Lower Ischemic Heart Disease Diagnostic Costs With Treadmill Stress CMR Versus SPECT: A Multicenter, Randomized Trial.
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ABSTRACT:
SUBMITTER: Raman SV
PROVIDER: S-EPMC7415648 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Children with heart disease may require repeated X-Ray cardiac catheterization procedures, are more radiosensitive, and more likely to survive to experience oncologic risks of medical radiation. Cardiovascular magnetic resonance (CMR) is radiation-free and offers information about structure, function, and perfusion but not hemodynamics. We intend to perform complete radiation-free diagnostic right heart catheterization entirely using CMR fluoroscopy guidance in an unselected cohort of pediatric patients; we report the feasibility and safety.We performed 50 CMR fluoroscopy guided comprehensive transfemoral right heart catheterizations in 39 pediatric (12.7 ± 4.7 years) subjects referred for clinically indicated cardiac catheterization. CMR guided catheterizations were assessed by completion (success/failure), procedure time, and safety events (catheterization, anesthesia). Pre and post CMR body temperature was recorded. Concurrent invasive hemodynamic and diagnostic CMR data were collected.During a twenty-two month period (3/2015 - 12/2016), enrolled subjects had the following clinical indications: post-heart transplant 33%, shunt 28%, pulmonary hypertension 18%, cardiomyopathy 15%, valvular heart disease 3%, and other 3%. Radiation-free CMR guided right heart catheterization attempts were all successful using passive catheters. In two subjects with septal defects, right and left heart catheterization were performed. There were no complications. One subject had six such procedures. Most subjects (51%) had undergone multiple (5.5 ± 5) previous X-Ray cardiac catheterizations. Retained thoracic surgical or transcatheter implants (36%) did not preclude successful CMR fluoroscopy heart catheterization. During the procedure, two subjects were receiving vasopressor infusions at baseline because of poor cardiac function, and in ten procedures, multiple hemodynamic conditions were tested.Comprehensive CMR fluoroscopy guided right heart catheterization was feasible and safe in this small cohort of pediatric subjects. This includes subjects with previous metallic implants, those requiring continuous vasopressor medication infusions, and those requiring pharmacologic provocation. Children requiring multiple, serial X-Ray cardiac catheterizations may benefit most from radiation sparing. This is a step toward wholly CMR guided diagnostic (right and left heart) cardiac catheterization and future CMR guided cardiac intervention.ClinicalTrials.gov NCT02739087 registered February 17, 2016.
| S-EPMC5585983 | biostudies-literature
Project description:BackgroundNoninvasive myocardial imaging modalities, such as cardiac magnetic resonance (CMR), single photon emission computed tomography (SPECT), and Positron emission tomography (PET), are well-established and extensively used to detect cardiac amyloid (CA). The purpose of this study is to directly compare CMR, SPECT, and PET scans in the diagnosis of CA, and to provide evidence for further scientific research and clinical decision-making.MethodsPubMed, Embase, and Cochrane Library were searched. Studies used CMR, SPECT and/or PET for the diagnosis of CA were included. Pooled sensitivity, specificity, positive and negative likelihood ratio (LR), diagnostic odds ratio (DOR), their respective 95% confidence intervals (CIs) and the area under the summary receiver operating characteristic (SROC) curve (AUC) were calculated. Quality assessment of included studies was conducted.ResultsA total of 31 articles were identified for inclusion in this meta-analysis. The pooled sensitivities of CMR, SPECT and PET were 0.84, 0.98 and 0.78, respectively. Their respective overall specificities were 0.87, 0.92 and 0.95. Subgroup analysis demonstrated that 99mTc-HMDP manifested the highest sensitivity (0.99). 99mTc-PYP had the highest specificity (0.95). The AUC values of 99mTc-DPD, 99mTc-PYP, 99mTc-HMDP were 0.89, 0.99, and 0.99, respectively. PET scan with 11C-PIB demonstrated a pooled sensitivity of 0.91 and specificity of 0.97 with an AUC value of 0.98.ConclusionOur meta-analysis reveals that SEPCT scans present better diagnostic performance for the identification of CA as compared with other two modalities.
| S-EPMC8499558 | biostudies-literature
Project description:Background: Myocardial perfusion imaging modalities, such as cardiac magnetic resonance (CMR), single-photon emission computed tomography (SPECT), and positron emission tomography (PET), are well-established non-invasive diagnostic methods to detect hemodynamically significant coronary artery disease (CAD). The aim of this meta-analysis is to compare CMR, SPECT, and PET in the diagnosis of CAD and to provide evidence for further research and clinical decision-making. Methods: PubMed, Web of Science, EMBASE, and Cochrane Library were searched. Studies that used CMR, SPECT, and/or PET for the diagnosis of CAD were included. Pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio with their respective 95% confidence interval, and the area under the summary receiver operating characteristic (SROC) curve were calculated. Results: A total of 203 articles were identified for inclusion in this meta-analysis. The pooled sensitivity values of CMR, SPECT, and PET were 0.86, 0.83, and 0.85, respectively. Their respective overall specificity values were 0.83, 0.77, and 0.86. Results in subgroup analysis of the performance of SPECT with 201Tl showed the highest pooled sensitivity [0.85 (0.82, 0.88)] and specificity [0.80 (0.75, 0.83)]. 99mTc-tetrofosmin had the lowest sensitivity [0.76 (0.67, 0.82)]. In the subgroup analysis of PET tracers, results indicated that 13N had the lowest pooled sensitivity [0.83 (0.74, 0.89)], and the specificity was the highest [0.91 (0.81, 0.96)]. Conclusion: Our meta-analysis indicates that CMR and PET present better diagnostic performance for the detection of CAD as compared with SPECT.
| S-EPMC8138058 | biostudies-literature
Project description:Stress cardiac magnetic resonance (CMR) has typically involved pharmacologic agents. Treadmill CMR has shown utility in single-center studies but has not undergone multicenter evaluation.Patients referred for treadmill stress nuclear imaging (SPECT) were prospectively enrolled across 4 centers. After rest (99m)Tc SPECT, patients underwent resting cine CMR. In-room stress was then performed using an MR-compatible treadmill with continuous 12-lead electrocardiogram monitoring. At peak stress, (99m)Tc was injected, and patients rapidly returned to the MR scanner isocenter for real-time, free-breathing stress cine and perfusion imaging. After recovery, cine and rest perfusion followed by late gadolinium enhancement acquisitions concluded CMR imaging. Stress SPECT was then acquired in adjacent nuclear laboratories. A subset of patients not referred for invasive coronary angiography within 2 weeks of stress underwent coronary computed tomography angiography. Angiographic data available in 94 patients showed sensitivity of 79%, specificity of 99% for exercise CMR with positive predictive value of 92% and negative predictive value of 96%. Agreement between treadmill stress CMR and angiography was strong (?=0.82), and moderate between SPECT and angiography (?=0.46) and CMR versus SPECT (?=0.48).The multicenter EXACT trial indicates excellent diagnostic value of treadmill stress CMR in typical patients referred for exercise SPECT.
| S-EPMC5015300 | biostudies-literature
Project description:ObjectivePrevalence and prognostic impact of cardiovascular disease differ between patients with or without diabetes. We aimed to explore differences in the prevalence and prognosis of myocardial ischemia by automated quantification of total perfusion deficit (TPD) among patients with and without diabetes.Research design and methodsOf 20,418 individuals who underwent single-photon emission computed tomography myocardial perfusion imaging, 2,951 patients with diabetes were matched to 2,951 patients without diabetes based on risk factors using propensity score. TPD was categorized as TPD = 0%, 0% < TPD < 1%, 1% ≤ TPD < 5%, 5% ≤ TPD ≤ 10%, and TPD >10%. Major adverse cardiovascular events (MACE) were defined as a composite of all-cause mortality, myocardial infarction, unstable angina, or late revascularization.ResultsMACE risk was increased in patients with diabetes compared with patients without diabetes at each level of TPD above 0 (P < 0.001 for interaction). In patients with TPD >10%, patients with diabetes had greater than twice the MACE risk compared with patients without diabetes (annualized MACE rate 9.4 [95% CI 6.7-11.6] and 3.9 [95% CI 2.8-5.6], respectively, P < 0.001). Patients with diabetes with even very minimal TPD (0% < TPD < 1%) experienced a higher risk for MACE than those with 0% TPD (hazard ratio 2.05 [95% CI 1.21-3.47], P = 0.007). Patients with diabetes with a TPD of 0.5% had a similar MACE risk as patients without diabetes with a TPD of 8%.ConclusionsFor every level of TPD >0%, even a very minimal deficit of 0% < TPD < 1%, the MACE risk was higher in the patients with diabetes compared with patients without diabetes. Patients with diabetes with minimal ischemia had comparable MACE risk as patients without diabetes with significant ischemia.
| S-EPMC6971784 | biostudies-literature
Project description:BackgroundIn this study, we aimed to analyze the hospitalization costs for immobile patients with hemorrhagic stroke (IHS) or ischemic stroke (IIS) in China and to determine the factors associated with hospitalization costs.MethodsWe evaluated patients with IHS and IIS hospitalized between November 2015 and July 2016 in six provinces or municipality cities of China. Linear regression analysis was used to examine the association with hospitalization costs and predictors.ResultsIn total, 1573 patients with IHS and 3143 with IIS were enrolled and analyzed. For IHS and IIS, the average length of stay (LoS) was 17.40 ± 12.3 and 14.47 ± 11.55 days. The duration of immobility was 12.11 ± 9.98 and 7.36 ± 9.77 days, respectively. Median hospitalization costs were RMB 47000.68 (interquartile range 19,827.37, 91,877.09) for IHS and RMB 16578.44 (IQR 7020.13, 36,357.65) for IIS. In both IHS and IIS groups, medicine fees accounted for more than one-third of hospitalization costs. Materials fees and medical service fees accounted for the second and third largest proportions of hospital charges in both groups. Linear regression analysis showed that LoS, hospital level, and previous surgery were key determinants of hospitalization costs in all immobile patients with stroke. Subgroup analysis indicated that hospital level was highly correlated with hospitalization costs for IHS whereas pneumonia and deep vein thrombosis were key factors associated with hospitalization costs for IIS.ConclusionsWe found that hospitalization costs were notably higher in IHS than IIS, and medicine fees accounted for the largest proportion of hospitalization costs in both patient groups, perhaps because most patients ended up with complications such as pneumonia thereby requiring more medications. LoS and hospital level may greatly affect hospitalization costs. Increasing the reimbursement ratio of medical insurance for patients with IHS is recommended. Decreasing medicine fees and LoS, preventing complications, and improving treatment capability may help to reduce the economic burden of stroke in China.
| S-EPMC7526192 | biostudies-literature
Project description:Imaging in heart failure (HF) provides data for diagnosis, prognosis and disease monitoring. Both MRI and nuclear imaging techniques have been successfully used for this purpose in HF. Positron Emission Tomography-Cardiac Magnetic Resonance (PET-CMR) is an example of a new multimodality diagnostic imaging technique with potential applications in HF. The threshold for adopting a new diagnostic tool to clinical practice must necessarily be high, lest they exacerbate costs without improving care. New modalities must demonstrate clinical superiority, or at least equivalence, combined with another important advantage, such as lower cost or improved patient safety. The purpose of this review is to outline the current status of multimodality PET-CMR with regard to HF applications, and determine whether the clinical utility of this new technology justifies the cost.
| S-EPMC5487818 | biostudies-other
Project description:BACKGROUND:Efficacy of reperfusion therapy can be assessed as myocardial salvage index (MSI) by determining the size of myocardium at risk (MaR) and myocardial infarction (MI), (MSI?=?1-MI/MaR). Cardiovascular magnetic resonance (CMR) can be used to assess MI by late gadolinium enhancement (LGE) and MaR by either T2-weighted imaging or contrast enhanced SSFP (CE-SSFP). Automatic segmentation algorithms have been developed and validated for MI by LGE as well as for MaR by T2-weighted imaging. There are, however, no algorithms available for CE-SSFP. Therefore, the aim of this study was to develop and validate automatic segmentation of MaR in CE-SSFP. METHODS:The automatic algorithm applies surface coil intensity correction and classifies myocardial intensities by Expectation Maximization to define a MaR region based on a priori regional criteria, and infarct region from LGE. Automatic segmentation was validated against manual delineation by expert readers in 183 patients with reperfused acute MI from two multi-center randomized clinical trials (RCT) (CHILL-MI and MITOCARE) and against myocardial perfusion SPECT in an additional set (n?=?16). Endocardial and epicardial borders were manually delineated at end-diastole and end-systole. Manual delineation of MaR was used as reference and inter-observer variability was assessed for both manual delineation and automatic segmentation of MaR in a subset of patients (n?=?15). MaR was expressed as percent of left ventricular mass (%LVM) and analyzed by bias (mean?±?standard deviation). Regional agreement was analyzed by Dice Similarity Coefficient (DSC) (mean?±?standard deviation). RESULTS:MaR assessed by manual and automatic segmentation were 36?±?10% and 37?±?11%LVM respectively with bias 1?±?6%LVM and regional agreement DSC 0.85?±?0.08 (n?=?183). MaR assessed by SPECT and CE-SSFP automatic segmentation were 27?±?10%LVM and 29?±?7%LVM respectively with bias 2?±?7%LVM. Inter-observer variability was 0?±?3%LVM for manual delineation and -1?±?2%LVM for automatic segmentation. CONCLUSIONS:Automatic segmentation of MaR in CE-SSFP was validated against manual delineation in multi-center, multi-vendor studies with low bias and high regional agreement. Bias and variability was similar to inter-observer variability of manual delineation and inter-observer variability was decreased by automatic segmentation. Thus, the proposed automatic segmentation can be used to reduce subjectivity in quantification of MaR in RCT. CLINICAL TRIAL REGISTRATION:NCT01379261. NCT01374321.
| S-EPMC4779553 | biostudies-literature
Project description:BACKGROUND:Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE:The aim of this study is to compare the effects and costs of the innovative Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) intervention with usual care CR. METHODS:In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS:The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS:The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15022.
| S-EPMC7011127 | biostudies-literature
Project description:ImportanceAt present, the choice of noninvasive testing for a diagnosis of significant coronary artery disease (CAD) is ambiguous, but nuclear myocardial perfusion imaging with single-photon emission tomography (SPECT) or positron emission tomography (PET) and coronary computed tomography angiography (CCTA) is predominantly used for this purpose. However, to date, prospective head-to-head studies are lacking regarding the diagnostic accuracy of these imaging modalities. Furthermore, the combination of anatomical and functional assessments configuring a hybrid approach may yield improved accuracy.ObjectivesTo establish the diagnostic accuracy of CCTA, SPECT, and PET and explore the incremental value of hybrid imaging compared with fractional flow reserve.Design, setting, and participantsA prospective clinical study involving 208 patients with suspected CAD who underwent CCTA, technetium 99m/tetrofosmin-labeled SPECT, and [15O]H2O PET with examination of all coronary arteries by fractional flow reserve was performed from January 23, 2012, to October 25, 2014. Scans were interpreted by core laboratories on an intention-to-diagnose basis. Hybrid images were generated in case of abnormal noninvasive anatomical or functional test results.Main outcomes and measuresHemodynamically significant stenosis in at least 1 coronary artery as indicated by a fractional flow reserve of 0.80 or less and relative diagnostic accuracy of SPECT, PET, and CCTA in detecting hemodynamically significant CAD.ResultsOf the 208 patients in the study (76 women and 132 men; mean [SD] age, 58 [9] years), 92 (44.2%) had significant CAD (fractional flow reserve ≤0.80). Sensitivity was 90% (95% CI, 82%-95%) for CCTA, 57% (95% CI, 46%-67%) for SPECT, and 87% (95% CI, 78%-93%) for PET, whereas specificity was 60% (95% CI, 51%-69%) for CCTA, 94% (95% CI, 88%-98%) for SPECT, and 84% (95% CI, 75%-89%) for PET. Single-photon emission tomography was found to be noninferior to PET in terms of specificity (P < .001) but not in terms of sensitivity (P > .99) using the predefined absolute margin of 10%. Diagnostic accuracy was highest for PET (85%; 95% CI, 80%-90%) compared with that of CCTA (74%; 95% CI, 67%-79%; P = .003) and SPECT (77%; 95% CI, 71%-83%; P = .02). Diagnostic accuracy was not enhanced by either hybrid SPECT and CCTA (76%; 95% CI, 70%-82%; P = .75) or by PET and CCTA (84%; 95% CI, 79%-89%; P = .82), but resulted in an increase in specificity (P = .004) at the cost of a decrease in sensitivity (P = .001).Conclusions and relevanceThis controlled clinical head-to-head comparative study revealed PET to exhibit the highest accuracy for diagnosis of myocardial ischemia. Furthermore, a combined anatomical and functional assessment does not add incremental diagnostic value but guides clinical decision-making in an unsalutary fashion.
| S-EPMC5710451 | biostudies-literature