Background In 2006, we reported results of a randomized trial of laparoscopic paraesophageal hernia repair (LPEHR), comparing primary diaphragm repair (PR) with primary repair buttressed with a ...biologic prosthesis (small intestinal submucosa SIS). The primary endpoint, radiologic hiatal hernia (HH) recurrence, was higher with PR (24%) than with SIS buttressed repair (9%) after 6 months. The second phase of this trial was designed to determine the long-term durability of biologic mesh-buttressed repair. Methods We systematically searched for the 108 patients in phase I of this study to assess current clinical symptoms, quality of life (QOL) and determine ongoing durability of the repair by obtaining a follow-up upper gastrointestinal series (UGI) read by 2 radiologists blinded to treatment received. HH recurrence was defined as the greatest measured vertical height of stomach being at least 2 cm above the diaphragm. Results At median follow-up of 58 months (range 42 to 78 mo), 10 patients had died, 26 patients were not found, 72 completed clinical follow-up (PR, n = 39; SIS, n = 33), and 60 repeated a UGI (PR, n = 34; SIS, n = 26). There were 20 patients (59%) with recurrent HH in the PR group and 14 patients (54%) with recurrent HH in the SIS group (p = 0.7). There was no statistically significant difference in relevant symptoms or QOL between patients undergoing PR and SIS buttressed repair. There were no strictures, erosions, dysphagia, or other complications related to the use of SIS mesh. Conclusions LPEHR results in long and durable relief of symptoms and improvement in QOL with PR or SIS. There does not appear to be a higher rate of complications or side effects with biologic mesh, but its benefit in reducing HH recurrence diminishes at long-term follow-up (more than 5 years postoperatively) or earlier.
Abstract Background context There have been no full-scale trials of the optimal number of visits for the care of any condition with spinal manipulation. Purpose To identify the dose-response ...relationship between visits to a chiropractor for spinal manipulation and chronic low back pain (cLBP) outcomes and to determine the efficacy of manipulation by comparison with a light massage control. Study design/setting Practice-based randomized controlled trial. Patient sample Four hundred participants with cLBP. Outcome measures The primary cLBP outcomes were the 100-point modified Von Korff pain intensity and functional disability scales evaluated at the 12- and 24-week primary end points. Secondary outcomes included days with pain and functional disability, pain unpleasantness, global perceived improvement, medication use, and general health status. Methods One hundred participants with cLBP were randomized to each of four dose levels of care: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for 6 weeks. At sessions when manipulation was not assigned, they received a focused light massage control. Covariate-adjusted linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 18, 24, 39, and 52 weeks. Results For the primary outcomes, mean pain and disability improvement in the manipulation groups were 20 points by 12 weeks and sustainable to 52 weeks. Linear dose-response effects were small, reaching about two points per six manipulation sessions at 12 and 52 weeks for both variables (p<.025). At 12 weeks, the greatest differences from the no-manipulation control were found for 12 sessions (8.6 pain and 7.6 disability points, p<.025); at 24 weeks, differences were negligible; and at 52 weeks, the greatest group differences were seen for 18 visits (5.9 pain and 8.8 disability points, p<.025). Conclusions The number of spinal manipulation visits had modest effects on cLBP outcomes above those of 18 hands-on visits to a chiropractor. Overall, 12 visits yielded the most favorable results but was not well distinguished from other dose levels.
Background When fixed with bone ingrowth, a tight diaphyseal press fit, or cement, the humeral component of a shoulder arthroplasty may present problems of malposition, stress shielding, or ...periprosthetic fracture or difficulty with removal at revision arthroplasty. We have avoided the need for these fixation methods by using impaction cancellous autografting of the humeral stem, minimizing contact between the prosthetic stem and the humeral cortex. This study presents the radiographic survivorship of impaction-autografted humeral implants using component subsidence as the primary endpoint. Methods We reviewed 286 primary anatomic shoulder arthroplasties having an average follow-up of 4.9 ± 2.7 years. Initial postoperative radiographs and minimum 2-year follow-up radiographs were evaluated by 3 observers to assess subsidence. Results Two different implants (Humeral Replacement Prosthesis HRP and Global Advantage prosthesis) were used. Of 286 stems, 267 (93.4%) had not subsided. The Global Advantage prosthesis had a subsidence-free survival rate of 98.5% at 5 years. The stiffer-stemmed HRP used early during the study had a higher rate of subsidence compared with the currently used Global Advantage stem (hazard ratio, 5.6; P = .001). Radiolucent lines of 2 mm or greater were less common for the Global Advantage prosthesis than for the HRP in each of 7 zones ( P < .001). Total shoulder arthroplasty was associated with a higher rate of subsidence compared with hemiarthroplasty (hazard ratio, 2.6; P = .12). Conclusions Impaction autografting provides a secure, durable, bone-preserving means of humeral component fixation in anatomic shoulder arthroplasty.
Abstract Objective To understand the decisional practices of anesthesia providers in managing intraoperative glucose levels. Design This is a retrospective cohort study. Setting Operating rooms in an ...academic medical center. Patients Adult patients undergoing surgery. Intervention Intraoperative blood glucose management based on an institutional protocol. Measurements Glucose management data was extracted from electronic medical records to determine compliance to institutional glucose management protocol that prescribes hourly glucose measurements and insulin doses to maintain glucose levels between 100 to 140 mg/dL. Effect of patient and surgery specific factors on compliance to glucose management protocol was explored. Main results In 1903 adult patients compliances to hourly glucose measurements was 72.5% and correct insulin adjustments was 12.4%. Insulin was under-dosed compared to the prescribed value by a mean of 0.85 U/h (95% CI 0.76-0.95). Multivariate analysis showed that compliance to hourly glucose measurements decreased with increasing length of the procedure (OR = 0.92 per hour, 95% CI 0.89-0.95) but increased with ASA status codes (OR = 1.25 per ASA unit, 95% CI = 1.06-1.49). Greater compliance to correct insulin adjustment was found in diabetic patients compared with non-diabetic patients (OR = 1.31, 95% CI 1.09-1.55). On average, providers administered progressively more insulin with an additional 0.11 U/h (95% CI = 0.00-0.21 for every additional 10 kg/m2 of BMI and 0.20 U/h (95% CI = 0.01-0.39) less in diabetic patients than in non-diabetic patients. With the above practice pattern, the mean ± SD of glucose level was 158 ± 36 mg/dL. Hypoglycemic (< 60 mg/dL) incident rate was 0.1% (9/8301 measurements) while hyperglycemic (> 180 mg/dL) incident rate was 28%. Glucose levels were within the target range (100-140 mg/dL) only 28% of the time. Conclusions Low compliance and considerable variability in initiating and following institutional glucose management protocol were observed.
Abstract Objectives The aim of this study was to investigate whether and what carotid plaque characteristics predict systemic cardiovascular outcomes in patients with clinically established ...atherosclerotic disease. Background Advancements in atherosclerosis imaging have allowed assessment of various plaque characteristics, some of which are more directly linked to the pathogenesis of acute cardiovascular events compared to plaque burden. Methods As part of the event-driven clinical trial AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes), subjects with clinically established atherosclerotic disease underwent multicontrast carotid magnetic resonance imaging (MRI) to detect plaque tissue composition and high-risk features. Prospective associations between MRI measurements and the AIM-HIGH primary endpoint (fatal and nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome, and symptom-driven revascularization) were analyzed using Cox proportional hazards survival models. Results Of the 232 subjects recruited, 214 (92.2%) with diagnostic image quality constituted the study population (82% male, mean age 61 ± 9 years, 94% statin use). During median follow-up of 35.1 months, 18 subjects (8.4%) reached the AIM-HIGH endpoint. High lipid content (hazard ratio HR per 1 SD increase in percent lipid core volume: 1.57; p = 0.002) and thin/ruptured fibrous cap (HR: 4.31; p = 0.003) in carotid plaques were strongly associated with the AIM-HIGH endpoint. Intraplaque hemorrhage had a low prevalence (8%) and was marginally associated with the AIM-HIGH endpoint (HR: 3.00; p = 0.053). High calcification content (HR per 1 SD increase in percent calcification volume: 0.66; p = 0.20), plaque burden metrics, and clinical risk factors were not significantly associated with the AIM-HIGH endpoint. The associations between carotid plaque characteristics and the AIM-HIGH endpoint changed little after adjusting for clinical risk factors, plaque burden, or AIM-HIGH randomized treatment assignment. Conclusions Among patients with clinically established atherosclerotic disease, carotid plaque lipid content and fibrous cap status were strongly associated with systemic cardiovascular outcomes. Markers of carotid plaque vulnerability may serve as novel surrogate markers for systemic atherothrombotic risk.
Objectives The purpose of this study was to test the lipid depletion hypothesis and to establish the time course of change in carotid plaque morphology and composition during lipid therapy using ...high-resolution magnetic resonance imaging (MRI). Background Lipid therapy is thought to improve plaque stability and reduce cardiovascular events by targeting the plaque rupture risk features such as large lipid core, thin fibrous cap, and high level of inflammatory infiltrates. However, the plaque stabilizing process during lipid therapy has not been clearly demonstrated in humans and in vivo. Methods Subjects with coronary or carotid artery disease, apolipoprotein B ≥120 mg/dl, and lipid treatment history <1 year, were randomly assigned to atorvastatin monotherapy or to atorvastatin-based combination therapies with appropriate placebos for 3 years. All subjects underwent high-resolution, multicontrast bilateral carotid MRI scans at baseline and annually for 3 years. All images were analyzed for quantification of wall area and plaque composition blinded to therapy, laboratory results, and clinical course. Results After 3 years of lipid therapy, the 33 subjects with measurable lipid-rich necrotic core (LRNC) at baseline had a significant reduction in plaque lipid content: LRNC volume decreased from 60.4 ± 59.5 mm3 to 37.4 ± 69.5 mm3 (p < 0.001) and %LRNC (LRNC area/wall area in the lipid-rich regions) from 14.2 ± 7.0% to 7.4 ± 8.2% (p < 0.001). The time course showed that %LRNC decreased by 3.2 (p < 0.001) in the first year, by 3.0 (p = 0.005) in the second year, and by 0.91 (p = 0.2) in the third year. Changes in LRNC volume followed the same pattern. Percent wall volume (100 × wall/outer wall, a ratio of volumes) in the lipid-rich regions significantly decreased from 52.3 ± 8.5% to 48.6 ± 9.7% (p = 0.002). Slices containing LRNC had significantly more percent wall volume reduction than those without (−4.7% vs. −1.4%, p = 0.02). Conclusions Intensive lipid therapy significantly depletes carotid plaque lipid. Statistically significant plaque lipid depletion is observed after 1 year of treatment and continues in the second year, and precedes plaque regression. (Using Magnetic Resonance Imaging to Evaluate Carotid Artery Plaque Composition in People Receiving Cholesterol-Lowering Medications The CPC Study; NCT00715273 ).
Abstract Objective Pelvic venous incompetence can cause symptomatic varicose veins in the perineum, buttock, and thigh. Presentation, symptom severity, and response to treatment of pelvic source ...varicose veins are not well defined. Currently available tools to measure the severity of lower extremity venous disease and its effects on quality of life may be inadequate to assess disease severity in these patients. The purpose of this study was to evaluate the histories, demographics, and clinical presentations of women with pelvic source varicose veins and to compare these data to a population of women with nonpelvic source varicose veins. Methods A total of 72 female patients with symptomatic pelvic source varicose veins were prospectively followed up. Age, weight, height, parity, and birth weights of offspring were recorded. Both pelvic source varicose veins and saphenous incompetence were identified by duplex ultrasound. Patients were queried as to their primary symptoms, activities that made their symptoms worse, and time when their symptoms were most prominent. Severity of disease was objectively evaluated using the revised Venous Clinical Severity Score (rVCSS) and 10-point numeric pain rating scale (NPRS). Results Compared with women without a pelvic source of varicose veins (N = 1163), patients with pelvic source varicose veins were younger (mean, 44.6 ± 8.6 vs 52.6 ± 12.9 years; P < .001), had lower body mass index (mean, 21.9 ± 2.8 vs 25.8 ± 6.2; P < .001), and had larger babies than the U.S. population mean (mean, 3656 ± 450 g vs 3389 ± 466 g; P < .001). The most common symptoms were aching (68%), throbbing (47%), and heaviness (35%). In premenopausal patients, 70% noted that symptoms were worst during menses. NPRS score varied from 0 to 8 (mean, 4.9). The correlation between rVCSS (mean 5.6 ± 1.9) and NPRS was small ( r = 0.26; P = .03). There was a modest correlation between older age and lower NPRS scores ( r = −0.39; P < .001). Conclusions Women with pelvic source varicose veins are a unique subset of patients. They are younger and thinner than those with nonpelvic source varicose veins, have larger infants than the general U.S. population, and have an inverse correlation between age and pain. As the majority of premenopausal patients have increased symptoms during menses, this may be due to hormonal influence. As it is poorly associated with patient-reported discomfort, the rVCSS is a poor tool for evaluating pelvic source varicose veins. A disease-specific tool for the evaluation of pelvic source varicose veins is critically needed, and this study is a first step in that endeavor.
The majority of medical providers, nurses, and patients agree that appearance is important for patient care. However, at our institution, concerns regarding providers' white coats as fomites are ...expressed primarily by providers and nurses, not by patients. We provide a framework for approaching this important issue through a structured quality-improvement process.
Background Recent articles in this journal showed the clinical importance of the position of the humeral head center in relation to the glenoid. However, the precision, reproducibility, and ...sensitivity of this and other methods of documenting the head center position have not been evaluated in detail. Materials and methods We used templates to fit a coordinate system to the scapular anatomy visible on standardized radiographs. Two observers then used these templates to measure the position of the head center relative to this coordinate system on 25 normal shoulder radiographs and on 25 radiographs of shoulders with cuff tear arthropathy (CTA). Results Head center measurements had excellent precision. Normal shoulder radiographs showed a consistent head center position (0.7 ± 1.7 mm medial and 0.6 ± 1.3 mm inferior to the coordinate origin on the anteroposterior view and 0.1 ± 1.3 mm medial and 0.0 ± 1.3 mm anterior to the coordinate origin on the axillary view). The head center of CTA shoulder radiographs was 10.18 ± 5.16 mm above the coordinate origin on the anteroposterior view, significantly different from that for the normal shoulder radiographs ( P < .001). Discussion The relative position of the humeral head center to the scapula determines the resting length and the moment arms of the scapulohumeral muscles. Correlation of shoulder function with the head center position may provide insights into both shoulder pathomechanics and the optimization of shoulder arthroplasty. Conclusion This practical technique showed a high degree of precision and reproducibility for normal and CTA shoulder radiographs as well as a high level of discrimination between these two groups.
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