Faith Selzer

Prevalence and risk factors of carotid plaque in women with systemic lupus erythematosus

OBJECTIVE To determine the prevalence of carotid atherosclerosis and associated risk factors in women with systemic lupus erythematosus (SLE). METHODS Carotid plaque and intima-media wall thickness (IMT) were measured by B-mode ultrasound in women with SLE. Risk factors associated with carotid plaque and IMT were determined at the time of the ultrasound scan and included traditional cardiovascular risk factors, SLE-specific variables, and inflammation markers. RESULTS The 175 women with SLE were predominantly white (87%), with a mean age of 44.9 years (SD 11.5). Twenty-six women (15%) had a previous arterial event (10 coronary [myocardial infarction or angina], 11 cerebrovascular [stroke or transient ischemic attack], and 5 both). The mean +/- SD IMT was 0.71 +/- 0.14 mm, and 70 women (40%) had focal plaque. Variables significantly associated with focal plaque (P < 0.05) included age, duration of lupus, systolic, diastolic, and pulse pressure, body mass index, menopausal status, levels of total and low-density lipoprotein (LDL) cholesterol, fibrinogen and C-reactive protein levels, SLE-related disease damage according to the Systemic Lupus International Collaborating Clinics (SLICC) damage index (modified to exclude cardiovascular parameters), and disease activity as determined by the Systemic Lupus Activity Measure. Women with longer duration of prednisone use and a higher cumulative dose of prednisone as well as those with prior coronary events were more likely to have plaque. In logistic regression models, independent determinants of plaque (P < 0.05) were older age, higher systolic blood pressure, higher levels of LDL cholesterol, prolonged treatment with prednisone, and a previous coronary event. Older age, a previous coronary event, and elevated systolic blood pressure were independently associated with increased severity of plaque (P < 0.01). Older age, elevated pulse pressure, a previous coronary event, and a higher SLICC disease damage score were independently related to increased IMT (P < 0.05). CONCLUSION B-mode ultrasound provides a useful noninvasive technique to assess atherosclerosis in women with SLE who are at high risk for cardiovascular disease. Potentially modifiable risk factors were found to be associated with the vascular disease detected using this method.

A comparison of bare-metal and drug-eluting stents for off-label indications.

BACKGROUND Recent reports suggest that off-label use of drug-eluting stents is associated with an increased incidence of adverse events. Whether the use of bare-metal stents would yield different results is unknown. METHODS We analyzed data from 6551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry according to whether they were treated with drug-eluting stents or bare-metal stents and whether use was standard or off-label. Patients were followed for 1 year for the occurrence of cardiovascular events and death. Off-label use was defined as use in restenotic lesions, lesions in a bypass graft, left main coronary artery disease, or ostial, bifurcated, or totally occluded lesions, as well as use in patients with a reference-vessel diameter of less than 2.5 mm or greater than 3.75 mm or a lesion length of more than 30 mm. RESULTS Off-label use occurred in 54.7% of all patients with bare-metal stents and 48.7% of patients with drug-eluting stents. As compared with patients with bare-metal stents, patients with drug-eluting stents had a higher prevalence of diabetes, hypertension, renal disease, previous percutaneous coronary intervention and coronary-artery bypass grafting, and multivessel coronary artery disease. One year after intervention, however, there were no significant differences in the adjusted risk of death or myocardial infarction in patients with drug-eluting stents as compared with those with bare-metal stents, whereas the risk of repeat revascularization was significantly lower among patients with drug-eluting stents. CONCLUSIONS Among patients with off-label indications, the use of drug-eluting stents was not associated with an increased risk of death or myocardial infarction but was associated with a lower rate of repeat revascularization at 1 year, as compared with bare-metal stents. These findings support the use of drug-eluting stents for off-label indications.

Vascular Stiffness in Women With Systemic Lupus Erythematosus

Large-vessel manifestations of systemic lupus erythematosus (SLE), a multisystem disease characterized by disturbances in the immune system, include higher than expected rates of hypertension and cardiovascular disease. Reductions in the elasticity of central arteries may act as a marker of early changes that predispose to the development of major vascular disease. This study evaluated risk factors associated with aortic stiffness measured by pulse wave velocity (PWV) in women with SLE. We expected SLE-specific factors, especially variables indicative of inflammation and active disease, to be associated with increasing PWV. The study population included 220 women currently enrolled in the Pittsburgh Lupus Registry. All risk factor data were collected on the day of the ultrasound examinations. PWV waveforms were collected from the right carotid and femoral arteries by Doppler probes. The mean age of the women was 45.5±10.8 years, the median SLE disease duration approximated 9 years, and the mean PWV was 6.1±1.7 m/s. Multiple regression models were stratified by menopausal status. Among postmenopausal women, PWV risk factors were primarily traditional factors and included age, systolic blood pressure, family history of vascular disease, carotid plaque, creatinine, obesity, glucose, white cell count, and cumulative SLE organ damage. Among premenopausal women, PWV risk factors consisted of a mix of SLE-related and traditional variables and included higher C3 levels, presence of ds-DNA antibodies, nonuse of hydroxychloroquine, lower leukocyte count, higher mean arterial pressure, and carotid plaque. SLE-specific variables appeared to be associated with increases in aortic PWV, indicating central artery stiffening. This was seen most clearly among premenopausal women. This finding may partially explain the higher rates of cardiovascular disease and hypertension observed in young women with SLE.

Access site hematoma requiring blood transfusion predicts mortality in patients undergoing percutaneous coronary intervention: Data from the National Heart, Lung, and Blood Institute Dynamic Registry

To determine both the etiology of and outcomes associated with access site hematoma requiring transfusion (HRT) in patients undergoing percutaneous coronary intervention (PCI).

Psychopathology before surgery in the Longitudinal Assessment of Bariatric Surgery-3 (LABS-3) Psychosocial Study

BACKGROUND Current and previous psychopathology in bariatric surgery candidates is believed to be common. Accurate prevalence estimates, however, are difficult to obtain given that bariatric surgery candidates often wish to appear psychiatrically healthy when undergoing psychiatric evaluation for approval for surgery. Also, structured diagnostic assessments have been infrequently used. METHODS The present report concerned 199 patients enrolled in the longitudinal assessment of bariatric surgery study, who also participated in the longitudinal assessment of bariatric surgery-3 psychopathology substudy. The setting was 3 university hospitals, 1 private not-for-profit research institute, and 1 community hospital. All the patients were interviewed independently of the usual preoperative psychosocial evaluation process. The patients were explicitly informed that the data would not be shared with the surgical team unless certain high-risk behaviors, such as suicidality, that could lead to adverse perioperative outcomes were reported. RESULTS Most of the patients were women (82.9%) and white (nonwhite 7.6%, Hispanic 5.0%). The median age was 46.0 years, and the median body mass index was 44.9 kg/m2. Of the 199 patients, 33.7% had ≥1 current Axis I disorder, and 68.8% had ≥1 lifetime Axis I disorder. Also, 38.7% had a lifetime history of a major depressive disorder, and 33.2% had a lifetime diagnosis of alcohol abuse or dependence. All these rates were much greater than the population-based prevalence rates obtained for this age group in the National Comorbidity Survey-Replication Study. Also, 13.1% had a lifetime diagnosis and 10.1% had a current diagnosis of a binge eating disorder. CONCLUSION The current and lifetime rates of psychopathology are high in bariatric surgery candidates, and the lifetime rates of affective disorder and alcohol use disorders are particularly prominent. Finally, binge eating disorder is present in approximately 1 in 10 bariatric surgery candidates.

Impact of age on procedural and 1-year outcome in percutaneous transluminal coronary angioplasty: A report from the NHLBI Dynamic Registry

BACKGROUND Older age has been associated with adverse outcomes in patients undergoing percutaneous coronary intervention (PCI). As PCI technology evolves and the US population becomes proportionally older, assessment of PCI in older age groups is essential. METHODS From the National Heart, Lung, and Blood Institute Dynamic Registry, 4620 PCI-treated patients (1997 to 1999) were studied. Differences in clinical presentation, treatment strategy, and inhospital and 1-year outcomes were compared between patient age groups: younger (<65 years, n = 2537); older (65 to 79 years, n = 1776); and elderly (> or =80 years, n = 307). RESULTS Older and elderly patients had more cardiac and comorbid noncardiac conditions and more extensive and complex arteriosclerosis, including stenoses in bypass grafts. Stent use was similar as age increased (72% vs 73% vs 73%), as was the use of IIb/IIIa receptor antagonists (29% vs 26% vs 28%). Rates of successful treatment of all attempted lesions were 93%, 92%, and 89%, respectively. Adjusted relative risks of inhospital death (1.0 vs 2.91 vs 3.64) and myocardial infarction (1.0 vs 1.35 vs 2.57) increased by age group, as did 1-year mortality rates (1.0 vs 1.87 vs 3.02). However, the relative magnitude of excess mortality rates at 1 year was comparable to that observed by age in the US general population. Age was not associated with 1-year risk of myocardial infarction or coronary artery bypass grafting. CONCLUSIONS Although new technologies may allow for treatment of complex disease in older and elderly patients with comorbid disease, the increased procedural risk remains substantial in these patients. After PCI, the long-term relative risk of death is similar to that expected among persons of similar ages in the general population.

Insulin Therapy and Glycemic Control in Hospitalized Patients With Diabetes During Enteral Nutrition Therapy A randomized controlled clinical trial

OBJECTIVE To compare two subcutaneous insulin strategies for glycemic management of hyperglycemia in non–critically ill hospitalized patients with diabetes during enteral nutrition therapy (ENT). RESEARCH DESIGN AND METHODS Fifty inpatients were prospectively randomized to receive sliding-scale regular insulin (SSRI) alone (n = 25) or in combination with insulin glargine (n = 25). NPH insulin was added for persistent hyperglycemia in the SSRI group (glucose >10 mmol/l). RESULTS Glycemic control was similar in the SSRI and glargine groups (mean ± SD study glucose 8.9 ± 1.6 vs. 9.2 ± 1.6 mmol/l, respectively; P = 0.71). NPH insulin was added in 48% of the SSRI group subjects. There were no group differences in frequency of hypoglycemia (1.3 ± 4.1 vs. 1.1 ± 1.8%; P = 0.35), total adverse events, or length of stay. CONCLUSIONS Both insulin strategies (SSRI with the addition of NPH for persistent hyperglycemia and glargine) demonstrated similar efficacy and safety in non–critically ill hospitalized patients with type 2 diabetes during ENT.

Determining in-stent stenosis of carotid arteries by duplex ultrasound criteria.

Purpose: To develop customized duplex ultrasound criteria for assessment of in-stent restenosis in the carotid arteries. Methods: A retrospective review was conducted of 605 patients who underwent carotid artery stenting (CAS) from July 1996 to August 2004 at a single institution. Data on the stented carotid artery were accumulated from patients who had carotid angiography and duplex ultrasound (US) within 30 days of each other. Preliminary review found 118 pairs of ultrasound scans and angiograms in stented carotid arteries. Peak systolic velocity (PSV), end-diastolic velocity (EDV), and internal carotid artery to common carotid artery ratio (ICA/CCA) were examined. Angiographic stenosis was graded by NASCET criteria and compared to velocity parameters at clinically relevant levels of stenosis. The Student t test was used to compare similarly obtained data from 41 nonstented carotid arteries. Results: PSV, ICA/CCA ratio, and EDV increased to a greater degree in stented arteries with stenosis. In 50% to 69% stenotic arteries, mean ICA/CCA ratio was 4.74±0.61 in stented versus 3.68±0.24 in nonstented carotid arteries (p=0.043). In arteries with ≥0% stenosis, there were increases in PSV (475±22 versus 337±26 cm/s, p=0.001), EDV (172±23 versus 122±8 cm/s, p = 0.043), and the ICA/CCA ratio (8.18±2.19 versus 5.11 ±0.66, p=0.063) in stented versus nonstented arteries, respectively. To detect ≥70% angiographic stenosis, PSV≥350 cm/s had 100% sensitivity, 96% specificity, 55% positive predictive value (PPV), and 100% negative predictive value (NPV); an ICA/CCA ratio ≥4.75 had 100% sensitivity, 95% specificity, 50% PPV, and 100% NPV. To predict >50% stenosis, combining PSV≥225 cm/s and ICA/PCA ratio ≥2.5 increased sensitivity (95%), specificity (99%), PPV (95%), NPV (99%), and accuracy (98%). Conclusions: PSV and ICA/CCA increase with stenosis to a greater extent in stented carotid arteries, necessitating revision of existing US criteria to follow CAS patients. To determine ≥70% in-stent stenosis, PSV≥350 cm/s and ICA/CCA ratio ≥4.75 are sensitive criteria. To determine ≥50% stenosis, combining PSV≥225 cm/s and ICA/PCA ratio ≥2.5 is optimal.

Comparison of in-hospital and one-year outcomes in patients with and without diabetes mellitus undergoing percutaneous catheter intervention (from the National Heart, Lung, and Blood Institute Dynamic Registry) ☆

Extrapolation of improvements in percutaneous coronary intervention (PCI) and outcomes to patients with diabetes has not been systematically examined in clinical practice. Two waves of consecutive patients (n = 4,629) who underwent PCI from July 1997 to June 1999 enrolled in the National Heart, Lung, and Blood Institute Dynamic Registry comprise the study population. There were 1,058 patients with treated diabetes and 3,571 patients without clinically evident diabetes. As a group, patients with diabetes tended to have more clinical, angiographic, and procedural risk factors. Although crude in-hospital mortality rates were higher in patients with diabetes (diabetics 2.3%, nondiabetics 1.3%; p = 0.02), the adjusted risk of in-hospital death (odds ratio 1.46, 95% confidence interval [CI] 0.80 to 2.66) was not significantly different. At 1 year, patients with diabetes had a significantly higher adjusted risk of mortality (risk ratio [RR] 1.80, 95% CI 1.35 to 2.41) and need for repeat revascularization (RR 1.40, 95% CI 1.13 to 1.74). There was a significant interaction between stent use and diabetic status with the need for repeat revascularization (adjusted RR in nondiabetics 0.73, 95% CI 0.61 to 0.88; adjusted RR in patients with diabetes 1.20, 95% CI 0.88 to 1.65). Beta blockers at the time of hospital discharge were significantly associated with reduced mortality rates at 1 year in both groups.

Modeling and Risk Prediction in the Current Era of Interventional Cardiology A Report From the National Heart, Lung, and Blood Institute Dynamic Registry

Background—Validation of in-hospital mortality models after percutaneous coronary interventions using multicenter data remains limited. Methods and Results—This study evaluated whether multivariable mortality models developed during the pre-stent era by New York State, American College of Cardiology (ACC)–National Cardiovascular Data Registry, Northern New England Cooperative Group, Cleveland Clinic Foundation, and the University of Michigan are relevant in patients undergoing percutaneous coronary intervention in the 1997 to 1999 National Heart, Lung, and Blood Institute Dynamic Registry. Of 4448 Dynamic Registry patients, 73% received ≥1 stent and 28% received a IIB/IIIA receptor inhibitor. In-hospital mortality occurred in 64 patients (1.4%). The New York state model predicted mortality in 69 patients (1.5%; 95% confidence bounds [CI], 0.89% to 1.70%); Northern New England predicted mortality in 60 patients (1.3%; 95% CI, 1.0% to 1.7%); and Cleveland Clinic predicted mortality in 76 patients (1.7%; 95% CI, 1.3% to 2.1%). Among high-risk subgroups, with these 3 models, observed and predicted in-hospital mortality rates in general were not different. The other 2 models yielded different results. The University of Michigan predicted fewer deaths (n=47; 1.1%; 95% CI, 0.7% to 1.3%), and the ACC Registry model predicted 603 deaths (13.5%; 95% CI, 12.6% to 14.4%). Using the ACC Registry model, predicted mortality was higher than observed in each subgroup. Conclusions—Application of 5 mortality risk models developed from different data sets to patients undergoing percutaneous coronary intervention in the Dynamic Registry predicted, in 3 models, mortality rates that were not significantly different than those observed. In both high and low risk subgroups, the University of Michigan slightly underpredicted mortality, and the ACC Registry predicted significantly higher mortality than that observed.