Cost-effectiveness of screening of coronary artery disease in patients with type 2 DIABetes at a very high cardiovascular risk (SCADIAB study) rational and design.

BACKGROUND: Screening for coronary artery disease (CAD) remains broadly performed in patients with type 2 diabetes (T2DM), although the lack of evidence. We conduct a real-world evidence (RWE) study to assess the risk of major clinical outcomes and economic impact of routine CAD screening in T2DM individuals at a very high cardiovascular risk. METHODS: SCADIAB is a comparative nationwide cohort study using data from the French National Health Data System. The main inclusion criteria are: age ≥ 40 years, DT2 diagnosed for ≥ 7 years, with ≥ 2 additional cardiovascular risk factors plus a history of microvascular or macrovascular disease, except CAD. We estimated ≥ 90,000 eligible participants for our study. Data will be extracted from 01/01/2008 to 31/12/2019. Eligible participants will be identified during a first 7-year selection period (2008-2015). Each participant will be assigned either in experimental (CAD screening procedure during the selection period) or control group (no CAD screening) on 01/01/2015, and followed for 5 years. The primary endpoint is the incremental cost per life year saved over 5 years in CAD screening group versus no CAD screening. The main secondary endpoints are: total 5-year direct costs of each strategy; incidence of major cardiovascular (acute coronary syndrome, hospitalization for heart failure, coronary revascularization or all-cause death), cerebrovascular (hospitalization for transient ischemic attack, stroke, or carotid revascularization) and lower-limb events (peripheral artery disease, ischemic diabetic foot, lower-limb revascularization or amputation); and the budget impact for the French Insurance system to promote the cost-effective strategy. Analyses will be adjusted for a high-dimension propensity score taking into account known and unknown confounders. SCADIAB has been funded by the French Ministry of Health and the protocol has been approved by the French ethic authorities. Data management and analyses will start in the second half of 2021. DISCUSSION: SCADIAB is a large and contemporary RWE study that will assess the economic and clinical impacts of routine CAD screening in T2DM people at a very high cardiovascular risk. It will also evaluate the clinical practice regarding CAD screening and help to make future recommendations and optimize the use of health care resources. Trial registration ClinicalTrials.gov Identifier: NCT04534530 ( https://clinicaltrials.gov/ct2/show/NCT04534530 ).

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.

Trends in the Use of Cardiac Imaging for Patients With Heart Failure in Canada.

Importance: Cardiac imaging is a component of the provision of medical care for patients with heart failure that has experienced a broad expansion in past decades. However, there is a paucity of studies examining the patterns of use of cardiac imaging modalities in real-world clinical practice. Objectives: To investigate temporal trends in the use and costs of cardiac imaging for the examination of patients with heart failure in Canada and to examine the association between the institution of an accreditation program and the use of echocardiography. Design, Setting, and Participants: A repeated cross-sectional study based on population-based administrative databases in Ontario, Canada, of individuals with heart failure identified using a validated algorithm based on hospital admissions and ambulatory physician claims was conducted between April 1, 2002, and March 31, 2017. Main Outcomes and Measures: The incidence and prevalence of heart failure and the age- and sex-adjusted rate of use and costs of cardiac imaging, including resting and stress echocardiography, myocardial perfusion scintigraphy, invasive coronary angiography, computed tomography, magnetic resonance imaging, and positron emission tomography. Results: A total of 882 355 adults (50.1% women; median age, 76 years [interquartile range, 66-83 years]) with prevalent heart failure were identified. The age- and sex-standardized prevalence of heart failure remained stable during the study (2.4% [95% CI, 2.4%-2.4%] in 2002 and 2.0% [95% CI, 2.0%-2.0%] in 2016). There was an increase in the rate of use of resting echocardiography, from 386 tests (95% CI, 373-398) per 1000 patients with heart failure in 2002 to 533 (95% CI, 519-547) per 1000 patients in 2011. Coinciding with the initiation of an accreditation program for echocardiography in 2012, there was an immediate reduction in the rate of use (-59.5 tests per 1000 patients with heart failure; P < .001), which was followed by a plateau in subsequent years. At the same time, there was a 10.8% relative reduction in the use of myocardial perfusion scintigraphy and an 11.2% relative reduction in the use of invasive coronary angiography from 2011 to 2016 and the incorporation of newer modalities after they became publicly insured health services. Conclusions and Relevance: These findings suggest that resting echocardiography remains the most used imaging technique for patients with heart failure, exceeding the use of and the cost spent on other modalities. Stabilization in the use of traditional imaging modalities coincided temporally with the emergence of advanced techniques and provincewide quality improvement policy initiatives.

Appropriate utilization of cardiac magnetic resonance for the assessment of heart failure and potential associated cost savings.

BACKGROUND: The rapid growth in cardiac imaging utilization has led to the development of appropriate use criteria (AUC) in an effort to control costs. Recently, cardiac MRI has developed into a valuable modality in the evaluation of cardiac disease. However, there are no studies examining the appropriate use of cardiac MRI in clinical practice. PURPOSE: To determine the appropriate utilization of cardiac MRI in a large quaternary care institution and to compare percentages of appropriate utilization pre- and postpublication of the AUC document. We hypothesized that percentages of appropriate cardiac MRI utilization will be similar to those of other comparable cardiac imaging modalities and that there would be a significant change in appropriate use pre- and post-AUC publication. STUDY TYPE: Retrospective cohort study. POPULATION: In all, 2032 consecutive patients undergoing cardiac MRI for the assessment of heart failure between 2012-2016. FIELD STRENGTH: 1.5T. ASSESSMENT: Data were collected and an appropriateness category was assigned for each cardiac MRI. STATISTICAL TESTS: Rates of major cardiac risk factors were compared between those undergoing cardiac MRIs pre- and post-AUC using the chi-square and the Mann-Whitney tests for categorical and continuous variables, respectively. Appropriateness classification was compared pre- and post-AUC publication using the chi-square test. RESULTS: There were no significant differences in the prevalence of major cardiovascular risk factors before and after publication of the AUC. 95.5% of all cardiac MRIs were appropriate based on the AUC. Further, there was a significant difference when comparing the appropriateness classification before and after publication of the AUC (P = 0.0003), potentially associated with annual cost savings of ∼$14.8 million. DATA CONCLUSION: We report a very high percentage of appropriate use of cardiac MRI and a significant increase in the proportion of tests classified as appropriate after AUC publication. LEVEL OF EVIDENCE: 3 Technical Efficacy: Stage 5 J. Magn. Reson. Imaging 2019;49:e132-e138.

Criteria for the Management of Technological Assets in Cardiovascular Imaging.

Adequate, updated and functional technology is essential in cardiology. In Spain, the economic scenario has strongly impacted technology renewal programs and obsolescence is a growing problem. The current report attempts to describe the current situation and the conditions that must concur to update, replace or adopt new technologies in the field of cardiology.

The use of cardiac-CT alone to exclude left atrial thrombus before atrial fibrillation ablation: Efficiency, safety, and cost analysis.

BACKGROUND: Atrial fibrillation (AF) is a growing financial burden on the healthcare system. Cardiac computed tomographic angiography (CCTA) is needed for pulmonary vein mapping before AF ablation (AFA). CCTA has shown to be an alternative to transesophageal echocardiogram (TEE) to rule out left atrial appendage thrombus (LAAT) pre-AFA. We aim to examine the safety, cost-effectiveness, and time-efficiency of utilizing CCTA alone to rule out LAAT before AFA. METHODS: We prospectively screened patients with paroxysmal AF undergoing cryoablation. CCTA with delayed enhancement was performed within 72 hours of AFA. Once LAAT was ruled out, patients were enrolled and planned TEE was cancelled. A retrospective control cohort that had both CCTA and TEE prior to AFA was identified. Direct cost data, electrophysiology laboratory utilization time, and 30-day stroke outcomes were collected from the EMR, follow-up phone calls, or clinic visits, and comparative analyses were performed. RESULTS: Seventy patients met the inclusion criteria in the prospective CCTA-only cohort, and 71 for the retrospective CCTA+TEE cohort. Baseline characteristics were similar between the two groups. There was a nonsignificant reduction in overall cost ($15,870 ± 1,710 vs $16,557 ± 2,508, P = 0.06) in CCTA-only cohort, whereas the electrophysiology laboratory utilization time was significantly reduced (241.6 ± 41.7 vs 181.3 ±36.4 minutes, P < 0.001). There were no strokes reported on 30-day follow-up in the CCTA-only group. CONCLUSIONS: In low-to-intermediate stroke risk patients with paroxysmal AF undergoing cryoablation, eliminating TEE and employing CCTA-only strategy to rule-out LAAT improves electrophysiology laboratory efficiency without influencing periprocedural cost or increasing postprocedural stroke risk.

Imaging the myocardial ischemic cascade.

Non-invasive imaging plays a growing role in the diagnosis and management of ischemic heart disease from its earliest manifestations of endothelial dysfunction to myocardial infarction along the myocardial ischemic cascade. Experts representing the North American Society for Cardiovascular Imaging and the European Society of Cardiac Radiology have worked together to organize the role of non-invasive imaging along the framework of the ischemic cascade. The current status of non-invasive imaging for ischemic heart disease is reviewed along with the role of imaging for guiding surgical planning. The issue of cost effectiveness is also considered. Preclinical disease is primarily assessed through the coronary artery calcium score and used for risk assessment. Once the patient becomes symptomatic, other imaging tests including echocardiography, CCTA, SPECT, PET and CMR may be useful. CCTA appears to be a cost-effective gatekeeper. Post infarction CMR and PET are the preferred modalities. Imaging is increasingly used for surgical planning of patients who may require coronary artery bypass.

Cost-effectiveness of anatomical and functional test strategies for stable chest pain: public health perspective from a middle-income country.

OBJECTIVES: The aim of this research is to evaluate the relative cost-effectiveness of functional and anatomical strategies for diagnosing stable coronary artery disease (CAD), using exercise (Ex)-ECG, stress echocardiogram (ECHO), single-photon emission CT (SPECT), coronary CT angiography (CTA) or stress cardiacmagnetic resonance (C-MRI). SETTING: Decision-analytical model, comparing strategies of sequential tests for evaluating patients with possible stable angina in low, intermediate and high pretest probability of CAD, from the perspective of a developing nation's public healthcare system. PARTICIPANTS: Hypothetical cohort of patients with pretest probability of CAD between 20% and 70%. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome is cost per correct diagnosis of CAD. Proportion of false-positive or false-negative tests and number of unnecessary tests performed were also evaluated. RESULTS: Strategies using Ex-ECG as initial test were the least costly alternatives but generated more frequent false-positive initial tests and false-negative final diagnosis. Strategies based on CTA or ECHO as initial test were the most attractive and resulted in similar cost-effectiveness ratios (I$ 286 and I$ 305 per correct diagnosis, respectively). A strategy based on C-MRI was highly effective for diagnosing stable CAD, but its high cost resulted in unfavourable incremental cost-effectiveness (ICER) in moderate-risk and high-risk scenarios. Non-invasive strategies based on SPECT have been dominated. CONCLUSIONS: An anatomical diagnostic strategy based on CTA is a cost-effective option for CAD diagnosis. Functional strategies performed equally well when based on ECHO. C-MRI yielded acceptable ICER only at low pretest probability, and SPECT was not cost-effective in our analysis.

Three-dimensional printing in cardiology: Current applications and future challenges.

Three-dimensional (3D) printing has attracted a huge interest in recent years. Broadly speaking, it refers to the technology which converts a predesigned virtual model to a touchable object. In clinical medicine, it usually converts a series of two-dimensional medical images acquired through computed tomography, magnetic resonance imaging or 3D echocardiography into a physical model. Medical 3D printing consists of three main steps: image acquisition, virtual reconstruction and 3D manufacturing. It is a promising tool for preoperative evaluation, medical device design, hemodynamic simulation and medical education, it is also likely to reduce operative risk and increase operative success. However, the most relevant studies are case reports or series which are underpowered in testing its actual effect on patient outcomes. The decision of making a 3D cardiac model may seem arbitrary since it is mostly based on a cardiologist's perceived difficulty in performing an interventional procedure. A uniform consensus is urgently necessary to standardize the key steps of 3D printing from imaging acquisition to final production. In the future, more clinical trials of rigorous design are possible to further validate the effect of 3D printing on the treatment of cardiovascular diseases. (Cardiol J 2017; 24, 4: 436-444).

Outcomes-Based CV Imaging Research Endpoints and Trial Design: From Pixels to Patient Satisfaction.

The categories and quality of evidence documenting the value of noninvasive cardiovascular imaging have evolved substantially over the last several decades. From an initial emphasis on the diagnostic accuracy of various imaging modalities, cardiovascular imaging has matured into an outcomes-based field that now provides evidence on adverse events, safety, cost, and patient quality-of-life endpoints, and does so in the setting of large randomized trials. This review aims to highlight types of outcomes endpoints, including updating the hierarchy of evidence for diagnostic imaging as first proposed by Fryback and Thornbury, and critically reviewing their application in the current cardiovascular imaging evidence base. We describe the range of data categories generated to date for the various imaging modalities, and indicate how this provides insights into contemporary study design and future directions in cardiovascular imaging outcomes research.

Imaging Registries and Single-Center Series.

Randomized controlled trials are often regarded as the pinnacle of research designs, valued for their rigor and internal validity. However, their high costs and selected patient populations limit their applicability, and complementary study designs are needed to guide evidence. In the realm of cardiovascular imaging, research designs using single-center series and registries have contributed key foundational insights into diagnosis, resource use and cost patterns, and prognosis as derived from practical, "real-world" settings. This review highlights the strengths and limitations of these study designs, provides notable examples, and indicates future directions for research.

Comparative Effectiveness Trials of Imaging-Guided Strategies in Stable Ischemic Heart Disease.

The evaluation of patients with suspected stable ischemic heart disease is among the most common diagnostic evaluations with nearly 20 million imaging and exercise stress tests performed annually in the United States. Over the past decade, there has been an evolution in imaging research with an ever-increasing focus on larger registries and randomized trials comparing the effectiveness of varying diagnostic algorithms. The current review highlights recent randomized trial evidence with a particular focus comparing the effectiveness of cardiac imaging procedures within the stable ischemic heart disease evaluation for coronary artery disease detection, angina, and other quality of life measures, and major clinical outcomes. Also highlighted are secondary analyses from these trials on the economic findings related to comparative cost differences across diagnostic testing strategies.

Appropriate Use Criteria for Echocardiography: Evolving Applications in the Era of Value-Based Healthcare.

The current climate in healthcare is increasingly emphasizing a value-based approach to diagnostic testing. Cardiac imaging, including echocardiography, has been a primary target of ongoing reforms in healthcare delivery and reimbursement. The Appropriate Use Criteria (AUC) for echocardiography is a physician-derived tool intended to guide utilization in optimal patient care. To date, the AUC have primarily been employed solely as justification for reimbursement, though evolving broader applications to guide clinical decision-making suggest a far more valuable role in the delivery of high-quality and high-value healthcare.

Temporal changes in appropriateness of cardiac imaging.

BACKGROUND: Appropriate use criteria (AUC) for cardiac imaging have been available for almost 10 years. The extent to which there has been a reported improvement in appropriate use is undefined. OBJECTIVES: This study systematically reviewed published evidence to identify whether the promulgation of AUC has led to an improvement in the proportion of appropriate cardiac imaging requests. METHODS: Electronic databases were systematically searched for English-language papers related to AUC and cardiovascular imaging. We found 59 reports involving 103,567 tests that were published from 2000 to 2012. The rate of appropriate testing over time was analyzed in a meta-regression. RESULTS: New AUC were associated with apparent improvements in appropriateness for transthoracic echocardiography (TTE) (80% [95% confidence interval (CI): 0.75 to 0.84] vs. 85% [95% CI: 0.81 to 0.89]), transesophageal echocardiography (TEE) (89% [95% CI: 0.81 to 0.94] vs. 95% [95% CI: 0.93 to 0.96]) and computed tomography angiography (CTA) (37% [95% CI: 0.21 to 0.55] vs. 55% [95% CI: 0.44 to 0.65]) but not stress echocardiography (53% [95% CI: 0.45 to 0.61] vs. 52% [95% CI: 0.42 to 0.61]) or single-photon emission computed tomography (72% [95% CI: 0.66 to 0.77] vs. 68% [95% CI: 0.60 to 0.74]). Although there were no correlations between the proportion of appropriate TTEs and published year (p = 0.36) for 2007 AUC, there was a positive correlation between proportion of appropriateness and the year of publication (p = 0.01) for 2011 AUC. There was a significant decrease in the proportion of appropriateness over time using the 2007 TEE AUC (p = 0.03) and 2006 CT AUC (p = 0.02). There were no meaningful associations between appropriateness and publication year for stress echocardiography, CTA, or single-photon emission computed tomography. CONCLUSIONS: Rates of reported appropriate use in imaging show improvements for TTE and CTA but not for stress imaging and TEE. The observed reductions in imaging studies are not matched by reported rates of appropriate use.

Diagnostic performance and comparative cost-effectiveness of non-invasive imaging tests in patients presenting with chronic stable chest pain with suspected coronary artery disease: a systematic overview.

Several non-invasive imaging techniques are currently in use for the diagnostic workup of adult patients with stable chest pain suspected of having coronary artery disease (CAD). In this paper, we present a systematic overview of the evidence on diagnostic performance and comparative cost-effectiveness of new modalities in comparison to established technologies. A literature search for English language studies from 2009 to 2013 was performed, and two investigators independently extracted data on patient and study characteristics. The reviewed published evidence on diagnostic performance and cost-effectiveness support a strategy of CTCA as a rule out (gatekeeper) test of CAD in low- to intermediate-risk patients since it has excellent diagnostic performance and as initial imaging test is cost-effective under different willingness-to-pay thresholds. More cost-effectiveness research is needed in order to define the role and choice of cardiac stress imaging tests.

Cost-effectiveness of follow-up of pulmonary nodules incidentally detected on cardiac computed tomographic angiography in patients with suspected coronary artery disease.

BACKGROUND: Pulmonary nodules (PNs) are often detected incidentally during coronary computed tomographic (CT) angiography, which is increasingly being used to evaluate patients with chest pain symptoms. However, the efficiency of following up on incidentally detected PN is unknown. METHODS AND RESULTS: We determined demographic and clinical characteristics of stable symptomatic patients referred for coronary CT angiography in whom incidentally detected PNs warranted follow-up. A validated lung cancer simulation model was populated with data from these patients, and clinical and economic consequences of follow-up per Fleischner guidelines versus no follow-up were simulated. Of the 3665 patients referred for coronary CT angiography, 591 (16%) had PNs requiring follow-up. The mean age of patients with PNs was 59±10 years; 66% were male; 67% had ever smoked; and 21% had obstructive coronary artery disease. The projected overall lung cancer incidence was 5.8% in these patients, but the majority died of coronary artery disease (38%) and other causes (57%). Follow-up of PNs was associated with a 4.6% relative reduction in cumulative lung cancer mortality (absolute mortality: follow-up, 4.33% versus non-follow-up, 4.54%), more downstream testing (follow-up, 2.34 CTs per patient versus non-follow-up, 1.01 CTs per patient), and an average increase in quality-adjusted life of 7 days. Costs per quality-adjusted life-year gained were $154 700 to follow up the entire cohort and $129 800 per quality-adjusted life-year when only smokers were included. CONCLUSIONS: Follow-up of PNs incidentally detected in patients undergoing coronary CT angiography for chest pain evaluation is associated with a small reduction in lung cancer mortality. However, significant downstream testing contributes to limited efficiency, as demonstrated by a high cost per quality-adjusted life-year, especially in nonsmokers.

How I do it: judging appropriateness for TTE and TEE.

The increasing cost of healthcare is a widespread international problem to which the cost of imaging has been an important contributor. Some imaging tests are ordered inappropriately and contribute to wasted use of resources. Appropriate use criteria have been developed in the USA in order to guide test selection, but there are a number of problems, including the evidence base for these criteria and the steps that can be taken to change physician practice. A restrictive approach to test ordering is difficult to fit to the nuances of clinical presentation and may compromise patient care. We propose an alternative approach to physician guidance based on the most common markers of inappropriate testing.

Cost-effectiveness of different diagnostic strategies in suspected stable coronary artery disease in Portugal.

BACKGROUND: Cost-effectiveness is an increasingly important factor in the choice of a test or therapy. OBJECTIVE: To assess the cost-effectiveness of various methods routinely used for the diagnosis of stable coronary disease in Portugal. METHODS: Seven diagnostic strategies were assessed. The cost-effectiveness of each strategy was defined as the cost per correct diagnosis (inclusion or exclusion of obstructive coronary artery disease) in a symptomatic patient. The cost and effectiveness of each method were assessed using Bayesian inference and decision-making tree analyses, with the pretest likelihood of disease ranging from 10% to 90%. RESULTS: The cost-effectiveness of diagnostic strategies was strongly dependent on the pretest likelihood of disease. In patients with a pretest likelihood of disease of ≤50%, the diagnostic algorithms, which include cardiac computed tomography angiography, were the most cost-effective. In these patients, depending on the pretest likelihood of disease and the willingness to pay for an additional correct diagnosis, computed tomography angiography may be used as a frontline test or reserved for patients with positive/inconclusive ergometric test results or a calcium score of >0. In patients with a pretest likelihood of disease of ≥ 60%, up-front invasive coronary angiography appears to be the most cost-effective strategy. CONCLUSIONS: Diagnostic algorithms that include cardiac computed tomography angiography are the most cost-effective in symptomatic patients with suspected stable coronary artery disease and a pretest likelihood of disease of ≤50%. In high-risk patients (pretest likelihood of disease ≥ 60%), up-front invasive coronary angiography appears to be the most cost-effective strategy. In all pretest likelihoods of disease, strategies based on ischemia appear to be more expensive and less effective compared with those based on anatomical tests.