Carisa M. Cooney

Botox Therapy for Ischemic Digits

Background: Treating patients with Raynauds phenomenon who have chronic pain and ulcerations is extremely challenging. Unrelenting pain can lead to dysfunction and disuse, rendering the patient debilitated and/or chronically depressed. Pharmacologic vasodilators and surgical sympathectomies offer variable benefits. Outcomes of symptomatic patients treated with botulinum toxin type A (Botox) injections for Raynauds phenomenon are presented. Methods: A retrospective study focused on patient outcomes was performed on 19 patients diagnosed with Raynauds phenomenon. Patients suffered from chronic ischemic hand pain. All patients had vascular studies to rule out occlusive disease. Fifty to 100 units of Botox were injected into the palm around each involved neurovascular bundle. Preinjection and postinjection laser Doppler scanning was performed on most patients to measure blood flow. Results: Sixteen of 19 patients (84 percent) reported pain reduction at rest. Thirteen patients reported immediate relief; three reported more gradual pain reduction over 1 to 2 months. Three patients had no or minimal pain relief. Tissue perfusion results demonstrated a marked change in blood flow (–48.15 percent to 425 percent) to the digits. All patients with chronic finger ulcers healed within 60 days. Most patients [n = 12 (63 percent)] remained pain-free (13 to 59 months) with a single-injection schedule. Four patients (21 percent) required repeated injections because of recurrent pain. Conclusions: Vascular function is abnormal in patients with Raynauds phenomenon. Although its mechanism is unknown, Botox yielded a distinct improvement in perfusion and reduction in pain in patients failing conservative management. Continued research may lead to more specific and reliable treatment for Raynauds patients.

The Lupus Family Registry and Repository

The Lupus Family Registry and Repository (LFRR) was established with the goal of assembling and distributing materials and data from families with one or more living members diagnosed with SLE, in order to address SLE genetics. In the present article, we describe the problems and solutions of the registry design and biometric data gathering; the protocols implemented to guarantee data quality and protection of participant privacy and consent; and the establishment of a local and international network of collaborators. At the same time, we illustrate how the LFRR has enabled progress in lupus genetics research, answering old scientific questions while laying out new challenges in the elucidation of the biologic mechanisms that underlie disease pathogenesis. Trained staff ascertain SLE cases, unaffected family members and population-based controls, proceeding in compliance with the relevant laws and standards; participant consent and privacy are central to the LFRRs effort. Data, DNA, serum, plasma, peripheral blood and transformed B-cell lines are collected and stored, and subject to strict quality control and safety measures. Coded data and materials derived from the registry are available for approved scientific users. The LFRR has contributed to the discovery of most of the 37 genetic associations now known to contribute to lupus through 104 publications. The LFRR contains 2618 lupus cases from 1954 pedigrees that are being studied by 76 approved users and their collaborators. The registry includes difficult to obtain populations, such as multiplex pedigrees, minority patients and affected males, and constitutes the largest collection of lupus pedigrees in the world. The LFRR is a useful resource for the discovery and characterization of genetic associations in SLE.

Comprehensive Observations of Resident Evolution: A Novel Method for Assessing Procedure-Based Residency Training

Background: Assessment of surgical skills in the operating room remains a challenge. Increasing documentation requirements of the Accreditation Council for Graduate Medical Education are necessitating mechanisms to document trainee competence without hindering operative turnover. The authors created a comprehensive electronic resource to facilitate plastic surgery training program compliance with changes mandated by Next Accreditation System Milestones and the ACGME. Methods: In 2013, the authors implemented the Comprehensive Observations of Resident Evolution, or CORE, a Web-based tool to assess plastic surgery residents. It comprises a rapid electronic assessment of resident operating room performance completed after each surgery; a data dashboard displaying graphical summaries of resident progress by case, Milestone, or current procedural terminology code; and an electronic Milestones tracker (MileMarker), which enables ongoing trainee assessments. Results: From January through October of 2014, 24 residents completed nearly 1300 Operative Entrustability Assessments. Thirty-eight percent of residents reported more immediate feedback regarding operative performance. The assessment demonstrates construct validity, which distinguishes novice residents from experienced residents. Individual case data identify resident-specific operative strengths and weaknesses. Using assessment data, the first two Clinical Competency Committee reviews were 81 percent and 87 percent shorter than Milestones pilot test site reports (average, 11.5 and 8 minutes versus 60 minutes per resident, respectively). Conclusions: Comprehensive Observations of Resident Evolution is capable of capturing operative performance data on all operating room cases by primary current procedural terminology code. It increases immediate attending/trainee feedback and assessment transparency, enables trainee self-monitoring, and informs end-of-rotation reviews, programwide assessments, and tailoring of training to address specific needs. It is a valuable resource for tracking resident progress in real-time while maintaining compliance with evolving ACGME requirements.

Integrating the NAS Milestones and Handheld Technology to Improve Residency Training and Assessment

OBJECTIVE To incorporate the use of an intuitive and robust assessment tool in conjunction with the Next Accreditation System Milestones to maximize opportunities for trainee performance feedback and continuous trainee assessment, with the long-term goal of increasing the rate of performance improvement and mastery of knowledge and surgical skills. DESIGN Pilot study. SETTING Johns Hopkins Medicine, Baltimore, MD. Primary, tertiary, and quaternary clinical care; institutional environment. PARTICIPANTS Experimental group: two randomly selected postgraduate year-1 integrated training program residents per year for 2 consecutive years from the Department of Plastic and Reconstructive Surgery. CONTROL GROUP traditionally trained residents from the integrated training program in the Department of Plastic and Reconstructive Surgery. Study duration: 7 years (until residents complete residency training). ANTICIPATED RESULTS This assessment strategy would create large amounts of informative data on trainees, which can be cross-referenced to determine trainee progress. Assessment data would be collected continuously from all faculty surgeons. Comparisons of faculty and resident self-assessments would facilitate resident evaluations. Ease of use of the data collection structure would improve faculty evaluation compliance and timely resident case report completion. CONCLUSIONS Improving the efficiency and efficacy of competency documentation is critical. Using portable technologies is an intuitive way to improve the trainee assessment process. We anticipate that this 2-pronged approach to trainee assessments would quickly provide large amounts of informative data to better assess trainee progress and inform Milestone assessments in a manner that facilitates immediate feedback. Assessments of faculty and resident satisfaction would help us further refine the assessment process as needed. If successful, this format could easily be implemented by other training programs. APPLICABLE PROJECT AREA Innovations in Surgical Education: Milestones.

Neoadjuvant Chemotherapy and Short-term Morbidity in Patients Undergoing Mastectomy With and Without Breast Reconstruction

IMPORTANCE Neoadjuvant chemotherapy (NC) is increasingly being used in patients with breast cancer, and evidence-based reports related to its independent effects on morbidity after mastectomy with immediate breast reconstruction are limited. OBJECTIVE To determine the effect of NC on 30-day postoperative morbidity in women undergoing mastectomy with or without immediate breast reconstruction. DESIGN, SETTING, AND PARTICIPANTS All women undergoing mastectomy with or without immediate breast reconstruction from January 1, 2005, through December 31, 2011, at university and private hospitals internationally were analyzed using the American College of Surgeons National Surgical Quality Improvement Program 2005-2011 databases. Patients who received NC were compared with those without a history of NC to estimate the relative odds of 30-day postoperative overall, systemic, and surgical site morbidity using model-wise multivariable logistic regression. EXPOSURE Neoadjuvant chemotherapy. MAIN OUTCOMES AND MEASURES Thirty-day postoperative morbidity (overall, systemic, and surgical site). RESULTS Of 85,851 women, 66,593 (77.6%) underwent mastectomy without breast reconstruction, with 2876 (4.3%) receiving NC; 7893 patients were excluded because of missing exposure data. The immediate breast reconstruction population included 19,258 patients (22.4%), with 820 (4.3%) receiving NC. After univariable analysis, NC was associated with a 20% lower odds of overall morbidity in the group undergoing mastectomy without breast reconstruction (odds ratio [OR], 0.80; 95% CI, 0.71-0.91) but had no significant effect in the immediate breast reconstruction group (OR, 0.98; 95% CI, 0.79-1.23). After adjustment for confounding, NC was independently associated with lower overall morbidity in the group undergoing mastectomy without breast reconstruction (OR, 0.61; 95% CI, 0.51-0.73) and the immediate tissue expander reconstruction subgroup (OR, 0.49; 95% CI, 0.30-0.84). Neoadjuvant chemotherapy was associated with decreased odds of systemic morbidity in 4 different populations: complete sample (OR, 0.59; 95% CI, 0.49-0.71), mastectomy without breast reconstruction (OR, 0.59; 95% CI, 0.48-0.72), any immediate breast reconstruction (OR, 0.57; 95% CI, 0.37-0.88), and the tissue expander subgroup (OR, 0.41; 95% CI, 0.23-0.72). CONCLUSIONS AND RELEVANCE Our study supports the safety of NC in women undergoing mastectomy with or without immediate breast reconstruction. Neoadjuvant chemotherapy is associated with lower overall morbidity in the patients undergoing mastectomy without breast reconstruction and in those undergoing tissue expander breast reconstruction. In addition, the odds of systemic morbidity were decreased in patients undergoing mastectomy with and without immediate breast reconstruction. The mechanisms behind the protective association of NC remain unknown and warrant further investigation.

Low incidence of complications using polyglactin 910 (Vicryl) mesh in breast reconstruction: A systematic review

BACKGROUND Mastectomy and breast reconstruction are essential parts of the treatment of breast cancer. Acellular dermal matrices (ADMs) have been used for the reconstruction of the lower pole due to many advantages; however, its cost is seen as a major drawback in this era of concern for the allocation of health-care funds. Recently, polyglactin 910 (Vicryl; Ethicon, Somerville, NJ, USA) mesh has been published as an alternative. We assessed the published literature, in particular investigating for studies that compare Vicryl mesh with ADM. METHODS We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. Searched databases included Medline/PubMed, Cochrane Reviews, Embase, Web of Science, ClinicalTrials, and SCOPUS. Search criteria were as follows: (1) reporting of clinical data using Vicryl mesh in breast reconstruction, (2) reporting of original data, and (3) outcome of interest reported. RESULTS We retrieved 290 de-duplicated articles. After title and abstract screening, we dismissed 258 articles, and thus full text was reviewed for 32 articles; only three retrospective articles met inclusion criteria. The total population included 112 patients and 156 breasts. The reported incidence of complications was as follows: infection 2.6% (confidence interval (CI): 0.7-6.6%), reconstruction failure 3.2% (CI: 1.0-7%), and seroma 1.3% (CI: 0.2-4.6%). A seven- to 12-fold cost difference was reported. Follow-up length ranged from 1.2 to 3.6 years. No studies directly compared Vicryl mesh with ADM. CONCLUSIONS Although the evidence is limited, polyglactin 910 (Vicryl) mesh for immediate breast reconstruction appears to be a potentially safe, effective, and less expensive alternative to ADM. Prospective studies are needed to further compare mesh with ADM.

Increased flap weight and decreased perforator number predict fat necrosis in DIEP breast reconstruction

Background: Compromised perfusion in autologous breast reconstruction results in fat necrosis and flap loss. Increased flap weight with fewer perforator vessels may exacerbate imbalances in flap perfusion. We studied deep inferior epigastric perforator (DIEP) and muscle-sparing transverse rectus abdominis myocutaneous (MS-TRAM) flaps to assess this concept. Methods: Data from patients who underwent reconstruction with DIEP and/or MS-TRAM flaps between January 1, 2010 and December 31, 2011 (n = 123) were retrospectively reviewed. Patient demographics, comorbidities, intraoperative parameters, and postoperative outcomes were collected, including flap fat necrosis and donor/recipient site complications. Logistic regression analysis was used to examine effects of flap weight and perforator number on breast flap fat necrosis. Results: One hundred twenty-three patients who underwent 179 total flap reconstructions (166 DIEP, 13 MS-TRAM) were included. Mean flap weight was 658 ± 289 g; 132 (73.7%) were single perforator flaps. Thirteen flaps (7.5%) developed fat necrosis. African American patients had increased odds of fat necrosis (odds ratio, 11.58; P < 0.001). Odds of developing fat necrosis significantly increased with flap weight (odds ratio, 1.5 per 100 g increase; P < 0.001). In single perforator flaps weighing more than 1000 g, six (42.9%) developed fat necrosis, compared to 14.3% of large multiple perforator flaps. Conclusions: Flaps with increasing weight have increased risk of fat necrosis. These data suggest that inclusion of more than 1 perforator may decrease odds of fat necrosis in large flaps. Perforator flap breast reconstruction can be performed safely; however, considerations concerning race, body mass index, staging with tissue expanders, perforator number, and flap weight may optimize outcomes.

Mastectomy Weight and Tissue Expander Volume Predict Necrosis and Increased Costs Associated with Breast Reconstruction.

Introduction: Impaired vascular perfusion in tissue expander (TE) breast reconstruction leads to mastectomy skin necrosis. We investigated factors and costs associated with skin necrosis in postmastectomy breast reconstruction. Methods: Retrospective review of 169 women with immediate TE placement following mastectomy between May 1, 2009 and May 31, 2013 was performed. Patient demographics, comorbidities, intraoperative, and postoperative outcomes were collected. Logistic regression analysis on individual variables was performed to determine the effects of tissue expander fill volume and mastectomy specimen weight on skin necrosis. Billing data was obtained to determine the financial burden associated with necrosis. Results: This study included 253 breast reconstructions with immediate TE placement from 169 women. Skin necrosis occurred in 20 flaps for 15 patients (8.9%). Patients with hypertension had 8 times higher odds of skin necrosis [odd ratio (OR), 8.10, P < 0.001]. Patients with TE intraoperative fill volumes >300 cm3 had 10 times higher odds of skin necrosis (OR, 10.66, P =0.010). Volumes >400 cm3 had 15 times higher odds of skin necrosis (OR, 15.56, P = 0.002). Mastectomy specimen weight was correlated with skin necrosis. Specimens >500 g had 10 times higher odds of necrosis and specimens >1000 g had 18 times higher odds of necrosis (OR, 10.03 and OR, 18.43; P =0.003 and P <0.001, respectively). Mastectomy skin necrosis was associated with a 50% increased inpatient charge. Conclusion: Mastectomy flap necrosis is associated with HTN, larger TE volumes and mastectomy specimen weights, resulting in increased inpatient charges. Conservative TE volumes should be considered for patients with hypertension and larger mastectomy specimens.

Primary versus Flap Closure of Perineal Defects following Oncologic Resection: A Systematic Review and Meta-Analysis.

Background: Abdominoperineal resection and pelvic exenteration for resection of malignancies can lead to large perineal defects with significant surgical-site morbidity. Myocutaneous flaps have been proposed in place of primary closure to improve wound healing. A systematic review was conducted to compare primary closure with myocutaneous flap reconstruction of perineal defects following abdominoperineal resection or pelvic exenteration with regard to surgical-site complications. Methods: A comprehensive literature search was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines in the MEDLINE, EMBASE, Google Scholar, and Cochrane Library databases. After data extraction from included studies, meta-analysis was performed to compare outcome parameters defining surgical-site complications of flap and primary closure. Results: Our systematic review yielded 10 eligible studies (one randomized controlled trial and nine retrospective studies) involving 566 patients (226 flaps and 340 primary closures). Eight studies described rectus abdominis myocutaneous flaps and two studies used gracilis flaps. In meta-analysis, primary closure was more than twice as likely to be associated with total perineal wound complications compared with flap closure (OR, 2.17; 95 percent CI, 1.34 to 3.14; p = 0.001). Rates of major perineal wound complications were also significantly higher in the primary closure group (OR, 3.64; 95 percent CI, 1.43 to 7.79; p = 0.005). There was no statistically significant difference between primary and flap closure for minor perineal wound complications, abdominal hernias, length of stay, or reoperation rate. Conclusions: This is the first systematic review with meta-analysis comparing primary closure with myocutaneous flap closure for pelvic reconstruction. The authors’ results have validated the use of myocutaneous flaps for reducing perineal morbidity following abdominoperineal resection or pelvic exenteration. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Preoperative Anemia and Postoperative Outcomes in Immediate Breast Reconstructive Surgery: A Critical Analysis of 10,958 Patients from the ACS-NSQIP Database.

Background: Preoperative anemia is independently associated with adverse outcomes after general and cardiac surgery. Outcomes after breast reconstruction are not established. We assessed the effect of preoperative anemia on 30-day postoperative morbidity and length of hospital stay (LOS) in patients undergoing immediate breast reconstruction. Methods: We identified patients undergoing immediate breast reconstruction from 2008 to 2010 from the American College of Surgeons’ National Surgical Quality Improvement Program database (a prospective outcomes-based registry from hospitals worldwide). De-identified data were obtained for demographics, preoperative risk factors, 30-day morbidity, and LOS. Morbidity variables included flap/graft/prosthesis, cardiac, respiratory, neurological, urinary, wound, and venous thromboembolism outcomes. Logistic regression assessed the crude and adjusted effect of anemia (hematocrit <36%) on postoperative 30-day morbidity. Measures of central tendency of LOS were compared across increasing severities of anemia in patients developing adverse events versus controls. Results: The study population included 10,958 patients; 1556 (16.74%) had preoperative anemia. Crude odds ratio for 30-day morbidity was significantly higher in anemic patients, unadjusted odds ratio = 1.33 (P < 0.008). This prevailed after extensive adjustment for confounding, yielding an adjusted odds ratio = 1.38 (P < 0.03). Patients who experienced adverse effects had protracted LOS, and the presence of anemia significantly amplified this effect. Conclusions: These data provide new insight into the effect of anemia in immediate breast reconstruction, demonstrating an independent association between preoperative anemia and 30-day morbidity. These findings suggest treating anemia when possible; however, prospective studies should explore the efficacy, safety, and cost-effectiveness of such treatments.