ReShape Procedure Reference Guide

Transcription

1 ReShape. The Non-Surgical Weight Loss Procedure. ReShape Procedure Reference Guide

2 NOTE: This guide does not replace the Instructions For Use (IFU) and should be used in combination with the IFUs supplied with the products.

3 Readiness Evaluation

4 Readiness Evaluation Readiness Evaluation Evaluate and educate to prepare each individual for success. Evaluation Visit 1: Consultation Visit 2: Clinic Visit 4

5 Baseline Assessment Screen and assess prior to first visit Educate patient on what to expect Review patient qualifications Visit 1: Consultation Assess patient s level of commitment Evaluate patient s needs and goals Set expectations Review risks and complications Optional: administer general psychological evaluation Review pre-procedure history and conduct physical exam Document current medications Determine if patient is qualified for procedure Schedule procedure date Readiness Evaluation Visit 2: Pre-procedure Prep Review post-insertion medications Review pre- and post-insertion instructions Review schedule of visits/coaching sessions Review Patient Guide Book Register patient on Patient Portal Conduct initial coaching session or connect patient with coach Call patient two days prior to procedure to review instructions 5

6 Readiness Evaluation 6

7 Medications

8 Medications Medications A patient who is supplied with and educated on these medications will be better prepared to handle the most common side effects. Purpose Name Directions Proton Pump Inhibitor (PPI) e.g. Omeprazole Must be started at least three days prior to insertion and taken every day until balloon removal Antispasmodics Antiemetics/ Anti-nausea Anti-anxiety Pain reliever e.g. Levsin (Hyoscyamine) e.g. Reglan, Zofran, Phenergan e.g. Ativan (Lorazepam) e.g. Lortab Prescribed for use immediately postinsertion and PRN Prohibited Medications Patient s PCP should determine if patient can be off of the prohibited medications for the duration of the balloon placement: Anticoagulants Chronic oral, injectable, or inhaled steroids Chronic aspirin over 81 mg/day Chronic NSAIDs Other medications known to be gastric irritants or to reduce GI motility The medications listed are guidelines only. Physicians should choose the appropriate medications for patient. 8

9 Dietary Guidelines

10 Dietary Guidelines Dietary Guidelines Pre-insertion Diet Pre-insertion diet 48 hours prior Eat only soft foods or easily digested foods such as milk, fruit juices, eggs, cheese, custards, puddings, strained soups, cooked vegetables, rice, baked potatoes, and breads No raw fruits and vegetables, coarse breads and cereals, rich desserts or fried foods Meat in any form is prohibited; eggs, liquid protein supplements, and tofu are allowed 24 hours prior Clear liquids only such as juice, clear broth, tea, Jell-O and popsicles No food in any form 12 hours prior No food or liquid of any form Stomach should be empty before procedure 10

11 Post-insertion Diet Instructions: Days 1-3 Days 1-3: Clear Liquid Diet Suggestions Clear broth Jell-O Ice chips Small sips of water Diluted juices Sports drinks Herbal and decaf tea Popsicles Instructions Avoid carbonated drinks, coffee, and alcohol Drink small sips Try warm fluids Stay hydrated Dietary Guidelines Patients will need to follow a specialized, progressive diet immediately following the procedure, so it is equally important to review the post-insertion diet at this visit. The dietary guidelines are outlined in this chart and can also be found in the Patient Guide Book. Please instruct to avoid carbonated beverages, as well as caffeine and alcohol. The dietary goal for the first few days following the procedure is to stay hydrated 11

12 Dietary Guidelines Dietary Guidelines (continued) Post-insertion Diet Instructions: Days 4-7 Days 4-7: Smooth, Puréed Food Suggestions Instructions Liquid protein supplements and smoothies Skim or 1% milk Yogurt (without chunks of fruit) Puréed fruit Soft cooked and puréed vegetables Soups (strained or blended) Cream of wheat or oatmeal, thinned Sugar-free pudding Eat food and sip liquids very slowly and stop eating at first sign of fullness; portion sizes may vary from two tablespoons to one cup of food per meal Aim for five small puréed meals per day Stay hydrated and drink water 30 minutes after each meal Beginning days 4-7, the patient will need to transition to a smooth or puréed diet. This should begin after all signs of nausea have passed. Many patients prefer liquid protein supplements for ease of use along with yogurt, puréed fruit, strained soups, and soft cooked vegetables. It is important to counsel the patient to chew food thoroughly, eat very slowly, and stop eating or drinking at first sign of fullness. If they are not tolerating solid foods after 10 days, they should call your office or check in with the dietitian. Focusing on liquids is still important in this phase. 12

13 Post-insertion Diet Instructions: Days 8 and Beyond Days 8-10: Soft Foods Suggestions Tofu Soft, poached fish Lean ground meats Deli meats, thinly sliced Canned tuna packed in water Canned chicken packed in broth Scrambled eggs Cottage cheese Toast Well-cooked vegetables Soft fruit with skin removed Instructions Chew food thoroughly Eat very slowly and stop eating at first sign of fullness; portion sizes will vary Avoid eating and drinking at the same time Stay hydrated and drink water 30 minutes after every meal Beginning days 8 and beyond, the patient will need to transition to a soft and then a regular diet. Emphasize eating slowly and stop eating at the first sign of fullness. Portion sizes will vary for each patient and with each meal as the stomach volume will be smaller after balloon placement. Meals during the first month may only consist of a few bites. We ve also included a sample soft foods menu in the Patient Guide Book to help guide them. Please counsel the patient to limit or eliminate liquid calories such as juice or liquid protein supplements after this phase as they do not provide a sense of satiety and may increase hunger symptoms overall. Once they have completed the diet progression, it is important to transition to protein and fiber rich foods for each meal. 13 Dietary Guidelines

14 Dietary Guidelines Dietary Guidelines (continued) Soft Foods Sample Menu Days 8-10: Soft Diet Sample Menu* Breakfast ¼ cup of soft fruit such as banana or melon 1 scrambled egg ¼ cup skim milk Mid-morning Snack ¼ cup of sugar-free pudding or liquid protein drink Lunch ¼ cup canned chicken or tuna prepared with 1 tablespoon low-fat mayo ½ piece toast ¼ cup mango Mid-afternoon Snack ½ cup non-fat yogurt Dinner 2 ounces soft, poached fish or ¼ cup lean ground turkey ¼ cup steamed zucchini squash or carrots ¼ cup cottage cheese *Portion sizes will vary. It s important to not overeat and to stop eating at first sign of fullness. The Patient Guide Book shows a sample menu for convenience during this time 14

15 Pre-removal Diet Pre-removal Diet 48 hours prior Only soft or easily digested foods such as milk, fruit juices, eggs, cheese, custards, puddings, strained soups, cooked vegetables, rice, baked potatoes, and breads No raw fruits and vegetables, coarse breads and cereals, rich desserts or fried foods Meat in any form is prohibited; eggs, liquid protein supplements, and tofu are allowed 24 hours prior Clear liquids only No food in any form 12 hours prior No food or liquid of any form Stomach should be empty before procedure Dietary Guidelines 15

16 Dietary Guidelines Dietary Guidelines (continued) Additional Dietary Recommendations Portion Sizes Recommended portion sizes will vary per patient as stomach volume will be smaller after dual balloon placement. Meals during the first few months may only consist of a few bites. When transitioning from liquid to solid foods, patients should be encouraged to chew thoroughly, eat slowly, and to stop eating at first sign of fullness. Monitor and address portion sizes at each coaching session for continued weight loss throughout the program. Fluids Water should be consumed minutes after the meal. This will encourage hydration and prevent constipation. Encourage small, frequent sips throughout the day. Advise patients to limit consumption of liquid calories after the clear liquid diet phase as they do not provide a sense of satiety. This includes continued use of liquid protein supplements after the first few weeks following implantation. Once patients have completed the diet progression they should transition to proteinrich solid foods instead. 16

17 Vitamin Mineral Supplementation While there are no specific vitamin and mineral supplementation requirements during the balloon implant period, if vitamin mineral supplements are prescribed, a chewable supplement might be beneficial to avoid gastric irritation. Dietary Guidelines Note: For diet related questions please contact patientcare@reshapemedical.com 17

18 Dietary Guidelines Dietary Guidelines (continued) Are They Still Hungry? Discuss Mindful Eating Techniques Many people who have the ReShape Procedure struggle with food and react mindlessly to food triggers. Mindful eating is much more than eating slowly, without distraction. While that s important, many times food triggers and feelings we identify as hunger, isn t hunger at all. For example, when a patient feels hungry, instead of reacting to the hunger and mindlessly eating the food, coach the patient to pause and ask the question, Am I physically hungry? Mindful eating empowers patients to finally break old automatic eating habits like eating from boredom, stress or while watching TV and discover strategies that work better for them. Step 1. Stop and ask Am I physically hungry? Step 2. If yes, eat something nourishing. Step 3. If no, identify and explore where the hunger is coming from. Is it Head Hunger It s Noon and must be time to eat Eye Hunger Wow! That looks so delicious! Nose Hunger Ah, I want that food, it smells so good 18

19 Mouth Hunger I just need something to chew Heart Hunger Eating this will make me feel better Step 4. Resolve the true source of the hunger and ask What do I really need? What can I do instead? Leave the room. Go for a walk. Talk to a friend. Remember, it s not all about food. No amount of food will make them feel better if they are eating from stress or to cure boredom. Only by recognizing the non-food triggers or the true source of their hunger and learning to meet their other needs in more effective ways will they stop the overeating cycle and feel better. Dietary Guidelines 19

20 Dietary Guidelines 20

21 Risks and Complications

22 Risks and Complications Risks and Complications Review known adverse events (AEs) and complications with patient. Most AEs can be treated by adjusting the patient s diet, encouraging PPI usage, monitoring the prohibited meds usage, and reminding the patient to stay hydrated. Nausea, Vomiting, Abdominal Pain & Discomfort Most patients will experience some degree of nausea, vomiting, abdominal pain and discomfort For some patients, symptoms subside quickly; for others they last longer Symptoms usually resolve within the first 30 days Treatment Most symptoms can be treated with prescribed medications and in some cases IV hydration may be necessary In more severe cases, patients may opt for early balloon removal Educate and encourage patients to call you or return to the clinic for treatment rather than go to the ER 22

23 Balloon Deflations Detection starts with patient: Blue-green tinted urine Physical difference pay close attention to stomach sensations Onset or increase in AE symptoms Treatment Confirmation through: Ultrasound X-ray with barium swallow CT scan Endoscopy Risks and Complications Removal of balloons should be scheduled as soon as possible once deflation is confirmed Others Diarrhea, constipation, change in bowel habits GERD, heartburn, indigestion Gas, belching, bloating Dehydration, weakness, fatigue Esophageal, oropharyngeal pain Gastric ulcers, erosions 23

24 Risks and Complications Contraindications: Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions. Prior open or laparoscopic bariatric surgery. Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn s disease. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses. A gastric mass. A hiatal hernia > 5 cm or 5 cm with associated severe or intractable gastro-esophageal reflux symptoms. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope. Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device. Severe coagulopathy. Hepatic insufficiency or cirrhosis. Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow-up visits and removal of the device after 6 months. Alcoholism or drug addiction. Patients unwilling to participate in an established medicallysupervised diet and behavior modification program, with routine medical follow-up. Patients receiving daily-prescribed treatment with aspirin, antiinflammatory agents, anticoagulants or other gastric irritants. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system. Patients who have ever developed a serotonin syndrome AND are currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)] should not undergo placement of the device. Patients who are pregnant or breast-feeding. 24

25 Patient Instructions

26 Patient Instructions 26 Patient Instructions Call patient to review the following instructions two days before the procedure. Pre-insertion Diet Medications Exclusion Criteria Stomach must be empty before procedure 48 hours before: Eat only soft foods meat in any form is prohibited 24 hours before: Consume only clear liquids no food in any form 12 hours before: Stop all food and drink Failure to follow dietary guidelines may result in cancellation of the procedure Some medications may need to be stopped in the days leading up to the procedure (e.g., blood thinners) Review current medications with patient and provide instructions Patient may need to consult with their PCP/specialist Review possible anatomic findings that can potentially disqualify patient from balloon treatment These endoscopic findings may be old diagnosis or new findings so thorough discussions with the patient about their medical history is important Other complications may occur during the procedure, so endoscopy and insertion procedure should be discussed

27 Plan for Recovery Patient will undergo sedation that will require someone to drive them home Patient may need to take a few days off of work/school to get through the post-insertion symptoms Prescriptions should be filled prior to procedure day Patient Instructions Recovery Patient should expect to experience nausea, vomiting, and abdominal pain Patient should be ambulatory as soon as possible and sit in an upright position rather than recline after the procedure Hydration is important small sips of warm water are better than large sips of cold water. Carbonated drinks are not recommended Provide instructions on prescribed medication usage for proactive management of these symptoms at home Patient may need to take a few days off of work/ school to get through the post-insertion symptoms 27

28 Patient Instructions Initial Coaching Session Plan for One Hour During Visit 2 In-office Review Patient Guide Book Register patient on portal Provide an education session for the patient covering the pre- and post-insertion diet Home Education Goals Daily Life Start patient on food journaling to gain perspective on their current food intake Prepare home and workplace for dietary changes post-insertion Set up the wireless scale Develop an overall treatment plan Prepare patient for necessary dietary and behavioral change Set short-term, attainable goals for diet and exercise that will be reviewed at each follow-up Develop a therapeutic relationship with the patient Use Patient Portal to maintain food, weight, and exercise log 28

29 Follow-up Care

30 Follow-up Care Follow-up Care First 6 Months Month 1 Post-insertion Follow-up Care Reminders Day 1 Day 7-14 (one clinic visit) Patient needs the most care and follow-up within two weeks post-insertion Extra care and attention should be made to patient through phone calls, s, and clinic visits Call patient within 24 hrs post-insertion Call patient every few days until symptoms subside Patient clinic visit Remind patient of: Rx meds Alternative home therapies Maintaining liquid diet (progressive diet) IV hydration therapy if necessary Light to moderate exercise Check vitals Monitor PPI usage Perform physical exam No NSAID or prohibited meds usage 30

31 Months 2 5 Post-insertion Follow-up Care General In-Office Procedures Check vitals Take weight Monitor PPI usage Confirm patient isn t taking any NSAIDs or prohibited medications Assess, treat, and monitor symptoms, short and long-term complications Month 5 Schedule removal procedure Follow-up Care Coaching Session Therapy (as needed) Labs Provide customized coaching based on patient s progress Review portal dashboard Monitor weight and body composition Review dietary guidelines and assess food consumption and overall nutritional status Review goals Behavioral and emotional support One-on-one or group sessions As needed or indicated by institutional practices 31

32 Follow-up Care Month 6 Post-insertion Follow-up Care and Removal Prep General In-Office Procedures Check vitals Take weight Monitor PPI usage Confirm patient isn t taking any NSAIDs or prohibited medications Assess, treat, and monitor symptoms, short, and long-term complications Coaching Session Therapy (as needed) Provide customized coaching based on patient s progress Emphasize importance of continued behavior modification Monitor weight and body composition Review dietary guidelines and assess food consumption and overall nutritional status Review goals Behavioral and emotional support One-on-one or group sessions 32

33 Balloon Removal Prep Review of pre- and post-insertion instructions Post-insertion expectations Review of possible complications caused by the endoscopy or removal procedures Schedule balloon removal if not previously scheduled Follow-up Care Important Reminders Call patient two days prior to removal to review removal instructions Call patient 1 2 weeks post-removal to make sure he/she is transitioning well 33

34 Follow-up Care Beyond 6 Months Months 7 12 Post-removal Follow-up Care Coaching Session Provide customized coaching based on patient s progress Dietary support Exercise support Educational support Monitor weight and activity level Review dietary guidelines and assess food consumption and overall nutritional status Review goals Ongoing patient portal is available past 12 months General In-office Procedures (as needed) Therapy (as needed) Check vitals Take weight Assess, treat, and monitor symptoms Behavioral and emotional support One-on-one or group sessions 34

35 Important ReShape Integrated Dual Balloon System Safety Information Indications: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of kg/m2 and one or more obesity-related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone. Contraindications: The ReShape Integrated Dual Balloon System is not recommended for patients with conditions that may increase the risk of poor results (e.g., prior gastrointestinal surgery with sequelae, prior open or laparoscopic bariatric surgery, inflammatory diseases of the GI tract, potential upper GI bleeding), who are unwilling to participate in an established medically supervised diet and behavior modification program, who have alcohol or drug addictions, who receive daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants, or who currently are or may be pregnant or breast-feeding. Warnings: The maximum placement period for the ReShape Integrated Dual Balloon is 6 months. The risk of intragastric balloon deflation and intestinal obstruction (and therefore possible complications related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months. The presence of blue-green urine or sudden loss of satiety, increased hunger and/or weight gain may be a sign of balloon deflation. Failure of patients to take prescribed daily proton-pump inhibitor medication increases the risk of gastric ulceration or perforation. Adverse Events: Placement of the ReShape Integrated Dual Balloon requires an endoscopic procedure with sedation. Potential risks associated with an endoscopic procedure and sedation include adverse reaction to sedation (headache, muscle pain, nausea), infection, pneumonia, and respiratory distress. Potential risks associated with the ReShape Integrated Dual Balloon include ulceration, perforation, abdominal pain, nausea, vomiting, bloating, belching, heartburn, dehydration, and sore throat. These complications may be severe enough to require early removal of the ReShape Integrated Dual Balloon. Although the ReShape Dual Balloon design provides an anti-migration feature, there is the potential risk of device migration and intestinal obstruction. The risk of intestinal obstruction is increased if the device is not removed after six months. If intestinal migration occurs, surgical or endoscopic removal may be required. Important: For full safety information please talk with your doctor, or call ReShape Customer Support at YES-RESHAPE ( ). CAUTION: Rx only. 35

36 100 Calle Iglesia, San Clemente, CA Customer Service Phone: YES-RESHAPE Fax: RESHAPE and the RESHAPE MEDICAL logo are registered trademarks of ReShape Medical, Inc. All other brand/product names are trademarks of their respective owners ReShape Medical, Inc. All rights reserved Rev. A