Implementation and Analysis of a Lean Six Sigma Program in Microsurgery to Improve Operative Throughput in Perforator Flap Breast Reconstruction.

PURPOSE: Perforator flaps have become a preferred method of breast reconstruction but can consume considerable resources. We examined the impact of a Six Sigma program on microsurgical breast reconstruction at an academic medical center. METHODS: Using methods developed by Motorola and General Electric, we applied critical pathway planning, workflow analysis, lean manufacturing, continuous quality improvement, and defect reduction to microsurgical breast reconstruction. Primary goals were to decrease preoperative-to-cut time and total operative time, through reduced variability and improved efficiency. Secondary goals were to reduce length of stay, complications, and reoperation. The project was divided into 3 phases: (1) Pre-Six Sigma (24 months), (2) Six Sigma (10 months), (3) and Post-Six Sigma (24 months). These periods (baseline, intervention, control) were compared by Student t test and χ analysis. RESULTS: Over a 5-year period, 112 patients underwent 168 perforator flaps for breast reconstructions, by experienced microsurgeons. Total operative time decreased from 714 to 607 minutes (P < 0.01), across the study period, with the greatest drop occurring in unilateral cases, from 672 to 498 minutes (P < 0.01). Length of stay decreased from 6.3 to 5.2 days (P = 0.01). Overall complication rates (35.9% vs 30%, not significant) and take-back rates (20.5% vs 23.9%, not significant) remained similar over the 5-year period. Physician revenue/minute increased from US $6.28 to US $7.59, whereas hospital revenue/minute increased from US $21.84 to US $25.11. CONCLUSIONS: A Six Sigma program in microsurgical breast reconstruction was associated with better operational and financial outcomes. These incremental gains were maintained over the course of the study, suggesting that these benefits were due, in part, to process improvements. However, continued reductions in total operative time and length of stay, well after the intervention period, support the possibility that "learning curve" phenomenon may have contributed to the improvement in these outcomes.

Laser-assisted indocyanine green angiography: a critical appraisal.

BACKGROUND: Laser-assisted indocyanine green angiography (ICG-A) has been promoted to assess perfusion of random skin, pedicled, and free flaps. Few studies address its potential limitations. METHODS: Thirty-seven patients who underwent reconstructive procedures with ICG-A were studied retrospectively to determine the correlation between clinical findings and ICG-A. Indocyanine green angiography underestimated perfusion when areas of less than or equal to 25% uptake were not debrided and remained perfused. Indocyanine green angiography overestimated perfusion when areas with greater than 25% uptake developed necrosis. RESULTS: Of 14 random skin flaps, ICG-A underestimated perfusion in 14% and overestimated in 14%. In 16 patients undergoing perforator flap breast reconstruction, ICG-A correlated with computed tomographic angiogram (CTA) in 85%. Indocyanine green angiography underestimated perfusion in 7% and overestimated in 7%. In 8/11 patients undergoing fasciocutaneous flaps, ICG-A aided in donor site selection. In 3/6 ALT flaps, a better unilateral blush was found that correlated with Doppler. In all 3, a dominant perforator was found. In 11 patients, there was a 9% underestimation of flap perfusion. In 3 pedicled flaps, there was a 66% underestimation and 33% overestimation of perfusion. CONCLUSIONS: Indocyanine green angiography often confirmed our clinical/radiologic findings in abdominal perforator and fasciocutaneous flaps. It tended to underestimate perfusion in pedicle and skin flaps. When clinical examination was obvious, ICG-A rendered clear-cut findings. When clinical examination was equivocal, ICG-A tended to provide ambiguous findings, demonstrating that a distinct cutoff point does not exists for every patient or flap. Indocyanine green angiography is a promising but expensive technology that would benefit from standardization. Further research is needed before ICG-A can become a reliable tool for surgeons.

Perioperative corticosteroid reduces hospital stay after fronto-orbital advancement.

Facial swelling is common after fronto-orbital advancement. Edema and closure of the palpebral fissures can lead to prolonged hospitalization. The purpose of this study was to determine if perioperative corticosteroid shortens hospital stay after this procedure.We retrospectively studied consecutive children younger than 2 years who underwent primary fronto-orbital advancement between 1990 and 2008. Patients were categorized into 2 groups: group 1 patients were not given corticosteroid; group 2 patients received tapered perioperative dexamethasone. Primary outcome variables included length of hospital stay and infection rate.A total of 161 patients were included in the study. Hospitalization was significantly shorter (P = 0.008) for group 2 (n = 65; median duration, 3.0 d) than group 1 (n = 96; median duration, 5.0 d). Infection rates did not differ between groups (group 1, 2.1%; group 2, 1.5%; P = 0.8).Perioperative corticosteroid shortens hospitalization after fronto-orbital advancement without increasing the incidence of postoperative infection. The cost of postoperative hospital care was reduced by 27.2%.

Pediatric rib lesions: a 13-year experience.

BACKGROUND: Rib lesions in the pediatric population are rare but significant processes and are often neoplastic. METHODS: All patients with primary rib lesions evaluated by the Department of Surgery at Children's Hospital Boston from 1992 to 2005 were studied. The patient's diagnosis, sex, symptoms and their duration, radiologic evaluation, biopsy status, surgical procedure, and follow-up were assessed. RESULTS: Thirty-three patients, ages 3 to 23 years (median, 12.7 years), were evaluated. Sixteen patients (48%) had benign and 17 (52%) had malignant lesions. Within the benign cohort of 16 patients, there were 6 osteochondromas, 4 aneurysmal bone cysts, and 2 fibrous dysplasias as well as 1 of each of the following: enchondroma, periosteal chondroma, eosinophilic granuloma, and chondrophyte. Within the malignant cohort of 17 patients, 13 were diagnosed with Ewing's sarcoma, 3 with osteogenic sarcoma, and 1 with chondrosarcoma. The sex distribution for the malignant group was 11 (65%) females and 6 (35%) males. CONCLUSIONS: Rib tumors are rare entities in the pediatric population. However, a significant number of rib lesions are malignant. Therefore, proper diagnosis and expeditious treatment are critical.

Reduction of hepatocellular injury after common bile duct ligation using omega-3 fatty acids.

PURPOSE: Bile duct obstruction and subsequent cholestasis produces hepatocellular injury and an inflammatory response. Fatty acid constitution of cell membranes plays a major role in the inflammatory cascade. Omega-3 fatty acids are antiinflammatory. We proposed that omega-3 fatty acid supplementation would reduce hepatocellular damage and cell death in a model of murine common bile duct ligation. METHODS: Mice underwent bile duct ligation and were administered either control soy diet (omega-6) or Menhaden diet (omega-3), and parameters of liver injury were measured at postoperative days 1, 4, and 8. Serum was analyzed for liver function tests. Liver tissue was scored for histologic necrosis and inflammation, and apoptosis was qualitatively measured. RESULTS: At day 8, comparing control and Menhaden, liver function tests were not significantly different. The H&E slides were analyzed and scored. At day 4, the mean necrosis scores for the Menhaden-fed group was 0.01 +/- 0.028 and 0.46 +/- 0.108 for the soy-fed group (P = .001) and at day 8, 0.420 +/- 0.107 and 1.22 +/- 0.132 (P < .001). The mean portal inflammation score for day 4 Menhaden-fed and soy-fed mice was 1.40 +/- 0.245 for both groups (P = 1.00) and for day 8, 1.80 +/- 0.200 and 2.80 +/- 0.200 (P = .008). At day 1, the median terminal deoxynucleotidyl transferase biotin-dUTP nick end labeling scores of the Menhaden vs soy group were 6.0 and 0.0 (P < .001); day 4, 24.0 and 3.0 (P < .001); and day 8, 0.0 and 3.0 (P < .001), respectively. CONCLUSION: Although there appears to be a trend toward biochemical protection and a marked reduction of necrosis and inflammation, there was no significant liver function test difference between control and Menhaden groups. Considering our data of blunted histologic hepatotoxicity with omega-3 fatty acid supplementation, we hypothesize that this may be a method of reducing long-term complications of liver injury secondary to diseases of cholestasis such as biliary atresia, namely fibrosis and cirrhosis.

Inhibition of intra-abdominal adhesion formation with the angiogenesis inhibitor sunitinib.

OBJECTIVE: To determine the effects of sunitinib, a vascular endothelial growth factor receptor 2 (VEGFR-2) antagonist, on intra-abdominal adhesions. BACKGROUND: In the United States, complications from adhesions cost $1 billion and account for 846,000 inpatient days annually. Endothelial mitogens, such as VEGF, are up-regulated during adhesion formation. Sunitinib, a tyrosine kinase inhibitor with antiangiogenic and antitumor properties, may prevent or reduce postoperative abdominal adhesions by VEGFR-2 inhibition. METHODS: The cecum of 37 mice were abraded to promote adhesion formation and a silicone patch was sutured to the abdominal wall. The mice were randomized into two groups: Group 1 was treated with sunitinib in methylcellulose by oral gavage daily and Group 2 (control) received methylcellulose alone. After 10 d the mice were sacrificed and intra-abdominal adhesions were scored. The experiment was then repeated and mice were sacrificed on postoperative day 30 to assess the long-term effects of sunitinib. RESULTS: All 19 control mice developed intra-abdominal adhesions. Six of the 18 (33.3%) mice in the treatment group were adhesion-free. Collectively, the sunitinib-treated mice had a lower adhesion score [2.0 (IQR 0.0-5.0; range 0-8.0)] than the control group [5.0 (IQR 3.0-8.0; range 2.0-10.0) (P = 0.002)]. Long-term results were consistent with this finding [sunitinib 0.0 (IQR 0.0-3.0; range 0-7) and control 6.0 (IQR 3.0-7.0; range 0-12) (P = 0.049)]. CONCLUSION: Adhesion formation is angiogenesis-dependent and is in part mediated through VEGFR-2. Sunitinib, a VEGFR-2 antagonist, significantly reduces adhesion formation in a murine model. Antiangiogenic therapy may be an efficacious strategy to prevent or treat adhesions after intra-abdominal procedures.

Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease.

BACKGROUND: Parenteral nutrition-associated liver disease can be a progressive and fatal entity in children with short-bowel syndrome. Soybean-fat emulsions provided as part of standard parenteral nutrition may contribute to its pathophysiology. METHODS: We compared safety and efficacy outcomes of a fish-oil-based fat emulsion in 18 infants with short-bowel syndrome who developed cholestasis (serum direct bilirubin level of > 2 mg/dL) while receiving soybean emulsions with those from a historical cohort of 21 infants with short-bowel syndrome who also developed cholestasis while receiving soybean emulsions. The primary end point was time to reversal of cholestasis (3 consecutive measurements of serum direct bilirubin level of < or = 2 mg/dL). RESULTS: Among survivors, the median time to reversal of cholestasis was 9.4 and 44.1 weeks in the fish-oil and historical cohorts, respectively. Subjects who received fish-oil-based emulsion experienced reversal of cholestasis 4.8 times faster than those who received soybean emulsions and 6.8 times faster in analysis adjusted for baseline bilirubin concentration, gestational age, and the diagnosis of necrotizing enterocolitis. A total of 2 deaths and 0 liver transplantations were recorded in the fish-oil cohort and 7 deaths and 2 transplantations in the historical cohort. The provision of fish-oil-based fat emulsion was not associated with essential fatty acid deficiency, hypertriglyceridemia, coagulopathy, infections, or growth delay. CONCLUSIONS: Parenteral fish-oil-based fat emulsions are safe and may be effective in the treatment of parenteral nutrition-associated liver disease.

A critical role for matrix metalloproteinases in liver regeneration.

BACKGROUND: Matrix metalloproteinases (MMPs), tumor necrosis factor-alpha (TNF-alpha), and interleukin-6 (IL-6) are mediators of liver regeneration. To determine whether MMPs are required for normal hepatic regeneration, we performed 67% hepatectomies on mice treated with a broad-spectrum MMP-inhibitor, and assessed the effect on liver regeneration and urinary MMP activity. METHODS: Mice were subjected to sham operations, 67% hepatectomy, or 67% hepatectomy plus treatment with the broad-spectrum MMP inhibitor Marimastat. Urine collected preoperatively and for 8 d postoperatively was tested for MMP-2 and MMP-9 activity using zymography. Serum aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, bilirubin, TNF-alpha, IL-6, and hepatocyte growth factor levels were measured. Liver sections were analyzed by CD31 immunohistochemistry and microvessel density. Mitotic index and proliferating cell nuclear antigen labeling index were determined. RESULTS: The mean regenerating liver weight on postoperative day 8 was 0.72 +/- 0.01 grams for the hepatectomy Marimastat group, and 0.83 +/- 0.02 grams for the hepatectomy control group (P < 0.001). Urinary MMP-9 activity was elevated during hepatic regeneration, and decreased on postoperative day 8 when the liver returned to its preoperative mass. In contrast, urine from hepatectomy Marimastat mice, in which liver regeneration was successfully inhibited, showed consistently low levels of MMP-2 and MMP-9 activity. The hepatectomy Marimastat group also exhibited elevated serum IL-6 levels on post-operative day 8, while serum TNF-alpha soluble receptor II levels were unchanged. Hepatocyte growth factor levels were not significantly different between the control hepatectomy and hepatectomy Marimastat groups at days 2, 4, and 8. Liver microvessel density was reduced in the hepatectomy Marimastat group at day 4. Mitotic index and proliferating cell nuclear antigen index were significantly decreased in the Marimastat hepatectomy group at post-operative day 2. CONCLUSIONS: The broad-spectrum MMP-inhibitor Marimastat inhibits liver regeneration. Microvessel density is reduced at day 4. Furthermore, urinary MMP-9 is elevated during liver regeneration, and this effect is not observed when regeneration is inhibited by the broad-spectrum MMP-inhibitor Marimastat.

Risk of vascular anomalies with Down syndrome.

OBJECTIVE: Patients with Down syndrome have a reduced risk of developing solid tumors. This protective effect has been attributed to increased gene dosage from an additional copy of chromosome 21, and elevated expression of endostatin has been implicated. We hypothesized that vascular anomalies, including infantile hemangioma, an angiogenesis-dependent vascular tumor, and vascular malformations might be similarly inhibited in patients with Down syndrome. PATIENTS AND METHODS: The Children's Hospital Boston Vascular Anomalies Center database was searched for patients with Down syndrome between 1999 and 2007. In addition, the records of patients with Down syndrome treated at Children's Hospital Boston and the National Birth Defects Center between 1985 and 2007 were reviewed to find concurrent vascular anomalies. Two-sided exact binomial tests were used to evaluate whether patients with vascular anomalies are at reduced risk for Down syndrome or if patients with Down syndrome are at less risk for vascular anomalies compared with the general population. Ninety-five-percent confidence intervals were calculated on the basis of the risk of Down syndrome (1 in 800) and vascular anomalies (1 in 22) in the general population. RESULTS: Two of the 7354 patients evaluated in our vascular anomalies unit had Down syndrome. Both patients had a lymphatic malformation: one in the orbit and the other in the lower extremity. Six of the 633 patients with Down syndrome had a vascular anomaly (infantile hemangioma [n = 4] or lymphatic malformation [n = 2]). The risk of concurrent Down syndrome and vascular anomalies was different from the corresponding risk in the general population. CONCLUSIONS: Patients with Down syndrome have a reduced risk of vascular anomalies compared with the general population. Elevated expression of antiangiogenic proteins may protect these patients from developing vascular anomalies, as well as solid tumors.

Pediatric anorectal impalement with bladder rupture: case report and review of the literature.

Rectal impalement involves foreign body trauma to the anus or rectum resulting in intra- or extraperitoneal rupture. Evaluation of suspected rectal impalement injury involves careful history and physical examination. Ruling out rectal perforation in patients with reported impalement is critical even if there is no evidence of trauma to the perineum. There are few reports on pediatric impalement and only 1 reported case of pediatric rectal impalement with bladder rupture. We report a rectal impalement with extraperitoneal bladder injury in a 12-year-old boy and review the literature on treatment of these injuries.

Current clinical applications of omega-6 and omega-3 fatty acids.

BACKGROUND: Recent years have brought a resurgence of research interest in fatty acids, with studied fields running the gamut of human disease. This movement has run in parallel with an increased interest in using nutrition modalities as therapeutic measures, as opposed to their conventional role as energy sources. The aim of this manuscript is to provide a basic review of current clinical applications of omega-6 and omega-3 fatty acids, with a particular focus on the latter. METHODS: A selective review of the voluminous literature, including randomized controlled trials, meta-analyses, population studies, and case reports, was used to compile data and identify trends in pertinent clinical applications of fatty acid therapy. CONCLUSIONS: There are a myriad of disorders and maladies that seem to benefit from fatty acid supplementation, specifically omega-3 fatty acids. It has clearly been shown that omega-3 fatty acid supplementation provides a protective benefit in heart disease, and in particular sudden cardiac death. Rheumatoid arthritis (RA) is another disease entity that has been proven to benefit from this nutrition intervention, with improvement in symptoms and diminished nonsteroidal antiinflammatory drug (NSAID) usage. In addition, many psychiatric disorders, particularly schizophrenia and major depressive disorder (MDD), have shown positive results when supplementation has been used as an adjunct to standard pharmacotherapy. The remainder of clinical applications for omega-3 fatty acids requires further investigation. Specifically, according to preliminary clinical evidence, parenteral administration of fatty acids warrants further study.

Predicting outcome and directing therapy for papillary thyroid carcinoma.

HYPOTHESIS: The prognosis of papillary thyroid carcinoma has been stratified into low- and high-risk groups. Patients in the high-risk group can be substratified on the basis of increasing age, with implications for prognosis and treatment. DESIGN: Retrospective study. SETTING: Tertiary care center. PATIENTS: A total of 727 patients with papillary thyroid cancer treated at Lahey Clinic, Burlington, Mass, from 1940 to 1998. INTERVENTIONS: Stratification into low- and high-risk groups based on age, metastases, extent, and size. High-risk patients were substratified into "younger" and "older" high-risk groups by age younger than 60 years or 60 years and older, respectively. Effects of surgery, lymph node dissection, and radiation therapy were examined. Main Outcome Measure Survival. RESULTS: Of the 727 patients, 585 (80.5%) were classified as low risk and 142 (19.5%) as high risk. The 20-year survival was 97.8% in low-risk patients and 61.3% in high-risk patients (P<.001); it was 72.3% in the younger high-risk group and 45.1% in the older high-risk group (P<.001). Older high-risk patients had a survival advantage with bilateral thyroidectomy: 54.7% 20-year survival for those undergoing bilateral thyroidectomy and 25.0% for unilateral thyroidectomy (P =.004). In the older high-risk group, patients with lymph node dissection (n = 22) had a 20-year survival of 72.4% vs 30.2% in patients who did not undergo lymph node dissection (n = 38) (P =.03). Twenty-year survival in low-risk, younger high-risk, and older high-risk patients receiving radioactive iodine vs no radiation was 100% vs 97.6% (P =.24), 64.2% vs 73.2% (P =.53), and 44.7% vs 44.4% (P =.53). CONCLUSIONS: Papillary thyroid carcinoma in low-risk patients had a favorable prognosis regardless of treatment. Older high-risk patients had a survival benefit with total thyroidectomy and lymph node dissection. Radioactive iodine did not affect 20-year survival in any of the risk groups.