Michael P. Walkup

Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization.

OBJECTIVES The study assessed clinical outcomes of closure device use following percutaneous coronary revascularization using current standards of anticoagulation and antiplatelet therapy. BACKGROUND Evaluation of the outcomes of patients by use of vascular closure devices during coronary interventions employing current standards of anticoagulation and glycoprotein (GP) IIb/IIIa inhibitor therapy is limited. METHODS We evaluated outcomes of 4,525 consecutive patients who underwent percutaneous coronary intervention between July 1997 and April 2000. All patients received anticoagulation with heparin and GP IIb/IIIa inhibitor therapy with abciximab. The closure method was manual in 1,824 patients, Angioseal in 524 patients and Perclose in 2,177 patients. Procedural and hospital vascular outcomes were evaluated. RESULTS Closure device success was 97.1% Angioseal and 94.1% Perclose (p < 0.05). Minor vascular complications occurred in 1.8% of manual patients, 1.1% of Angioseal patients and 1.2% of Perclose patients (p = NS); major complications occurred in 1.3% of manual patients, 1.1% of Angioseal patients and 1.0% of Perclose patients (p = NS). Multivariate logistic regression identified only closure device failure as an independent predictor of a vascular complication. In patients with successful closure with a device, minor complications (0.8% vs. 1.8%, p < 0.05) and any complication (1.5% vs. 2.5%, p < 0.05) were reduced compared to manual compression. CONCLUSIONS Arterial closure following coronary interventions using anticoagulation and GP IIb/IIIa inhibitor therapy can be safely and effectively performed, with vascular complication rates similar to or lower than with manual pressure. Additionally, vascular complication rates using GP IIb/IIIa inhibitor therapy regardless of the method of arterial closure are equivalent to or lower than previously published rates of vascular complications.

The Lifestyle Interventions and Independence for Elders Pilot (LIFE-P): 2-Year Follow-up

BACKGROUND It is well recognized that physical activity (PA) is important for older adults; yet, clinicians remain pessimistic about the ability of older adults with compromised function to adhere to long-term treatment and to maintain behavior change once treatment has been terminated. METHODS We examined the functional status of older adults at a field center (Wake Forest University) 2 years after completing 12 months of treatment in the Lifestyle Interventions and Independence for Elders Pilot study. At baseline, participants were randomized to either a PA or a successful aging (SA) control group. Outcome measures included an interview assessment of PA, the Short Physical Performance Battery (SPPB), and performance on a 400-m self-paced walking test. RESULTS Two years after the formal intervention had ended, participants who were originally in the PA group continued to engage in more minutes of moderate PA and tended to have better SPPB and walking speed than those in the SA group (effect sizes [ES]: SPPB = 0.40, walking speed = 0.37). Seven (12.7%) participants in the PA group failed the 400-m walk at the 36-month follow-up assessment, whereas this number was 11 (21.6%) in the SA group. CONCLUSION Older adults who have compromised physical function are able to sustain some of the benefits derived from participating in structured PA 2 years after supervised treatment has been terminated.

One-year changes in symptoms of depression and weight in overweight/obese individuals with type 2 diabetes in the Look AHEAD study.

Depressed individuals are frequently excluded from weight loss trials because of fears that weight reduction may precipitate mood disorders, as well as concerns that depressed participants will not lose weight satisfactorily. The present study examined participants in the Look AHEAD study to determine whether moderate weight loss would be associated with incident symptoms of depression and suicidal ideation, and whether symptoms of depression at baseline would limit weight loss at 1 year. Overweight/obese adults with type 2 diabetes (n = 5,145) were randomly assigned to an Intensive Lifestyle Intervention (ILI) or a usual care group, Diabetes Support and Education (DSE). Of these, 5,129 participants completed the Beck Depression Inventory (BDI) and had their weight measured at baseline and 1 year. Potentially significant symptoms of depression were defined by a BDI score ≥10. Participants in ILI lost 8.6 ± 6.9% of initial weight at 1 year, compared to 0.7 ± 4.8% for DSE (P < 0.001, effect size = 1.33), and had a reduction of 1.4 ± 4.7 points on the BDI, compared to 0.4 ± 4.5 for DSE (P < 0.001, effect size = 0.23). At 1 year, the incidence of potentially significant symptoms of depression was significantly lower in the ILI than DSE group (6.3% vs. 9.6%) (relative risk (RR) = 0.66, 95% confidence interval (CI) = 0.5, 0.8; P < 0.001). In the ILI group, participants with and without symptoms of depression lost 7.8 ± 6.7% and 8.7 ± 6.9%, respectively, a difference not considered clinically meaningful. Intentional weight loss was not associated with the precipitation of symptoms of depression, but instead appeared to protect against this occurrence. Mild (or greater) symptoms of depression at baseline did not prevent overweight/obese individuals with type 2 diabetes from achieving significant weight loss.

Intensive Lifestyle Intervention Improves Physical Function Among Obese Adults With Knee Pain: Findings From the Look AHEAD Trial

Lifestyle interventions have resulted in weight loss or improved physical fitness among individuals with obesity, which may lead to improved physical function. This prospective investigation involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at baseline (n = 2,203). The purposes of this investigation were to determine whether an Intensive Lifestyle Intervention (ILI) condition resulted in improvement in self‐reported physical function from baseline to 12 months vs. a Diabetes Support and Education (DSE) condition, and whether changes in weight or fitness mediated the effect of the ILI. Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and physical function subscales, and WOMAC summary score. ILI participants exhibited greater adjusted mean weight loss (s.e.) vs. DSE participants (−9.02 kg (0.48) vs. −0.78 kg (0.49); P < 0.001)). ILI participants also demonstrated more favorable change in WOMAC summary scores vs. DSE participants (β (s.e.) = −1.81 (0.63); P = 0.004). Multiple regression mediation analyses revealed that weight loss was a mediator of the effect of the ILI intervention on change in WOMAC pain, function, and summary scores (P < 0.001). In separate analyses, increased fitness also mediated the effect of the ILI intervention upon WOMAC summary score (P < 0.001). The ILI condition resulted in significant improvement in physical function among overweight and obese adults with diabetes and knee pain. The ILI condition also resulted in significant weight loss and improved fitness, which are possible mechanisms through which the ILI condition improved physical function.

Lifestyle Interventions and Independence for Elders Pilot Study: Recruitment and Baseline Characteristics

OBJECTIVES: To describe several recruitment parameters derived from the Lifestyle Interventions and Independence for Elders pilot (LIFE‐P) study for use in a full‐scale trial of mobility disability prevention.

Relationship Between Physical Functioning and Physical Activity in the Lifestyle Interventions and Independence for Elders Pilot

OBJECTIVES: To determine whether participation in usual moderate‐intensity or more‐vigorous physical activity (MVPA) is associated with physical function performance and to identify sociodemographic, psychosocial, and disease‐related covariates that may also compromise physical function performance.

Effect of 1 year of an intentional weight loss intervention on bone mineral density in type 2 diabetes: results from the Look AHEAD randomized trial.

Intentional weight loss is an important component of treatment for overweight patients with type 2 diabetes, but the effects on bone density are not known. We used data from the Look AHEAD trial to determine the impact of an intensive lifestyle weight loss intervention (ILI) compared with diabetes support and education (DSE) on changes in bone mineral density (BMD) over 12 months. Overweight and obese adults with type 2 diabetes were randomly assigned to ILI or DSE. In a substudy of BMD conducted at 5 of 16 clinical centers, hip, spine, and whole body dual X‐ray absorptiometry scans were obtained at baseline and 1‐year later on 642 of 739 ILI and 632 of 740 DSE participants. At baseline, mean age was 58.4 years, and average body mass index was 35.2 kg/m2. Total hip BMD T‐score was <−2.5 in 1% and <−1.0 in 8%. At 1 year, weight loss was greater in ILI than DSE (−8.6% versus −0.7%), and glycemic control and fitness were also improved. Bone loss over 1 year was greater in ILI at the total hip (−1.4% versus −0.4%; p < 0.001) and femoral neck (−1.5% versus −0.8%; p = 0.009), but change in BMD for the lumbar spine and whole body did not differ between groups. In ILI, bone loss at the total hip was independently associated with weight loss in men and women and with poorer glycemic control in men, but was not associated with changes in fitness. One year of an intensive lifestyle intervention in adults with type 2 diabetes, resulting in weight loss, was associated with a modest increase in hip bone loss despite improved fitness and glycemic control.

Activity Patterns of Obese Adults with Type 2 Diabetes in the Look Ahead Study

PURPOSE This study describes baseline physical activity (PA) patterns of individuals with type 2 diabetes mellitus (T2DM) enrolled in the multicenter Look AHEAD Study using an objective measure of PA (accelerometry). METHODS A total of 2240 participants (age = 59.0 ± 6.8 yr and body mass index (BMI) = 36.5 ± 6.0 kg·m−²) with T2DM provided data for this substudy. Participants were instructed to wear an accelerometer during waking hours for 7 d. Accelerometry data were analyzed to identify periods meeting the criteria of ≥3 MET·min−¹ for Q10 min(moderate- to vigorous-intensity PA (MVPA)) and ≥6 MET·min−¹ for ≥10 min (vigorous-intensity PA (VPA)). Self-reported PA was also assessed with a questionnaire. Accelerometry and self-reported PA data were compared across categories of BMI, sex, race, age, fitness, diabetes medication usage, and history of cardiovascular disease. RESULTS Self-reported PA was lower at higher levels of BMI, was higher in males, was lowest for African-American/black, and was positively associated with fitness. Multivariate analyses for accelerometer-measured MVPA and VPA showed that more PA bouts per day, minutes per bout, METs per minute, and MET-minutes were associated with higher fitness. For MVPA, bouts per day were higher in men, and METs per minute were higher in women. For VPA, bouts per day was positively associated with increasing age and differed by race/ethnicity. METs per minute were significantly lower at higher levels of BMI and in women. Diabetes medication usage and history of cardiovascular disease were not associated with patterns of PA examined. CONCLUSIONS Results provide information on factors that contribute to PA patterns in adults with T2DM when PA is assessed using both objective and subjective measures. These data may inform interventions to improve PA in adults with T2DM

Migrant Farmworker Field and Camp Safety and Sanitation in Eastern North Carolina

ABSTRACT Migrant farmworkers are exposed to numerous workplace hazards, with pesticides being a ubiquitous occupational exposure. This analysis describes farmworker experiences of field and camp safety conditions and their safety behaviors, and delineates farmworker characteristics associated with safety conditions and behaviors. Data were collected from 255 migrant farmworkers up to 4 times at monthly intervals during the 2007 agricultural season in eastern North Carolina. Measures assess field safety conditions and camp sanitation required by federal and state regulations. Most of the farmworkers were Latino men from Mexico. About 20% had not received pesticide safety training across the season; many of those who received such training did not understand it. Water for washing was not available for about one-third of the workers; soap and towels were not available for over half. About 20% lived in camps with more than eight workers per showerhead and about 20% lived in camps that failed to meet the standard of 30 or fewer workers per washtub/washing machine. Important predictors of variation included H2A visa status and years of experience. Four themes emerged from the analysis: (1) safety regulations are not consistently met; (2) farmworkers do not always practice safety behaviors; (3) camps become more crowded and less compliant during the middle of the agricultural season; and (4) workers with H2A visas experience better conditions and practice more safety behaviors than do workers who do not have H2A visas. Further research needs to account for social and cultural factors. Regulations should be compared with pesticide metabolite levels to measure their effectiveness. More effort is needed to enforce existing regulations.

Characterization of angiotensin-(1–7) receptor subtype in mesenteric arteries

Mesenteric arteries from male Sprague-Dawley rats were mounted in a pressurized myograph system. Ang-(1-7) concentration-dependent responses were determined in arteries preconstricted with endothelin-1 (10(-7)M). The receptor(s) mediating the Ang-(1-7) evoked dilation were investigated by pretreating the mesenteric arteries with specific antagonists of Ang-(1-7), AT(1) or AT(2) receptors. The effects of Ang-(3-8) and Ang-(3-7) were also determined. Ang-(1-7) caused a concentration-dependent dilation (EC(50): 0.95 nM) that was blocked by the selective Ang-(1-7) receptor antagonist D-[Ala(7)]-Ang-(1-7). Administration of a specific antagonist to the AT(2) receptor (PD123319) had no effect. On the other hand, losartan and CV-11974 attenuated the Ang-(1-7) effect. These results demonstrate that Ang-(1-7) elicits potent dilation of mesenteric resistance vessels mediated by a D-[Ala(7)]-Ang-(1-7) sensitive site that is also sensitive to losartan and CV-11974.