How We Added Lap-Band Surgery

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Find out if this cutting-edge weight-loss surgery is right for your facility.


For years, the medical community has been searching for a solution to the problem of chronic obesity. While the time-honored prescription of diet and exercise is still the first line of attack, there are many people for whom lifestyle changes alone are only somewhat effective and sometimes don't work at all, regardless of their commitment to achieving a healthy weight.

As a laparoscopic surgeon, I had researched weight-loss surgeries, including gastric bypass, for many years, but I was never convinced to add them to my surgical repertoire. I didn't doubt the procedures' effectiveness in achieving long-term, permanent weight loss, but I felt the mortality and morbidity rates were too high. Even when performed laparoscopically (as many weight-loss surgeries are), the procedures seemed too prone to complications, including leaks between the stomach and small bowel.

About two years ago, I learned of a new device called the Lap-Band, which the FDA approved in June 2001. This inflatable silicone band is placed around the upper portion of the stomach to create a small pouch. The band is connected to an access port that is sutured to the abdominal muscle wall. The access port lets the surgeon inject saline into the band, tightening it around the stomach. This causes the opening between the stomach pouch and the lower stomach to become smaller, limiting the amount of food the patient can eat. It also slows the rate at which food empties into the rest of the stomach. The patient eats less and feels satisfied more quickly, which causes weight loss.

As I researched the Lap-Band procedure, I learned of its three main advantages as compared to other obesity procedures:

  • It's less invasive. The procedure is entirely laparoscopic and can be done in about an hour, which means that patients spend less time under general anesthesia. Also, only the stomach is affected - unlike Roux-en-Y, there's no rerouting of the digestive tract.
  • It's adjustable and completely reversible. Patients who aren't losing enough weight can have their bands tightened. There also may be cases where patients need their bands loosened. For example, a patient who becomes pregnant can have her band loosened to allow for the nourishment of the fetus. Patients can also have their bands loosened to enable a physician to do an endoscopic exam. There's always the chance that researchers might develop an "obesity pill," making the need for surgery obsolete. If this happens, Lap-Band patients can get their devices removed and have no lasting effects on their bodies.
  • The risk of complications is lower. The most serious complication is that the band may erode through the stomach, but this is uncommon. The band can also slip from its position on the upper stomach - there's a 10 percent chance of this happening within the first two or three years, requiring laparoscopic replacement or removal of the band. The saline port may also flip over, requiring laparoscopic correction under local anesthesia. But because there's no rerouting of the digestive organs, fewer sutures and less anesthesia, the morbidity rate is very low overall, and certainly lower than those of other obesity surgeries.

Indications for Lap-Band Surgery

Individuals may be eligible for Lap-Band surgery if they

  • have a BMI of 40 kg/m2 or higher or weigh at least 100 pounds or more than their ideal weight.
  • have a BMI of at least 35 kg/m2 and have a significant medical condition that is linked to obesity.
  • have been overweight for more than five years.
  • have made serious attempts to lose weight and have had only short-term success.
  • do not have any other disease that may have caused their obesity.
  • are prepared to make substantial changes in eating habits and lifestyle.
  • are willing to undergo long-term follow-up care and monitoring.
  • do not drink alcohol in excess.
  • are at least 18 years old.

After watching a colleague perform the procedure, I decided that it was reasonably straightforward and used the skills I already had. I attended a training program offered by the Lap-Band's manufacturer, Inamed. The company requires that all surgeons interested in offering the surgery attend this program and perform at least two proctored procedures. I started doing the procedure in December 2002 and have performed 49 cases so far.

There's a great need for obesity surgery, so if you're thinking of offering it in your facility, chances are you won't be lacking for patients. But offering the surgery is only the first step. To help patients achieve long-term, permanent weight loss, you need to develop a comprehensive program with extensive pre-op, operative and long-term post-op care.

The pre-op process
Although this procedure may be done in a day surgery center on an outpatient basis, I prefer to do it in a full-service hospital and have patients stay overnight. Our hospital has all the laparoscopic equipment and instruments needed to do the procedure, as well as larger beds, surgical tables and other specialty equipment needed to handle obese patients. The hospital also provides conference-room space where we hold seminars to attract and educate prospective patients, which is the first crucial step of our program.

Our Lap-Band seminars are free and open to the public; also, all prospective patients who call our office about the procedure are encouraged to attend a seminar before making an appointment. At each seminar, I describe the procedure in detail, along with all potential risks and benefits and pre- and post-op regimens. I also make a point to describe the other operations commonly performed to treat morbid obesity, and how they compare to Lap-Band. The patients who take the next step and make a pre-op consultation appointment are highly knowledgeable about the procedure, and in most cases, they're already committed to following through.

After meeting patients one-on-one and determining whether they might be good candidates in a short pre-op visit, we schedule a "mega-appointment," which lasts about half a day. During this appointment, patients undergo extensive evaluations with a dietician, an exercise physiologist and a psychologist. We stress that the surgery is really only the first step - patients will have to commit to changing eating and exercising habits forever. To prepare them physically and mentally for surgery, we also put them on a strict three-week diet that consists of one small meal and two high-protein liquid meal supplements per day. The diet accomplishes three things: First, it helps patients lose an initial eight to 10 pounds, putting them on the road to successful weight loss. Second, it helps shrink the liver, which is usually very large and can make laparoscopy extremely difficult. Third, it tests patient commitment - patients who can't stay on the regimen probably won't be able to handle the even more stringent dietary restrictions after surgery.

Six to eight days before surgery, patients visit us again for a battery of pre-op tests, including an EKG and bloodwork. Then, when they are fully prepared (and when we've obtained the necessary insurance approvals), it's finally time for the procedure.

The Efficacy of LAGB

Laparoscopic adjustable gastric banding (LAGB) does not induce weight loss or resolve comorbidities as effectively as gastric bypass, the traditional surgical standard for obesity. Gastric bypass results in weight loss of about 68 percent of excess weight at one year, and patients tend to maintain the weight loss.[1] LAGB, according to a review of studies, induces weight loss of 45 percent at one year.[1] In my experience with 15 patients, LAGB resulted in average weight loss of 38.4 percent of excess weight at 36 months. Resolution of comorbidities is often much more dramatic with gastric bypass. One study showed that 90 percent of gastric bypass patients had significantly improved or resolved comorbidities,[2] and another study showed that 60 percent of patients with obesity-related comorbidity were free of medication for these comorbidities three years after surgery.[3] Recent research even suggests that the bypass itself may directly arrest the pathophysiologic process of type 2 diabetes, as it can induce rapid control of diabetes within days after surgery irrespective of weight loss.[4]

Further, different patients tend to respond very differently to LAGB, and we do not yet know which patients stand to benefit the most. In my experience with 15 patients, just 11 percent achieved at least a 50 percent reduction in excess weight. In another recent study of 115 patients, the average percent of excess weight loss varied tremendously - from 1.5 to 83 percent at nine months and from 1 to 98.7 percent at 12 months.[5] Some researchers are beginning to evaluate patient-selection criteria, and one study showed that patients with the following characteristics or conditions tended to lose less weight after LAGB: Older age, higher body mass index (BMI >50), hyperinsulinemia, insulin resistance, type 2 diabetes and polycystic ovary syndrome.[6]

- Eric J. DeMaria, MD

References
1. Msika S. Surgery of morbid obesity in the adult: Clinical efficacy of different surgical procedures. J Chir (Paris). 2002;139:194-204.
2. Brolin RE, Kenler HA, Gorman JH, Cody RP. Long-limb gastric bypass in the super-obese, a prospective randomized study. Ann Surg. 1992;215:387-395.
3. Hall JC, Watts JM, O'Brien PE, et al. Gastric surgery for morbid obesity. The Adelaide Study. Ann Surg. 1990;211:419-427.
4. Rubino F, Gagner M. Potential of surgery for curing type 2 diabetes mellitus. Ann Surg. 2002;236(5):554-559.
5. Ren CJ, Horgan S, Ponce J. US experience with the LAP-BAND system. Amer J Surg. 2002;184:46S-50S.
6. Dixon JB, O'Brien PE. Selecting the optimal patient for LAP-BAND placement. Am J Surg. 2002;184(6B):17S-20S.

The procedure
Patients arrive for the procedure two to three hours pre-op. We prep by putting support stockings on the legs and administering subcutaneous heparin to protect against deep vein thrombosis (DVT). We also administer a pre-op antibiotic to guard against infection. In the OR, we place sequential compression devices on the legs to further protect against DVT. We then administer general anesthesia.

The procedure itself involves making five incisions for the laparoscope and other instruments. After flushing the air out of the Lap-Band, it is placed around the uppermost part of the stomach, creating a pouch that holds about 15 to 30ccs. It is then secured by suturing the lower wall of the stomach to the upper stomach, creating a tunnel of tissue for the band that holds it in place. Finally, the saline port is placed under the fat layer of the abdominal wall. While the procedure isn't especially complex, it does have some tricky elements - in particular, positioning the band at exactly the right place on the stomach can be especially challenging.

After the procedure, we remove the endotracheal tube and recover patients from anesthesia and then bring them to the PACU, where they stay from 45 to 90 minutes. Afterward, some patients might feel they're fully recovered from the anesthesia, but I don't feel they're ready to leave yet. Obese patients have a significant risk of delayed narcotic effect that can cause respiratory suppression, and some patients may experience post-op edema around the surgical site that makes them unable to swallow anything, even fluids. Both of these conditions generally resolve on their own, but they require careful observation. Therefore, to monitor patients adequately, I keep all my patients in the hospital for at least one night.

Patients generally leave the hospital the next day and spend the next few weeks healing and adjusting to their new eating regimens, which they have designed with our dietician. I generally see them at one week post-op. After about six weeks, most of the post-op swelling has resolved, and some patients may even be reverting to their old eating habits. This is when our post-op program begins.

A customized fit
When I first place the Lap-Band, it doesn't contain any saline. For the first month after surgery, most patients will still lose weight because the device and the edema from the surgery make the opening between the pouch and the lower stomach smaller. As the edema resolves, the opening gets larger, and patients find that they can eat more. To maintain weight loss, we need to start gradually filling the band.

I perform adjustments in the office unless I can't feel the port easily, in which case I have patients come to the hospital so I can use C-arm fluoroscopy. Without fluoroscopy, the procedure takes about two minutes, but even with fluoro, it doesn't take more than a half-hour. First, I numb the area over the port, then use a non-coring needle and a small syringe to fill the band with 1.5ccs of fluid. After the first filling, I generally add only 0.2 to 0.3ccs of fluid at a time. The band can hold up to 4ccs of fluid, but most patients need only about 2.5ccs.

Even though adjustments are simple procedures, finding the proper fill volume takes time and patience on the part of the surgeon and the patient. Patients know that they are optimally adjusted when they feel full after eating a small appetizer-sized meal and are consistently losing at least one-to-two pounds per week. Most patients have about four adjustments before they achieve this level of success.

Results and reviews
When patients commit to the Lap-Band procedure, they learn to have realistic expectations. They know that achieving their ideal body weight, while possible, is not the goal. Rather, the aim is to lose enough weight so that they feel better and the medical conditions that are caused or made worse by their obesity, such as diabetes and hypertension, are improved or even resolved. On this level, our program has certainly been a big success. Since I started performing Lap-Band surgery about a year ago, my patients have lost an average of 45 pounds, and one patient has lost about 140 pounds so far. No patient has gained weight. More importantly, all patients who had high blood pressure, diabetes or other obesity-exacerbated conditions have seen some improvement, and 30 percent have been able to eliminate the medications they were taking for these conditions.

One of the biggest criticisms of the Lap-Band is that the weight doesn't come off as quickly or as completely as with other surgeries. But I don't believe that slower weight loss is a bad thing; in fact, I prefer that patients lose weight slowly to reduce unwanted after-effects, such as skin sagging. And I believe that if surgeons and patients commit to long-term post-op care, including the appropriate adjustments, they'll experience weight loss that is comparable to that experienced by other obesity-surgery patients. I suspect that one of the reasons that some may not be seeing optimal results with the Lap-Band is because the surgeons who perform this procedure may not be providing the necessary long-term post op care. Surgeons are not accustomed to developing long-term relationships with their patients, which is what this procedure requires.

Laparoscopic Gastric Banding: A New Paradigm for Obesity Surgery?

Eric J. DeMaria, MD
Richmond, Virginia

The prevalence of obesity - coupled with the fact that conservative weight-loss therapies are prone to failure - has caused some medical experts to consider broadening the role of bariatric surgery for the treatment of obesity. The long-held idea that bariatric surgery is a last resort for patients on the extreme end of the scale may soon go by the wayside. Laparoscopic adjustable gastric banding (LAGB, or the Lap-Band) is one potentially outpatient, minimally invasive procedure that is causing us to re-think this paradigm.

Although many surgeons who perform LAGB view the procedure as a first-line surgical intervention for obese patients requiring surgery, I believe LAGB will ultimately play a more refined role. Namely, the procedure may be useful as a surgical intervention designed to intercept excessive weight gain before it becomes life-threatening. Secondarily, it may serve as a surgical option for patients with advanced obesity who refuse more invasive intervention, like gastric bypass.

LAGB may be best suited as a surgical tool for obese patients whose disease is in the earlier stages because it is less effective than the current surgical standard, gastric bypass. Although LAGB induces less weight loss over a longer time than gastric bypass, the weight loss can be enough to effectively ward off morbid obesity and the development or advancement of its comorbidities. In fact, research shows that the longer a patient has obesity-related diabetes, the less likely surgery will resolve the condition. In addition, other research suggests that early surgical intervention on younger, healthier patients greatly reduces their risk of future surgery.

Here's what you need to consider if you're thinking about adding LAGB to your facility:

  • Patient selection. The efficacy of LAGB can vary drastically from patient to patient, and we do not yet have clear patient-selection criteria. In the outpatient setting, I recommend considering only those surgical candidates with the least significant disease, as these patients are typically less likely to have acute complications and may benefit the most from this surgery. By today's standards, we perform obesity surgery to induce weight loss and resolve comorbid conditions in patients who are morbidly obese [body mass index (BMI) '40], who have major obesity (BMI '35) with comorbidities or who have been obese for five years without weight control.
  • Hospital-based care. Since most candidates who qualify as outpatients currently require a 23-hour stay, and since obese patients often have comorbidities that complicate anesthesia - such as coronary artery disease, sleep apnea, diabetes, potential for thromboembolism and difficult airway management - surgeons should perform the procedure in a hospital-based setting. In addition, obese patients typically require such specialized equipment as larger OR tables, recovery beds and even toilets.

Ultimately, with time and experience, we may be able to operate on some of these patients in the freestanding surgical setting. Even in morbidly obese patients, the procedure takes just one hour and is technically less demanding, safer and less invasive than laparoscopic gastric bypass.

  • Complications. LAGB is associated with fewer surgical risks than gastric bypass (it avoids the risk of intestinal anastomosis, for example), but it is not benign. In one U.S. study of 115 patients, five patients experienced acute complications (stoma obstruction, pneumonia, conversion to open procedure, hemorrhage), five patients had wound infections and 12 patients experienced longer-term complications.
  • Reimbursement. The LAGB device costs about $3,000, roughly equivalent to the costs associated with gastric bypass. Insurers may be reluctant to reimburse for LAGB since it is not as effective. Currently, we define "medically significant" weight loss as that which induces resolution of comorbidities.

Dr. DeMaria ([email protected]) is the director of the Minimally Invasive Surgery Center, Virginia Commonwealth University, Richmond, Va.

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