Predicting Complications in Immediate Alloplastic Breast Reconstruction: How Useful Is the American College of Surgeons National Surgical Quality Improvement Program Surgical Risk Calculator?

BACKGROUND: Complications following immediate breast reconstruction can have significant consequences for the delivery of postoperative chemotherapy and radiation therapy. Identifying patients at higher risk of complications would ensure that immediate breast reconstruction does not compromise oncologic treatment. The American College of Surgeons National Surgical Quality Improvement Program Surgical Risk Calculator is an online tool in the public domain that offers individualized preoperative risk prediction for a wide range of surgical procedures, including alloplastic breast reconstruction. This study evaluates the usefulness of this tool in patients undergoing immediate breast reconstruction with tissue expanders at a single institution. METHODS: Details of 278 patients who underwent immediate breast reconstruction with tissue expander placement were entered into the calculator to determine the predicted complication rate. This was compared to the rate of observed complications on chart review. The predictive model was evaluated for calibration and discrimination using the statistical measures used in the original development of the calculator. RESULTS: The predicted rate of complications (5.2 percent) was significantly lower that the observed rate (16.2 percent; p < 0.01). The Hosmer-Lemeshow test confirmed lack of fit of the model. The C statistic was 0.62 and the Brier score was 0.173, indicating that the model had poor predictive power and could not discriminate between those who were at risk for complications and those who were not. CONCLUSIONS: The American College of Surgeons National Surgical Quality Improvement Program universal Surgical Risk Calculator underestimated the proportion of patients that would develop complications in this cohort. In addition, it was unable to effectively identify individual patients at increased risk, suggesting that this tool would not make a useful contribution to preoperative decision-making in this patient group.

Functional electrical stimulation therapy for severe hemiplegia: Randomized control trial revisited.

BACKGROUND: Stroke is the leading cause of long-term disability. Stroke survivors seldom improve their upper-limb function when their deficit is severe, despite recently developed therapies. PURPOSE: This study aims to assess the efficacy of functional electrical stimulation therapy in improving voluntary reaching and grasping after severe hemiplegia. METHOD: A post hoc analysis of a previously completed randomized control trial ( clinicaltrials.gov , No. NCT00221078) was carried out involving 21 participants with severe upper-limb hemiplegia (i.e., Fugl-Meyer Assessment-Upper Extremity [FMA-UE] ≤ 15) resulting from stroke. FINDINGS: Functional Independence Measure Self-Care subscores increased 22.8 (±6.7) points in the intervention group and 9 (±6.5) in the control group, following 40 hr of equal-intensity therapy. FMA-UE score changes were 27.2 (±13.5) and 5.3 (±11.0) for the intervention and control groups, respectively. IMPLICATIONS: The results may represent the largest upper-limb function improvements in any stroke population to date, especially in those with severe upper-limb deficit.

Why Some Mastectomy Patients Opt to Undergo Delayed Breast Reconstruction: Results of a Long-Term Prospective Study.

BACKGROUND: Delayed breast reconstruction is an option for women who have undergone mastectomy; however, uptake is low. The purpose of this study was to identify premastectomy and postmastectomy demographic, clinical, and psychosocial predictors of uptake of delayed breast reconstruction in the long-term survivorship period. METHODS: This was a prospective longitudinal survey study of mastectomy patients in which a repeated measures design was used to evaluate uptake of delayed breast reconstruction. Demographic, clinical, and psychosocial variables were collected before mastectomy and 1 year after mastectomy. Information regarding uptake of delayed breast reconstruction was collected at approximately 6 years after mastectomy. A predictive model was designed using a multivariate logistic regression model and Akiake information criterion stepwise algorithm. RESULTS: Ninety-six mastectomy patients were followed from before mastectomy to 75.2 months after mastectomy, and 35 women (36.5 percent) underwent delayed breast reconstruction. Women who elected for delayed breast reconstruction experienced worsening of body concerns from before mastectomy to 1 year after mastectomy, compared with women who did not elect to undergo delayed breast reconstruction (p = 0.03). Mean scores for psychological distress were significantly worse both before mastectomy and 1 year after mastectomy in women who went on to undergo delayed breast reconstruction compared with those who did not undergo delayed breast reconstruction (p = 0.034 and p = 0.022, respectively). A predictive model for the uptake of delayed breast reconstruction was developed using demographic, clinical, and psychosocial characteristics. The area under the receiver operating characteristic curve was 85 percent, indicating good precision. CONCLUSIONS: Women who are experiencing higher levels of distress, anxiety, and body concerns both before and after mastectomy appear to be significantly likely to select delayed breast reconstruction. This may have implications for postreconstruction satisfaction and psychosocial functioning. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

A Comparison of Psychological Response, Body Image, Sexuality, and Quality of Life between Immediate and Delayed Autologous Tissue Breast Reconstruction: A Prospective Long-Term Outcome Study.

BACKGROUND: This is the first study to use generic distress, cancer-specific, and procedure-specific measures to prospectively evaluate psychological responses, body image, sexuality, and health-related quality of life in immediate compared with delayed breast reconstruction. METHODS: Consecutive patients undergoing autologous immediate and delayed breast reconstruction (June of 2009 to December of 2010) completed the Hospital Anxiety and Depression Scale, Body Image Scale, Sexuality Scale, and BREAST-Q preoperatively and postoperatively (6, 12, and 18 months). Linear mixed-effects analyses between each outcome and time point were performed. RESULTS: One hundred six women underwent mastectomy with immediate (n = 30) and delayed breast reconstruction (n = 76). Before reconstruction, 26 percent of patients had abnormal anxiety scores and 9 percent had abnormal depression scores, with no significant differences between groups. Patients awaiting delayed breast reconstruction had significantly impaired prereconstruction body image (p = 0.01) and sexuality (p = 0.01) and worse satisfaction with breast (p < 0.01), psychological (p < 0.01), and sexual well-being (p < 0.01). At 18 months after immediate and delayed breast reconstruction, there was significant improvement in anxiety, depression, body image, sexuality, and health-related quality of life. CONCLUSIONS: This single-center study shows that mastectomy with immediate breast reconstruction may protect breast cancer patients from a period of psychosocial distress, poor body image, and diminished sexual well-being compared with those waiting for delayed breast reconstruction. In patients who are oncologically eligible and strongly interested in breast reconstruction, efforts should be made to provide immediate breast reconstruction to decrease the interval of psychosocial distress, poor body image, and impaired sexuality.

Can the ACS-NSQIP surgical risk calculator predict post-operative complications in patients undergoing flap reconstruction following soft tissue sarcoma resection?

INTRODUCTION: The ACS-NSQIP surgical risk calculator is an open-access on-line tool that estimates the risk of adverse post-operative outcomes for a wide range of surgical procedures. Wide surgical resection of soft tissue sarcoma (STS) often requires complex reconstructive procedures that can be associated with relatively high rates of complications. This study evaluates the ability of this calculator to identify patients with STS at risk for post-operative complications following flap reconstruction. METHODS: Clinical details of 265 patients who underwent flap reconstruction following STS resection were entered into the online calculator. The predicted rates of complications were compared to the observed rates. The calculator model was validated using measures of prediction and discrimination. RESULTS: The mean predicted rate of any complication was 15.35 ± 5.6% which differed significantly from the observed rate of 32.5% (P = 0.009). The c-statistic was relatively low at 0.626 indicating poor discrimination between patients who are at risk of complications and those who are not. The Brier's score of 0.242 was significantly different from 0 (P < 0.001) indicating poor correlation between the predicted and actual probability of complications. CONCLUSION: The ACS-NSQIP universal risk calculator did not maintain its predictive value in patients undergoing flap reconstruction following STS resection. J. Surg. Oncol. 2016;114:570-575. © 2016 Wiley Periodicals, Inc.

Predictors and consequences of intraoperative microvascular problems in autologous breast reconstruction.

INTRODUCTION: Microvascular complications can have devastating consequences in breast reconstruction. Because of the relatively low rate of complications, it can be difficult to identify significant predictors of failure. This study explores the importance of intraoperative microvascular problems in the development of postoperative complications and seeks to identify risk factors that may predict such events. METHODS: Three hundred and eighty-four patients undergoing 562 microvascular breast reconstructions were eligible for inclusion in this study. Bivariate and multivariate logistic regressions were performed to identify factors showing a significant association with intraoperative microvascular problems and postoperative microvascular complications. RESULTS: In multivariate logistic regression, intraoperative problems were an independent risk factor for the development of postoperative microvascular complications (odds ratio [OR] 2.7, 95% confidence interval [CI] 1.1-6.6, p = 0.02). Smoking was the only independent predictor of intraoperative events (OR 2.4, 95% CI 1.1-5.3, p = 0.03). While intraoperative problems are predisposed to postoperative microvascular complications in general, those that were thrombotic in nature could be corrected by early recognition and intraoperative revision in the majority of cases. CONCLUSIONS: This study identifies intraoperative microvascular problems as significant predictors of postoperative complications in breast reconstruction. Smoking increases the rate of intraoperative problems, and although many can be corrected, preoperative smoking cessation may reduce the complexity of microsurgery and optimize postoperative outcomes.

Can the American College of Surgeons NSQIP surgical risk calculator identify patients at risk of complications following microsurgical breast reconstruction?

INTRODUCTION: The American College of Surgeons National Surgery Quality Improvement Program (ACS NSQIP) Surgical Risk Calculator is an open access online tool that estimates the risk of adverse post-operative events for a wide range of surgical procedures. This study evaluates the predictive value of the ACS NSQIP calculator in patients undergoing microvascular breast reconstruction. STUDY DESIGN: Details of 759 microvascular breast reconstructions in 515 patients were entered into the online calculator. The predicted rates of post-operative complications were recorded and compared to observed complications identified on chart review. The calculator was validated using three statistical measures described in the original development of the ACS NSQIP model. RESULTS: The calculator predicted that complications would occur in 11.1% of breast reconstructions while the observed rate was 10.5%. Hosmer-Lemeshow test did not find any statistical difference between these rates (p = 0.69) indicating that the calculator accurately measured what is was intended to measure. The area under the receiver operating curve or c-statistic (measure of discrimination) was found to be low at 0.548, indicating the model has random performance in this patient population. The Brier score was higher than that reported in the original ACS calculator development (0.094 vs 0.069) demonstrating poor correlation between predicted probability and actual probability. CONCLUSIONS: This study demonstrates that while the ACS NSQIP Universal risk calculator can predict the proportion of patients that will develop complications it cannot effectively discriminate between patients who are at risk of complications and those who are not.

Incidentalomas associated with abdominal and pelvic CT angiograms for abdominal-based breast free flap reconstruction.

Computed tomography angiography (CTA) is routinely performed prior to breast reconstruction using deep inferior epigastric perforator (DIEP) flaps to provide better surgical planning and improve preoperative decision making. These investigations occasionally result in unexpected findings in otherwise asymptomatic women. Unexpected findings on imaging in a population of women with previous breast cancer or strong breast cancer risk factors can lead to undue stress and anxiety. The aim of this study is to determine the incidence of unexpected findings in preoperative CT angiograms and to correlate these with patient and breast cancer characteristics. A retrospective chart review from May 2008 to December 2012 was performed reviewing all patients who underwent DIEP flap breast reconstruction. Radiology reports of their preoperative CT angiograms, details of unexpected findings, patients' past medical and cancer history, additional radiological investigations, outcomes, and interventions were reviewed. In total, 360 patients met the inclusion criteria for the study. Sixty-four percent of the patients who underwent CTA imaging had incidental findings. Further imaging was suggested in 48% of this group. The most common incidentalomas were hepatic (47%), bone (24%), and renal (20%). "Incidentalomas" were associated with patients' underlying comorbidities (p = 0.001) and age (p = 0.01). "Radiographically suspicious incidentalomas" were associated with the underlying comorbidities (p = 0.001). The radiologists most commonly suggested investigation methods such as ultrasound (41%), another CT (28%), bone scan (21%), and magnetic resonance imaging (MRI; 14%). No incidentalomas were found to be malignant on further recommended investigation in this study and no breast cancer reconstruction was delayed as a result of the discovery of incidentalomas or their subsequent investigations. It is important to counsel patients of the possibility of incidental findings and the resulting sequelae prior to CTA investigations for breast cancer reconstruction and involve them in shared decision making if additional investigations are required.

Long-Term Psychosocial Functioning in Women with Bilateral Prophylactic Mastectomy: Does Preservation of the Nipple-Areolar Complex Make a Difference?

INTRODUCTION: Nipple-sparing prophylactic mastectomy (PM) is an option for women at high-risk for breast cancer, and may offer better cosmetic results than a skin-sparing PM where the nipple-areolar complex (NAC) is removed. However, there may be residual breast cancer risk due to the maintained NAC. It is unclear if sparing the NAC with PM impacts on psychosocial functioning, including cancer-related distress and body image after PM. METHODS: This was a cross-sectional survey study of women who had undergone bilateral PM (no previous breast cancer) recruited through surgical or cancer genetics clinics. All women completed standardized questionnaires assessing cancer-related distress, anxiety, depression, satisfaction with decision, decision regret, and health-related quality of life related to breast surgery. Outcomes were compared between women with nipple-areola-sparing PM (NAC-PM) and skin-sparing PM (SS-PM). RESULTS: Overall, 137 women completed the study; 53 (39%) had NAC-PM and 84 (61%) had SS-PM. The mean age of the study population was 41.5 years [standard deviation (SD) 8.8] and the mean time between PM and questionnaire completion was 50 months (SD 31). On the BREAST-Q, we found that women with NAC-PM had significantly higher levels of satisfaction with breasts (p = 0.01), satisfaction with outcome (p = 0.02), and sexual well-being (p < 0.001) compared with SS-PM. No statistically significant differences in total cancer-related distress (p = 0.89), anxiety (p = 0.86), or depression (p = 0.93) were observed between the two groups. CONCLUSIONS: Overall, women with NAC-PM had better body image and sexual functioning compared with women with SS-PM, while both groups had comparable levels of cancer-related distress and perception of breast cancer risk.

The role of botulinum toxin a in the establishment of symmetry in pediatric paralysis of the lower lip.

IMPORTANCE: Botulinum toxin A has been described as an effective adjunct treatment for achieving symmetry in adults with facial paralysis. Few investigators have described the use of botulinum toxin A in pediatric patients with facial paralysis. OBJECTIVE: To present our preliminary experience with botulinum toxin A in pediatric patients presenting with asymmetry of the lower lip. DESIGN, SETTING, AND PARTICIPANTS: We performed a retrospective medical record review of all pediatric patients (age range, 4-17 years; mean [SD] age, 11.2 [4.7] years) with facial paralysis who were treated with botulinum toxin A injections from January 1, 2004, through December 31, 2012. Patients presented for treatment at The Hospital for Sick Children, Toronto, Ontario, Canada, or the Massachusetts Eye and Ear Infirmary, Boston. MAIN OUTCOMES AND MEASURES: Using facial analysis software, we measured lower lip asymmetry in the patients' photographs before and after treatment, at rest, and in a dynamic state. We performed analysis of variance to assess for improvement in symmetry. RESULTS: We identified 18 patients with the following 3 primary indications for treatment: focal lip asymmetry (n = 11), extensive hemifacial asymmetry (n = 5), and focal synkinesis (n = 2). We found no complications related to botulinum toxin A treatment. The mean (SD) dynamic deviation before the injection was 3.5 (1.7) mm, whereas the mean dynamic deviation after the injection was 1.5 (0.8) mm. The mean (SD) deviation correction was evaluated at 61% (6%) and was statistically significant (P = .04). CONCLUSIONS AND RELEVANCE: Botulinum toxin A injection is a safe procedure for improving localized asymmetry in pediatric patients with facial paralysis. Preliminary results indicate that botulinum toxin A may be an effective treatment for lower lip asymmetry in children and adolescents. LEVEL OF EVIDENCE: 4.

A single pre-operative antibiotic dose is as effective as continued antibiotic prophylaxis in implant-based breast reconstruction: A matched cohort study.

PURPOSE: Infections following implant-based breast reconstruction can lead to devastating consequences. There is currently no consensus on the need for post-operative antibiotics in preventing immediate infection. This study compared two different methods of infection prevention in this group of patients. METHOD: A retrospective matched cohort study was performed on consecutive women undergoing implant-based breast reconstruction at University Health Network, Toronto (November 2008-December 2012). All patients received a single pre-operative intravenous antibiotic dose. Group A received minimal interventions and Group B underwent maximal prophylactic measures. Patient (age, smoking, diabetes, co-morbidities), oncologic and procedural variables (timing and laterality) were collected. Univariate and multivariate logistic regression were performed to compare outcomes between the two groups. RESULTS: Two hundred and eight patients underwent 647 implant procedures. After matching the two treatment groups by BMI, 94 patients in each treatment group yielding a total of 605 implant procedures were selected for analysis. The two groups were comparable in terms of patient and disease variables. Post-operative wound infection was similar in Group A (n = 11, 12%) compared with Group B (n = 9, 10%; p = 0.8). Univariate analysis revealed only pre-operative radiotherapy to be associated with the development of infection (0.004). Controlling for the effect of radiotherapy, multivariate analysis demonstrated that there was no statistically significant difference between the two methods for infection prevention. CONCLUSIONS: Our findings suggest that a single pre-operative dose of intravenous antibiotics is equally as effective as continued antibiotic prophylaxis in preventing immediate infection in patients undergoing implant-based breast reconstructions.

Systematic Review: Aesthetic Assessment of Breast Reconstruction Outcomes by Healthcare Professionals.

BACKGROUND: Achieving an aesthetic outcome following postmastectomy breast reconstruction is both an important goal for the patient and plastic surgeon. However, there is currently an absence of a widely accepted, standardized, and validated professional aesthetic assessment scale following postmastectomy breast reconstruction. METHODS: A systematic review was performed to identify all articles that provided professional assessment of the aesthetic outcome following postmastectomy, implant- or autologous tissue-based breast reconstruction. A modified version of the Scientific Advisory Committee's Medical Outcomes Trust (MOT) criteria was used to evaluate all professional aesthetic assessment scales identified by our systematic review. The criteria included conceptual framework formation, reliability, validity, responsiveness, interpretability, burden, and correlation with patient-reported outcomes. RESULTS: A total of 120 articles were identified: 52 described autologous breast reconstruction, 37 implant-based reconstruction, and 29 both. Of the 12 different professional aesthetic assessment scales that exist in the literature, the most commonly used scale was the four-point professional aesthetic assessment scale. The highest score on the modified MOT criteria was assigned to the ten-point professional aesthetic assessment scale. However, this scale has limited clinical usefulness due to its poor responsiveness to change, lack of interpretability, and wide range of intra- and inter-rater agreements (Veiga et al. in Ann Plast Surg 48(5):515-520, 2002). CONCLUSIONS: A "gold standard" professional aesthetic assessment scale needs to be developed to enhance the comparability of breast reconstruction results across techniques, surgeons, and studies to aid with the selection of procedures that produce the best aesthetic results from both the perspectives of the surgeon and patients.

A prospective study of mastectomy patients with and without delayed breast reconstruction: long-term psychosocial functioning in the breast cancer survivorship period.

INTRODUCTION: For women who have mastectomy, breast reconstruction is an option which may improve psychosocial functioning. The purpose of this study was to evaluate changes in psychosocial functioning over a long follow-up period after mastectomy, specifically examining the differences between those with mastectomy alone and those who underwent postmastectomy delayed breast reconstruction (DBR). METHODS: This was a prospective longitudinal survey study of women with mastectomy in which a repeated measures design was used to compare psychosocial function scores over 3 timepoints: 1) pre-mastectomy; 2) one year post-mastectomy; and 3) long-term post-mastectomy (mean 6.3 years). In addition, psychosocial functioning was compared between the mastectomy alone group and the group who elected for DBR. RESULTS: 67 women who completed questionnaires at all three time points were included. The long-term follow-up time post-mastectomy was 75.2 months (6.3 years). Twenty-eight women (41.8%) underwent DBR in the study period. For the entire cohort, between one-year and long-term post-mastectomy, there were significant improvements in scores for body concerns (P = 0.03), cancer-related distress (P = 0.01), and total distress (P = 0.04). At long-term follow-up, women with DBR had significantly higher levels of total distress (P = 0.01), obsessiveness (P = 0.03), and cancer-related distress (P = 0.02) compared to those with mastectomy alone. There were no differences in quality of life between the two groups at any time point. CONCLUSIONS: Psychosocial functioning improves over time in patients treated with mastectomy in the long-term breast cancer survivorship period, which may be related to the effect of time post-treatment, rather than an effect of choice for or against DBR.

Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial.

PURPOSE: Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals. We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction. METHODS: We conducted a pilot randomized controlled trial (RCT) where participants were randomly assigned to the intervention with routine education or routine education alone. The outcomes evaluated were decisional conflict, decision self-efficacy, satisfaction with information, perceived involvement in care, and uptake of reconstruction following surgical consultation. Trial feasibility and acceptability were evaluated, and effect sizes were calculated to determine the primary outcome for the full-scale RCT. RESULTS: Of the 41 patients enrolled, recruitment rate was 72 %, treatment fidelity was 98 %, and retention rate was 95 %. The Cohen's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education (0.69, 95 % CI = 0.02-1.42), while the effect sizes of increase in decision self-efficacy (0.05, 95 % CI = -0.60-0.71) and satisfaction with information (0.11, 95 % CI = -0.53-0.76) were small. A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction (14/20 or 70 %) compared to the intervention group (8/21 or 38 %) P = 0.06. CONCLUSIONS: A pre-consultation educational group intervention improves patients' shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.

Transversus abdominis plane block reduces morphine consumption in the early postoperative period following microsurgical abdominal tissue breast reconstruction: a double-blind, placebo-controlled, randomized trial.

BACKGROUND: The analgesic efficacy of the transversus abdominis plane peripheral nerve block following abdominal tissue breast reconstruction has not been studied in a randomized controlled trial. METHODS: The authors conducted a double-blind, placebo-controlled, 1:1 allocation, two-arm parallel group, superiority design, randomized controlled trial in patients undergoing microsurgical abdominally based breast reconstruction. Intraoperatively, epidural catheters were inserted under direct vision through the triangle of Petit on both sides of the abdomen into the transversus abdominis plane just before rectus fascial closure. Patients received either bupivacaine (study group) or saline (placebo group) through the catheters for 2 postoperative days. All patients received hydromorphone by means of a patient-controlled analgesic pump. The primary outcome was the difference in the parenteral opioid consumption on each postoperative day between the groups. The secondary outcome measures included the following: total in-hospital opioid; antinausea medication; pain, nausea, and sedation scores; Quality of Recovery Score; time to ambulation; and hospital stay duration. RESULTS: Between September of 2011 and June of 2013, 93 patients were enrolled: 49 received bupivacaine and 44 received saline. There were 11 postoperative complications (13 percent); none were related to the catheter. Primary outcomes were completed by 85 of 93 patients (91.3 percent); the mean parenteral morphine consumption was significantly reduced on postoperative day 1 in the bupivacaine group (20.7±20.1 mg) compared with 30.0±19.1 mg in the control group (p=0.02). There were no significant differences in secondary outcomes. CONCLUSION: Following abdominally based breast reconstruction, transversus abdominis plane peripheral nerve block is safe and significantly reduces morphine consumption in the early postoperative period. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Influence of different rehabilitation therapy models on patient outcomes: hand function therapy in individuals with incomplete SCI.

OBJECTIVES: The primary objective was to compare the benefits of single (COT1) versus double (COT2) dose of conventional occupational therapy (COT) in improving voluntary hand function in individuals with incomplete, sub-acute C3-C7 spinal cord injury (SCI). The secondary objective was to compare these two interventions versus functional electrical stimulation therapy plus COT (FES + COT). DESIGN: Retrospective analysis. Setting Inpatient spinal cord rehabilitation center, Toronto. PARTICIPANTS: Individuals with traumatic incomplete sub-acute SCI. INTERVENTIONS: Data from Phases I and II (ClinicalTrials.gov ID NCT00221117) randomized control trials were pooled together for the purpose of this study. Participants in the COT1 group received 45 hours of therapy, the COT2 group received 80 hours of therapy, and the FES + COT group received 40 hours of COT therapy +40 hours of FES therapy. OUTCOME MEASURES: We analyzed the functional independence measure (FIM) and the spinal cord independence measure (SCIM) self-care sub-scores. Results The mean change scores on the FIM self-care sub-score for the COT1, COT2, and FES + COT groups were 12.8, 10, and 20.1 points, respectively. Similarly, the mean change scores on the SCIM self-care sub-score for the COT1, COT2, and FES + COT groups were, 2.6, 3.16, and 10.2 points, respectively. CONCLUSION: Increased rehabilitation intensity alone may not always be beneficial. The type of intervention plays a significant role in determining functional changes. In this instance, receiving one (COT1) or two (COT2) doses of COT resulted in similar outcomes, however, FES + COT therapy yielded much better outcomes compared to COT1 and COT2 interventions.

Using propensity score analysis to compare major complications between DIEP and free muscle-sparing TRAM flap breast reconstructions.

BACKGROUND: Previous studies comparing muscle-sparing transverse rectus abdominis myocutaneous (TRAM) versus deep inferior epigastric artery perforator (DIEP) free flaps have not considered procedure selection bias. Propensity score analysis provides a statistical approach to consider preoperative factors in flap selection, and was used to compare major complications (breast and abdominal) between these microsurgical breast reconstruction (free muscle-sparing TRAM versus DIEP). METHODS: This study evaluated major breast and abdominal complications in 292 consecutive patients (428 free abdominal flaps). Propensity scores were calculated for patient differences affecting flap selection (DIEP versus free muscle-sparing TRAM). Multivariate logistic models using selected covariates separately analyzed breast and abdominal complications between flap methods. RESULTS: There were 83 major complications (28 percent): breast, 20 percent; abdomen, 8 percent. Using propensity scores, the adjusted odds of abdominal complications were significantly higher in free muscle-sparing TRAM than in DIEP flaps (OR, 2.73; 95 percent CI, 1.01 to 7.07). With prior chemotherapy, body mass index significantly increased abdominal complications (OR, 1.16; 95 percent CI, 1.01 to 1.34). Using propensity scores, there was no significant association between reconstruction method and breast complications; diabetics had significantly increased breast complications (OR, 4.19; 95 percent CI, 1.14 to 15.98). Previous abdominal operations (OR, 1.77; 95 percent CI, 0.96 to 3.30) and immediate reconstruction (OR, 1.86; 95 percent CI, 0.94 to 3.71) approached significance. CONCLUSIONS: Propensity score analysis indicated significantly higher abdominal complications in free muscle-sparing TRAM compared with DIEP flaps. This study highlights the importance of separately evaluating recipient breast and donor abdominal complications and use of propensity scores to minimize procedure selection bias. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial.

BACKGROUND: Breast reconstruction using the free muscle-sparing transversus abdominus myocutaneous or deep inferior epigastric perforator flaps are common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdominal donor site remains a major source of postoperative pain. Conventional postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side effects such as sedation, headache, nausea, vomiting, breathing difficulties and bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane peripheral nerve block. METHODS/DESIGN: This study is a double-blind, placebo-controlled, randomized controlled trial designed to rigorously test the effectiveness of a transversus abdominis plane catheter delivering intermittent local anesthetic in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. The primary objective of this study is compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups including the patient-controlled anesthesia amounts and oral narcotic doses converted to intravenous morphine equivalent units. The secondary outcome measures include the following parameters: total in-hospital cumulative opioid consumption; daily patient-reported pain scores; total in-hospital cumulative anti-nausea consumption; nausea and sedation scores; and Quality of Recovery score; time to first bowel movement, ambulation, and duration of hospital stay. DISCUSSION: Autologous breast reconstruction using abdominal tissue is rapidly becoming the reconstructive option of choice for postmastectomy patients across North America. A substantial component of the pain experienced by patients after this abdominally based procedure is derived from the abdominal wall incision. By potentially decreasing the need for systemic opioids and their associated side effects, this transversus abdominis plane block study will utilize the most scientifically rigorous double-blind, placebo-controlled, randomized controlled trial methodology to potentially improve both clinical care and health outcomes in breast cancer surgery patients. TRIAL REGISTRATION: Clinicaltrials.gov NCT01398982.