Andrea L. Pusic

Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q.

Background: Measuring patient-reported outcomes has become increasingly important in cosmetic and reconstructive breast surgery. The objective of this study was to develop a new patient-reported outcome measure to assess the unique outcomes of breast surgery patients. Methods: Patient interviews, focus groups, expert panels, and a literature review were used to develop a conceptual framework and a list of questionnaire items. Three procedure-specific questionnaires (augmentation, reduction, and reconstruction) were developed and cognitive debriefing interviews used to pilot each questionnaire. Revised questionnaires were field tested with 1950 women at five centers in the United States and Canada (response rate, 72 percent); 491 patients also completed a test-retest questionnaire. Rasch measurement methods were used to construct scales, and traditional psychometric analyses, following currently recommended procedures and criteria, were performed to allow for comparison with existing measures. Results: The conceptual framework included six domains: satisfaction with breasts, overall outcome, and process of care, and psychosocial, physical, and sexual well-being. Independent scales were constructed for these domains. This new patient-reported outcome measure “system” (the BREAST-Q) contains three modules (augmentation, reconstruction, and reduction), each with a preoperative and postoperative version. Each scale fulfilled Rasch and traditional psychometric criteria (including person separation index 0.76 to 0.95; Cronbach’s alpha 0.81 to 0.96; and test-retest reproducibility 0.73 to 0.96). Conclusions: The BREAST-Q can be used to study the impact and effectiveness of breast surgery from the patient’s perspective. By quantifying satisfaction and important aspects of health-related quality of life, the BREAST-Q has the potential to support advocacy, quality metrics, and an evidence-based approach to surgical practice.

Free flap reexploration: Indications, treatment, and outcomes in 1193 free flaps

Background: Microvascular free tissue transfer is a reliable method for reconstruction of complex surgical defects. However, there is still a small risk of flap compromise necessitating urgent reexploration. A comprehensive study examining the causes and methods of avoiding or treating these complications has not been performed. The purpose of this study was to review the authors’ experience with a large number of microvascular complications over an 11-year period. Methods: This was a retrospective review of all free flaps performed from 1991 to 2002 at Memorial Sloan-Kettering Cancer Center. All patients who required emergent reexploration were identified, and the incidence of vascular complications and methods used for their management were analyzed. Results: A total of 1193 free flaps were performed during the study period, of which 6 percent required emergent reexploration. The most common causes for reexploration were pedicle thrombosis (53 percent) and hematoma/bleeding (30 percent). The overall flap survival rate was 98.8 percent. Venous thrombosis was more common than arterial thrombosis (74 versus 26 percent) and had a higher salvage rate (71 versus 40 percent). Salvaged free flaps were reexplored more quickly than failed flaps (4 versus 9 hours after detection; p = 0.01). There was no significant difference in salvage rate in flaps requiring secondary vein grafting or thrombolysis as compared with those with anastomotic revision only. Conclusions: Microvascular free tissue transfer is a reliable reconstructive technique with low failure rates. Careful monitoring and urgent reexploration are critical for salvage of compromised flaps. The majority of venous thromboses can be salvaged. Arterial thromboses can be more problematic. An algorithm for flap exploration and salvage is presented.

Free-flap mandibular reconstruction: a 10-year follow-up study.

&NA; Free‐flap reconstruction of oncologic mandibular defects has become the modern standard of care. However, no previous studies have established the long‐term results of such reconstructions. The objective of this study was to review functional and aesthetic outcomes in patients a decade after free‐flap mandibular reconstruction. A single surgeon’s experience with free‐flap reconstruction of the mandible was retrospectively reviewed. Eightytwo consecutive patients who underwent reconstruction from January of 1987 to December of 1990 were identified. Of the 34 patients still alive, 20 agreed to participate (response rate, 59 percent). To assess complications and functional outcome, patients were interviewed using validated questions and questions developed specifically for the study. Aesthetic outcome was judged by two independent observers. Panorex radiographs were obtained to assess bone resorption. Bone height was measured at standardized locations on the body, ramus, and symphysis and compared with the immediate postoperative Panorex radiographs. Differences in Panorex magnification were adjusted for by comparison of miniplate measurements. Mean length of follow‐up was 11 years. Mean patient age at the time of the study was 48 years. Nineteen of 20 patients had malignant disease, one of whom had a local recurrence during the follow‐up period. Two patients received radiation therapy preoperatively and 13 postoperatively. Mean length of mandible resection was 13 cm. Defect types were as follows (Jewer’s classification): 12 L, 4 H, 3 LC, and 1 LCL. All flaps survived. At 10‐year follow‐up, aesthetic outcome was judged to be excellent in 55 percent of patients, good in 20 percent, fair in 15 percent, and poor in 10 percent. The aesthetic results were remarkably stable over time. Slight accentuation of subtle postoperative asymmetry became evident as facial aging progressed. Dental rehabilitation in the study group included five patients with osteointegrated implants and seven with conventional dentures. Seventy percent of patients reported a regular diet. The remainder required a soft diet. Food tolerance was good, as rated by the List Scale (mean score, 77 percent). Seventeen patients had easily intelligible speech, whereas three were intelligible with effort. At the midbody of the mandible, 92 percent of the postoperative bone height was preserved; at the midramus, 93 percent was maintained; and at the symphysis, 92 percent remained. In several patients, there was greater age‐related bone loss from the residual native mandible compared with the reconstructed site. One patient developed an orocutaneous fistula following postoperative radiation therapy. Nine patients had miniplates removed, either because of plate problems or to allow implant placement. There were no cases of osteoradionecrosis, bone fracture, or miniplate fracture. There was no significant long‐term disability related to the donor site. Free‐flap reconstruction of the mandible provides excellent functional and aesthetic results that remain stable over time. Bone resorption is surprisingly minimal, even in the face of postoperative radiation therapy. The majority of patients are able to tolerate a regular diet and to either wear dentures or acquire osteointegrated implants. Acceptable speech and appearance are restored and continue to be a source of patient satisfaction at least a decade after surgery. (Plast. Reconstr. Surg. 110: 438, 2002.)

Predicting Complications following Expander/Implant Breast Reconstruction : An Outcomes Analysis Based on Preoperative Clinical Risk

Background: Complications following postmastectomy reconstruction can cause significant morbidity. The compound effect of individual risk factors on the development of complications following expander/implant reconstruction has not, however, been well delineated. This study evaluated the impact of clinical risk factors to predict complications following postmastectomy expander/implant reconstruction. Methods: From 2003 through 2004, 1170 expander/implant reconstructions were performed at a single center. A prospectively maintained database was reviewed. Variables including age, smoking status, body mass index, history of diabetes, hypertension, chemotherapy and/or radiation, as well as timing and laterality of reconstruction were evaluated. The primary endpoint was the development of a complication; the secondary endpoint was failure of reconstruction. Results: Over the 2 year study period, 1170 expander/implant reconstructions were performed in 884 patients. The odds of developing complications was 2.2 times greater in smokers (p < 0.001) and 2.5 times greater in women over 65 (p = 0.008). Patients who were obese were at nearly two times the odds of having complications (p = 0.02), as were patients with hypertension (p = 0.02). Similarly, the odds of reconstructive failure were five times greater in smokers (p < 0.001). Age was not a significant predictor of reconstructive failure (p = 0.09); yet, failure was nearly seven times greater in obese patients (p < 0.001), and four more times likely in those who were hypertensive (p = 0.005). Conclusions: Smoking, obesity, hypertension, and age over 65 were independent risk factors for perioperative complications following expander/implant breast reconstruction. Smoking, obesity, and hypertension were similarly associated with reconstructive failure. This information can be used to evaluate overall procedural risks and individualize reconstructive options.

Acellular human dermis implantation in 153 immediate two-stage tissue expander breast reconstructions: determining the incidence and significant predictors of complications.

Background: Little information exists on the incidence of complications after acellular human dermis implantation in two-stage tissue expander breast reconstruction. The purpose of this study was to evaluate the incidence of postoperative adverse events and identify significant predictors of complications in acellular human dermis tissue expander breast reconstruction. Methods: This study accrued all patients from January of 2004 through April of 2008 undergoing two-stage immediate tissue expander breast reconstruction using acellular human dermis. A total of 153 expanders were placed. Complications were assessed. Univariate and multivariate logistic regression modeling was performed. Comparison of complication rates using the traditional (non–acellular human dermis) technique from concurrent (2004 to 2008) and consecutive time periods (2001 to 2003) for 2910 and 1170 expanders, respectively, is provided. Results: A total of 153 expanders were implanted in 96 women: 39 unilateral and 57 bilateral. Eleven (7.2 percent) were removed due to infection (n = 5, 3.3 percent), exposure (n = 4, 2.6 percent), or patient preference (n = 2, 1.3 percent). Other complications included cellulitis (3.9 percent), seroma (7.2 percent), hematoma (2.0 percent), mastectomy flap necrosis (4.6 percent), and leak/failed expansion (0.0 percent); 92.8 percent were successfully expanded and exchanged for a permanent implant. Eleven seromas (7.2 percent) were identified; nine underwent aspiration. None of these resulted in infection or reconstructive failure. Univariate analysis revealed age, body mass index, axillary dissection, and postoperative chemotherapy to be associated with reconstructive failure (p < 0.05). Multivariate analysis revealed that age, body mass index, and axillary dissection are independent risk factors for developing complications (p < 0.05). Conclusion: Acellular human dermis is a useful adjunct for intraoperative pocket development in immediate tissue expander reconstruction but can result in an increased risk of complications, in particular, seroma and reconstructive failure.

Validation of the Caprini Risk Assessment Model in Plastic and Reconstructive Surgery Patients

BACKGROUND The Venous Thromboembolism Prevention Study (VTEPS) Network is a consortium of 5 tertiary referral centers established to examine venous thromboembolism (VTE) in plastic surgery patients. We report our midterm analyses of the studys control group to evaluate the incidence of VTE in patients who receive no chemoprophylaxis, and validate the Caprini Risk Assessment Model (RAM) in plastic surgery patients. STUDY DESIGN Medical record review was performed at VTEPS centers for all eligible plastic surgery patients between March 2006 and June 2009. Inclusion criteria were Caprini score ≥3, surgery under general anesthesia, and postoperative hospital admission. Patients who received chemoprophylaxis were excluded. Dependent variables included symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) within the first 60 postoperative days and time to DVT or PE. RESULTS We identified 1,126 historic control patients. The overall VTE incidence was 1.69%. Approximately 1 in 9 (11.3%) patients with Caprini score >8 had a VTE event. Patients with Caprini score >8 were significantly more likely to develop VTE when compared with patients with Caprini score of 3 to 4 (odds ratio [OR] 20.9, p < 0.001), 5 to 6 (OR 9.9, p < 0.001), or 7 to 8 (OR 4.6, p = 0.015). Among patients with Caprini score 7 to 8 or Caprini score >8, VTE risk was not limited to the immediate postoperative period (postoperative days 1-14). In these high-risk patients, more than 50% of VTE events were diagnosed in the late (days 15-60) postoperative period. CONCLUSIONS The Caprini RAM effectively risk-stratifies plastic and reconstructive surgery patients for VTE risk. Among patients with Caprini score >8, 11.3% have a postoperative VTE when chemoprophylaxis is not provided. In higher risk patients, there was no evidence that VTE risk is limited to the immediate postoperative period.

Measuring quality of life in cosmetic and reconstructive breast surgery: a systematic review of patient-reported outcomes instruments.

Background: Patient-reported outcomes in cosmetic and reconstructive breast surgery are increasingly important for clinical research endeavors. Traditional surgical outcomes, centered on morbidity and mortality, remain important but are no longer sufficient on their own. Quality of life has become a crucial research topic augmenting traditional concerns focused on complications and survival. Given this, reliable and valid patient questionnaires are essential for aesthetic and reconstructive breast surgeons. Methods: The authors performed a systematic literature review to identify patient-reported outcome measures developed and validated for use in cosmetic and reconstructive breast surgery patients. Qualifying instruments were assessed for adherence to international guidelines for health outcomes instrument development and validation. Results: The authors identified 227 health outcomes questionnaires used in breast surgery studies. After 135 generic instruments, 65 ad hoc instruments, seven oncologic instruments, 11 education questionnaires, and two non-English-language questionnaires were excluded, seven measures remained. Detailed analysis revealed that six of the seven measures had undergone limited development and validation. Only one measure, the Breast-Related Symptoms Questionnaire, demonstrated adequate development and validation in its target population. It had, nevertheless, significant content limitations. Conclusions: Valid, reliable, and responsive instruments to measure patient-reported outcomes in cosmetic and reconstructive breast surgery are lacking. To demonstrate the benefits of aesthetic and reconstructive breast surgery, future research to rigorously develop and validate new cosmetic and reconstructive breast surgery-specific instruments is needed.

Simplifying microvascular head and neck reconstruction: A rational approach to donor site selection

The purpose of this study was to review the authors’ 13-year experience with free tissue transfer for head and neck oncology patients. This study was a retrospective review of 728 free flaps performed in 698 patients. Recipient sites were subdivided by region into the mandible (N = 253), mid face/orbit (N = 190), hypopharynx (N = 134), oral cavity (N = 104), skull base (N = 36), and scalp (N = 11). The overall free flap success rate was 98.6%. Seventy-nine flaps (10.9%) were reexplored for vascular compromise. Ten flaps (1.4%) were lost in their entirety. The overall complication rate was 17.5%. Four donor sites (forearm, fibula, rectus, and jejunum) were used for 92% of the patients. The results of the study confirm the efficacy of free tissue transfer in the reconstruction of oncological head and neck defects. In this series the free forearm, fibula, rectus, and jejunum flaps have become the workhorse donor sites for the vast majority of defects.Disa JJ, Pusic AL, Hidalgo DH, et al. Simplifying microvascular head and neck reconstruction: a rational approach to donor site selection. Ann Plast Surg 2001;47:385–389

A paradigm shift in U.S. breast reconstruction: Part 2. The influence of changing mastectomy patterns on reconstructive rate and method.

Background: The aims of the current study were to (1) measure trends in the type of mastectomy performed, (2) evaluate sociodemographic/hospital characteristics of patients undergoing contralateral prophylactic mastectomy versus unilateral mastectomies, and (3) analyze reconstruction rates and method used following different mastectomy types. Methods: Mastectomies from 1998 to 2008 were analyzed using the Nationwide Inpatient Sample database. Mastectomies (n = 178,603) were classified as either unilateral, contralateral prophylactic, or bilateral prophylactic. Reconstructive procedures were categorized into either implant or autologous. Longitudinal trends were analyzed with Poisson regression and sociodemographic/hospital variables were analyzed with logistic regression. Results: Unilateral mastectomies decreased 2 percent per year, whereas contralateral and bilateral prophylactic mastectomies increased significantly by 15 and 12 percent per year, respectively (p < 0.01). Independent predictors for contralateral prophylactic mastectomy (compared with unilateral mastectomy) were patients younger than 39 years, Caucasian and Hispanic race, private insurance carriers, treated in teaching hospitals, and from South and Midwest regions. Contralateral prophylactic mastectomy is the only group with increased reconstruction rates throughout the study period (p < 0.01). Although implant use increased for all mastectomy types, it remains greater in bilateral and contralateral prophylactic mastectomy. Conclusions: There is increasing use of bilateral mastectomies in the United States, particularly in patients with unilateral cancer. Although implant use has increased for all mastectomy types, they are used most commonly following bilateral and contralateral prophylactic mastectomies. Changing mastectomy patterns are one factor underlying the paradigm shift away from autologous tissue to implant-based reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Microvascular reconstruction of the hypopharynx: defect classification, treatment algorithm, and functional outcome based on 165 consecutive cases.

&NA; The objectives of this study were three‐fold: to develop a scheme for classification of hypopharyngeal defects, to establish a reconstructive algorithm based on this system, and to assess the functional outcome of such reconstruction. This study is a retrospective review of a 14‐year experience with 165 consecutive microvascular reconstructions of the hypopharynx in 160 patients. The average patient age was 59 years (95 percent CI, 37 to 81). Thirtyfour patients were operated on for recurrent disease; 71 had preoperative radiotherapy. Partial defects were reconstructed with radial forearm flaps (n = 52); circumferential defects were reconstructed with jejunum (n = 90); and extensive, noncircumferential longitudinal defects were reconstructed with rectus abdominis flaps (n = 23). The overall free flap success rate was 98 percent. Six flaps required reexploration, two of which were salvaged. The incidence of fistula was 7 percent and stricture, 4 percent. Preoperative radiotherapy was significantly associated with risk of recipient site complications (OR, 2.3; 95 percent CI, 1.0 to 5.0). Follow‐up data were available on 95 percent of patients: 53 percent were able to tolerate an unrestricted diet, 23 percent a soft diet, 12 percent liquids only, and 12 percent were limited to tube feedings. The treatment algorithm for microvascular hypopharyngeal reconstruction is based on the type of defect with partial defects with radial forearm flaps, circumferential defects reconstructed with free jejunal flaps, and extensive, multilevel defects reconstructed with rectus abdominis myocutaneous flaps. Microvascular reconstruction of pharyn geal defects is highly successful with few postoperative complications. With appropriate flap selection, functional outcome can be optimized. (Plast. Reconstr. Surg. 111: 652, 2003.)