Jennifer B. Hamill

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.

Postoperative enoxaparin prevents symptomatic venous thromboembolism in high-risk plastic surgery patients.

Background: Venous thromboembolism is a major patient safety issue. The Plastic Surgery Foundation–sponsored Venous Thromboembolism Prevention Study examined whether postoperative enoxaparin prevents symptomatic venous thromboembolism in adult plastic surgery patients. Methods: In 2009, four sites uniformly adopted a clinical protocol. Patients with a Caprini score of 3 or higher received postoperative enoxaparin prophylaxis for the duration of inpatient stay. Venous Thromboembolism Prevention Study historical control patients had an operation between 2006 and 2008 but received no chemoprophylaxis for 60 days after surgery. The primary study outcome was symptomatic 60-day venous thromboembolism. Results: Three thousand three hundred thirty-four patients (1876 controls and 1458 enoxaparin patients) were included. Notable risk reduction was present in patients with a Caprini score greater than 8 (8.54 percent versus 4.07 percent; p = 0.182) and a Caprini score of 7 to 8 (2.55 percent versus 1.15 percent; p = 0.230) who received postoperative enoxaparin. Logistic regression was limited to highest risk patients (Caprini score ≥7) and demonstrated that length of stay greater than or equal to 4 days (adjusted odds ratio, 4.63; p = 0.007) and Caprini score greater than 8 (odds ratio, 2.71; p = 0.027) were independent predictors of venous thromboembolism. When controlling for length of stay and Caprini score, receipt of postoperative enoxaparin was protective against venous thromboembolism (odds ratio, 0.39; p = 0.042). Conclusions: In high-risk plastic surgery patients, postoperative enoxaparin prophylaxis is protective against 60-day venous thromboembolism when controlling for baseline risk and length of stay. Hospitalization for 4 or more days is an independent risk factor for venous thromboembolism. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Assessing persistent pain and its relation to affective distress, depressive symptoms, and pain catastrophizing in patients with chronic wounds: a pilot study.

Roth RS, Lowery JC, Hamill JB: Assessing persistent pain and its relation to affective distress, depressive symptoms, and pain catastrophizing in patients with chronic wounds: A pilot study. Am J Phys Med Rehabil 2004;83:827–834. Objective:The purpose of this study was to examine pain experience among patients with chronic wounds, assess the utility of pain assessment scales for chronic wound-related pain, and determine the relation of wound-related pain to wound stage, affective distress, depressive symptoms, and pain catastrophizing. Design:In this cross-sectional study of patients with a mix of chronic wounds (n = 69) recruited for a study evaluating a telemedicine system for assessing chronic wounds, 19 men (12 with spinal cord injury) with wound-related pain were identified. Questionnaires included the Numerical Pain Rating Scale, McGill Pain Questionnaire, Brief Symptom Inventory, Center for Epidemiologic Studies Depression Scale, and the catastrophizing scale of the Coping Strategies Questionnaire. Results:The McGill Pain Questionnaire was more sensitive to pain experience than a single rating of pain intensity. Wound stage was positively related to severity of pain. Pain catastrophizing was positively related to pain intensity and higher levels of affective distress and depressive symptoms. Conclusions:Pain associated with chronic wounds is a significant clinical challenge for both patients and health practitioners.

Predictors of patient satisfaction in an outpatient plastic surgery clinic.

Although outcome measurement in medical care has traditionally included various aspects of clinical and functional status, patient satisfaction is another important metric in the assessment of health care quality. Determining which factors contribute most to patient satisfaction can assist health care providers in improving care. In an era of diminishing resources, satisfaction ratings can further aid third-party payers in determining who provides those services. The authors used the ordinal logistic regression method to develop a predictive model for patient satisfaction in an outpatient plastic surgery clinic. Consecutive patients who attended a university outpatient plastic surgery clinic were asked to complete the Visit Specific Patient Satisfaction Questionnaire (VSQ) after their clinic visit. Type of clinic (e.g., hand clinic, aesthetic clinic, breast clinic) and demographic variables like age, gender, race, and education were added to the questionnaire to control for possible confounding effects. The authors constructed an ordinal logistic regression model using the overall visit response as the dependent variable and the eight other response categories as independent variables. A total of 345 patients completed the VSQ, which takes each patient less than 2 minutes to complete. The patient response rate was more than 95%. Statistically significant predictors included (1) personal manner of physician (odds ratio [OR], 18.0; p = 0.0002), (2) time spent with physician (OR, 4.7; p = 0.0099), (3) length of time to get an appointment (OR, 4.6; p = 0.0055), and (4) explanation of what was done (OR, 3.9; p = 0.0263). There was no statistically significant association between overall satisfaction scores and the following factors: (1) length of wait in the clinic (OR, 2.7; p = 0.0747), (2) getting through to the clinic by phone (OR, 0.71; p = 0.5439), (3) convenience of the clinics location (OR, 2.3; p = 0.1368), and (4) technical skills of the physician (OR, 1.0; p = 0.9974). The predictive model was adjusted for possible confounding due to the type of clinic and demographic variables. In this study the most important predictors of patient satisfaction were those related to efficient clinic operation (scheduling of appointments and clinic waiting time) and the quality of the patient-physician interaction. Clinic facilities (like clinic location and ease of phone contact) were not significant predictors. Because patients often have difficulty assessing the technical skills of physicians, this variable was not a significant predictor. To improve patient satisfaction in plastic surgery outpatient clinics, efforts and resources should be directed toward expedient and empathic delivery of care.

The effect of postoperative enoxaparin on risk for reoperative hematoma.

Background: The risk of postoperative bleeding is the chief concern expressed by plastic surgeons who do not use pharmacologic prophylaxis against venous thromboembolism. The Plastic Surgery Foundation–funded Venous Thromboembolism Prevention Study examined whether receipt of postoperative enoxaparin prophylaxis changed 60-day reoperative hematoma rates. Methods: In 2009, the studys network sites uniformly adopted a “best practice” clinical protocol to provide postoperative enoxaparin to adult plastic surgery patients at risk for perioperative venous thromboembolism. Historical control patients (2006 to 2008) received no chemoprophylaxis for 60 days after surgery. Retrospective chart review identified demographic and surgery-specific risk factors that potentially contributed to bleeding risk. The primary study outcome was 60-day reoperative hematoma. Stratified analyses examined reoperative hematoma in the overall population and among high-risk patients. Multivariable logistic regression controlled for identified confounders. Results: Complete data were available for 3681 patients (2114 controls and 1567 enoxaparin patients). Overall, postoperative enoxaparin did not change the reoperative hematoma rate when compared with controls (3.38 percent versus 2.65 percent, p = 0.169). Similar results were seen in subgroup analyses for breast reconstruction (5.25 percent versus 4.21 percent, p = 0.737), breast reduction (7.04 percent versus 8.29 percent, p = 0.194), and nonbreast plastic surgery (2.20 percent versus 1.46 percent, p = 0.465). In the regression model, independent predictors of reoperative hematoma included breast surgery, microsurgical procedure, and post–bariatric surgery body contouring. Receipt of postoperative enoxaparin was not an independent predictor (odds ratio, 1.16; 95 percent CI, 0.77 to 1.76). Conclusion: Postoperative enoxaparin does not produce a clinically relevant or statistically significant increase in observed rates of reoperative hematoma. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk: II

Patient-Reported Outcomes 1 Year After Immediate Breast Reconstruction: Results of the Mastectomy Reconstruction Outcomes Consortium Study

Purpose The goals of immediate postmastectomy breast reconstruction are to minimize deformity and optimize quality of life as perceived by patients. We prospectively evaluated patient-reported outcomes (PROs) in women undergoing immediate implant-based or autologous reconstruction. Methods Women undergoing immediate postmastectomy reconstruction for invasive cancer and/or carcinoma in situ were enrolled at 11 sites. Women underwent implant-based or autologous tissue reconstruction. Patients completed the BREAST-Q, a condition-specific PRO measure for breast surgery patients, and Patient-Reported Outcomes Measurement Information System-29, a generic PRO measure, before and 1 year after surgery. Mean changes in PRO scores were summarized. Mixed-effects regression models were used to compare PRO scores across procedure types. Results In total, 1,632 patients (n = 1,139 implant, n = 493 autologous) were included; 1,183 (72.5%) responded to 1-year questionnaires. After analysis was controlled for baseline values, patients who underwent autologous reconstruction had greater satisfaction with their breasts than those who underwent implant-based reconstruction (difference, 6.3; P < .001), greater sexual well-being (difference, 4.5; P = .003), and greater psychosocial well-being (difference, 3.7; P = .02) at 1 year. Patients in the autologous reconstruction group had improved satisfaction with breasts (difference, 8.0; P = .002) and psychosocial well-being (difference, 4.6; P = .047) compared with preoperative baseline. Physical well-being of the chest was not fully restored in either the implant group (difference, -3.8; P = .001) or autologous group (-2.2; P = .04), nor was physical well-being of the abdomen in patients who underwent autologous reconstruction (-13.4; P < .001). Anxiety and depression were mitigated at 1 year in both groups. Compared with their baseline reports, patients who underwent implant reconstruction had decreased fatigue (difference, -1.4; P = .035), whereas patients who underwent autologous reconstruction had increased pain interference (difference, 2.0; P = .006). Conclusion At 1 year after mastectomy, patients who underwent autologous reconstruction were more satisfied with their breasts and had greater psychosocial and sexual well-being than those who underwent implant reconstruction. Although satisfaction with breasts was equal to or greater than baseline levels, physical well-being was not fully restored. This information can help patients better understand expected outcomes and may guide innovations to improve outcomes.

Technical Overview of a Web-based Telemedicine System for Wound Assessment

This report provides a technical overview of a Web-based telemedicine system for monitoring wounds in patients who do not have immediate access to the services of a consulting physician, including patients at home or in long-term-care facilities. Such a system would allow for the easy transmission and access of digital images of a patient’s wounds and would allow multiple types of data required for comprehensive management of a patient’s condition to be summarized and displayed. A store-and-forward method of data transmission was chosen for this project, rather than real-time videoconferencing, to limit the use of expensive technology and to maximize convenience for both the patient and the consulting physician. Under the store-and-forward technique, a clinician obtains wound data from the patient, then transmits these data to a Web site where the telemedicine physician can view data from multiple patients at his or her convenience.

Should Immediate Autologous Breast Reconstruction Be Considered in Women Who Require Postmastectomy Radiation Therapy? A Prospective Analysis of Outcomes.

Background: In women who require postmastectomy radiation therapy, immediate autologous breast reconstruction is often discouraged. The authors prospectively evaluated postoperative morbidity and satisfaction reported by women undergoing delayed or immediate autologous breast reconstruction in the setting of postmastectomy radiation therapy. Methods: Patients enrolled in the Mastectomy Reconstruction Outcomes Consortium study, who received postmastectomy radiotherapy and underwent immediate or delayed free abdominally based autologous breast reconstruction, were identified. Postoperative complications at 1 and 2 years after reconstruction were assessed. Patient-reported outcomes were evaluated using the BREAST-Q questionnaire preoperatively and at 1 and 2 years postoperatively. Bivariate analyses and mixed-effects regression models were used to compare outcomes. Results: A total of 175 patients met the authors’ inclusion criteria. Immediate reconstructions were performed in 108 patients and delayed reconstructions in 67 patients; 93.5 percent of immediate reconstructions were performed at a single center. Overall complication rates were similar based on reconstructive timing (25.9 percent immediate and 26.9 percent delayed at 1 year; p = 0.54). Patients with delayed reconstruction reported significantly lower prereconstruction scores (p < 0.0001) for Satisfaction with Breasts and Psychosocial and Sexual Well-being than did patients with immediate reconstruction. At 1 and 2 years postoperatively, both groups reported comparable levels of satisfaction in assessed BREAST-Q domains. Conclusions: From this prospective cohort, immediate autologous breast reconstruction in the setting of postmastectomy radiation therapy appears to be a safe option that may be considered in select patients and centers. Breast aesthetics and quality of life, evaluated from the patient’s perspective, were not compromised by flap exposure to radiation therapy. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Postmastectomy Radiation Therapy and Two-stage Implant-based Breast Reconstruction: Is There a Better Time to Irradiate?

Background: The ideal timing of postmastectomy radiation therapy (PMRT) in the setting of two-stage implant-based breast reconstruction remains unclear. In this cohort study, the authors sought to determine whether complication rates differed between patients who received PMRT following tissue expander placement (TE-XRT) and those who received PMRT after exchange for permanent implants (Implant-XRT) utilizing using prospective, multicenter data. Methods: Eligible patients in the Mastectomy Reconstruction Outcomes Consortium study from 11 institutions across North America were included in the analysis. All patients had at least 6-month follow-up after their last intervention (i.e., implant exchange for TE-XRT patients, and radiation for Implant-XRT patients). Complications including seroma, hematoma, infection, wound dehiscence, capsular contracture, and implant loss were recorded. Results: The authors identified a total of 150 patients who underwent immediate, two-stage implant-based breast reconstruction and received PMRT. Of these, there were TE-XRT 104 patients (69.3 percent) and 46 (30.7 percent) Implant-XRT patients. There were no differences in the incidence of any complications or complications leading to reconstructive failure between the two cohorts. After adjusting for patient characteristics and site effect, the timing of PMRT (i.e., TE-XRT versus Implant-XRT) was not a significant predictor in the development of any complication, a major complication, or reconstructive failure. Conclusion: In the setting of PMRT and two-stage implant-based reconstruction, patients who received PMRT after expander placement (TE-XRT) did not have a higher incidence or increased odds of developing complications than those who received PMRT after exchange for a permanent implant (Implant-XRT). CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Late Surgical-Site Infection in Immediate Implant-Based Breast Reconstruction

Background: Surgical-site infection causes devastating reconstructive failure in implant-based breast reconstructions. Large national database studies offer insights into complication rates, but only capture outcomes within 30 days postoperatively. This study evaluates both early and late surgical-site infection in immediate implant-based reconstruction and identifies predictors. Methods: As part of the Mastectomy Reconstruction Outcomes Consortium Study, 1662 implant-based breast reconstructions in 1024 patients were evaluated for early versus late surgical-site infection. Early surgical-site infection was defined as infection occurring within 30 days postoperatively; late surgical-site infection was defined as infection occurring 31 days to 1 year postoperatively. Minor infection required oral antibiotics only, and major infection required hospitalization and/or surgical treatment. Direct-to-implant patients had 1-year follow-up, and tissue expander patients had 1-year post-exchange follow-up. Results: Among 1491 tissue expander and 171 direct-to-implant reconstructions, overall surgical-site infection rate for tissue expander was 5.7 percent (85 of 1491) after first-stage, 2.5 percent (31 of 1266) after second-stage, and 9.9 percent (17 of 171) for direct-to-implant reconstruction. Over 47 to 71 percent of surgical-site infection complications were late surgical-site infection. Multivariate analysis identified radiotherapy and increasing body mass index as significant predictors of late surgical-site infection. No significant difference between the direct-to-implant and tissue expander groups in the occurrence of early, late, or overall surgical-site infection was found. Conclusions: The majority of surgical-site infection complications in immediate implant-based breast reconstructions occur more than 30 days after both first-stage and second-stage procedures. Radiotherapy and obesity are significantly associated with late-onset surgical-site infection. Current studies limited to early complications do not present a complete assessment of infection associated with implant-based breast reconstructions or their long-term clinical outcomes. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.