Age-related patterns of ambulatory blood pressure in a large cohort of individuals referred to Italian community pharmacies: results from the templar project.

OBJECTIVES: Ambulatory blood pressure monitoring (ABPM) provides extensive information on several BP parameters other than the average BP during daily life. Through this analysis of the TEMPLAR study, we sought to understand better the features of age-related changes in ABP patterns and phenotypes. METHODS: ABPMs were obtained in 53 350 individuals visiting 866 Italian community pharmacies (age 3-101 years, 54.3% female individuals). ABPM patterns were assessed across 10-year age categories. RESULTS: SBP steadily increased with age. DBP increased from the youth to the middle adulthood and then declined. Daytime BP was higher than night-time BP, but the difference narrowed with aging, reducing the prevalence of dippers. An enhanced SBP morning surge and increased prevalence of abnormal morning rise were observed with aging. SBP and DBP variabilities increased with age with a typical U or J shape, more evident in the case of DBP. The proportion of participants with ambulatory hypertension increased with age. However, an elevated daytime BP was more common in younger individuals and elevated night-time hypertension in older individuals. The prevalence of white-coat hypertension remained stable or slightly declined through the age groups, whereas that of masked hypertension steadily increased. CONCLUSION: Our results confirm that ABP patterns interplay and change in a complex way with age. Such changes, particularly the age-related increase in BP variability and prevalence of nocturnal hypertension, nondipping, enhanced morning rise, and masked hypertension, may increase the risk of cardiovascular events and must be carefully considered by the physician when managing BP in the elderly.

24-hour ambulatory blood pressure telemonitoring in patients at risk of atrial fibrillation: results from the TEMPLAR project.

Hypertension is the most common risk factor for atrial fibrillation (AF). The ability to screen for potential AF during blood pressure (BP) measurement may be a valuable tool for early AF detection. This study evaluated the frequency of irregular pulse rates suggestive of AF in subjects undergoing ambulatory BP monitoring (ABPM) and compared the characteristics of patients at low risk of presumed AF vs. those at high risk. ABPM recordings were obtained in 4419 subjects aged ≥65 years visiting 304 community pharmacies, with clinically validated automated monitors equipped with an algorithm for detecting possible AF episodes during BP measurement. Subjects with <30% of the readings suggestive of AF were categorized as having a low risk of AF, and those with ≥30% of readings were classified as high risk. A total of 531 subjects (12.0%) were categorized as having a high risk of AF, with the risk increasing with advancing age. Subjects at high risk of AF had lower average systolic BP, higher average diastolic BP and pulse rate (PR), increased BP and PR variabilities, and blunted sleep-associated reductions in BP and PR. In repeated recordings, the reliability of the AF detection algorithm per se was good (kappa 0.476, p = 0.0001; intraclass correlation coefficient 0.56, p = 0.0001). Simultaneous BP measurement and screening for potential AF by ABPM in elderly people in clinical practice may help improve BP control and the detection of subjects at high risk of AF. However, a finding of presumed AF must always be confirmed by an electrocardiogram (ECG).

Telehealth at scale can improve chronic disease management in the community during a pandemic: An experience at the time of COVID-19.

BACKGROUND: During the COVID-19 pandemic, telehealth became a vital resource to contain the virus's spread and ensure continuity of care of patients with a chronic condition, notably arterial hypertension and heart disease. This paper reports the experience based on a telehealth platform used at scale to manage chronic disease patients in the Italian community. METHODS AND FINDINGS: Patients' health status was remotely monitored through ambulatory blood pressure monitoring (ABPM), resting or ambulatory electrocardiogram (ECG), spirometry, sleep oximetry, and cardiorespiratory polysomnography performed in community pharmacies or general practitioners' offices. Patients also monitored their blood pressure (BP), heart rate (HR), blood oxygen saturation (SpO2), body temperature, body weight, waist circumference, blood glucose, and lipids at home through a dedicated smartphone app. All data conveyed to the web-based telehealth platform were used to manage critical patients by doctors promptly. Data were analyzed and compared across three consecutive periods of 2 months each: i) before the national lockdown, ii) during the lockdown (from March 9 to May 17, 2020), and iii) after the end of the containment measures. Overall, 13,613 patients visited community pharmacies or doctors' offices. The number of overall tests dropped during and rose after the lockdown. The overall proportion of abnormal tests was larger during the outbreak. A significant increase in the prevalence of abnormal ECGs due to myocardial ischemia, contrasted by a significantly improved BP control, was observed. The number of home users and readings exchanged increased during the pandemic. In 226 patients, a significant increase in the proportion of SpO2 readings and a significant reduction in the entries for all other parameters, except BP, was observed. The proportion of abnormal SpO2 and BP values was significantly lower during the lockdown. Following the lockdown, the proportion of abnormal body weight or waist circumference values increased. CONCLUSIONS: Our study results support the usefulness of a telehealth solution to detect deterioration of the health status during the COVID-19 pandemic. TRIAL REGISTRATION: The study is registered with ClinicalTrials.gov at number NCT03781401.

Feasibility of 24-h blood pressure telemonitoring in community pharmacies: the TEMPLAR project.

OBJECTIVES: Low-quality ambulatory blood pressure monitoring (ABPM) due to recurring artifacts may limit its clinical value. We evaluated the features and impact on BP control and patient management of ABPMs performed in Italian community pharmacies, according to their quality. METHODS: Twenty-four-hour ABPMs were obtained by a clinically validated, automated upper arm device and uploaded on a certified web-based telemedicine platform (www.tholomeus.net). The system automatically evaluated the quality of the recording according to current guidelines. In case of poor ABPM quality, the pharmacist was prompted to repeat the test. All the ABPMs were labeled as valid or invalid. Demographic and clinical characteristics of the patients and BP control were compared between the two groups. RESULTS: A total of 45 232 ABPMs were obtained in as many patients through 812 pharmacies (87.7% recordings were valid). Factors significantly associated with a better ABPM quality were younger age, use of antihypertensive medications, presence of at least one cardiovascular risk factor, concomitant disease or treatment, a test performed in the coldest months, and residence in the cooler northern regions of the country. The 24-h and daytime ambulatory BP level and the prevalence of ambulatory hypertension and white-coat hypertension were higher, and the prevalence of masked hypertension lower in patients with valid recordings. High odds of obtaining a valid recording were observed in patients repeating the ABPM. CONCLUSION: Ambulatory BP telemonitoring is feasible in community pharmacies as long as potential predictors of unsuccessful outcomes are taken into account and adequately managed.

Telehealth in chronic disease management and the role of the Internet-of-Medical-Things: the Tholomeus® experience.

INTRODUCTION: Telehealth is used to remotely and timely deliver clinical care, and its effectiveness for managing the most common chronic diseases has been proved by several studies. AREAS COVERED: Tholomeus® is a web-based clinically validated and certified telehealth solution operating in the context of the Internet-of-Medical-Things. It favors closed-loop connectivity between patients and caregivers, according to multidisciplinary and multifaceted interventions. Evidence collected in the last decade in 1,471 healthcare facilities and 135,333 patients has documented the usefulness of the service for improving access to care, and enhance screening and management of arterial hypertension, heart disease, chronic obstructive pulmonary disease, and obstructive sleep apnea. In addition to professional diagnostic tests, an AndroidTM Tholomeus® app used by 3,654 consumers in the last three years has helped document a high prevalence of impaired glucose tolerance, overweight or obesity, dyslipidemia, or uncontrolled blood pressure among users. EXPERT OPINION: The telehealth approach to chronic disease management is currently characterized by a high heterogeneity of solutions, often not supported by robust evidence for clinical efficacy and safety. The Tholomeus® solution seems to satisfy the current recommendations of software as a medical device solution, although further clinical evidence needs to be collected in prospective studies.

E-Health in Hypertension Management: an Insight into the Current and Future Role of Blood Pressure Telemonitoring.

PURPOSE OF REVIEW: Out-of-office blood pressure (BP) monitoring techniques, including home and ambulatory BP monitoring, are currently recommended by hypertension guidelines worldwide to confirm the diagnosis of hypertension and to monitor the appropriateness of treatment. However, such techniques are not always effectively implemented or timely available in the routine clinical practice. In recent years, the widespread availability of e-health solutions has stimulated the development of blood pressure telemonitoring (BPT) systems, which allow remote BP tracking and tighter and more efficient monitoring of patients' health status. RECENT FINDINGS: There is currently strong evidence that BPT may be of benefit for hypertension screening and diagnosis and for improving hypertension management. The advantage is more significant when BPT is coupled with multimodal interventions involving a physician, a nurse or pharmacist, and including education on lifestyle and risk factors and drug management. Several randomized controlled studies documented enhanced hypertension management and improved BP control of hypertensive patients through BPT. Potential additional effects of BPT are represented by improved compliance to treatment, intensification, and optimization of drug use, improved quality of life, reduction in risk of developing cardiovascular complications, and cost-saving. Applications based on m-health and making use of wearables or smartwatches integrated with machine learning models are particularly promising for the future development of efficient BPT solutions, and they will provide remarkable support decision tools for doctors. BPT and telehealth will soon disrupt hypertension management. However, which approach will be the most effective and whether it will be sustainable in the long-term still need to be elucidated.