Background The COURAGE trial reported similar clinical outcomes for patients with stable ischemic heart disease (SIHD) receiving optimal medical therapy (OMT) with or without percutaneous coronary ...intervention (PCI). The current post hoc substudy analysis examined the relationship between baseline stress myocardial ischemia and clinical outcomes based on randomized treatment assignment. Methods A total of 1,381 randomized patients (OMT n = 699, PCI + OMT n = 682) underwent baseline stress myocardial perfusion single-photon emission computed tomographic imaging. Site investigators interpreted the extent of ischemia by the number of ischemic segments using a 6-segment myocardial model. Patients were divided into those with no to mild (< 3 ischemic segments) and moderate to severe ischemia (≥ 3 ischemic segments). Cox proportional hazards models were calculated to assess time to the primary end point of death or myocardial infarction. Results At baseline, moderate to severe ischemia occurred in more than one-quarter of patients (n = 468), and the incidence was comparable in both treatment groups ( P = .36). The primary end point, death or myocardial infarction, was similar in the OMT and PCI + OMT treatment groups for no to mild (18% and 19%, P = .92) and moderate to severe ischemia (19% and 22%, P = .53, interaction P value = .65). There was no gradient increase in events for the overall cohort with the extent of ischemia. Conclusions From the COURAGE trial post hoc substudy, the extent of site-defined ischemia did not predict adverse events and did not alter treatment effectiveness. Currently, evidence supports equipoise as to whether the extent and severity of ischemia impact on therapeutic effectiveness.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Successful durable repair of severe degenerative mitral regurgitation with low operative mortality encourages intervention in asymptomatic patients rather than “watchful waiting.” Our ...objectives were to assess trends in patient characteristics, timing of intervention, and evolving surgical techniques at a high-volume center, and determine effects of these changes on outcomes after mitral valve (MV) repair over a 25-year period. Methods From January 1, 1985, to January 1, 2011, 5,902 patients underwent isolated repair (with or without tricuspid repair for functional regurgitation) for degenerative MV disease at Cleveland Clinic. For illustration, the experience is presented in 3 eras: 1985 to 1997 (era 1, n = 1,184), 1997 to 2005 (era 2, n = 2,400), and 2005 to 2011 (era 3, n = 2,318). Results In era 3, more patients were asymptomatic on presentation (44% in New York Heart Association NYHA class I vs 25% in era 1), with less heart failure (11% vs 29%) and atrial fibrillation (9.9% vs 23%). Full sternotomy decreased from era 1 (n = 1,100/93%) to era 2 (n = 602/25%) (era 3, n = 717/31%), and robotic surgery emerged (n = 577/25%) in era 3. Median length of stay shortened (era 1 = 7 days, era 2 = 5.9 days, era 3 = 5.2 days, p < 0.0001), and in-hospital mortality remained low (era 1 = 5/0.42%, era 2 = 5/0.21%, era 3 = 1/0.043%); 0.73% overall required reoperation on the repaired valve before discharge, and 97% had 0 to 1+ regurgitation at discharge. Conclusions Treatment trends over 25 years reveal that rather than watchful waiting, a more aggressive approach to degenerative MV disease, with earlier intervention for severe regurgitation in asymptomatic patients and less invasive operative techniques, is successful, safe, and effective.
Objectives The goal of this study was to compare the economic outcomes of patients undergoing different noninvasive tests to evaluate suspected coronary artery disease (CAD). Background Evaluation of ...noninvasive tests is shifting to an assessment of their effect on clinical outcomes rather than on their diagnostic accuracy. Economic outcomes of testing are particularly important in light of rising medical care costs. Methods We used an observational registry of 1,703 patients who underwent coronary computed tomography angiography (CTA) (n = 590), positron emission tomography (PET) (n = 548), or single-photon emission computed tomography (SPECT) (n = 565) for diagnosis of suspected CAD at 1 of 41 centers. We followed patients for 2 years, and documented resource use, medical costs for CAD, and clinical outcomes. We used multivariable analysis and propensity score matching to control for differences in baseline characteristics. Results Two-year costs were highest after PET ($6,647, 95% confidence interval CI: $5,896 to $7,397), intermediate after CTA ($4,909, 95% CI: $4,378 to $5,440), and lowest after SPECT ($3,965, 95% CI: $3,520 to $4,411). After multivariable adjustment, CTA costs were 15% higher than SPECT (p < 0.01), and PET costs were 22% higher than SPECT (p < 0.0001). Two-year mortality was 0.7% after CTA, 1.6% after SPECT, and 5.5% after PET. The incremental cost-effectiveness ratio for CTA compared with SPECT was $11,700 per life-year added, but was uncertain, with higher costs and higher mortality in 13% of bootstrap replications. Patients undergoing PET had higher costs and higher mortality than patients undergoing SPECT in 98% of bootstrap replications. Conclusions Costs were significantly lower after using SPECT rather than CTA or PET in the evaluation of suspected coronary disease. SPECT was economically attractive compared with PET, whereas CTA was associated with higher costs and no significant difference in mortality compared with SPECT.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objectives This study sought to compare the survival of asymptomatic patients with previous revascularization and ischemia, who subsequently underwent repeat revascularization or medical therapy ...(MT). Background Coronary artery disease is progressive and recurring; thus, stress myocardial perfusion scintigraphy (MPS) is widely used to identify ischemia in patients with previous revascularization. Methods Of 6,750 patients with previous revascularization undergoing MPS between January 1, 2005, and December 31, 2007, we identified 769 patients (age 67.7 ± 9.5 years; 85% men) who had ischemia and were asymptomatic. A propensity score was developed to express the associations of revascularization. Patients were followed up over a median of 5.7 years (interquartile range: 4.7 to 6.4 years) for all-cause death. A Cox proportional hazards model was used to identify the association of revascularization with all-cause death, with and without adjustment for the propensity score. The model was repeated in propensity-matched groups undergoing MT versus revascularization. Results Among 769 patients, 115 (15%) underwent revascularization a median of 13 days (interquartile range: 6 to 31 days) after MPS. There were 142 deaths; mortality with MT and revascularization were 18.3% and 19.1% (p = 0.84). In a Cox proportional hazards model (chi-square test = 89.4) adjusting for baseline characteristics, type of previous revascularization, MPS data, and propensity scores, only age and hypercholesterolemia but not revascularization were associated with mortality. This result was confirmed in a propensity-matched group. Conclusions Asymptomatic patients with previous revascularization and inducible ischemia on MPS realize no survival benefit from repeat revascularization. In this group of post-revascularization patients, an ischemia-based treatment strategy did not alter mortality.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Cardiovascular Imaging Research at the Crossroads Shaw, Leslee J., PhD; Min, James K., MD; Hachamovitch, Rory, MD, MS ...
JACC. Cardiovascular imaging,
03/2010, Volume:
3, Issue:
3
Journal Article
Peer reviewed
Open access
Cardiovascular (CV) imaging plays a critical role in therapeutic decision making and is performed in more than 10 million patients each year; a large share of the nearly 40 million patients living ...with CV disease. CV imaging may serve as a valuable component of a patient's evaluation, provided that its enhanced diagnostic findings invoke appropriate and targeted therapies that improve symptom burden and long-term outcomes and are not offset by the upfront procedural and induced costs of care. As well, the overall clinical benefit that imaging imparts to the patient must significantly outweigh any untoward risk, including radiation or procedural complications. Explosive growth in imaging has resulted in a rapid escalation of costs for testing encumbering an estimated $80 billion dollars annually and represents a sizeable portion of cardiologists' income. Concern remains that continued expansion of CV imaging services may further add to the complexity of health care services and magnify the societal burden of health care. The field of CV imaging is beset by high procedural use, high growth rates, and often, a lack of demonstrable quality. The end result of our current health care system and reimbursement models is an over emphasis on volume and throughput, extensive efforts necessary for justification of procedural use, and a broad referral population exceeding guideline-accepted best practices. An inextricable link between imaging markers and outcomes forms a critical nexus that can be used to establish the value of a test, and is now the standard upon which technology will be evaluated by private payers and governmental agencies alike. This new benchmark necessitates high-quality research to compare the effectiveness of CV imaging modalities to elicit improvements in health outcomes; representing a dramatic paradigm shift for the field of CV imaging research. In this review, we will discuss current health policy of CV imaging as well as the future of CV imaging-based comparative effectiveness research.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background Appropriate use criteria (AUC) for stress single-photon emission computed tomography (SPECT) are only one step in appropriate use of imaging. Other steps include pretest clinical risk ...evaluation and optimal management responses. We sought to understand the link between AUC, risk evaluation, management, and outcome. Methods We used AUC to classify 1,199 consecutive patients (63.8 ± 12.5 years, 56% male) undergoing SPECT as inappropriate, uncertain, and appropriate. Framingham score for asymptomatic patients and Bethesda angina score for symptomatic patients were used to classify patients into high (≥5%/y), intermediate, and low (≤1%/y) risk. Subsequent patient management was defined as appropriate or inappropriate based on the concordance between management decisions and the SPECT result. Patients were followed up for a median of 4.8 years, and cause of death was obtained from the social security death registry. Results Overall, 62% of SPECTs were appropriate, 18% inappropriate, and 20% uncertain (only 5 were unclassified). Of 324 low-risk studies, 108 (33%) were inappropriate, compared with 94 (15%) of 621 intermediate-risk and 1 (1%) of 160 high-risk studies ( P < .001). There were 79 events, with outcomes of inappropriate patients better than uncertain and appropriate patients. Management was appropriate in 986 (89%), and appropriateness of patient management was unrelated to AUC ( P = .65). Conclusion Pretest clinical risk evaluation may be helpful in appropriateness assessment because very few high-risk patients are inappropriate, but almost half of low-risk patients are inappropriate or uncertain. Appropriate patient management is independent of appropriateness of testing.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Objectives We compared analytical approaches to estimate the added value of myocardial perfusion single-photon emission computed tomography (MPS) variables in estimating coronary artery disease (CAD) ...outcomes. Background Stress MPS markers of regional ischemia are strong estimators of prognosis. Evidence published to date has not compared analytical methods to establish the added value of stress MPS and to define a clinically meaningful approach to detect improve classification of risk. Methods A total of 4,575 patients were consecutively and prospectively enrolled in the Myoview Prognosis Registry. Multivariable Cox proportional hazards model were employed to estimate CAD death or myocardial infarction (MI). Risk reclassification methods were also calculated. Results In risk-adjusted models (including age, sex, presenting symptoms, stress type, CAD history, and risk factors), stress MPS ischemia, rest and post-stress left ventricular ejection fraction (LVEF) (all p < 0.0001) were all significant estimators of CAD death or MI. In this multivariable model, 34% of the model chi-square was contributed by MPS ischemia. In receiver-operating characteristic curve analysis, the area under the curve increased from 0.61 to 0.66 when rest and post-stress LVEF were combined with pre-test CAD likelihood (p < 0.0001), increasing to 0.69 for MPS ischemia (p < 0.0001). The net reclassification improvement (NRI) by adding the Duke Treadmill Score (DTS) to a model including pre-test CAD likelihood was 0.112. The cost per NRI was $57 for the exercise test as compared with an office visit for risk stratification purposes. Further, the NRI by adding MPS ischemia to a model with the DTS and pre-test CAD likelihood was 0.358. The cost per NRI was $615 for the stress MPS as compared with an exercise test. Conclusions Stress-induced ischemia is independently predictive of near-term CAD outcomes. Analytical approaches that establish the reclassification of events provide a unique approach and may serve as a quality imaging metric for estimation of improved health outcomes for stress MPS as well as for comparison to other imaging modalities.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Aortic Size Assessment by Noncontrast Cardiac Computed Tomography: Normal Limits by Age, Gender, and Body Surface Area Arik Wolak, Heidi Gransar, Louise E. J. Thomson, John D. Friedman, Rory ...Hachamovitch, Ariel Gutstein, Leslee J. Shaw, Donna Polk, Nathan D. Wong, Rola Saouaf, Sean W. Hayes, Alan Rozanski, Piotr J. Slomka, Guido Germano, Daniel S. Berman Assessment of aortic size is possible from computed tomography (CT) scans obtained for coronary artery calcium (CAC) measurements. The current study assesses aortic size by gated noncontrast CT in a large cohort of low-risk, asymptomatic adults (n = 4,039) to establish normal reference values for ascending and descending thoracic aortic diameters, including standards by age, gender, and body surface area subsets. Mean (and upper normal limits) diameters were 33 ± 4 mm (41 mm) for ascending and 24 ± 3 mm (30 mm) for descending thoracic aorta. This study defines reference standards for the inclusion of thoracic aortic dimensions to be a part of the clinical report for CAC scanning.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Objectives The aim of this study was to evaluate the prognostic value of quantitative assessment of pericardial delayed hyperenhancement (DHE) among patients with recurrent pericarditis ...(RP). Background Pericardial DHE on cardiac magnetic resonance may persist beyond the acute phase of pericarditis, suggesting continued pericardial inflammation. Methods This is a retrospective cohort study of 159 patients with RP who underwent DHE imaging and had a follow-up period of more than 6 months. Pericardial inflammation was quantified on short-axis DHE sequences by contouring the pericardium, selecting normal septal myocardium as a reference region, and then quantifying the pericardial signal that was >6 SD above the reference. Our primary outcome was clinical remission; secondary outcomes were time to recurrence and recurrence rate. Results The mean age of our patients was 46 ± 14 years, and 52% were women. During a median follow-up period of 23 months (interquartile range: 15 to 34 months), 32 (20%) patients achieved clinical remission. In the multivariable Cox proportional hazards model, lower quantitative pericardial DHE (hazard ratio: 0.77; 95% confidence interval: 0.64 to 0.93; p = 0.008) was independently associated with clinical remission. When added to background clinical and laboratory variables, quantitative pericardial DHE had incremental prognostic value over baseline clinical and laboratory variables (integrated discrimination improvement: 8%; net reclassification improvement: 36%). Furthermore, patients with a higher quantitative DHE had shorter time to subsequent recurrence (p = 0.012) and had a higher recurrence rate at 6 months (p = 0.026). Conclusions Quantitative assessment of pericardial DHE was associated with clinical outcomes among patients with RP and provided incremental information regarding the clinical course of patients with RP.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Emergency department presentations with chest pain are expensive and often unrelated to coronary artery disease (CAD). Coronary computed tomographic angiography (CTA) may allow earlier discharge of ...low-risk patients, resulting in cost savings. We modeled clinical and economic outcomes of diagnostic strategies in patients with chest pain and at low risk of CAD: exercise electrocardiography (ECG), stress single-photon emission computed tomography (SPECT), stress echocardiography, and a CTA strategy comprising an initial CTA scan with confirmatory SPECT for indeterminate results. Our results suggest that a 2-step diagnostic strategy of CTA with SPECT for intermediate scans is likely to be less costly and more effective for the diagnosis of a patient group at low risk of CAD and a prevalence of 2% to 30%. The CTA strategies were cost saving (lower costs, higher quality-adjusted life-years) compared with stress ECG, echocardiography, and SPECT. Confirming intermediate/indeterminate CTA scans with SPECT results in cost savings and quality-adjusted life-year gains due to reduced hospitalization of patients who returned false-positive initial CTA test. However, CTA may be associated with a higher event rate in negative patients than SPECT, and the diagnostic and prognostic information for the use of CTA in the emergency department is evolving. Large comparative, randomized, controlled trials of the different diagnostic strategies are needed to compare the long-term costs and consequences of each strategy in a population of defined low-risk patients in the emergency department.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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