Monitoring Patients Reported Outcomes after Valve Replacement Using Wearable Devices: Insights on Feasibility and Capability Study: Feasibility Results.
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ABSTRACT:
SUBMITTER: Ocagli H
PROVIDER: S-EPMC8297062 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Elevated core temperature constitutes an important biomarker for COVID-19 infection; however, no standards currently exist to monitor fever using wearable peripheral temperature sensors. Evidence that sensors could be used to develop fever monitoring capabilities would enable large-scale health-monitoring research and provide high-temporal resolution data on fever responses across heterogeneous populations. We launched the TemPredict study in March of 2020 to capture continuous physiological data, including peripheral temperature, from a commercially available wearable device during the novel coronavirus pandemic. We coupled these data with symptom reports and COVID-19 diagnosis data. Here we report findings from the first 50 subjects who reported COVID-19 infections. These cases provide the first evidence that illness-associated elevations in peripheral temperature are observable using wearable devices and correlate with self-reported fever. Our analyses support the hypothesis that wearable sensors can detect illnesses in the absence of symptom recognition. Finally, these data support the hypothesis that prediction of illness onset is possible using continuously generated physiological data collected by wearable sensors. Our findings should encourage further research into the role of wearable sensors in public health efforts aimed at illness detection, and underscore the importance of integrating temperature sensors into commercially available wearables.
| S-EPMC7736301 | biostudies-literature
Project description:BackgroundWearable devices generate signals detecting activity, sleep, and heart rate, all of which could enable detailed and near-continuous characterization of recovery following critical illness.MethodsTo determine the feasibility of using a wrist-worn personal fitness tracker among patients recovering from critical illness, we conducted a prospective observational study of a convenience sample of 50 stable ICU patients. We assessed device wearability, the extent of data capture, sensitivity and specificity for detecting heart rate excursions, and correlations with questionnaire-derived sleep quality measures.ResultsWearable devices were worn over a 24-h period, with excellent capture of data. While specificity for the detection of tachycardia was high (98.8%), sensitivity was low to moderate (69.5%). There was a moderate correlation between wearable-derived sleep duration and questionnaire-derived sleep quality (r = 0.33, P = 0.03). Devices were well-tolerated and demonstrated no degradation in quality of data acquisition over time.ConclusionsWe found that wearable devices could be worn by patients recovering from critical illness and could generate useful data for the majority of patients with little adverse effect. Further development and study are needed to better define and enhance the role of wearables in the monitoring of post-ICU recovery.Trial registrationClinicaltrials.gov, NCT02527408.
| S-EPMC5698959 | biostudies-literature
Project description:AimsTranscatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices.Methods and resultsA total of 11 patients were treated with the Tendyne™ (N = 7) or the Tiara™ TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions. The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%.ConclusionsTMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement.
| S-EPMC7907022 | biostudies-literature
Project description:Population aging is related to a huge growth in healthcare and welfare costs. Therefore, wearable devices could be strategic for minimizing years of disability in old age and monitoring patients' lifestyles and health. The purpose of this study was to assess the feasibility of using smart devices to monitor patients' physical activity in a primary care setting. To assess the acceptance of this novel technology from the point of view of both patients and healthcare professionals, two questionnaires (one paper-based and one ex-novo developed) were administered to 11 patients with type 2 diabetes mellitus and a non-compliant behavior towards the therapeutic indications of their general practitioner (GP). Seven participants would continue to use a wearable activity tracker to monitor their health. We observed that 75% of patients reported a device's characteristics satisfaction level of over 80% of the total score assigned to this dimension. No differences were observed in the questionnaire's scores between the two professionals categories (GPs and nurses). Three dimensions (equipment characteristics, subjective norm, perceived risks, perceived ease-of-use and facilitating conditions) correlated > 0.5 with the device's acceptability level. Some weak correlations were observed between healthcare professionals' perception and patients' parameters, particularly between the dimensions of collaboration and web interface ease-of-use and patients' median number of steps and hours of sleep. In conclusion, despite the limited number of subjects involved, a good acceptance level towards these non-medical devices was observed, according to both patients' and healthcare professionals' impressions.
| S-EPMC8469467 | biostudies-literature
Project description:Mitral regurgitation is one of the most prevalent valvulopathies worldwide, and its surgical treatment is not feasible in all cases. The elderly and frail with several comorbidities and left ventricular dysfunction are often managed conservatively. Percutaneous treatment (repair or replacement) of the mitral valve has emerged as a potential option for those patients who are at a high risk for surgery. Mitral valve repair with the Mitraclip device proved both increased safety and mortality reduction in patients with severe mitral regurgitation. On the other hand, in the last decade, percutaneous mitral replacement opened new frontiers in the field of cardiac structural interventions. There are few mitral devices; some are in the early phase of development and some are waiting for CE mark of approval. The evolution of these devices was more complicated compared to the aortic technology due to the native mitral valve's complexity and access. This review aims to provide an overview of the current devices, their specific features, and their potential complications.
| S-EPMC7728606 | biostudies-literature
Project description:BackgroundWe conducted a prospective observational study of patients undergoing elective primary hip or knee replacements to examine the feasibility of a postoperative home monitoring system as transitional care to support patients following their surgery in real time.ObjectiveThe primary outcome was the mean percentage of successful wireless transmissions from home of blood pressure levels, heart rate, oxygen saturation levels, and pain scores until postoperative day 4 with a feasibility target of ≥90%.MethodsPatients with an expected length of stay ≤1 day, age 18-80 years, Revised Cardiac Risk Index ≤ class 2, and caretakers willing to assist at home were eligible. Patient satisfaction, as a secondary outcome, was also evaluated. Wireless monitoring equipment (remote patient monitoring, Telus Canada) was obtained and a multidisciplinary care team was formed.ResultsWe conducted the study after obtaining Research Ethics Board approval; 54 patients completed the study: 21 males, 33 females. In total, we evaluated 9 hips, 4 hip resurfacing, 26 total knees, and 15 hemi-knees. The mean transmission rate was 96.4% (SD 5.9%; 95% CI 94.8-98.0). The median response to "I would recommend the Remote Monitoring System program to future patients" was 4.5 (interquartile range 4-5), with 1 being "strongly disagree" and 5 "strongly agree." At 30 days postop, there was no mortality or readmission.ConclusionsThis is an evolving new paradigm for postoperative care and the first feasibility study on monitoring biometrics after primary hip or knee replacement. Postoperative home monitoring combines current technology with real-time support by a multidisciplinary transitional care team after discharge, facilitating postsurgical care with successful wireless transmission of vitals. The postoperative home monitoring implementation is, therefore, generalizable to other surgical discharges from hospitals.Trial registrationClinicalTrials.gov NCT02143232; https://clinicaltrials.gov/ct2/show/NCT02143232 (Archived by WebCite at http://www.webcitation.org/71ugAhhIk).
| S-EPMC7728409 | biostudies-literature
Project description:Abstract Aims High blood pressure (BP) is the commonest modifiable cardiovascular risk factor, yet its monitoring remains problematic. Wearable cuffless BP devices offer potential solutions; however, little is known about their validity and utility. We aimed to systematically review the validity, features and clinical use of wearable cuffless BP devices. Methods and results We searched MEDLINE, Embase, IEEE Xplore and the Cochrane Database till December 2019 for studies that reported validating cuffless BP devices. We extracted information about study characteristics, device features, validation processes, and clinical applications. Devices were classified according to their functions and features. We defined devices with a mean systolic BP (SBP) and diastolic BP (DBP) biases of <5 mmHg as valid as a consensus. Our definition of validity did not include assessment of device measurement precision, which is assessed by standard deviation of the mean difference—a critical component of ISO protocol validation criteria. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies version 2 tool. A random-effects model meta-analysis was performed to summarise the mean biases for SBP and DBP across studies. Of the 430 studies identified, 16 studies (15 devices, 974 participants) were selected. The majority of devices (81.3%) used photoplethysmography to estimate BP against a reference device; other technologies included tonometry, auscultation and electrocardiogram. In addition to BP and heart rate, some devices also measured night-time BP (n = 5), sleep monitoring (n = 3), oxygen saturation (n = 3), temperature (n = 2) and electrocardiogram (n = 3). Eight devices showed mean biases of <5 mmHg for SBP and DBP compared with a reference device and three devices were commercially available. The meta-analysis showed no statistically significant differences between the wearable and reference devices for SBP (pooled mean difference = 3.42 mmHg, 95% CI: −2.17, 9.01, I2 95.4%) and DBP (pooled mean = 1.16 mmHg, 95% CI: −1.26, 3.58, I2 87.1%). Conclusion Several cuffless BP devices are currently available using different technologies, offering the potential for continuous BP monitoring. The variation in standards and validation protocols limited the comparability of findings across studies and the identification of the most accurate device. Challenges such as validation using standard protocols and in real-life settings must be overcome before they can be recommended for uptake into clinical practice. Graphical Abstract Graphical abstract Wearable BP device system.
| S-EPMC9708022 | biostudies-literature
Project description:Background In the recent decades, the development of novel digital health technologies enables doctors to monitor ECG and vital signs remotely. But the data on applying the noninvasive wearable smartwatch on patients with transcatheter aortic valve replacement (TAVR) are unknown. Methods and Results We performed a prospective, observational cohort study to evaluate the feasibility of a novel, virtual, and remote health care strategy for patients with TAVR discharged to home with smart wearable devices. A total of 100 consecutive patients with severe aortic stenosis who underwent elective transfemoral TAVR were enrolled and received the Huawei smartwatch at least 1 day before TAVR. Vital signs, including heart rate, rhythm, oxygen saturation, and activity, were continuously recorded. Single-lead ECG was recorded twice per day in the week following TAVR discharge and at least 2 days a week for the subsequent month after TAVR discharge. A designated heart team member provided remote health care with the data from the smartwatch when the patient had a need. Thirty-eight cardiac events were reported in 34 patients after discharge, with most of the events (76.0%) detected and confirmed by the smartwatch. Six patients were advised and readmitted to the hospital for arrhythmia events detected by the smartwatch, of whom 4 patients received pacemaker implantation. The remaining 28 (82.4%) patients received telemedicine monitoring instead of face-to-face clinical visits, and 3 of them received new medication treatment under the online guidance of doctors. New-onset left branch bundle block was found in 48 patients, with transient characteristics, and recovered spontaneously in 30 patients, and new-onset atrial fibrillation was detected in 4 patients. There were no significant differences in the average weekly heart rates or the ratio of abnormal or low oxygen saturation when compared with the baseline. The average daily steps increased over time significantly (baseline, 870±1353 steps; first week, 1986±2406 steps; second week, 2707±2716 steps; third week, 3059±3036 steps; fourth week, 3678±3485 steps, P<0.001). Conclusions Smartwatches can facilitate remote health care for patients discharged to home after undergoing TAVR and enable a novel remote follow-up strategy. The majority of cardiac clinical events that occurred within 30-day follow-up were detected by the smartwatch, mainly because of the record of conduction abnormality. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04454177.
| S-EPMC9075450 | biostudies-literature
Project description:Transcatheter aortic valve replacement is the therapy of choice for patients with severe aortic stenosis who have prohibitive or high surgical risk. However, the benefit of TAVR is attenuated by the occurrence of major disabling stroke which is associated with increased mortality and early-reduced quality of life. Despite advances in TAVR technology, stroke remains a serious complication that is associated with significant negative outcomes. The majority of these occur in the acute phase following TAVR where cerebral embolic events are frequent. Cerebral embolic protection devices (CEPD) have been developed to minimize the risk of peri-procedural ischemic stroke during TAVR. CEPD have the potential to reduce intraprocedural burden of new silent ischemic injury. In this review we outline the etiology and incidence of stroke in TAVR population, and systematically review current evidence for cerebral embolic protection devices.
| S-EPMC6205957 | biostudies-literature
Project description:BackgroundThere are many problems with fitness trackers, such as device usability, which limit their large-scale application, and relevant studies are limited in terms of their sample size and evaluation methods. The purpose of the study was to evaluate the perceived usability of various mainstream fitness trackers on the market, and to learn about user feedback on feature preferences for each device.MethodsTrial use of seven mainstream fitness trackers (two smart watches and five smart wristbands) followed by a survey study were applied. The questionnaire was specifically developed for this study, which included two parts (user preferences and device usability in five dimensions). We recruited users to test the devices for at least 30 days and asked experienced users to provide feedback in order to evaluate each device, including the rating and user preference of each device.ResultsWe received 388 valid questionnaires, in which users rated their responses on a five-point Likert scale. (1) User preference: the average user satisfaction was 3.50-3.86 (points), and the rating for willingness to buy averaged between 3.36 and 3.59. More users were willing to wear (58.3-81.3%) and purchase (56.8-83.0%) the devices than were not. The top three general feature preferences were daily activity tracking, heart health monitoring, and professional fitness tracking. The top three health-related feature preferences were heart rate monitoring, daily pedometer, and professional fitness tracking. (2) Usability evaluation: product design was rated from 3.57 to 4.00; durability, 3.63-4.26; ease of use, 3.70-3.90; added features, 3.30-3.83; and user-rated accuracy, 3.44-3.78. A significant difference was observed in the rating of product design and durability among the different devices (p < 0.05) score.ConclusionsUsers generally had positive subjective intent regarding fitness trackers but were less satisfied with their cost effectiveness. The users preferred health related features such as heart health monitoring, and professional fitness tracking. The rating of most of the current mainstream fitness trackers was fair with some significant differences among the devices. Thus, further improvement is needed.
| S-EPMC6064199 | biostudies-literature