Asymptomatic coronary artery disease in a Norwegian cohort with type 2 diabetes: a prospective angiographic study with intravascular ultrasound evaluation.

AIMS: The prevalence of asymptomatic coronary artery disease (CAD) in type 2 diabetes (T2D) is unclear. We investigated the extent and prevalence of asymptomatic CAD in T2D patients by utilizing invasive coronary angiography (ICA) and intravascular ultrasound (IVUS), and whether CAD progression, evaluated by ICA, could be modulated with a multi-intervention to reduce cardiovascular (CV) risk. METHODS: Fifty-six T2D patients with ≥ 1 additional CV risk factor participated in a 2 year randomized controlled study comparing hospital-based multi-intervention (multi, n = 30) versus standard care (stand, n = 26), with a pre-planned follow-up at year seven. They underwent ICA at baseline and both ICA and IVUS at year seven. ICA was described by conventional CAD severity and extent scores. IVUS was described by maximal intimal thickness (MIT), percent and total atheroma volume and compared with individuals without T2D and CAD (heart transplant donors who had IVUS performed 7-11 weeks post-transplant, n = 147). RESULTS: Despite CV risk reduction in multi after 2 years intervention, there was no between-group difference in the progression of CAD at year seven. Overall, the prevalence of CAD defined by MIT ≥ 0.5 mm in the T2DM subjects was 84%, and as compared to the non-T2DM controls there was a significantly higher atheroma burden (mean MIT, PAV and TAV in the T2D population were 0.75 ± 0.27 mm, 33.8 ± 9.8% and 277.0 ± 137.3 mm3 as compared to 0.41 ± 0.19 mm, 17.8 ± 7.3% and 134.9 ± 100.6 mm3 in the reference population). CONCLUSION: We demonstrated that a 2 year multi-intervention, despite improvement in CV risk factors, did not influence angiographic progression of CAD. Further, IVUS revealed that the prevalence of asymptomatic CAD in T2D patients is high, suggesting a need for a broader residual CV risk management using alternative approaches. Trial registration Clinical trials.gov id: NCT00133718 ( https://clinicaltrials.gov/ct2/show/NCT00133718 ).

Correction to: Applicability and accuracy of pretest probability calculations implemented in the NICE clinical guideline for decision making about imaging in patients with chest pain of recent onset.

The original version of this article, published on 19 March 2018, unfortunately contained a mistake. The following correction has therefore been made in the original: The names of the authors Philipp A. Kaufmann, Ronny Ralf Buechel and Bernhard A. Herzog were presented incorrectly.

Applicability and accuracy of pretest probability calculations implemented in the NICE clinical guideline for decision making about imaging in patients with chest pain of recent onset.

OBJECTIVES: To analyse the implementation, applicability and accuracy of the pretest probability calculation provided by NICE clinical guideline 95 for decision making about imaging in patients with chest pain of recent onset. METHODS: The definitions for pretest probability calculation in the original Duke clinical score and the NICE guideline were compared. We also calculated the agreement and disagreement in pretest probability and the resulting imaging and management groups based on individual patient data from the Collaborative Meta-Analysis of Cardiac CT (CoMe-CCT). RESULTS: 4,673 individual patient data from the CoMe-CCT Consortium were analysed. Major differences in definitions in the Duke clinical score and NICE guideline were found for the predictors age and number of risk factors. Pretest probability calculation using guideline criteria was only possible for 30.8 % (1,439/4,673) of patients despite availability of all required data due to ambiguity in guideline definitions for risk factors and age groups. Agreement regarding patient management groups was found in only 70 % (366/523) of patients in whom pretest probability calculation was possible according to both models. CONCLUSIONS: Our results suggest that pretest probability calculation for clinical decision making about cardiac imaging as implemented in the NICE clinical guideline for patients has relevant limitations. KEY POINTS: • Duke clinical score is not implemented correctly in NICE guideline 95. • Pretest probability assessment in NICE guideline 95 is impossible for most patients. • Improved clinical decision making requires accurate pretest probability calculation. • These refinements are essential for appropriate use of cardiac CT.

Long-term follow-up of a hospital-based, multi-intervention programme in type 2 diabetes mellitus: impact on cardiovascular events and death.

Objective To report the long-term impact on cardiovascular (CV) outcomes and mortality of a 2-year hospital-based multi-interventional care programme as compared with general practitioner (GP)-provided standard care. Methods Patients with type 2 diabetes with ≥ 1 additional CV risk factor were randomized to 2 years of specialist-based, multi-intervention comprising lifestyle modification and specific pharmacological treatment, or GP-based standard care. After the 2-year intervention period, all participants returned to pre-study care, but were followed up for CV outcomes and mortality. The primary outcome was time to any first severe CV event or death. Results A total of 120 patients (31 women) were enrolled in the study. During the mean ± SD observational period of 8.7 ± 2.0 years, 27 patients (16 and 11 in the multi-intervention and standard care groups, respectively) experienced at least one primary outcome event, with a hazard ratio (HR) if allocated to the multi-intervention group of 1.73 (95% confidence interval (CI) 0.80, 3.75). The HR for total mortality was 1.82 (95% CI 0.66, 5.01). Conclusions Hospital-based multi-intervention in patients with type 2 diabetes mellitus improved long-term glycaemic control, but failed to reduce CV outcomes and deaths. Clinical trials.gov id: NCT00133718.

Low-dose CT coronary angiography for assessment of coronary artery disease in patients with type 2 diabetes--a cross-sectional study.

BACKGROUND: Silent coronary artery disease (CAD) is prevalent in type 2 diabetes mellitus (T2DM). Although coronary computed tomography angiography (CCTA) over recent years has emerged a useful tool for assessing and diagnosing CAD it's role and applicability for patients with T2DM is still unclarified, in particular in asymptomatic patients. We aimed to assess the role of CCTA in detecting and characterizing CAD in patients with T2DM without cardiac symptoms when compared to gold standard invasive coronary angiography (ICA). METHODS: This was a cross-sectional analysis of patients with T2DM without symptomatic CAD enrolled in the Asker and Baerum Cardiovascular Diabetes Study who, following clinical examination and laboratory assessment, underwent subsequently CCTA and ICA. RESULTS: In total 48 Caucasian patients with T2DM (36 men, age 64.0 ± 7.3 years, diabetes duration 14.6 ± 6.4 years, HbA1c 7.4 ± 1.1 %, BMI 29.6 ± 4.3 kg/m(2)) consented to, and underwent, both procedures (CCTA and ICA). The population was at intermediate cardiovascular risk (mean coronary artery calcium score 269, 75 % treated with antihypertensive therapy). ICA identified a prevalence of silent CAD at 17 % whereas CCTA 35 %. CCTA had a high sensitivity (100 %) and a high negative predictive value (100 %) for detection of patients with CAD when compared to ICA, but the positive predictive value was low (47 %). CONCLUSIONS: Low-dose CCTA is a reliable method for detection and exclusion of significant CAD in T2DM and thus may be a useful tool for the clinicians. However, a low positive predictive value may limit its usefulness as a screening tool for all CAD asymptomatic patients with T2DM. Further studies should assess the applicability for risk assessment beyond the evaluation of the vascular bed.

Mediastinitis after coronary artery bypass grafting increases the incidence of left internal mammary artery obstruction.

Mediastinitis after coronary artery bypass grafting (CABG) gives a longstanding chronic inflammation and has a detrimental negative effect on long-term survival. For this reason, we aimed to study the effect of mediastinitis on graft patency after CABG. The epidemiologic design was of an exposed (mediastinitis, n = 41) versus non-exposed (non-mediastinitis, controls, n = 41) cohort with two endpoints: (i) obstruction of saphenous vein grafts (SVG) and (ii) obstruction of the internal mammary artery (IMA) grafts. The graft patency was evaluated with coronary CT-angiography examination at a median follow-up of 2·7 years. The number of occluded SVG in the mediastinitis group was 18·9% versus 15·5% in the control group. Using generalized estimating equations model with exchangeable matrix, and confounding effect of ischaemic time and patients age, we found no significant association between presence of mediastinitis and SVG obstruction [rate ratio (RR) = 0·96, 95% CI (0·52-2·67), P = 0·697]. The number of occluded IMA grafts was 10·5% in the mediastinitis group and 2·4% in the control group. Using the Poisson regression model, we estimated RR = 5·48, 95% CI (1·43-21·0) and P = 0·013. There was a significant association between mediastinitis and IMA graft obstruction, when controlling for the confounding effect of ischaemic time, body mass index, presence of diabetes mellitus and the number of diseased vessels. Presence of mediastinitis increases the risk of IMA graft obstruction. This may confirm the importance of inflammation as a major contributor to the pathogenesis of atherosclerosis and explain the negative effect of mediastinitis on a long-term survival.

Individual patient data meta-analysis for the clinical assessment of coronary computed tomography angiography: protocol of the Collaborative Meta-Analysis of Cardiac CT (CoMe-CCT).

BACKGROUND: Coronary computed tomography angiography has become the foremost noninvasive imaging modality of the coronary arteries and is used as an alternative to the reference standard, conventional coronary angiography, for direct visualization and detection of coronary artery stenoses in patients with suspected coronary artery disease. Nevertheless, there is considerable debate regarding the optimal target population to maximize clinical performance and patient benefit. The most obvious indication for noninvasive coronary computed tomography angiography in patients with suspected coronary artery disease would be to reliably exclude significant stenosis and, thus, avoid unnecessary invasive conventional coronary angiography. To do this, a test should have, at clinically appropriate pretest likelihoods, minimal false-negative outcomes resulting in a high negative predictive value. However, little is known about the influence of patient characteristics on the clinical predictive values of coronary computed tomography angiography. Previous regular systematic reviews and meta-analyses had to rely on limited summary patient cohort data offered by primary studies. Performing an individual patient data meta-analysis will enable a much more detailed and powerful analysis and thus increase representativeness and generalizability of the results. The individual patient data meta-analysis is registered with the PROSPERO database (CoMe-CCT, CRD42012002780). METHODS/DESIGN: The analysis will include individual patient data from published and unpublished prospective diagnostic accuracy studies comparing coronary computed tomography angiography with conventional coronary angiography. These studies will be identified performing a systematic search in several electronic databases. Corresponding authors will be contacted and asked to provide obligatory and additional data. Risk factors, previous test results and symptoms of individual patients will be used to estimate the pretest likelihood of coronary artery disease. A bivariate random-effects model will be used to calculate pooled mean negative and positive predictive values as well as sensitivity and specificity. The primary outcome of interest will be positive and negative predictive values of coronary computed tomography angiography for the presence of coronary artery disease as a function of pretest likelihood of coronary artery disease, analyzed by meta-regression. As a secondary endpoint, factors that may influence the diagnostic performance and clinical value of computed tomography, such as heart rate and body mass index of patients, number of detector rows, and administration of beta blockade and nitroglycerin, will be investigated by integrating them as further covariates into the bivariate random-effects model. DISCUSSION: This collaborative individual patient data meta-analysis should provide answers to the pivotal question of which patients benefit most from noninvasive coronary computed tomography angiography and thus help to adequately select the right patients for this test.

Diagnosis of congenital hip dysplasia in the newborn.

BACKGROUND AND PURPOSE: Screening of newborn infants for congenital hip dysplasia may be done by clinical examination, ultrasound, or radiography--or a combination of these. Studies that have used clinical examination followed by ultrasound imaging for infants with certain risk factors have shown excellent results, but they were performed by very experienced practitioners. We wanted to find out whether the results of such screening would be equally good with less optimal staffing. Thus, we evaluated the real-life performance of a screening program for detection of congenital hip dysplasia in newborn infants. SUBJECTS AND METHODS: We performed a retrospective chart review of all infants (n = 1,983) referred for evaluation for suspected congenital hip dysplasia from one single obstetric hospital, where 19,820 infants had been screened from 1992 through 2001. Infants were referred either because of a positive finding during the Ortolani and Barlow examinations or because of the presence of risk factors. RESULTS: The reasons for referral of the 1,983 infants (10% of those examined) were: positive clinical signs in 255 (1.3% of all examined) and risk factors in 1,547 (7.8%), and a combination of both in 114 (0.6%). 67 other infants (0.3%) who had passed the initial pediatric screening were later referred from the local health centers. Finally, 23 of the 1,983 infants were subsequently referred again by their health center for renewed orthopedic evaluation. Of the infants who were treated (298/1,983 = 15% of those referred), those with a pathological examination result were represented proportionately more than infants who were referred because of risk factors (0.8% as opposed to 0.5%). Delayed diagnoses occurred in 1.7/1,000 infants. INTERPRETATION: The performance of a screening protocol for congenital hip dysplasia in a real-life setting involving several physicians both on the pediatric and orthopedic side may not live up to expectations based on the use of such a protocol in an optimized setting. This type of analysis of screening data may serve to pinpoint weaknesses, and thus lead to adjustments that may enhance quality.