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Biomedical subjects

H Nygaard

Publications and source records attributed to H Nygaard.

At least 19 recordsLinked to original sources

Design and evaluation of a handheld impedance plethysmograph for measuring heart rate variability.

Heart rate variability (HRV) analysis from 10s ECGs has been shown to be reliable. However, the short examination time warrants a user-friendly system that can be used for ad-hoc examinations without normal preparation, unlike ECG. A handheld device has been developed that can measure ultra-short HRV from impedance plethysmographic recordings of the pulse wave in distal superficial arteries. The prototype device was made user-friendly through a compact, pen-like design and the use of integrated metal electrodes that were especially designed for dry operation. The main signal processing was performed by a digital signal processor, where the discrete heart beats were detected using a correlation algorithm that could adapt to individual pulse wave shapes to account for biological variation. The novel device was evaluated in 20 mainly young volunteers, using 10 s time-correlated ECG recordings as the reference method. Agreement between the two methods in measuring heart rate and root mean square of successive differences in the heart beat interval (RMSSD) was analysed using correlation coefficients (Pearson's R2), mean differences with 95% confidence intervals and 95% limits of agreement, and Bland-Altman plots. The correlation between the two methods was R2 = 1.00 and R2 = 0.99 when heart rate and RMSSD were measured, respectively. The Bland-Altman plots showed suitable agreement between the novel device and standard 10 s ECGs, which was substantiated by 95% limits of agreement of the difference of +/- 0.1 beats min(-1) and approximately +/- 10 ms for heart rate and RMSSD, respectively. Therefore the evaluation showed no significant systematic error of the novel device compared with ECG.

Adult↗

Urinary bladder volume tracking using a Kalman filter.

This study introduced the Kalman filter procedure for tracking urinary bladder filling from intermittent bladder volume measurements taken by an ultrasonic bladder volume monitor. The Kalman filter was based on a double integrator as a model for the bladder filling process between micturitions and included a procedure to reset the filter in the event of a micturition. The performance of the Kalman filter was evaluated experimentally using an ultrasonic bladder volume monitor on seven male urologic patients. During cystometry, saline was infused into the patient's bladder at a constant rate of 30 ml min(-1) until it was full, and the volume of the bladder was recorded every 30 s by the bladder volume monitor. The evaluation showed that the filter significantly improved the precision of the measured volumes in terms of mean absolute errorby 4.2 ml (95% confidence interval: 0.7-7.7 ml) (p = 0.025) without affecting the system accuracy, i.e. slope (p= 0.92) and intercept (p= 0.32). Finally, the micturition reset procedure was verified using simulated data.

Humans↗

Design and evaluation of an ultrasound-based bladder volume monitor.

Ultrasonic bladder volume monitors have successfully been used in the diagnosis and treatment of various urological disorders. Ultrasonic bladder monitors have been developed but they have either been too bulky or too simple and inaccurate. A new, wearable ultrasonic bladder volume monitor has been designed for urological patients. The instrument consists of seven phased-array ultrasonic transducers ergonomically arranged in a circular pattern to optimise detection of the bladder walls perpendicular to the abdominal wall. A Bluetooth radio link was used to transmit data to a laptop computer, where the main signal processing was performed. After detection of bladder surface points, a three-dimensional convex hull representing the bladder was generated, and the volume was estimated. Accuracy, precision, drift over time, temperature dependency and dynamic performance were evaluated using ultrasound phantoms. Furthermore, the system was tested on one volunteer using magnetic resonance imaging (MRI) as reference. The apparatus showed no significant drift, systematic error or temperature effects. Percentage error during static volume measurements had a 95% central prediction interval of +/-7.5% and mean absolute percentage error of 2.9%. The dynamic performance analysis showed linearity in the analysed volume interval. The in vivo study showed a high degree of correlation (R2= 0.99) between the volume measured using MRI and that measured with the apparatus.

Diagnosis, Computer-Assisted↗

Evaluation of electrocardiogram T-wave dispersion measurement methods.

Methods for measuring the T-wave dispersion are difficult to improve, because the exact result is unknown. This study describes a flexible and cheap method for analysing the measurement problems. The analysis consisted of measuring the T-wave dispersion of electrocardiograms and vector loops with simulated dispersion. The vector loops were simulated using two primary T-waves that were identical, quasi-monophasic and located in orthogonal leads. The dispersion was the time delay between the primary T-waves. The electrocardiograms were projections of the vector loops on approximations to the orientations of leads in the standard 12-lead ECG. This simulation model was validated by matching simulated ECGs and vector loops with measured ECGs and vector loops drawn from a population of 247 patients with acute myocardial infarction. The analysis of the measurement problems was demonstrated by measuring an approximation to the classical QT-dispersion in ECGs with simulated dispersion in the interval 0-100 ms, in steps of 2 ms. This showed that the QT-dispersion was unable to measure the simulated dispersion accurately in the clinically relevant interval of 50-100 ms. The results indicated that the low prognostic accuracy of the QT-dispersion could be due to an inaccurate measurement method.

Aged↗

Improving the reproducibility of QT dispersion measures.

BACKGROUND: The low reproducibility of the QT dispersion (QTD) method is a major reason why it is not used in clinics. The purpose of this study was to develop QT dispersion parameters with better reproducibility and identification of patients with a high risk of ventricular arrhythmia or death. METHODS AND RESULTS: Three institutions using different methods for measuring QT intervals provided QT databases, which included more than 3500 twelve-lead surface ECGs. The data represented low and high risk subjects from the following groups: the normal population EpiSet (survivors vs dead from cardiovascular causes), acute myocardial infarction patients AmiSet (survivors vs dead) and remote myocardial infarction patients ArrSet (with vs without a history of ventricular arrhythmia). The EpiSet, AmiSet, and the ArrSet contributed with N = 122, 0, and 110 ECGs for reproducibility analysis, and 3244, 446, and 100 ECGs for the analysis of prognostic accuracy. The prognostic accuracy was measured as the area under the Receiver Operator Curve. The QT intervals were divided into six QT pairs; the longest pair consisted of the longest and the shortest QT intervals etc. The QT dispersion trend (QTDT) was defined as the slope of the linear regression of the N longest QT pairs after estimation of missing QT intervals by interpolation of measured QT intervals. The QTMAD and the QTSTD methods were defined as twice the mean absolute deviation and the standard deviation of the N longest QT pairs. The reproducibility was improved by 27% and 19% in the EpiSet and the ArrSet relative to the reproducibility of QTD. The accuracy improved for the EpiSet and the ArrSet and was maintained for the AmiSet. CONCLUSIONS: By using the three longest and the three shortest QT intervals in QTDT, QTMAD, or QTSTD, the reproducibility improved significantly while maintaining or improving the prognostic accuracy compared to QTD.

Aged↗

Heart motion-adapted MR velocity mapping of blood velocity distribution downstream of aortic valve prostheses: initial experience.

PURPOSE: To investigate blood flow velocities and shear rates at two distances downstream of an artificial aortic valve in patients. MATERIALS AND METHODS: Blood velocity was quantified downstream of the valve prosthesis (for replacement after aortic valve stenosis or combined stenosis and regurgitation) in 10 patients by using a magnetic resonance (MR) cine velocity mapping method in which the imaging section position is adapted according to the excursion of the valvular plane of the heart. Two acquisitions were performed to display the blood velocity distributions one-fourth valve diameter and one valve diameter downstream of the valve and to quantify blood volumes and shear rates. RESULTS: The velocity profiles measured during flow acceleration one-fourth valve diameter downstream were characterized by a distinct pattern of two lateral jets and one central jet of antegrade flow. High shear rates were found along the leaflet tips. The profiles obtained one valve diameter downstream were skewed, with varying velocity patterns among patients. Peak shear rates were found close to the vessel wall. With correction for through-plane motion of the valve, the mean apparent regurgitant fraction (+/- SD) was 14% +/- 6; the mean regurgitant fraction without correction was 9% +/- 5. CONCLUSION: The described noninvasive procedure for velocity mapping enables measurements close to the valve and thus evaluation of blood flow patterns with respect to valve design in humans.

Adult↗

[Turbulence and high intensity transient signals (HITS) as a parameter for optimum orientation of mechanical heart valves].

BACKGROUND: In previous studies, the impact of valve orientation on the hemodynamic performance of mechanical aortic valves has been demonstrated. This study investigates Turbulence (RNS values) and High Intensity Transient Signals (HITS) as a new and objective parameter for hemodynamics in various orientations of Medtronic Hall (MH) and St. Jude Medical (SJM) aortic valves. METHODS: Rotation devices carrying a MH or SJM valve were implanted into four pigs. The device allowed valve rotation without reopening the aorta. In various orientations, turbulent shear stresses (RNS values) and HITS were measured. RESULTS: RNS and HITS changed for both valve designs in the different orientations, with superior results for the MH in the hemodynamically best orientation. Downstream turbulence (RNS) and HITS varied in the same direction, but a one to one correlation was not observed. CONCLUSIONS: RNS and HITS vary with respect to valve orientation and design with superior results for the tilting disc valve. Both MH and SJM valves showed lower turbulence and HITS counts in their hemodynamically best orientations. HITS were related to downstream turbulence and the hemodynamic performance of the mechanical aortic valves.

Animals↗

A randomised, double-blind comparison of the efficacy and safety of citalopram compared to mianserin in elderly, depressed patients with or without mild to moderate dementia.

Depression is the most common psychiatric disorder among the elderly and in old age may interact with emotional and cognitive functioning. Depression in old age has been shown to be associated with degenerative changes in the brain. It is, therefore, important that in this patient population antidepressants with a favourable tolerability profile, such as the selective serotonin reuptake inhibitors (SSRIs), are examined for both antidepressant efficacy and effect on cognitive function and emotional impairment. This randomised, double-blind study compared the efficacy and tolerability of citalopram and mianserin in 336 elderly, depressed patients with or without dementia. Patients received either citalopram 20-40 mg/day or mianserin 30-60 mg/day for 12 weeks. The treatments were equivalent with respect to change in Montgomery-Asberg Depression Rating Scale (MADRS) total score; patients in both treatment groups responded well. Patients with dementia showed a smaller decrease in total MADRS score than patients without dementia. Both treatments were well tolerated with a relatively low incidence of adverse events. Fatigue and somnolence were more frequent with mianserin, while insomnia was more frequent with citalopram. Overall, this study showed that the two treatments were equivalent in efficacy, and that citalopram is an effective, well-tolerated and non-sedative treatment for elderly depressed patients with or without dementia.

Aged↗

Downstream turbulence and high intensity transient signals (HITS) following aortic valve replacement with Medtronic Hall or St. Jude Medical valve substitutes.

OBJECTIVE: High intensity transient signals (HITS) representing microembolization to the brain have been found to contribute to cognitive impairment and psychoneurological dysfunction in patients carrying a mechanical aortic valve. It is unknown, whether HITS represent gaseous or solid emboli. This animal study evaluates the impact of valve orientation on HITS for two different mechanical valves with both valves implanted in their best and worst orientation, which has been defined in previous studies with respect to downstream turbulence. METHODS: In four pigs a rotation device carrying either a Medtronic Hall (MH) or St. Jude Medical (SJM) valve size 23 mm was implanted. The device allowed rotation of the implanted valves without reopening of the aorta. Approximately 30 min after weaning from extracorporeal circulation, a Doppler probe was placed on both common carotid arteries. In different orientations of the implanted valves (best and worst position), HITS were detected by the Doppler probe and recorded for ten min by a transcranial Doppler sonography device (Medilab Inc., Estenfeld, Germany). RESULTS: HITS showed significant change with rotation for both valve designs. With the major orifice of the MH oriented towards the non-coronary leaflet (optimum position) very low HITS-counts (0.8-1.7/min) were observed. In the worst orientation HITS rose to 43-66/min. For the SJM the HITS count in the optimum position was 23.4-24/min and in the worst orientation 38-48/min. CONCLUSIONS: Valve orientation has an important impact on microembolization to the brain. In the optimum orientation (large orifice facing the non-coronary leaflet) the Medtronic Hall valve showed negligible incidence of HITS. The St. Jude Medical bileaflet valve showed less variation but demonstrated significant HITS counts at any orientation. As the MH in the worst position shows significantly higher turbulent stresses than the SJM but no higher incidence of HITS, a strong correlation between turbulence and HITS was not demonstrated by this study.

Animals↗

High-intensity transient signals (HITS) as a parameter for optimum orientation of mechanical aortic valves.

BACKGROUND: In previous studies [1,2], the impact of valve orientation on the hemodynamic performance of mechanical aortic valves has been demonstrated. This study investigates Turbulence (RNS values) and High Intensity Transient Signals (HITS) as a new and objective parameter for hemodynamics in different orientations of Medtronic Hall (MH) and St. Jude Medical (SJM) aortic valves. METHODS: A rotation device carrying MH or SJM valves was implanted in 4 pigs. The device allowed valve rotation without reopening the aorta. In different orientations, turbulent shear stresses (RNS values) and HITS were measured. RESULTS: RNS and HITS changed for both valve designs in various orientations, with superior results for the MH in the hemodynamically best orientation. Downstream turbulence (RNS) and HITS varied into the same direction, but a one-to-one correlation was not observed. CONCLUSIONS: RNS and HITS vary with respect to valve orientation and design with superior results for the tilting disc valve. Both MH and SJM valves showed lower turbulence and HITS counts in their hemodynamically best orientations. HITS were related to downstream turbulence and the hemodynamic performance of the mechanical aortic valves.

Animals↗

Weilby-Burton arthroplasty of the trapeziometacarpal joint of the thumb.

Twenty-three patients (25 thumbs) were treated by tendon interposition arthroplasty for trapeziometacarpal arthrosis as described by Weilby and modified slightly as described by Burton and Pellegrini. There was good (4/25, 16%) or complete (19/25, 76%) pain relief in 23 (92%) of the cases. Activities of daily living were generally easier. Mobility and strength of the thumb were satisfactory. One patient had signs of instability during a stress test. We conclude that our technique produces a stable and pain-free thumb joint. However, careful selection of the patients for this procedure is essential, and the patient must be given comprehensive information about all stages.

Adult↗

Microemulsion formulation of cyclosporin (Sandimmun Neoral) vs Sandimmun: comparative safety, tolerability and efficacy in severe active rheumatoid arthritis. On behalf of the OLR 302 Study Group.

OBJECTIVE: To compare the safety, tolerability and efficacy of the new oral microemulsion formulation of cyclosporin A (CyA; Sandimmun Neoral) and the original CyA formulation (Sandimmun), in patients with severe active rheumatoid arthritis (RA), over a 12-month period. METHODS: In this double-blind, multicentre study, patients were randomized to treatment with Neoral or Sandimmun, starting with 2.5 mg/kg/day, with dose adjustments after 4 weeks. Primary efficacy criteria included patients' assessment of disease activity. Pharmacokinetic and safety assessments were performed at regular intervals. RESULTS: Compared with Sandimmun, Neoral showed a consistent trend towards greater clinical efficacy from week 12 onwards, including a significant difference in patients' assessment of disease activity at the study end-points. A significantly lower increase in dose from baseline was observed with Neoral at week 24. Pharmacokinetic assessments at week 24 showed increased absorption and decreased variability with Neoral. No differences in safety were found between treatment groups. CONCLUSION: These observations indicate that Neoral is as safe and at least as effective as Sandimmun and have important implications for patient management given the increasing role for CyA in the treatment of severe, active RA.

Antirheumatic Agents↗

A new method for quantitative evaluation of perceived sounds from mechanical heart valve prostheses.

Closing clicks from mechanical heart valve prostheses are transmitted to the patient's inner ear mainly in two different ways: as acoustically transmitted sound waves, and as vibrations transmitted through bones and vessels. The purpose of this study was to develop a method for quantifying what patients perceive as sound from their mechanical heart valve prostheses via these two routes. In this study, 34 patients with implanted mechanical bileaflet aortic and mitral valves (St Jude Medical and On-X) were included. Measurements were performed in a specially designed sound insulated chamber equipped with microphones, accelerometers, preamplifiers and a loudspeaker. The closing sounds measured with an accelerometer on the patient's chest were delayed 400 ms, amplified and played back to the patient through the loudspeaker. The patient adjusted the feedback sound to the same level as the 'real-time' clicks he or she perceived directly from his or her valve. In this way the feedback sound energy includes both the air- and the bone-transmitted energies. Sound pressure levels (SPLs) were quantified both in dB(A) and in the loudness unit sone according to ISO 532B (the Zwicker method). The mean air-transmitted SPL measured close to the patient's ear was 23 +/- 4 dB(A). The mean air- and bone-transmitted sounds and vibrations were perceived by the patients as an SPL of 34 +/- 5 dB(A). There was no statistically significant difference in the perceived sound from the two investigated bileaflet valves, and no difference between aortic and mitral valves. The study showed that the presented feedback method is capable of quantifying the perceived sounds and vibrations from mechanical heart valves, if the patient's hearing is not too impaired. Patients with implanted mechanical heart valve prostheses seem to perceive the sound from their valve two to three times higher than nearby persons, because of the additional bone-transmitted vibrations.

Acoustics↗

Tilting disc versus bileaflet aortic valve substitutes: intraoperative and postoperative hemodynamic performance in humans.

BACKGROUND AND AIM OF THE STUDY: Due to an asymmetrical/eccentric flow profile at the level of the aortic valve, there is an optimal orientation for each aortic valve design. This study evaluates intraoperative flow dynamics (turbulence and pressure gradient) and follow up results (pressure gradient and left ventricular mass regression) for Medtronic Hall tilting disc (MH) and St. Jude Medical bileaflet (SJM) valves, with both valves in their optimum orientation as defined in previous animal experiments. METHODS: In a randomized prospective study, MH and SJM valves (size > or = 23 mm) were implanted in their optimum orientation in 24 patients with aortic stenosis. Turbulence measurements were performed intraoperatively via a perivascular ultrasound transducer; Reynold's normal stress (RNS) values were calculated as key markers for turbulent stresses. Transvalvular pressure gradients, interventricular septum and posterior wall thickness were measured by transesophageal echocardiography intraoperatively and six months postoperatively. RESULTS: Mean valve size was 23.8 mm in both groups. Intraoperative RNS values (MH 7.5 +/- 2.2 N/m2 versus SJM 9.8 +/- 2.3 N/m2) and pressure gradients (MH 10.0 +/- 2.6 mmHg versus SJM 20.0 +/- 3.4 mmHg) were significantly lower for the tilting disc valve. At six months follow up, pressure gradients were reduced by half for both valves (MH 5.3 +/- 1.7 mmHg; SJM 10.4 +/- 2.3 mmHg), with the difference between the valves being maintained. Left ventricular mass regression was accelerated for MH patients with regard to interventricular septum thickness. CONCLUSION: Our results indicate that the tilting disc mechanism shows superior hemodynamic performance with respect to turbulence and transvalvular pressure gradients compared with the bileaflet mechanism when both valves are implanted in their optimum orientation. This led to significant acceleration of interventricular septum mass regression. The superiority of the tilting disc mechanism is more pronounced in the smaller-sized valves.

Aged↗

Orientation of tilting disc and bileaflet aortic valve substitutes for optimal hemodynamics.

Procedures for implantation of mechanical aortic valves have to consider eccentric flow in the aortic root. We describe how to optimize orientation of tilting disc (Medtronic Hall) and bileaflet (St. Jude Medical) valves. In tilting disc valves, an asymmetric design faces an asymmetric flow. Hemodynamic performance of this valve type, regarding turbulence and pressure gradients, is close to normal physiology and superior to the bileaflet valve design. This difference is more pronounced the smaller the valve size.

Aortic Valve↗

Chordal force distribution determines systolic mitral leaflet configuration and severity of functional mitral regurgitation.

OBJECTIVES: The purpose of this study was to investigate the impact of the chordae tendineae force distribution on systolic mitral leaflet geometry and mitral valve competence in vitro. BACKGROUND: Functional mitral regurgitation is caused by changes in several elements of the valve apparatus. Interaction among these have to comply with the chordal force distribution defined by the chordal coapting forces (F(c)) created by the transmitral pressure difference, which close the leaflets and the chordal tethering forces (FT) pulling the leaflets apart. METHODS: Porcine mitral valves (n = 5) were mounted in a left ventricular model where leading edge chordal forces measured by dedicated miniature force transducers were controlled by changing left ventricular pressure and papillary muscle position. Chordae geometry and occlusional leaflet area (OLA) needed to cover the leaflet orifice for a given leaflet configuration were determined by two-dimensional echo and reconstructed three-dimensionally. Occlusional leaflet area was used as expression for incomplete leaflet coaptation. Regurgitant fraction (RF) was measured with an electromagnetic flowmeter. RESULTS: Mixed procedure statistics revealed a linear correlation between the sum of the chordal net forces, sigma[Fc - FT]S, and OLA with regression coefficient (minimum - maximum) beta = -115 to -65 [mm2/N]; p < 0.001 and RF (beta = -0.06 to -0.01 [%/N]; p < 0.001). Increasing FT by papillary muscle malalignment restricted leaflet mobility, resulting in a tented leaflet configuration due to an apical and posterior shift of the coaptation line. Anterior leaflet coapting forces increased due to mitral leaflet remodeling, which generated a nonuniform regurgitant orifice area. CONCLUSIONS: Altered chordal force distribution caused functional mitral regurgitation based on tented leaflet configuration as observed clinically.

Animals↗

In vivo analysis of dynamic tensile stresses at arterial end-to-end anastomoses. Influence of suture-line and graft on anastomotic biomechanics.

OBJECTIVE: to determine the influence of an anastomotic suture line and a graft on dynamic tensile stresses of vascular end-to-end anastomoses in vivo. MATERIAL AND METHODS: the abdominal aorta of twelve 35-kg pigs was used as an experimental model. Simultaneous recordings of internal arterial diameter and pressure were performed on each pig at 3 successive stages: (1) The genuine artery (REF), (2) artery-artery (A-A) and (3) graft-artery (G-A) anastomosis at 1-mm increments in the immediate perianastomotic area. Thereby, RD (relative distension), CC (compliance coefficient), E(p)(dynamic pressure-strain elastic modulus) and hysteresis loop areas could be calculated for every measuring point. RESULTS: the graft was significantly stiffer than REF. A-A and G-A anastomoses were significantly less compliant than REF. Maximum E(p), minimum CC and hysteresis loop areas were found at the anastomotic line due to minimum anastomotic RD. Downstream of the G-A anastomosis, the RD, CC, E(p)and loop areas were significantly different from REF, but significantly different from A-A. CONCLUSION: an animal model for acute studies of mechanical properties of vascular end-to-end anastomoses was developed. The main determinant for anastomotic biomechanics was the suture-line itself.

Anastomosis, Surgical↗

Development of velocity profiles and retrograde flow in the porcine abdominal aorta under different haemodynamic conditions.

Low and/or oscillating wall shear stresses are related to the development of atherosclerosis and this oscillation is influenced by changes in basic haemodynamics (exercise). The objective of this study was to provide in vivo data on the development of velocity profiles and oscillating blood velocities in the abdominal aorta under varying haemodynamic conditions. Six anaesthetized, 90-kg pigs were used in the study. Abdominal aortic velocity profiles across the anterior-posterior diameter were acquired at different axial positions using 10 MHz pulsed Doppler ultrasound. Measurements were obtained under normal conditions and during cardiac pacing up to 170 beats/min. Velocity profiles were obtained during heart rates ranging between 58 and 169 beats/min, and during flow rates ranging between 0.57 and 2.89 l/min. Main outcome measures included minimum velocities, frequency index, shape of velocity profiles (velocity distribution index), Reynolds' numbers, and Womersley's frequency parameter. Velocity profiles were blunted, with lowest velocities at the distal posterior vessel wall. Multiple regression analysis showed the development of velocity profiles to be inversely correlated with the pulsatility index, Womersley's frequency parameter and the mean Reynolds' number (r = 0.89, p < 0.0005). Minimum velocities were negatively correlated with the PI, Womersley's frequency parameter and positively with the mean Reynolds' number (r = 0.94, p < 10(-8)). Retrograde velocities (and hence oscillating wall shear stresses) were present at mean Reynolds' number < 1000. The oscillation of blood velocities at the wall in the porcine abdominal aorta was highly dependent on general haemodynamics (i.e. flow, heart rate and vessel diameter as expressed in the Reynolds' numbers and Womersley's frequency parameters). The velocity profiles in the abdominal aorta were found to be far from parabolic. These findings have important implications for the understanding and future modelling of the complex haemodynamics in the abdominal aorta and their relation to the development of atherosclerotic disease.

Animals↗