Functional Assessment System Research Articles

Novel measures of cognition and function for the AD spectrum in the Novel Measures for Alzheimer's Disease Prevention Trials (NoMAD) project: Psychometric properties, convergent validation, and contrasts with established measures.

This study derived composite scores for two novel cognitive measures, the No Practice Effect (NPE) battery and the Miami Computerized Functional Skills Assessment and Training system for use in early-stage Alzheimer's disease (AD) clinical trials. Their psychometric properties and associations with AD risk markers were compared to those of well-established measures. For 291 older adults with healthy cognition or early mild cognitive impairment, Exploratory factor analyses were used to identify the factor structure of the NPE. Factor and total scores were examined for their psychometric properties and associations with AD risk biomarkers. Composite scores from the novel cognitive and functional measures demonstrated better psychometric properties (distribution and test-retest reliability) and stronger associations with AD-related demographic, genetic, and brain risk markers than well-established measures, DISCUSSION: These novel measures have potential for use as primary cognitive and functional outcomes in early-stage AD clinical trials. Well-established cognitive tests may not accurately detect subtle cognitive changes. No Practice Effect (NPE) and Computerized Functional Skills Assessment and Training are novel measures designed to have improved psychometric properties. NPE had Executive Function, Cognitive Control/Speed, and Episodic Memory domains. Novel measures had better psychometric properties compared to established measures. Significant associations with Alzheimer's disease biomarkers were found with novel measures.

Ambient floor vibration sensing advances the accessibility of functional gait assessments for children with muscular dystrophies

Muscular dystrophies (MD) are a group of genetic neuromuscular disorders that cause progressive weakness and loss of muscles over time, influencing 1 in 3500–5000 children worldwide. New and exciting treatment options have led to a critical need for a clinical post-marketing surveillance tool to confirm the efficacy and safety of these treatments after individuals receive them in a commercial setting. For MDs, functional gait assessment is a common approach to evaluate the efficacy of the treatments because muscle weakness is reflected in individuals’ walking patterns. However, there is little incentive for the family to continue to travel for such assessments due to the lack of access to specialty centers. While various existing sensing devices, such as cameras, force plates, and wearables can assess gait at home, they are limited by privacy concerns, area of coverage, and discomfort in carrying devices, which is not practical for long-term, continuous monitoring in daily settings. In this study, we introduce a novel functional gait assessment system using ambient floor vibrations, which is non-invasive and scalable, requiring only low-cost and sparsely deployed geophone sensors attached to the floor surface, suitable for in-home usage. Our system captures floor vibrations generated by footsteps from patients while they walk around and analyzes such vibrations to extract essential gait health information. To enhance interpretability and reliability under various sensing scenarios, we translate the signal patterns of floor vibration to pathological gait patterns related to MD, and develop a hierarchical learning algorithm that aggregates insights from individual footsteps to estimate a person’s overall gait performance. When evaluated through real-world experiments with 36 subjects (including 15 patients with MD), our floor vibration sensing system achieves a 94.8% accuracy in predicting functional gait stages for patients with MD. Our approach enables accurate, accessible, and scalable functional gait assessment, bringing MD progressive tracking into real life.

A versatile pumpless multi-channel fluidics system for maintenance and real-time functional assessment of tissue and cells

To address the needs of the life sciences community and the pharmaceutical industry in pre-clinical drug development to both maintain and continuously assess tissue metabolism and function with simple and rapid systems, we improved on the initial BaroFuse to develop it into a fully functional, pumpless, scalable multi-channel fluidics instrument that continuously measures changes in oxygen consumption and other endpoints in response to test compounds. We and several other laboratories assessed it with a wide range of tissue types including retina, pancreatic islets, liver, and hypothalamus with both aqueous and gaseous test compounds. The setup time was less than an hour for all collaborating groups, and there was close agreement between data obtained from the different laboratories. This easy-to-use system reliably generates real-time metabolic and functional data from tissue and cells in response to test compounds that will address a critical need in basic and applied research.

Open-Source System for Real-Time Functional Assessment of In Vitro Filtration Barriers.

The integrity of the barrier between blood and the selective filtrate of solutes is important for homeostasis and its disruption contributes to many diseases. Microphysiological systems that incorporate synthetic or natural membranes with human cells can mimic biological filtration barriers, such as the glomerular filtration barrier in the kidney, and they can readily be used to study cellular filtration processes as well as drug effects and interactions. We present an affordable, open-source platform for the real-time monitoring of functional filtration status in engineered microphysiological systems. Using readily available components, our assay can linearly detect real-time concentrations of two target molecules, FITC-labeled inulin and Texas Red-labeled human-serum albumin, within clinically relevant ranges, and it can be easily modified for different target molecules of varying sizes and tags. We demonstrate the platform's ability to determine the concentration of our target molecules automatically and consistently. We show through an acellular context that the platform enables real-time tracking of size-dependent diffusion with minimal fluid volume loss and without manual extraction of media, making it suitable for continuous operational monitoring of filtration status in microphysiological system applications. The platform's affordability and integrability with microphysiological systems make it ideal for many precision medicine applications, including evaluation of drug nephrotoxicity and other forms of drug discovery.

A Portable Self‐Powered Turbine Spirometer for Rehabilitation Monitoring on COVID‐19

AbstractCoronavirus disease 2019 (COVID‐19) patients may experience persistent impairment of the lungs after recovery and discharge, which can cause a decline in pulmonary function. Therefore, regular pulmonary function tests are essential for COVID‐19 recovered patients, and portable, home‐based pulmonary function test devices are of great significance during the pandemic. Herein, a portable self‐powered turbine spirometer (PSTS) is designed for respiratory flow measurement and assessment of pulmonary function with high accuracy, humidity resistance, good durability, and low cost. The respiratory airflow can directly drive PSTS to produce a sinusoidal signal with a signal‐to‐noise of 40.64 dB. By utilizing the long short‐term memory (LSTM) model, the flow is successfully predicted, and the “lag‐before‐start” and “spin‐after‐stop” defects of the turbine spirometer are eliminated effectively. For pulmonary function tests, the flow‐volume loop curve can be obtained from PSTS, and pulmonary function parameters such as inspiratory capacity (IC), forced vital capacity (FVC) and forced expiratory volume in the first 1 s (FEV1) can be calculated. The accuracy of IC is over 95%, and others can reach over 97%. A portable smart pulmonary function assessment system is further developed and used to test the pulmonary function of COVID‐19 patients one month after symptom onset, demonstrating potential for assessing rehabilitation trends and long‐term follow‐up of COVID‐19 recovered patients.

Regulating Microvascular Free Flaps Reconstruction in "Schobinger Stage 4" Arteriovenous Malformations of Face.

Objectives Arteriovenous malformations (AVMs) are high-flow, aggressive lesions that cause systemic effects and may pose a risk to life. These lesions are difficult to treat as they have a tendency to recur aggressively after excision or embolization. So, it requires a regulating free flap with robust vascular flow averting the postexcisional ischemia-induced collateralization, parasitization, and recruitment of neovessels from the surrounding mesenchyme-a phenomenon precipitating and perpetuating the recurrence of AVM. Materials and Methods Sixteen patients (12 males and 4 females) with AVMs Schobinger type 4 involving face were treated from March 2015 to March 2021 with various free flaps: three free rectus abdominis flaps, one free radial forearm flap, and twelve free anterolateral thigh flaps were used for reconstruction following the wide local excision of Schobinger type 4 facial AVM. The records of these patients were analyzed retrospectively. The average follow-up period was 18.5 months. The functional and aesthetic outcomes were analyzed with institutional assessment scores. Results The average size of the flap harvested was 113.43 cm 2 . Fourteen patients (87.5%) had good-to-excellent score ( p = 0.035) with institutional aesthetic and functional assessment system. The remaining two patients (12.5%) had only fair results. There was no recurrence (0%) in the free flap group versus 64% recurrence in the pedicled flap and skin grafting groups ( p = 0.035). Conclusion Free flaps with their robust and homogenized blood supply provide a good avenue for void filling and an excellent regulating effect in inhibiting any locoregional recurrences of AVMs.

CNN-assisted SERS enables ultra-sensitive and simultaneous detection of Scr and BUN for rapid kidney function assessment.

Kidney disease is highly prevalent and may result in severe clinical outcomes. Serum creatinine (Scr) and blood urea nitrogen (BUN) are the most widely used biomarkers for kidney function assessment, yet when measured alone, the result can be affected by a variety of parameters such as age, gender, protein consumption, etc. Measuring Scr and BUN simultaneously can eliminate most of the external influences and greatly improve the assessment of kidney function. In this study, a real-time kidney function assessment system based on dual biomarker detection was proposed. Scr and BUN were determined using surface-enhanced Raman scattering (SERS) within the concentration range of 10-1 to 10-6 M and 0.28 to 100 mg dl-1, respectively. A one-dimensional convolutional neural network (1D-CNN) model was employed to quantitatively analyze the concentration of biomarkers from the SERS spectral measurements. Moreover, we simulated a variety of kidney health conditions with 16 groups of mixed Scr and BUN in serum. The proposed CNN-assisted SERS method was used to quantify both biomarkers and provide diagnostic results. The Au core-Ag shell nanoprobes provided ultra-sensitive SERS detection and the CNN model achieved excellent regression results with an R2 of 0.9871 in the testing dataset. The system demonstrated a rapid and robust evaluation for the assessment of kidney function, providing a promising idea for medical diagnosis with the help of spectroscopy and deep learning methods.

Importance of urodynamic evaluation of bladder function after secondary untethering in spina bifida patients: single center experience of 30 years

IntroductionA TCS after primary closure of meningomyeloceles is a known complication of the spina bifida disease. Data on the outcome after SSCU surgery is heterogeneous and lacking standardization. Thus we aimed to find a reliable system for assessment of the bladder function before and after SSCU surgery and document postoperative outcome.MethodsA retrospective study was performed on a cohort of patients with spina bifida diagnosis. In total, 130 patients underwent 182 SSCU surgeries, 56 of those met our inclusion criteria. A classification system, including two different methods, was used. The AC system used baseline pressure and detrusor over activity to define three levels of bladder dysfunction, the second method ranked the severity of bladder dysfunction by awarding points from 0 to 2 for bladder capacity, maximal detrusor pressure during autonomous contractions, leak point pressure and vesicoureteral reflux A high score is correlated with a severe bladder dysfunction.ResultsGender distribution was equally (male: n = 29; 51.8%; female: n = 27; 48.2%). The median age at SSCU was 902 years (range 0.5–22.8 years). After SSCU, the stage improved in 11 patients (19.6%), worsened in 11 (19.6%) patients and remained the same in 34 patients (60.7%) after intervention (AC score). Non-worsening was observed in a total of 45 cases (80.4%) (p < 0.001). MHS score (n = 27, 48.2%) improved, remained unchanged (n = 12, 21.4%), 17 patients worsened (30.4%). Non-worsening in postoperative bladder functional outcome was demonstrated in 39 cases (69.6%) over all (p < 0.005). Regardless of whether bladder function is categorized by AC or MHS, postoperative outcome worsened significantly when SSCU was performed due to increasing deterioration in motor function alone (p < 0.05). Of the 24 cases with NOD as indication, 22 (91.7%) had an unchanged (n = 10; 41.7%) or improved (n = 12; 50.0%), meaning positive neuro-orthopedic outcome, only 2 (8.3%) deteriorated (p < 0.001).ConclusionOur study presents reliable evaluation systems for bladder function in spina bifida patients. Since indications for SSCU surgery differ, it is important to know the possible effects on bladder function after this surgical procedure. Even a mild impairment of bladder function has a risk to deteriorate after SSCU surgery. Particularly interesting becomes this with regard to the fact that the prevalence of TCS might become more frequent with the rising numbers of prenatal closures of meningomyeloceles.

Outcome and Related Factors in Patients With Distal Radius Fracture After Rehabilitation Treatment

Background: Distal radius fracture is the most common forearm fracture in elderly people. Rehabilitation after the fracture could increase effectiveness of treatment as it could reduce pain and increase range of motion and strength of hand and wrist. Objective: To study the outcome and related factors in patients with distal radius fracture after rehabilitation treatment. Methods: The medical record of 30 patients diagnosed with distal radius fracture received rehabilitation treatment with at least 1-year follow-up period was reviewed. Primary outcome included pain, range of motion, grip strength, and deformity were combined to calculate the total score of modified scoring system for functional assessment. Secondary outcome was severity of fracture, treatment method, duration from fracture to rehabilitation treatment and rehabilitative facilities which were also analysed regarding the primary outcome. Results: Most good outcome was reported at 6 months after fracture. Only grip strength required a year to improve. Patients with poor outcome were mostly found in severely fractured group (15/16, 93.8%) with P &lt; .001. The overall total score turned good at 12 months after fracture. Other factors showed no significant correlation with primary outcome (P &gt; .05). Conclusions: Overall outcome was considered good at 12 months after fracture. Severe type of fracture predicted poorer outcome compared with mild type with statistical significance. No statistically significant difference was reported between patients received rehabilitation earlier and later than 2 months in accordance with treatment methods and rehabilitation settings.

Automatic assessment of dairy cows' rumen function over time and links to feed changes and milk production

A 3-dimensional (3D) vision-based system was previously designed to automatically estimate the rumen motility of individual cows. This longitudinal study aimed to explore the associations between 3D vision-based rumen function assessment and dairy cow feed changes and milk production on a commercial farm. The 3D vision system was attached to an automatic milking robot to estimate the ruminal contraction frequency and rumen fill in 42 lactating cows during each milking event for 66 d. Additionally, we collected data on milk production, milk composition, general health, and changes in feeding practices. The 3D vision system showed that half the cows displayed a drastic decrease in the estimated rumen fill when all cows began grazing. The grazing and decreased rumen fill were also associated with herd-level milk fat depression. Over the 66 d, one cow was detected with reduced milk production and suspected rumen dysfunction by the farmer. The 3D vision system, however, identified this cow as having sudden decreases in estimated ruminal contraction frequency and rumen fill 4 d before detection by the farmer. In this longitudinal study, the 3D vision-based rumen function assessment system showed potential as a useful management-supporting tool for dairy farmers. The system, however, requires further validation with more cows of various breeds and ages. We suggest validating the 3D vision system with rumen boluses, quantified adjustments in feeding practices, more cases with ruminal dysfunction, and systematic health assessments for future studies.

A Study Protocol for Evaluation of Clinical and Functional Outcomes of Forearm Bone Fractures Treated by Screw Intramedullary Nail

Background: The incidence of forearm fractures has increased rapidly over the past few years as a consequence of industrial accidents, interpersonal assaults, road traffic accidents, sports injuries, etc. The advantages of Closed or mini-open reduction using screw intramedullary nail and stable fixation include short duration and low-cost of surgery, 3 point fixation, and satisfactory union of the fracture. This study aims to assess the clinical, radiological, and functional outcomes of forearm bone fractures treated by Screw intramedullary nails.&#x0D; Materials and Methods: This will be a Prospective Observational study conducted on 25 skeletally mature patients reporting to the dept. of Orthopedics, AVBRH, Wardha. Patients with fracture of radius and ulna together or single bone diaphyseal fracture in the forearm will be enrolled in the study. The findings will be analyzed using parameters proposed by Anderson et. al. scoring system for functional assessment and radiological union. Statistical analysis would be done to conclude the findings.&#x0D; Expected Results: Significant clinical, radiological, and functional outcomes of forearm bone fractures treated by Screw intramedullary nail are expected.

Somatoneurological and psycho-pedagogical features of children with cerebral palsy in the context of their readiness for training in Paralympic sports

Introduction. Currently, Russia does not have a scientifically grounded medical and psychological support system for disabled children (DC), which allows involving them in classes in children and youth schools of adaptive physical education, preparing the country’s Paralympic DC reserve. Aim of the study. To develop and create a medical support system for the Paralympic DC reserve, capable of improving their quality of life and forming a medical and social lift. Materials and methods. Children aged from 1 year to 18 years had cerebral palsy (CP) with impaired motor functions of levels I and II according to the global motor function assessment system and the Manual Abilities Classification system and their families were monitored. A comprehensive assessment of the somatic, neurological, mental and nutritional status of CP children) was carried out, and a wide range of comorbid pathology was described. After the rehabilitation treatment with the use of complex personalized rehabilitation programs, dynamic monitoring of the condition of patients with cerebral palsy was carried out, followed by an assessment of the effectiveness of rehabilitation treatment and the impact on it the psychological readiness of patients, their parents to engage in Paralympic sports, as well as the socio-economic level of the family. The attitude of CP children and their parents to participate in the Paralympic movement was studied. All patients underwent a comprehensive study of somatic, neurological, orthopaedic, psychological and nutritional status. The socio-hygienic characteristics of families and the rehabilitation potential of DC and their families have been determined. Results. Children with cerebral palsy have a wide range of comorbid pathology, which requires the involvement of specialists of different profiles in the curation of patients. The use of complex personalized rehabilitation programs allows achieving positive dynamics after 14 days of rehabilitation treatment. Early introduction of botulinum therapy in the rehabilitation program of CP patients provides higher efficiency of rehabilitation treatment. Treatment of protein-energy deficiency in CP children should include correction of the diet using specialized products, metabolic therapy, enzyme and complex vitamin preparations. Differentiated medical, psychological and pedagogical counselling of parents of CP children will allow optimizing the solution of the state problem regarding the timely inclusion of persons with disabilities in adaptive physical education classes. Conclusion. The development and creation of a comprehensive medical and psychological support system solve an urgent medical and social problem, ensuring the integration of DC into society and improving the quality of life of both a sick child and his family members.

Treatment of postoperative tibial chronic osteomyelitis using bone transport techniques; an observational study

PurposePostoperative Tibial chronic osteomyelitis is one of the most challenging orthopaedic conditions especially when extensive, the anatomy of subcutaneous anteromedial part of the tibia with less soft tissue coverage complicates the situation. The extent of infected tibial part varies in size and duration from one patient to another. We report our experience using Bifocal and Monofocal bone transport techniques with regard to clinical outcome, recurrence of infection and re-fracture rate. MethodsThis is a retrospective observational review of 49 patients with postoperative Tibial chronic osteomyelitis which were treated using either Bifocal distraction compression BFDCO technique group I (31 patients) or Monofocal compression osteosynthesis MFCO technique Group II (18 patients). The average age of the patients was (41.6 ± 13.1 years), (range: 17–67 years). Leg length discrepancy was measured in 33 (58.9%) patients with an average of (1.4 ± 1.7 cm). Contracture of the ankle joint and equinus deformity were detected in 36 (64.3%) patients. Pre and Post-operative radiography together with Modified Irzhansky A.A et al. leg functional assessment system were used to assess the functional outcome. ResultsThe time spent in the Ilizarov fixator (External Fixation Index) in the first group was (142 ± 72 days) and in the second group was (75 ± 54 days). The infection recurred in 2 patients (6%) in group I and in 5 patients (28%) in group II. Lack of consolidation or re-fracture within 6 months after the dismantling of the apparatus was detected in 6 patients (19.5%) in group I and in 5 patients (27.8%) in group II. Lack of consolidation or re-fracture within 6 months after dismantling of the apparatus in group I was detected in 6 patients (19.5%) in group I and in 5 patients (27.8%) in Group II. The average functional state score (AFSS) in the first group was (12.45 ± 2.41) on admission and increased to (16.16 ± 2.99) on the final follow-up which corresponded to a “good” result. In the second group II the AFSS was (12.11 ± 2.22) on admission and increased to (15.06 ± 2.88) at the final follow-up which corresponded to a “satisfactory” result. ConclusionTreatment of Tibial chronic osteomyelitis using either Bifocal or Monofocal bone transport is an effective method. However our results have demonstrated better functional outcome and less infection recurrence and re-fracture rates when using the Bifocal distraction compression technique (BFDCO).

THE EFFECTIVENESS OF THE SYSTEM FOR ASSESSING THE FUNCTIONAL LITERACY OF STUDENTS IN COMPUTER SCIENCE BASED ON THE CRITERION APPROACH

In the article, based on the criterion approach, the effectiveness of the system for assessing the functional literacy of students in computer science is proved by conducting a pedagogical experiment and conclusions are drawn about the results of practical work. The teaching experience consists of three stages. At the ascertaining stage, it was revealed to what extent the assessment tasks in computer science were compiled taking into account the directions of functional literacy of students. At the applicant stage, tasks and tasks were developed to assess the functional literacy of students based on a criteria-based approach in computer science. At the educational and control stage, the influence of the functional literacy assessment system, developed on the basis of a criterion approach in computer science, on the quality of knowledge and the methodology of teaching students in computer science was revealed. In addition, during the practice, the educational and methodological manual "tasks for assessing the functional literacy of students in computer science" was used. During the training in the control groups, the assessment of knowledge was carried out according to the traditional method, and in the experimental groups on tasks to assess the functional literacy of students based on the criteria approach.

Functional assessment system for unmanned aerial navigation systems from the quality of information

Unmanned aerial navigation systems are not used in many military and non-military applications. However, these systems are susceptible be operated by hackers partially or completely. Therefore, in this article based on the JDL model for safety assessment of the drone’s framework it is proposed. Metrics for each level of the merger in conjunction with a mapping system in order to determine the dependence of data between different levels are proposed, considering the contextual user ratings.

Effectiveness of extended Carlson approach in treatment of lateral femoral condylar Hoffa fractures

To investigate the effectiveness of the extended Carlson approach in the treatment of lateral femoral condylar Hoffa fractures. The clinical data of 17 patients with lateral femoral condyle Hoffa fractures between September 2012 and January 2019 were retrospectively analyzed. There were 10 males and 7 females, with a mean age of 43 years (range, 32-68 years). Fractures were caused by traffic accident in 9 cases, by falling from height in 6 cases, and by the other mechanism in 2 cases. According to the Letenneur's classification, there were 8 cases of typeⅠ, 6 cases of type Ⅱ, and 3 cases of type Ⅲ. The mean time from injury to operation was 7 days (range, 3-32 days). All patients were treated with extended Carlson approach. Patients with Letenneur types Ⅰ and Ⅲ were fixed by a posterior antigliding plate combined with headless compression screws from anteroposterior direction, and patients with Letenneur typeⅡ were fixed by headless compression screws from anteroposterior direction. The anteroposterior and lateral X-ray films, CT and three-dimensional reconstruction of the knee joint were taken after operation to assess fracture healing and position of the internal fixators. The knee function was evaluated according to Letenneur's functional assessment system. All patients were followed up 13-28 months (mean, 15 months). All the incisions healed by first intention, and no complication such as fracture redisplacement, fracture nonunion, internal fixator fracture, and common peroneal nerve injury occurred. The mean time of fracture healing was 18 weeks (range, 16-32 weeks). At last follow-up, according to Letenneur's functional assessment system, the knee function was excellent in 12 cases and good in 5 cases, with an excellent and good rate of 100%. The extended Carlson approach for the treatment of lateral femoral condylar Hoffa fractures has the advantages of clear exposure, easy reduction and fixation, high fracture healing rate, few complications, and good recovery of knee joint function.

Detection of facial landmarks by a convolutional neural network in patients with oral and maxillofacial disease

Facial nerve dysfunction is common in patients with Bell’s palsy, trauma, tumour, or iatrogenic injuries. Imaging assessment is the most convenient method for patients and their treating physician. With developments in artificial intelligence (AI), manual work will be replaced. In this study, a database of facial images of patients with oral and maxillofacial diseases was set up to develop a facial nerve functional assessment system based on AI. This database was then used to evaluate the accuracy of a state-of-the-art algorithm for facial landmark detection named ‘HRNet’. Utilizing this database and with appropriate human intervention, HRNet was used in facial annotation. The accuracy of annotations was evaluated through the normalized mean error. A total of 912 images were collected from 300 people; 546 of these images had abnormal features including defects, swelling, scars, or facial paralysis. The accuracy for the abnormal group was lower than that for the normal group before and after training, but improvements in accuracy were identified in both groups post-training. In conclusion, this new database demonstrates the ability of HRNet to localize facial landmarks in patients with oral and maxillofacial diseases. More images for training should be added to this database to diversify it in the future.

Surgical treatment for antiplatelet intracerebral hemorrhage (SAP-ICH): protocol for a prospective cohort study of emergency surgery for severe spontaneous intracerebral hemorrhage patients on long-term oral antiplatelet treatment

BackgroundDespite the capability of emergency surgery to reduce the mortality of severe spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical treatment for severe spontaneous intracranial hemorrhage (SSICH) patients receiving long-term oral antiplatelet treatment (LOAPT) remains unclear. In consideration of this, the cohort study is aimed at figuring out the effect and safety of emergency surgery for SSICH patients on LOAPT.MethodsAs a multicenter and prospective cohort study, it will be conducted across 7 representative clinical centers. Starting in September 2019, the observation is scheduled to be completed by December 2022, with a total of 450 SSICH patients recruited. The information on clinical, radiological, and laboratory practices will be recorded objectively. All of the patients will be monitored until death or 6 months after the occurrence of primary hemorrhage.ResultsIn this study, two comparative cohorts and an observational cohort will be set up. The primary outcome is the effect of emergency surgery, which is subject to assessment using the total mortality and comparison in the survival rate of SSICH patients on LOAPT between surgical treatment and conservative treatment. The second outcome is the safety of surgery, with the postoperative hemorrhagic complication which is compared between the operated SSICH patients on and not on LOAPT. Based on the observation of the characteristics and outcome of SSICH patients on LOAPT, the ischemic events after discontinuing LOAPT will be further addressed, and the coagulation function assessment system for operated SSICH patients on LOAPT will be established.ConclusionsIn this study, we will investigate the effect and safety of emergency surgery for SSICH patients on LOAPT, which will provide an evidence for management in the future.Ethics and disseminationThe research protocol and informed consent in this study were approved by the Institutional Review Board of Beijing Tiantan Hospital (KY2019-096-02). The results of this study are expected to be disseminated in peer-reviewed journals in 2023.Trial registrationName: Effect and safety of surgical intervention for severe spontaneous intracerebral hemorrhage patients on long-term oral antiplatelet treatment.ChiCTR1900024406. Date of registration is July 10, 2019.

A Multi-Mode System for Myocardial Functional and Physiological Assessment during Ex Situ Heart Perfusion

Ex situ heart perfusion (ESHP) has proven to be an important and valuable step toward better preservation of donor hearts for heart transplantation. Currently, few ESHP systems allow for a convenient functional and physiological evaluation of the heart. We sought to establish a simple system that provides functional and physiological assessment of the heart during ESHP. The ESHP circuit consists of an oxygenator, a heart–lung machine, a heater–cooler unit, an anesthesia gas blender, and a collection funnel. Female Yorkshire pig hearts (n = 10) had del Nido cardioplegia (4°C) administered, excised, and attached to the perfusion system. Hearts were perfused retrogradely into the aortic root for 2 hours before converting the system to an isovolumic mode or a working mode for further 2 hours. Blood samples were analyzed to measure metabolic parameters. During the isovolumic mode (n = 5), a balloon inserted in the left ventricular (LV) cavity was inflated so that an end-diastolic pressure of 6–8 mmHg was reached. During the working mode (n = 5), perfusion in the aortic root was redirected into left atrium (LA) using a compliance chamber which maintained an LA pressure of 6–8 mmHg. Another compliance chamber was used to provide an afterload of 40–50 mmHg. Hemodynamic and metabolic conditions remained stable and consistent for a period of 4 hours of ESHP in both isovolumic mode (LV developed pressure: 101.0 ± 3.5 vs. 99.7 ± 6.8 mmHg,p= .979, at 2 and 4 hours, respectively) and working mode (LV developed pressure: 91.0 ± 2.6 vs. 90.7 ± 2.5 mmHg,p= .942, at 2 and 4 hours, respectively). The present study proposed a novel ESHP system that enables comprehensive functional and metabolic assessment of large mammalian hearts. This system allowed for stable myocardial function for up to 4 hours of perfusion, which would offer great potential for the development of translational therapeutic protocols to improve dysfunctional donated hearts.

A Multi-Mode System for Myocardial Functional and Physiological Assessment during Ex Situ Heart Perfusion.

Ex situ heart perfusion (ESHP) has proven to be an important and valuable step toward better preservation of donor hearts for heart transplantation. Currently, few ESHP systems allow for a convenient functional and physiological evaluation of the heart. We sought to establish a simple system that provides functional and physiological assessment of the heart during ESHP. The ESHP circuit consists of an oxygenator, a heart-lung machine, a heater-cooler unit, an anesthesia gas blender, and a collection funnel. Female Yorkshire pig hearts (n = 10) had del Nido cardioplegia (4°C) administered, excised, and attached to the perfusion system. Hearts were perfused retrogradely into the aortic root for 2 hours before converting the system to an isovolumic mode or a working mode for further 2 hours. Blood samples were analyzed to measure metabolic parameters. During the isovolumic mode (n = 5), a balloon inserted in the left ventricular (LV) cavity was inflated so that an end-diastolic pressure of 6-8 mmHg was reached. During the working mode (n = 5), perfusion in the aortic root was redirected into left atrium (LA) using a compliance chamber which maintained an LA pressure of 6-8 mmHg. Another compliance chamber was used to provide an afterload of 40-50 mmHg. Hemodynamic and metabolic conditions remained stable and consistent for a period of 4 hours of ESHP in both isovolumic mode (LV developed pressure: 101.0 ± 3.5 vs. 99.7 ± 6.8 mmHg, p = .979, at 2 and 4 hours, respectively) and working mode (LV developed pressure: 91.0 ± 2.6 vs. 90.7 ± 2.5 mmHg, p = .942, at 2 and 4 hours, respectively). The present study proposed a novel ESHP system that enables comprehensive functional and metabolic assessment of large mammalian hearts. This system allowed for stable myocardial function for up to 4 hours of perfusion, which would offer great potential for the development of translational therapeutic protocols to improve dysfunctional donated hearts.