Preoperative Risk Factors and Complication Rates in Facelift: Analysis of 11,300 Patients

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1 Facial Surgery Preoperative Risk Factors and Complication Rates in Facelift: Analysis of 11,300 Patients Aesthetic Surgery Journal 2016, Vol 36(1) The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com DOI: /asj/sjv162 Varun Gupta, MD, MPH; Julian Winocour, MD; Hanyuan Shi, BA; R. Bruce Shack, MD; James C. Grotting, MD; and K. Kye Higdon, MD Abstract Background: Facelift (rhytidectomy) is a prominent technique for facial rejuvenation with performed in the United States in Current literature on facelift complications is inconclusive and derives from retrospective studies. Objectives: This study reports the incidence and risk factors of major complications following facelift in a large, prospective, multi-center database. It compares complications of facelifts done alone or in combination with other cosmetic surgical procedures. Methods: A prospective cohort of patients undergoing facelift between 2008 and 2013 was identified from the CosmetAssure database. Primary outcome was occurrence of major complications, defined as complications requiring emergency room (ER) visit, hospital admission, or reoperation within 30 days of the procedure. Univariate and multivariate analysis evaluated risk factors including age, gender, BMI, smoking, diabetes, combined procedures, and type of surgical facility. Results: Of the patients enrolled in CosmetAssure, (8.8%) underwent facelifts. Facelift cohort had more males (8.8%), diabetics (2.7%), elderly (mean age 59.2 years) and obese (38.5%) induviduals, but fewer smokers (4.8%). Combined procedures accounted for 57.4% of facelifts. Facelifts had a 1.8% complication rate, similar to the rate of 2% associated to other cosmetic surgeries. Hematoma (1.1%) and infection (0.3%) were most common. Combined procedures had up to 3.7% complication rate compared to 1.5% in facelifts alone. Male gender (relative risk 3.9) and type of facility (relative risk 2.6) were independent predictors of hematoma. Combined procedures (relative risk 3.5) and BMI 25 (relative risk 2.8) increased infection risk. Conclusions: Rhytidectomy is a very safe procedure in the hands of board-certified plastic surgeons. Hematoma and infection are the most common major complications. Male gender, BMI 25, and combined procedures are independent risk factors. Level of Evidence: 2 Accepted for publication July 23, 2015; online publish-ahead-of-print November 17, Risk Facial rejuvenation remains one of the most commonly requested aesthetic procedures. A prominent surgical technique used is facelift (rhytidectomy) and many consider it the standard for treating the structures of the aging face. 1 Despite the large variety of surgical techniques, it maintains the common goal of restoring age-related anatomical changes including descent of facial fat, volume loss, and cutaneous expansion which result in changes in the facial Drs Gupta and Winocour are Plastic Surgery Fellows, Mr Shi is a Medical Student, Dr Shack is a Professor and Chairman, and Dr Higdon is an Assistant Professor, Department of Plastic Surgery, Vanderbilt University, Nashville, TN, USA. Dr Grotting is a Clinical Professor, Division of Plastic Surgery, University of Alabama at Birmingham, Birmingham, AL, USA; and CME/MOC Section Editor for Aesthetic Surgery Journal. Corresponding Author: Dr Varun Gupta, Department of Plastic Surgery, D-4207 Medical Center North, Nashville, TN , USA. varun.gupta@vanderbilt.edu Presented at: The Southeastern Society of Plastic and Reconstructive Surgeons annual meeting in Paradise Island, Bahamas in June 2014; and the American Society for Aesthetic Plastic Surgery s annual meeting in Montreal, Québec, Canada in May 2015.

2 2 Aesthetic Surgery Journal 36(1) shape. 2 According to the American Society of Aesthetic Plastic Surgeons (ASAPS) Cosmetic National Database, facelifts were performed in 2014, a 27.7% increase since It is the most common aesthetic surgical procedure performed in patients above age There are many medical considerations when performing a facelift, which include perioperative and anesthetic considerations in addition to surgical technique. 2,4 Aplethoraof accepted techniques exist for facelift surgery, as well as significant individual surgeon variation, leading to inconclusive data on outcomes. 1,4-6 Moreover, facelifts are often combined with other procedures to serve as powerful refinement tools for patients. Although the overall incidence of major complications is low, any complication can have a potentially devastating cosmetic outcome and pose a significant financial burden on the patient and the surgeon. Currently there exists a paucity of studies available detailing complication rates, especially for combined procedures, from large multi-institutional groups. 4 Many of the published studies are outdated or derive complication data from surveys of the American Society of Plastic Surgeons (ASPS) which suffer from response bias and are reliant on physician self-reporting. 5,7 Recognizing risk factors for major complications is crucial to ensuring patient safety. Failure of the medical team to inform patients of procedure risks and outcomes before surgery can lead to a dissatisfied patient. 8 The most common complications following facelift include hematoma, cutaneous slough or necrosis, seromas, wound dehiscence, hypertrophic scarring, nerve damage, alopecia, contour irregularities, and infection. 2,4,5,7,9-11 The most dangerous complications include hematoma (rates 1.0%-15%), infection (0.05%-0.18%), nerve injury (0.07%- 2.5%), skin slough (1.0%-1.85%), and systemic vascular complications like venous thromboembolism (VTE 0.1%). 7,9,12-15 A variety of risk factors including male gender, hypertension, diabetes, smoking, and body mass index (BMI) have been linked to many of these complications, with variable supporting evidence. 4,10,15,16 The objectives of this study are to report the incidence of major complications following facelift surgery using CosmetAssure (Birmingham, AL), a large, prospective, multicenter database; define procedures commonly combined with facelift; compare complication rates of facelifts done alone or in combination with other cosmetic surgical procedures; identify risk factors associated with significant complications; and to assess changes in facelift patient profile over a 5 year period. METHODS Study Population This prospective cohort study was approved by the Vanderbilt University Institutional Review Board (IRB # ). The study population comprised of a cohort of patients who enrolled into 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 CosmetAssure is an insurance program that covers cost of unexpected major complications from 24 covered cosmetic surgical procedures, which may not be reimbursed by the patient s primary insurer. CosmetAssure was introduced in 2003 and has been collecting data on patient risk factors since This insurance program covers all 50 states in the United States. It is available to American Board of Plastic Surgery (ABPS) - certified plastic surgeons and is endorsed by ASPS. The program is also available to ASPS candidates for membership who have passed the ABPS written examination. Every patient undergoing any covered procedure at participating practices is required to enroll in the program. Patients are entered in the database prior to undergoing the operation or occurrence of complication, thus making it a prospective cohort. Surgeon-reported major complications, filed as a claim, are recorded in the database. 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. Major complication is defined as that occurring within 30 days of the operation that requires hospital admission, emergency room visit, or a reoperation. This excludes complications that can be managed in clinic, such as minor wound infections and transient nerve paralysis, as they are not eligible for insurance claim. The covered major complications include hematoma, infection, pulmonary dysfunction, cardiac complication, wound-related problems, nerve injury, suspected or confirmed VTE, myocardial infarction, and fluid overload. The database lists all procedures performed on the patient, making it possible to study specific individual procedures as well as procedure combinations (i.e. patients undergoing multiple procedures under the same anesthetic.). The database also records demographic and comorbidity data including age, gender, BMI, smoking, diabetes, and type of surgical facility (accredited surgical centers ASC, hospitals and office-based surgical suites OBSS). Exposure In this study cohort, exposure was defined as the type of cosmetic surgical procedure(s) performed. Facelift was studied as the primary exposure, whether performed alone or in combination with other face procedures (blepharoplasty,

3 Gupta et al 3 brow lift, cheek implant, chin augmentation, facial resurfacing, hair replacement, otoplasty, rhinoplasty), body procedures (abdominoplasty, brachioplasty, buttock lift, calf implant, labioplasty, liposuction, lower body lift, thigh lift, upper body lift) and/or breast procedures (augmentation, reduction, revisional breast implant procedures, mastopexy, male breast surgery). Outcome Primary outcome was occurrence of any major complication(s) (as defined above) within 30 days of the procedure. Secondary outcome studied was the type of complication. Risk Factors The potential risk factors evaluated included age, gender, BMI, smoking, diabetes, type of facility, and combined 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 datasets; date of birth, date of surgery, and gender. This identifier was then used to match the claims dataset to the restructured enrollment dataset. Of the 2506 patients in the claims dataset, 20 did not match to the enrollment data using the identifier. These cases were manually matched to 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. Patient characteristics, risk factors, and complication rates between patients undergoing different procedure combinations were compared by two-tailed Student s t-test, Fisher exact test, or by Pearson chi-square tests. For purpose of univariate analysis, age and BMI were recoded as ordinal variables with clinically appropriate categories. Standard logistic regression analysis was performed to identify the independent risk factors for postoperative complications. For the purpose of logistic regression analysis, age and BMI were recoded to a dichotomous scale (Age > 70 Years/ 70 Years, BMI 25/ < 25). Outcomes were reported as 30-day incidence rates after the surgery. Unless otherwise noted, probability of type I error of less than 5% (P <.05) was used to determine statistical significance. All analyses were performed using SPSS 17.0 statistical software (SPSS Inc., Chicago, IL). RESULTS Between May 2008 and May 2013, a total of cosmetic surgery procedures were performed on patients enrolled into the CosmetAssure program. Overall, mean age was 40.9 ± 13.9 years, BMI 24.3 ± 4.4 kg/m 2, and majority of patients were women (93.5%). Major complication occurred in 2506 patients (1.9% complication rate). Demographics and Complications of Facelift Group A total of facelifts were performed, representing 6.14% of all cosmetic procedures. Of these, 4809 (42.6%) were performed as a solitary procedure and 6491 (57.4%) with additional procedures (Figure 1). The facelift Figure 1. Study design. Figure 2. Facelift complications.

4 4 Aesthetic Surgery Journal 36(1) cohort consisted of (91.2%) females and 997 (8.8%) males with a mean age of ± 9.4 years (Range 35 years - 90 years). The facelift patients had greater proportion of older (age > 70 years) patients (7.8% vs 0.8%, P <.01), males (8.8% vs 6.3%, P <.01), and diabetics (2.7% vs 1.8%, P <.01) but fewer smokers (4.8% vs 8.6%, P <.01). Similar to other procedures, facelifts were most commonly performed in ASCs (52.8%), followed by hospitals (24.8%). More facelift were performed in OBSS compared to other cosmetic procedures (22.4% vs 15.3%) (Table 1). A total of 205 major complications occurred in the facelift group (1.8% complication rate). Local complications were more common, occurring in 168 (1.5%) patients. Systemic complications occurred in 37 (0.3%) patients. Hematoma was the most common complication, representing 62% of all complications, at a rate of 1.1%. This was followed by infection in 0.3% patients, representing 15.1% of all complications. Incidence of other major complications like pulmonary dysfunction, cardiac, wound related complications, and suspected or confirmed VTE were <0.1% each (Figure 2). Risk Factors for Any Major Complication On univariate analysis, male gender, procedures performed in hospitals and ASCs, combined procedures and BMI 25 were associated with increased complications. Male patients had more than double risk of having a major complication (3.6% vs 1.6%, P <.01). Overweight patients Table 1. Characteristics of Facelift Patients Compared to Other Cosmetic Surgical Procedures (BMI 25) had a complication rate of 2.1% compared with 1.6% in normal weight patients (P =.04). Procedures performed in a hospital or ASC had a higher complication rate than OBSS (2.0% vs 1.0%, P <.01). An increased complication rate was also seen with combined procedures (2.0% vs 1.5%, P =.03). Smoking and Diabetes were not found to be significant risk factors. On multivariate logistic regression, independent risk factors (P <.05) included male gender (relative risk RR 2.1), multiple procedures (RR 1.4) and the procedure being performed in a hospital or ASC (RR 1.9) (Table 2). Risk Factors for Hematoma and Infection We performed an additional analysis to elucidate risk factors for the two most common complications: hematoma and infection. On univariate analysis, hematomas occurred in 3.4% of males undergoing facelifts, compared to 0.9% females (P <.01) (Figure 3A). Facelifts performed in OBSS had a lower incidence of hematoma (0.5%) compared to hospitals (1.2%), or ASCs (1.4%) (P <.05) (Figure 3B). On multivariate analysis, male gender (RR 3.86) and type of facility (Hospital-ASC vs OBSS) (RR 2.64) were independent predictors of hematoma (Table 3). Patients undergoing three or more additional procedures with facelift had a 0.86% incidence of major infection compared to 0.12% in facelifts done alone (P <.01)(Figure 4A). Obese patients (BMI 30) developed infection in 0.62% cases compared to 0.17% in their normal weight counterparts (BMI < 25) (P =.01) (Figure 4B). On multivariate Table 2. Multivariate Logistic Regression Analysis of All Complications Facelifts (n = 11,300) All Other Cosmetic Procedures (n = 117,707) P value Relative Risk 95% CI P value Gender (Male) <.01 Gender (Male) 997 (8.8%) 7360 (6.3%) <.01 Smoking 544 (4.8%) (8.6%) <.01 Diabetes 303 (2.7%) 2065 (1.8%) <.01 Type of facility <.01 Type of facility (ASC-Hospital) <.01 Combined procedure Accredited surgical center 5972 (52.8%) (57.8%) Diabetes Hospital 2802 (24.8%) (26.9%) Office-based surgical suite 2526 (22.4%) (15.3%) Complication 205 (1.8%) 2301 (2.0%).32 Age (Mean ± SD) ± ± 13.0 <.01 BMI (38.5%) (36.0%) <.01 BMI, body mass index. Age > 70 Years BMI Smoking ASC, ambulatory surgery center; BMI, body mass index; CI, confidence interval.

5 Gupta et al 5 Figure 3. (A) Univariate Analysis of Gender as a Risk Factor of Hematoma (n = 128). (B) Univariate analysis of type of facility as a risk factor of hematoma (n = 128). ASC, ambulatory surgery center; OBSS, office based surgery suite. Table 3. Multivariate Logistic Regression Analysis of Hematoma (n = 128) Relative Risk analysis, combined procedures (RR 3.52) and BMI 25 (RR 2.78) were independent predictors of infection (Table 4). Combined Procedures 95% CI P value Gender (Male) <.01 Type of facility (ASC-Hospital) <.01 Diabetes Age > 70 years Combined procedure BMI Smoking ASC, ambulatory surgery center; BMI, body mass index; CI, confidence interval. Facelift was performed as a combined procedure in 57.4% (6491) cases. When compared to patients having only a facelift, the cohort who underwent combined procedures had fewer older (age > 70 years) patients (5.6% vs 10.6%, P <.01) and males (7.5% vs 10.6%, P <.01) but more smokers (5.4% vs 4.0%, P <.01) (Figure 5). Procedures most commonly combined with facelift were blepharoplasty in 40.5% cases, brow lift in 18.9% and liposuction in 9.7% (Figure 6). 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. Thus, for the purpose of this study, we categorized all cosmetic procedures into three groups based on body region: face, body, and breast. Incidence of complications increased from 1.5% in facelifts done alone compared to 2.5% when facelifts were combined with procedures on two or more body regions (Figure 7). Table 5 depicts the frequency and complication rates of common procedure combinations. Facelift Patient Profile Over 5 Years Between 2008 and 2013, the proportion of patients undergoing facelifts increased from 7.4% to 9.7%. At the same time, facelifts performed as combined procedures steadily decreased from 64.3% to 55.2% (P <.01). The utilization of hospitals decreased from 32.4% to 24% with a corresponding increase in the use of ASCs (Figures 8 and 9). DISCUSSION Early in its evolution, the classic facelift involved mostly an undermining with simple skin excision approach, a refinement of which is still performed today (subcutaneous facelift). This is consistent with the term rhytidectomy, translated roughly to wrinkle excision (Greek ritis,wrinkle, and ektomi, excision). It was initially associated with a complication rate as high as 16.5% for major events like large hematomas, skin loss, hair loss, and nerve injury. 17 Understanding of risk factors and evolution of safer operative techniques have brought complication rates down to the single digits, with hematomas as the leading postoperative complication. 18 A large evolution in facelift techniques came with Skoog in 1974, and his concept of raising facial

6 6 Aesthetic Surgery Journal 36(1) Figure 4. (A) Univariate analysis of number of procedures as a risk factor of infection (n = 34). (B) Univariate analysis of body mass index as a risk factor of infection (n = 34). Table 4. Multivariate Logistic Regression Analysis of Infection (n = 34) Relative Risk 95% CI P value Combined procedure <.01 BMI <.01 Smoking Age > 70 years Diabetes Gender (Male) Type of facility (ASC-Hospital) ASC, ambulatory surgery center; BMI, body mass index; CI, confidence interval. Figure 5. Characteristics of patients undergoing facelifts alone or as combined procedures. BMI, body mass index; OBSS, office based surgery suite. Body Regions: Breast (augmentation, mastopexy, reduction, gynecomastia); Body (buttock lift, calf implant, labiaplasty, lower body lift, thigh lift, brachiplasty, upper body lift); Face (blepharoplasty, brow lift, cheek implant, chin augmentation, facial resurfacing, hair replacement, otoplasty, rhinoplasty). Numbers in red indicate statistical significance, P value <.05. flaps with a stretch resistant layer, Superficial Muscular Aponeurotic System (SMAS), to provide more longevity to the procedure. 1 In this study, we recorded 205 major complications for an overall major complication rate of 1.8%. Previous literature has demonstrated complication rates in the range of 0.1%-9.0%, even with secondary facelifts. 1,5,9,10,14,15,19-22 This database seems to be at the lower end of most available data, which is possibly related to the standardization of the practitioners in this database ( plastic surgeons who are certified or are candidates for certification by the ABPS) as well as an inclusion of only major complications. The distribution of complications is consistent with that of peer studies.

7 Gupta et al 7 Figure 6. Procedures frequently combined with facelift. Table 5. Complication Rate in Specific Combined Facelift Procedures Procedure Combination Frequency Percent Complication Rate (%) Facelift only Breast Body Other face procedures Body + Other face procedures Breast + Body Breast + Other face procedures + Breast + Body + Other face procedures Rhytidectomy Complications Body Regions: Breast (augmentation, mastopexy, reduction, gynecomastia); Body (buttock lift, calf implant, labiaplasty, lower body lift, thigh lift, brachiplasty, upper body lift); Other Face Procedures (blepharoplasty, brow lift, cheek implant, chin augmentation, facial resurfacing, hair replacement, otoplasty, rhinoplasty). In the literature, hematomas are consistently seen as the most common complication of facial rejuvenation surgery. 2,4,5,21 Hematomas usually arise within the first 24 hours postoperatively and can have significant consequences including endangering the vascularity of the skin flaps, delaying postoperative recovery, or compromising respiration. 1,9,21 Previous studies have speculated possible causation with factors including elevated BMI, hypertension, perioperative nausea/vomiting, tumescence with epinephrine, heparin prophylaxis, and possible protective effects with fibrin sealants. 4,21,23-26 Studies have also suggested a hematoma rate related to the facelift technique; with a decreased hematoma rate with limited incision techniques. 4 Figure 7. Complication rate in facelifts performed alone or as combined procedures. Body Regions: Breast (augmentation, mastopexy, reduction, gynecomastia); Body (buttock lift, calf implant, labiaplasty, lower body lift, thigh lift, brachiplasty, upper body lift); Face (blepharoplasty, brow lift, cheek implant, chin augmentation, facial resurfacing, hair replacement, otoplasty, rhinoplasty). Numbers in red indicate statistical significance, P value <.05. The reported incidences have ranged previously from 0%-9%, however, some of these studies do not differentiate between minor nonoperative hematomas and larger, or so called expanding, hematomas that can cause significant problems and require prompt surgical evacuation. 1,4,9,15,21,27,28 The largest complication survey to date (570 respondents, facelifts) suggested an operative hematoma rate of 1.3% in females and 4.4% in males. 5 We observed a 1.12% incidence of major hematoma (128 hematomas identified), which is lower than in most of the published literature. However, our study represents only those hematomas requiring ER visit, admission or re-exploration in the operating room. We found a predominance of hematomas in males with a RR of 3.86 compared to females. In 1977, Baker et al looked at facelift complications in males and found an incidence of hematoma of 8.7%. 16 More recently, Abboushi et al reported a significantly higher rate of hematoma in males (11.7%) compared to females (3.9%). 14 It is hypothesized that this gender gap resulting in increased hematoma rates in males is attributed to a hormonal factors, facial follicle differences, and the thicker, more vascular, facial flaps that are prominent in males. 16 The type of facility was also found to be a significant risk factor with higher hematoma rate in procedures performed in a hospital or ASC compared to OBSS. We hypothesize that this difference is likely due to plastic surgeons electing to operate on high risk patients at higher acuity facilities, such as hospital or ASC. However, in the absence of data on other potential risk factors such as American Society of Anesthesiologists physical status classification (ASA class) and cardio-pulmonary

8 8 Aesthetic Surgery Journal 36(1) Figure 8. Facelift patient profile, comorbidities, it is not feasible to delineate the confounding effect of surgical facility on complications. Grover et al investigated risk factors for hematoma in their series of 1078 consecutive facelifts. Facelift technique or cardio-pulmonary disease did not increase hematoma risk. They identified significant factors as smoking, aspirin or nonsteroidal antiinflammatory intake, male gender, preoperative systolic hypertension and, most significantly, performing an anterior corset platysmaplasty. 15 Smoking, age, and diabetes were not found to be significant risk factors in our study. Infection was the second most common major complication seen in this study, occurring in 0.3% facelifts. We found only combined procedures and high BMI to be risk factors for developing major infection. In the literature, a post-facelift infection, most commonly caused by Staphylococcus aureus, remains a rare entity. 2 This is believed to be due largely to the robust vascularity of the face. Pitanguy et al reported in their series of 8788 facelifts over 52 years an infection rate of 0.05%. 10 Leroy et al reported 11 procedures complicated by postoperative infection out of 6166 consecutive facelifts performed by 35 surgeons (infection rate 0.18%). 13 Systemic complications, most notably VTE, remains one of the most feared complications post aesthetic surgery with a paucity of published literature. A study by Reinisch et al in 2001 randomly surveyed one-third of ASAPS members (342, response rate of 80%) and reported deep venous thrombosis (DVT) in 0.35% and pulmonary embolism (PE) in 0.14% patients, for a total VTE rate of 0.49%. 29 This study also reported that 83.7% of the patients underwent general anesthesia and only 39% of respondents used VTE measures regularly. Abboushi et al, looking at a single center s series of VTE in facelifts done over 7 years, identified two incidences of imaging confirmed VTE in 630 patients (0.3% incidence). 14 In our study, confirmed VTE (either DVT or PE) occurred in only 4 patients (<0.1%). Unfortunately, the CosmetAssure database does not capture procedure details such as the type of anesthesia, surgery duration, and the use Figure 9. Facelift patient profile, ASC, ambulatory surgery center; BMI, body mass index. *Statistically significant, P <.05. of VTE prophylaxis, which could allow us to better evaluate these patients iatrogenic risk. Risk Factors Gender Many studies have previously identified gender as a risk factor in facelift, especially for development of postoperative hematoma ,28 In the current study, although males only constituted 8.8% of the sample, they had more complications (3.6% vs 1.6%, P <.01). Abboushi et al have previously looked at complications in facelift between males and females, and while complications were observed in 11.7% males compared to 5.5% females, this did not reach statistical significance (P =.07). 14 As with previous studies that have demonstrated a steady increase in the proportion of males undergoing facelift surgery (as high as 18.6%), 10,30 our study demonstrates an increase in male patients from 7.4% to 9.7% over the 5-year period. This is also consistent with the ASAPS Cosmetic National Database, which reports that males constituted 11.9% of all facelifts patients in Body Mass Index (BMI) BMI has been demonstrated to be a significant risk factor for complications in plastic surgery as well as other surgical specialties. 4,14,31 Increased BMI, and especially obesity, not only places the patient at greater risk for developing comorbidities (most notably diabetes, hypertension, and coronary artery disease), but also increases surgical morbidity and mortality as a whole. 31,32 Abboushi et al reported that the complication rate in patients with a BMI > 25 was 9.5%, compared to 4.7% in normal weight patients undergoing a facelift. They also found an increased risk of hematoma in patients with a BMI > The average BMI was 23.2, with the majority of patients (71.1%) having a BMI exceeding Our studies sample differs from this previous study with only a minority of our patients (38.5%)

9 Gupta et al 9 having a BMI 25, as opposed to 71.1% in that study. We report BMI 25 as a significant risk factor for infection with a relative risk of 2.78 (Table 4). However, BMI does not appear to be an independent risk factor for hematoma in our study. Type of Facility This study demonstrated that the type of facility where the facelift was performed is an independent predictor of complications, especially hematoma. Facelifts performed in an ASC or hospital had a RR of 1.91 for overall complications (Table 2) and 2.64 for hematoma (Table 3). These results are likely a representation of appropriate patient selection by plastic surgeons who are certified or are candidates for certification by the ABPS, where patients that are deemed higher risk undergo the procedure in more acute settings, including ASC or hospitals. We also observed that as the number of procedures combined with a facelift increased, the percentage of such cases performed in office-based surgical suites steadily decreased and instead took place in ASC or hospital settings (Figure 5). Outpatient plastic surgery in general has been shown to be safe with complication rates between 0.33% to 0.7%. 33 Currently, the safety protocols of office-based facilities are based on hospital-based ambulatory settings, overseen by the American Association for Accreditation of Ambulatory Surgery Facilities. 34 Extensive reviews of accredited outpatient plastic surgery facilities have demonstrated the proven safety of these facilities for appropriately selected patients by board certified plastic surgeons. 34,35 This study adds to this evidence with a complication rate of 1.0% in officebased surgical suites, 2.0% in accredited surgical centers, and 2.1% in hospitals. Combined Procedures In this study, the majority of facelifts (57.4%) were performed in combination with other aesthetic surgery procedures. The procedures they were most often combined with facelift were blepharoplasty, brow lift, and liposuction. Combined procedures were found to be a significant risk factor for overall complications with a RR 1.44, as well as an independent risk factor for postoperative infection (RR 3.52). The overall major complication rate increased from 1.5% with isolated facelift to 2.0% with one additional procedure on one body region and 2.5% with additional procedures on 2 body regions. When facelift was combined with another face, breast and body procedure the complication rate rose up to 3.7%. While the increase in complication rate in combined procedures is less than the sum of the complication rate of each procedure done separately, it still requires careful consideration, especially as this represents major complications following elective, non-medically necessary surgery. The patient demographic most likely to undergo combined procedures comprised of younger patients, females, smokers, and overweight patients. Pitanguy et al, in their retrospective study of 8788 cases, described a distinct increase in the concomitant use of liposuction from and with a rise from 34.4% to 92.9% of cases. 10 Abboushi et al described a lower rate of combined procedures with 76.4% being performed in isolation and 23.6% being performed in combination with another procedure (either face, body, breast, or other). Their most common concurrent procedure was liposuction at 5.5%. 14 A trend towards increased complications in combined procedures was seen that was believed to be in part related to the increased anesthetic time (increased on average 0.7 hours in combined cases). 14 Smoking Smoking continues to be a concerning factor for physicians to consider as a preoperative risk for facelift. Smoking has been looked at in numerous other studies to determine its effect on cosmetic outcomes and it has traditionally been associated with wound healing problems and tissue loss following a spectrum of cosmetic surgery procedures. Preoperative smoking cessation recommendations are in place for facelifts and other cosmetic procedures, but there are no established guidelines. Many surgeons are conflicted in their decisions to perform facelift on smokers. In an interdisciplinary survey, 56% of plastic surgeons replied that they would not perform facelift on current smokers and 35% would modify the surgery. 36 Cigarette smoking has been shown to increase the risk of suffering skin slough up to times. 37 Theories revolve around nicotine s effect of decreasing cutaneous blood flow through vasoconstrictive and hypoxic effects, but no conclusive pathophysiology has been defined. 38 Grover et al demonstrated, in their series of 1078 facelifts, a significant association of smoking with postoperative hematoma. 15 Abboushi et al described a prevalence of smoking of 4.9% in their series, which was comparable to 4.8% prevalence in our study. 14 As expected, this was significantly lower than 8.6% prevalence among patients undergoing other cosmetic procedures (Table 1), as well as 18.1% among US adults as reported by the Centers for Disease Control and Prevention. 39 This study did not find smoking to be a significant risk factor for major complications (2.0% vs 1.8%, P =.4). This likely reflects the due caution exerted by the board certified plastic surgeons when deciding to operate on patients who smoke. In addition, many of the complications attributed to smoking in previous studies have been related to wound healing and infections, the majority of which would not be captured in the CosmetAssure database. Another limitation of the CosmetAssure database is its inability to differentiate between current and former smokers. It also does not register whether the smoking status is based on patient self-report or laboratory tests such as urine

10 10 Aesthetic Surgery Journal 36(1) cotinine screening. A study by Payne et al found that patients seeking elective plastic surgery provide inaccurate information on their smoking habits. They reported that 26% of self-reported nonsmokers tested positive for cotinine, and 50% of smokers under-reported the amount they smoke. 40 These limitations may lead to an underestimation of risk of major complications posed by smoking. However, our study provides risk estimates based on the real world scenarios where patients are not routinely tested for urine cotinine. Interestingly, we observed that compared to patients getting facelift alone, those who underwent combined procedures had more smokers (5.4% vs 4.0%, P <.01)(Figure5). A combination of factors may explain this finding. Firstly, smokers may be more likely to demand or need combined procedures than nonsmokers. Secondly, the prevalence of smoking in the population decreases with age. 39 Moreover, life expectancy for smokers is at least 10 years shorter than for nonsmokers. 41 Therefore, patients undergoing facelifts only, who are older, are less likely to smoke than patients undergoing combined procedures, who are younger and, thus, are more likely to smoke. Age Age as a risk factor for any kind of surgical procedure has been controversial, often complicated by physiological agingrelated changes and underlying disease states. 42 Facelift surgery often is performed in an older subset of patients than other cosmetic procedures. This study did not find a significant difference in complication rates for older patients, who were defined as above 70 years of age. Twenty-two (2.5%) of the 878 older patients developed complications compared to 183 (1.8%) of the patients 70 years of age (P =.11). Martén et al similarly demonstrated no difference in major (2.9% vs 2.0%, P =.65) or minor (5.9% vs 6.1%, P =.99) complication rates following facelift between elderly patients (defined as 65) and younger patients (defined as <65). This was despite having a higher ASA score in the elderly group. 19 Becker et al equally demonstrated the safety of facelifts in patients 75, with similar complication rates to younger patients when matched for ASA class. 43 This is in contrast to Abboushi et al s study, which demonstrated an increased rate of overall complications in patients aged > 55 on univariate analysis (7.3% vs 2.8%, P =.03), however, this did not maintain significance on multivariate analysis (P =.06). 14 Diabetes Previous studies suggest that diabetes mellitus is often unrecognized in the surgical setting, and could lead to a decreased defense mechanism that increases the risk of infection and decreases healing capacity. 44 Insulin resistance could present with neutrophilic dysfunction and slowed inflammatory response, creating a stress window for possible pathogen invasion. Diabetes was not a significant risk factor for complications in our analyses. Of the 303 diabetes patients, 10 (3.3%) had a complication compared to 195 (1.8%) complications among non-diabetics (P =.07). Hypertension Multiple studies have reported a higher incidence of hematoma in facelift patients with perioperative hypertension. 4 In their retrospective review of 630 facelifts, Abboushi et al noted hypertension in 23.1% patients. They reported that patients with hypertension showed a strong tendency to develop hematoma (8.2% vs 3.5%, P =.017). However, hypertension was not found to be an independent predictor of hematoma on multivariate analysis (P =.19). 14 In another retrospective review of 1078 patients undergoing facelift, Grover et al found that preoperative systolic blood pressure above 150 mm Hg increased the risk of hematoma 3.6 times compared to lower blood pressure (P =.02). 15 Baker et al reviewed charts of 985 male patients who underwent facelift between 1966 and They reported that the incidence of major hematoma decreased from 8.7% to 3.97% after initiation of a strict perioperative blood pressure control regimen. 28 Beer et al found that prophylactic use of medications (clonidine, ondansetron, and intravenous paracetamol) during the postoperative period decreases the occurrence of acute hematoma in facelift patients. 23 Unfortunately, due to the absence of blood pressure data in our cohort, we are unable to evaluate hypertension as a risk factor for major hematomas. To the best of our knowledge this study represents the largest single database series of facelift patients. The CosmetAssure insurance database is a powerful tool for assessment of clinical outcomes of cosmetic surgery. It provides prospectively collected data, which is necessary for determining true incidence of complications and risk factors. It is a multi-center database encompassing hospitals, ASCs and OBSS, making the results generalizable to a wide variety of practice models. Previous studies looking at complications and risk factors often did not differentiate patients undergoing combined procedures. Our database is robust in establishing baseline complication rate following facelift as well as any procedure combination. A previous study has shown cross-validation of CosmetAssure data with the Tracking Operations and Outcomes for Plastic Surgeons (TOPS) database. 45 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 TOPS by potentially minimizing the under-reporting of complications. In addition, the dataset is validated by similar patient profile as that reported by ASAPS. 3 The relative frequency of procedures is different as the ASAPS estimate reports are based on data not only from plastic

11 Gupta et al 11 surgeons, but also from otolaryngologists and dermatologists. CosmetAssure offers coverage across all 50 states in the US. Even if CosmetAssure is more commonly used in certain regions of the country, this is unlikely to affect the effect size of risk factors, thus maintaining the internal validity of the study. The study of geographical variation in demographics of facelift patients is beyond the scope of the current study. The database goes a step further by establishing the minimum surgeon qualification ( plastic surgeons who are certified or are candidates for certification by the ABPS), thus avoiding variability in complications attributable to the credentials of the healthcare provider. In today s age, where facelifts and other cosmetic surgeries are being performed by a variety of healthcare providers, it is essential to demonstrate, and compare, outcomes of these providers with different board affiliations. While the CosmetAssure database has many advantages, a few of its limitations need to be addressed. The BMI information was missing for 1046 (0.8%) patients in the overall database and for 60 (0.5%) patients in the facelift cohort. We used BMI, along with date of surgery and date of birth, to create a unique identifier for restructuring the enrollment dataset. Multiple quality control measures were performed to confirm accuracy of restructuring. We manually looked at information on each patient who was missing BMI information from the unique identifier. There was no indication that more than one patient may have the same identifier due to this missing information. There was consistency in the type of facility and no duplication of the type of procedure. After linking the enrollment and claims datasets using another unique identifier, created with variables shared between the two datasets (date of birth, date of surgery and gender), we manually checked the type of procedures between the two datasets for all 2506 complications. This again demonstrated accuracy of the restructuring and linking procedures. Excluding the 1046 patients with missing BMI information from analysis would have resulted in loss of valuable data on other variables. In terms of risk factor analysis, the regression model automatically excluded cases with missing data. It is possible that despite these considerations there may be errors in information on a few patients. The database fails to include minor, but clinically significant, complications (seroma, wound breakdown, etc.) since these are managed in the clinic and do not require hospitalization, emergency room visit, or re-operation. These complications are significantly more common than major complications, and important to cosmetic outcomes and patient perceived results. Nerve injury, though a major complication of facelift, is usually treated conservatively and is likely to be underreported in the CosmetAssure database since it does not lead to a return to the operating room. The database does not register complications occurring after 30 days of the operation. This results in unknown final outcomes after the management of these complications. The database does not differentiate between facelift techniques, which widely differ in extent of skin and SMAS mobilization and may predispose patients to certain complications such as hematoma. No information is available on measures such as ASA class, VTE prophylaxis, preoperative antibiotics, intraoperative temperature and blood pressure management, or duration of surgery and thus their impact cannot be analyzed. The database lacks comprehensive information about patients other comorbidities. However, assessment of available health conditions (diabetes, obesity, and smoking) suggest that patient population seeking cosmetic surgery is significantly healthier compared to the general population of the United States, with low burden of comorbid conditions. Even though management of these major complications incur significant costs, it is possible that the plastic surgeon may write it off or be compensated by a patient s primary health insurance provider. Either of these scenarios, though very unlikely, may lead to underreporting of major complications to CosmetAssure. Finally, CosmetAssure is used by only a fraction of eligible plastic surgeons in the United States. CONCLUSIONS Rhytidectomy is a safe procedure with a low incidence of major complications. Hematoma and infection are the most common major complications, but still occur infrequently after facelift. 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