BB&T Contributing Editor

LAS VEGAS – Well over a million Americans have had a bariatric surgery, and it has been reported that anywhere from 12% to 45% have experienced enough weight regain that an additional surgery needs to be performed. At this year's 27th annual American Association of Metabolic and Bariatric Surgeons (ASMBS; Gainesville, Florida) meeting, much discussion centered on re-treatment of patients who previously had a bariatric surgery. For one reason, those patients' gastro-intestinal anatomies has often been altered, so their surgical options are limited. Another reason to focus on these patients is that most experimental new technologies first evaluate their products on these patients because what have they got to lose but weight?

A conundrum: what procedure for which patients?

With a significant number of patients having weight re-gain following surgery, there is much speculation as to whether certain patients do better with certain procedures. In Europe, bands have been the most popular choice but recent trends show that bypass procedures are eroding the number of bands placed.

The exact opposite has been true in the U.S. With three major carriers (Cigna, United Healthcare, Aetna) now covering sleeve gastrectomy, that procedure is now cannibalizing both the band and the bypass procedures, since it is relatively simple and has shown good results. Three different studies were presented here comparing sleeve gastrectomy to bypass and/or bands. One study showed the sleeve comparable to bypass at 3 years. Another showed equivalence with bypass and superiority over band at 1.4 years. The third study showed bypass superior to sleeve at 1 year.

It appears as though the question of which procedure for which patient remains to be answered. In fact, a discussion as to whether the duodenal switch procedure — once considered to cause too severe malnutrition — will become more popular in the U.S. This was debated by Peter Crookes, MD, Department of Surgery, University of Southern California Medical Center (Los Angeles).

“Although the duodenal switch (DS) is considered to be the most drastic of all bariatric procedures, and has unique complications, the value of the surgery should not be obscured,“ said Crookes. “Oftentimes, the patient has talked the surgeon into performing the procedure after chatting online with other DS patients. It's almost like a cult,“ he claimed.

DS patients typically have sustained weight loss with no weight re-gain and no dumping; however, they will live the rest of their lives with extreme gas and diarrhea and must adhere to a strict vitamin regimen or they will suffer severe malnutrition. Some surgeons now require patients who ask for the DS surgery to take Zenical for 3 months in order to experience what their new life will be like. The majority of those patients select another procedure following their Zenical trial. Surgeons are beginning to evaluate the benefit of having a safer surgery such as a band or bypass where, in some instances, up to 40% of the patients may have weight regain; or allow the patient to undergo a less safe procedure but where there is little possibility of weight regain.

The problem of DS is similar yet different than the same problem seen with bands and bypasses, and that is patient compliance. Most surgeons agree that it is not the surgeries that fail but rather the patients that fail due to non-compliance with their new lifestyle requirements. With bands and bypasses, compliance means a watchful diet and exercise, while with DS patients it means a strict regimen of vitamin supplements. In band and bypass patients, the consequences of non-compliance are weight regain and possible revision surgery; while with DS patients it means severe malnutrition. In Italy, where doctors are respected like gods and patients follow their instructions, the DS procedure is frequently used and the patients live long and full lives. Americans are less likely to follow instructions with gives rise for concern among U.S. surgeons to perform the procedure.

Bariatric practices that employ an integrated health program with continual post-op support for the patients – regardless of which procedure is performed – have significantly better results. Lack of compliance it seems, and not necessarily obesity, is the American chronic disease.

Although difficult to predict, it is critical that patients and surgeons select the best procedure for that specific patient because they only get one chance for reimbursement. Insurance companies require patients sign an agreement stating that they understand another bariatric surgery for weight re-gain will not be covered.

“Weight re-gain is widely under-reported,“ said Dean Mikami, MD, Ohio State University Medical Center (Columbus), who defined weight regain as either 20% re-gain of the lost weight after surgery, or regain of 50% of the excess weight loss. Studies have shown anywhere from a 15% to 50% of weight re-gain at two years following surgery. He noted, “Revision endoluminal surgery needs to be performed at 2-4 years after a “weight creep.“ If you wait longer, the results will be poor.“

Ethicon-Endosurgery sponsored an industry symposium on “Understanding the Mechanisms of Action in Obesity Surgery“ where Lee Kaplan, MD, PhD, Associate Professor of Medicine, Massachusetts General Hospital, Boston, Massachusetts, described physiologic and genetic underpinnings of the disease. Kaplan feels that a better understanding of the basic science behind the disease should lead to improved options for re-treatment of failed surgical patients, as well as for development of new technologies. Kaplan showed research data that demonstrated the “set point“ theory that individuals are genetically programmed for a set weight even when over or under fed. He showed the results of a study in mice where some were over fed and some were under fed, and during that process the overfed ones gained weight while the underfed ones lost weight. As soon as the mice were allowed to eat freely, they all returned to their original “set“ weight. Obesity results when the body's set point is “off“, which may be accountable for by mutations found on chromosome 6; a recent finding that researchers have been able to identify. Kaplan believes that bariatric surgery drives the body back to the “set point“ for patients but the faulty chromosome 6 remains, allowing them to regain the weight unless they stick to a lifestyle change in order to keep the weight off. He concluded, “Advancements in basic science will drive a rapid impact on surgery.“

Alan Wittgrove, MD, Bariatric Surgery, University of California San Diego Medical Center, (San Diego), considered to be the “father“ of the laparoscopic Roux-en-Y procedure, has recently gone into academics from private practice; or as he called it, “I went from Town to Gown.“ With regard to having to perform revision surgery on patients for weight re-gain, he stated, “There is no algorithm of which patient will do better with which procedure. It is important that we understand that the operations have longevity but that the patients' genetics and ability for compliance is what may fail. Obesity is a chronic disease, so naturally there will be failures.“ The interest in the area of revision surgery has grown; it is becoming apparent that with almost 2 million Americans having had the surgery, the numbers of failures has also grown. One clear fact is that there is a much higher rate of success with an integrated health (IH) approach, both pre-operatively to screen for appropriate patients, as well as for post-op support to assist the patient in maintaining their new lifestyle. Several surgeons said that the first thing they do when a patient starts to re-gain weight is to re-enroll them in an integrated health program. Integrated health includes cognitive behavior counseling, nutrition training, physical exercise programs, support groups, hunger management, psychiatric counseling, and/or medical management. Another first line of defense following weight re-gain is to use medical management (such as Phenteramine) after surgery, just like the patient probably tried prior to surgery. According to Wittgrove, medical management after weight re-gain following bariatric surgery often works quite well in some patients. Medical management and integrated therapy are two frontline options for treating weight re-gain prior to jumping into a revision surgery. Other options are to convert a failed band to a bypass, or add another surgical procedure if necessary. Patient education, which drives compliance, is key to success, which explains why all of the integrated health seminars at this meeting were sold out.

Once it is determined that revision surgery is necessary, new trans-orally delivered devices designed for primary weight loss are actually being tried first as a revision procedure. Without long term data, bariatric surgeons are more amenable to trying a new device on a patient that has already had a bariatric procedure than on a patient who needs a primary procedure. Mitch Roslin, MD, Bariatric Surgeon, Lenox Hill Hospital, (New York) in the same industry symposium said, “The least invasive procedure that allows even a modest weight loss and has reduced mortality and morbidity (than surgery) is okay to do.“

Roslin continued with a synopsis of less-invasive new devices in various states of development and cautioned that so far two trials, and possibly a third, have not met their endpoint, which makes it difficult for investors to continue to invest in this area without seeing any successes yet. He, as well as others, also alluded to the fact that eventually we may see a cosmetic market develop here in the U.S. for those products that may be considered a failure for obese patients could be considered successful for lower body mass index (BMI) patients (27-35 BMI) who just want to lose 20 pounds, even temporarily. Roslin grouped his new technologies by whether they acted by restriction, filled stomach space, or blocked the duodenum (See Table 1). It should be noted that all of these treatments are delivered trans-orally.

When it comes to space-filling products, “Old ideas always seem to get reinvented. We now have “Sons of Balloons“ being introduced,“ claimed Roslin. For the most part, these all seem to be short term, six-month devices that may be better suited for the cosmetic, cash pay market rather than to treat a chronic disease, although the concept of serial implants for the chronically obese has not yet been ruled out. Some reports from Europe, where balloons are widespread, claim that patient acceptance is beginning to wane due to severe nausea and vomiting the first month or so after implant. Although devices that can help achieve weight loss may work for both the severely obese as well as the modestly obese or even just heavy patient, the standards for each are quite different (See Table 2).

A postgraduate course on emerging technologies included presentations and discussions of single incision laparoscopic surgery, flexible endoscopy, and emerging endoluminal procedures. Demonstrating the enthusiasm for this topic, the ballroom must have held 300 people and was filled at 7 a.m. – in Las Vegas!

Mikami framed the content of the seminar by reviewing the results of an ASMBS membership survey published late 2008. The objective of the survey was to establish an acceptable level of risk and weight loss for primary and revision bariatric endoluminal procedures currently being developed. The survey was to also evaluate the expectations and concerns among bariatric surgeons regarding these novel procedures. More than 214 questionnaires were returned and tabulated (See Table 3).

The primary concern about trying a new device was unproven efficacy, followed by durability, poor weight loss, availability of equipment, and procedural risk. A majority of 58% would not be willing to recommend an endoluminal procedure until the efficacy has been established, regardless of the risk.

While the surgeons identified unproven efficacy as their main concern regarding new procedures, patients have identified not wanting surgery as their primary concern about having a conventional bariatric surgery. Clinical studies should hopefully bring these two groups together in order to start addressing the needs of 99% of our current obese population that qualify for surgery but don't get it.

Covidien, who hosted an industry symposium, has determined that only about 25% of all patients attending a seminar on bariatric surgery actually go on to have the surgery. Morbidly obese patients face major hurdles to access to bariatric/metabolic surgery; requiring a well-planned and coordinated effort by a multidisciplinary bariatric surgery team along with a network of other healthcare providers. Most patients have to navigate the tedious system themselves and often result in opting out of the surgery because the barriers are too great. In an attempt to capture a greater percentage of interested patients, Covidien has developed a software program “Seminar2Surgery“ that helps bariatric practices capture more patients. It is an exclusive, comprehensive, patient flow management solution designed to overcome the barriers that prevent patients, who are qualified and willing, from pursuing the surgery. Depending on the insurance carrier, 9 to 15 milestones must be navigated in order for a patient to qualify for surgery. This web-based patient management system helps drive the patients through the emotional and logistical barriers that they face prior to being approved for surgery. One practice that tried the Seminar2Surgery program reported a 30% improvement in conversions in getting their patients from a seminar to surgery. There are other such programs available, but Covidien claims that theirs is the only one that automatically steers the patients to the next step of their process. Seminar2surgery also collects data relating to what happened to the approximately 70% that did not get the surgery, providing the practice feedback as to where the root causes of failure are.

A new study presented here showed that those health insurance providers that required patients to compete a six-month medical weight loss program before bariatric surgery do no better than patients who have no such requirement. The study showed that insurance mandated medical weight loss programs demonstrated no clinical benefits over what patients normally do to prepare for bariatric surgery. “The most significant thing they seemingly do is unnecessarily delay surgery, which could be potentially harmful to patients,“ said Timothy Kuwada, MD, Carolinas Medical Center (Charlotte, North Crolina), the study's lead investigator who performed all the surgeries in the study.

Another new study presented at ASMBS showed patients denied bariatric surgery by their insurer developed a host of new obesity-related diseases and conditions including Type 2 diabetes, hypertension, and obstructive sleep apnea within three years. Several studies in past years have documented the cost effectiveness of bariatric surgery over medical management as well as the improved health benefits. It seems odd that in light of that information, insurers are still resistant to cover the surgery, unless they are just fighting the high cost per procedure. If that is the case, then the opportunity for less-invasive, less costly new devices should be welcomed by carriers once data is established.

Another cause for delay of getting the surgery is if a healthcare carrier doesn't cover bariatric surgery, or the type of surgery the patient desires, such as the newly popular sleeve gastrectomy. Several major carriers, including Aetna, Cigna, and United Healthcare, now cover this more recent entry into laparoscopic bariatric surgery, but many of the smaller carriers still do not cover it. Industry estimates that in the next five years about 300,000 Americans will have bariatric surgery annually with about one-third of those having a sleeve gastrectomy.

In a show of hands at an industry symposium hosted by Covidien (Dublin, Ireland), surgeons indicated that about half of the patients that come to a seminar for information on bariatric surgery do not have insurance coverage. Interestingly but not surprising given the current state of the economy, there were many medical procedure-leasing companies at the exhibit hall. According to Marc Morgan of Medical Financing, “Bariatrics is our second largest market next to the cosmetic surgery one.“ Medical Financing is a privately held company established in 1990 that focuses strictly on medical procedures, unlike many other medical financing companies that are often divisions of large finance firms. Morgan stated, “About 70% of all bariatric practices have some form of financing for their patients. It's become a necessity.“ The newer market, he said, was that now hospitals – not just private practices – are signing up for financing packages for their patients.