Moni B. Neradilek

Biologic Prosthesis to Prevent Recurrence after Laparoscopic Paraesophageal Hernia Repair: Long-term Follow-up from a Multicenter, Prospective, Randomized Trial

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.

Prognostic Factors for Bacterial Cultures Positive for Propionibacterium acnes and Other Organisms in a Large Series of Revision Shoulder Arthroplasties Performed for Stiffness, Pain, or Loosening

BACKGROUND Propionibacterium acnes has been grown on culture in half of the reported cases of chronic infection associated with shoulder arthroplasty. The presence of this organism can be overlooked because its subtle presentation may not suggest the need for culture or because, in contrast to many orthopaedic infections, multiple tissue samples and weeks of culture incubation are often necessary to recover this organism. Surgical decisions regarding implant revision and antibiotic therapy must be made before the results of intraoperative cultures are known. In the present study, we sought clinically relevant prognostic evidence that could help to guide treatment decisions. METHODS We statistically correlated preoperative and intraoperative observations on 193 shoulder arthroplasty revisions that were performed because of pain, loosening, or stiffness with the results of a Propionibacterium acnes-specific culture protocol. Regression models were used to identify factors predictive of a positive culture for Propionibacterium acnes. RESULTS One hundred and eight of the 193 revision arthroplasties were associated with positive cultures; 70% of the positive cultures demonstrated growth of Propionibacterium acnes. The rate of positive cultures per shoulder increased with the number of culture specimens obtained from each shoulder. Fifty-five percent of the positive cultures required observation for more than one week. Male sex, humeral osteolysis, and cloudy fluid were each associated with significant increases of ≥ 600% in the likelihood of obtaining a positive Propionibacterium acnes culture. Humeral loosening, glenoid wear, and membrane formation were associated with significant increases of >300% in the likelihood of obtaining a positive Propionibacterium acnes culture. CONCLUSIONS Preoperative and intraoperative factors can be used to help to predict the risk of a positive culture for Propionibacterium acnes. This evidence is clinically relevant to decisions regarding prosthesis removal or retention and the need for immediate antibiotic therapy at the time of revision shoulder arthroplasty before the culture results become available. LEVEL OF EVIDENCE Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Rotator Cuff Repair: Published Evidence on Factors Associated With Repair Integrity and Clinical Outcome

Background: Rotator cuff tears are common, and rotator cuff repair represents a major health care expense. While patients often benefit from rotator cuff repair, anatomic failure of the repair is not unusual. Purpose: To identify the published evidence on the factors associated with retears and with suboptimal clinical outcomes of rotator cuff repairs. Study Design: Systematic review and meta-analysis of articles with evidence levels 1-4. Methods: A total of 2383 articles on rotator cuff repairs published between 1980 and 2012 were identified. Only 108 of these articles, reporting on over 8011 shoulders, met the inclusion criteria of reporting quantitative data on both imaging and clinical outcomes after rotator cuff repair. Factors related to the patients, their shoulders, the procedures, and the results were systematically categorized and submitted for meta-analysis. Results: While the number of relevant articles published per year increased dramatically over the period of the study, the clinical and anatomic results did not show improvement over this period. The weighted mean retear rate was 26.6% at a mean of 23.7 months after surgery. Retears were associated with more fatty infiltration, larger tear size, advanced age, and double-row repairs. Clinical improvement averaged 72% of the maximum possible improvement. Patient-reported outcomes were generally improved whether or not the repair restored the integrity of the rotator cuff. The inconsistent and incomplete data in the published articles limited the meta-analysis of factors affecting the outcome of rotator cuff repair. Conclusion: In spite of a dramatic increase in the number of publications per year, there is little evidence that the results of rotator cuff repair are improving. The information needed to guide the management of this commonly treated and costly condition is seriously deficient. To accumulate the evidence necessary to inform practice, future clinical studies on the outcome of rotator cuff repair must report important data relating to each patient’s condition, the surgical technique, the outcome in terms of integrity, and the change in patient self-assessed comfort and function.

MR Imaging of Carotid Plaque Composition During Lipid-Lowering Therapy: A Prospective Assessment of Effect and Time Course

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 mm(3) to 37.4 ± 69.5 mm(3) (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).

Original ResearchMR Imaging of Carotid Plaque Composition During Lipid-Lowering Therapy: A Prospective Assessment of Effect and Time Course

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 mm(3) to 37.4 ± 69.5 mm(3) (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).

Carotid Artery Atherosclerosis: Effect of Intensive Lipid Therapy on the Vasa Vasorum—Evaluation by Using Dynamic Contrast-enhanced MR Imaging

PURPOSE To investigate whether short-term, intensive lipid therapy leads to changes in microvascular characteristics, as measured by using dynamic contrast material-enhanced (DCE) magnetic resonance (MR) imaging. MATERIALS AND METHODS Institutional review board approval and informed consent were obtained for this HIPAA-compatible study. Subjects with established coronary artery disease or carotid artery stenosis of 15% or greater determined by using ultrasonography and with levels of apolipoprotein B of 120 mg/dL (1.2 g/L) or greater were enrolled in an ongoing study (clinical trial NCT00715273). All received intensive lipid therapy to achieve targeted high- and low-density lipoprotein cholesterol levels and underwent serial serum monitoring including high-sensitivity C-reactive protein (HsCRP) level measurements. Carotid artery MR imaging examinations including morphologic and DCE MR images were obtained at baseline and 1 year after treatment. In subjects with advanced lesions (>2 mm thick), MR image analysis was performed, including measurement of lipid-rich necrotic core size and kinetic modeling of DCE MR images to assess changes in the transfer constant (K(trans)). The differences in K(trans) between baseline and 1-year follow-up were compared by using the Wilcoxon signed rank test, and associations were assessed by using the Spearman rank correlation coefficient. RESULTS Twenty-eight subjects with interpretable DCE MR imaging results at both baseline and 1-year follow-up were included. After 1 year of treatment, a significant reduction was found in mean K(trans) (0.085 min(-1) ± 0.037 [standard deviation] to 0.067 min(-1) ± 0.028, P = .02). Reduction in K(trans) was not significantly correlated with observed reductions in lipid-rich necrotic core size or reductions in HsCRP level. CONCLUSION These findings suggest that DCE MR imaging may be a useful imaging method for the assessment of the therapeutic response of the vasa vasorum in patients with atherosclerotic plaque.

Failure of the glenoid component in anatomic total shoulder arthroplasty: a systematic review of the English-language literature between 2006 and 2012.

BACKGROUND Although glenoid component failure is one of the most common complications of anatomic total shoulder arthroplasty, substantial evidence from the recent published literature is lacking regarding the temporal trend in the rate of this complication and the risk factors for its occurrence. METHODS We conducted a systematic review and identified twenty-seven articles presenting data on glenoid component failure rates that met the inclusion criteria. These articles represented data from 3853 total shoulder arthroplasties performed from 1976 to 2007. RESULTS Asymptomatic radiolucent lines occurred at a rate of 7.3% per year after the primary shoulder replacement. Symptomatic glenoid loosening occurred at 1.2% per year, and surgical revision occurred at 0.8% per year. There was no significant evidence that the rate of symptomatic loosening has diminished over time. Keeled components had greater rates of asymptomatic radiolucent lines compared with pegged components in side-by-side comparison studies. However, as a result of wide variability in outcomes reporting, only sex, Walch class, and diagnosis were significantly associated with the risk of glenoid component failure in the overall analysis. CONCLUSIONS This is the first systematic review of the published evidence on glenoid component failure. Although the authors of individual articles proposed various risk factors for glenoid component failure, many of these relationships were not significant in the present study. A consistent methodological approach to future investigations is likely to improve the quality of the evidence on which patients, techniques, and prostheses are selected for total shoulder arthroplasty.

Dose-Response and Efficacy of Spinal Manipulation for Care of Chronic Low Back Pain: A Randomized Controlled Trial

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.

Risk factors for chondrolysis of the glenohumeral joint: a study of three hundred and seventy-five shoulder arthroscopic procedures in the practice of an individual community surgeon.

BACKGROUND Glenohumeral chondrolysis is a complication of arthroscopic shoulder surgery characterized by the dissolution of the articular cartilage of the glenoid and the humeral head. An analysis of 375 intra-articular shoulder arthroscopic surgical procedures by an individual community orthopaedic surgeon was performed to explore which factors or combinations of factors might be associated with glenohumeral chondrolysis. METHODS The occurrence of chondrolysis was correlated with several demographic and surgical variables with use of hazard ratios from Cox proportional hazards models and Kaplan-Meier survivorship curves. Sensitivity analysis was used to examine the effect of two different definitions of the date of the onset of chondrolysis. RESULTS In this cohort, each case of documented chondrolysis was associated with the intra-articular post-arthroscopic infusion of a local anesthetic, either Marcaine (bupivacaine) or lidocaine. In an analysis of the group that received an intra-articular postoperative infusion of a local anesthetic, the risk of chondrolysis was found to be greater for those with one or more suture anchors placed in the glenoid, for younger patients, and for those who had the surgery near the end of the ten-year study period. CONCLUSIONS To our knowledge, this is the first Level-II retrospective cohort study of the factors associated with the development of post-arthroscopic glenohumeral chondrolysis. In this cohort of intra-articular shoulder arthroscopic procedures, chondrolysis was observed only in cases in which either Marcaine or lidocaine had been infused into the joint during the postoperative period. Avoiding such a postoperative infusion may reduce the risk of chondrolysis.

Concussion among female middle-school soccer players.

IMPORTANCE Despite recent increased awareness about sports concussions, little research has evaluated concussions among middle-school athletes. OBJECTIVES To evaluate the frequency and duration of concussions in female youth soccer players and to determine if concussions result in stopping play and seeking medical care. DESIGN, SETTING, AND PARTICIPANTS Prospective cohort study from March 2008 through May 2012 among 4 soccer clubs from the Puget Sound region of Washington State, involving 351 elite female soccer players, aged 11 to 14 years, from 33 randomly selected youth soccer teams. Of the players contacted, 83.1% participated and 92.4% completed the study. MAIN OUTCOMES AND MEASURES Concussion cumulative incidence, incidence rate, and description of the number, type, and duration of symptoms. We inquired weekly about concussion symptoms and, if present, the symptom type and duration, the event resulting in symptom onset, and whether the player sought medical attention or played while symptomatic. RESULTS Among the 351 soccer players, there were 59 concussions with 43 742 athletic exposure hours. Cumulative concussion incidence was 13.0% per season, and the incidence rate was 1.2 per 1000 athletic exposure hours (95% CI, 0.9-1.6). Symptoms lasted a median of 4.0 days (mean, 9.4 days). Heading the ball accounted for 30.5% of concussions. Players with the following symptoms had a longer recover time than players without these symptoms: light sensitivity (16.0 vs 3.0 days, P = .001), emotional lability (15.0 vs 3.5 days, P = .002), noise sensitivity (12.0 vs 3.0 days, P = .004), memory loss (9.0 vs 4.0 days, P = .04), nausea (9.0 vs 3.0 days, P = .02), and concentration problems (7.0 vs 2.0 days, P = .02). Most players (58.6%) continued to play with symptoms, with almost half (44.1%) seeking medical attention. CONCLUSIONS AND RELEVANCE Concussion rates in young female soccer players are greater than those reported in older age groups, and most of those concussed report playing with symptoms. Heading the ball is a frequent precipitating event. Awareness of recommendations to not play and seek medical attention is lacking for this age group.