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PubMed1995

Development of a microporous compliant small bore vascular graft.

PURPOSE: To produce biodurable small diameter microporous vascular grafts with self-sealing properties for vascular access, for peripheral vascular and potentially for coronary artery bypass. The prosthesis should retain compliance and pulsatile flow in situ using a unique modus operandi permitting wall compression which accommodates changes in volume. METHOD: We have utilized efficient low temperature coagulation technology to develop a unique range of small diameter microporous vascular grafts using ChronoFlex, a biodurable polycarbonate urethane. RESULTS: Grafts have been subjected to a range of in vitro and in vivo testing, demonstrating excellent physical and mechanical characteristics, self-sealing, maintenance of compliance and pulsatile flow in situ and patency up to twenty-two weeks.

Animals↗
PubMed2001

Reliable long-term non-pulsatile circulatory support without anticoagulation.

OBJECTIVE: The Terumo implantable left ventricular assist system (T-ILVAS) consists of a titanium centrifugal pump with a unique magnetically suspended impeller producing continuous (non-pulsatile) flow up to 10 l/min. The interior surface is heparin-coated and there is no purge system. We implanted the device into six sheep to ascertain in-vivo haemodynamic function, mechanical reliability and biocompatibility. METHODS: The T-ILVAS was implanted via left thoracotomy without cardiopulmonary bypass. The inflow cannula was placed in the left ventricular apex and a Dacron outflow graft anastomosed to the descending aorta. All animals recovered well. No anticoagulation (heparin or warfarin) was given after the surgery. Suspension position, motor current, impeller speed and pump flow were continuously monitored and stored by on-line computer. Serial blood samples were collected to determine haematological and biochemical indices of renal function, liver function and haemolysis. All animals were electively euthanized between 3 and 7 months postoperatively. The explanted pumps were examined for mechanical reliability and thrombus formation. Major organs were examined macroscopically and histologically for thromboembolism. RESULTS: All animals appeared completely normal for up to 210 days. At speeds between 1500 and 2000 rev./min the device pumped up to 8 l/min capturing all mitral flow. There were no major complications (pump failure, thromboembolism, haemorrhage, or driveline infection). Indices of haemolysis, liver and renal function remained within normal limits. All pumps were mechanically sound and free from thrombus. One embolus was found in a sectioned kidney. CONCLUSION: The T-ILVAS successfully supported the systemic circulation without anticoagulation for up to 210 days. Mechanical reliability and biocompatibility were demonstrated. Organ function remained within normal limits during continuous non-pulsatile flow.

Animals↗
PubMed2001

New pulsatile bioreactor for fabrication of tissue-engineered patches.

To date, one approach to tissue engineering has been to develop in vitro conditions to ultimately fabricate functional cardiovascular structures prior to final implantation. In our current experiment, we developed a new pulsatile flow system that provides biochemical and biomechanical signals to regulate autologous patch-tissue development in vitro. The newly developed patch bioreactor is made of Plexiglas and is completely transparent (Mediport Kardiotechnik, Berlin). The bioreactor is connected to an air-driven respirator pump, and the cell culture medium continuously circulates through a closed-loop system. We thus developed a closed-loop, perfused bioreactor for long-term patch-tissue conditioning, which combines continuous, pulsatile perfusion and mechanical stimulation by periodically stretching the tissue-engineered patch constructs. By adjusting the stroke volume, the stroke rate, and the inspiration/expiration time of the ventilator, it allows various pulsatile flows and different levels of pressure. The whole system is a highly isolated cell culture setting, which provides a high level of sterility, gas supply, and fits into a standard humidified incubator. The bioreactor can be sterilized by ethylene oxide and assembled with a standard screwdriver. Our newly developed bioreactor provides optimal biomechanical and biodynamical stimuli for controlled tissue development and in vitro conditioning of an autologous tissue-engineered patch.

Biocompatible Materials↗
PubMed2002

Method to correct for the effects of limited spatial resolution in phase-contrast flow MRI measurements.

Phase-contrast (PC) magnetic resonance imaging (MRI) flow measurements suffer from the effect of the point spread function (PSF) due to the limited sampling of k-space. The PSF, which in this case is a sinc function, deforms the flow profile and forms a ringing pattern around the vessel. In this work, an empirical method is presented that corrects for errors due to the deformation of the flow profile. The ringing pattern is used to obtain a well-defined vessel segmentation, which after correction provides more accurate vessel radius and volume flow rate (VFR). The correction method was developed from phantom measurements at constant flow and applied on phantom measurements at moderately pulsatile flow. After correction, the error of the estimated tube radius and the VFR was less than 10% and 5%, respectively. Corresponding errors without correction overestimated the radius by 60% and the VFR by 35%. Preliminary results indicate that the method is also valid in vivo. The variation in the estimated radius and VFR for different spatial resolution decreased when the method was applied. The presented method gives a more accurate estimation of the radius and VFR in vessels of the size of a few pixels without prior knowledge about the true vessel radius.

Blood Flow Velocity↗
PubMed1995

In vitro evaluation of a pulsatile assist device for a centrifugal pump using a new principle.

To induce a pulsatile flow in a centrifugal pump, we developed a new device (pulsatile assist device for centrifugal pump: PADCP) using a new concept. This device consists of a flexible polyurethane tube with an air chamber which is connected to the arterial side of the centrifugal pump circuit directly. A mock circulation system was used for evaluation of this PADCP. Thirty to 40 mm Hg of pulse pressure was obtained under 3-6 L/min of flow rate. By increasing the driving pressure of the PADCP from 200 to 600 mm Hg in a mock system, 4-48 mm Hg of pulse pressure was gained accompanied by a decrease in pump flow and increased left atrial pressure. The decreased pump flow and increased left atrial pressure were recovered easily by increasing the flow rate of the centrifugal pump. Pressures at the proximal site of the PADCP were less than 500 mm Hg. The PADCP was useful to induce a pulsatile flow in a centrifugal pump.

Blood Flow Velocity↗
PubMed2000

Ultrasonic determination of clot deposition rates in a milk-based, in-vitro procedure for thrombogenicity assessment.

BACKGROUND AND AIM OF THE STUDY: Thrombosis and thromboembolism remain the main problems associated with mechanical heart valves. We have devised a milk-based clotting technique to simulate in-vitro clinical incidence of thrombosis. Early results with the technique revealed good correlation between milk clot deposition and clinical thrombosis, but were limited in their ability to predict the course of clot deposition, as deposition could only be measured upon dismantling the apparatus. METHODS: Clot deposition was observed ultrasonically for both steady and pulsatile flows of a milk preparation through a cylindrical test chamber containing axisymmetric test bodies similar in shape to those used in earlier studies of thrombosis. Echo ultrasound images were recorded at regular time intervals, depicting the interface between clot deposits and flowing milk. From these images, the thickness of the clot deposit could be determined as a function of time. RESULTS: Milk clot deposition on the test bodies, while observed, could not be measured accurately due to faint reflections arising from significant differences between the angle of incidence and the angle of reflection of the ultrasound beam. However, measurement was possible at the wall of the test chamber where deposition rates revealed steady growth of clot, following an initial 'lag', with growth continuing until a maximum thickness is reached. In some experiments shedding of parts of the deposit was observed. In pulsatile flow, wall clot deposition rates and final clot thickness attained were significantly lower than in steady flow. CONCLUSION: Ultrasonic measurement of clot deposition rates is possible in our thrombogenicity assessment apparatus on surfaces perpendicular to the line of incidence of the ultrasound beam. With suitably designed viewing windows in an artificial heart, such measurements should enable the time course of clot deposition on artificial valves to be determined, with a view to identifying initial deposition sites and the dynamics of clot growth. Observations of the growth of clot on the test chamber wall in this study suggest that both the rate of deposition and nature of deposit formed are strongly influenced by fluid mechanical properties such as shear and mass transfer rates. In particular, our results appear to suggest a different structure of deposit, whose rate of deposition is relatively slow, under conditions of high shear.

Animals↗
PubMedDate not supplied

[Diastolic dysfunction in patients with chronic kidney failure on a hemodialysis program].

OBJECTIVE: The aim of this study was to analyse different ultrasound parameters for the assessment of isolated left ventricular diastolic dysfunction (LVDD) in patients with chronic renal failure (CRF) on periodic hemodialysis (HD), comparing pulsed wave Doppler with pulsed tissue Doppler. MATERIALS AND METHODS: Forty-seven patients with CRF on HD (61% were male; mean age was 51.0 +/- 16.5 years, mean HD time--3.7 +/- 3.8 years, 38% had hypertension, 17% had diabetes) were studied by echocardiography (bidimensional, M-Mode, flow pulsed Doppler and tissue Doppler imaging). All patients had symptoms of left heart failure-class II NYHA, were in sinus rhythm and had no symptoms of ischemic heart disease. The presence of abnormal LV regional contractility was the exclusion criteria. According to their mitral inflow profile Doppler characteristics, patients were included in two groups: Group A (E/A > 1; n = 21) and B (E/A < 1; n = 26). We compared: LV dimensions and function, left atrial (LA) dimension. Gaasch index, LV mass index. E and A wave velocities (in flow pulsatile Doppler and tissue Doppler). E/N ratio in tissue Doppler, isovolumetric relaxation time (IVRT) and deceleration time (DT). RESULTS: There were no significant differences in the prevalence of age > or = 65 years male sex, hypertension or diabetes between group A and B patients, and almost all patients were on hemodialytic treatment for more than one year (81% vs 85%: NS). LV hypertrophy was present in almost all group A and B patients (A--95% vs B--85.5%; NS). Group A, compared with group B, had a difference in the Gaasch index (2.45 +/- 0.3 vs 2.08 +/- 0.4; p < 0.05), E wave velocity in flow pulsatile Doppler and tissue Doppler (cm/sec) (110 +/- 27 vs 62 +/- 20; p < 0.001 and 41 +/- 15 vs 28.5 +/- 16; p < 0.05), E/A ratio in tissue Doppler (1.3 +/- 0.4 vs 0.8 +/- 0.3; p < 0.001). IVRT (msec) (80.7 +/- 15.2 vs 113.5 +/- 28.3; p < 0.001) and DT (msec) (189.7 +/- 24 vs 278.2 +/- 17.9; p < 0.001). According to the E'/A' ratio in tissue Doppler, group A patients were divided in another two groups: E'/A' > 1 (13/21--62%) and < 1 (8/21--38%) and a significantly longer IVRT (75.8 +/- 9.3 vs 100.9 +/- 3.2; p < 0.001) and DT (178 +/- 15 vs 240 +/- 20; p < 0.001) and a greater LA dimension (37.6 +/- 6.9 vs 44.6 +/- 6.9; p < 0.05) were found. CONCLUSIONS: Pulsed wave Doppler is the most useful non invasive method for assessment of global diastolic dysfunction. In our study, 17% of the patients had E/A < 1 only in the tissue Doppler study. These patients probably had a pseudonormal mitral pattern.

Adult↗
PubMed1989

Jamming of prosthetic heart valves by suture trapping: experimental findings.

The vulnerability of the Medtronic-Hall, Björk-Shiley Monostrut, Duromedics, and St. Jude Medical valves to occluder immobilization by sutures was determined under static and pulsatile flow conditions. Variables were cardiac output, cross-sectional diameter of suture, type of suture (braided versus monofilament) and position of the offending suture along the circumference of the valve ring. Under static conditions, pressures, ranging from 40 to 340 mmHg and 10 to 170 mmHg, were required to decompress obstructed Medtronic-Hall and Björk-Shiley Monostrut valves, respectively. As a result of different design characteristics and different occluder/orifice clearances the Medtronic-Hall valve showed its maximum opening pressure in case of interference with sutures at the axis of symmetry in both minor and major orifices, whereas for the Björk-Shiley Monostrut valve this was reached in the minor orifice. Under pulsatile flow conditions, in case of interference with Prolene 2-0 suture, the Duromedics valve showed irregularly delayed opening and an opening pressure difference of 50 mmHg at a cardiac output of 8 L/min, whereas leaflet motion and pressure difference in the St. Jude Medical valve were undisturbed under similar conditions. The necessary pressure difference for opening the Medtronic Hall valve reached 44mmHg at a cardiac output of 8 L/min. High and low risk of extrinsic leaflet obstruction in the Duromedics and St. Jude Medical valves, respectively, is related to the design of the hinge mechanisms and the wedge angle of their leaflets (2 degrees versus 25 degrees). Precautionary principles in implantation of prosthetic heart valves are stressed to prevent the potentially lethal complication of occluder immobilization.(ABSTRACT TRUNCATED AT 250 WORDS)

Equipment Failure↗
PubMed1986

Comparison of CW Doppler ultrasound spectra with the spectra derived from a flow visualization model.

The methods and results of a study to determine the accuracy of continuous wave (CW) Doppler spectral recordings by comparison to the spectra derived from the flow profiles photographed simultaneously in a pulsatile flow visualization model are reported in this paper. A pulsatile pump produced a flow velocity waveform, similar to that seen in the human femoral artery, in a quartz glass tube. The velocity profiles, which were made visible by using a photochromic dye/laser technique, were photographed, and at the same time the instantaneous Doppler spectra were recorded. A comparison of the Doppler data and the photographed profiles gave the following results. The Doppler spectrograms and those reconstructed from the flow visualization data were quite similar. Excellent agreement was observed between the instantaneous maximum and mean Doppler waveforms. Individual spectra showed some differences and these differences were quantified by the novel application of certain statistical shape descriptor coefficients that are based on the estimation of the higher order moments of the spectra. The Doppler spectra are generally more skewed towards higher frequencies, narrower, and more peaked than the flow visualization spectra. Analysis of the assumptions and various sources of error lead to the conclusion that the differences were probably caused by ultrasound beam nonuniformity and the effects of refraction, causing a reduction of the beam field response at the tube edges. It is concluded that provided certain precautions are taken in the measurement technique, the CW Doppler ultrasound spectra fairly accurately represent the true velocity profile.

Blood Flow Velocity↗
PubMed2002

Early experience with a new technique and technology designed for the study of pulsatile cardiopulmonary bypass in the rat.

The benefits of pulsatile flow during the period of cardiopulmonary bypass (CPB) applied during open-heart surgery remains controversial. We have developed a rodent (rat) model of CBP that has been designed to functionally mimic the clinical setting, principally, but not solely, for the study of pulsatile CPB. The successful development of this model centres on the design of the bypass circuitry and the surgical approach employed. The entire circuit is similar to clinical equipment in terms of its construction, configuration, performance, material surface area to blood volume ratio, and priming volume to blood volume ratio. The overall priming volume of the perfusion circuitry is less than 12 ml. Early studies confirm that the pumping technology functions well, gas exchange was adequate at all times, and blood pressure exhibited a normal CPB profile and haemodynanmic response to pulsatile blood flow. We conclude that this is an effective tool for investigating the pathophysiology of pulsatile blood flow during CPB.

Animals↗
PubMed2002

The ABCs of research on pulsatile versus nonpulsatile perfusion during cardiopulmonary bypass.

The literature suggests that pulsatile flow should be routinely used during cardiopulmonary bypass (CPB) in moderate- to high-risk cardiac surgery patients, especially those who must undergo more than 45 minutes of aortic crossclamping. Nevertheless, the use of pulsatile versus nonpulsatile perfusion remains controversial, mainly owing to a lack of precise, complete quantification of pressure-flow waveforms. This editorial briefly summarizes the major factors, or 'basic ABCs, ' that affect the validity of research in this area. A. Because pulsatile flow depends on an energy gradient, investigators must quantify the difference in the hemodynamic energy levels produced by specific pulsatile and nonpulsatile pumps before meaningful direct comparison of these two perfusion modes can be possible. B. The energy equivalent pressure (EEP) formula should be used for this purpose. C. In conducting clinical trials of the perfusion modes, researchers must use appropriate patient-selection criteria, use pulsatile flow continuously during CPB, and choose extracorporeal-circuit components carefully. By following these basic ABCs, researchers will produce more valid and meaningful results that will translate into better outcomes for CPB patients.

Cardiac Surgical Procedures↗
PubMed1997

Behavior of nitric oxide infused at constant flow rates directly into a breathing circuit during controlled mechanical ventilation.

OBJECTIVES: This study was designed to test the hypothesis that the practice of infusing nitric oxide at constant flow rates directly into breathing circuits with intermittent (pulsatile) flow can lead to streaming and tidal pooling of the nitric oxide. This study was also designed to show the extent to which streaming and tidal pooling of nitric oxide affect nitric oxide delivery. DESIGN: A series of five in vitro experiments was performed. For each experiment, either one or two features of the nitric oxide delivery/sampling system were varied, and the effects of these variations were evaluated with regard to measured nitric oxide concentration changes. The results from each experiment were analyzed using either one- or two-factor analysis of variance. SETTING: University research laboratory. SUBJECTS: Breaths were provided by a mechanical ventilator that was connected to a lung model. A standard, corrugated, adult breathing circuit was used. Gas samples were obtained from either the lung model's bellows or selected sites within the breathing circuit. Nitric oxide concentrations were measured, using an electrochemical gas analyzer. INTERVENTIONS: The system features that were varied included the cross-sectional position of the sampling site within the breathing circuit, the distance between the infusion port and the sampling site, the breathing frequency, the distance between the Y-piece and the infusion port, and the airway (deadspace) volume. MEASUREMENTS AND MAIN RESULTS: Streaming of nitric oxide within the breathing circuit was detected as far as 25 cm downstream of the infusion site (p < .0001). Pooling of nitric oxide was detected both near and downstream of the infusion site (p < .0001). Increasing the breathing frequency from 5 to 30 breaths/min increased mixing thoroughness (p < .005). Increasing the distance between the Y-piece and the infusion port from 15 to 180 cm decreased nitric oxide delivery to our lung model (p < .0001). Interestingly, increasing airway (deadspace) volume from 150 to 450 mL decreased nitric oxide delivery to our lung model (p < .0001). CONCLUSIONS: Estimates of nitric oxide delivery using a constant flow rate of nitric oxide infused directly into a breathing circuit during controlled mechanical ventilation can be confounded by streaming and tidal propagation of nitric oxide pools. Improved reproducibility of reported dose-response relationships is likely to be achieved through further study of nitric oxide behavior within the breathing circuits. Reduced toxicity associated with nitric oxide inhalation may also be achieved through a better understanding of this nitric oxide behavior.

Administration, Inhalation↗
PubMedDate not supplied

Pulsatile ECMO in neonates and infants: first European clinical experience with a new device.

This study presents the first European clinical experience with the Medos DeltaStream DP1, a new pulsatile flow pump, in neonates and infants. Between January 2002 and December 2004, 420 patients at our institution underwent congenital heart surgery on cardiopulmonary bypass. During this period, 10 patients required extracorporeal membrane oxygenation (ECMO) support for acute postcardiotomy heart failure. Seven patients (median age 7 days, range 1-70 days), were supported by a nonpulsatile Biomedicus centrifugal pump, whereas three patients (aged 1 month, 1 year, and 12 years) were supported by a pulsatile Medos DP1. The DP1 is an extracorporeal rotary blood pump. The pump features a diagonal-flow impeller, and can be used for both continuous and pulsatile output. Special characteristics include a small priming volume of approximately 30 ml and a high pumping capacity. A temperature sensor and speed sensors are integrated in the pump. The pump has a delivery rate of up to 8 l/min and a speed range of 100-10,000 rpm. Overall mortality was 40% (4 of 10 patients), and all four deaths were in the nonpulsatile Biomedicus group. In the nonpulsatile group, the median support duration was 95 hours with a range of 48-140 hours. Two patients assisted with the pulsatile pump system were successfully weaned after 36 and 53 hours, respectively; the 12-year-old patient was successfully transplanted on the eighth postimplant day and discharged from the hospital on the 32nd posttransplant day. Although this preliminary experience doesn't allow for statistical analysis, clinically it was possible to observe a better performance in pulsatile flow recipients with faster lactate recovery, reduced need for inotropic support, reduced assistance duration in bridge-to-recovery settings, and smoother intensive care management. ECMO for postcardiotomy heart failure in neonates and infants still carries high mortality and morbidity rates. Pulsatile flow with the Medos DeltaStream DP1 pump system improves results by producing more physiologic hemodynamics, reducing the duration of support in the case of bridge to recovery, and improving end-organ function.

Body Surface Area↗
PubMed1994

Interleaved echo planar flow quantitation.

A method is presented for rapid blood flow quantitation. It combines multiple shot echo planar imaging principles with phase contrast velocity encoding gradients. Preliminary validation experiments performed on a flow phantom indicate a good correlation with actual flow values. Measurements of pulsatile flow in the ascending and descending aorta, acquired in just 4 s, with a temporal resolution of 50 ms, are demonstrated.

Aorta↗
PubMed1983

Spectrophotometric investigation of pulsatile blood flow for transcutaneous reflectance oximetry.

A new method to estimate arterial oxygen saturation is suggested based on the presence of the plethysmographic pulse. A prototype skin reflectance oximeter system utilizing a miniature solid state optical transducer has been constructed. Preliminary data collected from a group of volunteers indicated good quantitative correlation between skin reflectance and arterial oxygen saturation as determined by an earlobe oximeter. We are now investigating the dependency of the measurements on various physiological conditions and skin characteristics in order to determine appropriate calibration procedures. This study has demonstrated for the first time that arterial hemoglobin oxygen saturation can be measured quantitatively using transcutaneous reflectance techniques. However, more extensive work is needed to further develop this technique into a viable clinical tool.

Humans↗