Early-stage health technology assessment of fractional flow reserve coronary computed tomography versus standard diagnostics in patients with stable chest pain in The Netherlands.

OBJECTIVES: The aim of this early-stage Health Technology Assessment (HTA) was to assess the difference in healthcare costs and effects of fractional flow reserve derived from coronary computed tomography (FFRct) compared to standard diagnostics in patients with stable chest pain in The Netherlands. METHODS: A decision-tree model was developed to assess the difference in total costs from the hospital perspective, probability of correct diagnoses, and risk of major adverse cardiovascular events at one year follow-up. One-way sensitivity analyses were conducted to determine the main drivers of the cost difference between the strategies. A threshold analysis on the added price of FFRct analysis (computational analysis only) was conducted. RESULTS: The mean one-year costs were €2,680 per patient for FFRct and €2,915 per patient for standard diagnostics. The one-year probability of correct diagnoses was 0.78 and 0.61, and the probability of major adverse cardiovascular events was 1.92x10-5 and 0.01, respectively. The probability and costs of revascularization and the specificity of coronary computed tomography angiography had the greatest effect on the difference in costs between the strategies. The added price of FFRct analysis should be below €935 per patient to be considered the least costly option. CONCLUSIONS: The early-stage HTA findings suggest that FFRct may reduce total healthcare spending, probability of incorrect diagnoses, and major adverse cardiovascular events compared to current diagnostics for patients with stable chest pain in the Dutch healthcare setting over one year. Future cost-effectiveness studies should determine a value-based pricing for FFRct and quantify the economic value of the anticipated therapeutic impact.

Artificial intelligence in Medicare: utilization, spending, and access to AI-enabled clinical software.

OBJECTIVES: In 2018, CMS established reimbursement for the first Medicare-covered artificial intelligence (AI)-enabled clinical software: CT fractional flow reserve (FFRCT) to assist in the diagnosis of coronary artery disease. This study quantified Medicare utilization of and spending on FFRCT from 2018 through 2022 and characterized adopting hospitals, clinicians, and patients. STUDY DESIGN: Analysis, using 100% Medicare fee-for-service claims data, of the hospitals, clinicians, and patients who performed or received coronary CT angiography with or without FFRCT. METHODS: We measured annual trends in utilization of and spending on FFRCT among hospitals and clinicians from 2018 through 2022. Characteristics of FFRCT-adopting and nonadopting hospitals and clinicians were compared, as well as the characteristics of patients who received FFRCT vs those who did not. RESULTS: From 2018 to 2022, FFRCT billing volume in Medicare increased more than 11-fold (from 1083 to 12,363 claims). Compared with nonbilling hospitals, FFRCT-billing hospitals were more likely to be larger, part of a health system, nonprofit, and financially profitable. FFRCT-billing clinicians worked in larger group practices and were more likely to be cardiac specialists. FFRCT-receiving patients were more likely to be male and White and less likely to be dually enrolled in Medicaid or receiving disability benefits. CONCLUSIONS: In the initial 5 years of Medicare reimbursement for FFRCT, growth was concentrated among well-resourced hospitals and clinicians. As Medicare begins to reimburse clinicians for the use of AI-enabled clinical software such as FFRCT, it is crucial to monitor the diffusion of these services to ensure equal access.

Prospective Clinical Trial Comparing IV Esmolol to IV Metoprolol in CT Coronary Angiography: Effect on Hemodynamic, Technical Parameters and Cost.

BACKGROUND: Intravenous [IV] esmolol, an alternative to IV metoprolol for coronary computed tomography angiography [CCTA], has shorter half-life that decreases the risk of prolonged hypotension. The primary aim was to prospectively compare IV esmolol alone to IV metoprolol alone for effectiveness in achieving heart rate [HR] of 60 beats per minute[bpm] during CCTA. The secondary aim was to compare hemodynamic response, image quality, radiation dose and cost. MATERIALS AND METHODS: Institutional Review Board approved prospective randomized study of 28 CCTA patients medicated in a 1:1 blinded match with IV esmolol or IV metoprolol to achieve HR of 60 bpm. Serial hemodynamic response was measured at 6 specified times. Two cardiac radiologists independently scored the image quality. RESULTS: Both IV esmolol and IV metoprolol achieved the target HR. IV esmolol resulted in significantly less profound and shorter duration of reduction in systolic blood pressure [BP] than IV metoprolol with a difference of -10, -14 and -9 mm Hg compared to -20, -26 and -25 mmHg at 2, 15 & 30 min respectively. No significant difference in HR at image acquisition, exposure window, radiation dose and image quality. Although IV esmolol was expensive, the overall cost of care was comparable to IV metoprolol due to shortened post CCTA observation period consequent to faster restoration of hemodynamic status. CONCLUSION: Comparison of IV esmolol and IV metoprolol demonstrate that both are effective in achieving the target HR but significantly faster recovery of HR and BP in patients who receive IV esmolol was found.

Real-world clinical and cost analysis of CT coronary angiography and CT coronary angiography-derived fractional flow reserve (FFRCT)-guided care in the National Health Service.

AIM: To quantify the real-world clinical and cost impact of computed tomography (CT) coronary angiography (CTCA)-derived fractional flow reserve (FFRCT) in the National Health Service (NHS). MATERIALS AND METHODS: Consecutive clinical CTCA examinations from September to December 2018 with ≥1 stenosis of ≥25% underwent FFRCT analysis. The Heart Team reviewed clinical data and CTCA findings, blinded to FFRCT values, and documented hypothetical consensus management. FFRCT results were then unblinded and hypothetical consensus management re-recorded. Diagnostic waiting times for management pathways were estimated. A per-patient cost analysis for diagnostic certainty regarding coronary artery disease (CAD) management was performed using 2014-2020 NHS tariffs for pre- and post-FFRCT pathways. RESULTS: Two hundred and fifty-one CTCAs were performed during the study period. Fifty-seven percent (145/251) had no CAD or stenosis <25%. One study was non-diagnostic. Of the remaining 42% (105/251), two were ineligible for FFRCT and there was a 5% (5/103) failure rate. FFRCT led to a change in hypothetical management in 65% (64/98; p<0.001) patients with a functional imaging test cancelled in 17% (17/98) and a diagnostic angiogram cancelled in 47% (46/98). FFRCT-guided management had a reduced mean time to definitive investigation compared with CTCA alone (28 ± 4 versus 44 ± 4 days; p=0.004). Using the proposed 2020/21 tariff, CTCA + FFRCT for stenosis ≥50% resulted in a diagnostic pathway £44.97 more expensive per patient than usual care without FFRCT. CONCLUSIONS: In the real-world NHS setting, FFRCT-guided management has the potential to rationalise patient management, accelerate diagnostic pathways, and depending on the stenosis severity modelled, may be cost-effective.

Cost-effectiveness of Radial Access Percutaneous Coronary Intervention in Acute Coronary Syndrome.

Clinical trials have shown that radial access percutaneous coronary intervention (PCI) is associated with improved patient outcomes compared to femoral artery access. However, few studies have evaluated the cost-effectiveness of radial access PCI. This analysis sought to evaluate the cost-effectiveness of transradial versus transfemoral access PCI for patients with acute coronary syndrome (ACS) using data from the Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) trial. A decision analytic Markov model was constructed from an Australian health care perspective with a 2 year time horizon. The model simulated recurrent cardiovascular disease and death post PCI among a hypothetical cohort of 1000 individuals with ACS. Population and efficacy data were based on the MATRIX trial. Cost and utility data were drawn from published sources. Over a 2-year time horizon, radial access was predicted to save 12 (discounted) quality adjusted life years (QALYs) compared with femoral access PCI. Cost savings (discounted) amounted to AUD $51,305. Hence from a health economic point of view, radial access PCI was dominant over femoral access PCI. Sensitivity analyses supported the robustness of these findings. Radial access PCI is likely to be associated with both better outcomes and lower costs compared to femoral access PCI over 2 years post procedure. In conclusion, these findings support radial access being the preferred approach in PCI for ACS.

Appropriate utilization of cardiac computed tomography for the assessment of stable coronary artery disease.

BACKGROUND: Appropriate use criteria (AUC) have been developed in response to growth in cardiac imaging utilization and concern regarding associated costs. Cardiac computed tomography angiography (CCTA) has emerged as an important modality in the evaluation of coronary artery disease, however its appropriate utilization in actual practice is uncertain. Our objective was to determine the appropriate utilization of CCTA in a large quaternary care institution and to compare appropriate utilization pre and post publication of the 2013 AUC guidelines. We hypothesized that the proportion of appropriate CCTA utilization will be similar to those of other comparable cardiac imaging modalities and that there would be a significant increase in appropriate use post AUC publication. METHODS: We employed a retrospective cohort study design of 2577 consecutive patients undergoing CCTA between January 1, 2012 and December 30, 2016. An appropriateness category was assigned for each CCTA. Appropriateness classifications were compared pre- and post- AUC publication via the chi-square test. RESULTS: Overall, 83.5% of CCTAs were deemed to be appropriate based on the AUC. Before the AUC publication, 75.0% of CCTAs were classified as appropriate whereas after the AUC publication, 88.0% were classified as appropriate (p < 0.001). The increase in appropriate utilization, when extrapolated to the Medicare population of the United States, was associated with potential cost savings of approximately $57 million per year. CONCLUSIONS: We report a high rate of appropriate use of CCTA and a significant increase in the proportion of CCTAs classified as appropriate after the AUC publication.

Combined stress myocardial CT perfusion and coronary CT angiography as a feasible strategy among patients presenting with acute chest pain to the emergency department.

BACKGROUND: A combined approach of myocardial CT perfusion (CTP) with coronary CT angiography (CTA) was shown to have better diagnostic accuracy than coronary CTA alone. However, data on cost benefits and length of stay when compared to other perfusion imaging modalities has not been evaluated. Therefore, we aim to perform a feasibility study to assess direct costs and length of stay of a combined stress CTP/CTA and use SPECT myocardial perfusion imaging (SPECT-MPI) as a benchmark, among chest pain patients at intermediate-risk for acute coronary syndrome (ACS) presenting to the emergency department (ED). METHODS: This is a prospective two-arm clinical trial (NCT02538861) with 43 patients enrolled in stress CTP/CTA arm (General Electric Revolution CT) and 102 in SPECT-MPI arm. Mean age of the study population was 65 â€‹± â€‹12 years; 56% were men. We used multivariable linear regression analysis to compare length of stay and direct costs between the two modalities. RESULTS: Overall, 9 out of the 43 patients (21%) with CTP/CTA testing had an abnormal test. Of these 9 patients, 7 patients underwent invasive coronary angiography and 6 patients were found to have obstructive coronary artery disease. Normal CTP/CTA test was found in 34 patients (79%), who were discharged home and all patients were free of major adverse cardiac events at 30 days. The mean length of stay was significantly shorter by 28% (mean difference: 14.7 â€‹h; 95% CI: 0.7, 21) among stress CTP/CTA (20 â€‹h [IQR: 16, 37]) compared to SPECT-MPI (30 â€‹h [IQR: 19, 44.5]). Mean direct costs were significantly lower by 44% (mean difference: $1535; 95% CI: 987, 2082) among stress CTA/CTP ($1750 [IQR: 1474, 2114] compared to SPECT-MPI ($2837 [IQR: 2491, 3554]). CONCLUSION: Combined stress CTP/CTA is a feasible strategy for evaluation of chest pain patients presenting to ED at intermediate-risk for ACS and has the potential to lead to shorter length of stay and lower direct costs.

Coronary risk of patients with valvular heart disease: prospective validation of CT-Valve Score.

OBJECTIVE: To prospectively validate the CT-Valve score, a new risk score designed to identify patients with valvular heart disease at a low risk of coronary artery disease (CAD) who could benefit from multislice CT (MSCT) first instead of coronary angiography (CAG). METHODS: This was a prospective cohort study of patients referred for valve surgery in the Capital Region of Denmark and Odense University Hospital from the 1 February 2015 to the 1 February 2017. MSCT was implemented for patients with a CT-Valve score ≤7 at the referring physician's discretion. Patients with a history of CAD or chronic kidney disease were excluded. The primary outcome was the proportion of patients needing reevaluation with CAG after MSCT and risk of CAD among the patients determined to be low to intermediate risk. RESULTS: In total, 1149 patients were included. The median score was 9 (IQR 3) and 339 (30%) had a score ≤7. MSCT was used for 117 patients. Of these 29 (25%) were reevaluated and 9 (7.7%) had CAD. Of the 222 patients with a score ≤7 that did not receive an MSCT, 14 (6%) had significant CAD. The estimated total cost of evaluation among patients with a score ≤7 before implementation was €132 093 compared with €79 073 after, a 40% reduction. Similarly, estimated total radiation before and after was 608 mSv and 362 mSv, a 41% reduction. Follow-up at a median of 32 months (18-48) showed no ischaemic events for patients receiving only MSCT. CONCLUSION: The CT-Valve score is a valid method for determining risk of CAD among patients with valvular heart disease. Using a score ≤7 as a cut-off for the use of MSCT is safe and cost-effective.

Cardiac-CT and cardiac-MR cost-effectiveness: a literature review.

Cardiovascular diseases are still among the first causes of death worldwide with a huge impact on healthcare systems. Within these conditions, the correct diagnosis of coronary artery disease with the most appropriate imaging-based evaluations is of utmost importance. The sustainability of the healthcare systems, considering the high economic burden of modern cardiac imaging equipments, makes cost-effective analysis an important tool, currently used for weighing different costs and health outcomes, when policy makers have to allocate funds and to prioritize interventions, getting the most out of their financial resources. This review aims at evaluating cost-effective analysis in the more recent literature, focused on the role of Calcium Score, coronary computed tomography angiography and cardiac magnetic resonance.

Cost-effectiveness for imaging stable ischemic disease.

Stable ischemic heart disease remains a major cause of morbidity and mortality. Although there are multiple imaging modalities to diagnose and/or assist in the clinical management, the most cost-effective approach remains unclear. We reviewed the relevant and recent evidence-based clinical studies and trials to suggest the most cost-effective approach to stable ischemic heart disease. The limitations of these studies are discussed. Incorporating the results of recent multicenter trials, we suggest that for appropriate patients with coronary artery disease with any degree of stenosis or presence of coronary calcium, optimal medical therapy may be most cost-effective. Invasive coronary angiography and/or coronary revascularization would be primarily for non-responders or >/=50% left main stenosis. Stress cardiac magnetic imaging would be performed for those patients with non-diagnostic coronary CT angiography from motion and non-responders from optimal medical therapy in non-diagnostic coronary CT angiography group from high coronary calcium. These paths seem to be safe and cost-effective but requires modeling for confirmation.

Clinical and Economic Implications of Inconclusive Noninvasive Test Results in Stable Patients With Suspected Coronary Artery Disease: Insights From the PROMISE Trial.

BACKGROUND: Inconclusive noninvasive tests complicate the care of patients with suspected coronary artery disease, but their prevalence and impact on management, outcomes, and costs are not well described. METHODS: PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) patients were randomized to stress testing (n=4533) or computed tomographic angiography (CTA; n=4677). We assessed relationships between inconclusive results, subsequent testing, a composite outcome (death, myocardial infarction, or hospitalization for unstable angina), and healthcare expenditures. RESULTS: Overall, 8.0% of tests were inconclusive (9.7% stress, 6.4% CTA). Compared with negative tests, inconclusive tests were more often referred to a second noninvasive test (stress: 14.6% versus 8.5%, odds ratio [OR], 1.91; CTA: 36.5% versus 8.4%, OR, 5.95; P<0.001) and catheterization (stress: 5.5% versus 2.4%, OR, 2.36; CTA: 23.4% versus 4.1%, OR, 6.49; P<0.001), and composite outcomes were higher for both inconclusive tests (stress: 3.7% versus 2.0%, hazard ratio, 1.81, P=0.034; CTA: 5.0% versus 2.2%, hazard ratio, 1.85; P=0.044) and positive tests (stress: 8.3% versus 2.0%, hazard ratio, 3.50; CTA: 9.2% versus 2.2%, hazard ratio, 3.66; P<0.001). Twenty-four-month costs were higher for inconclusive tests than negative tests by $2905 (stress) and $4030 (CTA). CONCLUSIONS: Among patients with stable chest pain undergoing a noninvasive test, inconclusive results occurred in 6% of CTA and 10% of stress tests. Compared with those with conclusive negative tests, individuals with inconclusive results more often underwent subsequent testing, had increased medical costs, and experienced worse outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01174550.

Contemporary trend of acute kidney injury incidence and incremental costs among US patients undergoing percutaneous coronary procedures.

OBJECTIVES: To assess national trends of acute kidney injury (AKI) incidence, incremental costs, risk factors, and readmissions among patients undergoing coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) during 2012-2017. BACKGROUND: AKI remains a serious complication for patients undergoing CAG/PCI. Evidence is lacking in contemporary AKI trends and its impact on hospital resource utilization. METHODS: Patients who underwent CAG/PCI procedures in 749 hospitals were identified from Premier Healthcare Database. AKI was defined by ICD-9/10 diagnosis codes (584.9/N17.9, 583.89/N14.1, 583.9/N05.9, E947.8/T50.8X5) during 7 days post index procedure. Multivariable regression models were used to adjust for confounders. RESULTS: Among 2,763,681 patients, AKI incidence increased from 6.0 to 8.4% or 14% per year in overall patients; from 18.0 to 28.4% in those with chronic kidney disease (CKD) and from 2.4 to 4.2% in those without CKD (all p < .001). Significant risk factors for AKI included older age, being uninsured, inpatient procedures, CKD, anemia, and diabetes (all p < .001). AKI was associated with higher 30-day in-hospital mortality (ORadjusted = 2.55; 95% CI: 2.40, 2.70) and readmission risk (ORadjusted = 1.52; 95% CI: 1.50, 1.55). The AKI-related incremental cost during index visit and 30-day readmissions were estimated to be $8,416 and $580 per inpatient procedure and $927 and $6,145 per outpatient procedure. Overall excess healthcare burden associated with AKI was $1.67 billion. CONCLUSIONS: AKI incidence increased significantly in this large, multifacility sample of patients undergoing CAG/PCI procedures and was associated with substantial increase in hospital costs, readmissions, and mortality. Efforts to reduce AKI risk in US healthcare system are warranted.

In-Hospital Cost Comparison of Triple-Rule-Out Computed Tomography Angiography Versus Standard of Care in Patients With Acute Chest Pain.

PURPOSE: The purpose of this study was to evaluate the utilization of invasive and noninvasive tests and compare cost in patients presenting with chest pain to the emergency department (ED) who underwent either triple-rule-out computed tomography angiography (TRO-CTA) or standard of care. MATERIALS AND METHODS: We performed a retrospective single-center analysis of 2156 ED patients who presented with acute chest pain with a negative initial troponin and electrocardiogram for myocardial injury. Patient cohorts matched by patient characteristics who had undergone TRO-CTA as a primary imaging test (n=1139) or standard of care without initial CTA imaging (n=1017) were included in the study. ED visits, utilization of tests, and costs during the initial episode of hospital care were compared. RESULTS: No significant differences in the diagnosis of coronary artery disease, pulmonary embolism, or aortic dissection were observed. Median ED waiting time (4.5 vs. 7.0 h, P<0.001), median total length of hospital stay (5.0 vs. 32.0 h, P<0.001), hospital admission rate (12.6% vs. 54.2%, P<0.001), and ED return rate to our hospital within 30 days (3.5% vs. 14.6%, P<0.001) were significantly lower in the TRO-CTA group. Moreover, reduced rates of additional testing and invasive coronary angiography (4.9% vs. 22.7%, P<0.001), and ultimately lower total cost per patient (11,783$ vs. 19,073$, P<0.001) were observed in the TRO-CTA group. CONCLUSIONS: TRO-CTA as an initial imaging test in ED patients presenting with acute chest pain was associated with shorter ED and hospital length of stay, fewer return visits within 30 days, and ultimately lower ED and hospitalization costs.

Assessing the value of coronary artery computed tomography as the first-line anatomical test for stable patients with indications for invasive angiography due to suspected coronary artery disease. Initial cost analysis in the CAT-CAD randomized trial.

BACKGROUND: Clinical and safety outcomes of the strategy employing coronary computed tomography angiography (CCTA) as the first-choice imaging test have recently been demonstrated in the recently published CAT-CAD randomized, prospective, single-center study. Based on prospectively collected data in this patient population, we aimed to perform an initial cost analysis of this approach. METHODS: 120 participants of the CAT-CAD trial (age:60.6 ±â€¯7.9 years, 35% female) were included in the analysis. We analyzed medical resource use during the diagnostic and therapeutic episode of care. We prospectively estimated the cumulative cost for each strategy by multiplying the number of resources by standardized costs in accordance to medical databases and the 2015 Procedural Reimbursement Payment Guide. RESULTS: The total cost of coronary artery disease (CAD) diagnosis was significantly lower in the CCTA group as compared to the direct invasive coronary angiography (ICA) group ($50,176 vs $137,032) with corresponding per-patient cost of $836 vs $2,284, respectively. Similarly, the entire diagnostic and therapeutic episode of care was significantly less expensive in the CCTA group ($227,622 vs $502,827) with corresponding per-patient cost of $4630 vs $8,380, respectively. Overall, the application of CCTA as a first-line diagnostic test in stable patients with indications to ICA resulted in a 63% reduction of CAD diagnosis costs and a 55% reduction composite of diagnosis and treatment costs during 90-days follow-up. CONCLUSIONS: Application of CCTA as the first-line anatomic test in patients with suspected significant CAD decreased the total costs of diagnosis. This is likely attributable to reduced numbers of invasive tests and hospitalisations. Initial cost analysis of the CAT-CAD randomized trial suggests that this approach may provide significant cost savings for the entire health system.

Long-term health outcomes and cost-effectiveness of coronary CT angiography in patients with suspicion for acute coronary syndrome.

BACKGROUND: Randomized trials have shown favorable clinical outcomes for coronary CT angiography (CTA) in patients with suspected acute coronary syndrome (ACS). Our goal was to estimate the cost-effectiveness of coronary CTA as compared to alternative management strategies for ACP patients over lifetime. METHODS: Markov microsimulation model was developed to compare cost-effectiveness of competitive strategies for ACP patients: 1) coronary CTA, 2) standard of care (SOC), 3) AHA/ACC Guidelines, and 4) expedited emergency department (ED) discharge protocol with outpatient testing. ROMICAT-II trial was used to populate the model with low to intermediate risk of ACS patient data, whereas diagnostic test-, treatment effect-, morbidity/mortality-, quality of life- and cost data were obtained from the literature. We predicted test utilization, costs, 1-, 3-, 10-year and over lifetime cardiovascular morbidity/mortality for each strategy. We determined quality adjusted life years (QALY) and incremental cost-effectiveness ratio. Observed outcomes in ROMICAT-II were used to validate the short-term model. RESULTS: Estimated short-term outcomes accurately reflected observed outcomes in ROMICAT-II as coronary CTA was associated with higher costs ($4,490 vs. $2,513-$4,144) and revascularization rates (5.2% vs. 2.6%-3.7%) compared to alternative strategies. Over lifetime, coronary CTA dominated SOC and ACC/AHA Guidelines and was cost-effective compared to expedited ED protocol ($49,428/QALY). This was driven by lower cardiovascular mortality (coronary CTA vs. expedited discharge: 3-year: 1.04% vs. 1.10-1.17; 10-year: 5.06% vs. 5.21-5.36%; respectively). CONCLUSION: Coronary CTA in patients with suspected ACS renders affordable long-term health benefits as compared to alternative strategies.