Aetna considers open or laparoscopic vertical banded gastroplasty VBG medically necessary for members who meet the selection criteria for obesity surgery and who are at increased risk of adverse consequences of a RYGB due to the presence of any of the following co-morbid medical conditions:. These investigators presented a case report of a year old female with a maximum BMI of Relative risk of death over 10 years for white men left and women right who have never smoked in the United States by BMI. Mean baseline BMI was These investigators abstracted data regarding post-operative IH development, surgical site infection, and seroma or wound leakage and performed a meta-analysis.
There is rarely a good reason why obese patients even super obese patients can not delay surgery in order to undergo behavioral modification to improve their dietary and exercise habits in order to reduce surgical risks and improve surgical outcomes.
The patient may be able to lose significant weight prior to surgery in order to improve the outcome of surgery. Obesity makes many types of surgery more technically difficult to perform and hazardous. Weight loss prior to surgery makes the procedure easier to perform.
Weight reduction reduces the size of the liver, making surgical access to the stomach easier. By contrast, the liver enlarges and becomes increasingly infiltrated with fat when weight is gained prior to surgery.
A fatty liver is heavy, brittle, and more likely to suffer injury during surgery. Moreover, following surgery, patients have to follow a careful diet of nutritious, high-fiber foods in order to avoid nutritional deficiencies, dumping syndrome, and other complications. The total weight loss from surgery can be enhanced if it is combined with a low-calorie diet.
For these reasons, it is therefore best for patients to develop good eating and exercise habits before they undergo surgery. The pre-operative surgical preparatory regimen should include cessation counseling for smokers.
The National Institutes of Health Consensus Statement states that all smokers should be encouraged to quit, regardless of weight. Smoking cessation is especially important in obese persons, as obesity places them at increased risk for cardiovascular disease. Severely obese persons are at increased risk of surgical complications. Smoking cessation reduces the risk of pulmonary complications from surgery. Ideally, the surgical center where surgery is to be performed should be accomplished in bariatric surgery with a demonstrated commitment to provide adequate facilities and equipment, as well as a properly trained and funded appropriate bariatric surgery support staff.
Minimal standards in these areas are set by the institution and maintained under the direction of a qualified surgeon who is in charge of an experienced and comprehensive bariatric surgery team. This team should include experienced surgeons and physicians, skilled nurses, specialty-educated nutritionists, experienced anesthesiologists, and, as needed, cardiologists, pulmonologists, rehabilitation therapists, and psychiatric staff.
The American College of Surgeons ACS has stated that the surgeon performing the bariatric surgery be committed to the multidisciplinary management of the patient, both before and after surgery.
There is active collaboration with multiple patient care disciplines including nutrition, anesthesiology, cardiology, pulmonary medicine, orthopedic surgery, diabetology, psychiatry, and rehabilitation medicine. Appropriate technical skills in the performance of bariatric surgical procedures are acquired. A number of studies have demonstrated a relationship between surgical volumes and outcomes of obesity surgery. Most recently, an assessment by the Canadian Agency for Drugs and Technologies in Health CADTH Klarenbach et al, stated that their volume-outcome review found that higher surgical volumes were associated with better clinical outcomes.
CADTH was not, however, able to identify specific thresholds for surgical volume that were associated with better clinical outcomes. A Multidisciplinary Care Task Group Saltzman et al, conducted a systematic review of the literature to to provide evidence-based guidelines for patient selection and to recommend the medical and nutritional aspects of multi-disciplinary care required to minimize peri-operative and post-operative risks in patients with severe obesity who undergo weight loss surgery.
The Task Group recommended multi-disciplinary screening of weight loss surgery patients to ensure appropriate selection; pre-operative assessment for cardiovascular, pulmonary, gastrointestinal, endocrine, and other obesity-related diseases associated with increased risk for complications or mortality; pre-operative weight loss and cessation of smoking; peri-operative prophylaxis for deep vein thrombosis and pulmonary embolism PE ; pre-operative and post-operative education and counseling by a registered dietitian; and a well-defined post-surgical diet progression.
Multi-disciplinary assessment and care to minimize short- and long-term risks include: A Multidisciplinary Care Task Group Saltzman et al, recommended that operative candidates must be committed to the appropriate work-up for the procedure and to continued long-term post-operative medical management.
They must also be able to understand, and be adequately prepared for, potential complications. The Task Group recommended to decide on a case-by-case basis whether to proceed with surgery in patients who are unable to lose weight. The Task Group stated that registered dietitians are best qualified to provide nutritional care, including pre-operative assessment and post-operative education, counseling, and follow-up.
Weight loss surgery patients need to learn important new skills, including self-monitoring and meal planning. Many forms of weight loss surgery require patients to take lifelong nutritional supplements and to have lifelong medical monitoring.
Dedicated dietitians can help patients during their pre-operative education on new dietary requirements and stipulations and their post-surgical adjustment to those requirements. The Task Group also recommended a pre-operative assessment for micronutrient deficiencies.
The Task Group recommended that smokers should be encouraged to stop, preferably at least 6 to 8 weeks before surgery Saltzman et al, Patients should be encouraged to remain non-smokers after weight loss surgery to reduce the negative long-term health effects of smoking. Anderin et al found that weight loss before bariatric surgery is associated with marked reduction of risk of postoperative complications. Corresponding values in the 25th, 50th, and 75th percentile were 0.
Complications were noted in 9. Similarly, however, less pronounced risk reductions were found when comparing patients in the 50th with those in the 25th percentile of pre-operative weight loss. For patients in the highest range of body mass index BMI , the risk reduction associated with pre-operative weight loss was statistically significant for all analyzed complications, whereas corresponding risk reductions were only occasionally encountered and less pronounced in patients with lower BMI.
Surgery for severe obesity is usually considered an intervention of last resort with patients having attempted other forms of medical management such as behavior change, increased physical activity and drug therapy but without achieving permanent weight loss Colquitt et al, ; NIH, Ideally patients selected for surgery should have no major perioperative risk factors, a stable personality, no eating disorders, and have lost some weight prior to surgery. The patient's ability to lose weight prior to surgery makes surgical intervention easier and also provides an indication of the likelihood of compliance with the severe dietary restriction imposed on patients following surgery.
The NIH Consensus Conference on Surgical Treatment of Morbid Obesity states that obesity surgery should be reserved only for patients who have first attempted medical therapy: The Consensus Conference stated: If this goal is achieved, further weight loss can be attempted, if indicated through further evaluation.
The NIH Consensus Conference has stated that the patient should begin a nutrition and exercise program prior to surgery: The American Dietetic Association , in their position statement obesity surgery, recommends dietetic counseling and behavioral modification commencing prior to, not after, surgery: A preoperative behavior change program with psychological evaluation should be required.
Candidates for obesity surgery should begin a weight reduction diet prior to surgery. Obesity itself increases the likelihood of pulmonary complications and wound infections Choban et al, ; Abdel-Moneim, ; Holley et al, ; Myles et al, ; Nair et al, ; Bumgardner et al, ; Perez et al, ; Chang et al, ; Printken et al, Even relatively modest weight loss prior to surgery can result in substantial improvements in pulmonary function, blood glucose control, blood pressure, and other physiological parameters Anderson et al, ; Hakala et al, ; Kansanen et al, ; Pekkarinen et al, Factors such as blood glucose control, hypertension, etc.
Garza explained that the patient should lose weight prior to surgery to reduce surgical risks. Patients ought to be encouraged to lose as much weight as possible before surgery" Garza, Although the long-term effectiveness of weight reduction programs has been questioned, the Institute of Medicine has reported the substantial short-term effectiveness of certain organized physician-supervised weight reduction programs.
For maximal benefit, dieting should occur proximal to the time of surgery, and not in the remote past to reduce surgical risks and improve outcomes. Even if the patient has not been able to keep weight off long-term with prior dieting, the patient may be able to lose significant weight short term prior to surgery in order to improve the outcome of surgery. Given the importance of patient compliance in diet and self-care in improving patient outcomes after surgery, the appropriateness of obesity surgery in noncompliant patients should be questioned.
The American College of Surgeons has stated: These procedures are not for cosmesis but for prevention of the pathologic consequences of morbid obesity. The patient must be committed to the appropriate work-up for the procedure and for continuing long-term postoperative medical management, and understand and be adequately prepared for the potential complications of the procedure. Screening of the patients to ensure appropriate selection is a critical responsibility of the surgeon and the supporting health care team.
The Task Group stated that registered dietitians are best qualified to provide nutritional care, including pre-operative assessment and nutritional education and counseling. The Task Group also noted that weight loss surgery is contraindicated in those who are unable to comprehend basic principles of weight loss surgery or follow operative instructions. Obesity surgery is not indicated for persons with transient increases in weight Collazo-Clavell, Children and adolescents are rapidly growing, and are therefore especially susceptible to adverse long-term consequences of nutritional deficiencies from the reduced nutrient intake and malabsorption that is induced by obesity surgery.
It is not known whether the benefits of obesity surgery in children and adolescents outweigh the increased risks. According to a panel of experts Inge et al, ; Lawson et al, , bariatric surgery may be an appropriate treatment for severe obesity in adolescents who have completed bone growth. According to the recommendations by the expert panel, potential candidates for bariatric surgery should be referred to centers with multi-disciplinary weight management teams that have expertise in meeting the unique needs of overweight adolescents.
Consideration for bariatric surgery is generally warranted only when adolescents have experienced failure of 6 months of organized weight loss attempts and have met certain criteria: Surgery should only be performed at facilities that are equipped to collect long-term data on clinical outcomes.
The panel recommended the Roux-en-Y gastric bypass method of surgery over the simpler, newer technique of implanting an adjustable gastric band since gastric bands are less effective and younger patients would probably need replacement as they age.
There is established evidence that medical supervision of a nutrition and exercise program increases the likelihood of success Blackburn, In cases of suspected cirrhosis, biopsy may be indicated. Cazzo et al stated that non-alcoholic fatty liver disease NAFLD is common among subjects who undergo bariatric surgery and its post-surgical improvement has been reported. This study aimed to determine the evolution of liver disease evaluated through NAFLD fibrosis score 12 months after surgery.
It is a prospective cohort study which evaluated patients immediately before and 12 months following Roux-en-Y gastric bypass RYGB. Mean score decreased from 1. Resolution was statistically associated with female gender, percentage of excess weight loss, post-surgical BMI, post-surgical platelet count, and diabetes resolution.
The authors concluded that as previously reported by studies in which post-surgical biopsies were performed, RYGB leads to a great resolution rate of liver fibrosis. Since post-surgical biopsy is not widely available and has a significant risk, calculation of NAFLD fibrosis score is a simple tool to evaluate this evolution through a non-invasive approach.
Shalhub et al noted that non-alcoholic steatohepatitis NASH commonly occurs in obese patients and predisposes to cirrhosis.
Prevalence of NASH in bariatric patients is unknown. The aim of this study was to determine the role of routine liver biopsy in managing bariatric patients.
One pathologist graded all liver biopsies as mild, moderate or severe steatohepatitis. NASH was defined as steatohepatitis without alcoholic or viral hepatitis. Consecutive liver biopsies were compared to those liver biopsies selected because of grossly fatty livers. The two groups were similar in age, gender, and BMI. Both groups had a similar prevalence of cirrhosis. The authors concluded that routine liver biopsy documented significant liver abnormalities in a larger group of patients compared with selective liver biopsies, thereby suggesting that liver appearance is not predictive of NASH.
Liver biopsy remains the gold-standard for diagnosing NASH. The authors recommended routine liver biopsy during bariatric operations to determine the prevalence and natural history of NASH, which will have important implications in directing future therapeutics for obese patients with NASH and for patients undergoing bariatric procedures.
Arun et al stated that NAFLD is a chronic condition that can progress to cirrhosis and hepatocellular cancer. Currently, the only method to diagnose NASH is with a liver biopsy; however, sampling error may limit diagnostic accuracy. These researchers investigated the discordance of paired liver biopsies in individuals undergoing gastric bypass. The mean specimen size number of PTs for group 1 was The authors concluded that the results demonstrate that significant sampling variability exists in class 2 and 3 obese individuals undergoing screening liver biopsies for NAFLD.
The degree and histopathological discordance is dependent upon zonal location and types of injury. Nevertheless, a mm biopsy specimen without zone 3 cellular ballooning or fibrosis appears adequate to exclude the diagnosis of NASH. Surgery for obesity, termed bariatric surgery, includes gastric restrictive procedures and gastric bypass.
The gastric restrictive procedures include vertical banded gastroplasty accompanied by gastric banding which attempt to induce weight loss by creating an intake-limiting gastric pouch by segmenting the stomach along its vertical axis. The process of digestion is more or less normal.
Vertical banded gastroplasty VBG , a purely restrictive procedure, has fallen into disfavor because of inadequate long-term weight loss. Roux-en-Y gastric bypass RYGB combines restriction and malabsorption principles, and combines gastric segmentation along its vertical axis with a Roux-en-Y procedure, such that the food bypasses the duodenum and proximal small bowel.
Long-limb RYGB is similar to standard RYGB, except that the limb through which food passes is longer and is often used to treat super obese individuals. Because the normal flow of food is disrupted, available literature indicates that there is a greater potential for metabolic complications compared to gastric restrictive surgeries, including iron deficiency anemia, vitamin B deficiency and hypocalcemia, all of which can be corrected by oral supplementation.
Several studies have suggested that RYGB is a more effective weight loss procedure than VBG, offering the best combination of maximum weight control and minimum nutritional risk Sugerman et al, ; Howard et al, Pories et al reported Thus, the RYGB is "the current procedure of choice for patients requiring surgery for morbid obesity" Barrow; However, RYGB is associated with significantly more weight loss, and has become the procedure of choice for obesity surgery.
Gentileschi et al systematically reviewed the published literature on open and bariatric laparoscopic obesity surgery and concluded that the available evidence indicates that laparoscopic VBG and laparoscopic RYGB are as effective as their open counterparts. The assessment found that open and laparoscopic RYGB induces similar amounts of weight loss.
However, the assessment found that the profile of adverse events differs between the two approaches. Laparoscopic RYGB is a less invasive approach that results in a shorter hospital stay and earlier return to usual activities. The assessment found that the estimated mortality rate was low for both procedures, but somewhat lower for laparoscopic surgery than open surgery 0. The report found, on the other hand, that open surgery had higher rates of cardiopulmonary complications 2.
Regarding long-term adverse events, the rates of reoperation 9. A decision memorandum from the Centers for Medicare and Medicaid Services CMS, concluded that the evidence is sufficient that open and laparoscopic RYGB is reasonable and necessary for Medicare beneficiaries who have a BMI greater than 35 and have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity.
The assessment concluded that the evidence is not adequate to conclude that open or laparoscopic vertical banded gastroplasty is reasonable and necessary and they are therefore non-covered for all Medicare beneficiaries. Procedures that are mainly diversionary e. While appropriate surgical procedures for severe obesity primarily produce weight loss by restricting intake, intestinal bypass procedures produce weight loss by inducing a malabsorptive effect. The BPD was designed to address some of the drawbacks of the original intestinal bypass procedures, which resulted in unacceptable metabolic complications of diarrhea, hyperoxaluria, nephrolithiasis, cholelithiasis and liver failure.
The duodenal switch DS is a variant of the BPD procedure with a vertical subtotal gastrectomy and pylorus preservation, which eliminates the "dumping syndrome". The duodenum is divided just beyond the pylorus. The small bowel is then divided, and the end going to the cecum of the colon is connected to the short stump of the duodenum. This becomes the "enteral limb". The other end, leading from the gallbladder and pancreatic ducts, is connected onto the enteral limb at about 75 to cm from the iliocecal valve.
This limb is the "biliopancreatic limb". Some have advocated use of the DS procedure in the super-obese i. Patients who have this operation must have lifelong medical follow-up, since the side effects can be subtle, and can appear months to years after the surgery. Gastroplasty, more commonly known as "stomach stapling" and not to be confused with vertical banded gastroplasty VBG , is a technically simple operation, accomplished by stapling the upper stomach to create a small pouch into which food flows after it is swallowed.
The outlet of this pouch is restricted by a band of synthetic mesh, which slows its emptying, so that the person having it feels full after only a few bites of food. According to the available literature, patients who have this procedure seldom experience any satisfaction from eating, and tend to seek ways to get around the operation by eating more.
This causes vomiting, which can tear out the staple line and destroy the operation. Studies have reported that many patients must undergo another revisional operation to obtain the results they seek. It is often the first step in a 2-stage procedure when performing RYGB or duodenal switch. The report stated that the incidence of gastric sleeve dilatation appears to be an uncommon event, but the evidence is far from conclusive at this point.
A randomized controlled clinical trial comparing short-term 1-year outcomes of laparoscopic sleeve gastrectomy to laparoscopic RYGB found comparable reductions in body weight and BMI Karamanakos et al, This study was poorly reported, failing to discuss inclusion criteria for the trial and adverse events associated with the procedures.
The study also found that sleeve gastrectomy was associated with more severe complications than LASGB. The assessment noted that, due to limited evidence and poor quality of the trials comparing each pair of procedures, these conclusions should be viewed with caution. The CTAF assessment reported that the results of multiple case series and retrospective studies have suggested that sleeve gastrectomy as a primary procedure is associated with a significant reduction in excess weight loss.
The CTAF assessment found few comparative studies of sleeve gastrectomy. The CTAF assessment stated that, "[t]o date, long term outcomes from registry studies are relatively limited, but longer term follow-up will provide additional important information. Although the basic concept of gastric bypass remains intact, numerous variations are being performed at this time. Recent data demonstrate that surgeons are moving from simple gastroplasty procedures, favoring the more complex gastric bypass procedures as the surgical treatment of choice for the severely obese patient.
The gastric bypass operation can be modified, to alter absorption of food, by moving the Roux-en-Y-connection distally down the jejunum, effectively shortening the bowel available for absorption of food. The weight loss effect is then a combination of the very small stomach, which limits intake of food, with malabsorption of the nutrients, which are eaten, reducing caloric intake even further. In a sense, this procedure combines the least desirable features of the gastric bypass with the most troublesome aspects of the biliopancreatic diversion.
Although patients can have increased frequency of bowel movements, increased fat in their stools, and impaired absorption of vitamins, recent studies have reported good results. The loop gastric bypass developed years ago has generally been abandoned by most bariatric surgeons as unsafe.
Although easier to perform than the RYGB, it has been shown to create a severe hazard in the event of any leakage after surgery, and seriously increases the risk of ulcer forrmation, and irritation of the stomach pouch by bile.
Recent advances in laparoscopy have renewed the interest in gastric banding techniques for the control of severe obesity. The claimed advantage of LASGB is the adjustability of the band, which can be inflated or deflated percutaneously according to weight loss without altering the anatomy of the stomach.
This method entails encircling the upper part of the stomach using bands made of synthetic materials, creating a small upper pouch that empties into the lower stomach through a narrow, non-stretchable stoma. The reduced capacity of the pouch and the restriction caused by the band diminish caloric intake, depending on important technical details, thus producing weight loss comparable to vertical gastroplasties, without the possibility of staple-line disruption and lesser incidence of infectious complications.
However, distension of the pouch, slippage of the band and entrapment of the foreign material by the stomach have been described and are worrisome. Regarding performing adjustable gastric banding as an open procedure, the CMS decision memorandum concluded that the evidence is not adequate to conclude that open adjustable gastric banding is reasonable and necessary and therefore this procedure remains noncovered for Medicare beneficiaries.
The "mini gastric bypass" has been promoted as a new surgical treatment for severe obesity. While the name mini gastric bypass implies "small" and "simple", this is a major surgical procedure. The mini-gastric bypass uses a jejunal loop directly connected to a small gastric pouch, instead of a Roux-en-Y anastomosis. In this way, the mini-gastric bypass is similar to the loop gastric bypass; the latter procedure that has been abandoned by bariatric surgeons because of its inherent risks.
Specifically, performing a loop, rather than a Roux-en-Y, anastomosis to a small gastric pouch in the stomach may permit reflux of bile and digestive juice into the esophagus where it can cause esophagitis and ulceration, and may thus increase the risk of esophageal cancer. The Roux-en-Y modification of the loop bypass was designed to divert bile downstream, several feet below the gastric pouch and esophagus to minimize the risk of reflux.
The trend towards use of Roux-en-Y and away from loop gastric bypass was based on sound surgical experience of multiple surgeons with large series of patients. The published evidence supporting the mini-gastric bypass comes from descriptive reports and case series; the potential biases inherent in reports of case series are well known in clinical epidemiology. The evidence for the mini gastric bypass has come from a single investigator, thus raising questions about the generalization and validity of the reported findings.
The mini-gastric bypass has not been subjected to a prospective clinical outcome study in peer-reviewed publication. The Fobi pouch, developed by California surgeon Mathias A.
Fobi, is a modification of gastric bypass surgery. The modifications to gastric bypass surgery are designed to prevent post-surgical enlargement of the gastric pouch and stoma. In a traditional gastric bypass procedure, surgeons create a smaller stomach by stapling off a large section.
A problem with the traditional procedure is that the staples can break down, causing the stomach to regain its original shape -- and patients to start gaining weight again. Also, the stomach opening that leads into the intestines, which in surgery is made smaller to allow less food to pass through, often stretches as the years go by. With the Fobi pouch, there is no use of staples; rather, the stomach is bisected and hand-sewn them to maintain the separation.
A synthetic band is placed around the stomach opening to keep it from stretching. However, there is a paucity of direct comparative studies of the Fobi pouch to traditional gastric bypass surgery, causing colleagues to "question whether his technique is really an improvement on the traditional procedure" Davis, All of the published literature has been limited to descriptive articles, case series, and a prospective non-randomized controlled study.
These studies were from a single group of investigators, raising questions about the generalization of the findings. The intragastric balloon also known as the silicone intragastric balloon or SIB has been developed as a temporary aid for obese patients who have had unsatisfactory results in their clinical treatment for obesity and super obese patients with higher surgical Fernandes et al, Intragastric balloon is intended to reduce gastric capacity, causing satiety, making it easier for patients to take smaller amounts of food.
Randomized, controlled clinical studies, however, have found no increase in weight loss with the intragastric balloon plus dieting versus dieting alone Rigaud et al, ; Geliebter et al, ; Mathus-Vliegen et al, ; Lindor et al, One non-randomized controlled clinical study that reported positive results reported that results were not maintained after gastric balloon removal Ramhamadany et al, In addition, the intragastric balloon has been associated with potentially severe adverse effects, including gastric erosion, reflux, and obstruction.
This new device is intended to facilitate weight loss in obese adult patients by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood. The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure.
The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation. Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach. Patients are advised to follow a medically supervised diet and exercise plan to augment their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal.
It is meant to be temporary and should be removed 6 months after it is inserted. In the study Ponce et al, , individuals randomly selected to receive the ReShape Dual Balloon lost Six months following the device removal, patients treated with the ReShape Dual Balloon device kept off an average of 9.
Potential side effects for the procedure include headache, muscle pain, and nausea from the sedation and procedure; in rare cases, severe allergic reaction, heart attack, esophageal tear, infection, and breathing difficulties can occur.
Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion. This device should not be used in patients who have had previous gastro-intestinal or bariatric surgery or who have been diagnosed with inflammatory intestinal or bowel disease, large hiatal hernia, symptoms of delayed gastric emptying or active H.
Pylori infection; those who are pregnant or use aspirin daily should also avoid the device FDA, It is unclear what benefit there is from a temporary reduction in weight. Furthermore, an UpToDate review on " Bariatric surgical operations for the management of severe obesity: Descriptions " Lim, lists intragastric balloon as an investigational procedure.
Popov and colleagues examined the effect of intra-gastric balloons IGBs on metabolic outcomes associated with obesity. Medline, Embase, and Cochrane Database were searched through July Dual extraction and quality assessment of studies using Cochrane risk of bias tool were performed independently by 2 authors.
Primary outcomes included the change from baseline in metabolic parameters. A total of 10 RCTs and 30 observational studies including 5, subjects were analyzed. There was moderate-quality evidence for improvement in most metabolic parameters in subjects assigned to IGB therapy as compared to conventional non-surgical therapy in RCTs: The rate of serious AES was 1.
The authors concluded that IGBs were more effective than diet in improving obesity-related metabolic risk factors with a low rate of AEs, however the strength of the evidence was limited given the small number of participants and lack of long-term follow-up. On August 10, , the FDA announced that it has received 5 reports of unanticipated deaths that occurred from to the present in patients who received a liquid-filled intra-gastric balloon system to treat obesity; 4 reports involve the Orbera Intragastric Balloon System Apollo Endosurgery and 1 report involves the ReShape Integrated Dual Balloon System ReShape Medical.
All 5 patients died within 1 month or less of balloon placement; 3 patients died 1 to 3 days after the balloon was placed. The FDA stated that "At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices e. The FDA has also received 2 additional reports of deaths from to the present related to potential complications associated with balloon treatment: As part of the ongoing, FDA-mandated post-approval studies for these devices, the FDA will obtain more information to help evaluate the continued safety and effectiveness of these approved medical devices Brooks, Both patients were at a high risk and could not undergo another open or laparoscopic surgery to correct the leaks that were not healing.
In a prospective, single-center, randomized, single-blinded study, Eid et al examined the safety and effectiveness of endoscopic gastric plication with the StomaphyX device versus a sham procedure for revisional surgery in RYGB performed at least 2 years earlier patients to reduce regained weight.
These researchers planned for patients to be randomized 2: Adverse events were recorded. One-year follow-up was completed by 45 patients treated with StomaphyX and 29 patients in the sham treatment group. Primary efficacy outcome was achieved by There was one causally related adverse event with StomaphyX, that required laparoscopic exploration and repair. The authors concluded that StomaphyX treatment failed to achieve the primary efficacy target and resulted in early termination of the study.
The American College of Obstetricians and Gynecologists' practice bulletin on bariatric surgery and pregnancy ACOG, stated that bariatric surgery should not be considered a treatment for infertility.
Fridley et al reviewed the literature on the effectiveness of bariatric surgery for obese patients with idiopathic intracranial hypertension IIH with regard to both symptom resolution and resolution of visual deficits. The published literature was reviewed using manual and electronic search techniques. Data from each relevant manuscript were gathered, analyzed, and compared. These included demographic data, pre- and post-operative symptoms, pre- and post-operative visual field deficits, bariatric procedure type, absolute weight loss, changes in BMI, and changes in cerebrospinal fluid CSF opening pressure.
A total of 11 relevant publications including 6 individual case reports were found, reporting on a total of 62 patients. The Roux-en-Y gastric bypass was the most common bariatric procedure performed. In 13 patients both pre- and post-operative CSF pressures were recorded, with an average post-operative pressure decrease of mm H 2 O. Changes in weight loss and BMI varied depending on the reported post-operative follow-up interval.
The authors concluded that the published Class IV evidence suggested that bariatric surgery may be an effective treatment for IIH in obese patients, both in terms of symptom resolution and visual outcome. They stated that prospective, controlled studies are needed for better elucidation of its role.
Levin and colleagues stated that IIH occurs most frequently in young, obese women. Gastric bypass surgery has been used to treat morbid obesity and its co-morbidities, and IIH has recently been considered among these indications. These investigators presented a case report of a year old female with a maximum BMI of She also developed migraine headaches.
After a waxing and waning course and various medical treatments, the patient underwent laparoscopic Roux-en-Y gastric bypass surgery with anterior repair of hiatal hernia. Dramatic improvement in IIH headaches occurred by 4 months post-procedure and was maintained at 1 year, when she reached her weight plateau with a BMI of This added to the small number of case reports and retrospective analyses of the successful treatment of IIH with gastric bypass surgery, and brought this data from the surgical literature into the neurological domain.
It offered insight into an early time course for symptom resolution, and explored the impact of weight-loss surgery on migraine headaches. The authors concluded that this treatment modality should be further investigated prospectively to analyze the rate of headache improvement with weight loss, the amount of weight loss needed for clinical improvement, and the possible correlation with improvement in papilledema.
Handley et al systematically reviewed the effect of bariatric weight reduction surgery as a treatment for IIH. These investigators performed a comprehensive literature search using the following databases: No restrictions were placed on these searches, including the date of publication.
A total of 85 publications were identified, and after initial appraisal, 17 were included in the final review. Post-operative lumbar puncture opening pressure was shown to decrease by an average of The authors concluded that bariatric surgery for weight loss is associated with alleviation of IIH symptoms and a reduction in intracranial pressure. Furthermore, an improvement was observed in patients where conventional treatments, including neurosurgery, were ineffective.
They stated that further prospective randomized studies with control groups and a larger number of participants are lacking within the published studies to date. Pujol Gebelli et al stated that laparoscopic gastric plication is a new technique derived from sleeve gastrectomy. Plication of the greater curvature produces a restrictive mechanism that causes weight loss. The results of the first cases where this technique has been applied in this hospital were presented.
Plication of the gastric greater curvature was performed under general anesthetic and by laparoscopy using 3 lines of sutures and with an orogastric probe as a guide. Results of the morbidity, mortality and weight loss were presented.
A total of 13 patients were operated on 7 women. The maximum BMI varied between The most frequently found morbidity was nausea and vomiting. The authors concluded that laparoscopic gastric plication is a new surgical technique which gives equivalent short-term results as vertical gastrectomy.
It is a reproducible and reversible technique with results and indications still to be validated. Brethauer et al presented the results of a feasibility study using laparoscopic gastric plication for weight loss achieved without stapling or banding.
After institutional review board approval, 2 methods were used to achieve laparoscopic gastric volume reduction. In the 1st group anterior plication [AP] , the anterior gastric wall was folded inward from the fundus to the antrum using 2 rows of running sutures. The greater and lesser curvatures were approximated to create an intraluminal fold of the stomach. In the 2nd group greater curvature plication [GCP] , the short gastric vessels were divided, and the greater curvature was folded inward, with 2 suture lines to reduce the gastric capacity by a large intraluminal gastric fold.
The average pre-operative body mass index was Of the 15 patients, 9 underwent AP. For the 9 patients who underwent AP, the 6- and month endoscopic evaluations demonstrated comparable-size plications over time, except for in 1 patient, who had a partially disrupted fold. Of the 6 patients who underwent GCP, the 6- and month follow-up endoscopic examinations demonstrated a durable intraluminal fold, except for in 1 patient, with a partial disruption at the distal fold owing to a broken suture.
For patients completing 1 year of follow-up, the percentage of excess weight loss was No bleeding or infectious complications developed.
The 1st patient in the GCP group required re-operation and plication reduction owing to gastric obstruction.
The early weight loss results have been encouraging, with better weight loss in patients who underwent GCP. Both cases were corrected by reoperation. No mortality was observed. The authors concluded that laparoscopic adjustable gastric banded plication provides both restrictive and reductive effects and is reversible. The technique is safe, feasible, and reproducible and can be used as an alternative bariatric procedure. Ji et al conducted a systematic review of the currently available literature regarding the outcomes of laparoscopic gastric plication LGP for the treatment of obesity.
Less than 1 percent of the programs 50 million beneficiaries have used the benefit so far. The governor of New Jersey is much less fat than he used to be. Many see the accomplishment as essential if the Republican intends to make a bid for the White House.
The following definitions are used to describe whether an individual is obese: Respondents reporting doing no physical activity or exercise in the past 30 days The CDC recently changed its methodology. Obesity Research Research Support. Journal of Women's Health Comparative Study.
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Cardiovascular diseases , type 2 diabetes , obstructive sleep apnea , certain types of cancer , osteoarthritis , depression  . Excessive food, lack of exercise, genetics  . Societal changes, personal choices . Diet, exercise, medications, surgery   . Reduce life expectancy . Endocrinology and Reproductive medicine.
D ICD - Portals Access related topics. Find out more on Wikipedia's Sister projects. Protein-energy malnutrition Kwashiorkor Marasmus Catabolysis. B vitamins B 1: