Recent Advances in the Wearable Devices for Monitoring and Management of Heart Failure.

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Heart failure (HF) is an acute and degenerative condition with high morbidity and mortality rates. Early diagnosis and treatment of HF can significantly enhance patient outcomes through admission and readmission reduction and improve quality of life. Being a progressive condition, the continuous monitoring of vital signs and symptoms of HF patients to identify any deterioration and to customize treatment regimens can be beneficial to the management of this disease. Recent breakthroughs in wearable technology have revolutionized the landscape of HF management. Despite the potential benefits, the integration of wearable devices into HF management requires careful consideration of technical, clinical, and ethical challenges, such as performance, regulatory requirements and data privacy. This review summarizes the current evidence on the role of wearable devices in heart failure monitoring and management, and discusses the challenges and opportunities in the field.

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Actionable physical exam and structured data optimize quality of transitional care, allowing for significant reductions in readmissions and mortality. Heart failure (HF) is a leading cause of morbidity and mortality in nearly 5.7 million Americans. With improved survival and an aging patient population, the cost associated with HF management is expected to reach close to $70 billion by 2030.1Ponikowski P. Voors A.A. Anker S.D. et al.ESC Scientific Document Group2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC.Eur Heart J. 2016; 37 ([Erratum in: Eur Heart J 2016;PMID: 27206819]): 2129-2200Crossref PubMed Scopus (8578) Google Scholar Skilled nursing facilities (SNFs) are progressively used to care for older patients with significant comorbidities, including HF.2Orr N.M. Forman D.E. De Matteis G. Gambassi G. Heart failure among older adults in skilled nursing facilities: more of a dilemma than many now realize.Curr Geriatr Rep. 2015; 4: 318-326Crossref PubMed Scopus (15) Google Scholar However, morbidity and mortality rates are high for hospitalized HF patients discharged to SNFs, with 30-day readmission rates between 27% and 43%, owing to errors in transitions, inadequate discharge planning, and lack of appropriate follow-up with health care providers.3Jurgens C.Y. Goodlin S. Dolansky M. et al.American Heart Association Council on Quality of Care and Outcomes Research and the Heart Failure Society of America. Heart failure management in skilled nursing facilities: a scientific statement from the American Heart Association and the Heart Failure Society of America.Circ Heart Fail. 2015; 8: 655-687Crossref PubMed Scopus (34) Google Scholar Optimizing HF management in SNF populations who are underserved yet at high risk for hospitalization is a critical area of focus for value-based care. The COVID-19 pandemic has increased utilization of telemedicine for HF management. Telehealth is a growing field of importance owing to value-based care and population management incentives, as well as increased acceptance in the general and medical population since the COVID crisis. Numerous meta-analyses have demonstrated that compared to conventional care, the addition of telemedicine in HF management leads to reduced hospitalization and mortality.4Zhu Y. Gu X. Xu C. Effectiveness of telemedicine systems for adults with heart failure: a meta-analysis of randomized controlled trials.Heart Fail Rev. 2020; 25: 231-243Crossref PubMed Scopus (55) Google Scholar,5Gingele A.J. Ramaekers B. Brunner-La Rocca H.P. et al.Effects of tailored telemonitoring on functional status and health-related quality of life in patients with heart failure.Neth Heart J. 2019; 27: 565-574Crossref PubMed Scopus (10) Google Scholar However, there is a paucity of data regarding the use of virtual care in SNF and home care patients with HF. Telemedicine platforms have traditionally presented numerous obstacles, including affordability of equipment, difficult-to-use technology requiring extensive training, lack of standardization, and patient privacy issues. These barriers are especially challenging to SNF and home care populations, who often have significant comorbidities, functional impairments, and barriers to transportation and access.6Woo K. Dowding D. Factors affecting the acceptance of telehealth services by heart failure patients: an integrative review.Telemed J E Health. 2018; 24: 292-300Crossref PubMed Scopus (23) Google Scholar Telemedicine can offer these populations improved access, but this is typically at the expense of clinical data such as a comprehensive physical examination and other structured data including vitals, medication reconciliation, and laboratory results. Many of the most common and expensive cardiopulmonary diseases rely on physical examination for detection of decompensation or exacerbation (Figure 1). VPExam is a Health Insurance Portability and Accountability Act (HIPAA)–compliant medical device data system that assists in overcoming barriers to traditional telemedicine using a combination of augmented reality–based guidance leading a minimally trained nurse or medical assistant (MA) through appropriate camera positioning for video capture based on anatomical landmarks. VPExam augmented reality–guided overlays, combined with sample videos as well as text and audio instructions, teach users how to obtain optimal video recordings of clinical findings such as evaluation of jugular venous distention and degree of lower-extremity edema in a reproducible manner. VPExam is integrated with Bluetooth-enabled stethoscopes, including the Eko Duo with single-lead electrocardiogram (ECG), to capture a full heart and lung exam with active user instruction (Figure 2). Virtual physical examination components are customizable by providers to optimize an efficient clinical workflow. The type of physical exam can be customized by medical specialty. Default physical exam components for VPExam QI included evaluation with (1) head-to-toe pan, (2) oral mucosa, (3) jugular venous assessment, (4) lower-extremity edema evaluation, (5) cardiac auscultation with single-lead ECG at the right upper sternal border and right lower sternal border, and (6) pulmonary auscultation at 2 sites. VPExam app data acquisition creates a partnership between minimally trained users (nurses or MAs) and physicians to efficiently gather and transmit relevant medical data to the Physician Portal. On average, nurses/MAs required a single 20-minute training session before becoming clinically proficient to use the platform in clinical practice. VPExam nurse assessment was completed in under 5 minutes on average. VPExam data were reviewed by the managing physician using the Physician Portal in under 2 minutes on average prior to proceeding to real-time video encounter with the patient and saved in the electronic medical record (EMR). Time-efficient review of asynchronous, clinically relevant patient management data has proven critical for ongoing physician engagement when using virtual care telemedicine. In addition to physical exam data, VPExam allows nurses to transmit structured data including manual transmission of vitals, voice recognition–based virtual history and review of systems, medication reconciliation with photographs of pill bottles, and a document scanner to transmit laboratory results, orders, logs, ECGs, etc (Figure 3). Providers reviewed VPExam Physician Portal asynchronous data prior to initiating a real-time HIPAA-compliant video conference with the patient. The Eko stethoscope with ECG can also be used by the provider during real-time synchronous video conferencing in coordination with the nurse/MA user with the patient (Figure 3). VPExam routinely transmits digital physical exam data for comprehensive assessment of volume status, cardiopulmonary auscultation, ECG detection of arrhythmias, and structured data including vitals, medication reconciliation, and labs. VPExam Partner Portal allows physicians to collaborate with partners at SNFs and home care to schedule VPExam follow-up post discharge. VPExam Partner Portal sends automated e-mail notifications to administrators or directors of nursing at partner facilities. SNFs and home care have HIPAA-compliant access to coordination-of-care data as well as prepopulated electronic home care or SNF orders sent by physician users (Figure 3). VPExam also offers additional remote patient monitoring (RPM) using Apple Health and Google Fit Health Kit data transmission to the VPExam Provider Portal, including blood glucose, body mass index, cardio fitness, blood pressure, ECG, heart rate, oxygen saturation, walking heart rate, and weight (Figure 4). VPExam RPM allows for transmitting alerts such as tachycardia with arrhythmia from a smartwatch, revealing a patient going into atrial fibrillation, or greater than 3-pound weight gain from a Bluetooth scale, revealing a patient suffering from decompensation of HF. Abnormal RPM data can trigger deployment of personnel to perform VPExam in a patient's home or facility for earlier intervention by a physician. For VPExam QI, supplemental health kit–based RPM hardware was not routinely deployed as part of the workflow. The focus was placed on the core VPExam technology of a tablet paired with Bluetooth stethoscope to transmit physical exam data as the primary intervention in order to avoid additional confounders. VPExam QI was designed as a single-arm prospective comparative community case study recruiting patients admitted for HF at University Hospitals Regional Medical Centers with anticipated discharge to SNFs or home care as well as those requiring urgent cardiology consultation with VPExam intervention. Primary outcomes included the degree to which unique VPExam digital physical exam data to assess volume status, cardiopulmonary auscultation, ECG detection of arrhythmias, and structured data of vitals, medication reconciliation, and labs would impact individual transition-of-care management as well as VPExam impact 30-day all-cause rehospitalization rates. The design also sought to assess feasibility of transition-of-care workflows within SNFs and home care, compliance with follow-up, technical stability of the platform, nursing staff satisfaction with the platform, and financial analysis of virtual care networks. The study design attempted to overcome common barriers to traditional telemedicine. Training barriers were reduced using user-friendly VPExam augmented reality–guided overlays to guide new nurse and MA users through how to obtain optimal video recordings of clinical findings such as jugular venous distention and degree of lower-extremity edema. The VPExam platform was cost-effective, requiring only a tablet and Bluetooth stethoscope at each sending site, allowing for rapid scaling within the health system. VPExam was approved by a thorough institutional Information Technology (IT) Architecture review process by University Hospitals of Cleveland IT Department to ensure HIPAA and HITECH compliance. The goal of VPExam QI was to explore potential clinical benefits to active physician-directed disease management using the VPExam technology and workflows for patients undergoing transitions of care. VPExam QI focused on gathering data on patients being discharged to SNFs or home care from a community-based hospital. VPExam QI evaluated whether a comprehensive virtual care platform can enhance the quality of transitions of care. Three SNF and 1 home care partners were selected with the highest numbers of HF patients being discharged to their care from the 2 medical centers before initiation of the pilot to increase data acquisition. University Hospitals of Cleveland's IT department successfully deployed VPExam on over 550 hospital-owned devices and University Hospitals home care. Prior to deployment of VPExam QI, baseline hospital HF outcome data were collected. From June 2020 to June 2021, patients discharged from University Hospitals of Cleveland Regional Medical Centers received guideline-directed HF therapy in accordance with the American College of Cardiology expert consensus guidelines for HF management and follow-up. The same cardiologist and advanced practice providers managed the control population from June 2020 to June 2021, as well as the study population from July 2021 to December 2021, with VPExam acting as the primary intervention. The prospective single-arm community case study of VPExam QI used convenience sampling to recruit patients admitted with HF who met eligibility criteria from University Hospitals of Cleveland Regional Medical Centers. Twenty-one patients with 25 independent patient encounters received virtual care intervention using VPExam technology and established workflows. VPExam QI focused on patients who were being discharged to 3 partner SNFs or follow-up from University Hospitals home care. VPExam QI recruited patients for the 6-month period from July 2021 through December 2021. All patients approached agreed to participate. Once patients were enrolled in the VPExam QI, encounters were completed as routine follow-up appointments within 1–3 weeks of discharge. Partners were also permitted to enroll urgent encounters as part of VPExam QI in coordination with the research team to allow for urgent cardiology consultation. The intervention of VPExam was compared to historical community matched controls. The control group data were derived from historical community patient data from the hospital system in the months and year immediately prior to VPExam intervention. The control group received guideline-directed HF therapy without routine follow-up at their SNF or home care visits with cardiology-led telemedicine with physical exam data from the same cardiology team as the intervention group. To identify potential patients, a daily automated list was generated from the EMR of patients admitted to the 2 hospitals for HF, known as the "Currently Admitted Patients with Heart Failure" from Allscripts Sunrise EMR. HF patients were identified based on brain natriuretic peptide (BNP) of greater than 300 or left ventricular ejection fraction (LVEF) of less than 40%. The team emphasized enrollment of patients who had been readmitted to the hospital within the last 30 or 90 days, as well as patients' being active on cardiology consultation services. The team enrolled patients being discharged to 1 of 3 SNF partners or eligible for University Hospital Home Health with VPExam capabilities. Exclusion criteria included the following: (1) those not meeting the definition of HF patients used in VPExam QI; (2) severe dementia preventing the patient's participation; (3) patients who are unable or unlikely to comply with telemedicine encounters. VPExam QI's primary objective was to determine the degree of significance of physician-directed disease management based on unique VPExam data including volume status assessment, cardiopulmonary auscultation, ECG arrhythmia detection, and structured data transmission, as well as the downstream impact on 30-day all-cause rehospitalization rates. Outcome measures included the following: (1) identifying the degree of significance of disease-altering care (minor, moderate, or major) based on VPExam virtual care data (Table 1); (2) 30-day all-cause hospitalization rates; (3) compliance with follow-up visits post discharge; (4) nursing staff satisfaction with using the VPExam platform using a 6-point Likert scale (0 being completely dissatisfied to 5 being completely satisfied); (5) evaluation for technical errors of software using a 6-point Likert scale (0 meaning no technical error and 5 meaning unable to complete telemedicine encounter owing to technical error); and (6) 30- and 90-day all-cause mortality rates.Table 1Significance criteria for modification of clinical careModification of clinical careExampleMinor or no change in medical careStable patients with benign VPExam data without need to alter planned therapyModerate changes in medical careVPExam data result in diuretic and vasoactive medication adjustments or detecting errors in medication reconciliationEmergent changes in medical careVPExam used emergently to make decisions whether to triage a patient to the emergency room Open table in a new tab With each encounter, demographic data points were collected including sex, body mass index, tobacco abuse history, Charlson Comorbidity Index, NYHA classification, days since previous hospitalization, relevant echocardiogram data with LVEF, degree of valvular disease and pulmonary hypertension, and laboratory data including BNP and glomerular filtration rate trends (Table 2).Table 2Demographic and clinical characteristics of patient participantsCharacteristicsVPExam intervention groupAge, mean (SD), mean Comorbidity Index, mean based on mean based on mean on discharge from based on mean of modification to clinical care, reconciliation data to modification of care, status evaluation and ECG data medical of guideline-directed satisfaction mean error mean atrial body mass BNP brain natriuretic ECG glomerular filtration jugular venous left ventricular ejection based on Open table in a new tab atrial body mass BNP brain natriuretic ECG glomerular filtration jugular venous left ventricular ejection and functional characteristics were using were as mean or as The intervention was as a virtual care practice change to the quality of care. were collected and using a data in a on a All received the of the agreed to before and were to from the study at was from the or from of for the of or data included in this The community case study recruited patient with 25 independent encounters for patients discharged to SNFs or home care from 2 community University Hospitals of Cleveland Regional Centers. patients were on average (Table of the population was and only were active The average body mass of the study population was BNP on was on average The average glomerular filtration rate on discharge for patients was The mean was those patients, had HF with reduced and had HF with were to be in NYHA or NYHA The mean Charlson Comorbidity was a with significant and an satisfaction of using this platform was for 25 of nursing staff that were also regarding technical with the use of the platform on a 6-point Likert scale, with meaning no technical error and 5 meaning unable to use the platform owing to technical For nursing staff in the the was No technical errors were detected partners at 3 SNFs and deployment on over 550 home medical VPExam QI patients received clinical follow-up for and data for 3 months VPExam were no patients who and there were no All patients and 25 encounters at partner SNFs and home care nurses were with VPExam visits by VPExam Partner Portal. total of of study encounters with home care services and of encounters at the 6-month of hospitalized HF patients at University Hospitals of Cleveland Regional Hospitals were enrolled into VPExam QI. Cardiology management was based on guideline-directed of patients were on total of of patients were on and of patients were on on follow-up visits during the The most common for or was acute by including by of patient encounters required only or less significant clinical modification of care, 84% of patient encounters required moderate-significance changes in clinical modification based VPExam follow-up (Table The most common moderate-significance changes diuretic adjustments of and vasoactive medication adjustments of moderate-significance clinical included of medication reconciliation errors in of encounters and of in of encounters. modification encounters were by volume status assessment (47.6%), cardiopulmonary auscultation (33.3%), ECG detection of (14.2%), and structured data transmission of vitals, medication reconciliation, and satisfaction with the platform was high. Prior to deployment of VPExam QI, baseline hospital HF outcome data were collected. From June 2020 to June 2021, patients discharged from University Hospitals of Cleveland Regional Medical Centers received guideline-directed HF therapy in accordance with the American College of Cardiology expert consensus guidelines management and follow-up. The same cardiologist and advanced practice providers managed the control population from June 2020 to June 2021, as well as the intervention population from July 2021 to December 2021, with VPExam acting as the primary intervention. The historical control population of HF patients discharged from University Hospitals of Cleveland Regional Medical Centers from June 2020 to June 2021 had an average all-cause readmission rate of with total encounters. intervention with VPExam QI 30-day hospital rates to for the HF population, with total encounters. the encounters of VPExam QI, the all-cause 30-day hospital rate was VPExam was associated with a relative risk reduction for 30-day readmission compared to historical community matched than of VPExam QI patients were recruited in months 1 and 2 of the pilot when the readmission rate for the hospital system to historical However, by months of the pilot more than of VPExam patients were recruited and readmission rates fell to for 4 months (Figure HF patients with HF mortality rate hospitalization is at 30 days, at 1 and at 5 et the American Heart Association and Heart disease and a from the American Heart PubMed Scopus Google Scholar Thirty-day mortality in VPExam QI was lower at 30 days, at with a relative risk reduction of compared to historical controls. 90-day mortality of the study population was at a patient population that was high risk significant comorbidities, as by an average Charlson Comorbidity of The VPExam QI used the ongoing for a providers to the patients and quality for transitions of care. also hospital systems overcome to new technology workflows. barriers identified in review preventing of quality the following: (1) the of HF can be and make to (2) guideline-directed are owing to on their and (3) SNF providers can be managing HF owing to and at (4) there is and lack of between SNF patients, and their (5) there are in of and access to for care of and (6) there are and N.M. Forman D.E. De Matteis G. Gambassi G. Heart failure among older adults in skilled nursing facilities: more of a dilemma than many now realize.Curr Geriatr Rep. 2015; 4: 318-326Crossref PubMed Scopus (15) Google K. Dowding D. Factors affecting the acceptance of telehealth services by heart failure patients: an integrative review.Telemed J E Health. 2018; 24: 292-300Crossref PubMed Scopus (23) Google M. C. emergency department from skilled nursing facilities through an emergency physician telemedicine J 2020; PubMed Google et failure management in nursing a J 2018; PubMed Scopus (10) Google Scholar VPExam QI that unique VPExam overcome many of these barriers a virtual care between hospital systems and partner SNFs and home care. VPExam deployment to SNFs and home care is and VPExam virtual care high compliance with follow-up, with high satisfaction from nursing for patient management structured data transmission of the platform to modification in clinical management over of encounters. data transmission of improved detection of hypertension, and often in traditional telemedicine. data transmission of medication reconciliation often identified transition-of-care data transmission of labs including BNP and blood stability improved the quality of medical VPExam is also to clinical decisions with unique physical exam status including jugular venous distention and lower-extremity edema modification management in of encounters. and asynchronous stethoscope auscultation of the heart to and as well as auscultation of the to and modification management in over of encounters. and asynchronous single-lead ECG transmission for arrhythmia detection including atrial modification management in over of encounters. The that virtual care in transitions of care to SNFs and home care offer a to quality of care and risk of errors for cardiopulmonary VPExam was associated with improved adjustments in medication based on physical exam data, errors in medication reconciliation, and of medication compliance. a the reduction in 30-day hospitalization and mortality the that unique VPExam virtual care data care providers to optimize transitional quality of care traditional guideline-directed quality adoption of virtual care, there are also financial for of SNF to emergency is to increased morbidity and as well as significant M. C. emergency department from skilled nursing facilities through an emergency physician telemedicine J 2020; PubMed Google Scholar The average cost of readmission is VPExam clinical modification is associated with a significant reduction in 30-day there are over readmissions for HF, readmissions for cardiac arrhythmias, and readmissions with from VPExam cardiopulmonary and volume status evaluation chronic pulmonary disease with with and failure with readmissions of with and Hospital by 2021 for Research and Scholar VPExam the cost of patients to and including cost and nursing Virtual care also the risk of diseases such as COVID the health care as well as the to the including potential need for In addition to the financial to using virtual care to the cost of the platform can also increase individual provider VPExam data were to a of encounter on average, increasing to with an average increase in of and relative VPExam services are eligible for RPM using and with VPExam QI received RPM from including and the VPExam QI is a quality and feasibility study during an COVID crisis. that of virtual care in other hospital systems at a scale as a quality be to outcomes the of care. Virtual care offers earlier detection of clinical decompensation to underserved and decisions by in reduced risk of hospital and mortality on discharge. In improved transitional care assists health care systems in care and more efficient utilization of and care significant of the VPExam QI is the scale of a owing to the to and allow for data in a a case study with the most appropriate for The were deployed from community-based hospitals in that not be to more or health care be by access to especially for health for VPExam technology deployment was with 3 SNFs and a home care the has to SNFs in of patients home with home care services. Patients discharged to SNFs and home care on average have greater and barriers to care than patients discharged to home without such services. the intervention of VPExam QI was focused on the HF The research team included 2 2 2 cardiology nurse and 1 with training were during VPExam QI encounters to of data analysis and guideline-directed VPExam QI encounters were completed as routine follow-up appointments or urgent of the for a lack of significance modification of clinical management in the VPExam QI was that the of the study team to access to cardiology care for urgent an VPExam was not established with partner SNFs and home care. The of VPExam technology in these of encounters can be in the by the platform with a clinical team supporting these of encounters and offers greater potential virtual care to transitions of care in the underserved SNF and home care patient populations a to high readmission rates in HF VPExam offers to efficiently transmit virtual physical exam cardiopulmonary and volume status with supplemental structured data, including vitals, medication reconciliation, and labs critical to HF management. platforms offer to optimize quality of care, readmission and mortality rates. Virtual care in HF management is a intervention with quality for SNF and home care patients, who traditionally have access to care. not only focus on how virtual care can be integrated to quality of care, but also the of health care the growing of health care and hospital for digital research allows physicians the to the be used in workflows to optimize and quality of care. The the and University Hospitals of Cleveland Heart and for financial and institutional for digital physician and clinical The VPExam QI study was by University Hospitals of Cleveland Heart and The is the of the and not the of University Hospitals of

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Guiding heart failure care by invasive hemodynamic measurements: Possible or useful?
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Treatment of Heart Failure with Abnormal Left Ventricular Systolic Function in the Elderly
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Treatment of Heart Failure with Abnormal Left Ventricular Systolic Function in the Elderly

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