Venous Thromboembolism in the Cosmetic Patient: Analysis of 129,007 Patients

Transcription

1 Research Venous Thromboembolism in the Cosmetic Patient: Analysis of 129,007 Patients Aesthetic Surgery Journal 2017, 2016, Vol (3) The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com DOI: /asj/sjw173 Julian Winocour, MD; Varun Gupta, MD, MPH; Christodoulos Kaoutzanis, MD; Hanyuan Shi, BA; R. Bruce Shack, MD; James C. Grotting, MD; and K. Kye Higdon, MD Abstract Background: Venous thromboembolism (VTE) is one of the most feared postoperative complications in cosmetic surgery. The true rate of VTE in this patient population remains largely unknown with current American Society of Plastic Surgeons (ASPS) prophylaxis recommendations partially extrapolated from other surgical specialties. Objectives: This study analyzed the risk factors for VTE in cosmetic surgical procedures. Methods: A prospective cohort of patients who underwent aesthetic surgery between 2008 and 2013 was identified from the CosmetAssure database. Primary outcome was occurrence of a clinically significant VTE within 30 days of surgery. Risk factors analyzed included age, gender, body mass index (BMI), smoking, diabetes, type of surgical facility, procedure by body region, and combined procedures. Results: A total of 129,007 patients were identified, of which 116 (0.09%) had a confirmed VTE. Combined procedures had a significantly higher overall rate of VTE compared to solitary procedures (0.20% vs 0.04%, P <.01). On multivariate logistic regression, significant risk factors for VTE (P <.05) included body procedures (RR 13.47), combined procedures (RR 2.4), increasing BMI (RR 1.06), and age (RR 1.02). Gender, smoking, diabetes, and type of surgical facility were not found to be significant risk factors. Face procedures (0.01%) and breast procedures (0.01%) had the lowest VTE rates, followed by combined face/body (0.16%), body procedures (0.21%), and combined body/breast procedures (0.28%). Conclusions: The incidence of VTE after cosmetic procedures is relatively low. However, the risk increases with combined procedures as well as with particular body areas, most notably trunk and extremities. Equally, significant patient risk factors exist, including BMI and age. Level of Evidence: 2 Accepted for publication August 16, ; online publish-ahead-of-print September 21, Venous thromboembolism (VTE) is one of the most feared postoperative complications in all surgical specialties. Due to the high morbidity and even mortality that accompanies VTE, a great deal of emphasis is placed on the prevention of this complication. According to the Centers for Disease Control and Prevention (CDC), it is estimated that as many as 900,000 Americans suffer a VTE yearly with an estimation of 60,000 to 100,000 deaths. 1 However, due to the silent nature of the disease, along with the low rate of conducted autopsies in the United States, these numbers are likely greatly underestimated. 2 In the post-surgical setting, VTE can have significant sequelae, leading to extended hospital stays that can burden both patients and hospital systems. 3,4 The pervasiveness of these post-surgical incidences varies by illness Risk Drs Winocour and Kaoutzanis are Plastic Surgery Fellows, Mr Shi is a Medical Student, Dr Shack is a Professor and Chairman, and Drs Gupta and Higdon are Assistant Professors, Department of Plastic Surgery, Vanderbilt University, Nashville, TN. Dr Grotting is a Clinical Professor, Division of Plastic Surgery, University of Alabama at Birmingham, Birmingham, AL; and CME/MOC Section Editor for Aesthetic Surgery Journal. Corresponding Author: Dr Julian Winocour, Department of Plastic Surgery, D-4207 Medical Center North, Nashville, TN , USA. julian.winocour@vanderbilt.edu Presented at: the American Society of Plastic Surgery annual meeting in Boston, MA in October 2015; and as a poster at the Southeastern Society of Plastic and Reconstructive Surgeons annual meeting in Orlando, FL in June 2016.

2 338 Aesthetic Surgery Journal 37(3) severity, hospitalization, and surgery type. Current estimates put the prevalence of VTE (symptomatic or silent) at up to 15% to 40% in general surgery, 15% to 40% in gynecologic surgery, 15% to 40% in neurosurgery, 40% to 60% in orthopaedic surgery, and 40% to 80% in major trauma cases. 5,6 Studies have shown that outpatient and ambulatory surgical cases are very safe, having a VTE incidence ranging from 0.001% to 0.15%. 7,8 Although most elective plastic surgery cases fall into this group, the American Society of Plastic Surgeons (ASPS) estimates at least 18,000 annual cases of deep venous thrombosis (DVT) in all plastic surgery cases across the country, based on extrapolation from other surgical groups (2001). 4,5 However, this does not separate cosmetic from reconstructive plastic surgery patients, who more often suffer complications. 9 Studies on specific cosmetic procedures do exist, but not as a collective whole. Surgeon surveys, largely voluntary, have reported variable cosmetic VTE incidences ranging from 0.012% to 2%. 10,11 However, the low response rates and small sample sizes cannot reliably predict actual rates for the cosmetic surgical population. 12 Reporting an accurate incidence of VTE and its risk factors in cosmetic surgery cases is needed to make valid recommendations for surgical risk assessment and prophylaxis. Many plastic surgeons do not follow or even know the ASPS guidelines for preoperative VTE prevention and treatment. 13 The Caprini Risk Assessment Model (RAM) was specifically developed for assessing perioperative and 60-day postoperative thrombotic risk after surgery in 2005, and later modified in However, it has been previously shown that the 2005 Caprini RAM is a better predictor of the VTE risk than the 2010 modifications in adult plastic surgery patients. 14 Patient factors (eg, past and current medical history, immobilization, age, medications) and surgical factors (eg, minor surgery vs major surgery) are used to recommend the possible need for mechanical and chemoprophylaxis. The ASPS has approved the Caprini RAM and other risk assessment tools to better identify high-risk plastic surgery patients, mostly in those undergoing reconstructive procedures Further research is needed for aesthetic surgery patients to better validate risk factors in the Caprini RAM and provide comprehensive recommendations for prophylaxis for this patient population. The purpose of this study was to determine the incidence of VTE in patients following aesthetic surgical procedures, using a large prospective, multicenter database (CosmetAssure, Aesthetic Surgeons Financial Group, Birmingham, AL). This study also investigated differences in VTE risk among cosmetic procedures performed alone and in combination. METHODS The Vanderbilt University Institutional Review Board (IRB) approved this prospective cohort study (IRB # ). Study Population The study population consisted of a cohort of patients who enrolled in the CosmetAssure insurance program and underwent cosmetic surgical procedure(s) between May 2008 and May The CosmetAssure database was accessed in February 2014 following IRB approval. Database As previously described by our group, CosmetAssure is an insurance program introduced in 2003 that offers financial coverage of unexpected major complications related to cosmetic surgical procedures, which may not be reimbursed by patient s primary health insurance. 19 The program is offered in all 50 states in the United States. It is available exclusively to American Board of Plastic Surgery (ABPS) - certified plastic surgeons and to the American Society of Plastic Surgeons (ASPS) Candidates for Membership who have passed the ABPS Written Examination. Furthermore, the CosmetAssure program mandates that all surgical procedures by approved surgeons be performed in accredited facilities. Patients who undergo one or more of the covered procedures by a participating plastic surgeon at an accredited facility must be enrolled into the program prior to any procedure, making it a prospective cohort. Surgeon-reported major complications, filed as a claim, are recorded in the database. A major complication is defined as that occurring within 30 days of the operation that requires hospital admission, an emergency room visit, or a reoperation. This excludes complications that can be managed in the surgeon s office, such as seromas, minor wound infections, minor wound dehiscence, or sloughing, as they are not applicable for an insurance claim. The covered major complications include hematoma, infection, pulmonary dysfunction, cardiac complication, suspected or confirmed VTE, wound related problems, myocardial infarction, and fluid overload. Other major complications (nerve injury, urinary retention etc.) have been reported to CosmetAssure but may not qualify for expense reimbursement. The database lists all procedures performed on the patient, making it possible to study specific individual procedures as well as procedure combinations (ie, patients undergoing multiple procedures under the same anesthetic). The database also records demographic and comorbidity data including age, gender, body mass index (BMI), smoking, diabetes mellitus (DM), and type of surgical facility [office-based surgical suite (OBSS), accredited surgical center (ASC), hospitals]. Personnel employed by CosmetAssure enter data provided by the surgeon at the time of patient enrollment, as well as any claims filed by the surgeon. CosmetAssure, being a private insurance company, has a vested interest in maintaining an accurate database for actuarial and audit purposes.

3 Winocour et al 339 Exposure In this study cohort, exposure was defined as the type of cosmetic surgical procedure(s) performed. Each procedure was studied when performed alone or in combination with other cosmetic procedures. Risk Factors The potential risk factors evaluated include age, gender, BMI, smoking, DM, type of surgical facility, procedure by body region, and combined procedures. Surgical facility information was limited to the type of healthcare setting in which the service was provided. Outcome Primary outcome was the occurrence of any clinically significant VTE, either deep venous thrombosis (DVT) or pulmonary embolism (PE), requiring an emergency room visit, hospital admission, or reoperation within 30 days of the index operation. The CosmetAssure database captures both suspected and confirmed VTE. Suspected VTE represents patients that required work-up for clinical symptoms of a thrombotic event, however, was proven to be negative and, therefore, required no further management. Suspected VTE was excluded from the analysis. Demographic Variables and Surgical Procedures Distribution of factors including age, gender, BMI, smoking, diabetes mellitus, type of surgical facility, and combined procedures were compared between patients with and without a confirmed VTE. The dataset included 24 unique cosmetic surgical procedures, and patients underwent anywhere from 1 to 7 procedures, resulting in more than 700 procedure combinations. For the purpose of this study, we categorized all cosmetic procedures into 3 groups based on body region. These groups were face (ie, blepharoplasty, browlift, cheek implant, chin augmentation, facelift, facial resurfacing, hair replacement, otoplasty, rhinoplasty), breast (ie, augmentation, mastopexy, male breast surgery, reduction, revision breast implant procedures), and body (ie, abdominoplasty, brachioplasty, buttock lift, calf implant, labioplasty, liposuction, lower body lift, thigh lift, upper body lift). Patients who underwent more than 1 cosmetic procedure under the same anesthetic were considered to have combined procedures. In addition, we looked at outcomes in each of the 24 surgical procedures performed as a solitary procedure to offset the potential effect-modification from combining procedures. Statistical Analysis Two separate, de-identified, datasets were obtained from CosmetAssure, one with the enrollment data and other with claims information. The enrollment dataset contained entries for each unique procedure. Thus a patient undergoing combined procedures had separate entries for each procedure. A unique identifier was created using variables; date of birth, date of surgery, and BMI. Using this unique identifier, the enrollment dataset was restructured such that a patient undergoing combined procedures was counted once with each of the procedures listed as a separate variable. Another unique identifier was created with variables shared between the enrollment and claims dataset, 20 did not match to the enrollment data using the identifier. These cases were manually matched to the enrollee s with closest demographic characteristics. Kolmogorov-Smirnov statistic was used to check normal distribution of continuous variables; age and BMI. The only missing data were absent BMI information for 1046 (0.8%) patients. These patients were included in the analysis without replacing these missing data points. Patients with missing BMI information were automatically excluded in regression analysis. Patient characteristics, risk factors, and complication rates between patients undergoing different procedure combinations were compared by two-tailed student, Fisher exact test, or by Pearson chi-square tests. For purpose of univariate analysis, age and BMI were recorded as ordinal variables with clinically appropriate categories, whereas for multivariate regression they were analyzed as continuous variables. Standard logistic regression analysis was performed to identify the independent risk factors for VTE as a postoperative complication. Unless otherwise noted, the probability of a type I error of less than 5 percent (P <.05) was used to determine statistical significance. All analyses were performed using IBM SPSS Statistics 23.0 software (IBM Corporation, Armonk, NY). Figure 1. Study design of CosmetAssure database ( ).

4 340 Aesthetic Surgery Journal 37(3) RESULTS Between May 2008 and May 2013, a total of 183,914 cosmetic surgery procedures were performed on 129,007 patients enrolled into the CosmetAssure program. The overall mean age was 40.9 ± 13.9 years (range, 5-93 years), mean BMI was 24.3 ± 4.6 kg/m 2 (range, kg/m 2 ), and the majority of patients were women (93.5%). The majority of cases in the database were isolated procedures (67.5%), whereas 32.5% of cases were combined. Major complications occurred in 2506 patients (1.9% overall rate). The most common complications were hematomas (0.9%) and surgical site infections (0.5%). A total of 116 confirmed VTE events were recorded (0.09% incidence), which represented 4.63% of all complications in the database (Figure 1). Confirmed VTE occurred in 112 females (96.6%) and 3 males (3.4%) with a mean age of 45.5 ± 10.3 years (range, years) and a mean BMI of 27.8 ± 5.3 kg/m 2 (range, kg.m 2 ). This was in contrast to the non-vte cohort, which had a mean age of 40.9 ± 13.9 years (range, 5-93 years, P <.01) and mean BMI of 24.3 ± 4.6 kg/m 2 (range, kg/m 2, P <.01, Table 1). The VTE group had a lower prevalence of smokers (3.4% vs 8.2%, P =.03). The prevalence of diabetes was not significantly different between the VTE and non-vte groups (0.9% vs 1.8%, P =.37), nor was the Table 1. Characteristics of Cohort Age in years (mean ± SD) No VTE (n = 128,891) VTE (n = 116) P Value 40.9 ± ± 10.3 <.01* Age 40 years 65,513 (50.8%) 83 (71.6%) <.01* Gender (female) 120,538 (93.5%) 112 (96.6%).12 BMI kg/m 2 (mean ± SD) 24.3 ± ± 5.3 <.01* BMI 25 46,245 (36.2%) 80 (69.0%) <.01* Smoking 10,617 (8.2%) 4 (3.4%).03* Diabetes 2367 (1.8%) 1 (0.9%).37 Type of facility Hospital 34,438 (26.7%) 39 (33.6%).19 OBSS 20,522 (15.9%) 14 (12.1%) ASC 73,931 (57.4%) 63 (54.3%) Combined procedures 41,804 (32.4%) 82 (70.7%) <.01* Body procedure 48,372 (37.5%) 108 (93.1%) <.01* ASC, accredited surgical center; BMI, body mass index; OBSS, office-based surgical suite; SD, standard deviation; VTE, venous thromboembolism. proportion of male patients (3.4% vs 6.5%, P =.12). The two groups were similar in terms of the type of facility in which the surgery was performed, with the majority being performed in an ASC, followed by hospital setting, and finally OBSS. Patient demographics and other characteristics comparing the two patient populations (ie, VTE and non-vte) are shown in Table 1. Single Procedures The dataset included 24 unique cosmetic surgical procedures, and patients underwent anywhere from 1 to 7 procedures resulting in a large number of procedure combinations. For the purpose of this study, we categorized all cosmetic procedures into three groups based on body region: face, body, and breast. The highest incidence of VTE in a single procedure was thigh lift (0.25%) followed by lower body lift (0.23%) and abdominoplasty (0.20%). The VTE incidences for single procedures are shown in Table 2. As a proportion of VTE occurring in single aesthetic procedures, abdominoplasty (52.9%), liposuction (20.6%), and breast augmentation (11.8%) accounted for the majority of the events (Figure 2). Body procedures made up 93.1% (108/116) of all confirmed VTEs and had a significantly higher overall incidence of VTE compared to all other face and breast Table 2. Single Procedure Type and Frequency of Venous Thromboembolism Procedure Frequency % of VTE Cases VTE Rate (%) Thigh lift % 1 (0.25%) Lower body lift % 1 (0.23%) Abdominoplasty % 18 (0.20%) Brachioplasty % 1 (0.13%) Liposuction 11, % 7 (0.06%) Breast reduction % 1 (0.03%) Rhinoplasty % 1 (0.03%) Breast augmentation 41, % 4 (0.01%) Breast lift % 0 (0%) Buttock lift 407 0% 0 (0%) Blepharoplasty % 0 (0%) Facelift % 0 (0%) Gynecomastia % 0 (0%) Upper body lift 26 0% 0 (0%) VTE, venous thromboembolism.

5 Winocour et et al al Combined Procedures Figure 2. Breakdown of procedure cases of VTE. Risk Factors procedures (0.22% vs 0.01%, P <.01) (Table 3). In single procedures, body procedures again had a significantly higher overall incidence of VTE compared to breast and face procedures (0.12% vs 0.01% and 0.01% respectively, P <.01). Table 3. Multiple Procedure Combinations and Frequency of Venous Thromboembolism Total VTE (%) P Value Single 87, (0.04%) <.01* Combined 41, (0.20%) 1 87, (0.04%) 2 31, (0.16%) (0.26%) (0.53%) Procedures Number of total procedures <.01* DISCUSSION Procedure combinations Face 20,702 3 (0.01%) Breast 58,295 5 (0.01%) Body 32, (0.21%) Breast + face (0.00%) Body + face (0.16%) 13, (0.28%) (0.23%) Breast + body Body + breast + face On univariate analysis, age 40 (0.13% vs 0.05%, P <.01), BMI 25 (0.17% vs 0.04%, P <.01), and combined procedures (0.20% vs 0.04%, P <.01) were associated with statistically significant increased incidence of VTE (Figure 3). In combined procedures it was shown that there was a steady increase in the incidence of VTE with each additional procedure (1: 0.04%; 2: 0.16%; 3: 0.26%; 4: 0.53%, P <.01). Similarly, this was true for BMI by category ( : 0.04%; : 0.14%; : 0.24%; >40: 0.33%, P <.01). Patients undergoing body procedures were found to have a significant increased risk of suffering a VTE compared to non-body procedures (0.22% vs 0.01%, P <.01). On multivariate logistical regression, independent risk factors (P <.01) included body procedures (RR 13.47) and combined procedures (RR 2.40). BMI and age were analyzed as continuous variables and maintained significance on multivariate regression (RR 1.06, 1.02 respectively). Gender, smoking, diabetes, and the facility in which the procedure was performed were not found to be significant risk factors. These results are summarized in Table 4. <.01* VTE, venous thromboembolism. Body region: Face (blepharoplasty, browlift, cheek implant, chin augmentation, facelift, facial resurfacing, hair replacement, otoplasty, rhinoplasty), Breast (augmentation, reduction, revisional breast implant procedures, mastopexy, male breast surgery), Body (brachioplasty, buttock lift, calf implant, labioplasty, liposuction, lower body lift, thigh lift, upper body lift). In recent years, there has been a significant increase in the popularity and media reporting of cosmetic surgery. Most importantly, this has stressed patient safety, especially in ambulatory surgical centers and office-based operating rooms and, thus, increased the efforts to optimize patient outcomes. Elucidating patient specific risk factors and accurate specialty specific procedure complication rates have allowed better patient selection and education to achieve more predictable results. VTE, including both DVT and PE, remains one of the most feared complications in all specialties in medicine. Pulmonary embolism is one of the leading causes of in-hospital mortality and has gained the interest of large accreditation organizations, with an estimated 500,000 events in the United States per year and affecting A significant portion of the cases in the database were combined procedures (32.5%, Table 3). Combined procedures had a significantly higher overall incidence of VTE compared to single procedures (0.20% vs 0.04%, P <.01) (Figure 3). Equally, there was a steady increase in the incidence of VTE as more numbers of cases were combined; 1 case alone (0.04%), 2 cases (0.16%), 3 cases (0.26%), 4 cases (0.53%). When different combinations of procedures was examined, combined body/breast procedures (37/ 13,447 procedures, 0.28%) had the highest VTE incidence (Table 3, Figure 4).

6 6 342 Aesthetic Aesthetic SurgerySurgery JournalJournal 37(3) approximately 1% of all in-hospital patients.13 In the postsurgical patient, the period of highest risk for a fatal PE is within the first 3 to 7 postoperative days, with the estimated 28-day mortality for a first episode of VTE being 11%.5,20,21 The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), reported that between January 2001 and June 2006, there were 23 deaths among 1,141,418 outpatient aesthetic surgery procedures, 13 of which resulted from PE (57%). The procedures with the highest rate of postoperative mortality were abdominoplasty followed by facelift surgery in combination with other related procedures.22 In this study, the overall incidence of VTE in all patients undergoing aesthetic surgery, defined as confirmed DVT/ PE, was 0.10%. This is similar to previously published rates for outpatient surgeries and lower than that in Figure 3. Univariate analysis of (A) age, (B) BMI, (C) combined procedures, (D) number of procedures, (E) body procedures, and (F) gender as risk factors of VTE (*P <.05).

7 Winocour et al 343 Figure 4. Single vs combined procedures (*P <.05). reconstructive procedures, which have been around 0.3% to 2%. 11,14,23 The demographics of our cohort are very representative of cosmetic patients in the United States, who are mostly younger and healthier females. This population is different from the average reconstructive patient, who is on average more variable in their comorbidities and on average of older age. The rate of VTE in these different plastic surgery subspecialties have been previously examined and has been shown to be as high as 23% in burn patients. 9,24 Our prospective analysis, to the best of our knowledge, represents one of the largest in current literature to highlight single procedures as well as combined procedures in aesthetic surgery, and to examine a multitude of factors that may impact development of VTE. Much debate exists on specific risk factors for VTE in different patient populations. A large study by Tran et al analyzed 49,028 patients who underwent mastectomy surgery (NSQIP database), where 114 cases of VTE were identified Table 4. Risk Factors for Venous Thromboembolism: Multivariate Logistic Regression Relative Risk P Value 95% CI Body procedures * < Combined procedures 2.40 * < BMI 1.06 * < Age 1.02 * < Gender (female) Facility (hospital) Smoking Diabetes BMI, body mass index; CI, confidence interval. (0.23% incidence). 25 The only preoperative risk factor identified in this group was BMI 30 (RR 1.91), and significant intraoperative risk factors included placement of a venous catheter (RR 2.67), operative time greater than 3 hours (RR 4.36), and immediate breast reconstruction (RR 3.23). Postoperative admission to hospital (inpatient surgery) was associated with an increased risk (RR 3.75). Specific rates in the subspecialty of aesthetic surgery have varied significantly depending on the procedure performed, and a paucity of literature exists for specific risk factors for this patient population as they are generally healthier and more carefully selected for elective surgery. Traditionally, abdominoplasty and other body contouring procedures have been associated with the highest rates of VTE. Van Uchelen and Grazer and Goldwyn previously published rates of VTE in abdominoplasty of 1.4% and 2.0% respectively. 26,27 Higher rates have been published in more extensive body contouring procedures. 17,28,29 Significant incidence rates have been published in other procedures, including up to 1.1% in liposuction and in rhytidectomy of up to 0.49%. 20,23,30 Age Age has been proposed to affect a patient s thrombosis risk in many ways. Older patients may have increased morbidity from the presence of more illnesses and coagulation potential than younger patients. 20,31 An analysis of population studies in 2003 examined the epidemiology of VTE and revealed that the incidence of first-time VTE rises exponentially with age. A sharp increase was found after age 40, and then again after age 70 where the risk of first-time VTE (age 70-79) was 300 to 500 cases/100,000 persons compared with 30 cases/100,000 persons in those aged 25 to 35 years. 32 Anderson et al in their population based study looking at the VTE rate in the Worcester, Massachusetts, metropolitan area demonstrated an incidence rate increase of approximately 200 between the ages of 20 and 80 years. 33 The authors later demonstrated that the risk approximately doubled with each decade of life after the age of ,33 They observed the highest increase after the age of Cosmetic patients in our study were more likely to suffer a VTE if they were older than 40 years of age (0.13% vs 0.05%, P <.01) and advancing age was an independent risk factor on multivariate analysis. Although incidence rates of DVT/PE events have been shown to increase exponentially with age from the above mentioned populationbased studies, we did not see a trend of increasing complication rates. 31,33 We reported that 71.6% of confirmed VTE in our population were from individuals older than 40 years, similar to that of a comparable study of elective aesthetic plastic surgery procedures by Valente et al at 82.3%. 34

8 344 Aesthetic Surgery Journal 37(3) Gender Gender can also have an effect on the risk of VTE, most likely related to other factors such as the usage of oral contraceptive use (OCPs), hormone-replacement therapy (HRT), and pregnancy in women. 35 Increased estrogen levels have been shown to lower levels of protein S, which contribute to thrombosis. 5 Further, estrogen can activate the endogenous fibrinolytic system, perhaps leading to pro-coagulant effects and resistance to anticoagulants like protein C. 35,36 During pregnancy, a combination of reduced blood flow and production of clotting factors (VIII, X, fibrinogen) can lead to an increased risk of VTE. 37 Women taking an OCP with both estrogen and progestin, which according to the CDC is the case in 17.1% of all women in the United States, have been shown to have a 2- to 3-fold increased risk of VTE. 5,38 While HRT has a lower biological potency than OCPs, with estrogen levels 80% to 85% lower, it still entails an increased VTE rate of 2- to 4-fold. 31 This is also seen in men taking estrogen therapy for prostate cancer. 31 One would expect that based on the higher rate of estrogen use in women, that this would clearly pose an increased VTE risk; however, Anderson et al demonstrated in their population based study a significantly higher rate of VTE in men compared to women for all age groups. 33 This was also the case in Wes et al s analysis of body contouring patients. 39 The explanation for this finding is unclear. Our study showed that women were 2.1 times as likely to have a VTE, but the difference was not statistically significant. Most previous studies have looked at direct risk factors such as hormone therapy use, history of stillborn infant, recurrent spontaneous abortions, premature birth with toxemia, or growth-restricted infant rather than gender as a risk factor for VTE. 18,34 Unfortunately, these specific risk factors are not currently available in the CosmetAssure database and may represent confounding factors that are not accounted for in our analysis. Obesity According to the CDC, an adult who has a BMI 25 to 29.9 is considered overweight, 30 considered obese, and 40 considered morbidly obese. Morbid obesity has been shown previously to increase venous stasis and decrease venous return through altered lower extremity venous hemodynamics and increased intra-abdominal pressure. 8,14,34,40 This is especially the case in the postoperative state. 5 Stein et al investigated during a 21-year period ( ) the relative risk of VTE in obese and non-obese patients and found a relative risk of DVT of 2.4 and PE of 2.21 in obese patients. 41 They also reported that obesity had the greatest impact on the risk of VTE in patients aged less than 40 years, as well as on females more than males. 41 This was corroborated by a case control study in the Netherlands, which looked at 474 consecutive outpatients being treated for a first episode of DVT ( ). Controlling for age and sex, these authors demonstrated a greater than 2-fold increase in the risk of DVT (RR 1.5 to 3.4) in patients with a BMI Further, Tran and colleagues analysis of 49,028 mastectomy patients demonstrated BMI to be the sole preoperative significant risk factor for VTE (12 preoperative risk factors analyzed). Patients with a BMI 30 had a relative risk of 1.91 for the development of a VTE. 25 This was also investigated in autologous breast reconstructive surgery (Nationwide Inpatient Sample database) that demonstrated an odds ratio of 3.7 in obese patients. 3 These studies are contrasted by Heit et al s published population-based case-control study in Olmsted County, Minnesota ( ) that failed to demonstrate BMI as an independent risk factor for VTE. 43 Printen et al specifically looked at the subgroup of morbidly obese patients (BMI 40) in postoperative surgical gastric bypass patients and demonstrated no increased risk compared to other BMI groups. 44 In our analysis, we observed a trend of a statistically significant increase in VTE incidence in overweight (0.14%), obese (0.24%), and morbidly obese (0.22%) compared to patients with BMI of 18.5 to 24.9 (0.04%). This association was conformed on multivariate analysis (Table 4). As we have previously reported, both overweight (BMI ) and obesity (BMI 30) are independent predictors of VTE with relative risks of 1.67 (95% CI ) and 2.56 (95% CI ) respectively. 45 Smoking Smoking is a well-established risk factor for atherosclerotic disease and increases the overall risk of complications in plastic surgery patients, especially in terms of wound healing. However, the role of smoking as an independent risk factor for VTE remains controversial. Smoking and nicotine can lead to increased production and activation of fibrinogen, which could alter the hemostatic system. The Copenhagen Heart Study looking at risk factors for VTE demonstrated a dose-response relationship with the amount smoking (equating 1 g tobacco to 1 cigarette); 1 to 14 g (Hazard Ratio [HR] 1.29), 15 to 24 g (HR 1.42), 25 g (HR 1.52). 46 Risk was found to not be increased in ex-smokers. One of the largest meta-analysis published, included studies from 1966 to 2013, demonstrated a slightly increased risk of VTE, with an overall combined relative risk of 1.23 for current smokers, and 1.17 for ever smokers. 46 They found that a patient s risk of VTE increased by 6.1% for every additional ten pack-year history of smoking in a dose-response relationship. 37 However, this analysis selected studies that were representative of the

9 Winocour et al 345 general population, which might differ from the surgical patient. Tran et al analyzed 49,028 mastectomy patients and did not find preoperative smoking to be a risk factor for VTE, although it trended towards significance (P =.06). 25 This is in contrast to Valente et al s prospective observational study of elective aesthetic plastic surgery procedures, which demonstrated an odds ratio of with nonsmokers. 34 Smokers only made up 8.2% of our study population, probably due to careful selection by plastic surgeons, and did not represent an independent risk factor for VTE. Diabetes According to the CDC, in the United States, 9.3% of the population is currently diagnosed with diabetes mellitus; however, 27.8% of all people with diabetes are undiagnosed Hyperglycemia associated with diabetes damages the microvasculature and impairs phagocytosis, leading to increased wound infections, prolonged healing, and microvascular occlusive disease (retinopathy, nephropathy, neuropathy). This also leads to arterial vascular disease, which is the mechanism believed to lead to an increased risk of VTE. 40 However, many previous published studies are confounded by other medical illnesses in their assessment of diabetes role as an independent risk factor. 43 Heit et al utilized the population-based resources of the Rochester Epidemiology Project (Olmsted County, MN) to analyze the association between diabetes and VTE. On univariate analysis, they found a positive association between diabetes diagnosed clinically (OR 1.32) as well as based on strict glucose criteria (OR 1.47). 47 Nevertheless, this association was attenuated when BMI was controlled for, and finally not present on multivariate analysis when the authors controlled for nursing home confinement or hospitalization for acute medical illness. 43 Holst et al conducted a population-based study using the Copenhagen City Heart Study database to look at risk factors for VTE. They found an association between VTE and diabetes only in women (HR 1.63). 46 In our study, we did not observe an increased relative risk of VTE for patients with diabetes, although only 1.8% of our cosmetic surgery population reported being diabetic. Facility In the United States, there has been a significant transition of the facility where procedures are performed, from 90% in hospital settings in 1979 to currently 80% in outpatient facilities. 50 In order to optimize patient safety, the ASPS Board of Directors convened the Task Force on Patient Safety in Office-based Surgical Facilities in Since that time, numerous studies have been published demonstrating the safety of Accredited Outpatient Plastic Surgery facilities, and the ASPS and ASAPS have mandated all outpatient cosmetic and reconstructive surgery to be performed in an accredited and/or licensed facility A large study reviewing the Internet-Based Quality Improvement and Peer Review Program developed by the AAAASF demonstrated 31 VTE events (14 DVT, 17 PE) from 411,670 procedures analyzed during a 2-year period ( ). This constituted a PE rate of 0.004%, and DVT rate of 0.003%. 54 Byrd et al published the experience from the Dallas Day Surgical Center and reported 2 PEs (0.04%) occurring from their 6-year experience ( ). 52 There is a consensus that these facilities are safe for patients, as long as the surgeon accurately identifies thromboembolic risk in a patient who is undergoing an appropriate ambulatory or office-based surgical procedure. 55 In this study, we did not observe any significant differences in VTE rates between outpatient facilities (OBSS/ASC) and hospitals where the surgery was performed. Procedure Type Body contouring procedures have been proven to be associated with the highest rate of thromboembolic disease. 17 Specifically, abdominoplasty alone and combined with another surgical procedure is believed to be the cosmetic procedure most associated with death from PE. 22,54 During these procedures, intra-abdominal pressure increases from internal plication, fascial tightening, and abdominal binder tightening; this, in addition to decreased ambulation from pain, and increased anesthetic duration is believed to predispose the patient to venous thrombosis. 4 These operations are becoming more frequent, especially with the increased demand for weight loss procedures and the resulting body skin laxity. Current guidelines by the ASPS on VTE risk, are based on the guidelines by the American College of Chest Physicians and do not include data from plastic surgery procedures. 6,17 This stratifies patients according to the Caprini risk assessment module that is based on specific risk factors; however, it is not well known what elements of the score are most impactful, especially in the subset of healthier cosmetic surgical patients. It equally fails to include body region/specific procedure as well in its assessment of patients, which has been shown previously to be an important consideration in cosmetic procedures. Hatef et al acknowledged this increased risk in body lift/circumferential abdominoplasty and abdominoplasty with intraabdominal procedures and proposed the addition of these procedures as a specific risk factor to emphasize the VTE risk and prophylaxis need. 17 Wes et al specifically looked at VTE in body contouring procedures through the NSQIP database and found an OR of 2.75 specifically in trunk contouring, as well as an increased risk in BMI equal or greater than 30 kg/m 2, patients requiring inpatient admission and in age

10 346 Aesthetic Surgery Journal 37(3) equal or greater than 45 years. 39 Equally, this study included both plastic surgeons and general surgeons and demonstrated an increased risk of VTE in general surgeons performing body contouring procedures. In our study, 93.1% of all VTEs recorded were associated with body procedures. Thigh lift, lower body lift, and abdominoplasty had the highest incidences of VTE per procedure. Body procedures had a RR of 12.9, the highest of any independent risk factor. We report a 0.23% rate of VTE for abdominoplasty, which falls into the low end of the current published numbers for VTE incidence (0.067%-1.1%). 10,22,26,56,57 The incidence of VTE in other individual procedures correlated with previously published rates. In this study, liposuction had a VTE rate of 0.06%, while other studies have reported rates of 0.02% to %. 13,58 Our analysis has shown a 0.03% VTE incidence for breast reduction and 0.01% for augmentation which is consistent with the existing literature. 3,16,26,57 We also reported a 0.03% VTE incidence for rhytidectomies, which was consistent with other studies with rates ranging from 0.01% to 0.35%. 13,23,59 Combined Procedures The concept of combined surgery has received much publicity with the presumed advantages of a single recovery period and reduced surgical costs. This has led to an increase in the practice of combined procedures in the last decade, driven by increased patient demand, and advances in surgical techniques, anesthesia, pharmacology, and postoperative care. 25 Equally, cosmetic procedures are often being combined with non-cosmetic procedures in order to have one overall recovery period, most commonly body contouring procedures with elective gynecologic surgery In elective cosmetic surgery, patient safety and minimizing morbidity remain of paramount importance. This study included 41,886 cosmetic combined procedures, which made up 32.5% of all procedures. Our analysis has shown that 82 out of the 116 VTEs occurred in patients who underwent combined procedures (Figure 2). Combined procedures had an overall rate of VTE of 0.20%, which was significantly higher (P <.01) when compared to 0.04% for single procedures (Figure 3). Previous published VTE rates of combined procedures have ranged from 0.06% to 9.3%, with an especially increased risk if the combined procedure included an abdominoplasty or a body contouring procedure. 9,17,39 Early studies have shown that combining abdominoplasty with intra-abdominal and gynecology procedures have increase risks, including higher rates of blood transfusion and a significantly higher rate of VTE This study found that the risk of VTE significantly increased in a step-wise manner with the number of procedures: 1 (0.04%), 2 (0.16%), 3 (0.26%), and 4 (0.53%). This was especially the case if the combined combination included a body procedure (Figure 4). This was equally demonstrated in Wes et al s NSQIP analysis, which demonstrated that for body contouring procedures there was an increased risk of VTE for 2 regions contoured (OR 1.64) and for more than 2 regions contoured (OR 4.01). 39 Previous studies have equally demonstrated the effect of prolonged anesthesia/surgical time on VTE, especially in combined procedures, however, this is not available in the CosmetAssure database. 23 The CosmetAssure database is a powerful registry that assesses the majority of major clinical outcomes following cosmetic surgery. In contrast to other retrospective single or multi-institutional databases, CosmetAssure prospectively collects information about the patient encounter and postoperative sequelae for cases across the United States. Given that all patients of a participating practice must enroll in the program, it is not possible to select only high-risk patients, which may artificially inflate complication rates. Experience and training are accounted for, as only board certified plastic surgeons operating at accredited facilities are included. This multi-center database encompasses hospitals, ASCs, and Accredited OBSSs, making the results generalizable to a wide variety of practice models. The outcomes we have evaluated are objective and well defined. Since CosmetAssure offers significant incentive to a surgeon for reporting a complication, in form of payment of the claim, this database offers major advantage over databases that rely on voluntary self-report by potentially minimizing the under-reporting of complications. CosmetAssure, being a private insurance company, has a vested interest in maintaining an accurate database for actuarial and audit purposes. Moreover, participating practices are subject to random audits to ensure compliance. A cohort with such high degree of ascertainment of exposure and outcome data is necessary for precise determination of incidence of major complications and their risk factors. Previous queries from this database have been cross-validated with other registries such as TOPS (Tracking Operations and Outcomes for Plastic Surgeons) and the NSQIP database, which are retrospective designs. 57 Limitations The CosmetAssure database has some limitations despite its unique overall contribution to our understanding of aesthetic surgery complications. The database itself has only recently started registering outcomes past 30 days, which could result in underreporting final outcomes. The timing of postoperative VTE remains a debatable subject and varies greatly between types of surgeries and different surgical fields patient populations. While it has previously been published that VTE risk is highest in the first 2 weeks postoperatively and may remain elevated for up to 2 to 3 months postoperatively, other more recent studies have

11 Winocour et al 347 demonstrated that the risk is present for up to 12 months postoperatively. 2,5,21,64-66 These late VTE events would not be captured in the CosmetAssure database and may lead to underreporting of events. Universally, VTEs are underreported because a large number of them are silent and either do not become symptomatic or are not diagnosed as the cause of a death, which would not be captured by the database. Previous analyses by our group also suggest that CosmetAssure does not differentiate between the types of surgical techniques for a given procedure, which could have an effect on VTE risk. 45,67,68 As far as other factors that may contribute to the risk of VTE, no information is available in the database for American Society of Anesthesiologists (ASA) classification, anesthesia type, chemoprophylaxis and mechanical prophylaxis, intraoperative temperature and blood pressure management, intraoperative blood loss, or duration of surgery. In addition, there is no information about hormone therapy use, over the counter contraceptives, or other medications that could influence a patient s VTE risk. Although patients who elect to undergo cosmetic procedures are relatively healthy, there is no information on history of blood disorders, blood dyscrasias, or venous insufficiency that could contribute to a prothrombotic state. 34 Finally, even though management of VTE incurs significant costs, it is possible that the plastic surgeon may write it off or be compensated by patient s primary health insurance provider. Either of these scenarios, though very unlikely, may lead to under-reporting of major complications to CosmetAssure. CONCLUSION This review provides a comprehensive analysis of VTE rates in the cosmetic surgical population. As expected, the occurrence of VTE in cosmetic procedures is relatively low, with an overall incidence of 0.09%. 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