplasty (PCI) for acute myocardial infarction (MI). In this report we present a patient who underwent PCI for acute anterior MI. Coronary flow reserve (CFR) assessment performed after balloon dilatation suggested possible improvement of coronary flow after stenting. However, we did not observe any improvement in CFR just after stent implantation. We conclude that in patients treated with primary PCI the use of additional pharmacological treatment to prevent microcirculation injury during reperfusion and slow-flow or no-reflow phenomenon should be considered.

[Safety and efficacy of ANGIOGUARD protection device for the prevention of distal embolization during PCI in patients with unstable angina]. / Bezpieczenstwo i efektywnosc filtra wiencowego ANGIOGUARD w prewencji mikroembolizacji podczas angioplastyki wiencowej u chorych z niestabilna dusznica bolesna.

UNLABELLED: The use of IIbIIIa receptor blockers decreases the number of major ischemic adverse cardiac events during PCI. However, microinfarcts (post procedural CK-MB elevations) still occur despite optimal antithrombotic treatment. In patients (pts) with increased risk of atheroembolization during PCI the use of additional mechanical protection of embolization can be considered. The purpose of the study was to determine safety and efficacy of additional use of first generation coronary filter (Angioguard) to prevent microembolization during PCI in pts with unstable angina (UA). METHODS: 31 pts with UA (Braunwald IIB, IIIB) undergoing urgent PCI were randomized in the catheterization laboratory for additional use of Angioguard coronary filter or not (placebo). All pts were treated with aspirin, ticlopidine (500 mg/d), heparin (60 U/kg, ACT 200-300 sec.) and eptifibatide (bolus 2 x 180 micrograms/kg i.v. and 2 micrograms/kg/min. infusion for 18-24 h). We analyzed the extent of microembolization (serial CK-MB), presence of embolic material in the device after procedure, technical problems. Major cardiac events (death, myocardial infarction (MI), urgent target vessel revascularization (TVR)) were also considered. RESULTS: PCI was successful in all pts. There was no death, Q wave MI or urgent TVR. Angioguard was successfully installed in 100% pts; however balloon predilatation was necessary in 9 (60%) pts. In 9 pts (60%) there was no possibility to prevent embolization oflarge side branches that originated close to the culprit lesion. Presence of embolic material in the filter was confirmed in microscopic analysis of each device. However CK-MB level was elevated in 4 pts (29%) in Angioguard group comparing to 0% in control group without protection device. CONCLUSION: First generation Angioguard protection device do not successfully prevent distal embolisation during PCI in pts with UA and its use is associated with many technical problems.