Economic evaluation of the effect of needle and syringe programs on skin, soft tissue, and vascular infections in people who inject drugs: a microsimulation modelling approach.

BACKGROUND: Needle and syringe programs (NSP) are effective harm-reduction strategies against HIV and hepatitis C. Although skin, soft tissue, and vascular infections (SSTVI) are the most common morbidities in people who inject drugs (PWID), the extent to which NSP are clinically and cost-effective in relation to SSTVI in PWID remains unclear. The objective of this study was to model the clinical- and cost-effectiveness of NSP with respect to treatment of SSTVI in PWID. METHODS: We performed a model-based, economic evaluation comparing a scenario with NSP to a scenario without NSP. We developed a microsimulation model to generate two cohorts of 100,000 individuals corresponding to each NSP scenario and estimated quality-adjusted life-years (QALY) and cost (in 2022 Canadian dollars) over a 5-year time horizon (1.5% per annum for costs and outcomes). To assess the clinical effectiveness of NSP, we conducted survival analysis that accounted for the recurrent use of health care services for treating SSTVI and SSTVI mortality in the presence of competing risks. RESULTS: The incremental cost-effectiveness ratio associated with NSP was $70,278 per QALY, with incremental cost and QALY gains corresponding to $1207 and 0.017 QALY, respectively. Under the scenario with NSP, there were 788 fewer SSTVI deaths per 100,000 PWID, corresponding to 24% lower relative hazard of mortality from SSTVI (hazard ratio [HR] = 0.76; 95% confidence interval [CI] = 0.72-0.80). Health service utilization over the 5-year period remained lower under the scenario with NSP (outpatient: 66,511 vs. 86,879; emergency department: 9920 vs. 12,922; inpatient: 4282 vs. 5596). Relatedly, having NSP was associated with a modest reduction in the relative hazard of recurrent outpatient visits (HR = 0.96; 95% CI = 0.95-0.97) for purulent SSTVI as well as outpatient (HR = 0.88; 95% CI = 0.87-0.88) and emergency department visits (HR = 0.98; 95% CI = 0.97-0.99) for non-purulent SSTVI. CONCLUSIONS: Both the individuals and the healthcare system benefit from NSP through lower risk of SSTVI mortality and prevention of recurrent outpatient and emergency department visits to treat SSTVI. The microsimulation framework provides insights into clinical and economic implications of NSP, which can serve as valuable evidence that can aid decision-making in expansion of NSP services.

Understanding value and patient complexity among common inpatient vascular surgery procedures.

OBJECTIVE: Vascular surgery patients are highly complex, second only to patients undergoing cardiac procedures. However, unlike cardiac surgery, work relative value units (wRVU) for vascular surgery were undervalued based on an overall patient complexity score. This study assesses the correlation of patient complexity with wRVUs for the most commonly performed inpatient vascular surgery procedures. METHODS: The 2014 to 2017 National Surgical Quality Improvement Program Participant Use Data Files were queried for inpatient cases performed by vascular surgeons. A previously developed patient complexity score using perioperative domains was calculated based on patient age, American Society of Anesthesiologists class of ≥4, major comorbidities, emergent status, concurrent procedures, additional procedures, hospital length of stay, nonhome discharge, and 30-day major complications, readmissions, and mortality. Procedures were assigned points based on their relative rank and then an overall score was created by summing the total points. An observed to expected ratio (O/E) was calculated using open ruptured abdominal aortic aneurysm repair (rOAAA) as the referent and then applied to an adjusted median wRVU per operative minute. RESULTS: Among 164,370 cases, patient complexity was greatest for rOAAA (complexity score = 128) and the least for carotid endarterectomy (CEA) (complexity score = 29). Patients undergoing rOAAA repair had the greatest proportion of American Society of Anesthesiologists class of ≥IV (84.8%; 95% confidence interval [CI], 82.6%-86.8%), highest mortality (35.5%; 95% CI, 32.8%-38.3%), and major complication rate (87.1%; 95% CI, 85.1%-89.0%). Patients undergoing CEA had the lowest mortality (0.7%; 95% CI, 0.7%-0.8%), major complication rate (8.2%; 95% 95% CI, 8.0%-8.5%), and shortest length of stay (2.7 days; 95% CI, 2.7-2.7). The median wRVU ranged from 10.0 to 42.1 and only weakly correlated with overall complexity (Spearman's ρ = 0.11; P < .01). The median wRVU per operative minute was greatest for thoracic endovascular aortic repair (0.25) and lowest for both axillary-femoral artery bypass (0.12) and open femoral endarterectomy, thromboembolectomy, or reconstruction (0.12). After adjusting for patient complexity, CEA (O/E = 3.8) and transcarotid artery revascularization (O/E = 2.8) had greater than expected O/E. In contrast, lower extremity bypass (O/E = 0.77), lower extremity embolectomy (O/E = 0.79), and open abdominal aortic repair (O/E = 0.80) had a lower than expected O/E. CONCLUSIONS: Patient complexity varies substantially across vascular procedures and is not captured effectively by wRVUs. Increased operative time for open procedures is not adequately accounted for by wRVUs, which may unfairly penalize surgeons who perform complex open operations.

Telemedicine platforms and their use in the coronavirus disease-19 era to deliver comprehensive vascular care.

Implementation of telemedicine for patient encounters optimizes personal safety and allows for continuity of patient care. Embracing telehealth reduces the use of personal protective equipment and other resources consumed during in-person visits. The use of telehealth has increased to historic levels in response to the coronavirus disease 2019 (COVID-19) pandemic. Telehealth may be a key modality to fight against COVID-19, allowing us to take care of patients, conserve personal protective equipment, and protect health care workers all while minimizing the risk of viral spread. We must not neglect vascular health issues while the coronavirus pandemic continues to flood many hospitals and keep people confined to their homes. Patients are not immune to diseases and illnesses such as stroke, critical limb ischemia, and deep vein thrombosis while being confined to their homes and afraid to visit hospitals. Emerging from the COVID-19 crisis, incorporating telemedicine into routine medical care is transformative. By leveraging digital technology, the authors discuss their experience with the implementation, workflow, coding, and reimbursement issues of telehealth during the COVID-19 era.

Costs Associated With Early Vascular and Biliary Complications in Liver-Transplanted Patients in a Hospital in Antioquia, Colombia 2019: A Case Series.

OBJECTIVES: Vascular and biliary complications associated with liver transplants involve high morbidity and mortality as well as cost overrun for health systems. Efforts to prioritize their prevention require not only clinical information but also information on costs that reflect the economic burden on health systems. The objective of this study was to describe cost overrun incurred from early vascular and biliary complications after liver transplant. METHODS: This cases series included liver transplant patients treated at the San Vicente Foundation University Hospital, Rionegro, Antioquia, from January 1, 2013, to December 31, 2018. All liver transplant patients treated during the above period were included; the absence of clinical records on the variables of interest was considered the exclusion criterion. A probabilistic analysis of patient cost was performed. Monte Carlo simulations as well as a 1-way sensitivity analysis per transplant cost component were performed. RESULTS: Records from 154 patients were assessed. The average patient age was 56.9 (SD 10.9) years; 42.9% of patients were women. Of all, 36.4% patients were classified as Child C, and the average Model for End-Stage Liver Disease score was 19.6. The average cost for patients without complications was $27 834.82, whereas that for patients with early vascular complications was $36 747.83 and for those with early biliary complications was $38 523.74. CONCLUSION: Early vascular and biliary complications after liver transplant increase healthcare costs, with the increase being significant in patients with biliary complications.

Time trends and social security burden of temporary work disability due to chronic venous disease in Brazil.

BACKGROUND: Chronic venous disease (CVD) and disability are worldwide problems and have significant socioeconomic implications. This study aims to analyze the time trends and social security burden of temporary work disability due to CVD in Brazil. METHODS: An ecological time series study using the Brazilian Social Security System database was performed from 2005 to 2014. Data from all benefits granted to workers with temporary disability due to CVD were analyzed. The cases were identified using diagnosis codes I83-I83.9 of the International Classification of Diseases 10th Revision (ICD-10). The time trend analyses were performed by the Joinpoint Regression Model, with sex, age, regions, income, and category of affiliation as variables. Crude and age-standardized rates were calculated. RESULTS: A total of 429,438 benefits were granted for temporary work disability due to CVD from 2005 to 2014, with a growing trend and an age-standardized annual percent change (APC) of 3.4 (95% CI: 2.6-4.2) (p < 0.05). Social security expense increased 3.5-fold, and the number of days in benefit doubled from 2005 to 2014. In total, 27,017,818 working days were lost. The average duration of benefits was 55.3 days. The majority of workers were women (68.2%) (p < 0.001), between 30 and 59 years old, employed, had a monthly income ≤2 minimum wages (MW) (83.2%), and lived in the regions southeast (53.6%) and south (29.3%). Significantly higher APCs were observed for women than for men (APC: 4.9, 95% CI: 4.0-5.7 versus APC: 1.2, 95% CI: 0.1-2.4). All regions in Brazil had a significant growing trend, except in the north. No significant growth was observed in the age group of 60-69 years. A decreasing trend was observed in workers with monthly incomes above 2 MW (p < 0.05). CONCLUSIONS: Temporary work disability due to CVD and social security burden showed increasing trends with millions of working days lost, particularly among women and low-income workers. Preventing disability is challenging, and public policies are needed to reduce the social and economic impact of disability. Therefore, measures for promoting health at the workplace should be encouraged.

A Systematic Review of Economic Evaluations in Vascular Surgery.

BACKGROUND: With increasing healthcare costs and the emergence of new technologies in vascular surgery, economic evaluations play a critical role in informing decision-making that optimizes patient outcomes while minimizing per capita costs. The objective of this systematic review is to describe all English published economic evaluations in vascular surgery and to identify any significant gaps in the literature. METHODS: We conducted a comprehensive English literature review of EMBASE, MEDLINE, The Cochrane Library, Ovid Health Star, and Business Source Complete from inception until December 1, 2018. Two independent reviewers screened articles for eligibility using predetermined inclusion criteria and subsequently extracted data. Articles were included if they compared 2 or more vascular surgery interventions using either a partial economic evaluation (cost analysis) or full economic evaluation (cost-utility, cost-benefit, and/or cost-effectiveness analysis). Data extracted included publishing journal, date of publication, country of origin of authors, type of economic evaluation, and domain of vascular surgery. RESULTS: A total of 234 papers were included in the analysis. The majority of the papers included only a cost analysis (183, 78%), and there were only 51 papers that conducted a full economic analysis (22%). The 51 papers conducted a total of 69 economic analyses. This consisted of 32 cost-effectiveness analyses, 29 cost-utility analyses, and 8 cost-benefit analyses. The most common domains studied were aneurysmal disease (89, 38%) and peripheral vascular disease (50, 21%). Economic evaluations were commonly published in the Journal of Vascular Surgery (83, 35%) and Annals of Vascular Surgery (32, 14%), with most study authors located in the United States (127, 54%). There was a trend of economic evaluations being published more frequently in recent years. CONCLUSIONS: The majority of vascular surgery economic evaluations used only a cost analysis, rather than a full economic evaluation, which may not be ideal in pursuing interventions that simultaneously optimize cost and patient outcomes. The literature is lacking in full economic evaluations-a trend persistent in other surgical specialties-and there is a need for full economic evaluations to be conducted in the field of vascular surgery.

Vascular complications associated with percutaneous left ventricular assist device placement: A 10-year US perspective.

BACKGROUND: Over the last decade, there has been a significant increase in the use of percutaneous left ventricular assist devices(p-LVADs). p-LVADs are being increasingly used during complex coronary interventions and for acute cardiogenic shock. These large bore percutaneous devices have a higher risk of vascular complications. We examined the vascular complication rates from the use of p-LVAD in a national database. METHODS: We conducted a secondary analysis of the National In-patient Sample (NIS) dataset from 2005 till 2015. We used the ICD-9-CM procedure codes 37.68 and 37.62 for p-LVAD placement regardless of indications. We investigated common vascular complications, defining them by the validated ICD 9 CM codes. χ2 test and t test were used for categorical and continuous variables, respectively for comparison. RESULTS: A total of 31,263 p-LVAD placements were identified during the period studied. A majority of patients were male (72.68%) and 64.44% were white. The overall incidence of vascular complications was 13.53%, out of which 56% required surgical treatment. Acute limb thromboembolism and bleeding requiring transfusion accounted for 27.6% and 21.8% of all vascular complications. Occurrence of a vascular complication was associated with significantly higher in-hospital mortality (37.77% vs. 29.95%, p < .001), length of stay (22.7 vs. 12.2 days, p < .001) and cost of hospitalization ($ 161,923 vs. $ 95,547, p < .001). CONCLUSIONS: There is a high incidence of vascular complications with p-LVAD placement including need for vascular surgery. These complications are associated with a higher in-hospital, LOS and hospitalization costs. These findings should be factored into the decision-making for p-LVAD placement.

Impact of Treating Oral Disease on Preventing Vascular Diseases: A Model-Based Cost-effectiveness Analysis of Periodontal Treatment Among Patients With Type 2 Diabetes.

OBJECTIVE: Previous randomized trials found that treating periodontitis improved glycemic control in patients with type 2 diabetes (T2D), thus lowering the risks of developing T2D-related microvascular diseases and cardiovascular disease (CVD). Some payers in the U.S. have started covering nonsurgical periodontal treatment for those with chronic conditions, such as diabetes. We sought to identify the cost-effectiveness of expanding periodontal treatment coverage among patients with T2D. RESEARCH DESIGN AND METHODS: A cost-effectiveness analysis was conducted to estimate lifetime costs and health gains using a stochastic microsimulation model of oral health conditions, T2D, T2D-related microvascular diseases, and CVD of the U.S. POPULATION: Model parameters were obtained from the nationally representative National Health and Nutrition Examination Survey (NHANES) (2009-2014) and randomized trials of periodontal treatment among patients with T2D. RESULTS: Expanding periodontal treatment coverage among patients with T2D and periodontitis would be expected to avert tooth loss by 34.1% (95% CI -39.9, -26.5) and microvascular diseases by 20.5% (95% CI -31.2, -9.1), 17.7% (95% CI -32.7, -4.7), and 18.4% (95% CI -34.5, -3.5) for nephropathy, neuropathy, and retinopathy, respectively. Providing periodontal treatment to the target population would be cost saving from a health care perspective at a total net savings of $5,904 (95% CI -6,039, -5,769) with an estimated gain of 0.6 quality-adjusted life years per capita (95% CI 0.5, 0.6). CONCLUSIONS: Providing nonsurgical periodontal treatment to patients with T2D and periodontitis would be expected to significantly reduce tooth loss and T2D-related microvascular diseases via improved glycemic control. Encouraging patients with T2D and poor oral health conditions to receive periodontal treatment would improve health outcomes and still be cost saving or cost-effective.

Prior authorization as a utilization management tool for elective superficial venous procedures results in high administrative cost and low efficacy in reducing utilization.

OBJECTIVE: Prior authorization (PA) is a process used by payers for safety and cost savings purposes, but it has received criticism for being time-consuming and costly because of administrative burden. Our study evaluated efficacy of PA applied to in-office lower extremity superficial venous procedures. METHODS: All in-office lower extremity venous procedures scheduled to be performed at our institution in 2017 were included in the study. Variables of interest were type of procedure, initial PA status (approved or denied), rationale for the decision, and final status after appeal. Cost analysis was performed using Centers for Medicare and Medicaid Services allowable rates to approximate billing and reimbursement data (proprietary) as well as calculated using industry averages. RESULTS: For 2017, of 1959 procedures scheduled, 57.9% (n = 1134) required PA. Of these, only 6.1% (n = 69) received initial PA denial, and nearly 40% of the denials (n = 27) were overturned after appeal. Of the 42 denials that were upheld, 15 resulted in cancellations; the remainder were performed by patient self-pay (n = 11) or by the provider pro bono (n = 16). Overturned denials were a result of either submission of incomplete clinical data on initial PA request or insufficient documentation of clinical necessity. When Centers for Medicare and Medicaid Services allowable rates were applied for cost analysis, the denials resulted in <$60,000 payer savings. Administrative expenses totaled >$110,000 when industry standards were applied, which far exceeds any calculated payer savings using the same methods. The 15 denials resulting in procedure cancellations (1.3% of all PAs) could be considered a net savings to the health care system but only approximated a mere $30,000. CONCLUSIONS: Our study demonstrates that PA is not a cost-effective measure for utilization management of outpatient superficial venous procedures when surgeon practices are already well aligned with insurance guidelines. For these physicians and physician groups, the administrative cost associated with the PA process exceeds the savings seen by the insurance companies.

Inguinal vascular complications after ablation of atrial fibrillation: an economic impact assessment.

AIMS: Ablation of atrial fibrillation (AF) is recommended in the guidelines as a Class Ia/IIa indication. However, associated complications should not be dismissed; specifically, inguinal vascular complications (IVC). Although IVCs are generally considered trivial, they represent an economic burden for the procedure-performing hospital and the patient. Therefore, the ability to monitor and ultimately minimize potential complications is of considerable interest. METHODS AND RESULTS: An economic model was developed to calculate the economic impact for certain IVC-types from a large German single-centre perspective in 2015 and 2016. Twenty-nine of 1040 (2.79%) and 48 of 1152 (4.17%) AF-ablation patients had documented IVC in 2015 and 2016 (P = 0.08), respectively. Inguinal vascular complications that required invasive treatment (thrombin, intervention, surgery) occurred in 0.58% of the 2015 and in 0.87% of the 2016 AF-ablation cases. The expected excess costs (incorporating direct costs, benefit lost adjusted for reimbursement) per patient treated with AF-ablation were 139.54€ and 153.31€ in 2015 and 2016, respectively. This was mostly driven by opportunity costs, which could reach 15 544.71€ for certain IVC. Sensitivity analysis revealed the probability of occurrence, length of stay of certain IVC types, and the revenue per day influenced the expected costs per AF-ablation patient. CONCLUSION: Even relatively benign complications such as IVC can result in considerable cost increases. Therefore, measures to reduce them should be established and implemented.

Preoperative dementia is associated with increased cost and complications after vascular surgery.

OBJECTIVE: Dementia represents a major risk factor for medical complications and has been linked to higher rates of complication after surgery. Given the systemic nature of vascular disease, medical comorbidities significantly increase cost and complications after vascular surgery. We hypothesize that the presence of dementia is an independent predictor of increased postoperative complications and higher health care costs after vascular surgery. METHODS: The Vascular Quality Initiative database was queried for all patients undergoing vascular surgery at a single academic medical center from 2012 to 2017. All modules were included (open abdominal aortic aneurysm, suprainguinal bypass, lower extremity bypass, amputation, carotid endarterectomy, endovascular aortic aneurysm repair, thoracic endovascular aortic aneurysm repair, and peripheral endovascular intervention). An institutional clinical data repository was queried to identify patients with International Classification of Diseases, Ninth Revision diagnosis codes for dementia as well as total hospital cost and long-term survival using Social Security records from the Virginia Department of Health. Hierarchical logistic and linear regression models were fit to assess risk-adjusted predictors of any complication and inflation-adjusted cost. Kaplan-Meier and Cox proportional hazards models were used for survival analysis. RESULTS: A total of 2318 patients underwent vascular surgery and were captured by the Vascular Quality Initiative during the past 5 years, with 88 (3.8%) having a diagnosis of dementia. Patients with dementia were older and had higher rates of medical comorbidities, and the most common procedure was major amputation. In addition, dementia patients had a significantly higher rate of any complication (52% vs 16%; P < .0001) and increased 90-day mortality (14% vs 4.8%; P = .0002). Furthermore, dementia was associated with significant resource utilization, including preoperative length of stay (LOS), postoperative LOS, intensive care unit LOS, and inflation-adjusted total hospital cost (all P < .0001). Hierarchical modeling demonstrated that dementia was the strongest preoperative predictor for any complication (odds ratio, 8.64; P < .0001) and had the largest risk-adjusted impact on total hospital cost ($22,069; P < .0001). Finally, survival analysis demonstrated that dementia is independently associated with reduced survival after vascular surgery (hazard ratio, 1.37; P = .018). CONCLUSIONS: This study demonstrated that dementia is one of the strongest predictors of any complication and increased hospital cost after vascular surgery. Given the high risk of clinical and financial maladies, patients with dementia should be carefully considered and counseled before undergoing vascular surgery.

Early Treatment at a Referral Center Improves Outcomes for Patients with Acute Vascular Disease.

BACKGROUND: Patients with acute vascular disease frequently need specialized management that may require transfer to a vascular referral center. Although transfer may be medically necessary, it can delay definitive care and is an indicator of incorrect triage to the initial hospital. Regionalization of acute vascular care could improve patient triage and subsequent outcomes. To evaluate the potential benefit from regionalization, we analyzed outcomes of patients treated for acute vascular disease at vascular referral centers. METHODS: Using a statewide database capturing all inpatient admissions in Maryland during 2013-2015, patients undergoing noncardiac vascular procedures on an acute basis were identified. Patients admitted to a vascular referral center were stratified by admission status as direct or transfer. The primary outcome was inpatient mortality, and the secondary outcome was resource use. Patient groups were compared by univariable analyses, and the effect of admission status on mortality was assessed by multivariable logistic regression. RESULTS: Of 4,873 patients with acute vascular disease managed at vascular referral centers, 2,713 (56%) were admitted directly, whereas 2,160 (44%) were transferred. Transfers to referral centers accounted for 71% of all interhospital transfers. The transfer-group patients were older, had more comorbidities, and higher illness severities. Patients who were transferred had higher mortality (14% vs. 9%, P < 0.0001), longer hospital lengths of stay, greater critical care-resource utilization, and higher costs. After adjusting for demographics, comorbidities, and illness severity, transfer status was independently associated with higher inpatient mortality. CONCLUSIONS: Primary treatment at a referral center is independently associated with improved outcomes for patients with acute vascular disease. Direct admission or earlier triage to a specialty center may improve patient and system outcomes and could be facilitated by standardization and regionalization of complex acute vascular care.

Report of the Society for Vascular Surgery and the American Venous Forum on the July 20, 2016 meeting of the Medicare Evidence Development and Coverage Advisory Committee panel on lower extremity chronic venous disease.

On July 20, 2016, a Medicare Evidence Development and Coverage Advisory Committee panel assessed the benefits and risks of currently used lower extremity chronic venous disease (CVD) treatments and their effects on health outcome of the American adult population. The main purpose of the meeting was to advise the Centers for Medicare & Medicaid Services on coverage determination for interventions used for treatment of CVD. A systematic review of the Agency for Healthcare Research and Quality was presented, followed by lectures of invited experts and a public hearing of representatives of professional societies and the industry. After discussing critical issues, the panel voted for key questions. This report summarizes the presented evidence to support recommendations of the Society for Vascular Surgery/American Venous Forum coalition and the presentations on selected discussion topics. These included important venous disease evidence gaps that have not been sufficiently addressed, venous disease treatment disparities and how they may affect the health outcomes of Medicare beneficiaries, and mechanisms that might be supported by the Centers for Medicare & Medicaid Services to improve the evidence base to optimize the care of patients with lower extremity CVD.

The evidence supporting treatment of reflux and obstruction in chronic venous disease.

On July 20, 2016, a Medicare Evidence Development and Coverage Advisory Committee panel convened to assess the evidence supporting treatment of chronic venous disease. Several societies addressed the questions posed to the panel. A multidisciplinary coalition, representing nine societies of venous specialists, reviewed the literature and presented a consensus opinion regarding the panel questions. The purpose of this paper is to present our coalition's consensus review of the literature and recommendations for chronic venous disease.