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Medical treatment of GERD is flawed :

Other treatments for GERD… Lee L Swanstrom MD, FACS Division of Minimally Invasive Surgery Legacy Health System Portland, OR. Medical treatment of GERD is flawed :. It is palliative only It doesn’t always work It doesn’t stop reflux It doesn’t alter the progression of Barrett’s to cancer

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Medical treatment of GERD is flawed :

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  1. Other treatments for GERD…Lee L Swanstrom MD, FACSDivision of Minimally Invasive SurgeryLegacy Health SystemPortland, OR

  2. Medical treatment of GERD isflawed: • It is palliative only • It doesn’t always work • It doesn’t stop reflux • It doesn’t alter the progression of Barrett’s to cancer • It is expensive

  3. PPI-associated Complications Increase Over Time 10 Increased renal failure 8 Years on PPI therapy Increase of osteoporosis-associated fractures 7 5 Increased risk of hip fracture 7 4x the risk of gastric polyps 6 1 Increased risk of acute coronary syndrome when used with Plavix 1 Increased gallbladder motility 2 Increased bacterial gastroenteritis 3 Increased risk of Clostridium difficile colitis4 Decreased innate immunity 5 References 1 Ho et al. JAMA 2009; 20:1364-7. 2Cahan et al. Surg Endosc 2006; 20:1364-7. 3Garcia Rodriguez et al. Clin Gastroenterol Hepatol 2007; 5:1418-23. 4 Cadle et al. Am J Health Pharm 2007; 64:2359-2363.5Alkim et al. Dig Dis Sci 2008; 53:347-51.6Jalving et al. Aliment Pharmacol Ther 2006; 24:1341-8. 7Targownik et al. CMAJ 2008;179:319-26. 8Geevasinga et al. Clin Gastroenterol Hepatol 2006; 4:597-4.

  4. The problem with laparoscopic fundoplication… • Can be dangerous • Expensive ($13,500 at Legacy) • Side effects can outweigh benefits for early or mild disease • Not enough surgeons, ORs, time or energy to do lap Nissen on everyone

  5. Other options? • Gastric bypass • Endoluminal treatments • Gastric emptying • Laparoscopic Prosthesis

  6. Roux-en-Y Gastric Bypass • Most frequently performed bariatric procedure in the US • First done in 1967 • Some technical modifications since (stomach is cut) • Laparoscopically since 1993 • 60 –80% loss EBW • 75 – 80% effective control of reflux

  7. Endoluminal antireflux surgery: • Radiofrequency ‘scarring’ of the LES (STRETTA) • FDA approved 2/20/00 • Bard Sewing machine “endoplication” (Endocynch) • FDA approved 2/20/00 • Endoscopic intramuscular injections (Enteryxx) • Approved under PMA 6/03 • Transgastric / endoscopic repair (N-do) • National trials 9/03

  8. Nissen Esophafix (Endogastric Solutions) “World's First Endoluminal Fundoplication” Brussels team performs world's first endoluminal fundoplication (100% trans-oral incision-less) with clinical aim of curing gastroesophageal reflux disease (GERD).

  9. TIF Highlights • TIF has been used in eight unbiased clinical studies • Those clinical studies demonstrate that: • TIF is safe • TIF restores the GE valve anatomy and function • Results have been proven measuring: • Symptoms and quality of life • Use of PPIs • Impedance • pH-metry • Manometry • TIF2 improves on TIF1 • TIF is more effective than EndoCinch or Plicator • Additional clinical studies on the TIF Procedure are underway

  10. 10 Clinical Studies = 6 Completed + 4 In Progress Study (n) Available Data (n) Study Status Published TIF1: -Feasibility (19) 2 yrs (14) Completed Yes - Multicenter (86) 2 yrs (51) 3-yr in progress No - Redo (15) 6 mo (15) Completed No - Registry Fraser (20) 7 mo (20) Completed No - Registry Bouvy (38) 10 mo (38) Completed No TIF2: -Feasibility (10) 6 mo (10) Completed Yes - Randomized vs. PPIs (120) 6 mo (14) Enrolling n/a - Feasibility in children (14) 3 mo (14) Completed n/a - RCT vs. Sham (60) n/a EC review n/a - RCT vs. LNF in children (300)n/a EC review n/a RCT –randomized controlled trial

  11. Current strategy Chronic GERD symptoms Comprehensive evaluation [EGD, 24 hr pH, motility] Severe disease High DeMeester, esophagitis, Barrett’s, stricture, etc Mild disease Laparoscopic ARS Endoscopic ARS Breakthrough reflux post lap ARS

  12. LINX™ Reflux Management System Reinforces the LES restoring the barrier function Expands during swallow allowing food to enter stomach Highest Magnetic Resistance Lowest Magnetic Resistance

  13. LINX™ Design • Device Design • Titanium beads with magnetic cores • Linked together by titanium wires • Links limit expansion distance between beads • Resists sphincter relaxation while allowing normal physiological function (swallowing, belching, etc) • Mechanism of Action: Increased yield pressure of LES

  14. Barium Swallow: 1 Day Post-Op

  15. Dissect Size Place Secure LINX™ Procedure

  16. Healing Response: Porcine Explant (4 mo)

  17. Clinical Outcomes - Feasibility1 pH Normalization 79% No PPI Use 89% Median HRQL Reduction 96% 87% Reduction 1 – Bonavina, J Gastrointetinal Surg. 2008

  18. Pivotal Trial • Prospective, multi-center, single-arm study • Patient as their own control • N=100 subjects • Target Indication - subjects diagnosed with pathologic GERD as defined by abnormal pH scores and incomplete clinical response from medical therapy • Primary endpoint • Normalized or >50% reduction in acid exposure @ 1 year • Secondary Endpoints • >50% reduction in GERD HRQL @ 1 year • >50% reduction in PPI use @ 1 year

  19. Conclusions: • Reflux is a disease – it presents in a continuum of symptoms and causes. It varies with individuals • Treatments must be individualized to the patient’s psychology and physiology

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