A 75-year-old man with hypertrophic obstructive cardiomyopathy underwent placement of a long-sensing vector implantable loop recorder (ILR) for unexplained syncope. One month later, ILR remote monitoring revealed unstable R-wave amplitudes ranging from very high (>1.9 mV) to very low (<0.2 mV) values. During an in-hospital clinic visit, the only site to establish communication with the ILR was the left posterior axillary area. Chest computed tomography confirmed ILR migration into the anterior costophrenic recess. The device was retrieved with forceps during video thoracoscopy without further complications.
UNASSIGNED: This is the first case report of migration of an implantable loop recorder diagnosed by remote monitoring.

BACKGROUND: Monitoring supine pulmonary artery pressures to guide heart failure (HF) management has reduced HF hospitalizations in select patients.
OBJECTIVE: The purpose of this study was to evaluate the effect of managing seated mean pulmonary artery pressure (mPAP) with the Cordella Pulmonary Artery sensor on outcomes in patients with HF.
METHODS: Following GUIDE-HF (Hemodynamic-GUIDEd Management of Heart Failure Trial), with U.S. Food and Drug Administration input, PROACTIVE-HF (A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial) was changed from a randomized to a single-arm, open label trial, conducted at 75 centers in the USA and Europe. Eligible patients had chronic HF with NYHA functional class III symptoms, irrespective of the ejection fraction, and recent HF hospitalization and/or elevated natriuretic peptides. The primary effectiveness endpoint at 6 months required the HF hospitalization or all-cause mortality rate to be lower than a performance goal of 0.43 events/patient, established from previous hemodynamic monitoring trials. Primary safety endpoints at 6 months were freedom from device- or system-related complications or pressure sensor failure.
RESULTS: Between February 7, 2020, and March 31, 2023, 456 patients were successfully implanted in modified intent-to-treat cohort. The 6-month event rate was 0.15 (95% CI: 0.12-0.20) which was significantly lower than performance goal (0.15 vs 0.43; P < 0.0001). Freedom from device- or system-related complications was 99.2% and freedom from sensor failure was 99.8% through 6 months.
CONCLUSIONS: Remote management of seated mPAP is safe and results in a low rate of HF hospitalizations and mortality. These results support the use of seated mPAP monitoring and extend the growing body of evidence that pulmonary artery pressure-guided management improves outcomes in heart failure. (Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial [PROACTIVE-HF]; NCT04089059).

BACKGROUND: For a decade, despite results from many studies, telemedicine systems have suffered from a lack of recommendations for chronic heart failure (CHF) care because of variable study results. Another limitation is the hospital-based architecture of most telemedicine systems. Some systems use an algorithm based on daily weight, transcutaneous oxygen measurement, and heart rate to detect and treat acute heart failure (AHF) in patients with CHF as early on as possible.
OBJECTIVE: The aim of this study is to determine the efficacy of a telemonitoring system in detecting clinical destabilization in real-life settings (out-of-hospital management) without generating too many false positive alerts.
METHODS: All patients self-monitoring at home using the system after a congestive AHF event treated at a cardiology clinic in France between March 2020 and March 2021 with at least 75% compliance on daily measurements were included retrospectively. New-onset AHF was defined by the presence of at least 1 of the following criteria: transcutaneous oxygen saturation loss, defined as a transcutaneous oxygen measurement under 90%; rise of cardiac frequency above 110 beats per minute; weight gain of at least 2 kg; and symptoms of congestive AHF, described over the phone. An AHF alert was generated when the criteria reached our definition of new-onset acute congestive heart failure (HF).
RESULTS: A total of 111 consecutive patients (n=70 men) with a median age of 76.60 (IQR 69.5-83.4) years receiving the telemonitoring system were included. Thirty-nine patients (35.1%) reached the HF warning level, and 28 patients (25%) had confirmed HF destabilization during follow-up. No patient had AHF without being detected by the telemonitoring system. Among incorrect AHF alerts (n=11), 5 patients (45%) had taken inaccurate measurements, 3 patients (27%) had supraventricular arrhythmia, 1 patient (9%) had a pulmonary bacterial infection, and 1 patient (9%) contracted COVID-19. A weight gain of at least 2 kg within 4 days was significantly associated with a correct AHF alert (P=.004), and a heart rate of more than 110 beats per minute was more significantly associated with an incorrect AHF alert (P=.007).
CONCLUSIONS: This single-center study highlighted the efficacy of the telemedicine system in detecting and quickly treating cardiac instability complicating the course of CHF by detecting new-onset AHF as well as supraventricular arrhythmia, thus helping cardiologists provide better follow-up to ambulatory patients.

UNASSIGNED: The CardioMEMS is an implantable device for hemodynamic monitoring approved by the US Food and Drug Administration for adult patients with heart failure. It has been used in the adult population without structural heart disease and with congenital heart diseases, but we do not have data in the pediatric population.
UNASSIGNED: We report the initial single-center experience of the CardioMEMS implantation in children. Feasibility of device implantation, procedural outcomes, and clinical utility in the pediatric population were evaluated.
UNASSIGNED: The CardioMEMS device was implanted without technical complications in 8 pediatric patients (mean age 7 years and mean weight 27.9 kg) with pulmonary hypertension (6/8, 75%) and heart failure (2/8, 25%). The device was delivered via femoral access in 7 (85%) patients and implanted in the left pulmonary artery in 7 (85%). The noninvasive recording of pulmonary pressures in patients with pulmonary hypertension allowed the monitoring of the evolution of mean pulmonary artery pressure, intensifying vasodilator treatment, and avoiding control cardiac catheterizations. In patients with heart failure, pulmonary hemodynamic monitoring guided the decongestive treatment prior to heart transplantation.
UNASSIGNED: The implantation of CardioMEMS in the pediatric population is a feasible procedure that allows the noninvasive hemodynamic monitoring of patients with heart failure and pulmonary hypertension. Its implementation in selected patients aids in outpatient follow-up and therapeutic management of patients with complex cardiac conditions, avoiding invasive procedures that require hospitalization. Further large-scale studies in the pediatric population are recommended.

Hypertensive disorders of pregnancy are a leading cause of pregnancy-related morbidity and mortality. The primary objective of this study was to compare the frequency of documentation of postpartum blood pressure through remote blood pressure monitoring with text-message delivered reminders versus office-based follow-up 7-10 days postpartum. The secondary objective was to examine barriers and facilitators of both care strategies from the perspectives of individuals who experienced a hypertensive disorder of pregnancy. We conducted a randomized controlled trial at a tertiary care academic medical center in the southeastern US with 100 postpartum individuals (50 per arm) from 2018 to 2019. Among 100 trial participants, blood pressure follow-up within 7-10 days postpartum was higher albeit not statistically significant between postpartum individuals randomized to the remote assessment intervention versus office-based standard care (absolute risk difference 18.0%, 95% CI -0.1 to 36.1%, p = 0.06). Patient-reported facilitators for remote blood pressure monitoring were maternal convenience, clarity of instructions, and reassurance from the health assessments. These positive aspects occurred alongside barriers, which included constraints due to newborn needs and the realities of daily postpartum life.

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BACKGROUND: Wearable physiological monitoring devices are promising tools for remote monitoring and early detection of potential health changes of interest. The widespread adoption of such an approach across communities and over long periods of time will require an automated data platform for collecting, processing, and analyzing relevant health information.
OBJECTIVE: In this study, we explore prospective monitoring of individual health through an automated data collection, metrics extraction, and health anomaly analysis pipeline in free-living conditions over a continuous monitoring period of several months with a focus on viral respiratory infections, such as influenza or COVID-19.
METHODS: A total of 59 participants provided smartwatch data and health symptom and illness reports daily over an 8-month window. Physiological and activity data from photoplethysmography sensors, including high-resolution interbeat interval (IBI) and step counts, were uploaded directly from Garmin Fenix 6 smartwatches and processed automatically in the cloud using a stand-alone, open-source analytical engine. Health risk scores were computed based on a deviation in heart rate and heart rate variability metrics from each individual\'s activity-matched baseline values, and scores exceeding a predefined threshold were checked for corresponding symptoms or illness reports. Conversely, reports of viral respiratory illnesses in health survey responses were also checked for corresponding changes in health risk scores to qualitatively assess the risk score as an indicator of acute respiratory health anomalies.
RESULTS: The median average percentage of sensor data provided per day indicating smartwatch wear compliance was 70%, and survey responses indicating health reporting compliance was 46%. A total of 29 elevated health risk scores were detected, of which 12 (41%) had concurrent survey data and indicated a health symptom or illness. A total of 21 influenza or COVID-19 illnesses were reported by study participants; 9 (43%) of these reports had concurrent smartwatch data, of which 6 (67%) had an increase in health risk score.
CONCLUSIONS: We demonstrate a protocol for data collection, extraction of heart rate and heart rate variability metrics, and prospective analysis that is compatible with near real-time health assessment using wearable sensors for continuous monitoring. The modular platform for data collection and analysis allows for a choice of different wearable sensors and algorithms. Here, we demonstrate its implementation in the collection of high-fidelity IBI data from Garmin Fenix 6 smartwatches worn by individuals in free-living conditions, and the prospective, near real-time analysis of the data, culminating in the calculation of health risk scores. To our knowledge, this study demonstrates for the first time the feasibility of measuring high-resolution heart IBI and step count using smartwatches in near real time for respiratory illness detection over a long-term monitoring period in free-living conditions.

BACKGROUND: The current literature inadequately addresses the extent to which remote monitoring should be integrated into care models for chronic respiratory diseases (CRDs).
OBJECTIVE: This study examined a remote monitoring program (RMP) in cystic fibrosis (CF) by exploring experiences, future perspectives, and use behavior over 3 years, with the aim of developing future directions for remote monitoring in CRDs.
METHODS: This was a mixed methods, multicenter, observational study in 5 Dutch CF centers following a sequential explanatory design. Self-designed questionnaires using the technology acceptance model were sent out to people with CF who had a minimum of 12 months of experience with the RMP and local health care professionals (HCPs). Questionnaire outcomes were used to inform semistructured interviews with HCPs and people with CF. Qualitative findings were reported following the COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist. Anonymous data on use frequency of all people with CF were analyzed.
RESULTS: Between the second quarter of 2020 and the end of 2022, a total of 608 people with CF were enrolled in the program, and a total of 9418 lung function tests and 2631 symptom surveys were conducted. In total, 65% (24/37) of HCPs and 89% (72/81) of people with CF responded to the questionnaire, and 7 HCPs and 12 people with CF participated in semistructured interviews. Both people with CF and HCPs were positive about remote monitoring in CF care and found the RMP a good addition to daily care (people with CF: 44/72, 61%; HCPs: 21/24, 88%). Benefits ranged from supporting individual patients to reducing health care consumption. The most valued monitoring tool was home spirometry by both people with CF (66/72, 92%) and HCPs (22/24, 92%). Downsides included the potential to lose sight of patients and negative psychosocial effects, as 17% (12/72) of people with CF experienced some form of stress due to the RMP. A large majority of people with CF (59/72, 82%) and HCPs (22/24, 92%) wanted to keep using the RMP in future, with 79% (19/24) of HCPs and 75% (54/72) of people with CF looking forward to more replacement of in-person care with digital care during periods of well-being. Future perspectives for the RMP were centered on creating hybrid care models, personalizing remote care, and balancing individual benefits with monitoring burden.
CONCLUSIONS: Remote monitoring has considerable potential in supporting people with CF and HCPs within the CF care model. We identified 4 practice-based future directions for remote monitoring in CF and CRD care. The strategies, ranging from patient driven to prediction driven, can help clinicians, researchers, and policy makers navigate the rapidly changing digital health field, integrate remote monitoring into local care models, and align remote care with patient and clinician needs.

OBJECTIVE: Early identification of worsening HF enables timely adjustments to prevent hospitalization. Recent studies show the HeartLogic™ algorithm detects congestion and reduces HF events. However, it is unclear which patients benefit most. Therefore, this study aims to identify and characterize HF patients who benefit most from CIED-based remote monitoring with HeartLogic™.
METHODS: In this multicenter retrospective study, patients with a CIED and HeartLogic™ algorithm under structured follow-up were included. Patients were classified as having \"substantial benefit\" or \"no benefit\" from monitoring.
RESULTS: In total, 242 patients were included (male n = 190, 79%, median age 61 years [IQR 61-77]). Median follow-up was 1.2 years [IQR 1.1-2.7]. Among 378 alerts, 266 were true positive (70%) and 112 false positive (30%). Of the 242 patients, 69 (29%) were classified as having \"substantial benefit\", while 173 (71%) had \"no benefit\" from HeartLogic™ monitoring. Univariate and multivariate analysis showed that patients with \"substantial benefit\" had higher NYHA functional class (OR 2.64, P = 0.004), higher NT-ProBNP (OR 1.02, P = 0.003), higher serum creatinine (OR 1.10, P < 0.001), lower LVEF (OR 1.19, P = 0.004), more severe mitral regurgitation (OR 2.16, P = 0.006), higher right ventricular end diastolic volume (OR 1.05, P = 0.040), higher pulmonary artery pressures (OR 1.19, P = 0.003), and were more likely to use loop diuretics (OR 2.79, P = 0.001). Among patients with \"substantial benefit,\" the positive predictive value (PPV) of HeartLogic™ to detect congestion was 92%.
CONCLUSIONS: The utilization of CIED-based HeartLogic™ driven HF care demonstrated pronounced efficacy, predominantly in patients exhibiting characteristics of HF at a more advanced disease stage.

BACKGROUND: The adoption of remote healthcare methods has been accelerated by the COVID-19 pandemic, but evidence suggests that some patients need additional support to engage remotely, potentially increasing health disparities if needs are not met. This study of COVID-19 remote home monitoring services across England explores experiences of and engagement with the service across different patient groups.
METHODS: This was a mixed-methods study with survey and interview data collected from 28 services across England between February and June 2021. Surveys were conducted with staff and patients and carers receiving the service. Interviews with staff service leads, patients and carers were conducted in 17 sites. Quantitative data were analysed using univariate and multivariate methods, and qualitative data were analysed using thematic analysis.
RESULTS: Survey responses were received from 292 staff and 1069 patients and carers. Twenty-three staff service leads, 59 patients and 3 carers were interviewed. Many service leads reported that they had considered inclusivity when adapting the service for their local population; strategies included widening the eligibility criteria, prioritising vulnerable groups and creating referral pathways. However, disparities were reported across patient groups in their experiences and engagement. Older patients reported the service to be less helpful (p = 0.004), were more likely to report a problem (p < 0.001) and had more difficulty in understanding information (p = 0.005). Health status (p = 0.004), ethnicity (p < 0.001), gender (p < 0.001) and employment (p = 0.007) were associated with differential engagement with monitoring, and minority ethnic groups reported more difficulty understanding service information (p = 0.001). Qualitative data found illness severity to be an important factor in the support required, and patients\' living situation and social network affected whether they found the service reassuring.
CONCLUSIONS: Addressing health disparities must be a key focus in the design and delivery of remote care. Services should be tailored to match the needs of their local population, encourage access through collaboration and referral pathways with other services and monitor their inclusiveness. Involving patients and staff in service design can illuminate the diversity of patients\' needs and experiences of care.
UNASSIGNED: The study team met with service user and public members of the BRACE PPI group and patient representatives from RSET in a series of workshops. Workshops informed study design, data collection tools, data interpretation and dissemination activities. Study documents (such as consent forms, topic guides, surveys and information sheets) were reviewed by PPI members; patient surveys and interview guides were piloted, and members also commented on the manuscript.