Cost-effectiveness Analysis of AngioJet and CDT for Lower Extremity Deep Vein Thrombosis Among Chinese Population.

AngioJet has sufficient safety and efficacy in the treatment of acute and subacute lower extremity deep vein thrombosis (LEDVT). But the price of consumables used by AngioJet is relatively high and there is a lack of relevant research on health economics to measure the benefits to patients. Objective of this study is to estimate the cost effectiveness of AngioJet compared with catheter-directed thrombolysis (CDT) among Chinese population. Using a Markov decision model, we compared the 2 treatment strategies in patients with LEDVT. The model captured the development of post-thrombotic syndrome (PTS), recurrent venous thromboembolism, and treatment-related adverse events within a lifetime horizon and the perspective of a third-party payer. Model uncertainty was assessed with one-way and Monte Carl sensitivity analyses. The clinical inputs were obtained from the literature. Costs obtained from the hospital accounts and the literature are expressed in US dollars ($). Utilities were defined as quality adjusted life years (QALY). In cost-effectiveness analysis, AngioJet accumulated $1064.6445/QALY compared with $2080.1561/QALY after CDT treatment alone. AngioJet has higher long-term cost-effectiveness than CDT at a willingness to pay threshold of $11 233.52. One-way sensitivity analysis showed that the utilities of PTS and post-LEDVT state had significant influence on the results and the model maintained a strong stability under ± 10% fluctuation of utilities. Monte Carl sensitivity analysis shows that AngioJet model has strong stability and AngioJet has higher long-term cost-effectiveness than CDT. AngioJet is likely to be a cost-effective alternative to the CDT for patients with LEDVT.

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-utility analysis: Mechanical thrombectomy plus thrombolysis in ischemic stroke due to large vessel occlusion in the public sector in Chile]. / Análisis de costo utilidad: trombectomía mecánica más trombólisis en accidente vascular cerebral isquémico debido a oclusión de grandes vasos en el sector público en Chile.

INTRODUCTION: Several studies demonstrate the therapeutic superiority of thrombolysis plus mechanical thrombectomy versus thrombolysis alone to treat stroke. OBJECTIVE: To analyze the cost-utility of thrombolysis plus mechanical thrombectomy versus thrombolysis in patients with ischemic stroke due to large vessel occlusion. METHODS: Cost-utility analysis. The model used is blended: Decision Tree (first 90 days) and Markov in the long term, of seven health states based on a disease-specific scale, from the Chilean public insurance and societal perspective. Quality-Adjusted Life-Years and costs are evaluated. Deterministic (DSA) and probabilistic (PSA) analyses were carried out. RESULTS: From the public insurance perspective, in the base case, mechanical thrombectomy is associated with lower costs in a lifetime horizon, and with higher benefits (2.63 incremental QALYs, and 1.19 discounted incremental life years), at a Net Monetary Benefit (NMB) of CLP 37,289,874, and an Incremental Cost-Utility Ratio (ICUR) of CLP 3,807,413/QALY. For the scenario that incorporates access to rehabilitation, 2.54 incremental QALYs and 1.13 discounted life years were estimated, resulting in an NMB of CLP 35,670,319 and ICUR of CLP 3,960,624/QALY. In the scenario that incorporates access to long-term care from a societal perspective, the ICUR falls to CLP 951,911/QALY, and the NMB raises to CLP 43,318,072, improving the previous scenarios. In the DSA, health states, starting age, and relative risk of dying were the variables with the greatest influence. The PSA for the base case corroborated the estimates. CONCLUSIONS: Thrombolysis plus mechanical thrombectomy adds quality of life at costs acceptable for decision-makers versus thrombolysis alone. The results are consistent with international studies.

INTRODUCCIÓN: Diversos estudios demuestran la superioridad terapéutica de la trombólisis más trombectomía mecánica, versus trombólisis sola, en el tratamiento del accidente vascular cerebral. OBJETIVOS: Analizar el costo utilidad de la trombólisis más trombectomía versus trombólisis sola en pacientes con accidente vascular cerebral isquémico con oclusión de grandes vasos. MÉTODOS: Evaluación de costo utilidad. Se ha utilizado un modelo mixto: árbol de decisión (primeros 90 días) y Markov en el largo plazo, de siete estados de salud definidos en escala específica de enfermedad, desde la perspectiva del seguro público chileno y societal. Se evalúan costos y años de vida ajustados por calidad. Se realizó análisis de incertidumbre determinístico y probabilístico. RESULTADOS: Bajo la perspectiva de seguro público, en el caso base la trombectomía mecánica se relaciona con menores costos en un horizonte de por vida, con mayores beneficios (2,63 años de vida ajustados por calidad incrementales, y 1,19 años de vida incrementales descontados), a un beneficio monetario neto de $37 289 874 pesos chilenos, y una razón incremental de costo utilidad de $3 807 413 pesos por años de vida ajustados por calidad. Para el escenario que agrega acceso a rehabilitación se estimaron 2,54 años de vida ajustados por calidad incremental y 1,13 años de vida descontados, resultando en un beneficio monetario neto de $35 670 319 pesos y razón incremental de costo utilidad de $3 960 624 pesos por años de vida ajustados por calidad. En el escenario que agrega el efecto de acceso a cuidados de larga duración con perspectiva societal, la razón incremental de costo utilidad cae hasta $951 911 pesos por años de vida ajustados por calidad y el beneficio monetario neto se eleva a $43 318 072 pesos, superando las estimaciones anteriores. En el análisis de incertidumbre determinístico, los estados de salud, edad de inicio de la cohorte y riesgo relativo de morir, fueron las variables con mayor influencia. El análisis de incertidumbre probabilístico para el caso base, corroboró las estimaciones. CONCLUSIONES: La trombólisis más trombectomía mecánica agrega calidad de vida a costos aceptables por el tomador de decisión, versus trombólisis sola. Los resultados son consistentes con los estudios internacionales.

Decade-Long Nationwide Trends and Disparities in Use of Comfort Care Interventions for Patients With Ischemic Stroke.

Background Stroke remains one of the leading causes of disability and death in the United States. We characterized 10-year nationwide trends in use of comfort care interventions (CCIs) among patients with ischemic stroke, particularly pertaining to acute thrombolytic therapy with intravenous tissue-type plasminogen activator and endovascular thrombectomy, and describe in-hospital outcomes and costs. Methods and Results We analyzed the National Inpatient Sample from 2006 to 2015 and identified adult patients with ischemic stroke with or without thrombolytic therapy and CCIs using validated International Classification of Diseases, Ninth Revision (ICD-9) codes. We report adjusted odds ratios (ORs) and 95% CI of CCI usage across five 2-year periods. Of 4 249 201 ischemic stroke encounters, 3.8% had CCI use. CCI use increased over time (adjusted OR, 4.80; 95% CI, 4.15-5.55) regardless of acute treatment type. Advanced age, female sex, White race, non-Medicare insurance, higher income, disease severity, comorbidity burden, and discharge from non-northeastern teaching hospitals were independently associated with receiving CCIs. In the fully adjusted model, thrombolytic therapy and endovascular thrombectomy, respectively, conferred a 6% and 10% greater likelihood of receiving CCIs. Among CCI users, there was a significant decline in in-hospital mortality compared with all other dispositions over time (adjusted OR, 0.46; 95% CI, 0.38-0.56). Despite longer length of stay, CCI hospitalizations incurred 16% lower adjusted costs. Conclusions CCI use among patients with ischemic stroke has increased regardless of acute treatment type. Nonetheless, considerable disparities persist. Closing the disparities gap and optimizing access, outcomes, and costs for CCIs among patients with stroke are important avenues for further research.

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 Analysis of Fibrinolysis vs Thoracoscopic Decortication for Early Empyema.

BACKGROUND: Surgical decortication is recommended by national guidelines for management of early empyema, but intrapleural fibrinolysis is frequently used as a first-line therapy in clinical practice. This study compared the cost-effectiveness of video-assisted thoracoscopic surgery (VATS) decortication with intrapleural fibrinolysis for early empyema. METHODS: A decision analysis model was developed. The base clinical case was a 65-year-old man with early empyema treated either by VATS decortication or intrapleural tissue plasminogen activator and deoxyribonuclease. The likelihood of key outcomes occurring was derived from the literature. Medicare diagnosis-related groups and manufacturers' drug prices were used for cost estimates. Successful treatment was defined as complete or nearly complete resolution of empyema on imaging. Effectiveness was defined as health utility 1 year after empyema. RESULTS: Intrapleural tissue plasminogen activator and deoxyribonuclease were more cost-effective than VATS decortication for treating early empyema for the base clinical case. Surgical decortication had a slightly lower cost than fibrinolysis ($13,345 vs $13,965), but fibrinolysis had marginally higher effectiveness at 1 year (health utility of 0.80 vs 0.71). Therefore, fibrinolysis was the more cost-effective option. Sensitivity analyses found that fibrinolysis as the initial therapy was more cost-effective when the probability of success was greater than 60% or the initial cost was less than $13,000. CONCLUSIONS: Surgical decortication and intrapleural fibrinolysis have nearly equivalent cost-effectiveness for early empyema in patients who can tolerate both procedures. Surgeons should consider patient-specific factors, as well as the cost and effectiveness of both modalities, when deciding on an initial treatment for early empyema.

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.

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.

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.

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.

In-hospital outcomes of catheter-directed thrombolysis versus anticoagulation in cancer patients with proximal deep venous thrombosis.

OBJECTIVE: The objective of this study was to determine the rate of complications of catheter-directed thrombolysis (CDT) in cancer patients with deep venous thrombosis (DVT) compared with anticoagulation therapy alone. METHODS: This observational study used the National Inpatient Sample database to screen for any cancer patients who were admitted with a principal discharge diagnosis of proximal lower extremity or caval DVT between January 2005 and December 2013. Patients treated with CDT plus anticoagulation were compared with those treated with anticoagulation alone using propensity score matching for comorbidities and demographic characteristics. The primary end point was in-hospital mortality. Secondary end points were acute intracranial hemorrhage, inferior vena cava filter placement, acute renal failure, blood transfusion rates, length of stay, and hospital charges. RESULTS: We identified 31,124 cancer patients with lower extremity proximal or caval DVT, and 1290 (4%) patients were treated with CDT. Comparative outcomes as assessed in the two matched groups of 1297 patients showed that there was no significant difference in in-hospital mortality of patients undergoing CDT plus anticoagulation compared with those treated with anticoagulation alone (2.6% vs 1.9%; P = .23). However, CDT was associated with increased risk of intracranial hemorrhage (1.3% vs 0.4%; P = .017), greater blood transfusion rates (18.6% vs 13.1 %; P < .001), and higher rates of procedure-related hematoma (2.4% vs 0.4%; P < .001). The length of stay (6.0 [4.0-10.0] days vs 4.0 [2.0-7.0] days; P < .001) and hospital charges ($81,535 [$50,968-$127,045] vs $22,320 [$11,482-$41,005]; P < .001) were also higher in the CDT group compared with the control group. CONCLUSIONS: There was no significant difference in in-hospital mortality of cancer patients who underwent CDT plus anticoagulation compared with anticoagulation alone. CDT was associated with increased in-hospital morbidity and resource utilization compared with anticoagulation alone. Further studies are needed to examine the effect of CDT on the development of PTS in this population.

Cost-utility analysis of mechanical thrombectomy between 6 and 24 hours in acute ischemic stroke.

BACKGROUND: Recently, two randomized controlled trials demonstrated the benefit of mechanical thrombectomy performed between 6 and 24 h in acute ischemic stroke. The current economic evidence is supporting the intervention only within 6 h, but extended thrombectomy treatment times may result in better long-term outcomes for a larger cohort of patients. AIMS: We compared the cost-utility of mechanical thrombectomy in addition to medical treatment versus medical treatment alone performed beyond 6 h from stroke onset in the UK National Health Service (NHS). METHODS: A cost-utility analysis of mechanical thrombectomy compared to medical treatment was performed using a Markov model that estimates expected costs and quality-adjusted life years (QALYs) over a 20-year time horizon. We present the results of three models using the data from the DEFUSE 3 and DAWN trials and evidence from published sources. RESULTS: Over a 20-year period, the incremental cost per QALY of mechanical thrombectomy was $1564 (£1219) when performed after 12 h from onset, $5253 (£4096) after 16 h and $3712 (£2894) after 24 h. The probabilistic sensitivity analysis demonstrated that thrombectomy had a 99.9% probability of being cost-effective at the minimum willingness to pay for a QALY commonly used in the UK. CONCLUSIONS: The results of this study demonstrate that performing mechanical thrombectomy up to 24 h from acute ischemic stroke symptom onset is still cost-effective, suggesting that this intervention should be implemented by the NHS on the basis of improvement in quality of life as well as economic grounds.

Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial.

BACKGROUND: In patients with acute deep vein thrombosis (DVT), pharmacomechanical catheter-directed thrombolysis (PCDT) in conjunction with anticoagulation therapy is increasingly used with the goal of preventing postthrombotic syndrome. Long-term costs and cost-effectiveness of these 2 treatment strategies from the perspective of the US healthcare system have not been compared. METHODS AND RESULTS: Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) randomized 692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355). Costs (2017 US dollars) were assessed over a 24-month follow-up period using a combination of resource-based costing, hospital bills, Medicare reimbursement rates, and the Drug Topics Red Book. Health state utilities were obtained from the Short Form-36. In-trial results and US life tables were used to develop a Markov cohort model to evaluate lifetime cost-effectiveness. For the PCDT group, mean costs of the initial procedure were $13 600; per-patient costs associated with the index hospitalization were $21 509 for PCDT and $3877 for standard care (difference=$17 632; 95% CI, $16 117-$19 243). The 24-month difference in costs was $20 045 (95% CI, $16 093-$24 120). Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point. Projected differences in lifetime costs of $16 740 and quality-adjusted life years (QALYs) of 0.08, yield an incremental cost-effectiveness ratio for PCDT of $222 041/QALY gained. In probabilistic sensitivity analysis, the probability that PCDT would achieve a lifetime incremental cost-effectiveness ratio <$50 000/QALY or <$150 000/QALY was 1% and 25%, respectively. For iliofemoral DVT, QALY gains with PCDT were greater, yielding an incremental cost-effectiveness ratio of $137 526/QALY; for femoral-popliteal DVT, standard therapy was an economically dominant strategy. CONCLUSIONS: With an incremental cost-effectiveness ratio >$200 000/QALY gained, PCDT is not an economically attractive treatment for proximal DVT. PCDT may be of intermediate value in patients with iliofemoral DVT. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00790335.

Fast-track thrombolysis protocol: A single-session approach for acute iliofemoral deep venous thrombosis.

OBJECTIVE: Catheter-directed thrombolysis in the treatment of acute iliofemoral deep venous thrombosis (IFDVT) often requires more than one interventional session to yield successful outcomes. Catheter-directed thrombolysis is generally expensive, requiring prolonged hospital stay that may be associated with increased local and systemic hemorrhagic complications. We developed the fast-track thrombolysis protocol (FTTP) to address these issues. The goal of FTTP is to restore patency during the initial session of thrombolysis, thereby minimizing costs and complications associated with prolonged thrombolysis. METHODS: A retrospective analysis of 38 patients treated for acute IFDVT using FTTP at our institution from January 2014 to February 2019 was performed. The protocol includes periadventitial injection of lidocaine at the venipuncture site under ultrasound guidance, contrast venography of the entire target segment, pharmacomechanical rheolytic thrombectomy of the occluded venous segment, tissue plasminogen activator infusion along the occluded segment, balloon maceration of the thrombus, and, if indicated, venous stent placement in areas of significant (≥50%) stenosis refractory to thrombolysis and balloon angioplasty. Once the thrombus was cleared, patients were prescribed oral antithrombotic therapy. RESULTS: Thirty-eight primary FTTPs (45 total interventions) were performed in 38 patients. The median age was 66 years (range, 39-93 years); 60.5% were female. Initial venous access was most often obtained through the popliteal vein, followed by the femoral and great saphenous veins. The mean operative time was 122 minutes (range, 59-249 minutes), and the median volume of tissue plasminogen activator infused was 10 mg (range, 4-20 mg). The median cost per procedure, including devices and medication, was $5374.45. Median postoperative length of stay was 1 day (range, 1-45 days). Successful single-session FTTP, as determined by completion venography, was accomplished in 81.5% (n = 31/38) of cases. The remaining seven cases (18.5%) required one additional session. Of the 38 patients, 30 (79%) required iliac vein stenting. Periprocedural complications consisted of one patient with retroperitoneal hemorrhage that was managed conservatively. No patients experienced rethrombosis within 30 days of FTTP. During the 5-year study period, there were no cases of pulmonary embolism, significant local or systemic hemorrhage, limb loss, or mortality. CONCLUSIONS: FTTP, as presented herein, appears to be a safe, effective, and cost-effective technique in the resolution of acute IFDVT.

Pre-thrombectomy intravenous thrombolytics are associated with increased hospital bills without improved outcomes compared with mechanical thrombectomy alone.

OBJECTIVE: To investigate whether significant differences exist in hospital bills and patient outcomes between patients who undergo endovascular thrombectomy (EVT) alone and those who undergo EVT with pretreatment intravenous tissue plasminogen activator (IV tPA). METHODS: We retrospectively grouped patients in an EVT database into those who underwent EVT alone and those who underwent EVT with pretreatment IV tPA (EVT+IV tPA). Hospital encounter charges (obtained via the hospital's charge capture process), final patient bills (ie, negotiated final bills as per insurance/Medicare rates), demographic information, existing comorbidities, admission and discharge National Institutes of Health Stroke Scale (NIHSS) score, and functional independence data (modified Rankin Scale score 0-2) were collected. Univariate and multivariate statistical analyses were performed. RESULTS: Of a total of 254 patients, 96 (37.8%) underwent EVT+IV tPA. Median NIHSS score at admission was significantly higher in the EVT+IV tPA group than in the EVT group (p=0.006). After adjusting for NIHSS admission score, patient bills and encounter charges in the EVT+IV tPA group were still found to be $3861.64 (95% CI $658.84 to $7064.45, p=0.02) and $158 071.29 (95% CI $134 641.50 to $181 501.08, p < 0.001) greater than in the EVT only group respectively. The EVT+IV tPA group had a higher complication rate of intracranial hemorrhage (ICH) (p=0.005). The EVT and EVT+IV tPA groups did not differ significantly in median discharge NIHSS score (p=0.56), functional independence rate at 90 days (p=0.96), or average length of hospital stay (p=0.21). CONCLUSION: Patients treated with EVT+IV tPA have greater hospital encounter charges and final hospital bills as well as higher rates of ICH than patients who undergo treatment with EVT only.

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.

Cost-Effectiveness of Alternative Anticoagulation Strategies for Postoperative Management of Total Knee Arthroplasty Patients.

OBJECTIVE: To evaluate the cost-effectiveness of prolonged (35-day) and standard-duration (14-day) anticoagulation therapy following total knee arthroplasty (TKA). METHODS: Using Markov modeling, we assessed clinical and economic outcomes of 14-day and 35-day anticoagulation therapy following TKA with rivaroxaban, low molecular weight heparin (LMWH), fondaparinux, warfarin, and aspirin. Incidence of complications of TKA and anticoagulation therapy (deep vein thrombosis [DVT], pulmonary embolism [PE], prosthetic joint infection [PJI], and bleeding) were derived from published literature. Daily costs ranged from $1 (aspirin) to $43 (fondaparinux). Primary outcomes included quality-adjusted life years (QALYs), direct medical costs, and incremental cost-effectiveness ratios (ICERs) at 1 year post-TKA. The preferred regimen was the regimen with highest QALYs maintaining an ICER below the willingness-to-pay threshold ($100,000/QALY). We conducted probabilistic sensitivity analyses, varying complication incidence and anticoagulation efficacy, to evaluate the impact of parameter uncertainty on model results. RESULTS: Aspirin resulted in the highest cumulative incidence of DVT and PE, while prolonged fondaparinux led to the largest reduction in DVT incidence (15% reduction compared to no prophylaxis). Despite differential bleeding rates (ranging from 3% to 6%), all strategies had similar incidence of PJI (1% to 2%). Prolonged rivaroxaban was the least costly strategy ($3,300 at 1 year post-TKA) and the preferred regimen in the base case. In sensitivity analyses, prolonged rivaroxaban and warfarin had similar likelihoods of being cost-effective. CONCLUSION: Extending postoperative anticoagulation therapy to 35 days increases QALYs compared to standard 14-day prophylaxis. Prolonged rivaroxaban and prolonged warfarin are most likely to be cost-effective post-TKA; the costs of fondaparinux and LMWH precluded their being preferred strategies.

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.