Gastric Artery Embolization for Weight Loss: Planning Next Steps

Transcription

1 Gastric Artery Embolization for Weight Loss: Planning Next Steps Aravind Arepally M.D. FSIR Division of Interventional Radiology Piedmont Health Care Adjunct Professor of Radiology Vanderbilt University Medical Center aravindarepall1

2 Aravind Arepally, M.D. Consultant/Advisory: Surefire Medical, Inc., BTG, Endobar

3 Bariatric Embolization ROADMAP Device Agnostic Phase 1A 5 PATIENTS SAFETY/efficacy M. ADVERSE EVENTS (0) JHU Dayton Albany Phase 1B 15 PATIENTS SAFETY/EFFICACY TBL+AE JHU/MT Sinai Phase 2 >60 PATIENTS EFFICACY TBL, AE, COST Multi-Center

4 My fear..

5 Change in weight (%) Effects of bariatric surgery on weight loss in Swedish obese subjects 0 Control Mean weight loss from baseline: 2% -10 Banding 14% -20 Vertical-banded gastroplasty 25% -30 Gastric bypass 32% Years Sjöström L, et al. N Engl J Med. 2007;357: Data are mean ±95% CI

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8 Regulatory Science Partnerships FDA Basic/Clinical Multidiscplinary

9 Regulatory Science Partnerships FDA Basic/Clinical Multidiscplinary

10 Challenges for Bariatric Devices Which patients to treat? Only Morbidly Obese? What is the standard for comparison? When do I do a sham comparison? What is the appropriate time endpoint?

11 Since 1985, Five bariatric devices approved in US Three in last year

12 FDA Guidelines issued May 2012 Benefit-Risk Paradigm Present a proposal for discussion regarding a Benefit-Risk assessment plan for clinical trial endpoints for obesity devices. Lerner, H., J. Whang, and R. Nipper, Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal. Surg Endosc, (3): p

13 Lerner, H., J. Whang, and R. Nipper, Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal. Surg Endosc, (3): p

14 %TBL Followup Comparison Sham Level 1 5% 6 months Diet/Exercise NO Level 2 8% 1 -- YES Level 3 10% 2 -- YES Level 4 13% 3 Lap Band YES

15 Regulatory Science Partnerships FDA Basic/Clinical Multidiscplinary

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17 Ulcer Distribution Note- All Healing and all non target location in body/antrum

18 Direction of Basic/Clincal Science Adjunctive Therapies Volume of Tissue Treated Delivery Platforms Bead Sizes

19 Y90 in the Gastric Arteries Manuscript submitted Pasciak AS, Bourgeois AC, Arepally A, Paxton B, Coan P, Nodit L, Adams J, Lux C, Bradley YC Bariatric Artery Y-90 in the Gastric Arteries for Accelerated Fibrosis

20 Degree of Embolization Manuscript Submitted Complete Two Vessels One Vessel

21 Future Directions: Clinical Research Understand Anatomy Understand Physiology Understand the Patients

22 Direction of Basic/Clincal Science Adjunctive Therapies Volume of Tissue Treated Delivery Platforms Bead Sizes

23 Regulatory Science Partnerships FDA Basic/Clinical Multidiscplinary

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26 In this issue of JAMA Surgery, an analysis of claims paid by BlueCross BlueShield for bariatric surgery patients for as long as 6 postoperative years failed to demonstrate a cost benefit for weight loss surgery

27 A David and Goliath story 2011 Global Sales ($Billion) (1) Pharmaceutical Agents 915 Medical Devices 286 Courtesy, David Cade, MD

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29 We conclude that the physician's armamentarium is getting stronger through the use of specific dietary modifications, novel medical devices and pharmacotherapy. Non-surgical interventions that mimic the metabolic benefits of bariatric surgery remain tenable alternatives for many patients and health-care professionals.

30 Planning Team Interventional Radiology Bariatric Surgeons Obesity Specialists Regulatory Experts Industry Partners Reiumbursment Specialists

31 NIH CMS The combination of all results in less than < 1% of penetration of market

32 Clinical Trial Design Design the Proper Trial Identify Patient Criteria Identify Optimal Endpoints Identify Key Partners

33 Next Steps: Summary Design next trial safe low cost sustained weight loss multidisplinary

34 BEAT OBESITY TEAM C.Weiss A. Fischman D. Kraitchman B. Paxton C. Kim R. Patel

35 NIBIB: NIH R01 EB RSNA Resident Research Grant SIR Foundation Resident Research Grant Merit Medical Surefire Medical Siemens Medical System Merit Medical Curt Cornell Melodie Domurad