A Noninvasive Method for Monitoring Intracranial Pressure During Postural Changes.

Intracranial hypertension (IH) is an important cause of secondary brain injury, and its association with poor outcomes has been extensively demonstrated. Pathological intracranial hypertension is defined as a persistent rise in intracranial pressure (ICP) to above 20-25 mmHg, with symptoms such as headaches, loss of consciousness, seizures, and focal deficits, as well as ischemic damage. Therefore, monitoring of ICP is invaluable in the management of these symptoms. However, invasive measurements of ventricular pressure (requiring a surgical procedure) are considered the gold standard, thus limiting the practicality of ICP measurements. Vivonics, Inc., is developing a noninvasive optical device to assess ICP for use by emergency medical personnel, called IPASS: Intracranial Pressure Assessment and Screening System. IPASS uses four near-infrared sensors to measure hemodynamic oscillations at four different locations. Three sensors are used as reference signals and one sensor is used to detect cerebral blood volume oscillations. Pulse arrival delays between the measured cerebral blood volume oscillations and the blood volume oscillations measured at the three reference locations are calculated and correlated with estimated ICP changes, herein modulated by specific positional changes (in a head-down maneuver).

Temperature- and Pressure-Regulating Insoles for Prevention of Diabetic Foot Ulcers.

Diabetic foot ulcers (DFUs) pose a major threat to the United States healthcare system as well as patients and their families. High ulcer recurrence rates indicate that existing preventive measures are not effective. A new generation of multimodal preventive devices may reduce ulceration and amputation rates. Because previous research has revealed that tissue maintained at cooler temperatures is more resistant to breaking down, the evaluated technology may prevent foot ulceration. The purpose of this study was to test previously designed Temperature and Pressure Monitoring and Regulating Insoles (TAPMARI) in diabetic neuropathic and healthy subjects. A cooling unit, a mini-water pump, a battery pack, and a microcontroller (or simply thermostat) were placed inside a box attached to the subjects' calf, which provided cooling inside the shoe. The microcontroller was set at 28°C. Eight subjects provided informed consent, 3 of whom had diabetic neuropathy. Subjects used the instrumented shoe on the right foot and the matching control shoe on the left and walked on a treadmill for 5 minutes at self-selected speeds. Baseline and postwalking thermographs were obtained with a thermal camera. At the 2-hour midpoint, subjects again walked on the treadmill for 5 minutes at self-selected speeds. Second baseline and postwalking thermographs were captured. Plantar pressure distributions were also quantified. The TAPMARI successfully regulated foot temperatures at or below the target temperature. The mean baseline temperature of the right (regulated) and left (control) feet were 28.1 ± 1.9°C (mean ± standard deviation) for all subjects. The mean temperatures at the end of the study were 25.9 ± 2.5°C (right) and 31.7 ± 1.6°C (left) in all subjects. In the diabetic neuropathy group, the final mean temperatures were 27.5 ± 2.4°C (right) and 31.6 ± 0.8°C (left), which indicated that the temperature goal was met inside the instrumented shoe. By regulating temperatures, TAPMARI may reduce the metabolic demands in the foot and prevent cell autolysis by eliminating the imbalance between oxygen demand and supply. This study warrants further development and testing of TAPMARI as well as investigating the clinical effectiveness in preventing DFUs.

Accuracy of cardiac ablation catheter guidance by means of a single equivalent moving dipole inverse algorithm to identify sites of origin of cardiac electrical activation.

We have developed a system that could potentially be used to identify the site of origin of ventricular tachycardia (VT) and to guide a catheter to that site to deliver radio-frequency ablation therapy. This system employs the Inverse Solution Guidance Algorithm based upon Single Equivalent Moving Dipole (SEMD) localization method. The system was evaluated in in vivo swine experiments. Arrays consisting of 9 or 16 bipolar epicardial electrodes and an additional mid-myocardial pacing lead were sutured to each ventricle. Focal tachycardia was simulated by applying pacing pulses to each epicardial electrode at multiple pacing rates during breath hold at the end-expiration phase. Surface potentials were recorded from 64 surface electrodes and then analyzed using the SEMD method to localize the position of the pacing electrodes. We found a close correlation between the locations of the pacing electrodes as measured in computational and real spaces. The reproducibility error of the SEMD estimation of electrode location was 0.21 ± 0.07 cm. The vectors between every pair of bipolar electrodes were computed in computational and real spaces. At 120 bpm, the lengths of the vectors in the computational and real space had a 95% correlation. Computational space vectors were used in catheter guidance simulations which showed that this method could reduce the distance between the real space locations of the emulated catheter tip and the emulated arrhythmia origin site by approximately 72% with each movement. We have demonstrated the feasibility of using our system to guide a catheter to the site of the emulated VT origin.

Temperature as a Causative Factor in Diabetic Foot Ulcers: A Call to Revisit Ulceration Pathomechanics.

BACKGROUND: Diabetic foot ulcers (DFUs) are a major burden to patients and to the health-care systems of many countries. To prevent or treat ulcers more effectively, predictive biomarkers are needed. We examined temperature as a biomarker and as a causative factor in ulcer development. METHODS: Thirty-seven individuals with diabetes were enrolled in this observational case-control study: nine with diabetic neuropathy and ulcer history (DFU), 14 with diabetic neuropathy (DN), and 14 nonneuropathic control participants (DC). Resting barefoot plantar temperatures were recorded using an infrared thermal camera. Mean temperatures were determined in four anatomical regions-hallux and medial, central, and lateral forefoot-and separate linear models with specified contrasts among the DFU, DN, and DC groups were set to reveal mean differences for each foot region while controlling for group characteristics. RESULTS: The mean temperature reading in each foot region was higher than 30.0°C in the DFU and DN groups and lower than 30.0°C in the DC group. Mean differences were greatest between the DFU and DC groups, ranging from 3.2°C in the medial forefoot to 4.9°C in the hallux. CONCLUSIONS: Increased plantar temperatures in individuals with a history of ulcers may include acute temperature increases from plantar stresses, chronic inflammation from prolonged stresses, and impairment in temperature regulation from autonomic neuropathy. Diabetic foot temperatures, particularly in patients with previous ulcers, may easily reach hazard thresholds indicated by previous pressure ulcer studies. The results necessitate further exploration of temperature in the diabetic foot and how it may contribute to ulceration.

A method to noninvasively identify cardiac bioelectrical sources.

BACKGROUND: We have introduced a method to guide radiofrequency catheter ablation (RCA) procedures that estimates the location of a catheter tip used to pace the ventricles and the target site for ablation using the single equivalent moving dipole (SEMD). OBJECTIVE: To investigate the accuracy of this method in resolving epicardial and endocardial electrical sources. METHODS: Two electrode arrays, each of nine pacing electrodes at known distances from each other, sutured on the left- and right-ventricular (LV and RV) epicardial surfaces of swine, were used to pace the heart at multiple rates, while body surface potentials from 64 sites were recorded and used to estimate the SEMD location. A similar approach was followed for pacing from catheters in the LV and RV. RESULTS: The overall (RV & LV) error in estimating the interelectrode distance of adjacent epicardial electrodes was 0.38 ± 0.45 cm. The overall endocardial (RV & LV) interelectrode distance error, was 0.44 ± 0.26 cm. Heart rate did not significantly affect the error of the estimated SEMD location (P > 0.05). The guiding process error became progressively smaller as the SEMD approached an epicardial target site and close to the target, the overall absolute error was ∼ 0.28 cm. The estimated epicardial SEMD locations preserved their topology in image space with respect to their corresponding physical location of the epicardial electrodes. CONCLUSION: The proposed algorithm suggests one can efficiently and accurately resolve epicardial electrical sources without the need of an imaging modality. In addition, the error in resolving these sources is sufficient to guide RCA procedures.

The single equivalent moving dipole model does not require spatial anatomical information to determine cardiac sources of activation.

Radio-frequency catheter ablation (RCA) is an established treatment for ventricular tachycardia (VT). A key feature of the RCA procedure is the need for a mapping approach that facilitates the identification of the target ablation site. In this study, we investigate the effect of the location of the reference potential and spatial anatomical constraints on the accuracy of an algorithm to identify the target site for ablation therapy of VT. This algorithm involves processing body surface potentials using the single equivalent moving dipole (SEMD) model embedded in an infinite homogeneous volume conductor to model cardiac electrical activity. We employed a swine animal model and an electrode array of nine electrodes that was sutured on the epicardial surface of the right ventricle. We identified two potential reference electrode locations: at an electrode most far away from the heart (R1) and at the average of all 64 body surface electrode potentials (R2). Also, we developed three spatial "constraining" schemes of the algorithm used to obtain the SEMD location: one that does not impose any constraint on the inverse solution (S1), one that constrains the solution into a volume that corresponds to the heart (S2), and one that constrains the solution into a volume that corresponds to the body surface (S3). We have found that R2S1 is the most accurate approach (p < 0.05 versus R1S1 at earliest activation time-EAT) for localizing epicardial electrical sources of known locations in vivo. Although the homogeneous volume conductor introduces systematic error in the estimated compared to the true dipole location, we have observed that the overall error of the estimated interelectrode distance compared to the true one was 0.4 ± 0.4 cm and 0.4 ± 0.1 cm for the R1S1 and R2S1 combinations, respectively, at the EAT (p = N.S.) and 1.0 ± 0.6 and 0.5 ± 0.4 cm, respectively, at the pacing spike time (PST, ). In conclusion, our algorithm to estimate the SEMD parameters from body surface potentials can potentially be a useful method to rapidly and accurately guide the catheter tip to the target site during a RCA procedure without the need for spatial anatomical information obtained by conventional imaging modalities.

Cardiac ablation catheter guidance by means of a single equivalent moving dipole inverse algorithm.

BACKGROUND: We developed and evaluated a novel system for guiding radiofrequency catheter ablation therapy of ventricular tachycardia. This guidance system employs an inverse solution guidance algorithm (ISGA) using a single equivalent moving dipole (SEMD) localization method. The method and system were evaluated in both a saline tank phantom model and in vivo animal (swine) experiments. METHODS: A catheter with two platinum electrodes spaced 3 mm apart was used as the dipole source in the phantom study. A 40-Hz sinusoidal signal was applied to the electrode pair. In the animal study, four to eight electrodes were sutured onto the right ventricle. These electrodes were connected to a stimulus generator delivering 1-ms duration pacing pulses. Signals were recorded from 64 electrodes, located either on the inner surface of the saline tank or on the body surface of the pig, and then processed by the ISGA to localize the physical or bioelectrical SEMD. RESULTS: In the phantom studies, the guidance algorithm was used to advance a catheter tip to the location of the source dipole. The distance from the final position of the catheter tip to the position of the target dipole was 2.22 ± 0.78 mm in real space and 1.38 ± 0.78 mm in image space (computational space). The ISGA successfully tracked the locations of electrodes sutured on the ventricular myocardium and the movement of an endocardial catheter placed in the animal's right ventricle. CONCLUSION: In conclusion, we successfully demonstrated the feasibility of using an SEMD inverse algorithm to guide a cardiac ablation catheter.

Forefoot plantar shear stress distribution in hallux valgus patients.

BACKGROUND: Hallux valgus is a common foot disorder often experienced with secondary callosities and metatarsalgia. Many factors including improper shoes might be responsible in the pathophysiology of the problem. Hallux valgus deformity has been shown to alter the biomechanics of the whole foot rather than affecting only the great toe. Due to changes in the biomechanical functioning of the first ray, other regions of the forefoot area have been shown to bear abnormal loads with increased vertical loading on medial, central and lateral forefoot regions. The purpose of this study was to investigate the pattern of forefoot plantar shear loading in hallux valgus patients and compare these results with those of control subjects. METHODS: A total of 28 subjects were recruited for the study of which 14 were clinically diagnosed with hallux valgus. A custom built platform was used to collect peak pressure and shear data. A repeated measures analysis of variance was used to analyze the recorded data. FINDINGS: Antero-posterior shear was significantly lower in the deformity group (p<0.05). The lateral forefeet of the patients, however, experienced slightly higher shear loads (p>0.05). INTERPRETATION: Propulsive shear force generation mechanism under the medial forefoot was impaired in the disorder group. In general, shear loading of the plantar feet shifted laterally. Previously hypothesized higher medio-lateral shear magnitudes under the hallux were not confirmed.

Validation of a novel catheter guiding method for the ablative therapy of ventricular tachycardia in a phantom model.

Accurate guidance of an ablation catheter is critical in the RF ablation (RFA) of ventricular tachycardia (VT). With current technologies, it is challenging to rapidly and accurately localize the site of origin of an arrhythmia, often restricting treatment to patients with hemodynamically stable arrhythmias. We investigated the effectiveness of a new guidance method, the inverse solution guidance algorithm (ISGA), which is based on a single-equivalent dipole representation of cardiac electrical activity and is suitable for patients with hemodynamically unstable VT. Imaging was performed in homogeneous and inhomogeneous saline-filled torso phantoms in which a catheter tip was guided toward a stationary electrical dipole source over distances of more than 5 cm. Using ISGA, the moving catheter tip was guided to within 0.61 +/-0.43 and 0.55 +/-0.39 mm of the stationary source in the homogeneous and inhomogeneous phantoms, respectively. This accuracy was achieved with less than ten movements of the catheter. These results suggest that ISGA has potential to provide accurate and efficient guidance for RFA procedures in the patient population with hemodynamically unstable arrhythmias.

MagScrew TAH: an update.

The MagScrew Total Artificial Heart (TAH) system is the result of a close collaboration among the Cleveland Clinic Foundation, Foster Miller Technologies, Wilson Greatbatch Ltd, and Whalen Biomedical Inc. The system components are the thoracic blood pumping unit with attached compliance chamber and refill port, implantable electronic control unit, implantable battery pack, transcutaneous energy transmission system, external battery pack, and a telemetry system for communication with the electronic control unit. System in vitro tests are underway for system characterization and durability demonstration, whereas in vivo tests were conducted to evaluate system performance and biocompatibility under physiologic conditions. The passively filling pump uses a left master alternate left and right ejection control mode and has a Starling law-like response to venous pressure. The in vitro tests documented excellent hydraulic pump performance with high device output of over 9 l/min at left atrial pressures below 12 mm Hg. Atrial balance was well maintained under all test conditions. The in vivo tests demonstrated good biocompatibility without use of anticoagulant therapy. Experimental durations have ranged between 0 and 92 days. Postexplant evaluation of tissue samples did not reveal any sign of thromboembolic events or tissue damage due to device operation.

MagScrew total artificial heart in vivo performance above 200 beats per minute.

PURPOSE: Downsizing pulsatile devices requires an increase of beat rate if flow capacity is to be maintained. We applied this concept to the preclinical MagScrew total artificial heart (TAH). DESCRIPTION: The device fills passively with a stroke volume of 45 ml and beat rates up to 250 beats per minute (bpm). EVALUATION: Stable hemodynamics were observed during a 30-day bovine implant with a flow of 8.7 +/- 1.2 L/min at beat rates of 204 +/- 18 bpm. Device filling was exceptional up to 250 bpm generating flow of greater than 12 L/min. Beat rate adapted to preload in a way similar to a Frank-Starling response. Left and right atrial pressures were balanced. The aortic pulse pressure was 49-70 mm Hg, which translates to a pulsatility index of 0.49-0.77. Organ functions were preserved and blood damage did not occur. CONCLUSIONS: Increasing the beat rate while downsizing the MagScrew TAH was successful with strong flow generation by passive filling. Pulsatility was maintained at high beat rates. This innovative approach may be used to develop small pulsatile pumps.

In vivo performance and biocompatibility of the MagScrew ventricular assist device.

Currently available ventricular assist devices (VADs) have limitations in long-term durability and blood compatibility. We evaluated a prototype of a pulsatile MagScrew VAD for in vivo hemodynamic performance and biocompatibility. The device is composed of an actuator, blood pump housing, diaphragm, pusher plate, and bioprosthetic valves. Its protein-coated ("biolized") blood-contacting surface inhibits clot formation. Forces between moving parts of the actuator are transmitted magnetically, eliminating a primary source of friction and wear. The pump fills passively and is highly preload sensitive. The device was implanted into three calves for 90, 10, and 57 days, respectively. No anticoagulants were given postoperatively. The device functioned without technical problems during the entire course of each experiment, with mean device flow ranging between 5.4 and 9.0 L/min. Autopsy of the first two calves revealed no sign of embolization and clean blood-contacting surfaces of the devices. The third experiment was complicated by a prosthetic valve endocarditis with infectious embolization, and a few small depositions were found in the pump. In conclusion, the MagScrew VAD has demonstrated a high level of performance and biocompatibility in three calves studied for 10-90 days. Vigorous development is in progress to bring this device to preclinical readiness and thus provide surgeons with the VAD of choice for permanent implantation.

In vitro controllability of the MagScrew total artificial heart system.

The purpose of this study was to evaluate the in vitro responses to preload and afterload of our total artificial heart (TAH), the MagScrew TAH. The TAH consists of two blood pumps and a control logic, developed at the Cleveland Clinic, OH, and the MagScrew actuator and its electronic control system, developed by Foster-Miller Technologies, Inc., Albany, NY. Tests were performed on a mock circulatory loop, using water as a test fluid. Preload sensitivity of the Mag-Screw TAH demonstrated a Frank-Starling response to preload in automatic mode. A peak flow of 10 L/min was obtained, with a left atrial pressure of 13 mm Hg. The relationship between right atrial pressure and left atrial pressure was well balanced when tested with a left bronchial shunt flow of 5% and a range of pulmonary artery and aortic pressures. With respect to afterload response, the left pump showed a relatively low sensitivity, which allowed the pump to maintain perfusion over a wide range of aortic pressures. The right pump, on the other hand, was much more sensitive to pulmonary artery pressure, which provided a measure of protection against pulmonary congestion. The very effective physiologic response of the MagScrew TAH is believed to result from employment of a left master, alternating ejection control logic, high inherent sensitivity of the blood pumps to atrial pressure, a lower effective stroke volume for the right pump, and a scaling of right side motor ejection voltage to 80% of that used for the left side ejection.

In vivo studies of the MagScrew total artificial heart in calves.

The purpose of this study was to evaluate the in vivo pump performance of our total artificial heart (TAH), the "MagScrew TAH." The TAH consists of a blood pump and control logic developed at the Cleveland Clinic and the MagScrew actuator and electronic control system developed by Foster-Miller Technologies, Inc. (Albany, NY). MagScrew TAH implantation was performed in two calves. Study durations were 50 and 5 days. The causes of termination were prosthetic valve endocarditis in one case and cable failure in the other. Mean left pump flow ranged from 8.0 to 9.7 L/min, with left atrial pressure of 3.0 to 16.0 mm Hg. Preload sensitivity of the MagScrew TAH demonstrated a Frank-Starling response to preload in automatic mode. The relationship between right and left atrial pressure was well balanced. Mean arterial pressure and mean pulmonary artery pressure were maintained within physiologic ranges over study duration. There were no signs of bleeding, hemolysis, or organ failure. The MagScrew TAH showed physiologic pump performance, and hemodynamics were well maintained without any organ failure. Further development testing will bring the MagScrew TAH to the point of preclinical readiness testing.