Evidence-Based Performance Measures for Autologous Breast Reconstruction: An American Society of Plastic Surgeons Quality Performance Measure Set.

The American Society of Plastic Surgeons commissioned the Autologous Breast Reconstruction Performance Measure Development Work Group to identify and draft quality measures for the care of patients undergoing autologous breast reconstruction and other breast reconstruction surgery. Four outcome measures and one process measure were identified. Outcomes include patient satisfaction with information for all breast reconstruction, a subscale of the BREAST-Q, and the length of stay, operative time, and rate of blood transfusion for autologous blood transfusion. The process measure looks at coordination of care around managing the breast reconstruction patient's care, with the physician coordinating the ongoing care, be it an oncologist, radiologist, other specialist, or primary care physician. All measures in this report were approved by the American Society of Plastic Surgeons Quality and Performance Measures Work Group and the American Society of Plastic Surgeons Executive Committee. The Work Group recommends the use of these measures for quality initiatives, continuing medical education, maintenance of certification, American Society of Plastic Surgeons' Qualified Clinical Data Registry reporting, and national quality-reporting programs.

Three-dimensional magnetic resonance imaging of fetal head molding and brain shape changes during the second stage of labor.

To demonstrate and describe fetal head molding and brain shape changes during delivery, we used three-dimensional (3D) magnetic resonance imaging (MRI) and 3D finite element mesh reconstructions to compare the fetal head between prelabor and the second stage of labor. A total of 27 pregnant women were examined with 3D MRI sequences before going into labor using a 1 Tesla open field MRI. Seven of these patients subsequently had another set of 3D MRI sequences during the second stage of labor. Volumes of 2D images were transformed into finite element 3D reconstructions. Polygonal meshes for each part of the fetal body were used to study fetal head molding and brain shape changes. Varying degrees of fetal head molding were present in the infants of all seven patients studied during the second phase of labor compared with the images acquired before birth. The cranial deformation, however, was no longer observed after birth in five out of the seven newborns, whose post-natal cranial parameters were identical to those measured before delivery. The changing shape of the fetal brain following the molding process and constraints on the brain tissue were observed in all the fetuses. Of the three fetuses presenting the greatest molding of the skull bones and brain shape deformation, two were delivered by cesarean-section (one after a forceps failure and one for engagement default), while the fetus presenting with the greatest skull molding and brain shape deformation was born physiologically. This study demonstrates the value of 3D MRI study with 3D finite element mesh reconstruction during the second stage of labor to reveal how the fetal brain is impacted by the molding of the cranial bones. Fetal head molding was systematically observed when the fetal head was engaged between the superior pelvic strait and the middle brim.

Correction to: Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations.

The article "Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations", written by Barbara Schwartzberg et al., was originally published electronically on the publisher's internet portal (currently SpringerLink) on July 9, 2018, without open access.

Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations.

BACKGROUND: An institutional review board-approved, multicenter clinical trial was designed to determine the efficacy and outcome of percutaneous laser ablation (PLA) in the treatment of invasive ductal breast carcinoma (IDC). Post-ablation magnetic resonance imaging (MRI) was compared with surgical pathology in evaluation of residual post-ablation IDC and ductal carcinoma in situ. METHODS: Patients with a single focus of IDC 20 mm or smaller by pre-ablation MRI were treated with PLA. The patients underwent a 28-day post-ablation MRI, followed by surgical resection. Cell viability criteria were applied to pre- and post-ablation pathology specimens, which evaluated hematoxylin-eosin (H&E), cytokeratin (CK) 8/18, estrogen receptor, and Ki67 staining patterns. RESULTS: In this study, 61 patients were reported as the intention-to-treat cohort for determination of PLA efficacy. Of these 61 patients, 51 (84%) had complete tumor ablation confirmed by pathology analysis. One subject's MRI imaging was not performed per protocol, which left 60 subjects evaluable for MRI pathology correlation. Five patients (8.3%) had residual IDC shown by both MRI and pathology. Post-ablation discordance was noted between MRI and pathology, with four patients (6.7%) false-positive and four patients (6.7%) false-negative. The negative predictive value (NPV) of MRI for all the patients was 92.2% (95% confidence interval [CI], 71.9-91.9%). Of the 47 patients (97.9%) with tumors 15 mm or smaller, 46 were completely ablated, with an MRI NPV of 97.7% (95% CI, 86.2-99.9%). CONCLUSIONS: Percutaneous laser ablation is a potential alternative to surgery for treatment of early-stage IDC. Strong correlations exist between post-ablation MRI and pathologic alterations in CK8/18, ER, and Ki67 staining.

Reasons for re-excision after lumpectomy for breast cancer: insight from the American Society of Breast Surgeons Mastery(SM) database.

BACKGROUND: There is marked variability of re-excision rates after initial lumpectomy for breast cancer. Reasons for re-excision and variability across surgeons have not been well documented. We hypothesized the American Society of Breast Surgeons (ASBrS) Mastery(SM) Program can identify reasons for re-excision. METHODS: Data from January 1 to 7 November 2013 were evaluated in the ASBrS Mastery(SM) Program to determine re-excision lumpectomy rate (RELR). On 1 June 2013, a tool to track reasons for re-excision was developed. Variation in re-excision rate by surgeon and patient characteristics was performed by Chi square test and Fisher's test for univariate analysis, then logistic regression with backwards elimination method for multivariate analysis. RESULTS: For 6,725 patients undergoing initial lumpectomy for cancer, 328 surgeons reported 1,451 (21.6 %) patients had one or more re-excisions. The most common reasons for re-excision were ink positive margins in 783 (49.7 %), margin <1 mm (34.3 %), and margin 1-2 mm (7.2 %). By multivariate analysis, re-excision rates were lower in patients aged less than 35 years, with White (non-) Hispanic ethnicity, and, among surgeons in solo practice, more years in practice and higher-volume practice. CONCLUSION: Half of re-excisions after initial lumpectomy were performed for margins that are positive. Most of the remainder were for negative close (<1-2 mm) margins. This information corroborates surgeon survey data regarding reasons for re-excision and provides proof of concept the Mastery(SM) Program can capture surgical outcome data in real time, providing opportunity and a method for future performance improvement.

Timing of Chemotherapy after MammoSite radiation therapy system breast brachytherapy: analysis of the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial.

PURPOSE: To evaluate cosmetic outcome and radiation recall in the American Society of Breast Surgeons registry trial, as a function of the interval between accelerated partial breast irradiation (APBI) and initiation of chemotherapy (CTX). METHODS AND MATERIALS: A total of 1440 patients at 97 institutions participated in this trial. After lumpectomy for early-stage breast cancer, patients received APBI (34 Gy in 10 fractions) with MammoSite RTS brachytherapy. A total of 148 patients received CTX within 90 days of APBI. Cosmetic outcome was evaluated at each follow-up visit and dichotomized as excellent/good or fair/poor. RESULTS: Chemotherapy was initiated at a mean of 3.9 weeks after the final MammoSite procedure and was administered 3 weeks after APBI in 94 patients (64%). The early and delayed groups were well balanced with respect to multiple factors that may impact on cosmetic outcome. There was a superior cosmetic outcome in those receiving chemotherapy >3 weeks after APBI (excellent/good in 72.2% at 3 weeks; p = 0.01). Radiation recall in those receiving CTX at 3 weeks (p = 0.09). CONCLUSION: The majority of patients receiving CTX after APBI have excellent/good cosmetic outcomes, with a low rate of radiation recall. Chemotherapy initiated >3 weeks after the final MammoSite procedure seems to be associated with a better cosmetic outcome and lower rate of radiation recall. An excellent/good cosmetic outcome in patients receiving CTX after 3 weeks was similar to the cosmetic outcome of the overall patient population who did not receive CTX.

Initial outcomes for patients treated on the American Society of Breast Surgeons MammoSite clinical trial for ductal carcinoma-in-situ of the breast.

BACKGROUND: The MammoSite device was designed as a breast brachytherapy applicator and is currently used to deliver accelerated partial breast irradiation (APBI). We hypothesized that APBI delivered with the MammoSite device would be well tolerated and be associated with a good cosmetic outcome in patients with ductal carcinoma-in-situ (DCIS). METHODS: From 2002 to 2004, 191 patients with DCIS were enrolled in a registry trial to assess the MammoSite applicator. Fifteen patients were excluded from analysis because of device- or patient-related factors; 7 patients were excluded after receiving a radiotherapy boost, thus leaving 169 patients available for study. Follow-up information was available for 158 patients. The average length of follow-up was 7.35 months. Forty-three patients had at least 1 year of follow-up. RESULTS: Skin spacing for the MammoSite applicator was as follows: < 5 mm, 3 patients (1.78%); 5 to 7 mm, 18 patients (10.65%); and > or = 7 mm, 148 patients (87.57%). Patients with a device-to-skin distance of > or = 7 mm had the best cosmetic result. Patients with a device-to-skin distance of > or = 7 mm also had a lower incidence of radiation dermatitis. Data on 43 patients who were followed up for at least 1 year confirmed these findings. Additional adverse events were primarily related to skin changes, with breast infections occurring in five patients (3.16%). No patient in the study has experienced a recurrence. CONCLUSIONS: APBI delivered via MammoSite is well tolerated in patients with DCIS, and the lowest toxicity was obtained in patients with the greatest device-to-skin distance. Long-term follow-up data regarding patient satisfaction, cosmesis, and efficacy are needed and will be determined from a recently opened large randomized study.

Descriptions and outcomes of insertion techniques of a breast brachytherapy balloon catheter in 1403 patients enrolled in the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial.

BACKGROUND: The use of the MammoSite brachytherapy balloon catheter is 1 option for the delivery of accelerated partial breast irradiation during breast cancer therapy. The device can be inserted into the breast using 3 different techniques. This report describes these methods of insertion and correlates the technique with outcome data collected in a multi-institutional registry trial. METHODS: In the registry trial, MammoSite catheters were inserted either (1) at the time of lumpectomy into an open cavity, (2) after surgery with ultrasound guidance through a separate small lateral incision into a closed cavity, or (3) after surgery by entering directly through the lumpectomy wound (the scar entry technique). Device placement techniques in 1403 patients with early stage breast cancer treated at 87 institutions by 223 different investigators were documented in the registry. Data collected included number of cases of each technique, age of patient, tumor size, skin spacing, catheter pull rates and reasons, infection, radiation recall, cosmesis, and recurrence. RESULTS: Catheter placement at the time of lumpectomy was performed in 619 patients (44%), after surgery with ultrasound guidance in 576 patients (41%), and the scar entry technique technique in 197 patients (14%). The type of technique was not associated with age of patient, tumor size, bra size, catheter size, skin spacing, infection, radiation recall, cosmesis, or recurrence. There was a statistically significant increased incidence of premature catheter removals for pathologically related reasons with the open-cavity technique compared with the 2 postoperative methods secondary to final histology reports disqualifying the patient after MammoSite placement. CONCLUSIONS: These registry data show that the MammoSite catheter can be inserted with any 1 of 3 different techniques. A postoperative placement, after the final pathology report is issued, decreases the incidence of premature removal of the catheter because of disqualifying pathology.

Surgical benefits conveyed by biopsy site marking system using ultrasound localization.

BACKGROUND: With vacuum-assisted biopsy technology all, or most, of a breast lesion may be removed during the initial biopsy; in such cases a metallic marker is often inserted at the site of the biopsy for future localization. The aim of this study was to evaluate the efficacy and impact of the Gel Mark Ultra biopsy site marking system (SenoRx, Aliso Viejo, CA) on the practice of needle localization breast biopsy. METHODS: We retrospectively analyzed the experience of 45 general surgeons across the United States in a variety of practice settings using the Gel Mark Ultra clip. Imaging-guided biopsy technique, localization quality, surgeon confidence, and margin status were assessed and compared against the broad data reported in the literature. RESULTS: A total of 432 records of patients who underwent imaging-guided breast biopsy with placement of Gel Mark Ultra clip were reviewed. Of these, 63 (15%) patients required definitive surgical intervention, for which 41 cases were localized with ultrasound and assessed for margin clearance. Clear margins were achieved in 37 (90%) of the 41 cases. These results are statistically superior (P < .01) to positive margins rates reported in the literature. CONCLUSIONS: The Gel Mark Ultra biopsy site marking system is a new localization device that provides a safe and effective alternative to traditional localization methods with a significant reduction in the percentage of positive margins, as well as advantages in terms of surgical approach, time, and patient comfort.

First analysis of patient demographics, technical reproducibility, cosmesis, and early toxicity: results of the American Society of Breast Surgeons MammoSite breast brachytherapy trial.

BACKGROUND: Eighty-seven institutions participated in a Registry Trial that was designed to collect data on the clinical use of the MammoSite breast brachytherapy catheter for delivering breast irradiation. Patient demographics, technical reproducibility, cosmesis, and early toxicity were evaluated. METHODS: From May 4, 2002 through July 30, 2004, 1419 patients with Stage 0, I, or II breast carcinoma who were undergoing breast-conserving therapy were enrolled on the trial. The device was placed in 1403 of these patients. The 1237 patients (87% of enrolled patients) who received accelerated partial breast irradiation (APBI) (34 grays prescribed to 1.0 cm in 10 fractions; 95% of patients who received APBI) constituted the study population; 86% of those patients (1068) had Stages I-II breast carcinoma (median tumor size, 10 mm), and 14% of those patients (169) had Stage 0 breast carcinoma. Ninety-one percent of the patients with invasive carcinoma (977 of 1068 patients) had negative lymph node status, and 99% of all patients had negative margins. The median patient age was 65 years. Systemic chemotherapy alone was administered to 79 patients with invasive carcinoma (7%), hormone therapy was administered to 501 patients (45%), and both were administered to 39 patients (4%). The median follow-up was 5 months. RESULTS: Five hundred fifty-four catheters (45%) were placed with an open cavity at the time of lumpectomy, and 683 catheters (55%) were placed with a closed cavity after lumpectomy. Skin spacing ranged from 2 mm to 75 mm (median, 10 mm). In 89% of patients, there was a minimum balloon-to-skin distance of 7 mm (2% of patients had distances < 5 mm). In terms of cosmetic assessment, 95% of patients (1030 of 1084 patients) who had a cosmetic assessment had a good/excellent result (last follow-up visit). Cosmetic results at 12 months were good/excellent in 92% of 248 evaluable patients. The median skin spacing (> or = 7 mm vs. < 7 mm) was associated significantly with a good/excellent cosmetic result (96.1% vs. 86.8%; P = 0.0001) overall and at 6 months (P = 0.006). Increasing skin spacing was associated with a good/excellent cosmetic result as a continuous variable (P < 0.0001). In total, 92 of 1140 evaluable patients (8.1%) developed an infection in the breast, which was device-related in 5.3% of patients (60 of 1140 patients). Good/excellent cosmetic results were noted in 86% of these patients (last follow-up visit). Fifteen of 442 evaluable patients (3.4%) developed a radiation recall reaction. Good/excellent cosmetic results were noted in 93% of these patients at their last follow-up visit. One local recurrence (0.1%) was reported (new primary carcinoma). CONCLUSIONS: Clinical evaluation of the ability of the MammoSite breast brachytherapy catheter to deliver APBI demonstrated acceptable technical reproducibility between multiple institutions and use in appropriate groups of patients. Cosmetic results at 12 months (92% good/excellent) were comparable to those reported with whole-breast RT. Early toxicity rates (infections, radiation recall) appeared to be acceptable.