IMPORTANCESmart technology via smartphone-compatible devices might improve blood pressure (BP) regulation in patients after myocardial infarction. OBJECTIVES To investigate whether smart technology in clinical practice can improve BP regulation and to evaluate the feasibility of such an intervention. DESIGN, SETTING, AND PARTICIPANTS This study was an investigator-initiated, single-center, nonblinded, feasibility, randomized clinical trial conducted at the Department of Cardiology of the Leiden University Medical Center between May 2016 and December 2018. Two hundred patients, who were admitted with either ST-segment elevation myocardial infarction or non-ST-segment acute coronary syndrome, were randomized in a 1:1 fashion between follow-up groups using smart technology and regular care. Statistical analysis was performed from January 2019 to March 2019. INTERVENTIONSFor patients randomized to regular care, 4 physical outpatient clinic visits were scheduled in the year following the initial event. In the intervention group, patients were given 4 smartphone-compatible devices (weight scale, BP monitor, rhythm monitor, and step counter). In addition, 2 in-person outpatient clinic visits were replaced by electronic visits. MAIN OUTCOMES AND MEASURESThe primary outcome was BP control. Secondary outcomes, as a parameter of feasibility, included patient satisfaction (general questionnaire and smart technology-specific questionnaire), measurement adherence, all-cause mortality, and hospitalizations for nonfatal adverse cardiac events. RESULTSIn total, 200 patients (median age, 59.7 years [interquartile range, 52.9-65.6 years]; 156 men [78%]) were included, of whom 100 were randomized to the intervention group and 100 to the control group. After 1 year, 79% of patients in the intervention group had controlled BP vs 76% of patients in the control group (P = .64). General satisfaction with care was the same between groups (mean [SD] scores, 82.6 [14.1] vs 82.0 [15.1]; P = .88). The all-cause mortality rate was 2% in both groups (P > .99). A total of 20 hospitalizations for nonfatal adverse cardiac events occurred (8 in the intervention group and 12 in the control group). Of all patients, 32% sent in measurements each week, with 63% sending data for more than 80% of the weeks they participated in the trial. In the intervention group only, 90.3% of patients were satisfied with the smart technology intervention. CONCLUSIONS AND RELEVANCEThese findings suggest that smart technology yields similar percentages of patients with regulated BP compared with the standard of care. Such an intervention (continued)

Objective Consistent with the aging population in the Western world, there is a growing number of elderly patients with ST-segment elevation myocardial infarction (STEMI). Primary percutaneous coronary intervention (PCI) is the recommended reperfusion strategy in elderly patients; risk models to determine which of these patients are prone to have poor clinical outcomes are, however, essential. The purpose of this study was to assess the association between frailty and short-term mortality and PCI-related serious adverse events (SAE) in elderly patients. Methods All STEMI patients (aged ≥70 years) treated with primary PCI in 2013–2015 at the Leiden University Medical Centre were assessed. The Safety Management Programme (VMS) score was used to identify frail elderly patients. The primary endpoint was 30-day all-cause mortality; the secondary endpoint included 30-day clinical death, target vessel failure, major bleeding, contrast induced kidney insufficiency and stroke. Results A total of 206 patients were included (79 ± 6.4 years, 119 [58%] male). The VMS score was ≥1 in 28% of all cases. Primary and secondary endpoint rates were 5 and 23% respectively. VMS score ≥1 was an independent predictor for both 30-day mortality (odds ratio [OR] 9.6 [95% confidence interval, CI 1.6–56.9] p -value = 0.013) and 30-day SAE (OR 2.9 [95% CI 1.1–7.9] p -value = 0.038). Conclusions VMS score for frailty is independently associated with short-term mortality and PCI-related SAE in elderly patients with STEMI treated with primary PCI. These results suggest that frailty in elderly patients is an important feature to measure and to be taken into account when developing risk models. Electronic supplementary material The online version of this article (10.1007/s12471-019-1240-7) contains supplementary material, which is available to authorized users.

BackgroundRecent evidence suggests that frequent monitoring using smartphone-compatible wearable technologies might improve clinical effectiveness and patient satisfaction of care.ObjectiveThe aim of this study is to investigate the clinical effectiveness and patient satisfaction of a smart technology intervention in patients admitted with a ST elevation myocardial infarction (STEMI) or non-ST acute coronary syndrome (NST-ACS).MethodsIn this single center, open, randomized controlled trial patients who suffered from STEMI or NST-ACS will be randomized 1:1 to an intervention group or control group. Both groups will be followed up to one year after the index event. The intervention group will take daily measurements with a smartphone-compatible electrocardiogram device, blood pressure (BP) monitor, weight scale, and activity tracker. Furthermore, two of four outpatient clinic visits will be replaced by electronic visits (1 and 6 months after index event). The control group will receive regular care, consisting of four outpatient clinic visits (1, 3, 6, and 12 months after index event). All patients will be asked to fill in validated questionnaires about patient satisfaction, quality of life, propensity of medication adherence, and physical activity.ResultsThe primary outcome of this trial will be percentage of patients with controlled BP. Secondary outcomes include patient satisfaction, health care utilization, major adverse cardiac events, medication adherence, physical activity, quality of life, and percentage of patients in which a sustained arrhythmia is detected.ConclusionsSmart technology could potentially improve care in postmyocardial infarction patients. This trial will investigate whether usage of smart technology can improve clinical- and cost-effectiveness of care.Trial RegistrationClinicaltrials.gov NCT02976376; https://clinicaltrials.gov/ct2/show/NCT02976376 (Archived by WebCite at http://www.webcitation.org/6tcvAdbdH)

Background Smartphone compatible wearables have been released on the consumers market, enabling remote monitoring. Remote monitoring is often named as a tool to reduce the cost of care. Objective The primary purpose of this paper is to describe a cost-utility analysis of an eHealth intervention compared to regular follow-up in patients with acute myocardial infarction (AMI). Methods In this trial, of which clinical results have been published previously, patients with an AMI were randomized in a 1:1 fashion between an eHealth intervention and regular follow-up. The remote monitoring intervention consisted of a blood pressure monitor, weight scale, electrocardiogram device, and step counter. Furthermore, two in-office outpatient clinic visits were replaced by e-visits. The control group received regular care. The differences in mean costs and quality of life per patient between both groups during one-year follow-up were calculated. Results Mean costs per patient were €2417±2043 (US $2657±2246) for the intervention and €2888±2961 (US $3175±3255) for the control group. This yielded a cost reduction of €471 (US $518) per patient. This difference was not statistically significant (95% CI –€275 to €1217; P=.22, US $–302 to $1338). The average quality-adjusted life years in the first year of follow-up was 0.74 for the intervention group and 0.69 for the control (difference –0.05, 95% CI –0.09 to –0.01; P=.01). Conclusions eHealth in the outpatient clinic setting for patients who suffered from AMI is likely to be cost-effective compared to regular follow-up. Further research should be done to corroborate these findings in other patient populations and different care settings. Trial Registration ClinicalTrials.gov NCT02976376; https://clinicaltrials.gov/ct2/show/NCT02976376 International Registered Report Identifier (IRRID) RR2-10.2196/resprot.8038

BACKGROUND Smartphone compatible wearables have been released on the consumers market, enabling remote monitoring. Remote monitoring is often named as a tool to reduce cost of care. OBJECTIVE The primary purpose of this paper is to describe a cost-utility analysis of an eHealth intervention compared to regular follow-up in patients with acute myocardial infarction (AMI). METHODS In this trial, patients with an AMI were randomized in a 1:1 fashion between an eHealth intervention and regular follow-up. The remote monitoring intervention consisted of a blood pressure monitor, weight scale, electrocardiogram (ECG) device and step counter. Furthermore, two in-office outpatient clinic visits were replaced by e-visits. The control group received regular care. The differences in mean costs and quality of life per patient between both groups during one year follow-up were calculated RESULTS Mean costs per patient were €2412 for the intervention, and €2888 for the control group. This yielded cost reduction of €475 per patient. This difference was not statistically significant (95% CI -€271;€1221; P=.212). The average quality adjusted life years (QALY) in the first year of follow was 0.74 for the intervention group and 0.69 for the control (difference -0.05, 95% CI -0.09;-0.01; P=.028). CONCLUSIONS eHealth in the outpatient clinic setting in patients who suffered from acute myocardial infarction is very likely to be cost-effective compared to regular follow-up. Further research should be done to corroborate these findings in other patient populations and different care settings. CLINICALTRIAL NCT02976376 INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.8038