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Biomedical subjects

V Barbaro

Publications and source records attributed to V Barbaro.

54 records · Page 3Linked to original sources

19 mm sized bileaflet valve prostheses' flow field investigated by bidimensional laser Doppler anemometry (part I: velocity profiles).

The investigation of the flow field downstream of a cardiac valve prosthesis is a well established task. In particular turbulence generation is of interest if damage to blood constituents is to be assessed. Several prosthetic valve flow studies are available in literature but they generally concern large-sized prostheses. The FDA draft guidance requires the study of the maximum Reynolds number conditions for a cardiac valve model to assess the worst case in turbulence by choosing both the minimum valve diameter and a high cardiac output value as protocol set up. Within the framework of a national research project regarding the characterization of cardiovascular endoprostheses, the Laboratory of Biomedical Engineering is currently conducting an in-depth study of turbulence generated downstream of bileaflet cardiac valves. Four models of 19 mm sized bileaflet valve prostheses, namely St Jude Medical HP Edwards Tekna, Sorin Bicarbon, and CarboMedics, were studied in aortic position. The prostheses were selected for the nominal annulus diameter reported by the manufacturers without any assessment of the valve sizing method. The hemodynamic function was investigated using a bidimensional LDA system. Results concern velocity profiles during the peak flow systolic phase, at high cardiac output regime, highlighting the different flow field features downstream of the four small-sized cardiac valves.

Aortic Valve↗

19 mm sized bileaflet valve prostheses' flow field investigated by bidimensional laser Doppler anemometry (part II: maximum turbulent shear stresses)

The investigation of the flow field generated by cardiac valve prostheses is a necessary task to gain knowledge on the possible relationship between turbulence-derived stresses and the hemolytic and thrombogenic complications in patients after valve replacement. The study of turbulence flows downstream of cardiac prostheses, in literature, especially concerns large-sized prostheses with a variable flow regime from very low up to 6 L/min. The Food and Drug Administration draft guidance requires the study of the minimum prosthetic size at a high cardiac output to reach the maximum Reynolds number conditions. Within the framework of a national research project regarding the characterization of cardiovascular endoprostheses, an in-depth study of turbulence generated downstream of bileaflet cardiac valves is currently under way at the Laboratory of Biomedical Engineering of the Istituto Superiore di Sanita. Four models of 19 mm bileaflet valve prostheses were used: St Jude Medical HP, Edwards Tekna, Sorin Bicarbon, and CarboMedics. The prostheses were selected for the nominal Tissue Annulus Diameter as reported by manufacturers without any assessment of valve sizing method, and were mounted in aortic position. The aortic geometry was scaled for 19 mm prostheses using angiographic data. The turbulence-derived shear stresses were investigated very close to the valve (0.35 D0), using a bidimensional Laser Doppler anemometry system and applying the Principal Stress Analysis. Results concern typical turbulence quantities during a 50 ms window at peak flow in the systolic phase. Conclusions are drawn regarding the turbulence associated to valve design features, as well as the possible damage to blood constituents.

Aortic Valve↗

Electromagnetic interference of analog cellular telephones with pacemakers.

The aim of this study was to verify whether there is a public health risk from the interference of analog cellular telephones with pacemakers. We used a human trunk simulator to reproduce an actual implant, and two cellular telephones working with the TACS (Total Access Communication System) standard. Results showed that the electromagnetic field radiated from the analog cellular telephones interfered with a large number of the pacemakers tested (10/25). When the telephone antenna was in close proximity to the pacemaker head, pacemaker desensitizing and sensitizing and pulse inhibition was detected at the moment of an incoming call and throughout ringing. In the worst case of pulse inhibition, the pacemaker skipped three nonconsecutive beats and then resumed its normal pacing, while the desensitizing and sensitizing phenomena persisted as long as the interfering signal was on. Pulse inhibition was also observed when the connection did not succeed. Maximum sensing threshold variation was about 186% (increase) and 62% (decrease) for desensitizing and sensitizing phenomena, respectively. It was also demonstrated that the signal emitted by analog cellular telephones during the crossing of contiguous cells could induce pacemaker pulse inhibition, but under our experimental conditions this event did not seem to pose a risk for the pacemaker patient.

Electromagnetic Fields↗

A simplified system to develop precision master models.

Master model construction using a plexiglass base is a procedure used in many dental laboratories. The following technique uses the Compact System to create a precision master model. This system is functionally superior to pour and base techniques because of its improved precision, better placement and improved cleanliness of the holes that receive the dowel pins.

Dental Casting Technique↗

Evaluation of tilting disc valves after fatigue life testing: preliminary results within a comparison program.

A fatigue life test, by accelerating the beat rate, simulates several years of virtual life of a prosthetic heart valve in a short period of time. The correlation between the in vivo life of a valve and in vitro testing expectations is as yet not well established, but reproducible test conditions yield precious information about wear and failure. The paper reports a qualitative analysis of mechanical valve wear as part of a comparison program designed to investigate the significance of fatigue testing with the ultimate aim of defining standard guidelines for these type of tests. Two tilting disc valves (29 mm) were subjected to 16 years of fatigue life simulated by means of a Rowan Ash fatigue tester (accelerated rate of 1,200 bpm). Fatigue-induced effects on valve disc and ring surfaces were observed under a monitor microscope to identify wear sites and patterns. A high speed cinematographic system was used to investigate the mechanisms responsible for the wear (wear modes). Valve closure was inspected at a 6,000 frame/s rate. Because of disc rotation during the tilting movement, the points of contact between disc and ring are distributed all around the disc edge but focally on the ring. On both sides of the disc, the surfaces present ring-like concentric grooves. After 16 years of fatigue life the valves showed neither severe wear nor alteration of their fluidodynamic behavior in the pulsatile flow test.

Biomechanical Phenomena↗

Do European GSM mobile cellular phones pose a potential risk to pacemaker patients?

A series of in vivo trials were carried out in order to verify whether the electromagnetic field radiated by GSM (Groupe Systemes Mobiles) mobile cellular phones might affect implanted pacemakers. Two European GSM phones of 2-watt power were tested and trials conducted on 101 pacemaker implanted outpatients attending day hospital for routine check-up, who volunteered for trials. Forty-three pacemaker models from 11 manufacturers were tested in all. When the sensing threshold of the pacemakers was set at a minimum and the antenna of the phone was in direct contact with the patient's chest, interference was detected for 26 implanted pacemakers. Specifically, pulse inhibition in 10 of 101 cases, ventricular triggering in 9 of 46 DDD-VDD pacemakers, and asynchronous pacing in 4 of 52 devices. Pulse inhibition was also observed combined with asynchronous pacing in 1 of 52 cases and with ventricular triggering in 2 of 46 cases. Minimum effect duration was ca. 3 seconds but in 6 cases effects continued as long as the interfering GSM signal was on. No permanent malfunctioning or changes in the programmed parameters were detected. Whenever interference was detected, trials were repeated to determine the maximum sensing threshold at which interference persisted (with the antenna in contact with the skin over the pacemaker). Then maximum distance between antenna and pacemaker at which interference occurred was determined at pacemaker maximum and minimum sensing threshold. Under our experimental conditions electromagnetic interference effects were detected at a maximum distance of 10 cm with the pacemaker programmed at its minimum sensing threshold.(ABSTRACT TRUNCATED AT 250 WORDS)

Electricity↗

New algorithm for the detection of the ECG fiducial point in the averaging technique.

The use of the coherent averaging technique applied to the electrocardiographic signal implies the location of a fiducial point as a synchronisation reference. An algorithm easily adaptable to a personal computer, operable in real time, insensitive to mains and to ECG-baseline fluctuations, with a low jitter value and the capacity to trigger any ECG signal wave or complex, has been developed. The algorithm detects those waveforms which, within certain confidence intervals, are morphologically equal to a reference wave. This wave is chosen by the user as the repetitive waveform within which the fiducial point is to be located. A two-window template and differential parameters are used. The possibility of building the template permits the user to adapt the algorithm to each patient's ECG. To evaluate its accuracy objectively, a software simulation was built of a generator capable of producing test signals as the sum of the 'useful' signal plus 'noise'. A jitter standard deviation of 1.65 ms was obtained in the worst test (SNR = 10 dB; noiseband = 0-50 Hz), which shows the excellent recognition accuracy of the algorithm.

Algorithms↗

Prosthetic heart valve evaluation in vitro: critical aspects of data comparability.

The technology of heart valve substitution has considerably improved in the last few years, but its reliability after implantation is still not good enough, hence the need to study new valve design and improve quality testing. Different pulse duplicators are used for heart valve testing, but the results depend very much on the system adopted and the measurement protocol. Tests on two pulse duplicators currently used at the Biomedical Engineering Laboratory at the Istituto Superiore di Sanità, Rome, are reported here. The most significant parameters for valve evaluation were measured following each system's own protocol. Attention was focused on vascular load tuning when setting up the system and on the relationship between drive unit flow waveform and valve regurgitation and energy loss measurements. Standardization criteria must be defined in order to ensure the reliable comparability of in vitro testing results.

Coronary Circulation↗

Pacemaker registration electronic-card. A proposal for a computerised system of storing of the pacemaker registration card.

This paper describes an example of a computerised system dedicated to store an Emergency Health Card into a compact and portable memory support such as the CMOS RAM CARD. Details are given from the system used and of the program developed for this task. In particular, patient, pacemaker and lead data are stored by the prototype system. The acquisition layout is similar to that of the European pacemaker registration card but some other sections are added. The possibilities of an introduction of a card system like this on E.E.C. countries is discussed.

Computer Systems↗

Implant effects on polyurethane and silicone cardiac pacing leads in humans: insulation measurements and SEM observations.

Recently, polyurethane cardiac pacing leads have been under discussion because of some failures, probably due to modification of surface insulating properties. In order to verify the reliability of polyurethane versus silicone rubber as coating material, the authors, starting from previous clinical research, have carried out a study of electrical insulation related to implant time. At the same time the outer and inner lead surfaces have been submitted to scanning electron microscope (SEM) analysis. The results show, for the polyurethane leads, a significant increase in the leakage or currents in explanted samples, and a significant degradation (cracking) of the outer surfaces.

Electric Conductivity↗

In vitro evaluation of prosthetic heart valves: towards comparable testing.

The Laboratory of Biomedical Engineering (of the National Health Institute, technical body of the Italian Health Service) performs in vitro testing of prosthetic heart valves for mechanical characteristics of materials, fatigue life, and fluidodynamic performance. Testing of materials is directed towards the physicomechanical characterization of the structural components of the valves, e.g. elasticity and resistance to stress of biological tissues and stents. Long-term fatigue life tests are conducted by means of systems which make valves beat at more than 1200 cycles/min. These tests are preceded and followed by geometrical characterization and by steady flow testing in order to obtain information about stenosis and leakage. Special attention is devoted to pulsatile flow testing which is performed on two pulse duplicators: the Dynatek system and the system developed by the University of Sheffield. The same valve was tested with these systems according to their different possible set-ups within the general requirements established by ISO-DIS 5840. This paper presents significant measurements, taking into account their dependence on the systems adopted. Results show (a) the difficulties in comparing test results because of different operating conditions, and (b) the systems' sensitivity with regards to some parameters which affect measurements under comparable set-up conditions (FDA Interlaboratory Comparison Testing Protocol).

Biomechanical Phenomena↗

Approaching comparability and results of pulsatile flow in vitro testing of prosthetic heart valves.

The testing of prosthetic heart valves under pulsatile conditions is still a subject for debate among researchers and competent standardization bodies. The laboratory of Biomedical Engineering, of the Istituto Superiore di Sanità in Rome, has reproduced the current inter-laboratory situation with several test apparatuses, focusing on the definition of significant measurement parameters and procedures to obtain reasonably comparable data. The laboratory is also equipped with a Laser Doppler Anemometer (LDA) and a High-Speed Cinematographic system (HSC). A 29 mm tilting disc valve model, was mounted in the aortic position. Under tightly controlled system conditions the analyses performed on two pulse duplicators (PDs) may be deemed consistent for the valve model tested. Useful results, on the same valve specimen, are reported concerning velocity profiles and turbulent shear stress values (TSS). Furthermore valve motion on the Sheffield PD was monitored during the closing phase, and related cinematic data reported. The applied methodologies can provide relevant data to support surgeon decision making.

Aortic Valve↗

Electromagnetic interference by GSM cellular phones and UHF radios with intensive-care and operating-room ventilators.

The aim of this study was to evaluate the risks deriving from the interference by radio handsets (GSM cellular phones and UHF radios) with intensive-care and operating-room ventilators. Tests were conducted in three hospitals in Rome on 22 lung ventilators in accordance with the recommended practice ANSI C63.18-1997. When electromagnetic interference (EMI) effects occurred, the authors determined maximum interference distances. They also evaluated the distances at which the use of a given handset would result in a 5% and a 95% probability of interference. The degree of risk posed by each observed event was estimated, and safe distances are suggested. EMI events of varying degrees and natures were observed even with transmitters placed at a considerable distance. All observed effects were temporary. Only three ventilators of a certain model stopped working altogether and had to be reset.

Electromagnetic Fields↗