Cost-effectiveness of Contemporary Statin Use Guidelines With or Without Coronary Artery Calcium Assessment in African American Individuals.

Importance: Clinical and economic consequences of statin treatment guidelines supplemented by targeted coronary artery calcium (CAC) assessment have not been evaluated in African American individuals, who are at increased risk for atherosclerotic cardiovascular disease and less likely than non-African American individuals to receive statin therapy. Objective: To evaluate the cost-effectiveness of the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guideline without a recommendation for CAC assessment vs the 2018 ACC/AHA guideline recommendation for use of a non-0 CAC score measured on one occasion to target generic-formulation, moderate-intensity statin treatment in African American individuals at risk for atherosclerotic cardiovascular disease. Design, Setting, and Participants: A microsimulation model was designed to estimate life expectancy, quality of life, costs, and health outcomes over a lifetime horizon. African American-specific data from 472 participants in the Jackson Heart Study (JHS) at intermediate risk for atherosclerotic cardiovascular disease and other US population-specific data on individuals from published sources were used. Data analysis was conducted from November 11, 2018, to November 1, 2019. Main Outcomes and Measures: Lifetime costs and quality-adjusted life-years (QALYs), discounted at 3% annually. Results: In a model-based economic evaluation informed in part by follow-up data, the analysis was focused on 472 individuals in the JHS at intermediate risk for atherosclerotic cardiovascular disease; mean (SD) age was 63 (6.7) years. The sample included 243 women (51.5%) and 229 men (48.5%). Of these, 178 of 304 participants (58.6%) who underwent CAC assessment had a non-0 CAC score. In the base-case scenario, implementation of 2013 ACC/AHA guidelines without CAC assessment provided a greater quality-adjusted life expectancy (0.0027 QALY) at a higher cost ($428.97) compared with the 2018 ACC/AHA guideline strategy with CAC assessment, yielding an incremental cost-effectiveness ratio of $158 325/QALY, which is considered to represent low-value care by the ACC/AHA definition. The 2018 ACC/AHA guideline strategy with CAC assessment provided greater quality-adjusted life expectancy at a lower cost compared with the 2013 ACC/AHA guidelines without CAC assessment when there was a strong patient preference to avoid use of daily medication therapy. In probability sensitivity analyses, the 2018 ACC/AHA guideline strategy with CAC assessment was cost-effective compared with the 2013 ACC/AHA guidelines without CAC assessment in 76% of simulations at a willingness-to-pay value of $100 000/QALY when there was a preference to lose 2 weeks of perfect health to avoid 1 decade of daily therapy. Conclusions and Relevance: A CAC assessment-guided strategy for statin therapy appears to be cost-effective compared with initiating statin therapy in all African American individuals at intermediate risk for atherosclerotic cardiovascular disease and may provide greater quality-adjusted life expectancy at a lower cost than a non-CAC assessment-guided strategy when there is a strong patient preference to avoid the need for daily medication. Coronary artery calcium testing may play a role in shared decision-making regarding statin use.

Utilization and in-hospital outcomes associated with atherectomy in the treatment of peripheral vascular disease: An observational analysis from the National Inpatient Sample.

Objective Percutaneous revascularization for patients with peripheral arterial disease has become a treatment of choice for many symptomatic patients. The presence of severe arterial calcification presents many challenges for successful revascularization. Atherectomy is an adjunctive treatment option for patients with severe calcification undergoing percutaneous intervention. We sought to analyze the impact of atherectomy on in-hospital outcomes, length of stay, and cost in the percutaneous treatment of peripheral arterial disease. Methods Patients with lower extremity peripheral arterial disease undergoing percutaneous revascularization were assessed, utilizing the National Inpatient Sample (2012-2014) and appropriate International Classification of Diseases, 9th Revision, Clinical Modification diagnostic and procedural codes. Patients who were not treated with atherectomy ( n = 51,037) were compared to those treated with atherectomy ( n = 11,408). Propensity score-matched analysis was performed to address baseline differences. Results After performing propensity score-matched analysis, 11,037 patients were included in each group. Utilization of atherectomy was associated with lower in-hospital mortality (2% vs. 1.4% p = 0.0006). All secondary outcomes were lower when using atherectomy except acute renal failure. Length of stay was slightly lower when using atherectomy (7.2 vs. 7.0 days, p = 0.0494). However, median cost was higher in patients treated with atherectomy ($21,589 vs. $24,060, p = <0.0001). Conclusion The use of atherectomy was associated with significantly decreased in-hospital mortality, adverse events, and length of stay. Though, cost associated with atherectomy use is increased, this is offset by decreased in-hospital adverse outcomes. Appropriate use of atherectomy devices is an important tool in revascularization of peripheral arterial disease in select patients.

Determinants of high device cost in current percutaneous coronary interventions.

BACKGROUND: Percutaneous coronary interventions (PCI), especially medical devices, consume large amounts of medical resources. It is important to know which type of lesions requires high device costs among current PCI. The purpose of this study was to investigate the association between lesion characteristics and medical device costs in current PCI. METHODS: We identified 593 coronary artery lesions in our PCI database between January 1, 2015 and December 31, 2015. The total PCI cost was calculated for each lesion. The highest quartile (Q1) of total PCI costs was defined as the highest cost group, whereas the other quartiles (Q2, Q3, Q4) were defined as the low-intermediate cost group. RESULTS: The mean PCI cost in the highest cost and low-intermediate cost groups was ¥1,032,943 ±â€¯211,912 and ¥532,547 ±â€¯112,127, respectively. In a multivariate logistic regression analysis, lesion length (10 mm increase: OR 2.93, 95% CI 2.25-3.82, P < 0.001), left main lesion (OR 2.96, 95% CI 1.02-8.60, P = 0.046), moderate to severe calcification (OR 16.43, 95% CI 7.97-33.88, P < 0.001), chronic total occlusion (CTO) (OR 5.83, 95% CI 2.07-16.39, P = 0.001), and bifurcation (OR 2.01, 95% CI 1.08-3.75, P = 0.027) were significantly associated with the highest cost group. CONCLUSIONS: Lesion characteristics including CTO, diffuse long lesion, calcification, and bifurcation were significantly associated with the highest device cost. Non-CTO complex lesions including bifurcation and calcification as well as CTO lesions require higher PCI device costs than non-complex lesions.

Cost-effectiveness of orbital atherectomy compared to rotational atherectomy in treating patients with severely calcified coronary artery lesions in Japan.

Compared to rotational atherectomy (RA), orbital atherectomy (OA) has been shown to decrease procedure failure and reintervention rates in the treatment of severely calcified coronary artery lesions. Our objective was to explore the cost-effectiveness of OA compared to RA in the Japanese healthcare system. A decision-analytic model calculated reintervention rates and consequent total 1-year costs. Effectiveness inputs were therapy-specific target lesion revascularization (TLR) rates and all-cause mortality, pooled from clinical studies. Index and reintervention costs were determined based on claims data analysis of n = 33,628 subjects treated in 2014-2016. We computed incremental cost-effectiveness in Japanese Yen (JPY) per life year (LY) gained based on differences in 1-year cost and projected long-term survival, assuming OA device cost between JPY 350,000 and ​JPY 550,000. OA was found to be associated with improved clinical outcomes (12-month TLR rate 5.0 vs. 15.7%) and projected survival gain (8.34 vs. 8.16 LYs (+0.17), based on 1-year mortality of 5.5 vs. 6.8%). Total 1-year costs were lower for device cost of JPY 430,000 or less, and reached a maximum ICER of JPY 753,445 per LY at the highest assumed device cost, making OA dominant or cost-effective across the tested range, at ICERs substantially below the willingness-to-pay threshold. In conclusion, orbital atherectomy for the treatment of severely calcified coronary artery lesions, compared to rotational atherectomy, is a cost-effective treatment approach in the Japanese healthcare system due to improved clinical performance.

Implications of Coronary Artery Calcium Testing for Treatment Decisions Among Statin Candidates According to the ACC/AHA Cholesterol Management Guidelines: A Cost-Effectiveness Analysis.

This review evaluates the cost-effectiveness of using coronary artery calcium (CAC) to guide long-term statin therapy compared with treating all patients eligible for statins according to 2013 American College of Cardiology/American Heart Association cholesterol management guidelines for atherosclerotic cardiovascular disease. The authors used a microsimulation model to compare costs and effectiveness from a societal perspective over a lifetime horizon. Both strategies resulted in similar costs and quality-adjusted life years (QALYs). CAC resulted in increased costs (+$81) and near-equal QALY (+0.01) for an incremental cost-effectiveness ratio of $8,100/QALY compared with the treat-all strategy. For 10,000 patients, the treat-all strategy would theoretically avert 21 atherosclerotic cardiovascular disease events, but would add 47,294 person-years of statins. With CAC costs <$100, and higher cost and/or disutility associated with statin therapy, CAC strategy was favored. These findings suggest the economic value of both approaches were similar. Clinicians should account for individual preferences in context of shared decision making when choosing the most appropriate strategy to guide statin decisions.

Cost-effectiveness analysis of the orbital atherectomy system: Two-year follow-up.

BACKGROUND: The presence of coronary artery calcification is associated with a significant burden of coronary artery disease along with being a predictor of increased adverse ischemic events. The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a novel device designed to facilitate treatment of calcified lesions. This study aimed to evaluate the cost-effectiveness of OAS compared to standard treatment. METHODS: A decision tree model utilizing ORBIT II clinical trial and Medicare data from the health system perspective was constructed. Target population was U.S. patients age≥65 with coronary atherosclerosis due to a calcified coronary lesion, both inpatients and outpatients, and combined over a time horizon of two years for costs and lifetime for mortality. OAS was compared to standard treatment (use of balloon angioplasty to prepare stent-placement site). Outcomes were costs of index event and target vessel revascularization in two years, life-years gained, and incremental cost-effectiveness ratios (ICERs). RESULTS: On average, OAS was projected to cost $1702 less than standard treatment for inpatients, $2360 more than standard treatment for outpatients, and $959 more than standard treatment overall; the projected mortality reduction implies 0.41 life-years gained. Compared to standard treatment, OAS was dominant in an inpatient setting, had an ICER of $5759 per QALY in the outpatient setting, and had an ICER of $2340 per QALY overall. These ICERs are below the accepted threshold for highly cost-effective interventions of $50,000 per QALY. CONCLUSIONS: Compared to standard treatment, OAS is likely to be cost-effective and was projected to be cost-saving in an inpatient setting. SUMMARY: A decision tree from the health system perspective was used to evaluate the cost-effectiveness of Diamondback 360® Coronary Orbital Atherectomy System (OAS), a novel device designed to facilitate treatment of calcified lesions. OAS was projected to cost $1702 less than standard treatment for inpatients, $2360 more than standard treatment for outpatients, and $959 more than standard treatment overall; the projected mortality reduction implies 0.41 life-years gained. Compared to standard treatment, OAS was dominant in an inpatient setting, had an ICER of $5759 per QALY in the outpatient setting, and overall had an ICER of $2340 per QALY.

Ultra low-dose chest ct with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery (CRICKET study): Rationale and design of a multicenter randomized trial.

BACKGROUND: Stroke after cardiac surgery is a severe complication with a persistently high incidence of 1.4 - 9.7%. Postoperative strokes are mainly embolic and can be provoked by manipulation and clamping of the aorta during cardiac surgery, resulting in the mobilization of atherothrombotic material and calcifications from the aortic wall. Computed tomography (CT) can offer preoperative visualization of aortic calcifications with low radiation exposure. We hypothesize that preoperative knowledge regarding the location and extent of aortic calcifications can be used to optimize surgical strategy and decrease postoperative stroke rate. METHODS/DESIGN: The CRICKET study (ultra low-dose chest CT with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery) is a prospective multicenter randomized clinical trial to evaluate whether non-contrast chest CT before cardiac surgery can decrease postoperative stroke rate by optimizing surgical strategy. Patients scheduled to undergo cardiac surgery aged 18 years and older are eligible for inclusion. Exclusion criteria are pregnancy, a chest/cardiac CT in the past three months, emergency surgery, concomitant or prior participation in a study with ionizing radiation and unwillingness to be informed about incidental findings. Subjects (n = 1.724) are randomized between routine care, including a chest x-ray, or routine care with an additional low dose chest CT. The primary objective is to investigate whether the postoperative in-hospital stroke rate is reduced in the CT arm compared to the routine care arm of the randomized trial. The secondary outcome measures are altered surgical approach based on CT findings and cost-effectiveness.

The clinical and cost burden of coronary calcification in a Medicare cohort: An economic model to address under-reporting and misclassification.

BACKGROUND: Coronary artery calcification (CAC) is a well-established risk factor for the occurrence of adverse ischemic events. However, the economic impact of the presence of CAC is unknown. OBJECTIVES: Through an economic model analysis, we sought to estimate the incremental impact of CAC on medical care costs and patient mortality for de novo percutaneous coronary intervention (PCI) patients in the 2012 cohort of the Medicare elderly (≥65) population. METHODS: This aggregate burden-of-illness study is incidence-based, focusing on cost and survival outcomes for an annual Medicare cohort based on the recently introduced ICD9 code for CAC. The cost analysis uses a one-year horizon, and the survival analysis considers lost life years and their economic value. RESULTS: For calendar year 2012, an estimated 200,945 index (de novo) PCI procedures were performed in this cohort. An estimated 16,000 Medicare beneficiaries (7.9%) were projected to have had severe CAC, generating an additional cost in the first year following their PCI of $3500, on average, or $56 million in total. In terms of mortality, the model projects that an additional 397 deaths would be attributable to severe CAC in 2012, resulting in 3770 lost life years, representing an estimated loss of about $377 million, when valuing lost life years at $100,000 each. CONCLUSIONS: These model-based CAC estimates, considering both moderate and severe CAC patients, suggest an annual burden of illness approaching $1.3 billion in this PCI cohort. The potential clinical and cost consequences of CAC warrant additional clinical and economic attention not only on PCI strategies for particular patients but also on reporting and coding to achieve better evidence-based decision-making.

Trends of elevated parathormone serum titers in hemodialysis patients on intensive therapy for bone disease: a multicenter study.

To determine the prevalence of controlled parathyroid hormone (PTH) serum levels with intensified therapy for chronic kidney disease mineral and bone disorder (CKD-MBD) in the dialysis population, we studied 563 chronic hemodialysis patients recruited from three different dialysis centers from three different major cities in the Kingdom of Saudi Arabia. The trend of the routine monthly chemistries related to CKD-MBD was evaluated besides the whole-molecule PTH serum levels over 28 months (January 2011 to April 2013). The cost ratios of the medications to the estimated dialysis total cost were calculated. There were 323 (57.4%) males in the study, and the mean age of the patients was 50.2±15.2 years; 371 (65.9%) patients were initiated on dialysis before 2011. The causes of the original kidney disease included diabetes mellitus in 163 (29%) patients. Parathyroidectomy was performed in 23 (4.1%) patients and only six (23%) patients underwent the operation during the study period; most of the parathyroidectomies (69%) were performed before 2011. The trend of the medians of monthly serum levels of calcium, phosphorus, albumin, bicarbonate, alkaline phosphatase, serum levels of PTH and vitamin D25 assays showed better control of the levels with time. The added cost of cinacalcet was more significant than the other drugs, including vitamin D and phosphate binders, but the cost was minimal in comparison with the whole dialysis bill. The ratios of the discontinuation rates to the total patient-months of treatment for the different drugs were in the range of 3-4% and mostly due to transient overdosing of medications. We conclude that the trends of the median serum levels of PTH and related minerals in the CKD patients in our dialysis patients suggested a good inclination toward control and prevention of the vascular calcifications prevalent in the CKD-MBD. The popularity of use of new drugs such as cinacalcet is promising and does not seem to add much to the current out-patient cost of chronic dialysis.

Coronary computed tomography as a cost-effective test strategy for coronary artery disease assessment - a systematic review.

Cardiovascular imaging imparts a huge burden on healthcare spending. Coronary CT angiography (CCTA) may provide a cost effective means of diagnosing coronary artery disease (CAD) and reducing downstream cost of testing. We performed a systematic search of literature for randomized controlled trials or prospective or retrospective non-randomized comparative studies or case series, decision analytic models and technology reports in which some or all of the patients underwent CCTA and looking at the cost effectiveness, comparative effectiveness and downstream test utilization associated with the use of CCTA. We found 42 articles matching our criteria. CCTA either as first line or as a layering test may represent a cost effective strategy for initial evaluation of patients with CAD prevalence of 10%-50% in both near-term and long-term diagnostic periods. For CAD prevalence ≥70%, ICA as initial test may represent cost effective strategy for diagnosis of stable chest pain. CCTA may represent cost-effective strategy when performed as a layering test to equivocal initial stress imaging before performing ICA. Use of CCTA is cost- and time-effective strategy for evaluation of low risk (<30% CAD prevalence) acute chest pain patients in emergency department and can be used for safe exclusion of acute coronary syndrome (ACS). Use of coronary calcium score as an initial test may require further evidence to be deemed cost-effective strategy. CCTA may represent a cost effective and may be associated with less downstream testing for diagnosis of stable chest pain patients in low to intermediate risk patients whereas for low risk acute chest pain patients, use of CCTA is associated with expedited patient management, less cost and safe exclusion of ACS.

A comparison of Diamond Forrester and coronary calcium scores as gatekeepers for investigations of stable chest pain.

To determine if calcium scores (CS) could act as a more effective gatekeeper than Diamond Forrester (DF) in the assessment of patients with suspected coronary artery disease (CAD). A sub-study of the Cardiac CT for the Assessment of Chest Pain and Plaque (CAPP) study, a randomised control trial evaluating the cost-effectiveness of cardiac CT in symptomatic patients with stable chest pain. Stable pain was defined as troponin negative pain without symptoms of unstable angina. 250 patients undergoing cardiac CT had both DF scores and CS calculated, with the accuracy of both evaluated against CT coronary angiogram. Criteria given in UK national guidelines were compared. Of the 250 patients, 4 withdrew. 140 (57 %) patients were male. The mean DF was 47.8 and mean CS 172.5. Of the 144 patients with non-anginal pain 19.4 % had significant disease (>50 % stenosis). In general the DF over estimated the presence of CAD whereas the CS reclassified patients to lower risk groups, with 91 in the high risk DF category compared to 26 in the CS. Both receiver operating curve and McNemar Bowker test analysis suggested the DF was less accurate in the prediction of CAD compared to CS [Formula: see text] Projected downstream investigations were also calculated, with the cost per number of significant stenoses identified cheaper with the CS criteria. Patients with suspected stable CAD are more accurately risk stratified by CS compared to the traditional DF. CS was more successful in the prediction of significant stenosis and appears to be more effective at targeting clinical resources to those patients that are in need of them.

An evidence-based guide for coronary calcium scoring in asymptomatic patients without coronary heart disease.

As public awareness and clinical use of CAC screening increases, physicians should, at a minimum, know the following information: 1) The presence of CAC indicates underlying CHD but does not predict luminal obstruction. 2) Non-contrast, prospectively ECG-gated cardiac EBCT and MDCT are sensitive, reproducible, rapid, and essentially equivalent imaging techniques commonly used to screen for CAC. 3) Currently, CAC screening is appropriate for all intermediate- risk patients and low-risk patients with a family history of premature CHD, and might be appropriate for all low-risk women. 4) The risks associated with CAC screening are a small but measurable excess risk of cancer and the risk of unnecessary downstream tests and procedures. 5) A CAC score of zero has a very high negative predictive value for CHD events. 6) Increasingly positive (non-zero) CAC scores are directly proportional to increased CHD event risk, and a CAC score >100 or greater than the 75th percentile indicates high risk. 7) Repeat screening to determine CAC progression or regression is not currently recommended.

Treating calcific aortic stenosis: an evolving science.

Calcific aortic stenosis is a common valvular disease, but its pathophysiology remains undetermined and important considerations exist for treatment. Pathophysiology, treatment by the advanced practice nurse, and literature review are discussed in the context of a case study.