Cost-Effectiveness of Empagliflozin in Combination with Standard Care versus Standard Care Only in the Treatment of Heart Failure Patients in Finland.

Purpose: Sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin has recently been shown to improve the outcomes of heart failure (HF) patients regardless of patient's left ventricular ejection fraction by reducing the combined risk of cardiovascular death or hospitalization for worsening HF. The aim of this study was to assess the cost-effectiveness of adding empagliflozin to the standard care (SC) in comparison to SC only in the treatment of HF in Finland. Patients and Methods: The assessment was performed in the cost-utility framework using two Markov cohort state-transition models, one for HF with reduced ejection fraction (HFrEF) and one for HF with preserved ejection fraction (HFpEF). The models have been primarily developed based on the EMPEROR-Reduced and EMPEROR-Preserved trials which informed the modelled patient characteristics, efficacy of treatments in terms of associated risks for heart failure hospitalizations, cardiovascular (CV) and non-CV death, treatment related adverse events (AE), and state- and event-specific health-related quality of life weights (EQ-5D). Direct health care costs were estimated from Finnish published references. Cost-effectiveness was assessed from health care payer perspective based on incremental cost-effectiveness ratio (ICER; cost per quality adjusted life-year [QALY] gained) and probability of cost-effectiveness (at willingness-to-pay [WTP] of 35,000 euros/QALY). The ICER was reported as the weighted (HFrEF, 43.5%; HFpEF, 56.5%) average result of the two models. Results: Empagliflozin + SC treatment increased the average quality-adjusted life-expectancy, and treatment costs of HF patients by 0.15 QALYs and 1,594 euros, respectively, when compared to SC. An additional QALY with empagliflozin was thus gained at a cost of 10,621 euros. The probability of empagliflozin + SC being cost-effective compared to placebo + SC was 77.6% and 83.5% with WTP of 35,000 and 100,000 euros/QALY, respectively. Conclusion: Empagliflozin is a cost-effective treatment for patients with HF in the Finnish health care setting.

Characteristics and costs of electric scooter injuries in Helsinki: a retrospective cohort study.

BACKGROUND AND PURPOSE: The incidence of electric scooter (e-scooter) injuries has increased drastically in numerous countries after widespread availability of shared e-scooters. The economic impact on society from a broader perspective has not been studied. We aimed to estimate the incidence of e-scooter injuries, describe the injury patterns, and estimate the costs of e-scooter injuries. PATIENTS AND METHODS: We performed a retrospective cohort study including all e-scooter-related injuries presented in the three adult emergency departments in Helsinki in 2021. We collected the patient data from the university hospital information system. Injury severity was evaluated based on the Abbreviated Injury Score. The cost of the hospital treatment was analyzed based on our hospital district's service price listing. In addition, we recorded the total amount of sick leave days and estimated their economic impact. RESULTS: In total, 446 e-scooter injuries were identified and taken into the analysis (434 affecting riders and 12 non-riders). The median age of the patients was 26 (IQR 22-33), and 59% were male. 257 (58%) of the of the injuries were minor, whereas 155 (35%) were moderate, 30 (7%) serious, 3 (0.7%) severe, and one (0.2%) critical. Furthermore, 220 (49%) of the patients sustained head injuries. A major spike in accident incidence was seen during the weekend (Friday to Sunday) nights, accompanied by a proportional increase in patients with alcohol intoxication. Including both the costs of the hospital care and absence from work, the approximated total cost of e-scooter injuries was 1.7 million euros, with a median cost of a single accident being 1148 euros (IQR 399-4263 €). INTERPRETATION: Considerable number of the injuries are moderate, severe, or worse. Comprehensive preventive measures must be conducted to decrease the incidence of e-scooter injuries. The use of helmets should be strongly encouraged to prevent severe head injuries. The nighttime bans during weekends and speed limits on e-scooters appear to be justifiable.

Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial.

BACKGROUND: Comprehensive geriatric assessment provided in hospital wards in frail patients admitted to hospital has been shown to reduce mortality and increase the likelihood of living at home later. Systematic geriatric assessment provided in emergency departments (ED) may be effective for reducing days in hospital and unnecessary hospital admissions, but this has not yet been proven in randomised trials. METHODS: We conducted a single-centre, randomised controlled trial with a parallel-group, superiority design in an academic hospital ED. ED patients aged ≥ 75 years who were frail, or at risk of frailty, as defined by the Clinical Frailty Scale, were included in the trial. Patients were recruited during the period between December 11, 2018 and June 7, 2019, and followed up for 365 days. For the intervention group, systematic geriatric assessment was added to their standard care in the ED, whereas the control group received standard care only. The primary outcome was cumulative hospital stay during 365-day follow-up. The secondary outcomes included: admission rate from the index visit, total hospital admissions, ED-readmissions, proportion of patients living at home at 365 days, 365-day mortality, and fall-related ED-visits. RESULTS: A total of 432 patients, 63 % female, with median age of 85 years, formed the analytic sample of 213 patients in the intervention group and 219 patients in the control group. Cumulative hospital stay during one-year follow-up as rate per 100 person-years for the intervention and control groups were: 3470 and 3149 days, respectively, with rate ratio of 1.10 (95 % confidence interval, 0.55-2.19, P = .78). Admission rates to hospital wards from the index ED visit for the intervention and control groups were: 62 and 70 %, respectively (P = .10). No significant differences were observed between the groups for any outcomes. CONCLUSION: Systematic geriatric assessment for older adults with frailty in the ED did not reduce hospital stay during one-year follow-up. No statistically significant difference was observed for any secondary outcomes. More coordinated, continuous interventions should be tested for potential benefits in long-term outcomes. TRIAL REGISTRATION: The trial was registered in the ClinicalTrials.gov (registration number and date NCT03751319 23/11/2018).

Epidemiology, pathophysiology and contemporary management of cardiogenic shock - a position statement from the Heart Failure Association of the European Society of Cardiology.

Cardiogenic shock (CS) is a complex multifactorial clinical syndrome with extremely high mortality, developing as a continuum, and progressing from the initial insult (underlying cause) to the subsequent occurrence of organ failure and death. There is a large spectrum of CS presentations resulting from the interaction between an acute cardiac insult and a patient's underlying cardiac and overall medical condition. Phenotyping patients with CS may have clinical impact on management because classification would support initiation of appropriate therapies. CS management should consider appropriate organization of the health care services, and therapies must be given to the appropriately selected patients, in a timely manner, whilst avoiding iatrogenic harm. Although several consensus-driven algorithms have been proposed, CS management remains challenging and substantial investments in research and development have not yielded proof of efficacy and safety for most of the therapies tested, and outcome in this condition remains poor. Future studies should consider the identification of the new pathophysiological targets, and high-quality translational research should facilitate incorporation of more targeted interventions in clinical research protocols, aimed to improve individual patient outcomes. Designing outcome clinical trials in CS remains particularly challenging in this critical and very costly scenario in cardiology, but information from these trials is imperiously needed to better inform the guidelines and clinical practice. The goal of this review is to summarize the current knowledge concerning the definition, epidemiology, underlying causes, pathophysiology and management of CS based on important lessons from clinical trials and registries, with a focus on improving in-hospital management.

Assessment of early treatment response by rapid cardiothoracic ultrasound in acute heart failure: Cardiac filling pressures, pulmonary congestion and mortality.

BACKGROUND: It is unclear how to optimally monitor acute heart failure (AHF) patients. We evaluated the timely interplay of cardiac filling pressures, brain natriuretic peptides (BNPs), lung ultrasound (LUS) and symptoms during AHF treatment. METHODS: We enrolled 60 patients who had been hospitalised for AHF. Patients were examined with a rapid cardiothoracic ultrasound (CaTUS) protocol, combining LUS and focused echocardiographic evaluation of cardiac filling pressures (i.e. medial E/e' and inferior vena cava index [IVCi]). CaTUS was done at 0, 12, 24 and 48 hours (±3 hours) and on the day of discharge, alongside clinical evaluation and laboratory samples. Patients free of congestion (B lines or pleural fluid) on LUS at discharge were categorised as responders, whereas the rest were categorised as non-responders. Improvement in congestion parameters was evaluated separately in these groups. The effect of congestion parameters on prognosis was also analysed. RESULTS: Responders experienced a significantly larger decline in E/e' (2.58 vs. 0.38, p = 0.037) and dyspnoea visual analogue scale (1-10) score (7.68 vs. 3.57, p = 0.007) during the first 12 hours of treatment, while IVCi and BNPs declined later without no such rapid initial decline. Among patients experiencing a >3 U decline in E/e' during the first 12 hours of treatment, 18/21 were to become responders ( p < 0.001). LUS response was the only congestion parameter independently predicting both 6-month survival regarding all-cause mortality and the composite endpoint of all-cause mortality or rehospitalisation for AHF. CONCLUSION: E/e' seemed like the most useful congestion parameter for monitoring early treatment response, predicting prognostically beneficial resolution of pulmonary congestion.

Combined Measurement of Soluble ST2 and Amino-Terminal Pro-B-Type Natriuretic Peptide Provides Early Assessment of Severity in Cardiogenic Shock Complicating Acute Coronary Syndrome.

OBJECTIVES: Mortality in cardiogenic shock complicating acute coronary syndrome is high, and objective risk stratification is needed for rational use of advanced therapies such as mechanical circulatory support. Traditionally, clinical variables have been used to judge risk in cardiogenic shock. The aim of this study was to assess the added value of serial measurement of soluble ST2 and amino-terminal pro-B-type natriuretic peptide to clinical parameters for risk stratification in cardiogenic shock. DESIGN: CardShock (www.clinicaltrials.gov NCT01374867) is a prospective European multinational study of cardiogenic shock. The main study introduced CardShock risk score, which is calculated from seven clinical variables at baseline, and was associated with short-term mortality. SETTING: Nine tertiary care university hospitals. PATIENTS: Patients with cardiogenic shock caused by acute coronary syndrome (n=145). INTERVENTIONS: In this substudy, plasma samples from the study patients were analyzed at eight time points during the ICU or cardiac care unit stay. Additional prognostic value of the biomarkers was assessed with incremental discrimination improvement. MEASUREMENTS AND MAIN RESULTS: The combination of soluble ST2 and amino-terminal pro-B-type natriuretic peptide showed excellent discrimination for 30-day mortality (area under the curve, 0.77 at 12 hr up to 0.93 at 5-10 d after cardiogenic shock onset). At 12 hours, patients with both biomarkers elevated (soluble ST2, ≥ 500 ng/mL and amino-terminal pro-B-type natriuretic peptide, ≥ 4,500 ng/L) had higher 30-day mortality (79%) compared to those with one or neither biomarkers elevated (31% or 10%, respectively; p < 0.001). Combined measurement of soluble ST2 and amino-terminal pro-B-type natriuretic peptide at 12 hours added value to CardShock risk score, correctly reclassifying 11% of patients. CONCLUSIONS: The combination of results for soluble ST2 and amino-terminal pro-B-type natriuretic peptide provides early risk assessment beyond clinical variables in patients with acute coronary syndrome-related cardiogenic shock and may help therapeutic decision making in these patients.

Use of point-of-care testing and early assessment model reduces length of stay for ambulatory patients in an emergency department.

BACKGROUND: To assess whether the use of point-of-care testing (POCT) and early assessment team (EAT) model shortens emergency department (ED) length of stay (LOS). METHODS: This prospective, observational study with comparison between three study periods was performed in three phases in a metropolitan ED with 57,000 annual visits. Data were collected from adult ambulatory patients who were discharged home. Phase 1 served as a control (n = 1559 in one month). In phase 2, a comprehensive POCT panel including complete blood count, sodium, potassium, glucose, C-reactive protein, creatinine, alkaline phosphatase, alanine aminotransferase, bilirubin, amylase, and D-dimer was launched (n = 1442 in one month). In phase 3 (n = 3356 in subsequent two months), POCT approach continued. In addition, the working process was changed by establishing an EAT consisting of an emergency medicine resident and a nurse. The team operated from 12 noon to 10 p.m. was. The primary outcome was LOS (hh:mm) in the ED. Waiting times for patients requiring laboratory testing were analysed also, including time from admission to laboratory blood sampling (A2S interval), time from blood sampling to results ready (S2R interval) and time from results to discharge (R2D interval). RESULTS: Median LOS of patients requiring laboratory tests in phase 1 was 3:51 (95 % confidence interval 03:38-04:04). During phase 2, introduction of POCT reduced median LOS by 29 min to 03:22 (03:12-03:31, p = 0.000). In phase 3, the EAT model reduced median LOS further by 17 min to 03:05 (02:59-03:12, p = 0.033). Altogether, the process was expedited by 46 min compared with the phase 1. Surprisingly, A2S interval was unaffected by the interventions among all patients needing laboratory testing. In comparison to phase 1, shortening of S2R interval was observed in phase 2 and 3, and that of R2D interval in all patients with laboratory assessments in phase 3. DISCUSSION: The present study included adult ambulatory patients and is the first one to examine the impact of comprehensive POC test panel, first alone and then with additional process change. As a result, LOS was reduced significantly for patients needing laboratory tests. Considerable shortening in LOS came from introduction of POCT, and EAT process decreased the LOS further. We used a comprehensive POC test panel in order to maximise the patient population benefiting from the positive impacts of POC on laboratory turnaround time and length of stay. In EAT, diverse setups exist, and these differences affect the interpretation of results. The process changes in phase 3 were done by rearranging work shifts and no extra resources were added. Regarding to staffing the process improvement was thus cost neutral. CONCLUSIONS: The advantage of POCT alone compared with central laboratory seemed to lie in shorter waiting times for results and earlier discharge home. Moreover, POCT and EAT model shorten LOS additively compared with conventional processes. However, a longer time is seemingly needed to adopt a new working process in the ED, and to establish its full benefit.

High-sensitivity troponin I for risk assessment in patients with atrial fibrillation: insights from the Apixaban for Reduction in Stroke and other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial.

BACKGROUND: High-sensitivity troponin-I (hs-TnI) measurement improves risk assessment for cardiovascular events in many clinical settings, but the added value in atrial fibrillation patients has not been described. METHODS AND RESULTS: At randomization, hs-TnI was analyzed in 14 821 atrial fibrillation patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial comparing apixaban with warfarin. The associations between hs-TnI concentrations and clinical outcomes were evaluated by using adjusted Cox analysis. The hs-TnI assay detected troponin (≥1.3 ng/L) in 98.5% patients, 50% had levels >5.4, 25% had levels >10.1, and 9.2% had levels ≥23 ng/L (the 99th percentile in healthy individuals). During a median of 1.9 years follow-up, annual rates of stroke or systemic embolism ranged from 0.76% in the lowest hs-TnI quartile to 2.26% in the highest quartile (>10.1 ng/L). In multivariable analysis, hs-TnI was significantly associated with stroke or systemic embolism, adjusted hazard ratio 1.98 (1.42-2.78), P=0.0007. hs-TnI was also significantly associated with cardiac death; annual rates ranged from 0.40% to 4.24%, hazard ratio 4.52 (3.05-6.70), P<0.0001, in the corresponding groups, and for major bleeding hazard ratio 1.44 (1.11-1.86), P=0.0250. Adding hs-TnI levels to the CHA2DS2VASc score improved c-statistics from 0.629 to 0.653 for stroke or systemic embolism, and from 0.591 to 0.731 for cardiac death. There were no significant interactions with study treatment. CONCLUSIONS: Troponin-I is detected in 98.5% and elevated in 9.2% of atrial fibrillation patients. The hs-TnI level is independently associated with a raised risk of stroke, cardiac death, and major bleeding and improves risk stratification beyond the CHA2DS2VASc score. The benefits of apixaban in comparison with warfarin are consistent regardless of hs-TnI levels. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00412984.

The COACH risk engine: a multistate model for predicting survival and hospitalization in patients with heart failure.

AIMS: Several models for predicting the prognosis of heart failure (HF) patients have been developed, but all of them focus on a single outcome variable, such as all-cause mortality. The purpose of this study was to develop a multistate model for simultaneously predicting survival and HF-related hospitalization in patients discharged alive from hospital after recovery from acute HF. METHODS AND RESULTS: The model was derived in the COACH (Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure) cohort, a multicentre, randomized controlled trial in which 1023 patients were enrolled after hospitalization because of HF. External validation was attained with the FINN-AKVA (Finish Acute Heart Failure Study) cohort, a prospective, multicentre study with 620 patients hospitalized due to acute HF. The observed vs. predicted 18-month survival was 72.1% vs. 72.3% in the derivation cohort and 71.4% vs. 71.2% in the validation cohort. The corresponding values of the c statistic were 0.733 [95% confidence interval (CI) 0.705-0.761] and 0.702 (95% CI 0.663-0.744), respectively. The model's accuracy in predicting HF hospitalization was excellent, with predicted values that closely resembled the values observed in the derivation cohort. CONCLUSION: The COACH risk engine accurately predicted survival and various measures of recurrent hospitalization in (acute) HF patients. It may therefore become a valuable tool in improving and personalizing patient care and optimizing the use of scarce healthcare resources.

The type of acute heart failure and the costs of hospitalization.

BACKGROUND: The costs of different classes of acute HF (AHF) are not known. METHODS: AHF patients (N = 620) were divided in a national, prospective, observational study into five clinical classes: cardiogenic shock, pulmonary oedema, congestive HF, hypertensive HF, and right HF. Index episode and 6-month readmissions were assessed and hospitalization costs were evaluated. RESULTS: The length of index episode, ICU/CCU stay and costs of index episode and cumulative 6-month costs differed significantly between the clinical classes. The highest cumulative 6-month hospitalization costs, 25,963 (15,053-44778) € (mean, 95% confidence interval) incurred in cardiogenic shock, followed by pulmonary oedema, 12,912 (11,006-15,148) €, and congestive HF, 9475 (8550-10,500) €. CONCLUSIONS: AHF leads to significant need for hospital care and high costs which differ significantly between clinical classes of AHF.