eHealth in hypertension and cardiovascular disease:Opportunities and challenges

In this thesis we investigate different aspects of eHealth for hypertension and cardiovascular disease, with a focus on remote monitoring programs for chronic care. We use the Dutch HartWacht program for patients with hypertension, cardiac arrhythmias and heart failure as an example that has been implemented in routine clinical care. We first focus on hypertension and identify areas that are attractive for future implementation of eHealth because of poor hypertension control. In the following chapters we present economical, legal and technical challenges that accompany eHealth implementation, in each chapter followed by potential solutions and opportunities. We identify success factors for cost-effective eHealth, provide a roadmap for GDPR-compliant solutions, present a novel technique for heartbeat detection through a bracelet and describe a protocol for efficient data handling in remote monitoring programs. In the second part of this thesis, we zoom in on the patients participating in eHealth programs. We evaluate the impact on quality of life of patients participating in the HartWacht program for cardiac arrhythmias and demonstrate equivalence compared to usual care. We then describe the feasibility of the HartWacht program for patients with hypertension in reducing blood pressure and present rationale, design and cohort profile of the Effectiveness of home-Monitoring of blood pressure in PAtients with difficult to Treat HYpertension (EMPATHY) trial. We conclude with an evaluation of the impact of the COVID-19 pandemic on the uptake of eHealth in primary care in the Netherlands

Telemedicine-Based Management of Oral Anticoagulation Therapy:Systematic Review and Meta-analysis

BACKGROUND: Oral anticoagulation is the cornerstone treatment of several diseases. Its management is often challenging, and different telemedicine strategies have been implemented to support it. OBJECTIVE: The aim of the study is to systematically review the evidence on the impact of telemedicine-based oral anticoagulation management compared to usual care on thromboembolic and bleeding events. METHODS: Randomized controlled trials were searched in 5 databases from inception to September 2021. Two independent reviewers performed study selection and data extraction. Total thromboembolic events, major bleeding, mortality, and time in therapeutic range were assessed. Results were pooled using random effect models. RESULTS: In total, 25 randomized controlled trials were included (n=25,746 patients) and classified as moderate to high risk of bias by the Cochrane tool. Telemedicine resulted in lower rates of thromboembolic events, though not statistically significant (n=13 studies, relative risk [RR] 0.75, 95% CI 0.53-1.07; I2=42%), comparable rates of major bleeding (n=11 studies, RR 0.94, 95% CI 0.82-1.07; I2=0%) and mortality (n=12 studies, RR 0.96, 95% CI 0.78-1.20; I2=11%), and an improved time in therapeutic range (n=16 studies, mean difference 3.38, 95% CI 1.12-5.65; I2=90%). In the subgroup of the multitasking intervention, telemedicine resulted in an important reduction of thromboembolic events (RR 0.20, 95% CI 0.08-0.48). CONCLUSIONS: Telemedicine-based oral anticoagulation management resulted in similar rates of major bleeding and mortality, a trend for fewer thromboembolic events, and better anticoagulation quality compared to standard care. Given the potential benefits of telemedicine-based care, such as greater access to remote populations or people with ambulatory restrictions, these findings may encourage further implementation of eHealth strategies for anticoagulation management, particularly as part of multifaceted interventions for integrated care of chronic diseases. Meanwhile, researchers should develop higher-quality evidence focusing on hard clinical outcomes, cost-effectiveness, and quality of life. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42020159208; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=159208.</p

The Re-Heart Registry: A Prospective, Interoperable, Standardised Clinical Registry of Outpatients With Heart Failure

Purpose: To describe the creation and implementation of the RE-Heart Registry, a prospective, interoperable, highly scalable and standardised clinical registry of outpatients with heart failure (HF). Methods and Results: We carried out the steps, as follows: (1) data standardisation in accordance with national and international data elements. Dataset included all applicable standardised data elements published by the American Heart Association (AHA), American College of Cardiology (ACC) with the National Cardiovascular Data Registry (NCDR)and the Brazilian Cardiovascular Registries, as a reference the BREATHE (I Brazilian Registry of Heart Failure) and PINNACLE (heart failure and atrial fibrillation); (2) development of an initial data collection and clinical research workflow; (3) development of electronic case reports using REDCap and in accordance with the HIPAA privacy rule; (4) pilot test and validation of the data collection and clinical research workflows and CRFs; (5) development of automated data quality reporting using REDCap. Data collection occurs at the outpatient department at the moment of inclusion and every 6 months (phone calls and visits to the outpatients department). Conclusions: The RE-Heart Registry represents a comprehensive database capable to represent real clinical practice favouring clinical research, technology assessment, services management and health policies

Role of telemedicine in the management of oral anticoagulation in atrial fibrillation: a practical clinical approach

COVID-19; Direct oral anticoagulant; TelemedicineCOVID-19; Anticoagulante oral directo; TelemedicinaCOVID-19; Anticoagulant oral directe; TelemedicinaCompared with face-to-face consultations, telemedicine has many advantages, including more efficient use of healthcare resources, partial relief of the burden of care, reduced exposure to COVID-19, treatment adjustment, organization of more efficient healthcare circuits and patient empowerment. Ensuring optimal anticoagulation in atrial fibrillation patients is mandatory if we want to reduce the thromboembolic risk. Of note, telemedicine is an excellent option for the long-term management of atrial fibrillation patients. Moreover, direct oral anticoagulants may provide an added value in telemedicine (versus vitamin K antagonists), as it is not necessary to monitor anticoagulant effect or make continuous dosage adjustments. In this multidisciplinary consensus document, the role of telemedicine in anticoagulation of this population is discussed and practical recommendations are provided.V Barrios has received consultancy/lecture fees from Bayer, BMS/Pfizer, Boehringer Ingelheim and Daiichi Sankyo. S Cinza-Sanjurjo has received honoraria for presentations from Bayer, Boehringer-Ingelheim, Daiichi Sankyo and Pfizer-BMS; advisory board fees from Bayer, Boehringer-Ingelheim, Daiichi Sankyo and Pfizer-BMS; and funding for studies from Bayer. J García-Alegría reports consulting fees and/or lectures honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb and Daiichi Sankyo. R Freixa-Pamias has received honoraria for presentations from Bayer, Boehringer-Ingelheim, Daiichi Sankyo and Pfizer-BMS. F Llordachs-Marques. No potential conflicts of interest were declared by the author. CA Molina reports consulting fees and/or honoraria from Novo Nordisk, Bayer, Pfizer, BMS, Daiichi Sankyo and Boehringer Ingelheim. A Santamaría has received honoraria per conferences from Octapharma, Novo Nordisk, Bayer, Pfizer, BMS, Sobi, Shire, Sanofi, LEO Pharma, Rovi, Daiichi Sankyo, Werfen and Ferrer. D Vivas reports no potential conflicts of interest were declared by the author. C Suárez has received speaker and/or advisory fees from Bayer, Pfizer/BMS, Daiichi Sankyo. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed

Diagnostyka elektrokardiograficzna w warunkach SOR za pomocą mobilnego jednoodprowadzeniowego urządzenia EKG

Introduction. Electrocardiography (ECG) is one of the basic diagnostic tests used in emergency departments and byemergency medical services. Life-threatening arrhythmias can be detected using a single-lead ECG. Therefore, single--lead ECG devices can be used for arrhythmia detection, as their availability steadily increases. Kardia Mobile from Alive-Cor is an example of such a device, recording a single-lead ECG and automatically detecting atrial fibrillation (AF) — themost common complex supraventricular tachyarrhythmia. The aim of our study was to evaluate the utility of a single-leadmobile ECG device in detecting AF in medical practice of emergency services. Material and methods. Study included 118 patients (62 women and 56 men) who were hospitalized in a hospitalemergency department and consented to examination with Kardia Mobile immediately after a standard 12-lead ECG.Results of both tests were subsequently compared. Ultimately, 121 different pairs of ECG recordings were analyzed (in3 cases an additional ECG recording was performed after an electrical cardioversion). Results. Sinus rhythm was identified in 99 patients and 22 were diagnosed with AF using a 12-lead ECG (reference).Kardia Mobile correctly detected AF in 19 of 22 patients with AF (sensitivity: 86.4%) and absence of AF in 96 of 99people without AF (specificity: 97%). Conclusions. Kardia Mobile device is effective in automated detection of AF among patients hospitalized in the emergencydepartment.Wstęp. Elektrokardiografia (EKG) jest jednym z podstawowych badań wykorzystywanych w praktyce szpitalnych oddziałów ratunkowych (SOR) i zespołów ratownictwa medycznego. Zaburzenia rytmu mogące powodować zatrzymanie krążenia należą do najważniejszych dla zdrowia pacjenta nieprawidłowości wykrywanych w badaniu EKG. Są one widoczne we wszystkich odprowadzeniach EKG, co pozwala używać do ich wykrywania jednoodprowadzeniowych aparatw EKG, których dostępność na rynku istotnie się zwiększyła. Przykładem takiego urządzenia jest Kardia Mobile firmy AliveCor, zdolne do akwizycji pojedynczego odprowadzenia EKG oraz do automatycznej detekcji rytmu zatokowego oraz migotania przedsionków (AF), najczęściej występującej złożonej tachyarytmii nadkomorowej. Celem pracy jest określenie przydatności mobilnych jednoodprowadzeniowych rejestratorów EKG detekcji AF w warunkach SOR. Materiał i metody. Do badania włączono 118 osób (62 kobiety i 56 mężczyzn) hospitalizowanych na SOR, które wyraziły zgodę na wykonanie badania urządzeniem Kardia Mobile bezpośrednio po wykonaniu standardowego 12-odprowadzeniowego badania EKG. Wyniki obu badań porównywano. Ostatecznie analizowano 121 różnych par odczytów EKG (u 3 pacjentów wykonano akwizycję EKG przed zabiegem kardiowersji elektrycznej i po nim). Wyniki. W 12-odprowadzeniowym (referencyjnym) zapisie EKG rytm zatokowy rozpoznano u 99 badanych, u 22 badanych rozpoznano AF. Urządzenie Kardia Mobile prawidłowo rozpoznało AF u 19 spośród 22 badanych z arytmią (czułość: 86,4%), a brak AF — u 96 z 99 badanych (swoistość: 97%). Wnioski. Urządzenie Kardia Mobile jest w efektywnym narzędziem w diagnostyce AF w warunkach SOR

Systematic-interdisciplinary approach to eHealth equipment design

eHealth has improved the performance of multiple health systems worldwide by integrating Information and Communication Technologies (ICTs) into national (structured and coordinated) strategies in the health sector. However, once the foundation is laid for the development and implementation of eHealth solutions, researchers, engineers, doctors and other stakeholders have no single way to develop eHealth solutions. Therefore, a systematic interdisciplinary method is proposed to design electronic health equipment to meet the requirements and needs of all people involved in the use of the equipment, and comply with the laws and regulations of different countries.On the basis of systematic and interdisciplinary methods, a method is proposed, that is, the collaborative use of different systematic methods allows stakeholders to continue to cooperate and share the experience. Consequently, the method will allow the design of eHealth devices that, regardless of their use, meet the needs of the user, the requirements of the personnel who will use them, the standards and regulations of the country where they are developed, and provide total satisfaction with the device. Finally, the eHealth solution is designed through systematic thinking, through the analysis of needs and needs, and through exploring different perspectives, observation backgrounds, participant participation, discussion and stakeholder consistency, so as to provide a sustainable product that meets all participants