Module 7 Weight-Loss Surgery: Candidates, Concerns, and Long-Term Care

Transcription

1 Module 7 Weight-Loss Surgery: Candidates, Concerns, and Long-Term Care Weight-Loss Surgery: Candidates, Concerns, and Long-Term Care...4 Introduction... 4 Think Ahead: Surgery Qualifications...5 Overview of Bariatric Surgery and Outcomes...6 Impact on Obesity-Related Comorbidities...6 Quiz: Mr. Smith's Health Improvements...8 Decreased Mortality... 8 When to Consider Bariatric Surgery...9 Other Requirements and Contraindications...10 Case #1: Dave Abbott Dave Abbott's Weight History...11 Assessing Patients for Surgery...12 Patient Requirements Risk Factors and Contraindications...14 Poll: Percentage of Patients Needing surgery...15 Does the Patient Meet the Criteria?...15 Gathering Information Quiz: What Is Next For Mr. Abbott?...16 Exploring Options Case #2: Ms. Murdock Quiz: Cut Points for Surgery Discussing the Possibility of Surgery...19 Further Discussion Bariatric Surgery Types Overview of Restrictive Surgeries...21 Overview of Malabsorptive/Restrictive Surgeries...22 Quiz: Ms Murdock and Surgery Selection...23 Vertical (Sleeve) Gastrectomy...24 Risks/Complications of Vertical (Sleeve)...25 Page 1 of 63

2 Laparoscopic Adjustable Gastric Banding (LAGB)...26 Risks/Complications of Adjustable Gastric Band...27 Roux-En-Y Gastric Bypass Risk/Complications of Roux-En-Y Gastric Bypass...30 BilioPancreatic Diversion (BPD)/Duodenal Switch (DS)...30 BilioPancreatic Diversion (BPD)/Duodenal Switch (DS)...32 Risks/Complications of BilioPancreatic Diversion/Duodenal Switch...33 Electrical Vagal Blocking Therapy...34 Risks/Complications of Vagal Blocking Therapy...35 Intragastric Balloon Modified Percutaneous Endoscopic Gastrostomy...37 Quiz: Review Surgery Types...38 Quiz: Ms. Murdock Referral for Surgery...38 Referring Ms. Murdock Pre-Surgical Evaluations and Counseling...39 Overview of Surgical Complications...40 Weight-Loss Outcomes of Surgery...41 Reasons for Poor Weight-Loss Outcome...42 Follow-Up After Surgery Behaviors for Weight Loss After Surgery...44 Guidelines for Follow-up After Surgery...45 Nutritional Deficiencies Other Vitamin Deficiencies...46 Other Mineral and Protein Deficiencies...47 Other Risks and Side Effects Post Surgery...48 Surgery Impact on Gut Hormones...49 Post-Surgery Diet Long-Term Post-Surgery Diet...51 Post-Surgery Psychological Issues...51 Ms. Murdock Post-Surgery Long-Term Followup...51 Quiz: Post-Surgery Habits Ms. Murdock Long Term Follow-Up...53 Ms. Murdock Follow-Up Interview...54 Page 2 of 63

3 Quiz: Ms. Murdock Identifying a Solution Long-Term Follow-up Module Summary Resources available through this module:...57 References used in this module:...58 Page 3 of 63

4 Module 3 WEIGHT-LOSS SURGERY: CANDIDATES, CONCERNS, AND LONG-TERM CARE Goal: To prepare the learner to select, advise, and refer qualifying adult obese patients for weight-loss surgery and provide appropriate care for patients following weight-loss surgery. After completing this module participants will be able to: Identify patients who meet criteria to be considered as candidates for bariatric surgery. Explain the advantages/disadvantages of different types of bariatric surgery to patients. Counsel patients regarding the behavioral, diet, and medication requirements following bariatric surgery. Provide appropriate medical management, as needed, for patients who have had bariatric surgery. Professional Practice Gaps Evidence-based guidelines recommend that providers advise adults with BMI 40kg/m 2 or BMI 35kg/m 2, with obesity-related comorbid conditions, who are motivated to lose weight and have not responded to behavioral treatment, whether they have tried pharmacotherapy or not, that bariatric surgery may be an appropriate option to improve health (Jensen et al., 2013). Referral to an experienced bariatric surgeon for consultation and evaluation is recommended for these patients. Although there is significant evidence to support these recommendations, one study indicated that 13% of qualifying patients were unaware that they were candidates for bariatric surgery, while 8% of qualifying patients had never heard about bariatric surgery (Afonso et al., 2010). In our survey of obesity experts (N=7), 86% believed that providers need to get better at selecting which patients to refer for possible weight-loss surgery. Of the primary care providers surveyed, 80% felt they needed training regarding the use of surgery in weight management (Tanner, 2011). INTRODUCTION Bariatric Surgery for Weight-Loss Weight-Loss surgery is one of the most effective treatments for obesity in terms of the amount of weight lost and successful weight-loss maintenance (Jensen et al., 2014). However, surgery is not an easy or perfect solution. Surgical and post-operative risks, discomfort, expense, and the significant relapse rate must be considered. Patients also must live with side effects and required dietary modifications. All of these issues vary with the surgery chosen. Primary care providers play a vital role in identifying potential candidates for bariatric surgery and helping patients make informed choices regarding the referral. In some cases, primary care also Page 4 of 63

5 provides long-term post-surgical follow-up. In order to weigh potential risks and benefits and support successful outcomes, providers must have a fairly comprehensive understanding of bariatric surgery. Meet the Patients: We will follow the stories of these patients in order to illustrate how to evaluate patients to determine the need for bariatric surgery referral, explain the referral, and follow patients post-surgically as needed: MR. ABBOTT Bariatric surgery eligibility. He meets some criteria for weight-loss surgery, but not others. He also has some unrealistic expectations of bariatric surgery. What criteria determine if a referral for bariatric surgery is appropriate for him? Do you know enough of the evidence regarding surgery for weight loss to give him a realistic picture? MS. MURDOCK Ms. Murdock asked some questions when she was referred for bariatric surgery. Three years post-bariatric surgery, she returns with recent onset of numbness, clumsiness, and pain Would you know enough about bariatric surgery to answer her questions to support a referral? Could her post-surgical symptoms be a side effect from her surgery? THINK AHEAD: SURGERY QUALIFICATIONS Think Ahead: Which patient most strongly qualifies for weight loss surgery per the AHA/ACC/TOS guidelines? 1. Paul has a BMI of 42 and is 120 pounds overweight. He has previously been on weight-loss medication but has seen very little response. Correct! This topic is discussed on Patient Requirements. 2. Alexa has diabetes and a BMI of 39. She has not previously been in any weight loss program. Incorrect. This topic is discussed on Patient Requirements. 3. Larry has high blood pressure and a BMI of 30. He says he's ready to try to lose weight. Incorrect. This topic is discussed on Patient Requirements. 4. Cynthia has a BMI of 40 and wants to have a surgical intervention, so she can still eat the high-fat foods she loves and still lose weight. Incorrect. This topic is discussed on Patient Requirements. Page 5 of 63

6 OVERVIEW OF BARIATRIC SURGERY AND OUTCOMES An Effective Treatment Component Bariatric surgery is an increasingly common and often effective weight-loss treatment component for severe obesity and for obesity with weight-related comorbidities. Approximately 179,000 weight-loss surgeries are completed per year (ASMBS, 2014). Evidence findings report: Bariatric surgery frequently produces sustainable, long-term weight loss (Jensen et al., 2014). Weight-related comorbidities are often resolved or prevented and the associated mortality is reduced. Surgery alone is not enough, however. Even with bariatric surgery, weight loss requires a comprehensive care system, especially after the relatively early phase when the majority of weight is lost. When considering surgery for patients, recommendations for dietary modifications and adequate exercise should also be made, as these components are essential for long-term success. Weight-Loss Outcomes Weight-loss surgery leads to profound weight loss in a significant percentage of cases, at least for the duration of most studies, which are generally less than 2 years. A review of the literature found a mean of 61.2% (58.1%-64.4% CI) of excess weight lost when all types of surgery were combined (Buchwald et al., 2004). Results varied by type of surgery from 47.5% of excess weight lost after the relatively more conservative, gastric banding, up to 70.1% of excess weight after the more extensive, biliopancreatic diversion or duodenal switch. Note that the percentage of excess weight lost, the figure that is reported in these studies, is a higher figure than the percentage of total weight lost. IMPACT ON OBESITY-RELATED COMORBIDITIES Weight-loss surgery leads to improvement and even resolution of many weight-related comorbidities. The supporting evidence includes the following: The Evidence for Post-Surgical Resolved or Improved Comorbidities A review of the evidence looking at four common obesity-related comorbidities post-surgically found the following: Page 6 of 63

7 DIABETES completely resolved in 76.8% and resolved or improved in 86% of patients HYPERTENSION resolved in 61.7% and resolved or improved in 78.5% of patients HYPERLIPIDEMIA improved in 70% or more of patients OBSTRUCTIVE SLEEP APNEA resolved in 85.7% and resolved or improved in 83.6% of patients (Buchwald et al., 2004) Examples of Clinical Studies Showing Improved Comorbidities Post-Surgically: EVIDENCE In the Swedish Obesity Study (n=2010), the surgical cohort (various surgery types combined) compared to a control group seeking but not receiving bariatric surgery, showed higher resolution of: Hypertension: 38% (1% control) Dyslipidemia: 54% (7% control) Diabetes: 79% (0% control) (Sjöström, 2007) In a 2-year follow-up study of 420 obese patients after gastric bypass (Adams et al., 2010), the following conditions or other health criteria were improved significantly in comparison to comparable, non-surgery control patients: Degree of obesity Blood pressure Lipids Glucose Insulin levels Sleep apnea Resting metabolic rate Aerobic capacity Health-related quality of life A long-term retrospective study of nearly 10,000 patients after gastric bypass found that the incidence of new diagnoses of type 2 diabetes was significantly lower post-surgically compared to non-surgical controls (Adams et al., 2010). Page 7 of 63

8 QUIZ: MR. SMITH'S HEALTH IMPROVEMENTS Mr. Smith Patient Name: Mr. Smith Age: 55 y/o Height: 5'10 Weight: 220 lbs BMI: 31.6 kg/m 2 Waist: Unknown BP: 145/83 Pulse: 90 Respiration: 18/min Chief Complaint: Sleep issues History of Present Illness: He has been having issues with sleeping for about four months and says that his wife thinks he sometimes stops breathing in the middle of the night. Medical History: He has tested as being pre-diabetic and shows signs of hypertension. Mr. Smith also has increased his alcohol consumption to two beers per day. Weight History: Mr. Smith's weight has increased steadily since you last saw him. No history of weight-loss attempts noted. Physical Activity Level: Low - He does not participate in physical activity because of time constraints. Question: Mr. Smith has returned to your office because he notes having issues with his sleep. You note that his weight has increased since his last visit and that he has evidence of other health issues in his file. If he were to qualify for surgery, which of the following issues would be positively impacted? (Choose all that apply) 1. Surgery would lower his risk of developing diabetes Mr. Smith is currently pre-diabetic. There is evidence that, with surgery, diabetes could be resolved or improved. However, at his current BMI, he does not yet meet the qualification for surgery. 2. His sleep issues would be improved Sleep apnea has been shown to improve significantly in patients post-surgery. However, at his current BMI, he does not yet meet the qualification for surgery. 3. His need to consume alcohol would decrease While his alcohol use is a concern, and the empty calories likely contribute partially to his weight gain, bariatric surgery does not necessarily lower the use of alcohol in patients. Also, at his current BMI, he does not yet meet the qualification for surgery. 4. His blood pressure would lower Surgery has been shown to lower blood pressure in patients, and this would also help his hypertension as well. However, at his current BMI, he does not yet meet the qualification for surgery. DECREASED MORTALITY The Evidence Reported reduced mortality rates after bariatric surgery: 40% reduction in mortality from all causes Page 8 of 63

9 60% reduction in mortality from cancer 92% reduction in mortality from Diabetes Mellitus (Adams et al., 2007) The prospective Swedish Obesity Study (SOS) showed a 29% reduction in deaths relative to the control group at an average follow-up of 10.9 years after bariatric surgery (Sjöström et al., 2007). WHEN TO CONSIDER BARIATRIC SURGERY BMI Cut Points for Considering Surgery The BMI cut point to be considered for bariatric surgery are: 40 kg/m 2 35 kg/m 2 if there is a weight-related significant comorbidity (Jensen et al, 2013). Comorbidity Considerations for Surgery Comorbidities that are considered indications for surgery in patients aged 18 to 60, along with a BMI over 35, are those that can be expected to improve with this treatment, for example, type 2 diabetes mellitus, cardiovascular disease, respiratory disease, severe joint disease, and severe psychological problems related to obesity (Fried, et al, 2013). Other Factors to Consider for Surgery Surgery for Weight Re-gain: Patients who have previously reached the BMI cutpoint, lost weight, and are now regaining it, are also candidates for bariatric surgery. Surgery for Adolescents: Surgery may be considered for adolescents with severe obesity (BMI > 40 kg/m 2 (or 99.5th percentile for age), skeletal maturity, at least one comorbidity, Page 9 of 63

10 failed evidence-based and supervised weight-loss attempt, access to specialized medical followup, and ability and willingness to participate in post-surgical weight loss program. Surgery for the Older Adults: Surgery may be considered for individuals over age 60 with a favorable risk-benefit ratio. Surgery becomes less likely to increase lifespan with age and so improvement of the quality of life is emphasized in this age group. (Fried, et al, 2013) OTHER REQUIREMENTS AND CONTRAINDICATIONS Other Requirements for Weight-Loss Surgery European Guidelines for Bariatric Surgery describe the following requirements: A period of medical management Ability to participate in long term follow-up Ability to care for self or have long-term family or social support that will supply such care (Fried, et al, 2013) Contraindications for Weight-Loss Surgery The following contraindications to bariatric surgery have been described: Non-stabilized psychotic disorders, severe depression, or personality and eating disorders unless advised by a specialist in obesity and psychiatry Alcohol use disorder or drug use disorder Life threatening diseases, in the short term (Fried, et al, 2013) Specific types of bariatric surgery, described later in this module, may have additional requirements and contraindications. CASE #1: DAVE ABBOTT In the first case, a patient with obesity has unrealistic expectations of weight-loss surgery. It illustrates how to assess a patient for bariatric surgery and provide him with more realistic expectations. Meet Your Patient Patient Name: Dave Abbott Age: 40 y/o Height: 5'11 Weight: 330 lbs BMI: 46 kg/m 2 Waist: 55" BP: 175/83 Pulse: 100 Respiration: 21/min Chief Complaint: Requesting bariatric surgery to eliminate the need for "diets." He is "sick" of being obese. History of Present Illness: Obese for many years, steady weight gain of 2-3 lbs/year. Page 10 of 63

11 Medical History: Recently developed mild asthma and signs of mild non-alcoholic fatty liver disease and had impaired fasting glucose (prediabetes). Currently treated for dyslipidemia, hypertension, and recurrent groin bacterial intertrigo. Weight History: Mr. Abbott's weight has increased slowly at a rate of 2 to 3 lbs per year in adulthood. No history of weight-loss attempts and no interest in "dieting." Physical Activity Level: Low - He avoids physical activity because of joint pain. Weight-Related Diagnoses: E66.01 Morbid Obesity; E65 Localized Adiposity (Central) CASE OBJECTIVES This case will cover the following objectives: Identify patients who meet criteria to be considered as candidates for bariatric surgery. Explain the advantages/disadvantages of different types of bariatric surgery to patients. Counsel patients regarding the behavioral, diet, and medication requirements following bariatric surgery. DAVE ABBOTT'S WEIGHT HISTORY To evaluate candidates for bariatric surgery, look for a sufficiently elevated BMI, related comorbidities, and history of trying to lose weight by other methods. WEIGHT HISTORY: Dave Abbott BMI: 46 (Class III Obesity) HEIGHT: 5'11" WEIGHT: 330 lbs History of Significant Changes in Weight Over Lifetime: Mr. Abbott's weight has remained fairly steady, increasing slowly at a rate of 2 to 3 lbs per year over his adult lifetime. MAXIMUM WEIGHT: 330 lbs, 2015 WEIGHT AGE 20: 175 lbs, 1995 WEIGHT ONE YEAR AGO: 326 lbs EPISODES OF RAPID WEIGHT GAIN AND RELATED TRIGGERS: Became despondent in the last year because of a relationship, which caused him to increase his eating. Waist Circumference: 44 inches Family History of Overweight/Obesity/Metabolic Disease: Father and mother both have a history of being overweight with varying successes in weight loss attempts. History of Weight-Loss Attempts: MOST RECENT WEIGHT-LOSS ATTEMPT: None PAST WEIGHT-LOSS ATTEMPTS: None Foods Often Craved: Sweet snacks throughout the day and late-night salty, high-fat snacks. Page 11 of 63

12 Eating Patterns: He eats out a lot, and snacks when he feels hungry at least 2x/day. Physical Activity: EXERCISE: Walking from car to destinations is his only activity; more intense exercise makes his joints hurt. SEDENTARY BEHAVIOR: Tends to stay home-bound, watching television or reading. ASSESSING PATIENTS FOR SURGERY Referral Protocol Step: Discuss option of bariatric surgery as part of a comprehensive weight-loss program, when indicated. MR. ABBOTT Mr. Abbott has a BMI of 46, with no history of weight loss attempts. Based on his medical information, does he meet the qualifications for surgery? Criteria for Weight-Loss Surgery Bariatric surgery can be a helpful solution for your patients who struggle with severe obesity and who are unable to achieve maintained weight loss. GUIDELINES FOR BARIATRIC SURGERY EVALUATION REFERRAL 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults recommend referral for evaluation for bariatric surgery if: A BMI 40 kg/m², (essentially > 100 lbs overweight) regardless of other medical conditions A BMI 35 kg/m² (approximately 80 lbs overweight) PLUS one or more significant obesityrelated conditions, such as high blood pressure, diabetes, sleep apnea, high cholesterol, or weight-related arthritis. The patient also needs to be: motivated to lose weight has not responded to behavioral treatment with or without pharmacotherapy with sufficient weight loss to achieve targeted health outcome goals (Jensen et al., 2013) Lifestyle Changes Are Important Even with adjunctive treatments of weight-loss surgery or pharmacotherapy, patients still need help to make better lifestyle choices that will ultimately lead to a negative energy balance. Generally, patients will still need regular long-term counseling and/or a comprehensive weight-loss program (Jensen et al., 2013). The behavioral treatment should support lifestyle change to a low calorie diet and additional exercise. Page 12 of 63

13 PATIENT REQUIREMENTS History, Expectations, and Commitment In addition to requirements in terms of BMI and comorbidities, patients must: Have a history of multiple failed weight-loss attempts by conventional methods, as documented by the physician. Shows a willingness to fully engage in weight-loss with effort and engagement. Understand the course of treatment and have realistic expectations and motivations. Be committed to lifelong maintenance programs for diet, vitamin supplementation, avoidance of alcohol, exercise, and follow-up with the healthcare team. (Jensen et al., 2014) Other Requirements Additionally, patients need to meet the following requirements for weight-loss surgery: Be 18 to 65 years of age (with some exceptions) Understand the procedure and implications, and accept the operative risks Have good social support Have no active substance abuse or clinically significant/unstable psychosis, depression, borderline personality disorder, or bulimia nervosa Have no known endocrine cause for their obesity Be of sound mind to understand the risks of surgery and the necessary long-term commitment Not have contraindications to undergo surgery (For women) planning not to get pregnant in the next 12 months (Kushner & AMA, 2011) In addition to requirements in terms of BMI and comorbidities, patients must: Have a history of multiple failed weight-loss attempts by conventional methods, as documented by the physician. Shows a willingness to fully engage in weight-loss with effort and engagement. Understand the course of treatment and have realistic expectations and motivations. Be committed to lifelong maintenance programs for diet, vitamin supplementation, avoidance of alcohol, exercise, and follow-up with healthcare team. (Jensen et al., 2014) Page 13 of 63

14 Other Requirements Additionally, patients need to meet the following requirements for weight-loss surgery: Be 18 to 65 years of age (with some exceptions) Understand the procedure and implications, and accept the operative risks Have good social support Have no active substance abuse or clinically significant/unstable psychosis, depression, borderline personality disorder, or bulimia nervosa Have no known endocrine cause for their obesity Be of sound mind to understand the risks of surgery and the necessary long-term commitment Not have contraindications to undergo surgery (For women) planning not to get pregnant in the next 12 months (Kushner & AMA, 2011) RISK FACTORS AND CONTRAINDICATIONS Increased Risk The following characteristics and conditions place the patient at increased risk with weight-loss surgery: Male sex Age >45 BMI > 50 Smokers History of unstable angina or CHF Sleep apnea Diabetes Hypertension History of thromboembolic events Functional status (Inability to walk 200 feet) (Mechanick et al., 2013; LABS, 2009; Padwal et al., 2013) How Common Eating Patterns Affect Post Surgical Outcomes Binge Eating Disorder and Night Eating Disorder: Binge eating and night eating disorders are not contraindications to undergoing weight-loss surgery. There is no evidence that patients with these disorders have worse outcomes, at least in the short run (ASMBS, 2004). In fact, these disorders are fairly common among patients having weight-loss surgery: 10-50% have some aspect of binge eating disorder. 40% have night eating syndrome (ASMBS, 2004) Page 14 of 63

15 Anorexia and Bulimia: However, anorexia or bulimia are likely to be contraindications due to the need to strictly follow the diet. POLL: PERCENTAGE OF PATIENTS NEEDING SURGERY Question: What percentage of patients meeting weight-loss surgery criteria (have commitment, meet requirements, and financially able) at your practice have you referred for possible surgery? Poll Data as of 6/13/2018: 1. Less than 10% 53% (52 votes) % 28% (27 votes) % 11% (11 votes) % 1% (1 vote) % 2% (2 votes) 6. More than 90% 5% (5 votes) DOES THE PATIENT MEET THE CRITERIA? The provider asks about another criterion for weight loss surgery, having tried to lose weight through recommended lifestyle changes and supports: Provider: Please tell me about your past weight-loss attempts. Mr. Abbott: I haven't tried much yet. I just don't like exercise or have time to cook healthy food. We go out to eat almost every day because it's much easier than cooking. I get really hungry and sometimes can't help but eat. MEETS CRITERIA FOR SURGERY SO FAR At 46 kg/m², Mr. Abbott's BMI is greater than or equal to the minimum cut point of 40 kg/m² At age 40, he falls within the 18 to 65 years (with some exceptions) age range DOES NOT MEET CRITERIA FOR SURGERY SO FAR Does not have a history of multiple failed weight-loss attempts by dieting, exercise, and medical therapies, as documented by the physician Page 15 of 63

16 GATHERING INFORMATION The provider needs to determine the following remaining criteria for weight loss surgery: Does Mr. Abbott: Have realistic expectations and motivations Understand the procedure and implications, as well as accept the operative risks Have good social support Have no active substance abuse or clinically significant/unstable psychosis, depression, borderline personality disorder, or bulimia nervosashow a commitment to lifelong maintenance programs The ongoing dialogue continues: Provider: Bariatric surgery involves risks and takes a lifelong change. You'd have to be careful about what you eat for the rest of your life and take required supplements. How do you feel about that? Mr. Abbott: I know I need to lose weight, but I'm not sure if I can diet. I really want to try to avoid medications, so I'm thinking surgery is my only way out. QUIZ: WHAT IS NEXT FOR MR. ABBOTT? MR. ABBOTT After reviewing his case, you consider all the options available to help Mr. Abbott achieve his weightloss goals. Question: What is the best weight management option(s) for Mr. Abbott at this time? 1. Referral to a bariatric surgeon for further evaluation Correct. Mr. Abbott is a candidate for weight-loss surgery in terms of his high BMI. But he has not tried dietary change and increased exercise to lose weight, which is a criterion for surgery. He will need to make lifestyle modifications for the surgery to be effective. Many bariatric centers will work with patients to prepare them and give them a realistic understanding of what is needed. So, even though Mr. Abott may not be quite a perfect candidate for surgery at this time, a referral is still indicated. 2. Explore diet and activity lifestyle changes with Mr. Abbott Correct. Even if a referral is made for evaluation for bariatric surgery, exploring Mr. Abbott's current diet and lifestyle will help identify areas where change is needed, even if he does eventually have weight-loss surgery. 3. Referral to a dietitian Possibly. If Mr. Abbott is being referred to a bariatric weight-loss center, they are likely to counsel him on his diet. But if he does not follow through with the referral, having a dietitian work with Mr. Abbott can help him create a healthy weight-loss plan. 4. Prescribe orlistat Page 16 of 63

17 Incorrect. Although he could be a candidate for weight-loss medication because of his high BMI, Mr. Abbot expressed an interest in bariatric surgery. Furthermore, he said he wanted to avoid weight-loss medication. EXPLORING OPTIONS The provider discusses the need to change diet and exercise, even with weight loss surgery. Empathy for a patient's frustrations and explanations of reasons for treatment recommendations can be helpful when recommending a treatment other than the one the patient wanted: Provider: I understand your frustration about your weight, and applaud you for taking steps to control it. I can make a referral to a surgeon to see what they think, but for bariatric surgery to be effective, you need to change your diet and exercise. I also recommend starting to make those changes, even before you are ready for surgery. Are you open to giving it a try? Mr. Abbott: I could use some help, because I haven't done well with diet and exercise on my own. Provider: I understand. Changing your diet and getting enough exercise is important even with weight loss surgery. One possibility is working with a dietitian who would help you find long term changes in diet with which you feel comfortable. The bariatric center where the surgeon practices will probably have a dietitian who will work with you to make those changes. If not, I can recommend someone. Mr. Abbott: I'll try to do what it takes. Thanks for the referral. Primary Care Role Primary care providers can play an important role in Triaging patients to determine which ones might be appropriate for evaluation for bariatric surgery Helping patients have realistic expectations about surgery including realizing the need for a healthy diet and exercise, whether or not they have surgery. Keep in mind many patients who qualify for weight loss surgery do not get it. Re-evaluation and follow-up at a later date to determine the success of prior treatment recommendations or referrals CASE #2: MS. MURDOCK The second case follows a patient who would like surgery from pre-surgical evaluation through postsurgical follow-up. Meet Your Patient Page 17 of 63

18 Patient Name: Stacy Murdock Age: 46 y/o Height: 5'6 Weight: 244 lbs BMI: 39.4 kg/m 2 Waist: 43" BP: 137/92 Pulse: 89 Respiration: 18/min Chief Complaint: Interested in bariatric surgery. History of Present Illness: Patient is concerned about her weight and its impact on overall health. She wants to explore the possibility of bariatric surgery. Medical History: Being treated for hypertension, dyslipidemia, weight-related venous stasis and phlebitis, and incontinence for over five years. Has impaired glucose tolerance (pre-diabetes). Weight History: Overweight for most of her life, she has been unable to reduce weight despite attempting to make dietary changes and increase exercise. Physical Activity Level: Increased walking, jogging at the gym but discontinued when it had no significant effect on weight. Weight-Related Diagnoses: E66.9 Obesity, unspecified; E65 Localized Adiposity (Central) CASE OBJECTIVES This case will cover the following objectives: Identify patients who meet criteria to be considered as candidates for bariatric surgery. Explain to patients the advantages/disadvantages of different types of bariatric surgery. Counsel patients regarding the behavioral, diet, and medication requirements following bariatric surgery. Provide appropriate medical management, as needed, for patients who have had bariatric surgery. QUIZ: CUT POINTS FOR SURGERY SECTION TOPIC Patients meeting criteria to be considered candidates for bariatric surgery. Review: Cut Points for Considering Surgery The BMI cut point to be considered for bariatric surgery is 40 kg/m 2 and 35 kg/m 2 if there is a weightrelated significant comorbidity (Jensen et al, 2013). Keep in mind that even with bariatric surgery, weight loss requires dietary modifications and adequate exercise exercise, especially for long term maintenance. Page 18 of 63

19 MS. MURDOCK has a BMI of 39.4 and is being treated for multiple obesity related comorbidities including hypertension and diabetes. Question: Based on this information Ms. Murdock is a candidate for: 1. Dietary modifications Incorrect. While dietary modifications alone can help, Ms. Murdock should also be referred for an exercise increase and bariatric surgery 2. Exercise increase Incorrect. In addition to an exercise increase, Ms. Murdock should also receive referrals for dietary modifications and bariatric surgery. 3. Referral for bariatric surgery alone Bariatric surgery requires a comprehensive approach that includes dietary modifications and exercise. 4. Dietary modifications and exercise increase Ms. Murdock's BMI and comorbidities also make her a candidate for bariatric surgery. 5. Dietary modifications, exercise increase, and referral for bariatric surgery Ms. Murdock's BMI and comorbidities also make her a candidate for bariatric surgery. DISCUSSING THE POSSIBILITY OF SURGERY The provider responds to Ms. Murdock's chief complaint, which involved an interest in obtaining bariatric surgery. The cut point for considering bariatric surgery if the patient has comorbidities is 35 kg/m 2. Ms. Murdock qualifies by having a BMI of 39.4 kg/m 2 plus significant weight-related comorbidities of hypertension, dyslipidemia, impaired glucose tolerance (pre-diabetes), weight-related venous stasis and phlebitis, and incontinence. Provider: I'm glad to hear you are ready to work toward weight loss. There will be many important health benefits. Ms. Murdock: Thanks. I've just reached a point where I know I need to lose weight, but I haven't been able to do so just by changing my diet or exercising. Surgery is my next option. Provider: It looks like you meet many of the criteria for surgery at this point, enough for a referral to find out if you are a candidate. Would you like to know a little about the types of surgery that is done today and what you might expect in terms of weight loss? Ms. Murdock: Oh, I didn't realize there were options. What's the difference between them? FURTHER DISCUSSION The provider goes over the different surgery types with Ms. Murdock to help her become better informed and prepare her to decide if she will accept a referral. Provider: Surgery changes your digestive track there are several different types. Some make you feel like eating less and others make you absorb less of the food you have eaten. Each surgery has different benefits, risks, side effects, and limitations on what you can eat. Your surgeon would explain these to you and make recommendations. Page 19 of 63

20 Ms. Murdoch: Well, I want whichever one is going to help me lose weight the best. I'm tired of being overweight and sick all the time. But my health is important to me. I don't want a surgery that interferes a lot with absorption of my food. The provider continues this very brief overview of the different weight loss surgery options for Ms. Murdock using a printed chart. (See our resources at the end.) PRACTICE TIP The restriction in how much food the patient can consume at one time after surgery varies by procedure. Some of the procedures will actually alter the hormonal signals from the gut resulting in less hunger. Talk to your patients about how they will have to modify their diets after surgery. BARIATRIC SURGERY TYPES SECTION TOPICS Explaining advantages/disadvantages of different types of bariatric surgery to patients. Ms. Murdock is interested in weight loss surgery and the provider has established that she meets the criteria and will make a referral. Ms. Murdock has stated that she does not want a surgery that interferes a lot with the absorption of food. Which type of weight loss surgery might be best for her? Types of Surgery The forms of bariatric surgery vary in terms of effectiveness for weight loss, risks, indications, side effects, and requirements for diet change (Tucker, 2013; Fiore, 2013; Mechanick et al., 2013). The patient's health and commitment to follow restrictions should also be considered. All of this should be discussed with patients. Surgeries can be divided into two types: Restrictive vs. Malabsorptive: In restrictive surgeries, part of the GI tract is made smaller, in several different ways. In malabsorptive surgery, less food is absorbed, often because part of the GI tract is bypassed. Malabsorptive surgeries are usually combined with some sort of restriction, as well. Laparoscopic vs. Open: Laparoscopic surgeries hold less risk and are more expensive. Open gastric bypass comprises only 3% of surgeries currently (Livingston, 2010). Devices: Implanted weight-loss devices are available that offer minor weight loss (FDA, 2015, 2016). Currently options include electrodes implanted near the vagus nerve in the region of the stomach to interrupt signals to eat more, an intragastric balloon to produce a feeling of fullness, and a tube placed surgically into the stomach to drain stomach contents after eating (FDA, 2016). Page 20 of 63

21 OVERVIEW OF RESTRICTIVE SURGERIES Restrictive Surgeries (Shrink stomach size, slow digestion) LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB) A band around the stomach divides it into two portions, slowing food transit. Pros and Cons: Relatively simpler and safer surgery than the others on this list and reversible however weight loss is less dramatic and patients are more likely to regain some weight long-term. This surgery comprised approximately 37% of cases completed in 2006 (Livingston, 2010). Weight Loss: 40 to 60% of excess weight at one year (ASMBS, 2014). Long-term: 47% of excess weight loss is maintained to 15 years post surgery in one practice (O'Brian et al, 2013). VERTICAL (SLEEVE) GASTRECTOMY Removes around 75% of the stomach (ASMBS,2014). Pros and Cons: Relatively simpler surgery than the remainder of the list, so a good choice if patient's risk is too high for other surgeries however, it is not reversible. This type of surgery has recently increased in popularity. Weight Loss: 55-70% of excess weight at 2 years (ASMBS, 2014). Page 21 of 63

22 OVERVIEW OF MALABSORPTIVE/RESTRICTIVE SURGERIES Malabsorptive/Restrictive Surgeries (Remove or bypass part of the digestive tract and shrink stomach size) ROUX-EN-Y GASTRIC BYPASS Stomach is divided into two, sealed off parts and the upper part is connected to the lower small intestines (Mechanick et al., 2013). Pros and Cons: Quick and dramatic weight loss and related health improvement however, it is irreversible and changes in food absorption reduce nutrients absorbed and limit what can be eaten. Most common type of surgery previously. Weight Loss: 50% to 67% of excess weight at 1-2 years (ASMBS, 2014). Long-term: 54% of excess weight loss is maintained at 10 or more years post surgery (O'Brian et al, 2013). BILIOPANCREATIC DIVERSION (BPD)/DUODENAL SWITCH (DS) OR LONG LIMB GASTRIC BYPASS More of the stomach is removed and more small intestine is bypassed. Pros and Cons: Even more dramatic weight loss than gastric bypass however, also more malabsorption (especially fats) with greater potential for malnutrition and side effects. Rarely used currently. Weight Loss: 75-80% of excess weight at 1 year (ASMBS, 2014). Page 22 of 63

23 Surgically Implanted Devices VAGAL BLOCKING THERAPY Subcutaneous implant in the lateral chest wall with wires extending into the abdomen to stimulate the vagus nerve and cause feelings of fullness. Pros and Cons: Does not cause malabsorption, less risky than some of the above surgeries, and reversible however only modest additional weight loss compared to controls (8.5% more of excess weight) (FDA, 2015). Weight Loss: 8.5% of excess weight at 1 year (FDA, 2015). PRACTICE TIP Consider warning patients to avoid alcohol indefinitely after their bariatric surgery, especially gastric bypass. QUIZ: MS MURDOCK AND SURGERY SELECTION Question: Ms. Murdock wants a surgery that is less likely to interfere with her nutrition. Which category of bariatric surgery best fits her preference? 1. Restrictive Surgery Correct. Maladsorptive surgeries, such as Roux-en-Y Gastric Bypass, and Biliopancratic Diversion/Duodenal Switch will have more impact on the absorption of nutrients and so she should be directed toward restrictive surgeries, such as an Adjustable Gastric Band or Vertical Sleeve Gastrectomy. 2. Malabsorptive Surgery Incorrect. Maladsorptive surgeries, such as Roux-en-Y Gastric Bypass, and Biliopancratic Diversion/Duodenal Switch will have more impact on the absorption of nutrients and so she should be directed toward restrictive surgeries, such as an Adjustable Gastric Band or Vertical Sleeve Gastrectomy. 3. Both (Neither category affects nutrient levels) Incorrect. Maladsorptive surgeries, such as Roux-en-Y Gastric Bypass, and Biliopancratic Diversion/Duodenal Switch will have more impact on the absorption of nutrients and so she should be directed toward restrictive surgeries, such as an Adjustable Gastric Band or Vertical Sleeve Gastrectomy. Page 23 of 63

24 4. Neither (Both surgeries affect nutrient levels equally) Incorrect. Maladsorptive surgeries, such as Roux-en-Y Gastric Bypass, and Biliopancratic Diversion/Duodenal Switch will have more impact on the absorption of nutrients and so she should be directed toward restrictive surgeries, such as an Adjustable Gastric Band or Vertical Sleeve Gastrectomy. VERTICAL (SLEEVE) GASTRECTOMY VERTICAL (SLEEVE) GASTRECTOMY This is a restrictive surgery, i.e., it shrinks stomach size and slows digestion. In a 1 hour laparoscopic procedure typically, the stomach is sutured into a narrow pouch that holds about ml (2 to 3 oz). There is no intestinal bypass. Typical hospital stay is 1-2 days and full recovery is seen in 2-3 weeks. Vertical (Sleeve) Gastrectomy was 42.1% of all surgeries in It is purely restrictive of calories. There is no change to absorption or digestive function. (ASMBS, 2014) MECHANISM OF ACTION Reduces food intake and food used by the body. This procedure also favorably alters gut hormones to suppress hunger and improve satiety. (ASMBS. 2014) Page 24 of 63

25 POST-SURGERY DIET Gradually change from liquid to puree to chopped foods. Patients limit themselves to calories/day (modified fast) for the first 24 months and thereafter (Wheaton Franciscan Healthcare, 2014) consisting of lean proteins, 5 servings of vegetables and 2 of complex carbohydrates. No drinking liquids with meals. EFFECTIVENESS Patients can expect to lose 55-70% of excess weight at about 2 years (ASMBS, 2014). In another study with long term results, weight loss at 1, 3 and 5 years was 76.8%, 69.7%, and 56.1% of excess weight respectively (Golomb et al., 2015). Effective for high risk/very high BMI individuals (BMI >60). The sleeve has fewer complications than Roux-en-Y or duodenal switch due to no intestinal bypass. Long-term success rate is unknown. (ASMBS, 2014) Long-term Data Available Reduction in hypertension was maintained at around 45% long-term; improvement in HDL was maintained long term. However, other comorbidity improvement declined over time: Diabetes remission declined from 50.7% at year one, to 38.2% at year 3, and 20.0% at year 5. Similar loss of year one improvement by year 5 was seen for triglycerides, going from a mean preoperatively of 155 to 106 at year one, but back to 126 mg/dl by year 5 (Galomb et al., 2015) RISKS/COMPLICATIONS OF VERTICAL (SLEEVE) RISKS/COMPLICATIONS OF VERTICAL (SLEEVE) GASTRECTOMY Complications (overall rate of approximately 2.9% to 5.1%) include Stenosis (1-2%) Sleeve dilation (unknown) Page 25 of 63

26 Gastric leak, hemorrhage, abscess, and stricture reported (Fuks et al., 2009; Lalor et al., 2008) General risks associated with surgery Non-reversible Vitamin deficiencies Nausea and vomiting Heartburn Inadequate weight loss, weight regain Leakage May require additional procedure to accomplish desired weight loss A risk for malabsorption of nutrients or dumping, seen in forms of surgery removing more of the stomach, is lower, because the pylorus is maintained. (Wheaton Franciscan Healthcare, 2014; ASMBS, 2014) LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB) LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB) This is a restrictive surgery it shrinks stomach size and slows digestion. An adjustable silicone ring is placed around the top part of the stomach, creating a pouch that is about 1-2 ounces. The band is placed via a laparoscopic procedure that typically lasts less than an hour. The band creates the feeling of satiety. The size of the effect varies depending on the diameter of the opening between the pouch and the rest of the stomach. A plastic tube runs from the band to a special device. One end of the device is near the surface of the skin allowing an injection of sterile salt water to fill up and tighten the band or loosen the band by removing the liquid. Adjustable Gastric Band accounted for 14.0% of weight-loss surgeries in It is purely restrictive of calories taken in; there is no change to absorption or digestive function. The procedure can be done on an outpatient basis or require an overnight stay. Full recovery is < 2 weeks (ASMBS, 2014). Page 26 of 63

27 MECHANISM OF ACTION This procedure moderately restricts food intake. It also works to delay stomach emptying and creates a sense of fullness. EFFECTIVENESS Patients should expect to lose 40-60% of their excess weight. Long-term, about 40% of patients regain most of their weight. (ASMBS, 2014) A long term, prospective study of outcomes at 15 years post laparoscopic adjustable gastric banding completed for 714 of 3227 patients, found that the loss of 47% of original excess weight was maintained (O'Brien et al, 2013). This surgery requires the most effort from the patient out of all the surgeries in order to be successful. Sometimes weight loss may be slow. Best for individuals more disciplined at following a strict diet and exercise regimen. POST-SURGERY DIET The post-surgical diet is a protein-sparing modified fast (Chang et al, 2014). Patients must eat 3 meals/day, consisting of less than 800 calories per day during the first months and thereafter (Mechanick et al., 2013). Certain foods may get stuck and must be avoided: bread, rice, nuts, dense meat. Eating these may cause pain and vomiting. Patients cannot drink with meals. Additionally, a lifetime nutritional supplement will be needed. RISKS/COMPLICATIONS OF ADJUSTABLE GASTRIC BAND RISKS/COMPLICATIONS Complications include: Band slippage (3-5%) Page 27 of 63

28 Gastric pouch or esophageal dilation (3-5%) Band erosion (1%) Port/device problem (2-5%) Need for revisional surgery or removal (10-15-year year failure rate near 40% in older studies (Failure is defined as need for a major reoperation or failure to lose 25% of excess weight) 24% failure rate including complications or insufficient weight loss at median of 8 years (44% of patients lost 50% or more of excess weight) (Van Nieuwenhove et al., 2011) Other complications include general risks of surgery, leaking, vitamin deficiency and narrowing of the stomach/small intestine connection (Wheaton Franciscan Healthcare, 2014). There is no malabsorption of nutrients. This procedure is reversible and has the lowest risk of nutritional deficiencies (ASMBS, 2014). Adjustable Gastric Band is also the least invasive and safest. It can be reversed and the stomach will go back to normal. ROUX-EN-Y GASTRIC BYPASS ROUX-EN-Y GASTRIC BYPASS This is a malabsorptive/restrictive surgery it removes or bypasses part of the digestive tract and shrinks stomach size and slows digestion. A one-ounce pouch of the stomach is connected to the small intestine where food and digestive juices are separated for the first 3 to 5 feet. (Pronounced: roo-on-why). This is typically achieved via a laparoscopic procedure that lasts around an hour and 40 minutes. Roux-En-Y Gastric Bypass accounted for 34.2% of weight-loss surgeries in It is mostly restrictive of calories with some limitation of calorie absorption. Typical hospital stay is 1-3 days and full recovery is seen in 4-6 weeks. (Mechanick et al., 2013) Page 28 of 63

29 MECHANISM OF ACTION Restricts food intake and decreases amount of food absorbed via the small intestine. Additionally, the rerouting of food alters the gut hormones that promote satiety and suppress hunger (Mechanick et al., 2013). EFFECTIVENESS Weight loss of 50% to 67% of excess weight at 1-2 years. At 10 years, 60-70% of patients will have lost at least 50% of their excess weight and kept it off. About 20% of patients regain most of their weight long-term (ASMBS, 2014). A meta-analysis of studies of post-surgical outcomes at least 10 years post-roux-en-y bypass surgery found that loss of around 54% of original excess weight was maintained (O'Brien et al, 2013). This surgery is most effective for individuals with a BMI of < 50. Late weight regain may be a problem for heavier patients (Mechanick et al., 2013). POST-SURGERY DIET The post-surgical diet is a protein-sparing modified fast (Chang et al, 2014) Patients must eat 3 small, high protein meals/day. To prevent Dumping Syndrome, in which food is too rapidly transported through the digestive track along with unpleasant symptoms, patients must avoid sugar and fats. In the first months, they must consume less than 800 calories/day then thereafter. (Mechanick et al., 2013) Page 29 of 63

30 RISK/COMPLICATIONS OF ROUX-EN-Y GASTRIC BYPASS RISKS/COMPLICATIONS Mild malabsorption of nutrients (lowest risk of deficiencies). The patient will have to take vitamin and protein supplements for the rest of his or her life (ASMBS, 2014). Long-term risks include: Peptic ulcer (3-5%) Small bowel obstruction (1%) Internal hernia (1-2%) Incisional hernia (0.8%) Stenosis (2%) Vitamin/nutrient malnutrition (10-25%) (Podnos et al., 2003) Other complications include general risks of surgery, dumping syndrome, anemia and leakage (Wheaton Franciscan Healthcare, 2014). DID YOU KNOW? The risk of alcoholism is increased after gastric surgery, especially bypass surgery, due to more rapid absorption (King et al, 2012). It may take a year or two after the surgery for it to result in alcohol use disorder. Therefore, alcohol intake after post-bypass surgery should be avoided. BILIOPANCREATIC DIVERSION (BPD)/DUODENAL SWITCH (DS) BILIOPANCREATIC DIVERSION (BPD)/DUODENAL SWITCH (DS) Also known as long limb Gastric Bypass, this surgery removes or bypasses part of the digestive tract, shrinking stomach size and slowing digestion. BPD/DS is primarily a malabsorptive procedure (especially of fats), because a large percentage of the small intestine is bypassed. Comprising only around 1% of weight-loss surgery; it is performed far less common than previously. However, a patient may have received this surgery in the past. In Vertical Gastrectomy With Duodenal Switch (DS), the stomach is sutured into a narrow pouch that holds about 4-5 oz. The distal portion of the small intestine is connected to the new stomach. When Page 30 of 63

31 the patient eats, the food goes from the new tubular stomach pouch directly into the last portion of the small intestine. Food bypasses about 3/4 of the small intestine. The portion of the small intestine that carries the bile and pancreatic juices is attached to the end of the small intestine to allow digestive juices to mix with the food. (ASMBS, 2014) MECHANISM OF ACTION Patient feels fuller sooner and absorption is decreased by diverting food past most of the small intestine. Additionally, gut hormones are regulated in a way that suppresses hunger and increases satiety. (ASMBS, 2014) EFFECTIVENESS This type of surgery results in the greatest weight loss: expect 75%-80% of excess weight to be lost. Long-term rate is unknown, but it is estimated 5-10% regain most of their weight (ASMBS, 2014). Effective for individuals with a BMI >50, those with a BMI less than 45 may lose too much weight. This surgical procedure is the most effective against diabetes (Anderson et al., 2013). POST-SURGERY DIET Limited to liquid and soft foods initially. Patients must eat 3 meals/day and follow a strict protein/vitamin supplementation regimen. The patient may be able to eventually consume near normal amounts of food. (ASMBS, 2014) Page 31 of 63

32 BILIOPANCREATIC DIVERSION (BPD)/DUODENAL SWITCH (DS) BILIOPANCREATIC DIVERSION (BPD)/DUODENAL SWITCH (DS) Also known as long limb Gastric Bypass, this surgery removes or bypasses part of the digestive tract, shrinking stomach size and slowing digestion. BPD/DS is primarily a malabsorptive procedure (especially of fats), because a large percentage of the small intestine is bypassed. Comprising only around 1% of weight-loss surgery; it is performed far less common than previously. However, a patient may have received this surgery in the past. In Vertical Gastrectomy With Duodenal Switch (DS), the stomach is sutured into a narrow pouch that holds about 4-5 oz. The distal portion of the small intestine is connected to the new stomach. When the patient eats, the food goes from the new tubular stomach pouch directly into the last portion of the small intestine. Food bypasses about 3/4 of the small intestine. The portion of the small intestine that carries the bile and pancreatic juices is attached to the end of the small intestine to allow digestive juices to mix with the food. (ASMBS, 2014) MECHANISM OF ACTION Patient feels fuller sooner and absorption is decreased by diverting food past most of the small intestine. Additionally, gut hormones are regulated in a way that suppresses hunger and increases satiety. (ASMBS, 2014) Page 32 of 63

33 EFFECTIVENESS This type of surgery results in the greatest weight loss: expect 75%-80% of excess weight to be lost. Long-term rate is unknown, but it is estimated 5-10% regain most of their weight (ASMBS, 2014). Effective for individuals with a BMI >50, those with a BMI less than 45 may lose too much weight. This surgical procedure is the most effective against diabetes (Anderson et al., 2013). POST-SURGERY DIET Limited to liquid and soft foods initially. Patients must eat 3 meals/day and follow a strict protein/vitamin supplementation regimen. The patient may be able to eventually consume near normal amounts of food. (ASMBS, 2014) RISKS/COMPLICATIONS OF BILIOPANCREATIC DIVERSION/DUODENAL SWITCH RISKS/COMPLICATIONS BPD/DS has the highest rate of complications. It causes malabsorption of fat (up to 70% or more) which can cause diarrhea and bloating. Additionally, it has the greatest potential for protein and longterm vitamin/mineral deficiencies (e.g. iron, calcium, zinc, and vitamin D). General risks associated with surgery Bowel obstruction Leakage Ulcers Dumping syndrome Diarrhea Bloating Page 33 of 63

34 Nutrient deficiencies Heartburn Nausea and vomiting (Wheaton Franciscan Healthcare, 2014; ASMBS, 2014; Anderson et al., 2013) ELECTRICAL VAGAL BLOCKING THERAPY ELECTRICAL VAGAL BLOCKING THERAPY This implanted device blocks nerve signals between the brain and stomach, which reduces hunger (EnteroMedics, 2015). The vagal blockade results in feeling full earlier during eating, reducing calorie intake. Intended for BMI of 40 to 45 kg/m 2, or a BMI of 35 to 39.9 kg/m 2 with an obesity-related comorbidity (EnteroMedics, 2015). MECHANISM OF ACTION The electrical vagal blocking device is implanted subcutaneously in the lateral chest wall with wires extending into the abdomen to stimulate the vagus nerve and cause feelings of fullness (FDA, 2015). The surgery involves dissecting out the nerves, which can be challenging in a morbidly obese patient (Brethauer, 2015). The FDA describes it as a "rechargeable electrical pulse generator, with wire leads and electrodes implanted surgically into the abdomen. It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full" (FDA, 2015). The device can be combined with other forms of weight loss surgery. EFFECTIVENESS In research trials, the treated group lost 8.5% more excess weight than controls after 12 months (FDA, 2015). About half of the experimental group lost at least 20% of their excess weight. Long-term effectiveness studies are needed. Page 34 of 63

35 POST-SURGERY DIET This device does not cause malabsorption of nutrients and does not decrease the size of any part of the digestive track, so no special diet is needed to avoid side effects or malnutrition. Patients do need to follow the recommended weight-loss plan of calorie restricted diet, increased activity, and behavioral support. (FDA, 2015) RISKS/COMPLICATIONS OF VAGAL BLOCKING THERAPY RISKS/COMPLICATIONS Serious adverse events: Nausea and vomiting, especially postsurgically Pain at the neuroregulator site Surgical complications. However, this outpatient procedure holds less risk than more extensive weight loss surgery. Other adverse events include pain, heartburn, problems swallowing, belching, mild nausea and chest pain. Studies of long-term effects are needed. An advantage over some other surgeries is that it is reversible. (FDA, 2015) INTRAGASTRIC BALLOON INTRAGASTRIC BALLOON TREATMENT A newer treatment, still being further developed is the use of intragastric balloons. These devices can be filled with saline, gas, or air and then inserted into the stomach to fill space and produce a sense Page 35 of 63

36 of fullness, thus reducing food consumption (Mion et al., 2013; Ponce et al., 2014). Methylene blue dye may be inserted in the balloon to signal to the patient if the balloon deflates prematurely (Brethauer, 2015). These reversible devices have been used effectively outside the United States for almost 20 years, producing mean weight loss of 25 40% (Ponce et al., 2014). One of the balloon treatments has been approved by the FDA for use in patients (HealthDay, 2015). Other factors to consider include (Brethauer, 2015): Behavioral therapy is recommended Not covered by insurance typically Side effects may result in need for anti-nausea and anti-spasmodic medications Variations in Balloon Products More intragastric balloons produce more weight loss, but the optimal safe number is still being studied. Further research is needed to determine tolerance levels and limits in the number that can be used safely. One of the FDA approved balloon products, is a dual-balloon that is implanted surgically. When tested vs a traditional weight-loss diet and exercise plan and no balloon (n=326), doubled weight loss on average at 24 weeks 7% of body weight lost with balloon vs. 3.3% with control (Ponce et al., 2014). After removal, 33% of weight loss was regained at an additional 24 weeks (Ponce et al., 2014). So the net weight lost after one year was 3.7% on average. This device is for obese adults with a BMI between 30 and 40 Balloons that are swallowed inside a dissolving pill and then filled with water by catheter are also in development (Chuttani et al, 2015). Early research reported that patients lost more than one-third of excess weight in a 4 month test period In a pilot study of 3 balloons, 17 overweight patients lost weight without significant medical side effects, losing excess weight of 12.4% (4 weeks), 29.2% (8 weeks), and 36.2% (12 weeks) and having overall health improvements (Mion et al., 2013). Not A Long-Term Solution Balloon treatment should not be seen as an ultimate solution for obesity (Alfredo et al., 2013). The balloons can only be used for six months at a time and should not be seen as an alternative to surgery (HealthDay, 2015). The removal of the balloons can lead to weight regain (Alfredo et al., 2013) and further exploration of the long-term effects of this type of treatment is needed. Page 36 of 63

37 MODIFIED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE TO DRAIN STOMACH This device, surgically placed in the stomach allows the patient to drain stomach contents after eating. Intended for patients with a BMI of 35 to 55 kg/m 2 who have not achieved weight loss with nonsurgical methods (FDA, 2016). Contraindications include pulmonary or cardiovascular disease, coagulation disorders, chronic abdominal pain, or conditions causing high risk from endoscopy. MECHANISM OF ACTION Direct removal of approximately 2/3 of food that has been consumed decreases caloric intake. Around a half hour after eating, the patient connects a pump to a disc-shaped port that is left in place to pump and rinse out part of the stomach contents. EFFECTIVENESS In research trials, after a year, in one study of 111 treated patients, average weight loss was 12.1 percent of total body weight compared to 3.6 percent for lifestyle therapy only controls (FDA, 2016). POST-SURGERY Patients should be monitored regularly and be in a program to change their lifestyle to healthier eating habits and reduced calories. The tube needs to be shortened after weight loss. The device Page 37 of 63

38 shuts off after around six weeks which supports the patient's return for treatment. Side effects are occasional and include indigestion, nausea, vomiting, constipation, and diarrhea. Risks are also described for surgical placement via endoscopy and problems related to the port, such as inflammation and leakage, which may require removal. (FDA, 2016) QUIZ: REVIEW SURGERY TYPES 1. Sleeve Gastrectomy This surgery has become the most common and is not reversible. 2. Biliopancreatic Diversion with Duodenal Switch (DS) Highest risk of nutritional deficiencies. This procedure narrows the stomach and bypasses the most of the small intestine of all the forms of surgery, so it produces the most malabsorption. It is not commonly used currently. 3. Roux-En-Y Gastric Bypass Stomach narrowed into a pouch plus bypass of a short segment of the small intestine. Formerly the most common type of weight-loss surgery 4. Vagal Blocking Therapy This surgery involves a subcutaneous neuroregulator implant with electrodes that block the vagus nerve. Risk of pain is slight. 5. Laparoscopic Adjustable Gastric Banding Laparoscopic Adjustable Gastric Banding is the most easily reversed of these surgeries. Vagal blocking therapy is also relatively easy to reverse but does not directly involve the stomach. QUIZ: MS. MURDOCK REFERRAL FOR SURGERY 1. Vertical (Sleeve) Gastrectomy Ms. Murdock requested a surgery that produces relatively more weight loss without malabsorption. Sleeve gastrectomy meets this criterion and produces loss of 55 to 80% of excess weight. 2. Adjustable Gastric Band Ms. Murdock requested a surgery that produces relatively more weight loss. The Vertical Sleeve produces more weight loss than the gastric band. 3. Roux-En-Y Gastric Bypass Ms. Murdock requested a surgery that produces relatively more weight loss without malabsorption. Sleeve gastrectomy has less malabsorption and produces loss of 55 to 80% of excess weight. 4. Vertical Gastrectomy With Duodenal Switch (DS) Ms. Murdock requested a surgery that produces relatively more weight loss without malabsorption. This surgery causes the most weight loss but also causes malabsorption of fat, which can cause diarrhea and bloating Page 38 of 63

39 REFERRING MS. MURDOCK Having completed a very brief overview of the surgical options, the provider next summarizes and answers questions: Provider: You will work with your surgeon on selecting which form of surgery you will have, but do you have any further questions now? Mrs. Murdock: Okay, what's the bypass surgery again? Is it the one where my stomach's restricted by a band or the one where they shrink my stomach with surgery? Provider: Gastric bypass surgery is usually a laparoscopic procedure, meaning it is completed through a relatively small incision. A one-ounce pouch of the stomach is connected to the small intestine. You would need to stay in the hospital 1-3 days. Mrs. Murdock: What's the success rate of something like that? I want to lose weight, but I'd rather not go through a big procedure if it's not going to give me good results. Provider: Typically, patients have seen a 50% loss of excess weight. This is the most common type of weight-loss surgery done today. Your surgeon can give you the latest figures. Mrs. Murdock: That sounds okay. I think I do want to go ahead and get a referral to the surgeon. I look forward to losing this weight finally! PRE-SURGICAL EVALUATIONS AND COUNSELING Prior to weight-loss surgery, patients need psychological assessment, counseling, and education for several purposes: Nutritional Pre-Surgical Assessment Nutrition assessment Nutrition education and preparation for dietary changes. (Bays et al., 2018) Psychological Pre-Surgical Assessment Mental health assessment Education for realistic expectations Self-esteem building Developing coping skills not based on food Potentially couples counseling as the change is often stressful for others as well Most of the evaluation and education is an integrated part of most weight-loss surgery programs, but regular counseling sessions may need to be added. (Bays et al., 2018) Medical Pre-Surgical Assessment Medical evaluation prior to surgery should include: Evaluation by a physician obesity specialist Consultation with the bariatric surgery specialist Page 39 of 63

40 As indicated, consultations with cardiology, pulmonary, gastroenterology, endocrinology (Bays et al., 2018) OVERVIEW OF SURGICAL COMPLICATIONS Risks of Bariatric Surgery Adverse intra-operative events occurr in around 5% of procedures (Lim et al., 2010; LABS, 2009). Splenic injuries (occurring in 3% of procedures) are the most common, followed by bowel ishemia and trocar injuries. Patient age (> 50) and male sex are associated with an increased prevalence of adverse intra-operative events. Additionally, the type of surgery performed affects the risk for adverse intra-operative events: 1. Open Roux-en-Y Gastric Bypass: 7.3% 2. Laparscopic Roux-en-Y Gastric Bypass: 5.5% 3. Laparoscopic Adjusted Gastric Band: 3% (Greenstein et al., 2014) Adverse intraoperative events increase risk for further health complications following surgery. Having an adverse event, independent of the type of procedure (open or laparoscopic), is associated with a 90% greater risk for post-surgery complications (Greenstein et al., 2014). Early Post-Operative Complications Abnormalities in healing (dehiscence, strictures) Other complications (erosions/ulcers, leaks and associated peritonitis or mediastinitis) (Mechanick et al., 2013) Mortality Short-term (< 1 year) mortality rates for bariatric surgery range from 0.07% to 0.6%, depending on the procedure. The mortality risks by type of procedure are: 1. Biliopancreatic/duodenal switch (0.6%). 2. Roux-en-y gastric bypass (0.38%) 3. Sleeve gastrectomy (0.29%) 4. Adjustable gastric band (0.07%) RISK FACTORS FOR MORTALITY INCLUDE: Sex (men) Age Hypertension Page 40 of 63

41 Multiple comorbidities BMI > 50 kg/m 2 Large amount of visceral fat (Chang et al., 2014; Hedberg et al., 2014; Mechanick et al., 2013) Post-Surgical Nutrition: Basic Principles The basic principles for nutrition following bariatric surgery vary with the procedure, but may include: Small meals 3-5 X per day Chew food thoroughly Avoid liquids during and for 30 minutes after meals Avoid concentrated sweets (to avoid dumping syndrome and lower calories) Take recommended multivitamin, also, frequently vitamin B12, iron with vitamin C, and calcium citrate with vitamin D (Bays et al., 2017) WEIGHT-LOSS OUTCOMES OF SURGERY After considering all options, the decision has been made that Ms. Murdock will be having a Vertical (Sleeve) Gastrectomy. What information can you provide her about the potential weight-loss outcomes from surgery? High Rate of Good Weight-Loss Outcomes Bariatric surgery is considered to have a good weight-loss outcome IF at least 40-50% of excess body weight is lost (Elkins et al., 2005). Most people having bypass surgery lose at least this much weight, but success rates vary with the procedure. The more drastic the surgical procedure, the more weight is lost and the higher the surgical and post-surgical risk. Unfortunately, long term studies into long term outcomes after bariatric and metabolic surgery are in short supply. The following offers some insight: Case Reports on Long Term Outcomes Page 41 of 63

42 Report #1: Case report data from one surgical practice that tracked consecutive patients having gastric bypass showed significant weight loss and maintenance of weight loss for 5 years post surgery (Callery, 2008). Years 0-2: A pattern of significant weight loss, averaging around 75% of excess weight after one year, continued at a slower pace over the next year to an average of around 80% of excess weight lost after 2 years. Years 2-4: Initial weight loss was followed by a slow regain of weight over the next two years to an average loss of 65% of original excess weight. Years 4-5: Weight appeared to stabilize in the next year, but many patients had been lost to follow-up. Report #2: A small cohort of patients were followed in another practice for 10 years (Schauer, 2015). The following insights were reported after observing 6 successful cases over this period: There was little desire to eat for around 6 months. Intitial rapid weight loss of around 40 to 50 pounds is followed by slower weight loss over the following months. Much of the weight loss was protein rather than fat, around 25% The basal metabolic rate was lowered by the period of very low food intake and did not return to original rates. After the initial 6 months, normal appetite returns and preventing weight gain again becomes a struggle. These successful cases all engaged in daily, fairly intense exercise and found that if they did not, they regained weight. They also carefully paid attention to following recommended diet. The high cost paid out of pocket was a high motivator for changing behaviors in order to succeed at weight loss. Bottom Line Bariatric surgery, on the average, is one of the most effective weight loss treatments and has relatively good, although not perfect, long-term maintenance rates. After initial dramatic weight loss, continued weight loss and maintenance involves fairly strict behavioral modifications in diet and physical activity. REASONS FOR POOR WEIGHT-LOSS OUTCOME Rates of Poor Weight-Loss Outcomes The surgical definition of a poor weight-loss outcome is losing less than 40-50% of excess body weight. The incidence of poor weight-loss outcome is: 15-17% of gastric bypass patients 25% (or more) in gastric band patients (Elkins et al., 2005) Page 42 of 63

43 Behaviors Contributing to Poor Weight Loss One approach to weight loss is to target behaviors known to result in poor weight-loss outcomes. In one study, patients who had poor weight loss after a year reported that they snacked, drank sodas, did not take vitamins and did not exercise (Elkins et al., 2005). The following behaviors decrease weight loss or even contribute to weight gain, especially the first two: Eating Behaviors: Shifting calories to carbohydrates Liquid or soft high calorie meals Eating frequently Spreading meals out over a long time Drinking liquids with meals or right after eating (empties stomach faster, decreasing satiety) Drinking high calorie liquids between meals Untreated depression Insufficient exercise (Elkins et al., 2005; Mechanick et al., 2013) FOLLOW-UP AFTER SURGERY Section Topics Counseling patients regarding the behavioral, diet, and medication requirements following bariatric surgery. Providing appropriate medical management, as needed, for patients who have had bariatric surgery. MS. MURDOCK Page 43 of 63

44 After talking about types of surgery, the provider next turns to explaining the impact surgery will have on her and the required lifestyle changes. What details need to be discussed in order to make sure she is making an informed decision? The following need to be considered after the patient has recovered from surgery: Nutritional Deficiencies Surgery's Impact on Gut Hormones Post-Surgery Diet Post-Surgery Psychological Supports BEHAVIORS FOR WEIGHT LOSS AFTER SURGERY The following behaviors are recommended daily after bariatric surgery to achieve sufficient weight loss (Spitznagel, et al., 2013). Surgery alone is generally not enough for long-term weight loss and maintenance. Physical activity: 30 to 60 minutes/day, at least 5 days/week Exercise built into daily routine Drinking before feeling thirsty Eating 5 meals or snacks/day Meals taking 20 to 30 minutes Check if they are feeling full after each bite Drinking 48 ounces or more per day Build weight training into daily routine Eat at least 5 fruits and vegetables per day (note that an emphasis on vegetables results in more weight loss) Eat 60 to 80 gm of protein per day* * Note that the post-surgery diet is similar to the Protein-sparing Modified Fast diet used for initial rapid weight loss in morbidly obese individuals. NON-adherence to the above recommended behaviors by patients who have had bariatric surgery varies, with adherence to some behaviors by most patients and adherence to other behaviors by few patients. For example: Most patient report drinking before feeling thirsty and taking minutes per meal (only 24.3% and 32.4% reporting NON-Adherence) Few patients report adherence to weight training and eating 5 fruits and vegetables (89.2% and 83.8% report NON-Adherence) (Spitznagel, et al., 2013). Individuals with cognitive impairment, which comprise around 23% of patients presenting for bariatric surgery and includes problems with attention and executive functioning, may benefit from external supports to achieve these behaviors. For example, checklists to review daily goals or an alarm to achieve time-related behaviors can be used to provide the external structure that might help support weight loss. Page 44 of 63

45 GUIDELINES FOR FOLLOW-UP AFTER SURGERY Guidelines recommend long-term, interdisciplinary follow-up of patients after bariatric surgery (Fried et al., 2013; Herber et al., 2013). The interdisciplinary team should recommend appropriate dietary modifications and provide adequate physical activity and behavioral support interventions. Guidelines note that the surgeon is responsible for long-term follow-up, however, some patients may be lost to surgical follow-up and present in primary care for the management of other conditions. The following guidelines are followed in general, but vary with the type of surgery. GUIDELINES FOR POST-SURGERY Frequency: Patients are seen around a month post-surgically, and then typically every 3 months for the first year, every 6 months in the second year, and annually thereafter. Monitoring status of comorbid conditions: Levels of blood glucose and lipids should be monitored in patients in order to ensure they are within normal limits or are treated when outside normal parameters (Fried et al, 2013; Herber et al., 2013). Medications, for example, in treatment of type 2 diabetes, hypertension, or high cholesterol may need to be adjusted (Fried et al, 2013). Monitoring weight loss: Adjust diet, activity level, and, if needed, pharmacological therapy (Fried et al, 2013). Gastric bands may need to be adjusted by a trained provider (Fried et al, 2013). Nutritional and metabolic status: Patients should be monitored for vitamin or mineral deficiencies and prescribed supplements as needed ((Fried et al, 2013; Herber et al., 2013). Compensatory vitamin and micronutrient supplements are routinely prescribed to prevent deficiencies, typically vitamin A, D, E, and K supplementation as well as recommendations for calcium preferably through food intake - 2g/day and adequate protein intake - 90 g/day (Fried et al, 2013). Laboratory tests are routinely performed to monitor nutritional and metabolic status and make adaptations in supplementation (Fried et al, 2013). Laboratory tests completed at least annually include the following: Fasting glucose (+HbA1c in diabetics), liver function tests, renal function, vitamins B1, B9 (folates), B12, and 25(OH) vitamin D3, ferritin, parathormone, albumin, Hb, Ca2+, basic blood cells, hemoglobin, and electrolytes (Fried et al, 2013). Additionally, other pharmacological treatments and surgical revisions may be needed for some patients (Fried et al, 2013). NUTRITIONAL DEFICIENCIES Ms. Murdock will be having a Vertical (Sleeve) Gastrectomy as her surgery type. What information about nutritional deficiencies should be discussed? Nutritional deficiencies, a common side effect of weight-loss surgery, are primarily caused by malabsorption. In more restrictive forms of surgery, malabsorption is relatively common post-surgery. Nutritional deficiencies can be avoided with diet changes and supplements to offset deficiencies, especially calcium, B-12, folate, iron, and protein (Herber et al. 2013; Mechanick et al., 2013). Page 45 of 63

46 Common Post-Surgical Nutritional Deficiencies Nutritional deficiencies that are common after bariatric surgery include: Iron Deficiency Anemia The most common deficiency after gastric bypass, occurs in up to 50% of patients. Causes: Decreased acid secretion in gastric pouch, H2 blockers and proton pump inhibitors, and decreased intake. Check CBC, iron, transferrin, ferritin 2x/year. Iron supplementation should be considered in all gastric bypass patients: Prevention/Counteraction: Multivitamin with iron, ferrous sulfate with vitamin C, chelated iron. If necessary IV iron infusions. (Xanthakos, 2009; Salgado, 2014) Vitamin B12 Deficiency Seen in 26-70% of patients after gastric bypass. Due to achlorhydria, decreased consumption, less intrinsic factor secretion Look for neurologic symptoms, megaloblastic anemia, low platelets, low WBC, glossitis Prevention/Counteraction: Supplement to keep levels in normal range. Oral administration is best if it can be absorbed; otherwise sublingually absorbed, subcutaneous, or intramuscular preparations can be used. (Xanthakos, 2009; Mechanick et al., 2013) Folate Deficiency Seen in up to 25% of patients after gastric bypass because absorption is facilitated by stomach HCl. Associated with Vitamin B12 deficiency and decreased consumption. Presents as megaloblastic anemia, low platelets, low WBC, and glossitis. Critical for pregnant women due to risk of neural tube defects. Prevention/Counteraction: Supplementation (1 mg/day). Part of routine multivitamin supplementation. (Xanthakos, 2009; Mechanick et al., 2013) Alcohol Absorption Is Increased In contrast to the decreased absorption of many nutrients, the rate of alcohol absorption is increased after bypass type bariatric surgeries (King et al., 2012). Therefore, alcohol intake is not recommended post-surgically. OTHER VITAMIN DEFICIENCIES In addition to the common vitamin deficiencies found post surgically, vitamin B12 and folate, other vitamins may be deficient: Fat Soluble Vitamins Vitamin A, D, and K all may be deficient. Page 46 of 63

47 Deficiency rates vary with the type of surgery and the vitamin. For example, 52%-69% are deficient in vitamin A, after biliopancreatic diversion, but only 10% are deficient after Roux-en-Y gastric bypass. Vitamin D deficiency is more common: Up to 80% are deficient. Evaluate patients who have had malabsorptive surgical procedures for vitamin A deficiency. Evaluate patients who had restrictive surgeries according to symptoms, such as ocular abnormalities. Evaluate for deficiencies in vitamin K (hepatopathy, coagulopathy, or osteoporosis) if symptoms present themselves. According to guidelines, there is insufficient evidence to support routine screening for essential fatty acids or vitamin E. Prevention/Counteraction: Provide oral replacements of vitamin D prophylactically of at least 3000 units per day titrated to therapeutic levels. More may be needed for malabsorptive surgical procedures. Provide replacements of other fat soluble vitamins as needed. (Xanthakos, 2009; Mechanick et al., 2013) Thiamine Thiamine levels are reduced due to decreased acid and duodenal exclusion in gastric bypass. They may also be affected by post-operative vomiting. Peripheral neurologic symptoms can occur within weeks. Wernicke s encephalopathy is reported as early as 3 months. Prevention/Counteraction: Routine supplementation as part of a multivitamin. If neurologic symptoms develop, additional parenteral supplementation may be needed. (Xanthakos, 2009; Mechanick et al., 2013) Other Vitamin Deficiency Other B vitamins: B2 (riboflavin), B3 (niacin), B6 (pyridoxine) Vitamin C (Xanthakos, 2009) OTHER MINERAL AND PROTEIN DEFICIENCIES In additional to Iron, other minerals may be deficient as well. Protein may also become deficient if not supplemented: Minerals Calcium deficiency is common and more common with malabsorptive procedures. Other mineral deficiencies are mostly seen in duodenal switch/other malabsorptive surgeries: Zinc (poor wound healing, immunity), Mg (hypertension, cramps, constipation), selenium (fatigue physical and mental), copper (microcytic anemia, Wilson's disease). May also see iodine, chromium, and potassium deficiencies. Copper and selenium deficiencies are also reported rarely (Bays et al, 2017). Prevention/Counteraction: 1) 1200 to 1500 mg of calcium is needed per day. This should be dietary as much as possible and citrated calcium should be taken in divided doses, due to the increased risk of myocardial infarction. Calcium supplementation is also used to reduce hyperoxaluria after malabsorptive procedures. 2) For other minerals, supplement with 2 daily vitamins with minerals, including mg elemental iron. Page 47 of 63

48 (Xanthakos, 2009; Mechanick et al., 2013) Protein Most common with malabsorptive surgeries, especially 1-2 years post surgery. Watch for edema, anasarca, hair loss, muscle wasting (watch Lean Body Mass). Check albumin and pre-albumin. Prevention/Counteraction: Routine physical activity following surgery can help prevent the loss of muscle. For counteraction, research has indicated that protein ingestion before sleep can increase muscle protein synthesis rates during overnight recovery (Snijders et al., 2015). Protein recommendations should be individualized according to gender, age, and weight, which can be guided by a nutritionist. The minimal protein intake is around 60 g/d and up to 1.5 g/kg ideal body weight per day for most patients. (Xanthakos, 2009; Mechanick et al., 2013) OTHER RISKS AND SIDE EFFECTS POST SURGERY In addition to potential nutritional deficiencies, the following side effects of weight-loss surgery are seen: DUMPING SYNDROME: The syndrome involves abdominal discomfort and sometimes rapid bowel evacuation and vomiting. As a result of surgical alterations, stomach contents exit into the small intestine too quickly. The partially digested food pulls fluid into the small intestine. Dumping syndrome usually occurs when the patient consumes too much food containing simple or refined sugars producing a hypertonic load that pulls more fluids. Dumping syndrome is a concern especially after more extensive forms of surgery involving gastric resection (NDDIC, 2013). Symptoms include: abdominal pain cramping flushing palpitations diaphoresis tachycardia hypotension (Elrazek & Elbanna, 2014) Patients who have had one of the forms of surgery that modify the size of the stomach (Roux en Y Gastric Bypass and Biliopancreatic Diversion) should be advised how to eat in order to avoid dumping syndrome (Elrazek & Elbanna, 2014). Dietary changes needed include protein-based meals and avoiding concentrated sweets and simple carbohydrates. If dumping happens early, around 10 to 30 minutes after eating, hydration before meals is advised (Fried, 2013). Patients having dumping syndrome 2 to 3 hours after a meal should be assessed for possible hypoglycemia. Post-prandial hypoglycemia can be reduced with regular meal times and low carbohydrate meals. Page 48 of 63

49 Symptoms of gastrointenstial leaks: Symptoms of dumping syndrome should be distinguished from those of gastrointestinal leaks. According to the 2013 EASO-IFSO-EC guidelines for bariatric surgery, symptoms of gastrointestinal leaks include "newly sustained tachycardia > 120 pulses/min for at least 6 h, fever, tachypnoea, newly established signs of hypoxia, increasing pain, and elevated C-reactive protein" (Fried, et al, 2013). CONSIDERATIONS FOR TREATMENT OF OTHER MEDICAL CONDITIONS For patients with type 2 diabetes, antidiabetic medications are adjusted immediately postoperatively and may need further adjustment with continued weight loss. Anti-hypertensive medications may need ongoing adjustment Some pharmacotherapies, such as non-steroidal and steroidal anti-inflammatories should be avoided, to avoid gastrointestinal bleeding. If needed, use immediate release rather than enteric coated formulations. (Fried, et al, 2013) EXCESSIVE WEIGHT LOSS OR PROTEIN MALNUTRITION Patients should be advised to maintain adequate protein intake to help prevent excessive loss of lean body mass (Fried, et al, 2013). Excessive weight loss or protein malnutrition is rare with gastric band, Roux-en-y gastric bypass, or sleeve patients and more common after biliopancreatic/duodenal switch (Mechanick et al., 2013). OTHER RISKS/SIDE EFFECTS Dairy intolerance (common) Increased alcohol absorption Bowel obstruction Internal hernia Gastric band erosion Changed absorption of medications, varying with type of surgery Gastric band slip Panniculitis (in skin folds after weight loss) (Mechanick et al., 2013; Virji & Murr, 2006) SURGERY IMPACT ON GUT HORMONES Weight-loss surgery also has a significant and powerful effect on many gut hormones, which appears to explain some of surgery's successful weight-loss outcomes. Ghrelin Ghrelin signals a need to eat and is produced in the fundus of the stomach. Ghrelin leads to food intake, increased gut motility, decreased insulin, and generation of fat and weight gain (Cummings & Overduin, 2007). CLINICAL APPLICATION: Gastric sleeve removes the fundus so it produces the greatest change in ghrelin, which is the likely reason for the success of gastric sleeve vs. other weight-loss surgeries (WIN, 2011). Page 49 of 63

50 Peptide YY (PYY) Peptide YY (PYY) delays gastric emptying (like GLP1) and intestinal transit. It may also inhibit NPY/AGRP. It too is produced in the distal small intestine and L cells in the colon (Kim et al., 2011). Glucagon-like Peptide-1 (GLP-1) Glucagon-like Peptide-1 (GLP-1) delays gastric emptying, suppresses glucagon, and enhances insulin release. It is produced In the distal small intestine and L cells in the colon (Cummings & Overduin, 2007). CLINICAL APPLICATION: Both PYY and GLP-1 are increased markedly in gastric bypass, mildly with sleeve gastrectomy, and unaffected by the band. This effect may partially explain the greater weight loss seen with gastric bypass compared to sleeve gastrectomy and gastric bands. (Salem & Bloom, 2010) Insulin Insulin is decreased in gastric bypass and sleeve gastrectomy (and unaffected in gastric banding). This effect highlights the potential of surgery (and also weight loss through dietary change) to decrease fat stores (Ferrannini & Mingrone, 2009). With the decrease in insulin, the diet should be watched carefully after surgery in order to ensure proper control over glucose. Leptin Leptin, secreted by adipose tissues, is decreased in gastric bypass and sleeve gastrectomy, but it is unaffected in gastric banding. Lower leptin increases hunger, via increased AgRP, NPY and ghrelin, and decreases satiety. Thus, there continues to be a need for a comprehensive weight-loss program post-surgically. Surgery alone is not a solution that is likely to succeed (Salem & Bloom, 2010). Unaffected Hormones Some hormones are relatively unaffected by surgery. For example, Glucose-Dependent Insulinotrophic Peptide (GIP) is produced in the proximal small intestine and does not show a large effect from gastric band and sleeve gastrectomy surgery (Vetter et al., 2009). POST-SURGERY DIET Diet is very important after bariatric surgery, in order to maintain proper nutrition post-surgery and ensure success. The food to eat differs at each stage as follows: FIRST 2 WEEKS POST-OP: Remain on a liquid diet. Focus on hydration first, then work on protein. NO carbonated beverages 2-4 WEEKS POST-OP: Move to a pureed diet. 4-8 WEEKS POST-OP: Transition to tiny amounts of real food. Adjust medications for glycemic control in type 2 diabetes as needed. (Elkins et al., 2005; Mechanick et al., 2013) Page 50 of 63

51 LONG-TERM POST-SURGERY DIET Once the immediate post-surgery dietary needs have been taken care of, the patient must commit to a list of long-term dietary changes: DIETARY CHANGES Sweets: Eliminate concentrated sweets to avoid dumping syndrome after gastric bypass and to restrict calories after any procedure. Portions: Focus on small portions and small plate size. Food selections: Choose protein first. Add a colorful vegetables/salad. Prepare for return of hunger: Hunger will return, so establish good eating patterns and choices early. Eating schedule: Eat 3 meals per day and planned protein-based snacks. MEDICAL CONSIDERATIONS Supplements: Take recommended nutritional supplements daily. Alcohol: Patients at risk for alcohol use disorder should eliminate alcohol consumption after malabsorptive procedures. All patients having gastric bypass surgery should make adjustments for accelerated alcohol absorption and higher blood concentrations postsurgically. Screen for risk and consider referral for substance use counseling if there is a risk. Diabetes medications: Note that medications for type 2 diabetes may need to be monitored continually with continued weight loss. (Elkins et al., 2005; Mechanick et al., 2013) POST-SURGERY PSYCHOLOGICAL ISSUES Some patients experience mental health problems post weight-loss surgery. Around 13% of patients experience increased depression after bariatric surgery (Ivizaj & Grilo, 2015). Changes that contribute to stress and depression post-surgically include: Being physically unable to use old ways of coping using food The required change in lifestyle Coping with reactions from others, including being more attractive to others and not knowing how to respond. For others, family and friends may feel uncomfortable with the change of weight loss. Finding out that weight loss doesn't solve all of one's problems Transfer of an addiction-like relationship with food to another addiction, such as drugs or alcohol or even exercise. Poor self-esteem and persistent, inaccurate body image Cognitive behavioral therapy can help address many of these problems and reduce depressive symptoms. MS. MURDOCK POST-SURGERY LONG-TERM FOLLOWUP Page 51 of 63

52 Maintenance Protocol Step: Follow patients post bariatric surgery and evaluate for compliance with the recommended post-surgical diet and supplements and for any complications. Your Patient, Ms. Murdock, Returns Ms. Murdock did go through with weight loss surgery 2 months ago: Patient Name: Stacy Murdock Age: 46 y/o Height: 5'6 Weight: 240 lbs BMI: 38.7 Waist: Unknown BP: 125/93 Pulse: 85 Respiration: 16/min Chief Complaint: Despite weight-loss surgery, she does not feel she is losing weight at a satisfactory pace. History of Present Illness: Underwent Roux-en-Y gastric bypass two months ago, and has not met her weight-loss goals immediately following surgery. She has only lost 4 lbs. Medical History: Prior to surgery: Hypertension, dyslipidemia, impaired glucose tolerance (prediabetes), weight-related venous stasis and phlebitis, and incontinence. Post surgery: All conditions have improved at least a little, and phlebitis and incontinence have resolved. QUIZ: POST-SURGERY HABITS 6 month followup The provider interviews Ms. Murdock to try to determine why she is losing so little weight despite being 6 months post gastric bypass surgery (Roux-en-y): Provider: I see that your weight loss hasn't met expectations to date. Ms. Murdoch: I lost a lot, but only at first. I am losing weight, but it's just slow-going. I just don't know what's wrong. I thought this was supposed to help. Provider: Maintaining a healthy diet is very important to successful weight loss. Ms. Murdoch: I know, and I'm trying! I don't eat between meals, and I even skip meals sometimes or just drink a soda or shake instead of heavy foods, so I can lose weight faster. Based on this conversation with Ms. Murdock, the following are reasons why she might be having trouble losing weight post-surgery: Choose all that apply: 1. Not exercising Feedback: Ms. Murdock does indicate that she exercises. 2. Drinking sodas Feedback: Correct Sodas are a contributing factor to poor weight loss post-surgery 3. Skipping meals Page 52 of 63

53 Feedback: Correct Spreading meals out, skipping them in between, is a contributing factor to poor weight loss postsurgery. 4. Snacking between meals Feedback: Ms. Murdock indicates that she does not snack between meals. 5. Liquid meals Feedback: Correct Substituting liquid meals for healthy, balanced meals is a contributing factor to poor weight loss postsurgery. MS. MURDOCK LONG TERM FOLLOW-UP Your Patient MS MURDOCK Ms. Murdock is now 3 years post-bariatric surgery and returns with the recent onset of new symptoms: Patient Name: Stacy Murdock Age: 49 y/o Height: 5'6 Weight: 175 lbs BMI: 28.2 Waist: Unknown BP: 125/93 Pulse: 85 Respiration: 16/min Chief Complaint: Recent onset of hand numbness and tingling, clumsiness when walking, joint pain, and mild exercise intolerance. History of Present Illness: Patient is concerned about new symptoms that started a month ago and have gradually increased. Medical History: 3 years ago, she underwent Roux-en-Y gastric bypass surgery. At baseline, she had been suffering from hypertension, dyslipidemia, impaired glucose tolerance (pre-diabetes), weight-related venous stasis and phlebitis, and incontinence. Follow up: Phlebitis and incontinence resolved post-surgically somewhat. She continues to have hypertension controlled with medication. Her glucose tolerance is improved to within normal limits and her A1C is also normal. Weight History: Her baseline weight was 244 and BMI was 39.5 kg/m 2. She lost about 30% of her body weight (69 lbs). Physical activity level: Moderately active using treadmill a total of 60 min/week until decreasing due to current health issues. Page 53 of 63

54 MS. MURDOCK FOLLOW-UP INTERVIEW After congratulating Ms. Murdock on her weight loss, the provider asks about her chief complaint of hand numbness and other possible neurological symptoms. Provider: I see that you have had success with weight loss since I last saw you, losing 69 pounds. Congratulations. Ms. Murdoch: Thanks. It's been a wonderful experience, losing the weight and becoming more aware of how to make healthy decisions regarding food and exercise. Provider: So, you've changed your diet and increased your exercise post-surgery? Ms. Murdoch: Yes, I exercise regularly and count my calories to make sure I don't gain the weight back. The surgery and my weight loss have helped with my blood sugar, too. I just wish my hypertension would clear up. Now I've got these new symptoms: my hands are numb and tingly and my joints hurt. I'm clumsy when walking and can't walk as far without getting tired. I don't know what's going on. Provider: When did that start? Ms. Murdoch: It started about two weeks ago with my hands. MS MURDOCK, age 46 QUIZ: MS. MURDOCK Question: Based on all clinical information and the patient interview, what is the likely cause of Ms. Murdock's symptoms: tingling and numb hands, balance problems, joint pain, and mild exercise intolerance? 1. Pinched nerve complication from gastric bypass surgery Correct. Because the Roux-En-Y gastric bypass involved connecting her stomach so that some of her small intestine is bypassed, she is likely to have nutrient deficiencies if she does not take appropriate supplements. B vitamin deficiency, especially B-12, could account for her symptoms. 2. Vitamin deficiency Incorrect. Eating sweets and fats after gastric bypass surgery can cause "Dumping syndrome." The neurological symptoms she is experiencing are more likely due to B vitamin deficiency. 3. Eating sweets Incorrect. Eating sweets and fats after gastric bypass surgery can cause "Dumping syndrome." The neurological symptoms she is experiencing are more likely due to B vitamin deficiency. 4. Eating too many fats Page 54 of 63

55 Incorrect. Nerve damage from surgery would have shown up sooner. IDENTIFYING A SOLUTION Putting together all available information, the provider discusses the likely cause of Ms. Murdock's symptoms; Provider: You mentioned that you are more aware of your diet and counting your calories now, in order to maintain your weight loss. Do you take any nutritional supplements along with your meals? Ms. Murdock: No, I do a pretty good job of identifying all the vitamins and minerals in my foods and making sure I have a good daily allowance. I'm very aware of food labels now. Provider: While it's great that you eat nutritious food, you still might not be getting all the vitamins and nutrients that you need. Because some of your intestines are bypassed, your body has more difficulty absorbing nutrients. So you need daily supplements. A deficiency in vitamin B-12, for example, could cause the symptoms that you describe. Ms. Murdock: Oh, I thought I was doing so well. So, if I take some vitamins, I should start feeling better? Provider: If it is indeed a deficiency, you may see improvements with supplements. Let's try the supplements and re-evaluate your symptoms in two weeks. Please feel free to call me if your symptoms begin to get worse. LONG-TERM FOLLOW-UP Long term follow-up is critical post-surgically. Patients should be monitored for signs and symptoms of common side effects and complications listed earlier. ROUTINE LABS Lab tests recommendations, following the malabsorptive surgeries, include the following: Every 3-6 months obtain CBC, glucose, liver function panel, lipid panel, iron studies, ferritin, vitamin B12, vitamin D-25, Basic Metabolic Panel; Include albumin, prealbumin, RBC-folate Intact parathyroid hormone (if hypercalcemic or if Vitamin D deficient), and calcium. Secondary hypoparathyroidism is very common in Vitamin D deficient post-op patients (Alexandrou et al, 2015). Optional surveillance includes thiamine, vitamin A, and zinc. Bone density recommended yearly until stable. Glycemic control for patients with type 2 diabetes mellitus needs to be constantly re-evaluated as the patient loses weight. (Mechanick et al., 2013; Aills et al., 2008) Page 55 of 63

56 GASTRIC BANDS Gastric bands will need to be evaluated and adjusted frequently for maximal weight loss (Mechanick et al., 2013). BONE LOSS Bariatric surgery is associated with increased skeletal fragility and potential risk of future fracture from excessive bone loss (Skibora, 2014). Bone mineral density declined by 12 months postoperatively. Precise mechanisms are not clear, but, in addition to decreased mechanical loading, there may be some effect from nutritional and neurohormonal alterations. Monitoring patients post-surgically for bone loss is prudent. PREGNANCY Pregnancy is contraindicated for at least 18 months post-surgically because of nutritional deficiencies and rapid weight loss (Virji & Murr, 2006). Appropriate modifications if a patient becomes pregnant post-surgically are described in guidelines (Mechanick et al., 2013). MODULE SUMMARY Criteria For Surgery Criteria to be recommended for bariatric surgery include: Age 18 to 65 BMI 40 kg/m² OR 35 kg/m² PLUS one or more significant obesity-related conditions No known endocrine cause for their obesity Motivated to lose weight Understand the procedure, implications, and risks No contraindications to undergo surgery Good social support No substance abuse No clinically significant/unstable psychosis, depression, borderline personality disorder, or bulimia nervosa (For Women) Not looking to get pregnant in the next 12 months Attempted behavioral treatment with or without pharmacotherapy with insufficient response (Jensen et al., 2013; Kushner & AMA, 2011) Types of Surgery Page 56 of 63