Preoperative Risk Factors and Complication Rates ...

Facial Surgery

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

Aesthetic Surgery Journal 2016, Vol 36(1) 1–13 © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: [email protected] DOI: 10.1093/asj/sjv162 www.aestheticsurgeryjournal.com

Varun Gupta, MD, MPH; Julian Winocour, MD; Hanyuan Shi, BA; R. Bruce Shack, MD; James C. Grotting, MD; and K. Kye Higdon, MD

Level of Evidence: 2

Accepted for publication July 23, 2015; online publish-ahead-of-print November 17, 2015.

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 37232-2345, USA. E-mail: [email protected] 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.

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Abstract Background: Facelift (rhytidectomy) is a prominent technique for facial rejuvenation with 126 713 performed in the United States in 2014. 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 129 007 patients enrolled in CosmetAssure, 11 300 (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.

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shape.2 According to the American Society of Aesthetic Plastic Surgeons (ASAPS) Cosmetic National Database, 126 713 facelifts were performed in 2014, a 27.7% increase since 1997.3 It is the most common aesthetic surgical procedure performed in patients above age 65.3 There are many medical considerations when performing a facelift, which include perioperative and anesthetic considerations in addition to surgical technique.2,4 A plethora of 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.

140082). 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 2013. The CosmetAssure database was accessed in February 2014 following IRB approval.

METHODS

Exposure

Study Population

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,

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 2008. 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).


This prospective cohort study was approved by the Vanderbilt University Institutional Review Board (IRB #

Database

Gupta et al

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

Statistical Analysis

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).

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

RESULTS

Figure 1. Study design.

Figure 2. Facelift complications.

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. Overall, mean age was 40.9 ± 13.9 years, BMI 24.3 ± 4.4 kg/m2, 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 11 300 facelifts were performed, representing 6.14% of all 183 914 cosmetic procedures. Of these, 4809 (42.6%) were performed as a solitary procedure and 6491 (57.4%) with additional procedures (Figure 1). The facelift


The potential risk factors evaluated included age, gender, BMI, smoking, diabetes, type of facility, and combined procedures.

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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 Facelifts (n = 11,300)

All Other Cosmetic Procedures (n = 117,707)

P value

Gender (Male)

997 (8.8%)

7360 (6.3%)