Christopher J. Pannucci

Use of acellular dermal matrix in breast reconstruction has been associated with increased complications. However, existing studies are generally small, from single centers, and underpowered to control for confounding using regression techniques. Here, the Tracking Outcomes and Operations in Plastic Surgery database was used to examine the effect of acellular dermal matrix on expander/implant loss when controlling for other confounders. Analysis was limited to patients having tissue expander or implant-based breast reconstruction. Surgeon-reported data, International Classification of Diseases, Ninth Edition codes, and Current Procedural Terminology codes were used to identify independent variables. The dependent variable of interest was 30-day rates of tissue expander or implant loss. Bivariate statistics were performed. Multivariable logistic regression identified independent predictors of expander/implant loss when controlling for other confounders. Data were available for 14,249 patients. The overall rate of expander/implant loss was 2.05 percent. Bivariate analysis demonstrated acellular dermal matrix was associated with an absolute increase in expander/implant loss of 0.7 percent (1.88 percent versus 2.58 percent, p = 0.012). The regression model demonstrated that rising body mass index, current smoking, and presence of diabetes were each independent predictors of expander/implant loss. When controlling for all other identified confounders, use of acellular dermal matrix was associated with a significant increase in expander/implant loss (odds ratio, 1.42; 95 percent confidence interval, 1.04 to 1.94; p = 0.026). Thirty-day risk for expander/implant loss after tissue expander or implant-based breast reconstruction was 2.05 percent. Use of acellular dermal matrix was associated with a 0.7 percent absolute risk increase for expander/implant loss. Risk, III.

Background: Venous thromboembolism is an important patient safety issue. The authors sought to compare the predictive capacity of the 2005 and 2010 Caprini Risk Assessment Models for perioperative venous thromboembolism risk. Methods: The authors performed a retrospective, observational, crossover study using an established surgical outcomes database. A total of 3334 adult plastic surgery patients were identified. Patients were risk-stratified using both the 2005 and 2010 Caprini Risk Assessment Models. Each patient served as his or her own control, resulting in precise matching for identified and unidentified confounders. The outcome of interest was 60-day, symptomatic venous thromboembolism. The predictive capacities of the 2005 and 2010 Caprini risk scores were compared. Results: Use of the 2010 Caprini Risk Assessment Model resulted in a systematic increase in the aggregate risk score. The median 2010 Caprini score was significantly higher than the median 2005 Caprini score (6 versus 5, p < 0.001). When compared with the 2010 model, the 2005 Caprini Risk Assessment Model was able to better separate the lowest and highest risk patients from one another. Patients classified as “super-high” risk (Caprini score >8) using the 2005 Caprini Risk Assessment Model were significantly more likely to have a 60-day venous thromboembolism event when compared with patients classified as super-high risk using the 2010 guidelines (5.85 percent versus 2.52 percent, p = 0.021). Conclusions: When compared with the 2010 Caprini Risk Assessment Model, the 2005 Caprini Risk Assessment Model provides superior risk stratification. The 2005 Caprini Risk Assessment Model is the more appropriate method to risk-stratify plastic surgery patients for perioperative venous thromboembolism risk. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Objective: To identify independent predictors of 30-day venous thromboembolism (VTE) events requiring treatment after outpatient surgery. Background: An increasing proportion of surgical procedures are performed in the outpatient setting. The incidence of VTE requiring treatment after outpatient surgery is unknown. Methods: Prospective observational cohort study using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database from 2005 to 2009. Adult patients who had outpatient surgery or surgery with subsequent 23-hour observation were included. The main outcome measure was 30-day VTE requiring treatment. Patients were randomly assigned to derivation (N = 173,501) or validation (N = 85,730) cohorts. Logistic regression examined independent risk factors for 30-day VTE. A weighted risk index was created and applied to the validation cohort. Stratified analyses examined 30-day VTE by risk level. Results: Thirty-day incidence of VTE for the overall cohort was 0.15%. Independent risk factors included current pregnancy (adjusted odds ratio [OR] = 7.80, P = 0.044), active cancer (OR = 3.66, P = 0.005), age 41 to 59 years (OR = 1.72, P = 0.008), age 60 years or more (OR = 2.48, P < 0.001), body mass index 40 kg/m² or higher (OR = 1.81, P = 0.015), operative time 120 minutes or more (OR = 1.69, P = 0.027), arthroscopic surgery (OR = 5.16, P < 0.001), saphenofemoral junction surgery (OR = 13.20, P < 0.001), and venous surgery not involving the great saphenous vein (OR = 15.61, P < 0.001). The weighted risk index identified a 20-fold variation in 30-day VTE between low (0.06%) and highest risk (1.18%) patients. Conclusions: Thirty-day VTE risk after outpatient surgery can be quantified using a weighted risk index. The risk index identifies a high-risk subgroup of patients with 30-day VTE rates of 1.18%.

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 study's 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

Background: The Institute of Medicine has identified a “quality chasm” between existing evidence and actual clinical practice. The Venous Thromboembolism Prevention Study has shown that enoxaparin prophylaxis is a safe and effective way of preventing postoperative venous thromboembolism. This article presents a “how-to” guide for implementation of a venous thromboembolism prophylaxis protocol. Methods: The Venous Thromboembolism Prevention Study prophylaxis protocol included provision of postoperative, prophylactic dose enoxaparin for the duration of inpatient stay. Compliance was considered at the individual patient level and defined as appropriate provision of protocol-appropriate enoxaparin prophylaxis. Multiple simultaneous interventions to improve protocol compliance were undertaken. Both physician and physician assistant “champions” were identified. Interventions included staff and surgeon educational sessions, discussion of venous thromboembolism–themed articles at journal club, and monthly e-mail reminders specific to the protocol, among others. Compliance rates over time were compared using the chi-square test. Results: The authors reviewed medical records from 945 consecutive admissions to the plastic surgery service who met Venous Thromboembolism Prevention Study eligibility criteria over a 30-month period. Initial education sessions significantly increased compliance over baseline (55 percent versus 10 percent; p < 0.001). After formal protocol adoption, compliance increased steadily over the first 9 months and peaked by 1 year. In the absence of any direct intervention, compliance remained stable at 90 percent for the final 12 months of the study. This was significantly increased when compared with the period of time immediately following protocol adoption (90 percent versus 77 percent; p < 0.001). Conclusion: This article provides readers with a practical approach for implementation of a venous thromboembolism prophylaxis protocol at their hospital.

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.

The Skin Products Assessment Research Committee was created by the Plastic Surgery Educational Foundation in 2006. The Skin Products Assessment Research study aims were to (1) develop an infrastructure for Plastic Surgery Educational Foundation-conducted, industry-sponsored research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System versus conventional therapy as treatment adjuncts for facial resurfacing procedures. The Skin Products Assessment Research study was designed as a multicenter, double-blind, randomized, controlled trial. The study was conducted in women with Fitzpatrick type I to IV skin, moderate to severe facial photodamage, and periocular and/or perioral fine wrinkles. Patients underwent chemical peel or laser facial resurfacing and were randomized to the Obagi Nu-Derm System or a standard care regimen. The study endpoints were time to reepithelialization, erythema, and pigmentation changes. Fifty-six women were enrolled and 82 percent were followed beyond reepithelialization. There were no significant differences in mean time to reepithelialization between Obagi Nu-Derm System and control groups. The Obagi Nu-Derm System group had a significantly higher median erythema score on the day of surgery (after 4 weeks of product use) that did not persist after surgery. Test-retest photographic evaluations demonstrated that both interrater and intrarater reliability were adequate for primary study outcomes. The authors demonstrated no significant difference in time to reepithelialization between patients who used the Obagi Nu-Derm System or a standard care regimen as an adjunct to facial resurfacing procedures. The Skin Products Assessment Research team has also provided a discussion of future challenges for Plastic Surgery Educational Foundation-sponsored clinical research for readers of this article.