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Biomedical subjects

G Rakhorst

Publications and source records attributed to G Rakhorst.

At least 19 recordsLinked to original sources

A novel tracheal tissue connector for fixation of laryngeal prostheses.

A tissue connector (TC), basically consisting of a ring that will be integrated into the trachea, is under development to study the fixation of laryngeal prostheses. Two experiments have been performed to test the TC in goats. In experiment 1, a polypropylene mesh was implanted around the trachea. The meshes were explanted after 6 and 12 weeks. In experiment 2, the actual TC consisted of two titanium rings (inner ring and outer ring) executed as quarter rings, fixed on each other, and a polypropylene mesh like a sandwich in between. The titanium inner ring was implanted between two tracheal rings thus penetrating the trachea with the mesh around the trachea and the fixed titanium outer ring on the outside of the trachea. The TCs were removed after 12 weeks. Experiment 1 showed that the mesh was entirely infiltrated by host tissue. Inflammatory cells and high vascularisation were observed in 3 of 4 implants. However, in experiment 2, the mesh was completely incorporated by mature connective tissue without inflammation reaction. At some areas, deposition of cartilage tissue was observed. In conclusion, the TC was firmly embedded in the trachea thus being appropriate for its intended use.

Animals↗

Flow analysis in vascular shunts that bypass the carotid artery.

When blood flow through a carotid artery is impaired and vascular surgery is necessary to restore adequate circulation a vascular shunt can be applied to maintain cerebral blood flow. Several vascular shunts are commercially available, but there is only limited test data on their flow capacity. The purpose of this study is to determine the flow capacity of three vascular shunt systems. A theoretical model has been developed for this purpose. To validate the model, in vitro flow measurements were taken. Application of the model showed that all shunts cause a decrease in blood flow. The amount of flow decrease varied widely from 13% (Javid shunt) to 55% (Pruitt-Inahara). In vitro measurements confirmed the validity of the model. In conclusion, it is important for the vascular surgeon to realise that vascular shunts show large differences in flow capacity. Of the three investigated shunts, the Javid has the highest flow capacity.

Arteriovenous Shunt, Surgical↗

Assessing medical technologies in development. A new paradigm of medical technology assessment.

OBJECTIVE: Our study aims to provide a practical contribution to the field of medical technology assessment within a new paradigm. This paradigm indicates the need for more comprehensive technology assessments in the development stage of a new technology. METHOD: We introduce a method, based on Saaty's Analytic Hierarchy Process, which quantitatively supports discussions between the various actors that shape the technology's development and diffusion. These discussions focus on technical, medical, social, and economical requirements relevant to the design and diffusion of the new technology. DISCUSSION: In contrast to more traditional technology assessments, our method encompasses the perspectives of the diverse actors in the social context of technology development and diffusion. It influences their decision making on technology design and diffusion in order to improve this technology's later clinical as well as social effectiveness.

Decision Support Techniques↗

Design and test of a vascular access device.

Transarterial left ventricular assist devices (LVADs), such as the Hemopump, IABP, and PUCA-pump, are meant to be introduced into the body via the femoral or axillary artery without major surgery. For certain applications, introduction is performed directly into the aorta via an open thorax procedure. A prototype of a vascular access device has been realized that allows direct access into the aorta as an alternative for the common surgical graft anastomosis suturing technique. The device consists of a metal tube acting as a circular knife to cut a hole in the aortic wall, a screw to store the removed part of the aortic wall, and a plastic tube that is introduced through the hole and tightly connected to the aortic wall. The device could be placed without aortic clamping. The device has been tested on a slaughterhouse porcine aorta. A low-pressurized aorta appeared to be the worst case; thus, two animal experiments in the low-pressurized pulmonary artery were performed. No leakage occurred for pressures between 40 and 300 mm Hg.

Anastomosis, Surgical↗

Development of an animal model of selective coronary atherosclerosis.

BACKGROUND: Atherosclerosis causes over 40% of all deaths in the USA and Western Europe. Although several hypotheses have been proposed, the etiology and pathogenesis of the atherosclerosis remain unknown. OBJECTIVE: To develop a model of selective coronary atherosclerosis in pigs. DESIGN: An animal model of selective coronary atherosclerosis was developed by combining a guide-wire-induced endothelial injury and cholesterol-enriched diet. METHODS: Twelve pigs were subjected to guide-wire-induced injury to endothelium of left anterior descending (LAD) coronary artery. Six animals (control group) were fed a standard pig food; the remaining six animals (cholesterol group) were fed a 6%-cholesterol-enriched diet. Three animals from the control group were killed immediately after the endothelial injury (acute control group). The other three animals in the control group (chronic control group) and all animals in the cholesterol-fed group were killed 4 weeks after the injury. RESULTS: The endothelial surface and the media of the left circumflex coronary artery LCX in all animals were intact. Long eccentric areas of endothelial injury were found in the LAD coronary arteries of animals in the acute control group. Numerous fibrous atherosclerotic plaques in LAD coronary arteries were found in animals in the chronic control group as well as in animals in the cholesterol-fed group, but were highly pronounced in animals in the last group. No accumulation of lipids was found in the plaques of animals in both groups. CONCLUSIONS: Administration of a 6%-cholesterol diet for 6 weeks is not sufficient to cause coronary atherosclerosis in pigs. Selective coronary atherosclerosis can be induced within 4 weeks with the same diet when the blood vessel has been injured with a guide wire.

Animals↗

Development of acute ischemic heart failure in sheep.

The goal of the present study was to develop a large animal model of acute ischemic left ventricular heart failure (LVHF) that can be used to assess the influence of the PUCA pump on the heart and circulatory system under realistic conditions. We tested the hypothesis that mild stenosis of the coronary artery in combination with mild ventricular pacing induces an acute heart failure condition, whereas the separate phenomena themselves do not lead to impaired heart function. Mean aortic pressure (AoP), left ventricular end-diastolic pressure (LVEDP), stroke volume (SV) and myocardial systolic shortening (MSS) were compared 30 minutes after a pacemaker (PM) induced tachycardia in anaesthetized sheep (n=3) without and with +/- 50% stenosis of the proximal LCx. All parameters measured restored to basic levels when stenosis was absent. When the LCx was partially occluded, mild PM-induced tachycardia resulted in decreased AoP (P=0.045) as well as in decreased SV (P=0.048); the LVEDP remained high (P=0.002). Also the recovery of MSS was impaired when stenosis was present (P=0. 002). These values indicate that acute heart failure conditions were present. The technique used proved to be safe and allowed fine-tuning of the demand ischemia by adapting heart frequency to the required heart failure conditions. The model can be used to study the effect of LV mechanical support during acute heart failure conditions.

Acute Disease↗

In vivo and in vitro experience with the PUCA-II, a single-valved pulsatile catheter-pump.

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.

Animals↗

Numerical simulation of the influence of a left ventricular assist device on the cardiovascular system.

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.

Animals↗

Medical technology assessment: the use of the analytic hierarchy process as a tool for multidisciplinary evaluation of medical devices.

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.

Decision Making↗

Mechanical circulatory support systems--a review.

Congestive Heart Failure (CHF) is a major health problem with a high mortality rate. Its ultimate therapy, heart transplantation, is limited by the shortage of donor hearts. Since decades researchers have been working to solve this problem by developing Mechanical Circulatory Support Systems (MCSS) that can replace or assist the failing heart. Short-term and intermediate-term ventricular assist devices are used nowadays frequently to bridge patients with severe heart failure to recovery. Long-term ventricular assist devices (VADs) and Total Artificial Hearts (TAHs) are used increasingly as a bridge to heart transplantations or as permanent circulatory support in patients with end-stage heart failure that are contraindicated for heart transplantation. The early TAHs and VADs were mainly driven from an external pneumatic drive unit. The latest generation TAHs and long-term assist devices are electrically powered, ultracompact, totally implantable, and have small wearable drive/control consoles, allowing patients to return to their daily activities. The article categorizes and reviews the development of MCSS, highlights the medical indications and contraindications of pump implantation, advantages and disadvantages of the various systems, and results of animal and clinical studies.

Adult↗

Biocompatibility of a novel tissue connector for fixation of tracheostoma valves and shunt valves.

Rehabilitation after laryngectomy often includes the use of a shunt valve and a tracheostoma valve to restore voice. To improve the fixation method of these valves, a new tissue connector has been developed, basically consisting of a ring that will be integrated into surrounding tracheal soft tissue. The valves can be placed in the ring. To test the principle of the tissue connector, a prototype consisting of a subcutaneous polypropylene mesh and a percutaneous titanium stylus was implanted into the backskin of 10 rats by a two-stage surgical procedure. We reasoned that if a firm connection can be realized with the skin, a firm connection with the trachea will also be possible. The subcutaneous part was implanted first, followed by the percutaneous part after 6 weeks. The complete tissue connector with surrounding tissue was removed 8 weeks later and examined histologically. The principle of the new tissue connector proved to be effective: hardly any epithelial downgrowth appeared, and adhesion of soft tissue was demonstrated. No infection or severe inflammation reaction was detected. The tissue connector seems appropriate for its intended use.

Administration, Cutaneous↗

Numerical simulation of the pulsating catheter pump: A left ventricular assist device.

The pulsating catheter (PUCA) pump, a left ventricular assist device, consists of a hydraulically or pneumatically driven membrane pump, extracorporeally placed and mounted to a valved catheter. The catheter is introduced into an easily accessible artery and positioned with its distal tip in the left ventricle. Blood is aspirated from the left ventricle during systole and ejected into the ascending aorta during diastole. A numerical model of the PUCA pump has been developed to determine the internal diameter of the PUCA pump catheter that allows a certain blood flow. The model considers a limitation of mechanical blood damage and determines the accompanying pressure and flow profile for driving the pump. For a flow of 5 L/min, a catheter with an internal diameter of at least 6. 95 mm is required. For 3 L/min, the minimal diameter is 5.50 mm. The latter catheter can be introduced in the axillary artery, the former via the aorta during an open thorax surgical procedure. To validate the numerical model, 2 different PUCA pump configurations were tested in vitro. Results showed a good resemblance between model and in vitro behavior of the PUCA pump.

Aorta↗

Evaluation of the optimal driving mode during left ventricular assist with pulsatile catheter pump in calves.

The pulsatile catheter (PUCA) pump, a left ventricular assist device, was tested during acute experiments in calves using asynchronous and ECG-synchronous assist modes. The aim of the study is to compare ECG-synchronous and asynchronous assist and to find the optimal driving mode for the PUCA pump with respect to left ventricular myocardial oxygen consumption (LV MVO2), pump flow, and coronary flow. LV MVO2 decreased significantly during the asynchronous (from 7.77 to 6.46 ml/min/100 g) as well as during the ECG-synchronous mode (from 8.88 to 7.84 ml/min/100 g). The pump flow was highest during the ECG-synchronous assist (2.94 L/min), followed by the asynchronous assist (2.79 L/min). The peak coronary flow depended strongly on pump ejection timing and showed the best flow patterns during the ECG-synchronous assist. We concluded that for PUCA pump support both asynchronous and ECG-synchronous assists significantly reduce LV MVO2 and that the pump flow generated is enough to maintain the systemic circulation. However, we find the ECG-synchronous mode preferable because this mode optimizes coronary flow patterns at the same time.

Animals↗

Time-related contact angle measurements with human plasma on biomaterial surfaces.

Axisymmetric drop shape analysis by profile (ADSA-P) was used to assess in time contact angle changes of human plasma drops placed on four different biomaterials. Results were related with conventional blood compatibility measurements: albumin adsorption, fibrinogen adsorption and platelet adhesion. While contact angle measurements with water are material-related but constant in time, contact angle measurements with plasma changed over time owing to protein adsorption on the solid-liquid interface. The contact medium plasma did not influence the initial contact angle. Contact angles on PDMS decreased most in time (41 degrees) and demonstrated highest levels of conventionally measured albumin and fibrinogen adsorption and platelet adhesion. PTFE, with the lowest contact angle decrease over a 500 minutes period (19 degrees), showed low fibrinogen and albumin adsorption as well as low platelet adhesion. PU and HDPE demonstrated almost similar initial contact angles with plasma and contact angle decreases (26 and 27 degrees), intermediate protein adsorption, and platelet adhesion. We conclude that biocompatibility properties of the tested materials may be more related to the behaviour of their contact angles in time, than to the initial hydrophobic or hydrophilic state.

Adsorption↗

Measuring changes in step parameters during an exhausting running exercise.

A treadmill with four force transducers was used to analyze gait during running. 39 volunteers ran on a treadmill until they were exhausted. The step parameter variances showed a very distinct change in time. 17 subjects showed a sudden increase in variance. The other 22 subjects did not show such an effect, probably because they stopped too soon. This was confirmed by lactate measurements. In conclusion, the described treadmill is able to register continuously the running pattern of healthy volunteers. During an exhausting exercise, the running pattern becomes irregular in the last phase of the exercise. Copyright 1998 Elsevier Science B.V.

Journal Article↗

Skeletal muscle perfusion measured by positron emission tomography during exercise.

The applicability of H215O-positron emission tomographic (PET) imaging for the assessment of skeletal muscle perfusion during exercise was investigated in five healthy subjects performing intermittent isometric contractions on a calf ergometer. The workload of the left calf muscles was kept constant in all exercises, while that of the right calf muscles was varied. During exercise H215O distribution in the calf muscles was measured by PET. Radioactivity measured in the left calf muscles was used as a reference for the radioactivity measured in the right calf muscles. In all studies, muscles were delineated by uptake of radioactivity. Four subjects demonstrated high radioactivity in the gastrocnemius medialis muscle, in one subject high radioactivity was distributed over the triceps surae muscles. The observed muscles demonstrated also local foci of radioactivity indicating regionally enhanced tissue perfusion. The right-left ratio of radioactivity in the active muscles increased as a function of the load. We conclude that inter- and intramuscle perfusion differences can be measured during exercise by H215O-PET imaging.

Adult↗

Evaluation of a porcine internal mammary artery (No-React II) as a small-diameter conduit.

BACKGROUND: The patency of biologic small-diameter vascular grafts in the aortocoronary position is still unsatisfactory. Most of the studies suggest that xenografts are to be avoided as an aortocoronary bypass. METHODS: The porcine internal mammary artery treated by the No-React II procedure was developed for use as an alternative coronary artery bypass conduit. The attempt of this study was to evaluate the patency and histologic changes of the porcine internal mammary artery in animals. Five calves underwent coronary artery bypass grafting with a porcine internal mammary artery graft to the right coronary artery. After euthanasia of the animals 103 days later, the samples of these grafts were studied morphologically for patency, structural changes, calcifications, and inflammatory and immunologic response. RESULTS: One animal died during the procedure as result of acute thrombosis of the porcine internal mammary artery graft. In the other 4 animals all grafts became occluded. In the histologic sections of the grafts we noted multiple calcifications and a host-graft immunologic reaction (severe chronic rejection). CONCLUSIONS: The present study demonstrates a very poor experience with the porcine internal mammary artery (No-React II) conduit. We do not recommend this prosthesis for clinical use in humans.

Animals↗