Resource and Infrastructure-Appropriate Management of ST-Segment Elevation Myocardial Infarction in Low- and Middle-Income Countries.

The 143 low- and middle-income countries (LMICs) of the world constitute 80% of the world's population or roughly 5.86 billion people with much variation in geography, culture, literacy, financial resources, access to health care, insurance penetration, and healthcare regulation. Unfortunately, their burden of cardiovascular disease in general and acute ST-segment-elevation myocardial infarction (STEMI) in particular is increasing at an unprecedented rate. Compounding the problem, outcomes remain suboptimal because of a lack of awareness and a severe paucity of resources. Guideline-based treatment has dramatically improved the outcomes of STEMI in high-income countries. However, no such focused recommendations exist for LMICs, and the unique challenges in LMICs make directly implementing Western guidelines unfeasible. Thus, structured solutions tailored to their individual, local needs, and resources are a vital need. With this in mind, a multicountry collaboration of investigators interested in LMIC STEMI care have tried to create a consensus document that extracts transferable elements from Western guidelines and couples them with local realities gathered from expert experience. It outlines general operating principles for LMICs focused best practices and is intended to create the broad outlines of implementable, resource-appropriate paradigms for management of STEMI in LMICs. Although this document is focused primarily on governments and organizations involved with improvement in STEMI care in LMICs, it also provides some specific targeted information for the frontline clinicians to allow standardized care pathways and improved outcomes.

Fast-track thrombolysis protocol for acute limb ischemia.

OBJECTIVE: Catheter-directed thrombolysis in the treatment of acute lower extremity arterial occlusions often requires several interventional sessions to generate successful outcomes. It is typically an expensive procedure, necessitating extended hospital length of stay (LOS) that may be associated with an increase in both local and systemic hemorrhagic complications. Five years ago, we created the fast-track thrombolysis protocol for arteries (FTTP-A) to deal with these concerns. The goal of our protocol is to re-establish patency during the first session of thrombolysis, thus decreasing costs and complications associated with prolonged periods of thrombolytic exposure. METHODS: A retrospective study of 42 patients who were treated for acute limb ischemia at our institution by FTTP-A from January 2014 to February 2019 was performed. FTTP-A includes periadventitial lidocaine injection at the arterial puncture site under ultrasound guidance, contrast arteriography of the entire targeted segment, pharmacomechanical rheolytic thrombectomy of the occluded arterial segment, tissue plasminogen activator infusion along the occluded segment, balloon maceration of the thrombus, and (if deemed necessary) placement of a stent in an area of significant (≥30%) stenosis that is refractory to balloon angioplasty and thrombolysis. After the stenosis or thrombus is cleared, patients are prescribed an oral anticoagulant agent. RESULTS: Primary FTTP-A (50 total interventions) was performed in 42 patients. The median age of patients was 67.2 ± 12.2 years (range, 41-98 years), and 54.8% were male; 59.5% of the procedures were performed on the left lower extremity. Initial arterial access was obtained through the common femoral artery in 39 of 42 cases (92.9%); in the remaining 3 cases, it was obtained in a left bypass access site, a right femoral-popliteal graft, and a right femoral-femoral graft. The mean operative time was 148.9 ± 62.9 minutes (range, 83-313 minutes), and the mean volume of tissue plasminogen activator infused was 9.7 ± 4.0 mg (range, 2-20 mg). The median cost including medications and interventional tools was $4673.19 per procedure. The mean postoperative LOS was 3.1 ± 4.5 days (range, 1-25 days). Median postoperative LOS was 1 day. Mean postoperative follow-up was 27 ± 19.2 months (range, 0-62 months). Single-session FTTP-A was successful in 81% (n = 34/42) of patients; the remaining 8 patients (19%) required a single additional session. Of the 42 patients, 34 (81%) required arterial stenting. Periprocedural complications consisted of one patient with hematuria, which resolved, and one patient with thrombocytopenia, which resolved. No patients experienced rethrombosis within 30 days of FTTP-A. During the 5-year study period, there was no significant local or systemic hemorrhage, limb loss, or mortality related to this protocol. CONCLUSIONS: FTTP-A appears to be a safe, efficacious, and cost-effective procedure in the resolution of acute lower extremity arterial occlusions.

Cost-Effectiveness of Magnetic Resonance Imaging-Guided Thrombolysis for Patients With Stroke With Unknown Time of Onset.

OBJECTIVES: Patients waking up with stroke symptoms are often excluded from intravenous thrombolysis with alteplase (IV-tpa). The WAKE-UP trial, a European multicenter randomized controlled trial, proved the clinical effectiveness of magnetic resonance imaging-guided IV-tpa for these patients. This analysis aimed to assess the cost-effectiveness of the intervention compared to placebo. METHODS: A Markov model was designed to analyze the cost-effectiveness over a 25-year time horizon. The model consisted of an inpatient acute care phase and a rest-of-life phase. Health states were defined by the modified Rankin Scale (mRS). Initial transition probabilities to mRS scores were based on WAKE-UP data and health state utilities on literature search. Costs were based on data from the University Medical Center Hamburg-Eppendorf, literature, and expert opinion. Incremental costs and effects over the patients' lifetime were estimated. The analysis was conducted from a formal German healthcare perspective. Univariate and probabilistic sensitivity analyses were performed. RESULTS: Treatment with IV-tpa resulted in cost savings of €51 009 and 1.30 incremental gains in quality-adjusted life-years at a 5% discount rate. Univariate sensitivity analysis revealed incremental cost-effectiveness ratio being sensitive to the relative risk of favorable outcome on mRS for placebo patients after stroke, the costs of long-term care for patients with mRS 4, and patient age at initial stroke event. In all cases, IV-tpa remained cost-effective. Probabilistic sensitivity analysis proved IV-tpa cost-effective in >95% of the simulations results. CONCLUSIONS: Magnetic resonance imaging-guided IV-tpa compared to placebo is cost-effective in patients with ischemic stroke with unknown time of onset.

A Cost Utility Analysis of Minimally Invasive Surgery with Thrombolysis Compared to Standard Medical Treatment in Spontaneous Intracerebral Haemorrhagic Stroke.

OBJECTIVES: Standard medical management of spontaneous intracerebral haemorrhage (ICH) and surgical hematoma evacuation starkly differ, and whilst landmark randomised control trials report no clinical benefit of early surgical evacuation compared with medical treatment in supratentorial ICH, minimally invasive surgery (MIS) with thrombolysis has been neglected within these studies. However, recent technological advancements in MIS have renewed interest in the surgical treatment of ICH. Several economic evaluations have focused on the benefits of MIS in ischaemic stroke management, but no economic evaluations have yet been performed comparing MIS to standard medical treatment for ICH. MATERIALS AND METHOD: All costs were sourced from the UK in GBP. Where possible, the 2019/2020 NHS reference costs were used. The MISTIE III study was used to analyse the outcomes of patients undergoing either MIS or standard medical treatment in this economic evaluation. RESULTS: The incremental cost-effectiveness ratio (ICER) for MIS was £485,240.26 for every quality-adjusted life year (QALY) gained. Although MIS resulted in a higher QALY compared to medical treatment, the gain was insignificant at 0.011 QALY. Four sensitivity analyses based on combinations of alternative EQ-5D values and categorisation of MIS outcomes, alongside alterations to the cost of significant adverse events, were performed to check the robustness of the ICER calculation. The most realistic sensitivity analysis showed a potential increase in cost effectiveness when clot size is reduced to <15ml, with the ICER falling to £74,335.57. DISCUSSION: From the perspective of the NHS, MIS with thrombolysis is not cost-effective compared to optimal medical treatment. ICER shows that intention-to-treat MIS would require a cost of £485,240.26 to gain one extra QALY, which is significantly above the NHS threshold of £30,000. Further UK studies with ICH survivor utilities, more replicable surgical technique, and the reporting of clot size reduction are indicated as the present sensitivity analysis suggests that MIS is promising. Greater detail about outcomes and complications would ensure improved cost-benefit analyses and support valid and efficient allocation of resources by the NHS.

Cost-effectiveness microsimulation of catheter-directed thrombolysis in submassive pulmonary embolism using a right ventricular function model.

Approximately 30-50% of hemodynamically stable patients presenting with acute pulmonary embolism (PE) have evidence of right ventricular (RV) dysfunction. These patients are classified as submassive PE and the role of reperfusion therapy remains unclear. We sought to identify the circumstances under which catheter-directed thrombolysis (CDT) would represent high-value care for submassive PE. We used a computer-based, individual-level, state-transition model with one million simulated patients to perform a cost-effectiveness analysis comparing the treatment of submassive PE with CDT followed by anticoagulation to treatment with anticoagulation alone. Because RV function impacts prognosis and is commonly used in PE outcomes research, our model used RV dysfunction to differentiate health states. One-way, two-way, and probabilistic sensitivity analyses were used to quantify model uncertainty. Our base case analysis generated an incremental cost-effectiveness ratio (ICER) of $119,326 per quality adjusted life year. Sensitivity analyses resulted in ICERs consistent with high-value care when CDT conferred a reduction in the absolute probability of RV dysfunction of 3.5% or more. CDT yielded low-value ICERs if the absolute reduction was less than 1.56%. Our model suggests that catheter-directed thrombolytics represents high-value care compared to anticoagulation alone when CDT offers an absolute improvement in RV dysfunction of 3.5% or more, but there is substantial uncertainly around these results. We estimated the monetary value of clarifying the costs and consequences surrounding RV dysfunction after submassive PE to be approximately $268 million annually, suggesting further research in this area could be highly valuable.

Individual Choice for the Aspiration Thrombectomy Treatment of Acute Iliofemoral Deep Venous Thrombosis.

OBJECTIVE: To compare clinical efficacy, safety and cost of AngioJet rheolytic thrombectomy (ART) plus catheter-directed thrombolysis (CDT) and manual aspiration thrombectomy (MAT) plus CDT for acute iliofemoral deep venous thrombosis (DVT). METHODS: This was a retrospective study. A total of 126 DVT patients met the inclusion criteria. Sixty-one patients were included in the ART group and sixty-five in the MAT group. Clinical parameters were used to compare the groups. Clinical outcomes, complications and various medical expenses were analyzed. RESULTS: Technical success rates were 100% in ART and MAT group. There was no significant difference in the rate of thrombus clearance (lysis grades II and III) between ART group (98.36%) and MAT group (100%) (P = 0.311). The incidence of venous damage was slightly higher in the MAT group (4.6%) than in the ART group (0%) (P = 0.245). The cost of the ART group ($8,291.7 ± 471.4) was significantly higher than that of the MAT group ($4,632.5 ± 441.7) (P < 0.001). CONCLUSIONS: ART and MAT appear similar with good clinical outcomes for acute iliofemoral DVT. MAT substantially lowers mean cost per patient compared to ART.

Financial Burden of Stroke Reflected in a Pilot Center for the Implementation of Thrombolysis.

Stroke represents a serious illness and is extremely relevant from the public health point of view, implying important social and economic burdens. Introducing new procedures or therapies that reduce the costs both in the acute phase of the disease and in the long term becomes a priority for health systems worldwide. The present study quantifies and compares the direct costs for ischemic stroke in patients with thrombolysis treatment versus conservative treatment over a 24-month period from the initial diagnosis, in one of the 7 national pilot centres for the implementation of thrombolytic treatment. The significant reduction (p < 0.001) of the hospitalization period, especially of the days in the intensive care unit (ICU) for stroke, resulted in a significant reduction (p < 0.001) of the total average costs in the patients with thrombolysis, both at the first hospitalization and for the subsequent hospitalizations, during the period followed in the study. It was also found that the percentage of patients who were re-hospitalized within the first 24-months after stroke was significantly lower (p < 0.001) among thrombolyzed patients. The present study demonstrates that the quick intervention in cases of stroke is an efficient policy regarding costs, of Romanian Public Health System, Romania being the country with the highest rates of new strokes and deaths due to stroke in Europe.

Is the Cost-Effectiveness of Stroke Thrombolysis Affected by Proportion of Stroke Mimics?

Background and Purpose- Differentiating ischemic stroke patients from stroke mimics (SM), nonvascular conditions which simulate stroke, can be challenging in the acute setting. We sought to model the cost-effectiveness of treating suspected acute ischemic stroke patients before a definitive diagnosis could be made. We hypothesized that we would identify threshold proportions of SM among suspected stroke patients arriving to an emergency department above which administration of intravenous thrombolysis was no longer cost-effective. Methods- We constructed a decision-analytic model to examine various emergency department thrombolytic treatment scenarios. The main variables were proportion of SM to true stroke patients, time from symptom onset to treatment, and complication rates. Costs, reimbursement rates, and expected clinical outcomes of ischemic stroke and SM patients were estimated from published data. We report the 90-day incremental cost-effectiveness ratio of administering intravenous thrombolysis compared with no acute treatment from a healthcare sector perspective, as well as the cost-reimbursement ratio from a hospital-level perspective. Cost-effectiveness was defined as a willingness to pay <$100 000 USD per quality adjusted life year gained and high cost-reimbursement ratio was defined as >1.5. Results- There was an increase in incremental cost-effectiveness ratios as the proportion of SM cases increased in the 3-hour time window. The threshold proportion of SM above which the decision to administer thrombolysis was no longer cost-effective was 30%. The threshold proportion of SM above which the decision to administer thrombolysis resulted in high cost-reimbursement ratio was 75%. Results were similar for patients arriving within 0 to 90 minutes of symptom onset as compared with 91 to 180 minutes but were significantly affected by cost of alteplase in sensitivity analyses. Conclusions- We identified thresholds of SM above which thrombolysis was no longer cost-effective from 2 analytic perspectives. Hospitals should monitor SM rates and establish performance metrics to prevent rising acute stroke care costs and avoid potential patient harms.

Retrospective comparison of ultrasound facilitated catheter-directed thrombolysis and systemically administered half-dose thrombolysis in treatment of pulmonary embolism.

This study retrospectively compared the outcomes of patients who received ultrasound facilitated catheter-directed thrombolysis (UFCDT) versus systemically administered 'half-dose' thrombolysis (HDT) in 97 patients with PE. The outcomes assessed included changes in baseline pulmonary artery systolic pressure (PASP), right ventricle/left ventricle ratio (RV/LV), cost and duration of hospitalization, death, bleeding, and recurrent venous thromboembolism in the short and intermediate term follow-up. Analyses were performed using a covariance adjustment propensity score approach to address baseline differences between groups in variables associated with PASP and RV/LV, covarying baseline scores. The baseline mean ± SE PASP dropped from 49.3 ± 1.1 to 32.5 ± 0.3 mmHg at 36 hours in the HDT group, and from 50.6 ± 1.2 to 35.1 ± 0.4 mmHg in the UFCDT group; group × time interaction p-value = 0.007. Corresponding drops in the RV/LV were from a baseline of 1.26 ± 0.05 to 1.07 ± 0.01 in the HDT group and from 1.30 ± 0.05 to 1.14 ± 0.01 in the UFCDT group at 36 hours; group × time interaction p-value = 0.269. Statistically significant decreases were noted in PASP and RV/LV for both the HDT and UFCDT at 36 hours and follow-up. PASP through follow-up was significantly lower in the HDT than the UFCDT group. Likewise, RV/LV was lower in the HDT group. The duration and cost of hospitalization were lower in the HDT group (6.2 ± 1.4 days vs 1.9 ± 0.3 days, p < 0.001; US$12,000 ± $3000 vs $74,000 ± $6000, p < 0.001). We conclude that both UFCDT and HDT lead to rapid reduction of PASP and RV/LV, whereas HDT leads to a lower duration and cost of hospitalization.

Regional Intervention of Stroke Care to Increase Thrombolytic Therapy for Acute Ischemic Stroke.

Background and Purpose- The aims of this study were to investigate the effect of an intervention to unblind data on r-tPA (recombinant tissue-type plasminogen activator) administration and sharing data with chief executive officers of participating hospitals, on r-tPA administration rates postintervention and on potential healthcare cost savings implemented at 26 Southeast Texas Regional Advisory Council hospitals. Methods- Retrospective analysis of prospective data on thrombolytic therapy from 26 Southeast Texas Regional Advisory Council hospitals, collected between April 2014 and June 2016. The control (blinded) period (Q2-2014 to Q2-2015) was followed by unblinding (Q3-2015). Results- Intervention was associated with 21.1% increase in r-tPA administration rates, with 38.5% increase in r-tPA administration with door-to-needle time ≤60 minutes. An absolute increase in r-tPA administration of 2.1% was seen with an average lifetime cost savings of $3.6 million. Conclusions- Transparent regional data sharing was associated with improved r-tPA administration and healthcare cost savings.

Catheter-Directed Thrombolysis Versus Pharmacomechanical Thrombectomy for Upper Extremity Deep Venous Thrombosis: A Cost-Effectiveness Analysis.

BACKGROUND: Upper extremity deep vein thrombosis represents (UEDVT) 2-3% of all deep vein thrombosis. Catheter directed thrombolysis (CDT) was replaced largely by pharmacomechanical thrombolysis (PMT) in our institution. In this study we compared the immediate and 1-year results as well as the total hospital costs between CDT and PMT in the treatment of UEDVT. METHODS: From 2006 to 2013, 55 patients with UEDVT were treated with either CDT or PMT at Helsinki University Hospital. Of them, 43 underwent thoracoscopic rib resection later to relieve phlebography-confirmed vein compression. This patient cohort was prospectively followed up with repeated phlebographies. CDT was performed to 24 patients, and 19 had PMT with a Trellis™ device. Clinical evaluation and vein patency assessment were performed with either phlebography or ultrasound 1 year after the thrombolysis. Primary outcomes were immediate technical success, 1-year vein patency, and costs of the initial treatment. RESULTS: The immediate overall technical success rate, defined as recanalization of the occluded vein and removal of the fresh thrombus, was 91.7% in the CDT group and 100% in the PMT group (n.s.). The median thrombolytic time was significantly longer in CDT patients than that in PMT patients (21.1 vs. 0.33 hr, P < 0.00001). There were no procedure-related complications. The 1-year primary assisted patency rate was similar in both the groups (91.7% and 94.7%). There were no recurrences of clinical DVT. The hospital costs for the acute period were significantly lower in the PMT group than those in the CDT group (medians: 11,476 € and 5,975 € in the CDT and PMT groups, respectively [P < 0.00001]). CONCLUSIONS: The clinical results of the treatment of UEDVT with CDT or PMT were similar. However, PMT required shorter hospital stay and less intensive surveillance, leading to lower total costs.

Centralising and optimising decentralised stroke care systems: a simulation study on short-term costs and effects.

BACKGROUND: Centralisation of thrombolysis may offer substantial benefits. The aim of this study was to assess short term costs and effects of centralisation of thrombolysis and optimised care in a decentralised system. METHODS: Using simulation modelling, three scenarios to improve decentralised settings in the North of Netherlands were compared from the perspective of the policy maker and compared to current decentralised care: (1) improving stroke care at nine separate hospitals, (2) centralising and improving thrombolysis treatment to four, and (3) two hospitals. Outcomes were annual mean and incremental costs per patient up to the treatment with thrombolysis, incremental cost-effectiveness ratio (iCER) per 1% increase in thrombolysis rate, and the proportion treated with thrombolysis. RESULTS: Compared to current decentralised care, improving stroke care at individual community hospitals led to mean annual costs per patient of $US 1,834 (95% CI, 1,823-1,843) whereas centralising to four and two hospitals led to $US 1,462 (95% CI, 1,451-1,473) and $US 1,317 (95% CI, 1,306-1,328), respectively (P < 0.001). The iCER of improving community hospitals was $US 113 (95% CI, 91-150) and $US 71 (95% CI, 59-94), $US 56 (95% CI, 44-74) when centralising to four and two hospitals, respectively. Thrombolysis rates decreased from 22.4 to 21.8% and 21.2% (P = 0.120 and P = 0.001) in case of increasing centralisation. CONCLUSIONS: Centralising thrombolysis substantially lowers mean annual costs per patient compared to raising stroke care at community hospitals simultaneously. Small, but negative effects on thrombolysis rates may be expected.

Financial burden of survivors of medically-managed myocardial infarction and its association with selected social determinants and quality of life in a lower middle income country.

BACKGROUND: Burden from ischemic heart disease is rising in Sri Lanka due to the demographic and epidemiological transitions. Documented literature is scarce on quality of life, financial burden and its determinants in relation to myocardial infarction (MI). This study was done to describe the financial burden among the survivors of MI managed only with drugs (i.e. those who did not undergo Percutaneous Coronary Intervention or Coronary Artery Bypass Graft) and its association with selected social determinants (SDHs) and quality of life (QOL). METHODS: A cross sectional study was done among MI survivors in 13 hospitals in the premier province of Sri Lanka. Out of 336 participants recruited at hospital stay, 270 responded through a self-administered questionnaire at 1 month post discharge. Questionnaire included sections on financial burden, selected SDHs and on QOL measured by the EQ-5D-3 L QOL tool. Presence of financial burden was determined using an operational definition. Associations were tested with Mann-Whitney-U test, Chi square test and Spearman-correlation-coefficient at 5% significant level. RESULTS: Around 40% (n = 116) had to seek financial support for out-of-pocket expenditure. Nearly 5% (n = 6) of previously employed participants had lost their job. Of the employed respondents (n = 139, 51.5%), 29% (n = 85) had limited physical activity and 40% (n = 115) had limitations of employment time. Of the respondents, 15.4% had to apply for a loan, 7.8% had to sell a property, 19.1% had an income loss and 33.8% had to restrict usual expenses. Financial burden was not significantly associated with gender (p = 0.146), ethnicity (p = 0.068), highest education (p = 0.184) and area of residence (p = 0.369). Influence of income (p = 0.001), social support (p = 0.002) and the health infrastructure (p < 0.001) were significantly associated with the occurrence of a financial burden. In the group with a financial burden, the index score (p = 0.002) and VAS score (p < 0.001) of EQ-5D-3 L were significantly lower. CONCLUSIONS: Financial burden is common among survivors of medically-managed occurring irrespective of the gender, ethnicity, education and the area. It is influenced significantly by the income, level of social support and the level of health infrastructure. The financial burden is influencing the post-discharge-1-month QOL.

Safety and Effectiveness of Intravenous Thrombolysis for Acute Ischemic Stroke Outside the Coverage of National Health Insurance in Taiwan.

PURPOSE: Only a small percentage of ischemic stroke patients were treated with intravenous thrombolysis in Taiwan, partly because of the narrow reimbursement criteria of the National Health Insurance (NHI). We aimed to assess the safety and effectiveness of intravenous thrombolysis not covered by the NHI. METHODS: This is a retrospective analysis of register data from four hospitals. All patients who received intravenous tissue plasminogen activator and fulfilled the American Heart Association/American Stroke Association (AHA/ASA) thrombolysis guidelines between January 2007 and June 2012 were distinguished into two groups: those in accordance (reimbursement group) and those not in accordance (non-reimbursement group) with the NHI reimbursement criteria. Primary outcome was symptomatic intracerebral hemorrhage (SICH). Secondary outcomes were dramatic improvement in the National Institutes of Health Stroke Scale (NIHSS) score at discharge, good functional outcome (modified Rankin Scale ≤2) at discharge, and all-cause in-hospital mortality. RESULTS: In 569 guideline-eligible patients, 177 (31%) were treated without reimbursement. The reasons for exclusion from reimbursement included age >80 (n=42), baseline NIHSS less than 6 (n=29), baseline NIHSS >25 (n=15), thrombolysis beyond 3 hours (n=49), prior stroke with diabetes (n=28), use of oral anticoagulant (n=2), and more than one contraindication (n=12). Overall, we observed no differences between the reimbursement and non-reimbursement groups in the rate of SICH (7% versus 6%), dramatic improvement (36% versus 36%), good functional outcome (39% versus 37%), and in-hospital mortality (8% versus 6%) Conclusion: In stroke patients treated with intravenous thrombolysis according to the AHA/ASA guidelines, the outcomes were comparable between the reimbursement and non-reimbursement groups.

Cost-Effectiveness of Endovascular Stroke Therapy: A Patient Subgroup Analysis From a US Healthcare Perspective.

BACKGROUND AND PURPOSE: Endovascular therapy in addition to standard care (EVT+SC) has been demonstrated to be more effective than SC in acute ischemic large vessel occlusion stroke. Our aim was to determine the cost-effectiveness of EVT+SC depending on patients' initial National Institutes of Health Stroke Scale (NIHSS) score, time from symptom onset, Alberta Stroke Program Early CT Score (ASPECTS), and occlusion location. METHODS: A decision model based on Markov simulations estimated lifetime costs and quality-adjusted life years (QALYs) associated with both strategies applied in a US setting. Model input parameters were obtained from the literature, including recently pooled outcome data of 5 randomized controlled trials (ESCAPE [Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke], EXTEND-IA [Extending the Time for Thrombolysis in Emergency Neurological Deficits-Intra-Arterial], MR CLEAN [Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands], REVASCAT [Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within 8 Hours of Symptom Onset], and SWIFT PRIME [Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment]). Probabilistic sensitivity analysis was performed to estimate uncertainty of the model results. Net monetary benefits, incremental costs, incremental effectiveness, and incremental cost-effectiveness ratios were derived from the probabilistic sensitivity analysis. The willingness-to-pay was set to $50 000/QALY. RESULTS: Overall, EVT+SC was cost-effective compared with SC (incremental cost: $4938, incremental effectiveness: 1.59 QALYs, and incremental cost-effectiveness ratio: $3110/QALY) in 100% of simulations. In all patient subgroups, EVT+SC led to gained QALYs (range: 0.47-2.12), and mean incremental cost-effectiveness ratios were considered cost-effective. However, subgroups with ASPECTS ≤5 or with M2 occlusions showed considerably higher incremental cost-effectiveness ratios ($14 273/QALY and $28 812/QALY, respectively) and only reached suboptimal acceptability in the probabilistic sensitivity analysis (75.5% and 59.4%, respectively). All other subgroups had acceptability rates of 90% to 100%. CONCLUSIONS: EVT+SC is cost-effective in most subgroups. In patients with ASPECTS ≤5 or with M2 occlusions, cost-effectiveness remains uncertain based on current data.

Predictors of costs from the hospital perspective of primary pulmonary embolism.

The objective of this study was to estimate the total hospital cost per patient admitted through the emergency department with a primary diagnosis of pulmonary embolism (PE), and to identify the main components and predictors of costs.Actual costs of care of 652 consecutive patients hospitalised in 10 general hospitals in Belgium, including 31 outlier patients in terms of length of stay (4.8%), were obtained by aggregating all cost components contributing to care of each patient.In both inlier and outlier patients, the mean total cost per patient increased linearly with the degree of severity of illness classes related to the All Patient Refined Diagnosis Related Group (p<0.0001). Medical procedures, nursing activities and hospitalisation accommodation were the main cost components. We identified six independent predictors of costs in inliers: age group, chronic pulmonary heart disease, heart failure, admission to intensive care unit, initial thrombolysis treatment and type of hospital. There was a statistically significant linear trend between age groups and costs (p<0.0001).An increasing burden of comorbid illness was strongly associated with increasing actual cost for caring hospitalised patients for PE. Increasing age was associated with an increase in all main cost components.

Acute Ischemic Stroke (AIS) patient management in French stroke units and impact estimation of thrombolysis on care pathways and associated costs.

BACKGROUND: Stroke is the second leading cause of death and a first leading cause of acquired disability in adults worldwide. This study aims to evaluate the current management and associated costs of acute ischemic stroke (AIS) for patients admitted in stroke units in France and over a one-year follow-up period as well as to assess the impact of improved thrombolytic management in terms of increasing the proportion of patients receiving thrombolysis and/or treated within 3 h from the onset of symptoms. METHODS: A decision model was developed, which comprises two components: the first corresponding to the acute hospital management phase of patients with AIS up until hospital discharge, extracted from the national hospital discharge database (PMSI 2011), and the second corresponding to the post-acute (post-discharge) phase, based on national treatment guidelines and stroke experts' advice. Five post-acute clinical care pathways were defined. In-hospital mortality and mortality at 3 months post-discharge was taken into account into the model. Patient journeys and costs were determined for both phases. Improved thrombolytic management was modeled by increasing the proportion of patients receiving thrombolysis from the current estimated level of 16.7 to 25% as well as subsequently increasing the proportion of patients treated within 3 h of the onset of symptoms post-stroke from 50 to 100%. The impact on care pathways was derived from clinical data. RESULTS: Among 202,078 hospitalizations for a stroke or a transient ischemic attack (TIA), 90,528 were for confirmed AIS, and 33% (29,999) of them managed within a stroke unit. After hospitalization, 60% of discharges were to home, 25% to rehabilitative care and then home, 2% to rehabilitative care and then a nursing home, 7% to long-term care, and 6% of stays ended with patient death. Of a total cost over 1 year of €610 million (mean cost per patient of €20,326), 70% concern the post-acute phase. By increasing the proportion of patients being thrombolyzed, costs are reduced primarily by a decrease in rehabilitative care, with savings per additional treated patient of €1,462. By adding improved timing, savings are more than doubled (€3,183 per additional treated patient). CONCLUSIONS: This study confirms that the burden of AIS in France is heavy. By improving thrombolytic management in stroke units, patient journeys through care pathways can be modified, with increased discharges home, a change in post-acute resource consumption and net savings.

Drivers of costs associated with reperfusion therapy in acute stroke: the Interventional Management of Stroke III Trial.

BACKGROUND AND PURPOSE: The Interventional Management of Stroke (IMS) III study tested the effect of intravenous tissue-type plasminogen activator (tPA) alone when compared with intravenous tPA followed by endovascular therapy and collected cost data to assess the economic implications of the 2 therapies. This report describes the factors affecting the costs of the initial hospitalization for acute stroke subjects from the United States. METHODS: Prospective cost analysis of the US subjects was treated with intravenous tPA alone or with intravenous tPA followed by endovascular therapy in the IMS III trial. Results were compared with expected Medicare payments. RESULTS: The adjusted cost of a stroke admission in the study was $35 130 for subjects treated with endovascular therapy after intravenous tPA treatment and $25 630 for subjects treated with intravenous tPA alone (P<0.0001). Significant factors related to costs included treatment group, baseline National Institutes of Health Stroke Scale, time from stroke onset to intravenous tPA, age, stroke location, and comorbid diabetes mellitus. The mean cost for subjects who had routine use of general anesthesia as part of endovascular therapy was $46 444 when compared with $30 350 for those who did not have general anesthesia. The costs of embolectomy for IMS III subjects and patients from the National Inpatient Sample cohort exceeded the Medicare diagnosis-related group payment in ≥75% of patients. CONCLUSIONS: Minimizing the time to start of intravenous tPA and decreasing the use of routine general anesthesia may improve the cost-effectiveness of medical and endovascular therapy for acute stroke. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00359424.

Cost-effectiveness of optimizing acute stroke care services for thrombolysis.

BACKGROUND AND PURPOSE: Thrombolysis in acute stroke is effective up to 4.5 hours after symptom onset but relies on early recognition, prompt arrival in hospital, and timely brain scanning. This study aimed to establish the cost-effectiveness of increasing thrombolysis rates through a series of hypothetical change strategies designed to optimize the acute care pathway for stroke. METHODS: A decision-tree model was constructed, which relates the acute management of patients with suspected stroke from symptom onset to outcome. Current practice was modeled and compared with 7 change strategies designed to facilitate wider eligibility for thrombolysis. The model basecase consisted of data from consenting patients following the acute stroke pathway recruited in participating hospitals with data on effectiveness of treatment and costs from published sources. RESULTS: All change strategies were cost saving while increasing quality-adjusted life years gained. Using realistic estimates of effectiveness, the change strategy with the largest potential benefit was that of better recording of onset time, which resulted in 3.3 additional quality-adjusted life years and a cost saving of US $46,000 per 100,000 population. All strategies increased the number of thrombolysed patients and the number requiring urgent brain imaging (by 9% to 21% dependent on the scenario). Assuming a willingness-to-pay of US $30,000 per quality-adjusted life year gained, the potential budget available to deliver the interventions in each strategy ranged from US $50,000 to US $144,000. CONCLUSIONS: These results suggest that any strategy that increases thrombolysis rates will result in cost savings and improved patient quality of life. Healthcare commissioners could consider this model when planning improvements in stroke care.