Cost-Effectiveness of Cardiovascular Magnetic Resonance in Diagnosing Coronary Artery Disease in the Australian Health Care System.

BACKGROUND: Coronary artery disease (CAD) remains a major public health problem in Australia and globally. A variety of imaging techniques allow for both anatomical and functional assessment of CAD and selection of the optimal investigation pathway is challenging. Cardiovascular magnetic resonance (CMR) is not widely used in Australia, partly due to perceived cost and lack of Federal Government reimbursement compared to the alternative techniques. The aim of this study was to estimate the cost-effectiveness of different diagnostic strategies in identifying significant CAD in patients with chest pain suggestive of angina using the evidence gathered in the Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease 2 (CE-MARC trial), analysed from the Australian health care perspective. METHODS: A decision analytic model coupled with three distinct Markov models allowed eight potential clinical investigation strategies to be considered; combinations of exercise electrocardiogram stress testing (EST), single-photon emission computed tomography (SPECT), stress CMR, and invasive coronary angiography (ICA). Costs were from the Australian health care system in Australian dollars, and outcomes were measured in terms of quality-adjusted life-years. Parameter estimates were derived from the CE-MARC and EUropean trial on Reduction Of cardiac events with Perindopril in patients with stable coronary Artery disease (EUROPA) trials, and from reviews of the published literature. RESULTS: The most cost-effective diagnostic strategy, based on a cost-effectiveness threshold of $45,000 to $75,000 per QALY gained, was EST, followed by stress CMR if the EST was positive or inconclusive, followed by ICA if the stress CMR was positive or inconclusive; this held true in the base case and the majority of scenario analyses. CONCLUSIONS: This economic evaluation shows that an investigative strategy of stress CMR if EST is inconclusive or positive is the most cost-effective approach for diagnosing significant coronary disease in chest pain patients within the Australian health care system.

Cost-effectiveness of cardiovascular imaging for stable coronary heart disease.

OBJECTIVE: To assess the cost-effectiveness of management strategies for patients presenting with chest pain and suspected coronary heart disease (CHD): (1) cardiovascular magnetic resonance (CMR); (2) myocardial perfusion scintigraphy (MPS); and (3) UK National Institute for Health and Care Excellence (NICE) guideline-guided care. METHODS: Using UK data for 1202 patients from the Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease 2 trial, we conducted an economic evaluation to assess the cost-effectiveness of CMR, MPS and NICE guidelines. Health outcomes were expressed as quality-adjusted life-years (QALYs), and costs reflected UK pound sterling in 2016-2017. Cost-effectiveness results were presented as incremental cost-effectiveness ratios and incremental net health benefits overall and for low, medium and high pretest likelihood of CHD subgroups. RESULTS: CMR had the highest estimated QALY gain overall (2.21 (95% credible interval 2.15, 2.26) compared with 2.07 (1.92, 2.20) for NICE and 2.11 (2.01, 2.22) for MPS) and incurred comparable costs (overall £1625 (£1431, £1824) compared with £1753 (£1473, £2032) for NICE and £1768 (£1572, £1989) for MPS). Overall, CMR was the cost-effective strategy, being the dominant strategy (more effective, less costly) with incremental net health benefits per patient of 0.146 QALYs (-0.18, 0.406) compared with NICE guidelines at a cost-effectiveness threshold of £15 000 per QALY (93% probability of cost-effectiveness). Results were similar in the pretest likelihood subgroups. CONCLUSIONS: CMR-guided care is cost-effective overall and across all pretest likelihood subgroups, compared with MPS and NICE guidelines.

Conservative gadolinium administration to patients with Duchenne muscular dystrophy: decreasing exposure, cost, and time, without change in medical management.

Cardiac MR (CMR) is increasingly used to assess for cardiac involvement in patients with Duchenne muscular dystrophy (DMD). The frequent use of gadolinium based contrast agents (GBCAs) has been called into question with reports of intracranial gadolinium deposition in patients receiving multiple administrations. We adopted a conservative GBCA administration policy, limiting the frequency of GBCA exposure in patients with previously documented late gadolinium enhancement. The aim of our study was to evaluate the clinical effects of this policy change. Data were retrospectively reviewed on 405 consecutive patients with DMD who underwent CMR evaluation. Patients were grouped into conservative GBCA administration or historical control. CMR reports were evaluated and clinical reports were reviewed to determine actionable changes. Ohio Medicaid reimbursements were used to estimate costs. A total of 187 patients comprised the conservative GBCA group and 218 patients the historical cohort. The conservative GBCA group had lower contrast administration rates (84% vs. 99%, p < 0.0001), shorter scan times (35.2 vs. 39.0 min, p < 0.0001), and lower estimated medical costs ($339 vs. $351/study). There was no change regarding the initial presence of first-time late gadolinium enhancement, and no difference in actionable change. Contrast administration substantially decreased 7 months post-policy change (65%) compared to the initial 7 months (96%, p < 0.0001). In the current era with unclear concern for intracranial gadolinium deposition, thoughtful GBCA administration is warranted in patients anticipated to undergo multiple CMRs. Our updated approach has resulted in fewer patients receiving contrast, shorter scan times, and less medical costs, without appreciable changes to patient management.

INCA (Peru) Study: Impact of Non-Invasive Cardiac Magnetic Resonance Assessment in the Developing World.

Background Advanced cardiac imaging permits optimal targeting of cardiac treatment but needs to be faster, cheaper, and easier for global delivery. We aimed to pilot rapid cardiac magnetic resonance ( CMR ) with contrast in a developing nation, embedding it within clinical care along with training and mentoring. Methods and Results A cross-sectional study of CMR delivery and clinical impact assessment performed 2016-2017 in an upper middle-income country. An International partnership (clinicians in Peru and collaborators from the United Kingdom, United States, Brazil, and Colombia) developed and tested a 15-minute CMR protocol in the United Kingdom, for cardiac volumes, function and scar, and delivered it with reporting combined with training, education and mentoring in 2 centers in the capital city, Lima, Peru, 100 patients referred by local doctors from 6 centers. Management changes related to the CMR were reviewed at 12 months. One-hundred scans were conducted in 98 patients with no complications. Final diagnoses were cardiomyopathy (hypertrophic, 26%; dilated, 22%; ischemic, 15%) and 12 other pathologies including tumors, congenital heart disease, iron overload, amyloidosis, genetic syndromes, vasculitis, thrombi, and valve disease. Scan cost was $150 USD, and the average scan duration was 18±7 minutes. Findings impacted management in 56% of patients, including previously unsuspected diagnoses in 19% and therapeutic management changes in 37%. Conclusions Advanced cardiac diagnostics, here CMR with contrast, is possible using existing infrastructure in the developing world in 18 minutes for $150, resulting in important changes in patient care.

Cost-effectiveness analysis of magnetic resonance imaging-conditional pacemaker implantation: Insights from a multicenter study and implications in the current era.

BACKGROUND: Magnetic resonance imaging (MRI)-conditional pacemakers (M-PPMs) grant patients greater accessibility to MRI scans. The cost-effectiveness of implanting M-PPM is unknown. OBJECTIVE: The purpose of this study was to determine the cost-effectiveness of M-PPM implantation. METHODS: Cost-effectiveness analysis was performed on patients receiving a M-PPM across 4 institutions. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the sum of the total incremental cost of implanting a M-PPM vs a conventional pacemaker and the cost of MRI scans by the utility of MRI scans in terms of quality-adjusted life-years (QALY) gained. QALY and lifespan of M-PPM (7-11 years) data were obtained from the literature. The benchmark of <$100,000 per QALY was used as the threshold for cost-effectiveness. Computer modeling/simulations were used to calculate the percentage of patients required to achieve this benchmark, to extrapolate the cumulative projected percentage of patients utilizing MRI scans over the lifespan of a M-PPM via the Weibull parametric survival model, and to conduct univariate and multivariate, probabilistic sensitivity analyses. RESULTS: The ICER during the follow-up period (21 ± 17 months) was $451,569. The cost-effectiveness ICER benchmark is reached 7.0 years postimplantation, when a projected 38% of recipients would receive MRI scans. The projected percentage of patients receiving MRI scans at 11 years was 58%, yielding an ICER of $74,221 per QALY. Henceforth, assuming increased MRI usage in regular PPM based on Centers for Medicare & Medicaid Services memo CAG00399R4 and decreased cost of M-PPM, M-PPM implantation is still cost-effective, with a lifetime ICER of $49,817 per QALY. CONCLUSION: M-PPM implantation is cost-effective over the lifespan of a M-PPM based on projected usage of MRI.

Clinical recommendations of cardiac magnetic resonance, Part I: ischemic and valvular heart disease: a position paper of the working group 'Applicazioni della Risonanza Magnetica' of the Italian Society of Cardiology.

Cardiac magnetic resonance (CMR) has emerged as a reliable and accurate diagnostic tool for the evaluation of patients with cardiac disease in several clinical settings and with proven additional diagnostic and prognostic value compared with other imaging modalities. This document has been developed by the working group on the 'application of CMR' of the Italian Society of Cardiology to provide a perspective on the current state of technical advances and clinical applications of CMR and to inform cardiologists on how to implement their clinical and diagnostic pathways with the inclusion of this technique in clinical practice. The writing committee consisted of members of the working group of the Italian Society of Cardiology and two external peer reviewers with acknowledged experience in the field of CMR.

Impact of Stress Cardiac Magnetic Resonance Imaging on Clinical Care.

Given the rising costs of imaging, there is increasing pressure to provide evidence for direct additive impact on clinical care. Appropriate use criteria (AUC) were developed to optimize test-patient selection and are increasingly used by payers to assess reimbursement. However, these criteria were created by expert consensus with limited systematic validation. The aims of this study were therefore to determine (1) rates of active clinical change resulting from stress cardiovascular magnetic resonance (CMR) imaging and (2) whether the AUC can predict these changes. We prospectively enrolled 350 consecutive outpatients referred for stress CMR. Categories of "active changes in clinical care" due to stress CMR were predefined. Appropriateness was classified according to the 2013 AUC. Multivariate logistic regression analysis was used to identify factors independently associated with active change. Overall, stress CMR led to an active change in clinical care in about 70% of patients. Rates of change in clinical care did not vary significantly across AUC categories (p = 0.767). In a multivariate model adjusting for clinical variables and AUC, only ischemia (odds ratio [OR] 6.896, 95% CI 2.637 to 18.032, p <0.001), known coronary artery disease (OR 0.300, 95% CI 0.161 to 0.559, p <0.001), and age (OR 0.977, 95% CI 0.954 to 1.000, p = 0.050) independently predicted significant clinical change. In conclusion, stress CMR made a significant impact on clinical management, resulting in active change in clinical care in about 70% of patients. AUC categories were not an independent predictor of clinical change. Clinical change was independently associated with the presence of ischemia, absence of known coronary artery disease, and younger age.

Incremental cost-effectiveness of dobutamine stress cardiac magnetic resonance imaging in patients at intermediate risk for coronary artery disease.

AIMS: The effectiveness of stress cardiac magnetic resonance (CMR) as a gatekeeper for coronary angiography (CA) has been established. Level five HTA studies according to the hierarchical model of diagnostic test evaluation are not available. METHODS: This cohort study included 1,158 consecutive patients (mean age 63 ± 11 years, 42 % women) presenting at our institution between January 1, 2003 and December 31, 2004 with suspected coronary artery disease (CAD) for an elective CA. The patients were assessed for eligibility and propensity score matching was applied to address selection bias regarding the patients' allocation to CMR or direct CA. Median patient follow-up was 7.9 years (95 % CI 7.8-8.0 years). The primary effect was calculated as relative survival difference. The cost unit calculation (per patient) at our institute was the source of costs. RESULTS: Survival was similar in CMR and CA (p = 0.139). Catheterizations ruling out CAD were significantly reduced by the CMR gate-keeper strategy. Patients with prior CMR had significantly lower costs at the initial hospital stay and at follow-up (CMR vs. CA, initial: 2,904 vs. 3,421, p = 0.018; follow-up: 2,045 vs. 3,318, p = 0.037). CMR was cost-effective in terms of a contribution of 12,466 per life year to cover a part of the CMR costs. CONCLUSION: Stress CMR prior to CA was saving 12,466 of hospital costs per life year. Lower costs at follow-up suggest sustained cost-effectiveness of the CMR-guided strategy.

Rationale and design of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2 trial (CE-MARC 2): a prospective, multicenter, randomized trial of diagnostic strategies in suspected coronary heart disease.

BACKGROUND: A number of investigative strategies exist for the diagnosis of coronary heart disease (CHD). Despite the widespread availability of noninvasive imaging, invasive angiography is commonly used early in the diagnostic pathway. Consequently, approximately 60% of angiograms reveal no evidence of obstructive coronary disease. Reducing unnecessary angiography has potential financial savings and avoids exposing the patient to unnecessary risk. There are no large-scale comparative effectiveness trials of the different diagnostic strategies recommended in international guidelines and none that have evaluated the safety and efficacy of cardiovascular magnetic resonance. TRIAL DESIGN: CE-MARC 2 is a prospective, multicenter, 3-arm parallel group, randomized controlled trial of patients with suspected CHD (pretest likelihood 10%-90%) requiring further investigation. A total of 1,200 patients will be randomized on a 2:2:1 basis to receive 3.0-T cardiovascular magnetic resonance-guided care, single-photon emission computed tomography-guided care (according to American College of Cardiology/American Heart Association appropriate-use criteria), or National Institute for Health and Care Excellence guidelines-based management. The primary (efficacy) end point is the occurrence of unnecessary angiography as defined by a normal (>0.8) invasive fractional flow reserve. Safety of each strategy will be assessed by 3-year major adverse cardiovascular event rates. Cost-effectiveness and health-related quality-of-life measures will be performed. CONCLUSIONS: The CE-MARC 2 trial will provide comparative efficacy and safety evidence for 3 different strategies of investigating patients with suspected CHD, with the intension of reducing unnecessary invasive angiography rates. Evaluation of these management strategies has the potential to improve patient care, health-related quality of life, and the cost-effectiveness of CHD investigation.

Sample size and cost analysis for pulmonary arterial hypertension drug trials using various imaging modalities to assess right ventricular size and function end points.

BACKGROUND: Placebo-controlled trials for pulmonary arterial hypertension are no longer acceptable because new therapies must show clinically significant effects on top of standard treatment. The purpose of this study was to estimate sample sizes and imaging costs for the planning of a hypothetical pulmonary arterial hypertension drug trial using imaging to detect changes in right ventricular size and function in response to combined therapy. METHODS AND RESULTS: Same-day cardiovascular MR (CMR) and 2-dimensional (2D) and 3D transthoracic echocardiography (2DTTE and 3DTTE) were performed in 22 patients with pulmonary arterial hypertension (54±13 years of age) twice, 6 months apart. Short-axis CMR cines and full-volume 3DTTE data sets of the right ventricle were used to measure end-diastolic volume and ejection fraction. Fractional area change was obtained from 2DTTE. Sample size calculations used a 2-sample t test model incorporating differences between baseline and 6-month measurements. Cost estimates were made using the Medicare fee schedule. No significant differences were noted between baseline and follow-up measurements. Large SDs reflected variable progression of disease in individual patients on standard therapy and measurement variability. These sources of variability resulted in intertechnique differences in sample sizes: to detect a change of 5% to 15% in 3DTTE-derived right ventricular ejection fraction and fractional area change or change of 15 to 30 mL in 3DTTE right ventricular end-diastolic volume; sample sizes were 2× to 2.5× those required by CMR. As a result, the total cost of a trial using complete TTE was greater than CMR, which was greater than limited TTE. CONCLUSIONS: Because of lower measurement variability, CMR is more cost saving in pulmonary arterial hypertension drug trials than echocardiography, unless limited TTE is used.

Comparison of image-guided radiotherapy technologies for prostate cancer.

Radiation oncology has seen a rapid increase in the use of image-guided radiotherapy technology (IGRT) for prostate cancer patients over the past decade. The increase in the use of IGRT is largely driven by the fact that these technologies have been approved by the Food and Drug Administration and are now readily reimbursed by many insurance companies. Prostate cancer patients undergoing intensity modulated radiotherapy (IMRT) now have access to a wide variety of IGRTs that can cost anywhere from $500,000 or more in upfront costs, and can add anywhere from 10 to 15 thousand dollars to a course of IMRT. Some of the IGRT options include daily cone beam computed tomography, ultrasound, orthogonal x-ray units using implanted fiducial markers, implanted radiofrequency markers with the ability to localize and track prostate motion during radiotherapy (Calypso 4D), and cine magnetic resonance imaging. Although these technologies add to the cost of IMRT, there is little direct comparative effectiveness data to help patients, physicians, and policy makers decide if one technology is better than another. In our critical review, the first of its kind, we summarize the advantages, disadvantages, and the limitations of each technology. We also provide an overview of existing literature as it pertains to the comparison of existing IGRTs. Lastly, we provide insights about the need for future outcomes research that may have a significant impact on health policies as it comes to reimbursement in the modern era.

Cost-effectiveness of cardiovascular magnetic resonance in the diagnosis of coronary heart disease: an economic evaluation using data from the CE-MARC study.

OBJECTIVE: To evaluate the cost-effectiveness of diagnostic strategies for coronary heart disease (CHD) derived from the CE-MARC study. DESIGN: Cost-effectiveness analysis using a decision analytic model to compare eight strategies for the diagnosis of CHD. SETTING: Secondary care out-patients (Cardiology Department). PATIENTS: Patients referred to cardiologists for the further evaluation of symptoms thought to be angina pectoris. INTERVENTIONS: Eight different strategies were considered, including different combinations of exercise treadmill testing (ETT), single-photon emission CT (SPECT), cardiovascular magnetic resonance (CMR) and coronary angiography (CA). MAIN OUTCOME MEASURES: Costs expressed as UK sterling in 2010-2011 prices and health outcomes in quality-adjusted life-years (QALYs). The time horizon was 50 years. RESULTS: Based on the characteristics of patients in the CE-MARC study, only two strategies appear potentially cost-effective for diagnosis of CHD, both including CMR. The choice is between two strategies: one in which CMR follows a positive or inconclusive ETT, followed by CA if CMR is positive or inconclusive (Strategy 3 in the model); and the other where CMR is followed by CA if CMR is positive or inconclusive (Strategy 5 in the model). The more cost-effective of these two rests on the threshold cost per QALY gained below which health systems define an intervention as cost-effective. Strategy 3 appears cost-effective at the lower end of the threshold range used in the UK (£20 000 per QALY gained), while Strategy 5 appears cost-effective at the higher end of the threshold range (£30 000 per QALY). The results are robust to various sources of uncertainty although prior likelihood of CHD requiring revascularisation and the rate at which false negative patients are eventually appropriately identified do impact upon the results. CONCLUSIONS: The CE-MARC study showed that CMR had superior diagnostic accuracy to SPECT and concluded that CMR should be more widely used in the investigation of patients with CHD. The economic evaluation results show that using CMR is also a cost-effective strategy and supports the wider adoption of this modality.

Impact of cardiac magnetic resonance imaging on cardiac device and surgical therapy: a prospective study.

Cardiac magnetic resonance (CMR) imaging may allow more appropriate selection of patients for cardiac device implantation and/or cardiac surgery. In this prospective observational study we evaluated the impact of CMR imaging on cardiac device and surgical therapy. All CMR examinations performed in a single centre over a 2 year period were prospectively recorded in a dedicated database under 4 clinical pathways [cardiomyopathy, viability, tumour/mass and arrythmogenic right ventricular cardiomyopathy (ARVC)]. Baseline data entered included planned cardiac device implantation and/or cardiac surgical intervention. Patients were contacted 6 months following CMR to evaluate the impact of CMR on planned therapy. Cost savings due to CMR were calculated as the number of surgical or device procedures averted following CMR scanning multiplied by their respective cost weights. Of 732 CMR examinations performed, the clinical pathway was cardiomyopathy in 488 (67 %), ARVC in 118 (16 %), viability in 92 (12 %) and tumour/mass in 34 (5 %). Six month follow-up was available in 666/732 patients. Following CMR, 56/150 (37 %) of patients with an initial plan for device implantation or cardiac surgery, did not undergo the planned intervention (P < 0.001, one-sample exact binomial test). Of 516 patients without an initial device or surgical plan, 33 (6 %) CMR resulted in device implantation or cardiac surgery (P < 0.001, Chi squared). Overall, the estimated saving due to CMR-guided management changes was AUD$737,270. CMR has a significant impact on patient management and offers potential cost savings with respect to selection of device and surgical therapy for cardiac disease.

Assessment of left ventricular volumes and mass with fast 3D cine steady-state free precession k-t space broad-use linear acquisition speed-up technique (k-t BLAST).

PURPOSE: To compare left ventricular (LV) volume and mass assessment using two-dimensional (2D) cine steady-state free precession (SSFP) and k-t space broad-use linear acquisition speed-up technique (k-t BLAST) accelerated 3D magnetic resonance imaging (MRI). MATERIALS AND METHODS: On a commercially available 1.5T MR scanner, 2D cine SSFP, six- and eight-fold accelerated 3D k-t BLAST were performed to evaluate LV volumes and mass in 17 volunteers. After semiautomatic segmentation of the different MR data sets, the resulting volumes and mass were compared according to the mean difference, 95% confidence interval, standard deviation (SD), Pearson's correlation coefficient, Bland-Altman analysis, and the Pitman-Morgan test. RESULTS: Data acquisition was successful in all subjects. The number of required breathholds was reduced from a maximal of five for the 2D cine SSFP sequence to two for 3D k-t BLAST sequences. Comparing LV volumes, there was excellent agreement between 2D and 3D cine 8x k-t BLAST SSFP volumes (mean difference +/- 2SD end-diastolic volume [EDV] = 5 +/- 8 mL, end-systolic volume [ESV] = 1 +/-12 mL, and stroke volume [SV] = 3 +/- 8 mL), and mass (-1.8 +/- 9 g). CONCLUSION: k-t BLAST-accelerated 3D sequences allow accurate assessment of LV volumes and mass compared to 2D cine SSFP. This method may reduce costs and increase patient comfort due to shortened data acquisition time and reduced number of breathholds.

Cardiac magnetic resonance imaging in small rodents using clinical 1.5 T and 3.0 T scanners.

Cardiac magnetic resonance (CMR) imaging can provide noninvasive, high resolution images of heart anatomy, viability, perfusion, and function. However, the adoption of clinical CMR imaging protocols for small rodents has been limited due to the small heart size and rapid heart rates. Therefore, most CMR studies in small rodents have been performed on non-clinical, high-field MR magnets. Because such high-field systems are not readily available at most institutions, the technical aspects that are needed to perform CMR on clinical 1.5 T and 3.0 T MR scanners are presented in this paper. Equipment requirements are presented, and a comprehensive description of the methods needed to complete a CMR exam including the animal preparation, imaging, and image analysis are discussed. In addition, the advanced applications of myocardial tagging and delayed-contrast-enhanced imaging are reviewed for the assessment of regional contractile function and myocardial viability, respectively.

A clinical cardiovascular magnetic resonance service: operational considerations and the basic examination.

Cardiovascular magnetic resonance (CMR) is now considered the "gold standard" for the assessment of regional and global systolic function, myocardial infarction and viability, and congenital heart disease. At specialized centers, CMR has become a clinical workhorse for the evaluation of ischemic heart disease and for heart failure and cardiomyopathies. Despite this versatility, general acceptance of CMR in cardiovascular medicine has progressed slowly. This article provides a basic understanding of important operational considerations when starting a CMR service and describes a conceptual framework of the components of a CMR examination.