Transoral Incisionless Fundoplication for GERD


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Do you often suffer in silence, taking over-the-counter and prescription medications to dull the effects of gastroesophageal reflux disease (GERD) without treating the condition itself? This revolutionary procedure, is new to the Springfield area medical community performed by Springfield Clinic General Surgeon James Fullerton, MD, who can help you find relief without invasive surgery.

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  • A quick review of the gastro-esophageal anatomy – previously new technologies for treating GERD focused on the LES. EGS believes that the GEV is the more important and powerful component of the anti-reflux barrier. There has been lots of misunderstanding of this anatomy, and a widespread understanding of the GEJ is just now coming to fruition. The group at Virginia Mason Medical Center in Seattle (where EGS ’ founder, Stefan Kramer, worked with other thought leaders Drs Hill, Lowe, Kozarek, etc) were invited to rewrite the chapter on the GEJ in Grays Anatomy, because before 1997, Grays Anatomy did not even mention the GE flap valve! This shows the drawing of the anatomy that has been published in Gray ’ s Anatomy since 1997 based on Dr. Hill and Kraemer ’ s research. Interestingly, the lower esophageal sphincter (LES) is a bit of a misnomer, since it does not have a band of smooth muscle cells typical of most ‘ sphincters ’ . Structurally it is not significantly different from the rest of the esophagus, and the increase in pressure at this site (LES high pressure zone) is likely an artifact of the presence of the diaphragm on the outside of the esophagus at this level. In cadavers, where there is no muscle tone, no reflux of the stomach contents is seen. This implies that something other than the LES is responsible for stopping reflux. The increase in pressure at the LES is also small, probably not enough to effectively cease all reflux. Instead, EGS is focusing on the GE flap valve. Surgery (i.e. Nissen, Hill, Toupet) has shown that restoring the angle of His and recreating the flap valve effectively stops reflux. As you know, the angle at which the esophagus enters the stomach creates this flap valve that rests against the lesser curve of the stomach to close off the stomach from the esophagus. It was demonstrated by Dr. Hill ’ s work that when the stomach is distended or the GEJ stretches out, it causes the angle of His to flatten and opens the esophagus to the stomach contents. The positive intragastric pressure causes reflux of the stomach contents if the GEV is not present. As a result of overeating, ingestion of carbonated beverages and eating large quantities of food rapidly, the stomach is stretched, the angle of His is lost and the GEV is open. The EsophyX product was designed to correct the anatomical defect which in the past was corrected by performing a Fundoplication (typically a Nissen or Toupet is performed) either open or laparoscopically.
  • Define Endoluminal Therapy - all surgical procedures that involve instrument penetration into the lumen of the gut in order to perform a surgical procedure.
  • Objective: Demonstrate the thought process of a patient goes through when contemplating treatment options for their pathology Script: “ When deciding upon a treatment for a specific pathology, patients will often make a selection based upon the effectiveness vs. the invasiveness of the procedure. In other words, “ Does it work, and how much does it hurt? ” What are your thoughts about this equation?
  • Transoral Incisionless Fundoplication for GERD

    1. 1. Transoral Incisionless Fundoplication James K. Fullerton, MD Department of General Surgery
    2. 2. Is this you?
    3. 3. Gastroesophageal Reflux Disease (GERD)
    4. 4. GERD Facts <ul><li>10% of adults suffer daily heartburn </li></ul><ul><li>Incidence increases after 40 yo </li></ul><ul><li>50% of patients require lifelong tx </li></ul><ul><li>Most GERD gets worse with time </li></ul><ul><li>Increased esophageal cancer risk with untreated severe GERD </li></ul>
    5. 5. Acid Reflux Symptoms <ul><li>Heartburn </li></ul><ul><li>Dysphagia or odynophagia </li></ul><ul><li>Hoarseness </li></ul><ul><li>Cough, asthma </li></ul><ul><li>Regurgitation </li></ul><ul><li>Pneumonia </li></ul><ul><li>Abdominal pain </li></ul>
    6. 6. Anatomy <ul><li>Lower Esophageal Sphincter (LES) </li></ul><ul><li>Relaxes to allow swallowing </li></ul>Angle of HIS Fundus <ul><li>Gastroesophageal Flap Valve (GEV) </li></ul><ul><li>180° flap valve, maintains closure against lesser curve of stomach </li></ul><ul><li>Is closed by pressure in the stomach to prevent reflux </li></ul>Esophagus Diaphragm Gray ’s Anatomy, 1997 <ul><li>Z Line </li></ul><ul><li>Marks where stomach and esophagus meet </li></ul>
    7. 7. GERD <ul><li>Acid reflux symptoms </li></ul><ul><li>Injury to the esophagus </li></ul><ul><li>Hiatal Hernia </li></ul>
    8. 8. Diagnosis <ul><li>Symptoms </li></ul><ul><li>Response to treatment </li></ul><ul><li>Tests </li></ul><ul><ul><li>Endoscopy </li></ul></ul><ul><ul><li>Upper GI </li></ul></ul><ul><ul><li>24 hour esophageal pH study </li></ul></ul><ul><ul><li>Esophageal manometry </li></ul></ul>
    9. 9. Upper Endoscopy (EGD)
    10. 10. What causes GERD? Intrinsic Factors: These can often be medically managed Esophageal clearance of acid Mucosal resistance to acid Ability of the stomach to empty Duodenal-gastric reflux
    11. 11. <ul><li>Extrinsic Factors: </li></ul><ul><li>Deterioration of natural barrier to reflux; the Antireflux Valve </li></ul>Normal Anatomy Fully Functional Valve Prevents Reflux Normal Anatomy Antireflux Valve Tight to the Scope What causes GERD
    12. 12. <ul><li>Extrinsic Factors: </li></ul><ul><li>Deterioration of natural barrier to reflux; the Antireflux Valve </li></ul>What causes GERD? Dysfunctional Valve Can’ t close to prevent reflux of stomach contents Dysfunctional Valve Can’ t close. Loose to the scope.
    13. 13. Reflux Complications <ul><li>Ulcers </li></ul><ul><li>Bleeding </li></ul><ul><li>Strictures </li></ul><ul><li>Lung problems </li></ul><ul><li>Barrett’s Esophagus </li></ul><ul><li>Esophageal Cancer </li></ul>
    14. 14. Treatment: Lifestyle Changes <ul><ul><ul><li>Weight loss </li></ul></ul></ul><ul><ul><ul><li>Raise head of bed </li></ul></ul></ul><ul><ul><ul><li>Smoking </li></ul></ul></ul><ul><ul><ul><li>Avoid late meals </li></ul></ul></ul><ul><ul><ul><li>Avoid acid inducing foods (caffeine, chocolate, alcohol) </li></ul></ul></ul>
    15. 15. Treatment: Medications <ul><li>Antacids </li></ul><ul><li>H2 blockers </li></ul><ul><li>Proton Pump Inhibitors (PPI) </li></ul>
    16. 16. PPIs are not the solution for severe or chronic reflux <ul><ul><li>Does not stop </li></ul></ul><ul><ul><ul><li>Reflux </li></ul></ul></ul><ul><ul><ul><li>Non Erosive Reflux Disease (NERD) </li></ul></ul></ul><ul><ul><ul><li>Regurgitation </li></ul></ul></ul><ul><ul><li>ANATOMICAL CHANGES NEED ANATOMICAL REPAIRS </li></ul></ul>Severe and Chronic GERD Normal Chronic GERD
    17. 17. Problems with Medical Tx <ul><li>Controlling symptoms not enough </li></ul><ul><ul><ul><li>High dose PPI failed to normalize pH in >1/3 pts </li></ul></ul></ul><ul><ul><ul><li>Sampliner RE, Am J Gastroenterol , 1994 </li></ul></ul></ul><ul><li>Not prevent biliopancreatic reflux </li></ul><ul><li>Lifelong need for medication </li></ul><ul><li>Does not cause regression or prevent development of dysplasia </li></ul>Sharma et al, Am J Gastroenterol , 1997 Shaffer et al, Gastroenterology , 1996
    18. 18. PPI Complications FDA Warnings Vitamin B12 Deficiency Increased Pneumonia Risk Reduced Gallbladder Motility Osteoporosis Related Fractures Drug Interaction Plavix Fundic Gland Polyps Magnesium Deficiency Bacterial Gastroenteritis Small Intestinal Bacterial Overgrowth
    19. 19. Indications for Surgery <ul><li>Esophagitis </li></ul><ul><li>PPIs required for control </li></ul><ul><li>Persistent symptoms despite medications </li></ul><ul><li>Presence of Barrett ’s esophagus </li></ul><ul><li>Non-acid symptoms of reflux (asthma, chronic cough, laryngitis…) </li></ul>
    20. 20. Surgery <ul><li>Fundoplication </li></ul><ul><ul><ul><li>Open </li></ul></ul></ul><ul><ul><ul><li>Laparoscopic </li></ul></ul></ul><ul><ul><ul><li>Endoscopic </li></ul></ul></ul>
    21. 21. Antireflux Surgery <ul><li>Effectively alleviates GERD symptoms </li></ul><ul><li>Abolishes reflux of gastric contents </li></ul><ul><li>Cheaper than lifelong medication </li></ul><ul><li>Studies have demonstrated that Antireflux surgery is better than medical tx in preventing progression to adenoCA </li></ul>Hofstetter et al, Ann Surg, 2001 McCallum et al, Gastroenterology , 1991 Ortiz et al, Br J Surg , 1996 Katz et al, Am J Gastroenterology , 1998
    22. 22. <ul><li>Aims to recreate the natural valve that stops fluids from the stomach refluxing back to the esophagus. </li></ul>Surgical Treatment
    23. 23. Laparoscopic Nissen Fundoplication
    24. 24. <ul><li>Average hospital stay 1.2 days </li></ul><ul><li>Resolution of symptoms at 1 year: 94% </li></ul><ul><li>Major complications: 2% </li></ul><ul><li>Long term complications: 2-62% </li></ul><ul><ul><li>Gas bloat </li></ul></ul><ul><ul><li>Difficulty swallowing </li></ul></ul>Lap Nissen Fundoplication Hunter JG, et al. Surgical Endoscopy 2001
    25. 25. Treatment Options Lifestyle Change Surgical Mild GERD Severe GERD Anatomical Changes Pharmaceutical (Rx and OTC) Today ’ s Approach A NEW Alternative TIF with EsophyX ® “ Front Line Surgical Management”
    26. 26. <ul><li>Incisionless Surgery </li></ul><ul><li>Recognized as Future of Surgery </li></ul><ul><li>Offers patients improved safety and recovery time </li></ul>Surgical Society Support
    27. 27. Medical and Surgical Therapies Medical Therapies 50% 50% 0% • Medical Therapies PPI, H2 Blockers • Lap Fundoplasty Open • Fundoplasty • TIF Fundoplasty 100% 100% Incisionless TIF Fundoplication • Lifestyle/Behavior Modifications
    28. 28. <ul><li>No incisions </li></ul><ul><ul><li>No scarring </li></ul></ul><ul><ul><li>No incisional herniation </li></ul></ul><ul><ul><li>Less potential for infection - nosocomial infection minimized </li></ul></ul><ul><li>Patient friendly </li></ul><ul><ul><li>Rapid return to work and normal activities </li></ul></ul>Transoral Incisionless Fundoplication (TIF)
    29. 29. TIF EsophyX
    30. 30. TIF <ul><li>Reconstructs the natural primary barrier to reflux by creating a robust valve </li></ul>
    31. 31. TIF <ul><li>45 - 60 minute procedure </li></ul><ul><li>Overnight stay (general anesthesia) </li></ul><ul><li>Post-op discomfort minimal </li></ul><ul><li>Rapid recovery – Most patients are back to work and most activities in a couple of days </li></ul>
    32. 32. Patient Selection <ul><li>Are on double-dose PPIs </li></ul><ul><li>Have nighttime symptoms even on medication </li></ul><ul><li>Have non-heartburn symptoms of reflux that can ’t be treated with medications </li></ul><ul><li>Are dissatisfied with current treatment </li></ul><ul><li>Are concerned about long-term use of PPIs </li></ul>
    33. 33. TIF
    34. 34. TIF EsophyX
    35. 35. TIF EsophyX
    36. 36. TIF meets surgical expectations Nissen TIF Recreates Angle Yes Yes Multiple sutures Yes Yes Reduces Hernia Yes Yes Nipple valve Yes Yes Tightens LES Yes Yes Crura closed Yes No Incisionless No Yes Noninvasive No Yes
    37. 37. TIF Manometry
    38. 38. Multicenter Trial (1 Yr) n = 79 <ul><li>Minimal risk of adverse events </li></ul><ul><li>Excellent QOL improvement 73% </li></ul><ul><li>Elimination of PPI use 85% </li></ul><ul><li>Esophagitis resolution 59% </li></ul><ul><li>Hiatal hernia reduction 71% </li></ul><ul><li>pH normalization 49% (Hill grade one) </li></ul>85% of Patients OFF daily PPIs
    39. 39. Effective and Safe <ul><li>TIF was shown to be effective in treating chronic GERD as indicated by the significantly improved quality of life and reduced dependency on daily PPIs . </li></ul><ul><li>The results at 12 and 24 mo supported a long-term maintenance of the anatomical integrity of TIF valves. </li></ul>
    40. 40. <ul><li>On double dose PPIs </li></ul><ul><li>Having nighttime symptoms even on your medication </li></ul><ul><li>Having non-heartburn symptoms of reflux that can ’t be treated with medications </li></ul><ul><li>Dissatisfied with your current treatment </li></ul><ul><li>Please see our staff to schedule an evaluation </li></ul>Are You:
    41. 41. <ul><li>Questions? </li></ul>