The incremental prognostic value of post-stress left ventricular ejection fraction (EF) and volume over perfusion has not been investigated.
We identified 1680 consecutive patients who underwent rest ...Tl-201/stress Tc-99m sestamibi gated single photon emission computed tomography (SPECT) and who were followed-up for 569+/-106 days. Receiver-operator characteristics analysis defined an EF<45%, an end-systolic volume (ESV) >70 mL, and an end-diastolic volume >120 mL as optimal thresholds, yielding moderate sensitivity and high specificity in the prediction of cardiac death. Patients with an EF> or = 45% had mortality rates <1%/year, despite severe perfusion abnormalities, whereas patients with an EF<45% had high mortality rates, even with only mild/moderate perfusion abnormalities (9.2%/year; P<0.00001). Similarly, an ESV< or = 70 mL was related to a low cardiac death rate (<1.2%/year), even for patients with severe perfusion abnormalities, whereas patients with an ESV>70 mL and only mild/moderate perfusion abnormalities had high death rates (8.2%/year; P<0.00001). Patients with an EF<45% and an ESV< or = 70 mL had low cardiac death rates (1.7%/year); those with an EF<45% but an ESV>70 mL had high death rates (7.9%/year; P<0.02). Multivariate Cox proportional hazards regression showed that perfusion variables and ESV were independent predictors of overall coronary events, whereas EF and ESV demonstrated incremental prognostic values over prescan and perfusion information in predicting cardiac death and cardiac death or myocardial infarction.
Post-stress EF and ESV by gated-SPECT have incremental prognostic values over prescan and perfusion information in predicting cardiac death, and they provide clinically useful risk stratification.
Strontium-82/Rubidium-82 (82Sr/82Rb) generators are used widely for positron emission tomography (PET) imaging of myocardial perfusion. In this study, the 82Rb isotope yield and production efficiency ...of two FDA-approved 82Sr/82Rb generators were compared.
N = 515 sequential daily quality assurance (QA) reports from 9 CardioGen-82® and 9 RUBY-FILL® generators were reviewed over a period of 2 years. A series of test elutions was performed at different flow-rates on the RUBY-FILL® system to determine an empirical correction-factor used to convert CardioGen-82® daily QA values of 82Rb activity (dose-calibrator ‘maximum’ of 50 mL elution at 50 mL·min−1) to RUBY-FILL® equivalent values (integrated ‘total’ of 35 mL elution at 20 mL·min−1). The generator yield (82Rb) and production efficiency (82Rb yield/82Sr parent activity) were measured and compared after this conversion to a common scale.
At the start of clinical use, the system reported 82Rb activity from daily QA was lower for CardioGen-82® vs RUBY-FILL® (2.3 ± 0.2 vs 3.0 ± 0.2 GBq, P < 0.001) despite having similar 82Sr activity. Dose-calibrator ‘maximum’ (CardioGen-82®) values were found to under-estimate the integrated ‘total’ (RUBY-FILL®) activity by ~ 24% at 50 mL·min−1. When these data were used to convert the CardioGen-82 values to a common measurement scale (integrated total activity) the CardioGen-82® efficiency remained slightly lower than the RUBY-FILL® system on average (88 ± 4% vs 95 ± 4%, P < 0.001). The efficiency of 82Rb production improved for both systems over the respective periods of clinical use.
82Rb generator yield was significantly under-estimated using the CardioGen-82® vs RUBY-FILL® daily QA procedure. When generator yield was expressed as the integrated total activity for both systems, the estimated 82Rb production efficiency of the CardioGen-82® system was ~ 7% lower than RUBY-FILL® over the full period of clinical use.
We sought to determine whether chronotropic incompetence (CI) adds incremental value in predicting cardiac death (CD) and all-cause mortality and to determine which marker of CI is superior.
...Chronotropic incompetence, defined by either a low percent heart rate (HR) reserve achieved or failure to achieve 85% maximal age-predicted heart rate (MA-PHR), is a predictor of mortality. These variables have not been examined together in a comprehensive myocardial perfusion single-photon emission computed tomographic (SPECT), or MPS, model.
A total of 10,021 patients who underwent exercise MPS, evaluated by a summed stress score (SSS), were followed up for 719 +/- 252 days. Percent HR reserve = (peak HR - rest HR)/(220 - age - rest HR) x 100, with <80% considered abnormal.
A total of 2,956 patients (29.5%) had low %HR reserve; 1,331 (13.3%) achieved <85% MA-PHR; and 1,296 (13.0%) had both. There were 234 deaths (93 CDs). On multivariate analysis, the SSS, %HR reserve, and inability to achieve 85% MA-PHR were predictors of all-cause mortality and CD (all p < 0.01). Myocardial perfusion SPECT was the most powerful predictor of CD (chi-square = 50). When the %HR reserve and ability to achieve 85% MA-PHR were considered, only the former remained a predictor of CD (p = 0.006 vs. p = 0.59).
In a comprehensive MPS model, CI was an important predictor of CD and all-cause mortality. Percent HR reserve was superior to the ability to achieve 85% MA-PHR in predicting CD; MPS was superior to both. Combined with previous studies, the findings suggest that %HR reserve should become the standard for assessing the adequacy of HR response during exercise testing, and that it should be routinely incorporated in risk stratification algorithms.
OBJECTIVES
The study aim was to determine observational differences in costs of care by the coronary disease diagnostic test modality.
BACKGROUND
A number of diagnostic strategies are available with ...few data to compare the cost implications of the initial test choice.
METHODS
We prospectively enrolled 11,372 consecutive stable angina patients who were referred for stress myocardial perfusion tomography or cardiac catheterization. Stress imaging patients were matched by their pretest clinical risk of coronary disease to a series of patients referred to cardiac catheterization. Composite 3-year costs of care were compared for two patients management strategies: 1) direct cardiac catheterization (aggressive) and 2) initial stress myocardial perfusion tomography and selective catheterization of high risk patients (conservative). Analysis of variance techniques were used to compare costs, adjusting for treatment propensity and pretest risk.
RESULTS
Observational comparisons of aggressive as compared with conservative testing strategies reveal that costs of care were higher for direct cardiac catheterization in all clinical risk subsets (range: $2,878 to $4,579), as compared with stress myocardial perfusion imaging plus selective catheterization (range: $2,387 to $3,010, p < 0.0001). Coronary revascularization rates were higher for low, intermediate and high risk direct catheterization patients as compared with the initial stress perfusion imaging cohort (13% to 50%, p < 0.0001); cardiac death or myocardial infarction rates were similar (p > 0.20).
CONCLUSIONS
Observational assessments reveal that stable chest pain patients who undergo a more aggressive diagnostic strategy have higher diagnostic costs and greater rates of intervention and follow-up costs. Cost differences may reflect a diminished necessity for resource consumption for patients with normal test results.
Aims
Evaluate anti‐interleukin‐1β (IL‐1β) antibody, canakinumab, in patients with type 2 diabetes and impaired glucose tolerance (IGT) in whom hyperglycaemia may trigger IL‐1β‐associated inflammation ...leading to suppressed insulin secretion and β‐cell dysfunction.
Methods
This 4‐week, parallel‐group study randomized 190 patients with type 2 diabetes 2 : 1, canakinumab versus placebo, into the following treatment arms: metformin monotherapy, metformin + sulfonylurea, metformin + sulfonylurea + thiazolidinedione or insulin ± metformin. IGT population (n = 54) was randomized 1 : 1, canakinumab versus placebo. Primary efficacy assessment was change from baseline in insulin secretion rate (ISR) relative to glucose 0–2 h.
Results
Mean changes from baseline to week 4 in ISR relative to glucose at 0–2 h or other time points were not statistically significant for canakinumab versus placebo across groups. ISR (relative to glucose) at 0–0.5 h (first‐phase insulin secretion) numerically favoured canakinumab versus placebo in insulin‐treated patients {difference in mean change from baseline point estimate (PE) 3.81 pmol/min/m2/mmol/l; p = 0.0525} and in the IGT group (PE 3.92 pmol/min/m2/mmol/l; p = 0.1729). Mean change from baseline in fasting plasma glucose favoured canakinumab in the type 2 diabetes/metformin group and the IGT group; however, differences were not statistically significant. Mean change from baseline in peak insulin level and insulin AUC 0–4 h were statistically significantly higher in the canakinumab group in IGT patients. Canakinumab was well tolerated and consistent with known safety experience.
Conclusions
The trend towards improving ISR relative to glucose 0–0.5 h in patients treated with insulin supports the hypothesis that insulin secretion can be improved by blocking IL‐1β.
We have developed a new, completely automatic 3-dimensional software approach to quantitative perfusion SPECT. The main features of the software are myocardial sampling based on an ellipsoid model; ...use of the entire count profile between the endocardial and epicardial surfaces; independence of the algorithm from myocardial shape, size, and orientation and establishment of a standard 3-dimensional point-to-point correspondence among all sampled myocardial regions; automatic generation of quantitative measurements and 5-point semiquantitative scores for each of 20 myocardial segments and automatic derivation of summed perfusion scores; and automatic generation of normal limits for any given patient population on the basis of data fractionally normalized to minimize hot spot artifacts.
The new algorithm was tested on the tomographic images of 420 patients studied with a rest 201TI (111-167 MBq, 35 s/projection)-stress 99mTc-sestamibi (925-1480 MBq, 25 s/projection) separate dual-isotope protocol on a single-detector camera, a dual-detector 90 degrees camera, and a triple-detector camera.
The algorithm was successful in 397 of 420 patients (94.5%) and 816 of 840 image datasets (97.1%), with a statistically significant difference between the success rates of the 201TI images (399/ 420, or 95.0%) and the 99mTc images (417/420, or 99.3%; P < 0.001). Algorithm failure was caused by extracardiac uptake (10/24, or 41.7%) or inaccurate identification of the valve plane because of low count statistics (14/24, or 58.3%) and was obviated by simply limiting the image volume in which the software operates. Reproducibility of measurements of summed perfusion scores (r = 0.999 and 1 for stress and rest, respectively), global defect extent (r = 0.999 and 1 for stress and rest, respectively), and segmental perfusion scores (exact agreement = 99.9%, kappa = 0.998 for stress and 0.997 for rest) was extremely high.
Automatic 3-dimensional quantitation of perfusion from 201Tl and 99mTc-sestamibi images is feasible and reproducible. The described software, because it is based on the same sampling scheme used for gated SPECT analysis, ensures intrinsically perfect registration of quantitative perfusion with quantitative regional wall motion and thickening information, if gated SPECT is used.
We sought to determine whether chronotropic incompetence (CI) adds incremental value in predicting cardiac death (CD) and all-cause mortality and to determine which marker of CI is superior.
...Chronotropic incompetence, defined by either a low percent heart rate (HR) reserve achieved or failure to achieve 85% maximal age-predicted heart rate (MA-PHR), is a predictor of mortality. These variables have not been examined together in a comprehensive myocardial perfusion single-photon emission computed tomographic (SPECT), or MPS, model.
A total of 10,021 patients who underwent exercise MPS, evaluated by a summed stress score (SSS), were followed up for 719 ± 252 days. Percent HR reserve = (peak HR − rest HR)/(220 − age − rest HR) × 100, with <80% considered abnormal.
A total of 2,956 patients (29.5%) had low %HR reserve; 1,331 (13.3%) achieved <85% MA-PHR; and 1,296 (13.0%) had both. There were 234 deaths (93 CDs). On multivariate analysis, the SSS, %HR reserve, and inability to achieve 85% MA-PHR were predictors of all-cause mortality and CD (all p < 0.01). Myocardial perfusion SPECT was the most powerful predictor of CD (chi-square = 50). When the %HR reserve and ability to achieve 85% MA-PHR were considered, only the former remained a predictor of CD (p = 0.006 vs. p = 0.59).
In a comprehensive MPS model, CI was an important predictor of CD and all-cause mortality. Percent HR reserve was superior to the ability to achieve 85% MA-PHR in predicting CD; MPS was superior to both. Combined with previous studies, the findings suggest that %HR reserve should become the standard for assessing the adequacy of HR response during exercise testing, and that it should be routinely incorporated in risk stratification algorithms.
Postexercise wall motion abnormality (WMA) in patients with normal resting myocardial perfusion may represent prolonged postischemic stunning, and may be related to the presence of severe ...angiographic coronary artery disease (CAD). This study assesses the diagnostic value of postexercise WMA by technetium-99m (Tc-99m) sestamibi gated single-photon emission computed tomography (SPECT) in patients with normal resting perfusion. Ninety-nine patients underwent exercise gated Tc-99m sestamibi/resting thallium-201 SPECT and coronary angiography within 90 days of nuclear testing. All patients had normal perfusion at rest. Multivariate logistic regression analysis demonstrated an incremental value of wall motion and perfusion over perfusion data alone in identifying severe and extensive CAD. Sensitivity for identifying any severely stenosed coronary artery by WMA was significantly higher than by severe perfusion defect (78% vs 49%, p <0.0001). Overall specificities of severe perfusion defect and WMA were 91% and 85%, respectively (p = NS). Thus, postexercise WMA detected by gated Tc-99m sestamibi SPECT in patients with normal resting perfusion is a sensitive marker of severe and extensive CAD.