Hospital Staff Perspectives on the Drivers and Challenges in Implementing a Virtual Rehabilitation Ward: Qualitative Study.

Background: Over the past decade, the adoption of virtual wards has surged. Virtual wards aim to prevent unnecessary hospital admissions, expedite home discharge, and enhance patient satisfaction, which are particularly beneficial for the older adult population who faces risks associated with hospitalization. Consequently, substantial investments are being made in virtual rehabilitation wards (VRWs), despite evidence of varying levels of success in their implementation. However, the facilitators and barriers experienced by virtual ward staff for the rapid implementation of these innovative care models remain poorly understood. Objective: This paper presents insights from hospital staff working on an Australian VRW in response to the growing demand for programs aimed at preventing hospital admissions. We explore staff's perspectives on the facilitators and barriers of the VRW, shedding light on service setup and delivery. Methods: Qualitative interviews were conducted with 21 VRW staff using the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework. The analysis of data was performed using framework analysis and the 7 domains of the NASSS framework. Results: The results were mapped onto the 7 domains of the NASSS framework. (1) Condition: Managing certain conditions, especially those involving comorbidities and sociocultural factors, can be challenging. (2) Technology: The VRW demonstrated suitability for technologically engaged patients without cognitive impairment, offering advantages in clinical decision-making through remote monitoring and video calls. However, interoperability issues and equipment malfunctions caused staff frustration, highlighting the importance of promptly addressing technical challenges. (3) Value proposition: The VRW empowered patients to choose their care location, extending access to care for rural communities and enabling home-based treatment for older adults. (4) Adopters and (5) organizations: Despite these benefits, the cultural shift from in-person to remote treatment introduced uncertainties in workflows, professional responsibilities, resource allocation, and intake processes. (6) Wider system and (7) embedding: As the service continues to develop to address gaps in hospital capacity, it is imperative to prioritize ongoing adaptation. This includes refining the process of smoothly transferring patients back to the hospital, addressing technical aspects, ensuring seamless continuity of care, and thoughtfully considering how the burden of care may shift to patients and their families. Conclusions: In this qualitative study exploring health care staff's experience of an innovative VRW, we identified several drivers and challenges to implementation and acceptability. The findings have implications for future services considering implementing VRWs for older adults in terms of service setup and delivery. Future work will focus on assessing patient and carer experiences of the VRW.

Clinicians' Perspectives on the Telehealth Serious Illness Care Program for Older Adults With Myeloid Malignancies: Single-Arm Pilot Study.

BACKGROUND: Serious illness conversations may help patients avoid unwanted treatments. We previously piloted the telehealth Serious Illness Care Program (SICP) for older adults with acute myeloid leukemia and myelodysplastic syndrome. OBJECTIVE: In this study, we aimed to understand the experience of the telehealth SICP from the clinician's perspective. METHODS: We studied 10 clinicians who delivered the telehealth SICP to 20 older adults with acute myeloid leukemia or myelodysplastic syndrome. Quantitative outcomes included confidence and acceptability. Confidence was measured using a 22-item survey (range 1-7; a higher score is better). Acceptability was measured using an 11-item survey (5-point Likert scale). Hypothesis testing was performed at α=.10 (2-tailed) due to the pilot nature and small sample size. Clinicians participated in audio-recorded qualitative interviews at the end of the study to discuss their experience. RESULTS: A total of 8 clinicians completed the confidence measure and 7 clinicians completed the acceptability measure. We found a statistically significant increase in overall confidence (mean increase of 0.5, SD 0.6; P=.03). The largest increase in confidence was in helping families with reconciliation and goodbye (mean 1.4, SD 1.5; P=.04). The majority of clinicians agreed that the format was simple (6/7, 86%) and easy to use (6/7, 86%). Clinicians felt that the telehealth SICP was effective in understanding their patients' values about end-of-life care (7/7, 100%). A total of three qualitative themes emerged: (1) the telehealth SICP deepened relationships and renewed trust; (2) each telehealth SICP visit felt unique and personal in a positive way; and (3) uninterrupted, unrushed time optimized the visit experience. CONCLUSIONS: The telehealth SICP increased confidence in having serious illness conversations while deepening patient-clinician relationships. TRIAL REGISTRATION: ClinicalTrials.gov NCT04745676; https://www.clinicaltrials.gov/study/NCT04745676.

Self-conducted sonographic monitoring of the knee in patients with haemophilia-A feasibility study.

INTRODUCTION/AIM: To evaluate whether patients with haemophilia (PwH) can be enabled to perform ultrasonography (US) of their knees without supervision according to the Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol and whether they would be able to recognize pathologies. METHODS: Five PwH (mean age 29.6 years, range 20-48 years) were taught the use of a portable US device and the HEAD-US protocol. Subsequently, the patients performed US unsupervised at home three times a week for a total of 6 weeks with a reteaching after 2 weeks. All images were checked for mapping of the landmarks defined in the HEAD-US protocol by a radiologist. In a final test after the completion of the self-sonography period, participants were asked to identify scanning plane and potential pathology from US images of other PwH. RESULTS: On the images of the self-performed scans, 82.7% of the possible anatomic landmarks could be identified and 67.5% of the requested images were unobjectionable, depicting 100% of the required landmarks. There was a highly significant improvement in image quality following reteaching after 2 weeks (74.80 ± 36.88% vs. 88.31 ± 19.87%, p < .001). In the final test, the participants identified the right scanning plane in 85.0% and they correctly identified pathology in 90.0% of images. CONCLUSION: Appropriately trained PwH can perform the HEAD-US protocol of their knee with high quality and are capable to identify pathologic findings on these standardized images. Asynchronous tele-sonography could enable early therapy adjustment and thereby possibly reduce costs.

Cochlear Implant Remote Assist: Clinical and Real-World Evaluation.

OBJECTIVES: To develop and evaluate Cochlear™ Remote Assist (RA), a smartphone-based cochlear implant (CI) teleaudiology solution. The development phase aimed to identify the minimum features needed to remotely address most issues typically experienced by CI recipients. The clinical evaluation phase assessed ease of use, call clarity, system latency, and CI recipient feedback. DESIGN: The development phase involved mixed methods research with experienced CI clinicians. The clinical evaluation phase involved a prospective single-site clinical study and real-world use across 16 clinics. STUDY SAMPLE: CI clinicians (N = 23), CI recipients in a clinical study (N = 15 adults) and real-world data (N = 57 CI recipients). RESULTS: The minimum feature set required for remote programming in RA, combined with sending replacements by post, should enable the clinician to address 80% of the issues typically seen in CI follow-up sessions. Most recipients completed the RA primary tasks without prior training and gave positive ratings for usefulness, ease of use, effectiveness, reliability, and satisfaction on the Telehealth Usability Questionnaire. System latency was reported to be acceptable. CONCLUSION: RA is designed to help clinicians address a significant proportion of issues typically encountered by CI recipients. Clinical study and real-world evaluation confirm RA's ease of use, call quality, and responsiveness.

Estimating the Thumb Rotation Angle by Using a Tablet Device With a Posture Estimation Artificial Intelligence Model.

MediaPipe Hand (MediaPipe) is an artificial intelligence (AI)-based pose estimation library. In this study, MediaPipe was combined with four machine learning (ML) models to estimate the rotation angle of the thumb. Videos of the right hands of 15 healthy volunteers were recorded and processed into 9000 images. The rotation angle of the thumb (defined as angle θ from the palmar plane, which is defined as 0°) was measured using an angle measuring device, expressed in a radian system. Angle θ was then estimated by the ML model by using parameters calculated from the hand coordinates detected by MediaPipe. The linear regression model showed a root mean square error (RMSE) of 12.23, a mean absolute error (MAE) of 9.9, and a correlation coefficient of 0.91. The ElasticNet model showed an RMSE of 12.23, an MAE of 9.95, and a correlation coefficient of 0.91; the support vector machine (SVM) model showed an RMSE of 4.7, an MAE of 2.5, and a correlation coefficient of 0.99. The LightGBM model achieved high values: an RMSE of 4.58, an MAE of 2.62, and a correlation coefficient of 0.99. Based on these findings, we concluded that the thumb rotation angle can be estimated with high accuracy by combining MediaPipe and ML.

Medical care services provision and stress experience in urologists during all waves of the COVID-19 pandemic in Germany.

Purpose: Urologists' practices reported decreasing medical care provision and increasing stress experience in the first wave of the COVID-19 pandemic. However, long-term effects of the pandemic are unknown. Methods: Medical record data of n = 127 urologists were used to assess changes in healthcare provision, comparing the pandemic with the pre-pandemic period. An online survey among n = 101 urologists was conducted to assess the physicians' perceptions of the identified healthcare provision and organizational changes and experiences of anxiety, stress, and support needs during the pandemic waves. Urologists consultations, specialists' referrals, hospital admissions, documented cancer diagnoses, urologists' perceptions of causes for these changes and experienced stress, anxiety and support needs. Results were demonstrated using descriptive statistics. Results: Over the first two years of the pandemic, there was a slight decline in consultations (-0,94%), but more intensive reduction in hospital admissions (-13,6%) and identified cancer diagnoses (-6,2%). Although patients' behavior was seen as the main reason for the changes, 71 and 61% of consultations of high-risk patients or urgent surgeries were canceled. Telemedical approaches were implemented by 58% of urologists, and 88% stated that the reduced cancer detection rate would negatively affect patients' outcomes. Urologists reported higher anxiety, stress, and need for support during all waves of the pandemic than other disciplines, especially females. Conclusion: The pandemic tremendously affects urologists' health care provision and stress experience, possibly causing long-term consequences for patients and physicians.

The development and validation of a digital biomarker for remote assessment of Alzheimer's diseases risk.

Background: Digital cognitive assessment is becoming increasingly widespread in ageing research and care, especially since the COVID-19 pandemic. Remote online collection provides opportunities for ageing and dementia professionals to collect larger datasets, increase the diversity of research participants and patients and offer cost-effective screening and monitoring methods for clinical practice and trials. However, the reliability of self-administered at-home tests compared to their lab-based counterparts often goes unexamined, compromising the validity of adopting such measures. Objective: Our aim is to validate a self-administered web-based version of the visual short-term memory binding task (VSTMBT), a potential digital biomarker sensitive to Alzheimer's disease processes, suitable for use on personal devices. Methods: A final cross-sectional sample of 37 older-adult (51-77 years) participants without dementia completed our novel self-administered version of the VSTMBT, both at home on a personal device and in the lab, under researcher-controlled conditions. Results: ANOVA and Bayesian t-test found no significant differences between the task when it was remotely self-administered by participants at home compared to when it was taken under controlled lab conditions. Conclusions: These results indicate the VSTMBT can provide reliable data when self-administered at-home using an online version of the task and on a personal device. This finding has important implications for remote screening and monitoring practices of older adults, as well as supporting clinical practices serving diverse patient communities. Future work will assess remote administration in older adults with cognitive impairment and diverse socio-economic and ethno-cultural backgrounds as well as a bench-to-bedside application.

High acceptability, convenience and reduced carbon emissions of tele-neurology outpatient services at a regional referral centre in Kenya.

Background: There is severe shortage of neurologists in sub-Saharan Africa. Tele-neurology consultations (TNC) can bridge this service gap, but there is very little published evidence on TNC in our setting, which we addressed through our study. Methods: We prospectively enrolled patients at our neurology outpatients from October 2020 to October 2021. We administered a post-TNC questionnaire which captured satisfaction/acceptability using Likert scales. A sub-group of participants who also did in-person consultations (IPC) were additionally administered post-IPC questionnaires. Statistical comparisons were made using the paired student t-test, and descriptive data expressed as median (inter-quartile range). Results: From 219 enrolled patients, 66.7% participants responded: 74.0% had both IPC and TNC; 63.0% were female; age was 40.9 (30.6-55.2) years; and 2.7% were from neighbouring countries. The commonest presentations were headache (30.8%), seizures (26.0%) and neurodegenerative disorders (15.1%). For TNC, >90% found it: (i) as comfortable as IPC (p = 0.35); (ii) didn't violate their privacy; (iii) saved time [3.0 (2.0-4.0) hours], travel [11.0 (7.2-21.1) km] and cost [$9.09 (4.55-18.18)]; and (iv) addressed their concerns satisfactorily such that they would use TNC again. Conversely, 15.1% didn't agree with TNC being as effective as IPC, and felt the neurologist did not satisfactorily identify all of their health problems (p = 0.03). In total, our TNC service saved our patients $6167, 1143 h, and 25,506 km of travel, translating to 3.5 t (equivalent to 21 newly-planted trees) of carbon dioxide emissions. Conclusions: Our study demonstrates that TNC is an acceptable, efficient, effective, and environmentally-sustainable care delivery model.

"ChatGPT, Can You Help Me Save My Child's Life?" - Diagnostic Accuracy and Supportive Capabilities to Lay Rescuers by ChatGPT in Prehospital Basic Life Support and Paediatric Advanced Life Support Cases - An In-silico Analysis.

BACKGROUND: Paediatric emergencies are challenging for healthcare workers, first aiders, and parents waiting for emergency medical services to arrive. With the expected rise of virtual assistants, people will likely seek help from such digital AI tools, especially in regions lacking emergency medical services. Large Language Models like ChatGPT proved effective in providing health-related information and are competent in medical exams but are questioned regarding patient safety. Currently, there is no information on ChatGPT's performance in supporting parents in paediatric emergencies requiring help from emergency medical services. This study aimed to test 20 paediatric and two basic life support case vignettes for ChatGPT and GPT-4 performance and safety in children. METHODS: We provided the cases three times each to two models, ChatGPT and GPT-4, and assessed the diagnostic accuracy, emergency call advice, and the validity of advice given to parents. RESULTS: Both models recognized the emergency in the cases, except for septic shock and pulmonary embolism, and identified the correct diagnosis in 94%. However, ChatGPT/GPT-4 reliably advised to call emergency services only in 12 of 22 cases (54%), gave correct first aid instructions in 9 cases (45%) and incorrectly advised advanced life support techniques to parents in 3 of 22 cases (13.6%). CONCLUSION: Considering these results of the recent ChatGPT versions, the validity, reliability and thus safety of ChatGPT/GPT-4 as an emergency support tool is questionable. However, whether humans would perform better in the same situation is uncertain. Moreover, other studies have shown that human emergency call operators are also inaccurate, partly with worse performance than ChatGPT/GPT-4 in our study. However, one of the main limitations of the study is that we used prototypical cases, and the management may differ from urban to rural areas and between different countries, indicating the need for further evaluation of the context sensitivity and adaptability of the model. Nevertheless, ChatGPT and the new versions under development may be promising tools for assisting lay first responders, operators, and professionals in diagnosing a paediatric emergency. TRIAL REGISTRATION: Not applicable.

Efficacy of mHealth aided 12-week meditation and breath intervention on change in burnout and professional quality of life among health care providers of a tertiary care hospital in north India: a randomized waitlist-controlled trial.

Introduction: Burnout is "Chronic workplace stress that has not been successfully managed." Professional quality of life (PQL) includes work related experiences of compassion satisfaction and compassion fatigue. Healthcare providers (HCPs) are highly susceptible to burnout and compassion fatigue due to their demanding work, which lowers PQL. Burnout leads to poor care, medical errors, and patient safety across healthcare disciplines. Yoga has been shown to improve resilience, reduce stress, and increase self-compassion and psycho-physiological coherence. This study compared HCPs in a mHealth-aided 12-week yoga-based meditation and breath intervention to waitlist controls for HCP burnout and PQL at a north Indian tertiary care hospital. Methods: This was randomized waitlist-controlled trial. Total 98 HCPs (62 males and 36 females) with an average age of 28.26 ± 3.547 years were enrolled consecutively from March 2021 to November 2022. Randomization was done with opaque sealed envelopes numbered in a computer-generated sequence. The experimental group (n = 49) received 12 online weekly yoga sessions and performed daily home practice (6 days a week). The waitlisted control group (n = 49) continued their daily routine. Maslach's burnout inventory (MBI), professional quality of life (PQL) and anthropometric measurements were assessed at baseline and after 12 weeks. Results: After 12 weeks, the MBI outcomes of emotional exhaustion, depersonalization, and personal accomplishment showed a highly significant difference between the two groups (p < 0.001). PQL outcomes of compassion satisfaction, burnout, and secondary trauma also differed significantly (p < 0.001). Within group analysis showed that MBI and PQL outcomes improved significantly (p < 0.001) for the experimental group after 12 weeks. Conclusion: The current study contributes to the existing evidence on the effectiveness of Yoga in managing stress and developing resilience among doctors, nurses, and other medical professionals. Integrating yoga into healthcare settings is crucial for addressing the detrimental impact of burnout on decision-making and promoting positive patient outcomes. mHealth technologies have the potential to enhance the user-friendliness of yoga-based interventions by personalizing the practice space and time. Yoga-based interventions and mHealth technologies can effectively address physician burnout, in a simple and implementable manner.

Effect of Tele-Medicine on Health Anxiety and Pregnancy-Related Anxiety in Pregnant Women during the COVID-19 Epidemic in Iran.

Background: The global spread of the new coronavirus has increased the necessity of innovations to increase the quality of health care. This study was intended to examine the impact of tele-medicine on health anxiety and pregnancy-related anxiety in pregnant women during the COVID-19 epidemic in Iran. Materials and Methods: This quasi-experimental study was performed between March and May 2020. Sampling was done using multi-stage random sampling method. A total of 104 pregnant women were in two groups (intervention: n = 52, control: n = 52). Data were collected using a demographic and obstetric information questionnaire, the Health Anxiety Questionnaire, and Van den Bergh's Pregnancy-Related Anxiety Questionnaire. The intervention group received counseling services for 2 months by researchers through telephone conversations, text messages, and applications such as WhatsApp, Telegram, and Instagram. In addition to routine pregnancy care, they could contact the researchers by phone and receive the necessary advice in case of any questions, ambiguities, or problems. The control group included pregnant women who received only routine pregnancy care. Results: After the intervention, health anxiety scores of pregnant women in the control group were significantly higher than those of the experimental group (t98 = 13.54, p < 0.001). Also, the mean (SD) scores of pregnancy-related anxiety in the control group were significantly higher compared with the intervention group (t98 = 3.80, p < 0.001). Conclusions: Using tele-medicine, especially during the COVID-19 pandemic can reduce unnecessary referrals of pregnant women to medical centers and their risk of developing the disease, on the one hand, and by reducing women's anxiety, however, it can improve psychological consequences.

Reducing the Impact of the COVID-19 Pandemic on Retinopathy of Prematurity Screening: Successful Strategies Learnt from a Multi-Center Tele-Medicine Program in India.

PURPOSE: Control of blindness due to retinopathy of prematurity (ROP) requires timely screening and treatment within 48-72 h. Anticipating that the coronavirus disease 2019 (COVID-19) pandemic would disrupt ROP services, we devised strategies ''on-the''-go"" to ameliorate this possiblity. We describe the successful outcomes of this approach in preventing infant blindness during the pandemic. METHODS: Data on the number of preemies recruited, screened and treated in the Karnataka Internet-assisted Diagnosis of Retinopathy of Prematurity (KIDROP) program were collected in a retrospective (2019, interval 1) - prospective (2020, interval 2) manner. We summarize 10 key strategies that were developed as we faced logistic, operational and implementation challenges. These included pragmatic methods of enhancing enrolment, transporting for screening and ensuring timely treatment in the outreach. RESULTS: The total number of ROP screening sessions was 20,598 (7,197 new) and 14,371 (5,773 new) during interval 1 and 2 respectively. Of these, 166 (2.3%) and 157 (2.7%) infants required treatment during interval 1 and 2 respectively. All infants needing treatment during the COVID period, were treated on time which was possible due to successful implementation of the 'on-the-go' strategies throughout the state of Karnataka. The fiscal equivalent of the blindness prevented during this period is USD 15.6 million. CONCLUSION: The greater decline in the number of ROP screening episodes in neonatal units in government hospitals was because several were converted to 'COVID only" hospitals. KIDROP's multi-zonal, decentralized strategy, which uses non-physician-based imaging in a telemedicine network, ensured that essential ROP services continued even during the lockdown.

Factors affecting the acceptance of tele-psychiatry: a scoping study.

BACKGROUND: In today's digital world, providing services through telemedicine has become an essential issue in health systems, and the Covid-19 pandemic has made this necessity even more apparent. On the other hand, mental health services are needed more than ever, and their nature makes their delivery via telemedicine more feasible than other specialized services. This study aimed to determine the factors affecting the acceptance of telemedicine among users of this technology in the field of mental health. METHODS: This article is a scoping review based on the PRISMA guidelines and without any time limit until June 20, 2022. The search was performed in PubMed, Scopus, Web of Science, and PsycINFO databases using keywords related to the three fields of telemedicine, acceptance, and mental disorders. Two authors independently selected the studies based on inclusion and exclusion criteria. Then the data were collected using a data extraction form, and finally, the results were determined using the content analysis method. RESULTS: Five main factors affect the acceptance of telemedicine among users of this technology in the field of mental health: perceived effectiveness, users' understanding of the effects of telemedicine on the quality and outcomes of care delivery, technological aspects, organizational change capacity, the nature of the disease and psychological and psychosocial factors. These main factors are associated with 21 related sub-factors. CONCLUSIONS: Revealing the factors affecting the acceptance of telemedicine among recipients and providers of services, as key actors in health systems, can help managers and policymakers to successfully implement telemedicine in the less-regarded field of mental health, especially in the early stages.

NEO-SAFE: a clinical model for patients and healthcare personnel safety in primary level hospitals.

Patient safety is a major concern in medicine. Approximately, 4 million infants die each year worldwide and 23% of these deaths are caused by perinatal asphyxia. To prevent the long-term damage of asphyxia, the resuscitation flowchart must be perfectly and promptly performed. However, high effectiveness in performing resuscitation can only be achieved and maintained if the algorithm is frequently executed. Therefore, maintaining a high level of patient care is difficult in some remote centres. The aim of this study was to evaluate the effectiveness of a new organizational model of care-network between Hub & Spoke hospitals to improve both the safety of the newborns in hospitals with a low number of births and the well-being of operators. Our project, NEO-SAFE (NEOnatal SAFety and training Elba), began in 2017 and involved the neonatal intensive care unit and the NINA Center of the Pisa University Hospital (hub) and the Hospital of Elba Island (spoke). It consisted of a continuous training program, both with 'classic' training course and 'on-job tutoring' (on side and remotely), of the health workers at spoke (i.e. nurses, midwives, and paediatricians). All four milestones of the study design were achieved. During the project, NINA Center instructors organized training courses for the staff in Portoferraio. These courses were based on learning technical and non-technical skills in a training course of increasing difficulty. Staff training needs were also monitored during the project by means of periodic questionnaires, sentinel events, and specific requests. The curve described by the rate of newborns transfer to the Pisa neonatal intensive care unit (hub) shows a monotonous decreasing trend line. On the other hand, this project allowed operators to develop greater self-confidence and greater safety in managing emergency situations, reducing stress for them and improving patient safety. The project allowed the creation of a safe, effective, low-cost, and reproducible organizational model for centres with a low number of births. Moreover, the tele-medicine approach is an important improvement in the assistance and is a window on the future.

Development and Evaluation of a Mixed-Reality Tele-ultrasound System.

OBJECTIVE: The objective of this feasibility study was to develop and assess a tele-ultrasound system that would enable an expert sonographer (situated at the remote site) to provide real-time guidance to an operator (situated at the imaging site) using a mixed-reality environment. METHODS: An architecture along with the operational workflow of the system is designed and a prototype is developed that enables guidance in form of audiovisual cues. The visual cues comprise holograms (of the ultrasound images and ultrasound probe) and is rendered to the operator using a head-mounted display device. The position and orientation of the ultrasound probe's hologram are remotely controlled by the expert sonographer and guide the placement of a physical ultrasound probe at the imaging site. The developed prototype was evaluated for its performance on a network. In addition, a user study (with 12 participants) was conducted to assess the operator's ability to align the probe under different guidance modes. RESULTS: The network performance revealed the view of the imaging site and ultrasound images were transferred to the remote site in 233 ± 42 and 158 ± 38 ms, respectively. The expert sonographer was able to transfer, to the imaging site, data related to position and orientation of the ultrasound probe's hologram in 78 ± 13 ms. The user study indicated that the audiovisual cues are sufficient for an operator to position and orient a physical probe for accurate depiction of the targeted tissue (p < 0.001). The probe's placement translational and rotational errors were 1.4 ± 0.6 mm and 5.4 ± 2.2º. CONCLUSION: The work illustrates the feasibility of using a mixed-reality environment for effective communication between an expert sonographer (ultrasound physician) and an operator. Further studies are required to determine its applicability in a clinical setting during tele-ultrasound.

Mobility and freedom of movement: A novel out-of-hospital treatment for pediatric patients with terminal cardiac insufficiency and a ventricular assist device.

Background: Due to rapid medical and technological progress, more and more pediatric patients with terminal cardiac insufficiency are being implanted with a ventricular assist device as a bridge to transplant without legal approval for hospital discharge. EXCOR® Active is a recently developed mobile driving unit for the EXCOR® ventricular assist device (EXCOR® VAD) with a long-lasting battery life that can manage small blood pumps, offering improved mobility for pediatric patients. This study strives to elaborate the requirements necessary for a safe home healthcare environment (HHE) for pediatric patients on EXCOR® VAD powered by the EXCOR® Active driving unit. Materials and methods: Patient- and device-related preconditions (medical, ethical, psychological, technical, structural, organizational) were analyzed with regard to feasibility and safety in three individual patient cases. Included were pediatric patients with terminal cardiac insufficiency in a stable medical condition receiving in-hospital treatment with a univentricular or biventricular EXCOR® VAD powered by EXCOR® Active. Analysis was single-center, data was obtained 05/2020-02/2022. Results: A total of three patients on EXCOR® VAD were identified for HHE treatment with the EXCOR® Active driving unit. Switch was performed safely and increased mobility led to improved psychomotor development and improved quality of life. No complications directly related to HHE-treatment occurred. One patient recently underwent an orthotopic heart transplant, one patient remains in HHE, and one patient died due to a complication not related to the HHE. Ethical approval for off-label use was obtained and patients and parents were given the required technical training and psychological support. Caregivers and medical professionals involved in the patients' care at home were briefed intensely. Remote consultations were implemented and interdisciplinary in-hospital checks reduced to a long-term 4-week-scheme. Conclusion: While it is challenging to discharge pediatric patients being treated with a paracorporeal ventricular assist device (EXCOR® VAD) from hospital, it is feasible and can be managed safely with the novel driving unit EXCOR® Active. A HHE may help to improve patients' psychomotor development, offer normalized social contacts and strengthen both patients' and parents' physical and mental resources. Legal approval and another study with a larger sample size are warranted.