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The Safety of Office-Based Surgery
Review of Recent Literature From Several Disciplines
John G. Hancox, MD;
Arun P. Venkat, MBA;
Brett Coldiron, MD;
Steven R. Feldman, MD, PhD;
Phillip M. Williford, MD
Arch Dermatol. 2004;140:1379-1382.
ABSTRACT
Objective To review recent literature pertaining to adverse outcomes and mortality associated with office-based surgery.
Study Selection Representative articles from the general and plastic surgery, medical, health regulatory, and dermatology literature.
Data Extraction Information regarding which surgical treatments should be performed, which specialties should perform them, what level of anesthesia is appropriate, and who should administer it was assessed, with particular attention to issues of patient safety.
Conclusions Office-based surgery is safe and cost-effective. We caution against attempts to prohibit or severely restrict this important aspect of medical care.
INTRODUCTION
The number of outpatient surgical procedures has expanded tremendously in recent years, from an estimated 400 000 outpatient procedures performed in 1984 to 8.3 million in 2000.1 In the 1980s, a shift from inpatient surgery to ambulatory surgery centers (ASCs) occurred,2 while in the 1990s a shift occurred to physician offices.3 Patient and physician convenience, ease of scheduling, and avoidance of nosocomial infections are benefits of outpatient surgical procedures. Furthermore, outpatient surgical treatments typically cost 60% to 70% less than similar inpatient procedures.1 Although most reports have found procedures in ASCs to be safe,2, 4 the lay press and the medical literature have questioned patient safety in physician offices.
Questions about which surgical treatments should be performed, which specialties should perform them, what level of anesthesia is appropriate, and who should administer it are emphasized in the medical literature. The level of regulation required is another contentious topic, as some have suggested that physician offices lack proper supervision.1, 5 With regard to adverse events and mortality, states have differing methods of obtaining data and, in some cases, have incomplete or no data. Such inadequacies make performing objective studies difficult.6 Most important is the question of patient safety; if office-based surgery (for select procedures) is as safe as inpatient surgery or surgery in an ASC, then the convenience, cost, and ease of scheduling justify the shift from the hospital to physician offices. One could go so far as to say that the current economic times not only justify but also demand a shift to the outpatient arena, particularly in a medical economic time in which the system is drowning under its own weight.
With this in mind, we review recent literature pertaining to adverse outcomes and mortality associated with office-based surgery. We evaluate representative manuscripts from the general and plastic surgery, medical, health regulatory, and dermatology literature and summarize the findings. From this evaluation of pertinent literature, we conclude that office-based surgery is safe and cost-effective, and we caution against attempts to prohibit or severely restrict this important aspect of medical care.
GENERAL SURGERY
From a Medicare database, Fleisher et al7 evaluated 564 267 total surgical treatments, of which 360 780 were performed in hospitals, 175 288 in ASCs, and 28 199 in physician offices. For all outpatient surgery, mortality rates at 7 days were 41 per 100 000 surgical treatments, and admission rates were 2530 per 100 000 procedures. Multivariate analysis identified advanced age (>85 years), male sex, prior inpatient admission within 6 months, invasive surgery, and the outpatient setting as factors associated with increased risk of death. However, rates were dependent on the procedure. Cataract extraction, hysteroscopy, inguinal hernia repair, arteriovenous grafting, knee arthroscopy, transurethral section of the prostate, and umbilical hernia repair were the riskiest in the outpatient setting; hemorrhoid surgery had a much lower incidence of adverse events in an office. Most important, no deaths occurred the day of surgery in the physician office. The authors emphasize the feasibility of doing database studies to evaluate risk objectively.
PLASTIC SURGERY
Morello and colleagues8 evaluated adverse events and deaths in more than 400 000 procedures in 241 plastic surgery offices accredited by the American Association for Accreditation of Ambulatory Surgery Facilities during 5 years. The adverse event rate was 0.47%, and there were 7 deaths, for a mortality rate of 1 per 57 000 procedures. They concluded that accredited office-based surgery by board-certified plastic surgeons presents the same risk as surgery in an ASC. In 4778 consecutive office-based plastic surgery cases that included intravenous sedation administered by a board-certified nurse anesthetist, Bitar et al9 found no deaths, ventilatory requirements, deep venous thromboses, or pulmonary emboli. There were only 12 anesthetic complications, and nausea and vomiting were most common. Another retrospective study10 of 5316 plastic surgery patients found a complication rate of 0.7%, and most complications were hematomas. Hoefflin et al11 found no deaths and no significant complications among 23 000 consecutive office-based procedures under general anesthesia. In a smaller prospective study among older patients, Hassan and Hodgkinson12 found a complication rate of 1.5%. The authors emphasize the feasibility of prospective studies to evaluate the safety of outpatient surgery.
ORAL AND MAXILLOFACIAL SURGERY
The field of oral surgery is rooted in office-based surgery; thus, its literature is relevant to our discussion. In a large retrospective study, Perrott et al13 evaluated 34 391 cases with a complication rate of 1.3%, all of which were minor and self-limited. By anesthesia type, complication rates were 0.4% with local anesthesia, 0.9% with conscious sedation, and 1.5% with general anesthesia. By questionnaire, D’Eramo et al14 evaluated adverse events associated with outpatient anesthesia in 1.7 million patients in Massachusetts. Two deaths occurred, and major complications were rare. The most common event was syncope (presumably vasovagal responses), present in 1 of 160 cases with local anesthesia. In contrast, for inpatient facial surgical treatments, Smyth15 found a 6% complication rate for surgical treatments, including primary closures, local flaps, and grafts. The inpatient surgical treatments may have been more complex or may have been in medically complicated patients.
LIPOSUCTION
Liposuction is the most commonly performed outpatient cosmetic surgery,6 and articles have focused on deaths and adverse events surrounding it. Platt et al16 reported 3 deaths and emphasized emboli and hypovolemia as important complications, while Barillo et al17 discussed 2 cases of necrotizing fasciitis. Rao et al18 published a high-profile article describing 5 deaths associated with tumescent liposuction or liposuction with dilute local anesthesia. The authors conclude that tumescent liposuction can be risky because of lidocaine toxicity or drug-to-drug interactions. Following that report, several letters to the editor reported similar events, including 6 deaths in southern California19 and 4 cases of cellulitis in France.20 Inexperienced physicians or poorly regulated offices have been blamed for complications with liposuction, and calls for legislation-regulated office surgery have been made.1, 5
Two of the 5 cases that Rao et al18 discussed in detail involved general anesthesia, and the other 2 included conscious sedation and parenteral anesthesia. This runs contrary to "true" tumescent liposuction, defined by other authors as involving only dilute local anesthesia.21 The type of anesthesia used is purported to be crucial by many authors. For instance, Hanke et al22 evaluated the safety of tumescent liposuction (only under local anesthesia) in 15 336 patients by way of a questionnaire. They found no deaths, emboli, perforations of viscera, or thrombophlebitis and concluded that tumescent liposuction is safer than liposuction under general anesthesia. To further stress its safety, Klein23 reported no deaths with tumescent liposuction under local anesthesia, and Coleman et al24 reported that 99% of liposuction malpractice cases were associated with systemic anesthesia. Housman and colleagues25 performed a national survey of more than 500 dermatologic surgeons who perform tumescent liposuction in the United States and found the procedure to be safe, with a complication rate lower than that of hospital-based procedures. Of 66 570 liposuction procedures performed by 267 physicians, no deaths occurred, and the rate of serious adverse events was 0.68 per 1000 cases.
FLORIDA
At the center of the controversy is the state of Florida. In light of emerging regulation of office surgical treatments across the nation, and the mandatory adverse event reporting in Florida, Coldiron26 evaluated 12 months of office surgery complications. Of 31 procedure-related complications, 6 deaths were recorded. One death occurred after an anaphylactic reaction to radiologic contrast media, and the other 5 involved general anesthesia. Adverse events were more often related to liposuction under general anesthesia than any other procedure. Coldiron27 also reported that in 2000 and 2001 in Florida there were no injuries or deaths associated with liposuction under local anesthesia. Moreover, 98% of all physicians reporting were board certified; anesthesiologists or nurse anesthetists provided all general and deep sedation, and no physicians performed surgical treatments outside of the scope of their training. Coldiron26 suggests that the level of anesthesia, not the location of the liposuction, may be the most important factor to consider.
Vila et al28 retrospectively evaluated 2 years of office and ASC adverse event data from Florida. Of 13 procedure-related deaths, 5 were related to cosmetic surgery. Eighty-five percent occurred with board-certified physicians, 38% occurred in an accredited office, and 15.4% were under the supervision of an anesthesiologist. The adverse event rates were 66 and 5.3 per 100 000 procedures for offices and ASCs, respectively, and the mortality rates were 9.2 and 0.78, respectively, per 100 000 procedures. They demonstrated a 10-fold increase in adverse events in offices vs ASCs, and they claim that 43 injuries and 6 deaths could have been prevented if all surgical treatments in Florida were performed in ASCs. In unpublished data (A.P.V., January 2004), our group reexamined the Florida data and found no significant difference in adverse events and mortality. We believe that the data by Vila et al underestimated the number of office procedures (the denominator), thus inflating the adverse event rate for offices, and included cases that were outside the study criteria and others that were actually performed in ASCs. The lack of standardization of reporting adverse events for ASCs and office procedures is highlighted by both studies.
DERMATOLOGY
The dermatology literature contains several recent articles pertaining to office-based surgery. Balkrishnan et al29 reported on a 2002 multidisciplinary conference evaluating the safety of office-based surgery. Researchers and practitioners from dermatology, ophthalmology, otolaryngology, plastic surgery, and anesthesiology demonstrated a low incidence of adverse events along with the benefits of continuity of care, increased patient satisfaction, and decreased nosocomial infections. In another article, Balkrishnan and coworkers6 performed a national survey of office-based cosmetic surgery adverse event reporting. Of the 48 continental states, only 5 were able to provide complete information about 13 cases of office-based complications. Thirteen states had incomplete information or were unable to provide any information, and 30 states reported no adverse events. Adverse event reporting varied tremendously, and the authors concluded that the data were inadequate to define the safety of office-based cosmetic surgery. The authors call for standardization of reporting complications of office-based surgical treatments so that modifiable risk factors can be identified.
MOHS MICROGRAPHIC SURGERY
Mohs micrographic surgery (MMS) is almost always performed in the physician office. Cook and Perone30 performed a prospective study of the incidence of adverse events occurring with MMS in 1052 consecutive patients at one center. No deaths occurred, and they found an adverse event rate of 1.64%, with none of the complications resulting in hospitalization. Hematoma and graft or flap necrosis were the most common events. In a prospective study, Otley at al31 reported low rates of adverse events in 653 patients receiving antiplatelet or anticoagulation therapy. Regarding infection, Futoryan and Grande32 found that 2.3% of 1047 MMS cases experienced infectious complications. This rate is excellent considering that MMS is considered a "clean contaminated" procedure33 (with occasional breaks in aseptic technique), in which a 5% to 15% infection rate is acceptable.34 In fact, this low rate of infection is more consistent with "clean" procedures, in which a 1% to 3% infection rate is acceptable.35
COMMENT
Is the physician office the "wild, wild, west of health care," as Quattrone5 suggests? Is the death rate from office-based liposuction higher than the death rate from motor vehicle crashes or homicides, as Lapetina and Armstrong1 claim? More than 125 news stories have reported on liposuction-related deaths. Such press is often more powerful than the medical literature in the minds of patients. Our brief review from several disciplines seems to counteract the contention that office surgery is risky. Retrospective and prospective studies indicate that office surgery, in the hands of skilled professionals and with proper patient selection, is as safe as surgery at an ASC or a hospital.
Although conflicting reports exist on the safety of office-based surgery compared with ASCs, one fact seems to be agreed on: adverse event reporting should be uniform so that adequate large-scale studies can correctly assess the risk. Until this is done, no definitive conclusions can be drawn, and opinion may be swayed by anecdotes and hyperbole. The level of anesthesia that is appropriate in the physician office remains debatable, although several studies9-11,13 we evaluated found that even systemic anesthesia (when done appropriately) is safe.
Another fact that seems to be clear is that procedures involving only local anesthesia or with minimal sedation (including true tumescent liposuction, excision or destruction of benign and malignant lesions, and MMS) are safe. Despite this, a concerning scenario would be the regulation of all office-based procedures. Potential regulations under consideration could mandate physicians to obtain hospital credentials and privileges to perform office-based surgery.36 This could have a tremendous effect on the practice of many physicians, including dermatologists; the consequence could be an enormous increase in the cost of managing common conditions such as cutaneous malignancies. Chen et al37 suggested the cost of managing nonmelanoma skin cancer (NMSC) to be 10 times higher in the inpatient setting vs the office ($5537 vs $492), and Manternach et al36 showed that dermatologists managed 82% of Medicare-related NMSC cases from 1998 to 1999. Given that more than 1.3 million cases of NMSC are diagnosed each year,38 loss of office-based surgery for this disease alone could increase the cost of managing NMSC by tens of millions of dollars. Given that most NMSC is excised with only local anesthesia, regulating procedures to treat NMSC seems unnecessary. The same could be said for other health care specialties; imagine if all dental work requiring anesthesia was performed in an ASC or hospital!
If all offices were required to be accredited, as some have suggested, this too could have significant consequences for health care payers, including patients with high deductibles or medical savings accounts. Once an office is accredited, additional facility reimbursement for different procedures may be obtainable from private payers (including patients) and Medicare. Such a move would add great expense to the already overburdened system, while eliminating the often unappreciated cost savings of office-based procedures.
We believe that office-based surgery should only be performed by properly trained physicians working within their scope of practice. We also acknowledge that, in selected cases, certified anesthetists or anesthesiologists should administer anesthesia and carefully monitor patients. We also advocate the uniform reporting of adverse events and mortality related to office-based surgery, so that the proper analysis can be performed and patient safety can be assured. With the available data, and in absence of the gold standard of randomized prospective trials, we contend that office-based surgery is safe and cost-effective.
AUTHOR INFORMATION
Correspondence: Phillip M. Williford, MD, Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1071 (pwillifo{at}wfubmc.edu).
Accepted for Publication: June 18, 2004.
Financial Disclosure: None.
Author Affiliations: Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC (Drs Hancox, Feldman, and Williford and Mr Venkat); and The Skin Cancer Center, Cincinnati, Ohio (Dr Coldiron).
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