The Cardica C-Port System: clinical and angiographic evaluation of a new device for automated, compliant distal anastomoses in coronary artery bypass grafting surgery--a multicenter prospective clinical trial

OBJECTIVES: The C-Port System (Cardica, Inc, Redwood City, Calif) integrates in one tool all functions necessary to enable rapid automated distal coronary anastomoses. The goal of this prospective, nonrandomized, and multicenter study is to determine the safety and efficacy of this novel anastomotic system. METHODS: Five centers enrolled 133 patients awaiting elective coronary artery bypass grafting surgery. Outcome variables were intraoperative device performance, incidence of device-related adverse events, predischarge and 6-month angiographic graft patency, and 12-month clinical outcome. Independent core laboratories performed qualitative and quantitative angiographic and computed tomographic assessments. RESULTS: The C-Port was used to perform a vein-to-coronary anastomosis in 130 patients. Intraoperative conversion to a hand-sewn anastomosis was necessary in 11 patients because of inadequate target site preparation, inappropriate target vessel selection, or both. Inadequate blood flow related to poor runoff required conversion in 3 additional patients. Three patients died before discharge of causes unrelated to the device. At discharge, 113 patients had a C-Port implant in place, and 104 C-Port anastomoses were studied by means of angiography, resulting in 100 FitzGibbon A, 3 FitzGibbon B, and 1 FitzGibbon 0 classifications. At 6 months, one additional patient died of a device-unrelated cause, and 98 patients were evaluated by means of angiography (n = 89). Overall patency (FitzGibbon A) was 92.1%. Three C-Port anastomoses were rated FitzGibbon B, and 4 were rated FitzGibbon 0. At 12 months, 107 (98.2%) of 109 alive patients were followed up, without any reports of device-related major adverse cardiac events. CONCLUSIONS: The C-Port System allows for a rapid, reliable, and compliant distal anastomosis and yields favorable 6-month angiographic and 12-month clinical results when compared with published studies.

Comparison and evaluation of ocular biometry using a new noncontact optical low-coherence reflectometer

To evaluate a new high-resolution noncontact biometer (Lenstar; Haag-Streit AG, Koeniz, Switzerland) using optical low-coherence reflectometry and to compare the clinical measurements with those obtained from the IOLMaster (Carl Zeiss, Jena, Germany) and the Pachmumeter (Haag-Streit AG).

Evaluation of endosonography as a new diagnostic tool for feline pancreatitis

The purpose of this study was to evaluate endosonography (EUS) as a potential diagnostic tool for feline pancreatitis. Eleven healthy cats and six cats diagnosed with pancreatitis based on an increased serum feline pancreatic lipase immunoreactivity (fPLI) concentration were included. Transabdominal ultrasound (AUS) and EUS were performed in all cats. The widths of both pancreatic limbs and echogenicity and homogenicity were assessed by AUS and EUS. Finally, findings from both modalities were subjectively compared. In the healthy cats, the right pancreatic limb was significantly smaller on EUS compared to AUS. Also, subjectively, general visualization of the normal pancreas was superior with EUS and, the pancreatic margins and parenchyma could be resolved better with EUS in all sick patients. In this study, EUS findings did not alter the diagnosis in six cats with pancreatitis when compared to AUS. However, EUS may be useful in cases where AUS fails due to obesity, hyperechoic mesentery, or excessive intestinal gas.

Evaluation of a new commercial enzyme-linked immunosorbent assay for the detection of porcine antibodies against Trichinella spp

Trichinellosis is a zoonotic disease that is caused by the nematode Trichinella spp. Both European Union regulations and guidelines from the World Organization for Animal Health foresee the possibility of conducting serological surveillance for Trichinella spp. A newly developed commercial enzyme-linked immunosorbent assay (ELISA) was evaluated against 2 existing diagnostic techniques: an in-house ELISA and an in-house Western blot. A total of 875 Trichinella larva-negative samples of pigs and 93 Trichinella larva-positive samples of both naturally and experimentally infected pigs were included in the study. Bayesian modeling techniques were used to correct for the absence of a perfect reference test. The sensitivity and specificity of the commercial ELISA was 97.1-97.8% and 99.5-99.8%, respectively. Sensitivity analysis demonstrated high stability in the models. In a serological surveillance system, ELISA-positive samples should be tested by a confirmatory test. The Western blot is a suitable test for this purpose. With the use of the results of the models, the sensitivity and specificity of a test protocol in both ELISA and Western blot were 95.9% and 99.9%, respectively. The high sensitivity and specificity were achieved with a lower limit of detection than that of the routine artificial digestion test, suggesting that serological surveillance is a valuable alternative in surveillance for Trichinella spp. in pig production.

Clinical evaluation of the new coat colour macchiato in a male Franches-Montagnes horse

In April 2008 a Franches-Montagnes colt was born with an unusual coat colour phenotype which had never been observed in that population before. The foal showed extended white markings on body and legs, a white head and blue eyes. As both parents have an unremarkable bay coat colour phenotype, a de novo mutation was expected in the offspring and a candidate gene approach revealed a spontaneous mutation in the microphthalmia associated transcription factor gene (MITF). A detailed clinical examination in 2010 indicated an impaired hearing capacity. As in the American Paint Horse large white facial markings in combination with blue eyes are associated with deafness, the hearing capacity of the stallion was closer examined performing brainstem auditory-evoked responses (BAER). The BAER confirmed bilateral deafness in the Franches-Montagnes colt. It is assumed that the deafness is caused by a melanocyte deficiency caused by the MITF gene mutation. Unfortunately, due to castration of the horse, the causal association between the mutation in the MITF gene and clinical findings cannot be confirmed by experimental matings.

Evaluation of a new six degrees of freedom couch for radiation therapy

Purpose: The aim of this work is to evaluate the geometric accuracy of a prerelease version of a new six degrees of freedom (6DoF) couch. Additionally, a quality assurance method for 6DoF couches is proposed. Methods: The main principle of the performance tests was to request a known shift for the 6DoF couch and to compare this requested shift with the actually applied shift by independently measuring the applied shift using different methods (graph paper, laser, inclinometer, and imaging system). The performance of each of the six axes was tested separately as well as in combination with the other axes. Functional cases as well as realistic clinical cases were analyzed. The tests were performed without a couch load and with a couch load of up to 200 kg and shifts in the range between −4 and +4 cm for the translational axes and between −3° and +3° for the rotational axes were applied. The quality assurance method of the new 6DoF couch was performed using a simple cube phantom and the imaging system. Results: The deviations (mean ± one standard deviation) accumulated over all performance tests between the requested shifts and the measurements of the applied shifts were −0.01 ± 0.02, 0.01 ± 0.02, and 0.01 ± 0.02 cm for the longitudinal, lateral, and vertical axes, respectively. The corresponding values for the three rotational axes couch rotation, pitch, and roll were 0.03° ± 0.06°, −0.04° ± 0.12°, and −0.01° ± 0.08°, respectively. There was no difference found between the tests with and without a couch load of up to 200 kg. Conclusions: The new 6DoF couch is able to apply requested shifts with high accuracy. It has the potential to be used for treatment techniques with the highest demands in patient setup accuracy such as those needed in stereotactic treatments. Shifts can be applied efficiently and automatically. Daily quality assurance of the 6DoF couch can be performed in an easy and efficient way. Long-term stability has to be evaluated in further tests.

Development and evaluation of a new instrument to measure visual exploration behavior

Effective visual exploration is required for many activities of daily living and instruments to assess visual exploration are important for the evaluation of the visual and the oculomotor system. In this article, the development of a new instrument to measure central and peripheral target recognition is described. The measurement setup consists of a hemispherical projection which allows presenting images over a large area of ±90° horizontal and vertical angle. In a feasibility study with 14 younger (21–49 years) and 12 older (50–78 years) test persons, 132 targets and 24 distractors were presented within naturalistic color photographs of everyday scenes at 10°, 30°, and 50° eccentricity. After the experiment, both younger and older participants reported in a questionnaire that the task is easy to understand, fun and that it measures a competence that is relevant for activities of daily living. A main result of the pilot study was that younger participants recognized more targets with smaller reaction times than older participants. The group differences were most pronounced for peripheral target detection. This test is feasible and appropriate to assess the functional field of view in younger and older adults.

Evaluation of a date rape prevention program for new students in a university setting

The purpose of this study was to design, implement and evaluate the effectiveness of a date rape prevention program among new students at Rice University. Six-hundred and fifteen new students were randomly assigned to one of eight residential colleges or dormitories. The distribution of students to each of the dormitories was carried out in accordance with a stratified random sampling procedure. The study population was divided into strata based on ethnicity, gender, geographical region, and academic major. The number of students randomly assigned to each of the eight dormitories was approximately 75. After this procedure was completed, each of the colleges was randomly selected to either the intervention or control group. A randomized pretest and posttest control group design was used to assess changes in attitudes, self-efficacy, and behavior with regard to date rape. All participants were given an anonymous pretest and posttest measuring attitudes, self-efficacy, and behavior immediately prior to and following the intervention. The intervention group attended the play Scruples, designed to promote date rape prevention, after which they were immediately posttested. After this initial posttest the intervention group also participated in an interactive group role-playing activity led by trained peer instructors. The control group was pretested and subject to the placebo intervention of a multiculturalism play and was posttested immediately afterwards. Later in the week this group saw the Scruples play only. Both control and intervention groups were sent a two month follow-up survey questionnaire, to measure any changes in attitudes, self-efficacy, and behavior over time. As hypothesized students who saw the play Scruples showed a change in attitudes immediately posttest but no difference in self-efficacy or behavior. The two month follow-up survey showed no change in attitudes, self-efficacy, or behavior. There was a difference at pretest in males and females attitudes, with males showing significantly more rape tolerant attitudes than females. Thus, the proposed research findings will provide a better understanding of the attitudes that perpetuate date rape, and will inform strategies for prevention programs. ^

Evaluation of a new experimental model to study bone healing after ridge expansion with simultaneous implant placement--a pilot study in minipigs.

OBJECTIVE To evaluate the suitability of a minipig model for the study of bone healing and osseointegration of dental implants following bone splitting and expansion of narrow ridges. MATERIAL AND METHODS In four minipigs, the mandibular premolars and first molars were extracted together with removal of the buccal bone plate. Three months later, ridge splitting and expansion was performed with simultaneous placement of three titanium implants per quadrant. On one side of the mandible, the expanded bone gap between the implants was filled with an alloplastic biphasic calcium phosphate (BCP) material, while the gap on the other side was left unfilled. A barrier membrane was placed in half of the quadrants. After a healing period of 6 weeks, the animals were sacrificed for histological evaluation. RESULTS In all groups, no bone fractures occurred, no implants were lost, all 24 implants were osseointegrated, and the gap created by bone splitting was filled with new bone, irrespective of whether BCP or a barrier membrane was used. Slight exposure of five implants was observed, but did not lead to implant loss. The level of the most coronal bone-to-implant contact varied without being dependent on the use of BCP or a barrier membrane. In all groups, the BCP particles were not present deep in the bone-filled gap. However, BCP particles were seen at the crestal bone margin, where they were partly integrated in the new bone. CONCLUSIONS This new minipig model holds great promise for studying experimental ridge splitting/expansion. However, efforts must be undertaken to reduce implant exposure and buccal bone resorption.

Continuous dynamic mapping of the corticospinal tract during surgery of motor eloquent brain tumors: evaluation of a new method

OBJECT The authors developed a new mapping technique to overcome the temporal and spatial limitations of classic subcortical mapping of the corticospinal tract (CST). The feasibility and safety of continuous (0.4-2 Hz) and dynamic (at the site of and synchronized with tissue resection) subcortical motor mapping was evaluated. METHODS The authors prospectively studied 69 patients who underwent tumor surgery adjacent to the CST (< 1 cm using diffusion tensor imaging and fiber tracking) with simultaneous subcortical monopolar motor mapping (short train, interstimulus interval 4 msec, pulse duration 500 μsec) and a new acoustic motor evoked potential alarm. Continuous (temporal coverage) and dynamic (spatial coverage) mapping was technically realized by integrating the mapping probe at the tip of a new suction device, with the concept that this device will be in contact with the tissue where the resection is performed. Motor function was assessed 1 day after surgery, at discharge, and at 3 months. RESULTS All procedures were technically successful. There was a 1:1 correlation of motor thresholds for stimulation sites simultaneously mapped with the new suction mapping device and the classic fingerstick probe (24 patients, 74 stimulation points; r(2) = 0.98, p < 0.001). The lowest individual motor thresholds were as follows: > 20 mA, 7 patients; 11-20 mA, 13 patients; 6-10 mA, 8 patients; 4-5 mA, 17 patients; and 1-3 mA, 24 patients. At 3 months, 2 patients (3%) had a persistent postoperative motor deficit, both of which were caused by a vascular injury. No patient had a permanent motor deficit caused by a mechanical injury of the CST. CONCLUSIONS Continuous dynamic mapping was found to be a feasible and ergonomic technique for localizing the exact site of the CST and distance to the motor fibers. The acoustic feedback and the ability to stimulate the tissue continuously and exactly at the site of tissue removal improves the accuracy of mapping, especially at low (< 5 mA) stimulation intensities. This new technique may increase the safety of motor eloquent tumor surgery.

Bacterial meningitis: insights into pathogenesis and evaluation of new treatment options: a perspective from experimental studies.

ABSTRACT  Bacterial meningitis is associated with high mortality and morbidity rates. Bacterial components induce an overshooting inflammatory reaction, eventually leading to brain damage. Pathological correlates of neurofunctional deficits include cortical necrosis, damage of the inner ear and hippocampal apoptosis. The hippocampal dentate gyrus is important for memory acquisition and harbors a neuronal stem cell niche, thus being potentially well equipped for regeneration. Adjuvant therapies aimed at decreasing the inflammatory reaction, for example, dexamethasone, and those protecting the brain from injury have been evaluated in animal models of the disease. They include nonbacteriolytic antibiotics (e.g., daptomycin), metalloproteinase inhibitors and modulators of the immunological response, for example, granulocyte colony-stimulating factor. Increasing research interest has recently been focused on interventions aimed at supporting regenerative processes.

Development and Evaluation of a New Tablet Computer Application for the Therapy of Brain-Injured Patients with Aphasia

Introduction Language is the most important mean of communication and plays a central role in our everyday life. Brain damage (e.g. stroke) can lead to acquired disorders of lan- guage affecting the four linguistic modalities (i.e. reading, writing, speech production and comprehension) in different combinations and levels of severity. Every year, more than 5000 people (Aphasie Suisse) are affected by aphasia in Switzerland alone. Since aphasia is highly individual, the level of difficulty and the content of tasks have to be adapted continuously by the speech therapists. Computer-based assignments allow patients to train independently at home and thus increasing the frequency of ther- apy. Recent developments in tablet computers have opened new opportunities to use these devices for rehabilitation purposes. Especially older people, who have no prior experience with computers, can benefit from the new technologies. Methods The aim of this project was to develop an application that enables patients to train language related tasks autonomously and, on the other hand, allows speech therapists to assign exercises to the patients and to track their results online. Seven categories with various types of assignments were implemented. The application has two parts which are separated by a user management system into a patient interface and a therapist interface. Both interfaces were evaluated using the SUS (Subject Usability Scale). The patient interface was tested by 15 healthy controls and 5 patients. For the patients, we also collected tracking data for further analysis. The therapist interface was evaluated by 5 speech therapists. Results The SUS score are xpatients = 98 and xhealthy = 92.7 (median = 95, SD = 7, 95% CI [88.8, 96.6]) in case of the patient interface and xtherapists = 68 in case of the therapist interface. Conclusion Both, the patients and the healthy subjects, attested high SUS scores to the patient interface. These scores are considered as "best imaginable". The therapist interface got a lower SUS score compared to the patient interface, but is still considered as "good" and "usable". The user tracking system and the interviews revealed that there is room for improvements and inspired new ideas for future versions.

Evaluation of New Cone-beam Computed Tomographic Criteria for Radiographic Healing Evaluation after Apical Surgery: Assessment of Repeatability and Reproducibility.

INTRODUCTION Conventional 2-dimensional radiography uses defined criteria for outcome assessment of apical surgery. However, these radiographic healing criteria are not applicable for 3-dimensional radiography. The present study evaluated the repeatability and reproducibility of new cone-beam computed tomographic (CBCT)-based healing criteria for the judgment of periapical healing 1 year after apical surgery. METHODS CBCT scans taken 1 year after apical surgery (61 roots of 54 teeth in 54 patients, mean age = 54.4 years) were evaluated by 3 blinded and calibrated observers using 4 different indices. Reformatted buccolingual CBCT sections through the longitudinal axis of the treated roots were analyzed. Radiographic healing was assessed at the resection plane (R index), within the apical area (A index), of the cortical plate (C index), and regarding a combined apical-cortical area (B index). All readings were performed twice to calculate the intraobserver agreement (repeatability). Second-time readings were used for analyzing the interobserver agreement (reproducibility). Various statistical tests (Cohen, kappa, Fisher, and Spearman) were performed to measure the intra- and interobserver concurrence, the variability of score ratios, and the correlation of indices. RESULTS For all indices, the rates of identical first- and second-time scores were always higher than 80% (intraobserver Cohen κ values ranging from 0.793 to 0.963). The B index (94.0%) showed the highest intraobserver agreement. Regarding interobserver agreement, the highest rate was found for the B index (72.1%). The Fleiss' κ values for R and B indices exhibited substantial agreement (0.626 and 0.717, respectively), whereas the values for A and C indices showed moderate agreement (0.561 and 0.573, respectively). The Spearman correlation coefficients for R, A, C, and B indices all exhibited a moderate to very strong correlation with the highest correlation found between C and B indices (rs = 0.8069). CONCLUSIONS All indices showed an excellent intraobserver agreement (repeatability). With regard to interobserver agreement (reproducibility), the B index (healing of apical and cortical defects combined) and the R index (healing on the resection plane) showed substantial congruence and thus are to be recommended in future studies when using buccolingual CBCT sections for radiographic outcome assessment of apical surgery.