Timing is Everything

Timing is Everything
Bariatric Surgery Transitioning to the ASC

By Kathy Dix

As more procedures transition to the ambulatory arena, some controversy has arisen over which procedures are truly safe to perform in an outpatient setting. Hospitals may claim that certain surgeries should always remain inpatient, but even these procedures are shifting to the less invasive location.

Bariatric surgery is one of these contentious areas — morbidly obese patients are already a higher risk for surgery, and may have comorbidities that increase that risk even further.

One comorbidity often found in this cohort is sleep apnea; a procedure to treat the problem is sometimes performed inpatient and sometimes outpatient.

Mary Talley Bowden, MD, an ear, nose, and throat (ENT) surgeon at Memorial Northwest in Houston, has performed surgery to treat sleep apnea for several years. “It depends on the severity of the sleep apnea, and upon the patient’s anatomy, but one of the most common procedures is uvulopalatopharyngoplasty, and if they have their tonsils still, then you take them out at the same time,” Talley Bowden says.

Tonsils are often a problem, but even if they are not, Talley Bowden will remove them as a matter of course. “I’ve seen many adults have really big tonsils, and they could definitely cause problems in terms of sleep apnea. Even if they’re small, they’re generally right in the area where you’re operating, and you just need to get them out even if they’re small because it will help regardless,” she adds.

The procedure involves taking off the uvula, then a small portion of the soft palate on either side of it, then the tonsils. Finally, Talley Bowden sews together the mucosa of the soft palate and a portion of the tonsillar pillars. “Not everybody would do that, but I do that because it gives you a tighter closure and a better airway,” she explains.

The general standard of care is to keep patients overnight. However, she says, “I was at the academy meeting this past fall, and Dennis Johnson had done a study. He discharged most of the patients and had no problems, but the conservative standard of care is to keep them at least 23 hours post-operatively, just because they’re at higher risk than your typical outpatient surgery patient for airway problems after surgery. I’ve been doing all my patients in the main OR and not in the outpatient surgery center, but if the outpatient surgery center would allow me to keep them overnight, then I would do them there. We have [an ASC] connected to our hospital, so there is the potential to transfer them to the main hospital, but in a freestanding facility, I wouldn’t do them.”

The patients are generally extubated immediately, and leave the OR breathing on their own. Some surgeons prefer to give patients the oxygen as a matter of course, whether or not they need it. Others will keep the patients overnight and monitor their oxygen saturation, waiting to see if they need it or not. “You feel more comfortable knowing how they’re going to do when they go home,” says Talley Bowden. “It depends on the person, if they have underlying lung problems (for example). It depends on the nursing, if you have good nurses who are going to pay attention if he’s de-satting, so I’ll try to leave the oxygen off. If someone has severe sleep apnea, I put them in the intensive care unit (ICU) overnight.”

And, she notes, she has not seen problems with insurance companies rejecting the claim for ICU costs.

Bariatric patients do not necessarily undergo the sleep apnea surgery, mainly because their apnea is due to being overweight rather than another anatomical issue. Often, Talley Bowden will conduct sleep studies on these patients and try them with a continuous positive airway pressure (CPAP) machine first. “Generally, they’ll get CPAP before getting an operation, because their goal is to lose enough weight so that their sleep apnea is better,” she clarifies. “I make everybody try CPAP.

Actually, I don’t use CPAP anymore; I use AutoPAP (auto-titrating continuous positive airway pressure). The new machines have recording devices, so they can bring those in with them, on a disk, and you can plug it in, see if they’ve been using it, for how many hours a night, if there’s a big mask leak. If they are not tolerating it or are not willing to try different masks, and if it is a morbidly obese person with no tonsils and their throat looks fine, you’re probably not going to do much with surgery. On the other hand, if you have somebody with huge tonsils, and they’re not too overweight, then you have a good chance of helping them with surgery. There is more surgery besides the uvulopalatopharyngoplasty, but if you go beyond that, you’re definitely not going to be in an outpatient environment.”

Children constitute another subgroup of patients undergoing this procedure. “Children also suffer from sleep apnea, and it is actually the most common indication for tonsillectomy and adenoidectomy in children,” Talley Bowden says. “Generally, these are all done on an outpatient basis unless the child is younger than three years old, lives far from the hospital, or has other comorbid conditions that could complicate his/her post-op course (for example, asthma).”

Christine Ren, MD, FACS, is an assistant professor at NYU Medical Center, a leading LAP-BAND surgeon and a member of the American Society for Bariatric Surgery. “Certainly, the bariatric operations are moving into the ambulatory arena, but primarily laparoscopic band surgery. I don’t think gastric bypass is by any means near being ambulatory surgery. It’s a severe operation, and I only know of one hospital that does send patients home, but it’s 23 hours and it’s in the hospital.

“It’s too dangerous in a high-risk patient population,” she explains. “The only bariatric surgery successfully being performed in ambulatory surgery centers is the laparoscopic adjustable gastric banding (LAP-BAND®) surgery. The main reason is because the surgery itself is very safe, and less invasive than having laparoscopic gall bladder surgery — cholecystectomy. Patients’ recovery is much faster with laparoscopic band surgery than after laparoscopic choly surgery.”

Ambulatory surgery center (ASC) surgeons are quite selective in choosing the patients who can undergo the procedure on an outpatient basis. The American Society for Bariatric Surgery (ASBS) is creating a centers of excellence program, which will provide guidelines for bariatric patient selection in an outpatient facility. “It is with the understanding that it will be LAP-BAND surgery,” Ren says. “The criteria would be having someone with a body mass index (BMI) less than 50, having an American Society of Anesthesia (ASA) classification of less than 3.” The regulations are strict — patients should be eliminated from the outpatient option if they have uncontrolled diabetes or uncontrolled blood pressure — patients should be medically stable.

“There is a publication by a very experienced group in Seattle that has reported on more than 500 laparoscopic band surgeries on morbidly patients with BMIs greater than 50, and they’ve had no mortalities and extremely low morbidity from the surgery, and very low readmission rates. Also, there is the component of anesthesia; you have to have an experienced anesthesiologist who will use certain medications on these patients that will allow for a quick recovery and discharge to home on the same day,” adds Ren.

The LAP-BAND is a much less complicated procedure than the standard Roux-en-Y gastric bypass; it may occasionally slip farther down the stomach, however. This complication “prevents the band from working properly to allow people to continue to lose weight,” Ren explains. “The most common symptom of band slippage is severe reflux or regurgitation, particularly in the middle of the night, and this would require the band to be loosened, and if the band is loosened, people will regain weight.

Their appetite will come back. So that’s the main reason for surgical revision of the band if the band slips. It happens in 3 percent of the population. The reoperation itself can be done laparoscopically in an ASC.”

In New York state, reimbursement is provided for the LAPBAND procedure by approximately 70 percent of insurance companies. However, “It’s not deemed an ambulatory surgery as of yet. I think the vast majority of surgeons are performing the surgery in the hospital, not in an ASC, but it has the potential to move that way. Medicare is covering laparoscopic band surgery, and that will then impact on the rest of the payors in the country.”

Efficacy of the LAP-BAND at three years is equivalent to the gastric bypass surgery. “The efficacy at one and two years is different,” Ren states. “Because the laparoscopic band surgery is less severe in nature, the weight loss is less severe in its rate, so it is uncommon for patients to lose 100 pounds in six months with laparoscopic band surgery. It’s entirely possible if they’re incredibly motivated, but typically, with the gastric bypass, the weight loss is within the first year, and that’s up to 65 percent to 75 percent of excess weight lost in a year to 18 months. But after that, the window of opportunity is closed, and they plateau, and on average, will go on to regain 10 percent to 20 percent of their excess weight. By the time they’re at three, four, five years, up to ten years, they’ve maintained about a 50 percent to 55 percent excess weight loss on average.

“The band, on the other hand, has a much more gradual weight loss. After the first year, the average weight loss is about 40 to 45 percent excess weight loss; the second year, they continue to lose to about 50 percent weight loss; and year three, they continue to lose a little more, to about 53 percent to 55 percent excess weight loss. It’s maintained out to eight years now, in published literature.”

Ren likens the devices to the fabled tortoise and hare. Gastric bypass provides rapid weight loss with some regain, while the LAP-BAND provides a steady, gradual weight loss. “The effects it has on the resolution of obesity-related illnesses is the same,” she points out.

Bariatric patients presenting with sleep apnea require special precautions. “They may have a slightly higher risk when they have narcotics on board — either from the anesthesia or postoperatively — that they’ll get really apneic and hypoxic,” she adds. “If you have any suspicion of sleep apnea, they should have a sleep study, so that the anesthesiologist is fully aware of their pulmonary status. If they have sleep apnea, they are counseled to bring their sleep mask with them post-operatively, so they can be placed on CPAP right away, or at least for the night after surgery.”

Ren keeps most patients for 23 hours after the inpatient surgery. They are required to stay a minimum of four hours. “Surgeons starting out on LAP-BAND surgery will keep the patients not eating or drinking overnight, and then do an esophagram the next morning, a swallow study, just to make sure there’s been no perforation of anything, and that the band is in the correct position. After we’ve done about 700 of these, we’ve stopped performing these swallows after surgery, because we had absolutely no injury to any organ, the band was not too tight, and there were no problems at all. We give them ice chips and let them drink four hours after surgery. And if they tolerate that, they can go home.”

The band is not filled until six weeks after the surgery. Then it is gradually tightened every four to six weeks until the ideal tightness is achieved. When patients present for the first tightening appointment, they are asked if they feel hunger. “If they are, that means the band is not tight enough and we have to tighten it, because there’s an interesting side effect of this band — it takes away their hunger and somehow stops them from thinking about food. I don’t know if it’s hormonal, or a stress receptor in the stomach, but it really happens,” she says.

Jeff Rosen, MD, FACS, MBA, is the medical director of the WISH Center (Weight Intervention Surgical Healthcare), which offers gastric bypass and LAP-BAND weight loss surgeries. The WISH Center — composed of five centers located around the country — is not outpatient. However, many patients are dis-charged well within 23 hours and sometimes in the same day.

Asked if this will gradually move to the ambulatory arena, Rosen replies, “I think there’s always going to be a mix, because some of these patients are very high risk, with multiple medical problems, and because there are such drastic changes, because they can’t resume the diet they were taking before, they may need to be monitored in the hospital. Some examples: a ‘brittle diabetic,’ with blood sugars that could go real high or real low, might need to be watched in the hospital for longer than just 23 hours, or if they have another problem, they may end up in the ICU. There are patients with severe sleep apnea, so severe that it might be potentially safer in the hospital setting. Some surgicenters are connected to a hospital, so if they feel the patient needs that setting, they just roll them right over. Some surgicenters are now going up to 48 hours in monitoring patients, and some people are doing thyroid surgery in the surgicenter, and keeping patients one or two days. They’re also doing bariatric gastric bypass, watching them for 23 hours and sending them home. We like watching two nights with the gastric bypass.”

The reasons for this are simple. “I think it’s the combination of comorbidities, and we’re also looking for a leak, or if people have venous thrombosis, or pulmonary embolism. The gastric bypasses are more complex operations than the laparoscopic band, so the actual risk right after surgery is higher than the laparoscopic band. That’s not to say it can’t be done in an outpatient setting, but they have to use ‘patient choice’ — choosing the right patients, possibly lower-risk patients who maybe are morbidly obese, but don’t have diabetes, sleep apnea, and have a BMI probably under 50 or 55. We operate on BMIs almost up to 100, and we know that for some of the higher BMIs like 70 and above, their postoperative course could be much harder. They get different kinds of fluid shifts, they require more fluids; we just feel at least at this time that they should be in the hospital setting.”

All patients are monitored with pulse oximetry and telemetry. They can bring their CPAP or BiPAP machines the night of surgery; the most severe patients might be put in the ICU.

Special preparations are needed for obese patients, says Rosen. “They need to have sequential compression devices available. We use a footboard and tape the patient’s legs to the bed, because we have them with the head up and feet down at almost 40 degrees and we don’t want them falling off the table. Make sure that padding is appropriate, so that areas of the body aren’t rubbing against any retractors, and make sure that all areas are supported appropriately, and that there are no acute angle of the arms. When arms are out at certain angles, you can actually have nerve damage, as the nerve goes across the armpit area — brachial plexus neuropathy can be permanent in some people.” For other patients in certain positions, such as having the legs slightly elevated, if that position is maintained for a long period of time, there is pressure on the gluteal and buttocks region, which can actually cause breakdown of muscle.

It is crucial, Rosen says, that the surgeons be consistent in the steps they take during each procedure. The anesthesia team must be prepared to handle an airway at any time. Rosen also recommends an item known as the “Hover Mat,” which resembles an air mattress and assists with patient positioning and can be used in the operating room (OR). “I’m not going to endorse one brand in particular, but I think it should be used on any patient over 150, 200 pounds,” he adds. “Another part (of preparation) is sensitivity to the patient. Sometimes people don’t really listen to what they’re saying to the patient — if the person rolling the patient from the holding area to the room says, ‘Man, if you could have just cut back eating, I bet you wouldn’t have needed this operation,’ that is enough to set things off. We at our hospital do sensitivity training, because this could be in radiology, the ER, on the floor, in the OR.”

Morgan Downey, JD, is the executive director and chief executive officer of the American Obesity Association (AOA). Downey has been doing healthcare advocacy work in Washington for approximately 30 years. Two and a half years ago, many major insurance plans decided to cut back on their coverage of bariatric surgery. “It was quite a serious problem, as a number of insurance carriers got out of the market,” Downey says. “Then there was a lot of negative comment about the surgery; some of it was not very accurate. The number of operations mushroomed at the time, and the employers and managed care plans in particular were taken by surprise at how rapidly the number of operations were proceeding. So they cut back, and a number of outside groups did assessments of the surgery in the published literature.

“In July 2004, Medicare said it would recognize obesity as a disease and would look at the effectiveness of various interventions. The first one was bariatric surgery. They held an advisory meeting in November 2004 in Baltimore, and the ASBS and others presented evidence about the surgery, its mortality and morbidity and effectiveness. It was a very positive response from the committee about the surgery, and subsequently, we and the surgeons and several companies submitted a request to expand coverage under Medicare, which we filed in April 2005.”

Downey continues, “Medicare recently announced a proposed expansion, which is now in a 30-day comment period, and it appears that a number of the insurance plans have taken a second look and have decided that they will reenter the market starting in 2006. Part of the reason for that is that the ASBS has launched a centers of excellence program, and what that is going to do is keep the procedures at hospitals, and with surgeons that do high volume and have comprehensive care. I think this will drive out some of the providers who are not very well trained, or who did not provide adequate follow-up, and that is acting to reassure the payors that the individuals at the institutions that they’ll be covering know what they’re doing, have the expertise, have the full range of pre- and post-surgery services available, and also have very heavily documented outcomes-based evaluations.

With the ASBS centers of excellence program, they have to participate in a database, they have to put in all of their patients and list all of their health outcomes, and the specific type of procedure that was used, etc. That’s going to drive reimbursement in the future, to feel that they’re paying for where the best people are doing it, and have a lower rate of complications and mortality because of that.”

The AOA has been working with Inamed on a survey of people with morbid obesity, at how they experienced their relationships with their significant others, and their employment situation. “We all get focused on the healthcare effects with obesity, and sometimes overlook the psychosocial problems that people in this category have,” Downey explains. “We did a survey that showed they have less frequent sexual relations with their partners, they’re more dissatisfied, they believe that their appearance or weight has resulted in the loss of job opportunities.

It’s a very disadvantaged population with multiple health and psychosocial problems. We collaborated on the Web site www.weighingyouroptions.com, which has information about surgical options, and encourages people to get more information about the procedures.”

Harvey Sugerman, MD, FACS, is the past president of the ASBS, emeritus professor of surgery at Virginia Commonwealth University in Richmond, and editor of the journal Surgery for Obesity and Related Diseases.

“The laparoscopic adjustable gastric band procedure is now being performed in a number of centers as an outpatient procedure,” he affirms. “As far as the Roux-en-Y gastric bypass operation, to my knowledge, it’s only being done at one center with a 23-hour stay, in Dallas. The laparoscopic band is done without a 23-hour stay; it’s being done purely as an outpatient procedure, at freestanding outpatient centers.”

There is concern about adequate postoperative monitoring of sleep apnea patients. The ASBS centers of excellence program, which will be approving bariatric surgery in outpatient centers, “will not approve programs that are performing the operation for patients with sleep apnea in an outpatient center,” Sugerman says. “It is felt that that’s one contraindication to its being done in a freestanding outpatient center. If they do it in a 23-hour stay environment with continuous monitoring with pulse oximetry, that’s a different issue. But in terms of freestanding outpatient centers, it’s not being supported.”

Sugerman, expanding on the potential transition of the surgery to an ambulatory environment says, “I think the LAP-BAND will progressively move to the ambulatory environment, but I would imagine that the gastric bypass procedure primarily will remain in the hospital environment. There may be more of a trend toward a 23-hour stay, but I doubt that that’s going to be a major evolution.”

The Number of Bariatric Surgical Procedures Performed Increased Substantially

The number of bariatric surgical procedures performed in the U.S. from 1998 to 2003 increased considerably, according to a study in a recent issue of the Journal of the American Medical Association.

Morbid obesity is an increasing health problem in the United States, according to background information in the article. In 2002, 5.1 percent of U.S. adults had a body mass index (BMI) higher than 40. The prevalence of individuals with a BMI higher than 40 quadrupled from 1:200 in 1986 to 1:50 in 2000; the prevalence of individuals with a BMI higher than 50 quintupled from 1:2000 to 1:400. The increasing prevalence and associated socio-demographic disparities of morbid obesity are serious public health concerns. Bariatric surgical procedures provide greater and more durable weight reduction than behavioral and pharmacological interventions for morbid obesity.

Heena P. Santry, MD, of the University of Chicago, and colleagues examined recent national population-based trends in bariatric surgical procedures, patient characteristics, and in-hospital complications to determine trends in newer techniques, in sociodemographic disparities, in co-existing illnesses, and in surgical complications due to these procedural and patient population changes. The researchers used the Nationwide Inpatient Sample to identify U.S. bariatric surgery admissions from 1998-2002 (with preliminary data for 12 states for 2003).

The researchers found that the estimated number of bariatric surgical procedures increased from 13,365 in 1998 to 72,177 in 2002. Based on preliminary statelevel data (1998-2003), the number of bariatric surgical procedures is projected to be 102,794 in 2003. Gastric bypass procedures accounted for more than 80 percent of all bariatric surgical procedures. From 1998 to 2002, there were upward trends in the proportion of females (81 percent to 84 percent), privately insured patients (75 percent to 83 percent), patients from ZIP code areas with highest annual household income (32 percent to 60 percent), and patients aged 50 to 64 years (15 percent to 24 percent). Length of stay decreased from 4.5 days in 1998 to 3.3 days in 2002. The adjusted in-hospital death rate ranged from 0.1 percent to 0.2 percent. The rates of unexpected reoperations for surgical complications ranged from 6 percent to 9 percent and pulmonary complications ranged from 4 percent to 7 percent. Rates of other inhospital complications were low.

“If our observed rate of growth continues, there will be approximately 130,000 bariatric procedures in 2005 and as many as 218,000 in 2010. The cost to the U.S. healthcare system will be substantial. However, in the absence of a nonsurgical option for morbid obesity, our findings regarding in-hospital safety of bariatric surgery are promising while our findings regarding worsening sociodemographic disparities are worrisome,” the authors write.

“Disproportionate socio-cultural pressures to be thin may explain the imbalance between men and women undergoing an elective procedure for weight loss. Type of insurance coverage also may play a role in socioeconomic disparities,” the researchers write. “Other sources of disparities include the possibility that cultural attitudes toward morbid obesity may differ by socioeconomic status, that primary care physicians may be less likely to refer patients of lower socioeconomic status for bariatric surgery, or that hospitals providing bariatric surgery may be less accessible to lower socioeconomic groups.”

The researchers add that public health campaigns focusing on the health dangers of obesity may help shift thinking about obesity from a cosmetic concern of women to a health concern for both sexes.

“With increased knowledge of bariatric surgery indications, risks, and benefits among healthcare professionals, bariatric surgery is likely to become the standard of care for morbidly obese individuals. Together, these changes should lead to more morbidly obese patients of both sexes and all socioeconomic groups seeking surgery. Although preventing obesity should remain the focus of U.S. healthcare, efforts must be made to ensure equal access to bariatric surgery irrespective of sex and socioeconomic status for those who are morbidly obese, have an indication for surgical intervention, and wish to undergo an elective surgical procedure to improve health, longevity, and quality of life,” the authors conclude.

Reference: JAMA. 2005; 294:1909-1917