The Case

A 54-year-old man with HIV was referred to a plastic surgeon for cosmetic surgery. In the plastic surgeon’s office, he underwent neck and facial liposuction with eyelid tightening under local anesthesia. There were no complications at the time of the procedure and the patient was sent home.

After arriving home, the patient noticed an expanding neck mass near the incision site and progressive shortness of breath. He contacted the plastic surgeon, who directed him to the nearest emergency department. Upon arrival, the patient was in severe respiratory distress and needed an emergent tracheostomy, secondary to neck swelling and edema. He was taken to the operating room, where he was found to have a laceration of the external jugular vein. The vessel was repaired and the patient required a prolonged stay in the intensive care unit. He eventually was discharged to home.

The Commentary

Location, location, location—this is the mantra of the real estate market. But is location a factor in the occurrence of the complication reported in the aforementioned case? Is patient safety better assured if surgery is performed in a hospital outpatient facility versus an ambulatory or office surgical facility setting? This question has generated considerable controversy, with proponents on both sides of the argument. The case presentation lacks many details and leaves several unanswered questions. Although the temptation is to see only operator-related complications, several additional causative factors may have been at play in this case:

1. Facility accreditation. Was the facility accredited by any of the three nationally known accrediting organizations: American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), or Accreditation Association for Ambulatory Health Care (AAAHC)? Was there state licensure or Medicare certification? Such accreditation generally ensures that the facility has all the equipment, staff, and medications needed to manage on-site adverse events and emergencies.
2. Patient status. What was the patient’s American Society of Anesthesiologists (ASA) status? In addition to his known HIV, could other comorbid conditions have made him a poor candidate for an office surgical procedure? A recent study (1) found that men have a two times greater risk of hematoma than women in cosmetic procedures, possibly due to higher rates of hypertension.
3. Surgical site marking. Did the surgeon mark the skin externally to identify the location of the external jugular vein prior to injecting the site? Safe and sound practice requires such identification of all potential high-risk areas, such as blood vessels, nerves, or areas of unstable skin due to radiation or other prior trauma.
4. Techniques used. What liposuction techniques were employed (dry, wet, superwet, tumescent, ultrasound)?(2) Currently, all of the “wet” methods appear to provide much easier “passes” of the cannulae for the operating surgeon; when lidocaine is used as part of the wetting solution, it also seems to reduce post-operative pain. Additionally, bleeding and post-operative bruising are far better controlled when epinephrine is part of the solution being instilled.
5. Cannulae. What size cannulae were used? Were they sharp or blunt? The sharp and larger diameter–tipped cannulae have, for the most part, faded out of use primarily because of the risks of nerve, vessel, skin, and muscle damage.
6. Post-operative wound management. Were pressure dressings or ice packs applied to the treated areas? Using these modalities as part of the post-operative wound management has been shown to be moderately effective in controlling swelling, edema, and, to some degree, hematomas.(3,4) These possible benefits and their minimal expense should prompt their general use.
7. Post-operative observation. In this case, given the type of vessel lacerated and its size, it is surprising that marked swelling was not immediately observed prior to the patient’s discharge. Was there a planned and implemented period of post-operative observation for possible immediate complications? The period for evaluation prior to discharge on any patient should be based on a validated scoring system. The most widely used is the Aldrete method, which estimates the adequacy of recovery based on the patient’s level of consciousness, activity, respiration, circulation, and color (similar to an Apgar score).(5) Patients should only be considered for discharge when all the parameters in this 10-point scale have been achieved. The method is not entirely prescriptive, however, since it does not define the time frame to meet the discharge parameters, and so the recovery time could be very short (eg, 30 minutes) to as long as several hours. Much is also dependent on procedure performed, ASA levels, and age of patient.
8. Post-operative instructions. Were written post-operative instructions given to alert the patient of any possible complications that could necessitate immediate attention?

One must be careful not to use any of the above as an indictment of office surgery procedures, since similar cases have occurred in other settings. For example, I know a case in which a patient died after an uncomplicated facelift performed under general anesthesia. The patient strangled from a hematoma under her dressing. This case took place in a community hospital’s outpatient department, not an ambulatory office.

That said, office-based facilities have been the site of many reports of serious complications and deaths. These reports have received tremendous media attention, especially in Florida. Between 2000 and 2002, Florida reported a ten-fold increase in adverse events in procedures done in office-based facilities versus freestanding ambulatory surgery centers.(6) However, when these cases were reevaluated with more rigorous techniques, the concerns were unfounded, with fewer than 1 adverse event in 10,000 cases.(6) In January 2002, a multi-disciplinary meeting convened by the National Institutes of Health also found a low degree of adverse events in office-based surgical procedures. These results mirrored similar studies (involving voluntary reporting) by the AAAASF (7), which found that the safety in accredited office-based surgery facilities was equivalent to that in hospital outpatient facilities.

In 1999, the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) mandated that to maintain membership in either society one must perform outpatient procedures only in an accredited facility (by JCAHO, AAAHC, or AAAASF) or in a state-licensed unit. Accreditation tells the potential patient that a certain standard of patient safety has been achieved and evaluated and assures the facility’s staff that they are working in a safe environment.

Despite the above data, adverse events in office-based facilities continue to be intensely reported by the media. In view of this, the ASPS convened a task force on patient safety in office-based facilities. One of its first advisories concerned liposuction (8) and incorporated many of the above concerns regarding cannula type, safe amounts of wetting solutions, amounts of fat extracted, and fluid replacement requirements.

This task force is developing additional guidelines, partly trying to fill an information void, since there are presently no reporting systems for office-based surgeries. One recent study used an internet and peer review reporting system to analyze 400,000 cases (since the report, the database has grown to more than 800,000 cases) performed in roughly 1200 accredited AAAASF facilities.(9) Of the 2,597 reported unanticipated sequelae, hematoma was the most common problem, reported in 0.18% of cases. Such hematomas represented nearly one-third of reported sequelae. Other lesser complications included infection, with an incidence of 0.09% of performed procedures. Cardiac irregularities and sequelae accounted for 0.007%. Less frequent complications were blood pressure alterations, deep venous thrombosis, and pulmonary embolism (each approximately 0.01%). A related study (10) of liposuction of the neck and jowls also found an extremely low risk of voluntarily reported complications.

It is estimated that 10 million procedures were performed in office-based facilities in the US in 2005 (11), a remarkable volume. Patients appear to value the convenience, privacy, staff consistency, and efficiency of such facilities. Nevertheless, the fact that only 1200 of 40,000 office-based facilities in the United States are currently accredited by the AAAASF is a concern (12); it should be noted that some other office-based practices are accredited through JCAHO (13) and AAAHC. All these organizations have fairly similar bases for evaluation of the facilities (Table) (14), scrutinizing all areas of the facilities carefully for possible safety hazards.(15)

Overall, our organization believes that the accreditation process is needed to ensure that office-based practices are as safe as hospital-based practices. Present evidence clearly demonstrates that the accredited office facility, staffed by appropriately trained and credentialed providers, is as safe as any other environment for care today.(16) To date, there have been no studies to the contrary. Additionally, for surgeries in office-based facilities, the length of the surgical procedures has no bearing on the frequency of safe outcomes.

Take-Home Points

• If performed in an accredited facility, office-based surgery is as safe as hospital-based surgery.
• All office-based surgical facilities should be accredited by AAAASF, JCAHO, AAAHC, or the equivalent.
• Evidence-based techniques should be employed in outpatient plastic surgery to reduce the risk of complications.
• Validated scoring systems should be used to assess adequacy of recovery from surgery prior to discharge post-operatively in office-based procedures.

James A. Yates, MD President, American Association for the Accreditation of Ambulatory Surgical Facilities

References

1. Baker DC, Stefani WA, Chiu ES. Reducing the incidence of hematoma requiring surgical evacuation following male rhytidectomy: a 30-year review of 985 cases. Plast Reconstr Surg. 2005;116:1973-1985. [ go to PubMed ]

2. Rohrich RJ, Beran SJ, Fodor PB. The role of subcutaneous infiltration in suction-assisted lipoplasty: a review. Plast Reconstr Surg. 1997;99:514-519. [ go to PubMed ]

3. Peck GC. Complications and Problems in Aesthetic Plastic Surgery. New York, NY: Gower Medical Publishing; 1992:sec. 3.8.

4. Wilkinson TS. Practical Procedures in Aesthetic Plastic Surgery. New York, NY: Springer-Verlag; 1994:241.

5. Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970;49:924-934. [ go to PubMed ]

6. Hancox JG, Venkat AP, Hill A, et al. Why are there differences in the perceived safety of office-based surgery? Dermatol Surg. 2004;30:1377-1379. [ go to PubMed ]

7. Morello DC, Colon GA, Fredricks S, Iverson RE, Singer R. Patient safety in accredited office surgical facilities. Plast Reconstr Surg. 1997;99:1496-1500. [ go to PubMed ]

8. Iverson R, Lynch D, and the American Society of Plastic Surgeons Committee on Patient Safety. Practice advisory on liposuction. Plast Reconstr Surg. 2004;113:1478-1490. [ go to PubMed ]

9. Keyes GR, Singer R, Iverson RE, et al. Analysis of outpatient surgery center safety using an internet-based quality improvement and peer review program. Plast Reconstr Surg. 2004;113:1760-1770. [ go to PubMed ]

10. Yu TC, Perez MI. Dermatologic liposuction: safety record and techniques. Cosmet Dermatol. 2004;17:209-212.

11. Office-Based Anesthesia and Surgery. American Society of Anesthesiologists Web site. Available at: http://www.asahq.org/patientEducation/officebased.htm. Accessed February 21, 2006.

12. Schneider EM. Most office-based surgery centers unregulated. Cosmetic Surgery Times. November-December 2005.

13. Office-Based Surgery Standards Sampler. Joint Commission on the Accreditation of Healthcare Organizations Web site.

14. Standards and Checklist. Gurnee, IL: American Association for Accreditation of Ambulatory Surgery Facilities; 2002.

15. Manuel BM, Nora PF, eds. Surgical Patient Safety: Essential Information for Surgeons in Today's Environment. Chicago, IL: American College of Surgeons; 2005.

16. Gordon N, Koch M. Duration of anesthesia as an indicator of morbidity and mortality in office-based facial plastic surgery. Arch Facial Plast Surg. 2006;8:47-53. [ go to PubMed ]

Table

Table. Bases for Evaluation of Surgical Facilities*

* Although each accrediting organization covers generally the same standards, the titles may vary somewhat.