Predicting Nipple–Areolar Involvement Using Preoperative Breast MRI and Primary Tumor Characteristics

Background

Preoperative assessment of the nipple–areolar complex (NAC) is invaluable when considering nipple-sparing mastectomy. Our hypothesis is that breast magnetic resonance imaging (MRI) may predict involvement of the NAC with tumor.

Methods

Clinical, histopathologic, and imaging data were compiled for patients who underwent preoperative breast MRI followed by mastectomy or nipple-sparing mastectomy for malignancy between 2006 and 2009. Blinded rereview of all MRI studies was performed by a breast MRI imager and compared to initial MRI findings. Multivariate analysis identified variables predicting NAC involvement with tumor.

Results

Of 77 breasts, 18 (23 %) had tumor involving or within 1 cm of the NAC. The sensitivity of detecting histopathologically confirmed NAC involvement was 61 % with history and/or physical examination, and 56 % with MRI. Univariate analysis identified the following variables as significant for NAC involvement: large tumors near the nipple on preoperative MRI, node-positive disease, invasive lobular carcinoma, advanced histopathologic T stage, and neoadjuvant chemotherapy. On multivariate analysis, only tumor size >2 cm and distance from tumor edge to the NAC <2 cm on MRI maintained significance. Pearson correlation coefficient for MRI size compared to histopathologic size was 0.53 (P < 0.0001).

Conclusions

MRI is not superior to thorough clinical evaluation for predicting tumor in or near the NAC. However, MRI-measured tumor size and distance from the NAC are correlated with increased risk of NAC involvement. The combination of preoperative history and physical examination, tumor characteristics, and breast MRI can aid the surgeon in predicting a tumor-involved nipple more than any single modality alone.     

Brief Report: A Preliminary Study of the Relationship between Repetitive Behaviors and Concurrent Executive Function Demands in Children with Autism Spectrum Disorder

Journal of Autism and Developmental Disorders - The present study evaluated the hypothesis that the strength of the relationship between executive function (EF) and repetitive behaviors and...     

Phase 3 evaluation of HP802‐247 in the treatment of chronic venous leg ulcers

In 2012 we reported promising results from a phase 2 clinical trial of HP802‐247, a novel spray‐applied investigational treatment for chronic venous leg ulcers consisting of human, allogeneic fibroblasts and keratinocytes. We now describe phase 3 clinical testing of HP802‐247, its failure to detect efficacy, and subsequent investigation into the root causes of the failure. Two randomized, controlled trials enrolled a total of 673 adult outpatients at 96 centers in North America and Europe. The primary endpoint was the proportion of ulcers with confirmed closure at the end of 12 weeks of treatment. An investigation into the root cause for the failure of HP802‐247 to show efficacy in these two phase 3 trials was initiated immediately following the initial review of the North American trial results. Four hundred twenty‐one patients were enrolled in the North American (HP802‐247, 211; Vehicle 210) and 252 in the European (HP802‐247, 131; Vehicle 121) trials. No difference in proportion of closed ulcers at week 12 was observed between treatment groups for either the North American (HP802‐247, 61.1%; Vehicle 60.0%; p = 0.5896) or the European (HP802‐247, 47.0%; Vehicle 50.0%; p = 0.5348) trials. Thorough investigation found no likelihood that design or execution of the trials contributed to the failure. Variability over time during the trials in the clinical response implicated the quality of the cells comprising HP802‐247. Concordance between the two separate, randomized, controlled trials with distinct, nonoverlapping investigative sites and independent monitoring teams renders the possibility of a Type II error vanishingly small and provides strong credibility for the unexpected lack of efficacy observed. The most likely causative factors for the efficacy failure in phase 3 was phenotypic change in the cells (primarily keratinocytes) leading to batch to batch variability due to the age of the cell banks.     

Thirty-Day Readmission After Laparoscopic Sleeve Gastrectomy—a Predictable Event?

Background

Thirty-day readmission post-bariatric surgery is used as a metric for surgical quality and patient care. We sought to examine factors driving 30-day readmissions after laparoscopic sleeve gastrectomy (LSG).

Methods

We reviewed 1257 LSG performed between March 2012 and June 2014. Readmitted and nonreadmitted patients were compared in their demographics, medical histories, and index hospitalizations. Multivariable regression was used to identify risk factors for readmission.

Results

Forty-five (3.6 %) patients required 30-day readmissions. Forty-seven percent were readmitted with malaise (emesis, dehydration, abdominal pain) and 42 % with technical complications (leak, bleed, mesenteric vein thrombosis). Factors independently associated with 30-day readmission include index admission length of stay (LOS) ≥3 days (OR 2.54, CI?=?[1.19, 5.40]), intraoperative drain placement (OR 3.11, CI?=?[1.58, 6.13]), postoperative complications (OR 8.21, CI?=?[2.33, 28.97]), and pain at discharge (OR?8.49, CI?=?[2.37, 30.44]). Patients requiring 30-day readmissions were 72 times more likely to have additional readmissions by 6 months (OR?72.4, CI?=?[15.8, 330.5]).

Conclusions

The 30-day readmission rate after LSG is 3.6 %, with near equal contributions from malaise and technical complications. LOS, postoperative complications, drain placement, and pain score can aid in identifying patients at increased risk for 30-day readmissions. Patients should be educated on postoperative hydration and pain management, so readmissions can be limited to technical complications requiring acute inpatient management.

     

Aerobic exercise intensity and time of stressor administration influence cardiovascular responses to psychological stress

This study examined cardiovascular responses as a function of time following exercise in which participants were exposed to a laboratory stressor. Ninety (42 women) young (18-35 years old) nonsmoking normotensive participants engaged in 30 min of high and low intensity (75-80% and 50-55% VO(2) max) aerobic exercise and a sedentary control condition. Participants were randomly assigned to a laboratory stressor 5, 30, or 60 min following the exercise bout. Results indicate that low and high intensity exercise significantly reduce heart rate (HR) and systolic and diastolic blood pressure reactivity and HR recovery values. An inverse relationship between intensity of exercise and subsequent cardiovascular reactivity was found. These findings suggest attenuated stress responses following acute exercise depend both on exercise intensity and the time of exposure to psychological stress following exercise.