Treating obesity with endoscopic bariatric therapy

Transcription

1 Treating obesity with endoscopic bariatric therapy Nitin Kumar MD Developmental Endoscopy Lab, BWH Abby Lowe MS RD LD Washington University School of Medicine

2 How to Submit a Question Your Participation Please continue to submit your text questions and comments using the Questions panel For more information, please [insert contact information] Note: Today s presentation is being recorded and will be provided within 48 hours.

3 Agenda Philosophy Groundwork The multidisciplinary team Registered Dietitian - scope of practice Other professionals Current devices Patient selection Intragastric balloon placement and management

4 Philosophy Comprehensive care of the patient Team approach Intensive lifestyle therapy and post-procedure care A different paradigm than most endoscopic procedures

5 EBT paradigm versus status quo Gastroenterology/endoscopy model PCP GI PCP GI

6 EBT paradigm versus status quo Endoscopic bariatric therapy model PCP PCP PCP PCP RD RD GI BH GI GI RD GI

7 Staff preparation Major reason patients with obesity avoid healthcare Bias-free culture from the top down Sensitivity: recognition action Respect, survey, improve

8 Sensitivity Obese patient patient with obesity Willpower commitment Fat, obese, heavy, large weight, BMI Ideal weight healthy weight Avoid commenting after taking weight Emphasize importance of behavior changes rather than weight Acknowledge difficulty of losing weight

9 Facility: weight limits and sizes Examination and procedure tables Scales (in privacy) Waiting room chairs Blood pressure cuffs and sequential compression sleeves Gowns Wheelchairs Doorways

10 Insurance Other considerations Ensure specific coverage is in place Consider procedure-specific coverage for patient Call coverage Ensure covering physicians aware of primary adverse effects

11 Dietitian Psychologist Behavior coach Physical therapist Exercise physiologist The team

12 Role of the Registered Dietitian Healthcare professional trained in Medical Nutrition Therapy and Behavior Therapy for Weight Loss. Serve as another point of contact and support for patients. Educate patients on evidence-based strategies for weight loss.

13 Role of the RD: Medical Nutrition Therapy Establish a calorie goal for patient and adjust as necessary based on patient feedback. Help to nutritionally manage symptoms. Work with patient to translate diet recommendations into real world application.

14 Role of the RD: Behavior Therapy Registered Dietitian competencies include: Cultural and population specific sensitivity. Motivational interviewing. Use of open-ended questioning to identify barriers to successful weight loss. Establishing SMART goals. Creating a patient driven nutrition care plan.

15 MISSION Weight Management Dietetic Practice Group (WM DPG) Empowering members to be food and nutrition leaders in weight management and lifestyle change VISION Optimizing healthy weight through food and nutrition

16 WM DPG Membership 4635 total members: 4522 in US; 113 international DC

17 Why Choose a WM DPG Dietitian? Access to networking opportunities and continuing education benefits in the field of weight management: Continuing education through newsletters, webinars, and annual Symposium Educational exchanges among members via Electronic Mailing Lists Bariatric Subunit with other members who specialize in bariatrics Networking through EMLs and conference events Stipends to attend continuing education conferences

18 Specialized Training in Weight Management Certificate of Training in Adult Weight Management Levels 1 and 2 Certificate, not certification In development: Certified Specialist in Obesity and Weight Management Multidisciplinary credential First exam expected in Fall 2016

19 Medical Team Collaboration Familiarity with medical language and collaborating with an interdisciplinary medical team. Required to receive continuing education to help ensure up-to-date evidence based recommendations. WM DPG: provide opportunities for its member to be educated on best practices for Endoscopic Bariatric Therapy.

20 The care model Intensity of therapy correlates with success Individual sessions Group behavior sessions Tele visits

21 Current status The FDA has approved two devices for primary endoscopic bariatric therapy Apollo Endosurgery Orbera ReShape Integrated Dual Balloon System Additional devices have completed pivotal trials

22 Apollo Endosurgery Orbera

23 Apollo Endosurgery Orbera 25.4% ( %) EWL at 12 months 11.3% ( %) TWL at 12 months Abdominal pain 33.7%, nausea 29%, early removal 7.5%, balloon migration 1.4%, gastrointestinal perforation 0.1% Met ASGE PIVI thresholds for clinical adoption primary EBT in Class II or III obesity EBT as bridge therapy to reduce risk of subsequent intervention

24 Apollo Endosurgery Orbera Gaur, et al. Balancing risk and reward: a critical review of the intragastric balloon for weight loss. Gastrointest Endosc. 2015;81(6):

25 ReShape Integrated Dual Balloon

26 ReShape Integrated Dual Balloon REDUCE: randomized controlled multicenter trial IDB (n=187) versus sham (n=139) Medically-supervised diet and exercise program in both In completers: IDB 27.9 ± 21.3% EWL versus 12.3 ± 22.1% with sham Intention to treat analysis TWL: 7.6 ± 5.5% versus 3.6 ± 6.3% with sham

27 ReShape Integrated Dual Balloon 9.1% rate of early removal for nonulcer device intolerance (7.7% with lower fill in shorter patients) Device- or procedure- related SAE: 3.0% 75% were ER visits for medical management of accommodative symptoms Esophageal mucosal tear on retrieval hemostatic clip (1) GE junction ulcer hemorrhage transfusion (1) Contained cervical esophageal perforation on retrieval IV antibiotics (1) Postretrieval pneumonitis antibiotics (1) 10% ulcer rate (after device modification) 6% deflation (no migrations)

28 Assessment Weight history Dietary history Life events that led to weight gain Therapies attempted and reasons for success or failure Obesity related co-morbidities Screen for eating disorders Screen for barriers to exercise and refer to PT if needed

29 Adult Patient selection BMI kg/m2 (IDB: co-morbidity) Has failed diet and lifestyle therapy Motivated and willing to adhere to program after removal Refer patients to medical weight loss or to bariatric surgeons as indicated

30 Exclusion Refer to psychologist positive for moderate to severe depression or eating disorders Poor control of psychiatric disorders or addiction Inflammatory disorders or ulcer Any gastric surgery Hiatal hernia if >5 cm, or <5 cm with severe symptoms Unable to take PPI Neoplastic process Achalasia or severe esophageal motility disorder Esophageal or pharyngeal stricture or diverticulum Bleeding conditions or coagulopathy Pregnancy or breast-feeding Cirrhosis or other severe systemic disease

31 Testing Laboratory Evaluation: CBC, CMP, PT/PTT/INR, fasting lipids, HgbA1c, TSH, vitamin D, +/- H. pylori testing CXR: some programs routinely perform CXR, many do not ECG or cardiac evaluation if the patient has cardiac symptoms Consider sleep study if OSA is a concern

32 Risk, benefits, and alternatives A significant proportion will have nausea, vomiting, and abdominal pain Weight loss expectations Magnitude Duration Patient education

33 Placement PPI started 1-2 weeks before Ensure commitment is in place for removal NPO for 12 hours prior Administer pre-procedure anti-emetics Hyoscyamine, aprepitant, scopolamine patch Ondansetron ± dexamethasone during procedure Verify NPO with endoscopy Check for hiatal hernia, ulcers and erosions, gastritis

34 Placement Insert catheter under endoscopic visualization when possible (ReShape over guidewire) Ensure fully lumenal positioning Fill balloon(s) ml for Orbera for IDB (pump-filled) Keep filling tube slack avoid sharp bends Observe patient for at least two hours; consider IV hydration

35 Management Pre Week 1 Week 2-4 Month 2-12 BE Consultation Screening Patient education Daily contact Weekly call Monthly contact Visit 1-2 weeks pre-removal RD Optimized diet plan Multiple contacts 1 visit Monthly contact F Fitness program Weekly contact Weekly contact

36 Diet and lifestyle Clear liquids for hours Frequent small sips on day 1, 8 oz every 4 h Gradual progression from full liquids to solid food, over 2-3 weeks Chew at least 20 times per bite, over 20 minutes per meal Work on durable behavior modification Dietitian input regarding: caloric intake, macronutrient proportions, tracking calories, reading labels Refer to other team members as needed

37 Management Make 3-7 calls during week 1 Initial symptoms improve over 3-5 days Address side effects as needed Zofran ODT 8 mg every 4-6 h on day 1 Hyoscyamine every 4 h PRN for cramping Ativan 1 mg TID PRN anxiety Percocet q 6 h PRN, #4 Maintain PPI until removal Expect weight loss rate to decrease after month 3

38 Dehydration Assess fluid intake and vomiting Bring to office for orthostatic blood pressure and send for IV hydration if needed Check electrolytes More detailed workup as needed

39 Gastroparesis Several weeks after placement GERD, nausea, halitosis, malodorous eructation Stop hyoscyamine Increase PPI to BID if needed Check potassium Trial of liquids, including soda, for 2-3 days Trial of erythromycin liquid 100 mg BID for 7 days If ineffective, trial of metoclopramide 10 mg before meals and bedtime for 7 days Lie on left side 2-3 hours to change balloon position

40 Deflation Symptoms Nausea, vomiting Abdominal pain, intermittent cramps, abdominal distention Change in bowel habits, bowel obstruction Methylene blue Loss of satiety, hunger, weight gain Check x-ray Endoscopic removal if in stomach, proximal duodenum, ileocecal valve Remove promptly to prevent bowel obstruction or need for emergent surgical removal

41 At six months Removal Earlier if pregnancy or elective/emergent foregut surgery Preparation Full liquids at 72 hours before Clear liquids at 24 hours consider soda Erythromycin liquid 100 mg BID day before NPO for 12 hours Hyoscyamine SL 1-2 hours before

42 Removal Removal Deflate balloons, removing all saline Orbera: grasp balloon, in retroflexion if necessary ReShape: puncture each balloon with 15 mm rat tooth alligator forceps and snare with hexagonal snare Taper PPI

43 Post-balloon Prepare patient for potential weight gain Ensure continued dietitian visits for additional 6 months and refer to other specialists Reinforce new behavioral and dietary habits Add adjunct therapy as needed

44 Conclusion Intragastric balloons are a tool part of a longterm, durable weight loss program The physician leads a team that provides comprehensive and ongoing care Success begins with patient selection and establishment of realistic expectations More intensive lifestyle therapy creates better outcomes Balloon explantation is not the end of care

45 ABE seminar: May 20 in San Diego -Metabolics, overview of management, lifestyle therapy, pharmacotherapy, EBT in depth -Device demonstration Questions?