Overview of Endoscopic Gastric Fundoplication


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Detailed overview of a new anti-reflux endoluminal procedure

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  • Here is an animated video of the EsophyX ELF procedure. The device rides over a standard endoscope. One technical challenge is that the device needs to be flexible and soft to make the 90 degree bend in the throat, then stiff and strong to perform surgery in the stomach. The endoscope is always introduced first so that the entire procedure is performed under visual control. The stomach is insufflated and the endoscope is placed in retroflex view. Under visual control, the device is advanced into the stomach. Before creating the valve, the anatomy needs to be in the correct configuration, so any hiatal hernia is reduced first. To do this, the endoscope is retracted back into the EsophyX device up to the clear window in the shaft of the device. Through this window the z-line is visualized. Once located, the invaginator is engaged which uses suction to bring the esophagus onto the shaft of the device. The device is advanced to elongate the esophagus, bringing the z-line to the level of the diaphragm, thus reducing hiatal hernia. Now that the anatomy is in the correct configuration, the valve can be created. The endoscope is advanced and returned to retroflex view. The tissue mold is partially closed, and the helical retractor is advanced out the tip of the tissue mold and twisted to engage it in the fundus tissue. The mold is opened out of the way and a long flap of tissue is pulled down (3-5 cm long flap). The flap mold is closed to compress the tissue and fasteners are delivered across the top of this length of tissue. This shows a close up of the fastener delivery, with the sylet pushing across, and the trailing leg, then lead leg of the H fastener dropping, as the fastener is pushed until it drops off the stylet. These are tension-free fasteners, because they do not put tension on the tissue in any one place. 2 fasteners (one posterior and one anterior) can be delivered at any one placement of the tissue mold. The system is disengaged, you move to a new location of the valve and repeat this procedure until a 270-310 degree circumference, tight valve has been created.
  • Overview of Endoscopic Gastric Fundoplication

    1. 1. Current Indications for Endoscopic Transoral Incisionless Fundoplication - TIF Stefan J.M. Kraemer, M.D . [email_address] July 24, 2008
    2. 2. Topics <ul><li>Key Aspects of GERD? </li></ul><ul><li>Scope of the Disease </li></ul><ul><li>Current Treatments and Surgical Options </li></ul><ul><li>Surgery –TIF (Natural Orifice Surgery) </li></ul><ul><ul><li>Transoral Incision-less Fundoplication (EsophyX) </li></ul></ul><ul><li>Patient Profile and Patient Experience </li></ul>
    3. 3. What Causes GERD? <ul><li>Esophageal dysmotility </li></ul><ul><li>Inadequate saliva production </li></ul><ul><ul><li>Saliva normally “buffers” any acid </li></ul></ul><ul><li>Impaired resistance of esophageal lining against acid </li></ul><ul><li>Lower Esophageal Sphincter (LES) dysfunction </li></ul><ul><ul><li>Poorly functioning sphincter muscle </li></ul></ul><ul><li>Gastroesophageal Junction (GEJ) incompetent </li></ul><ul><ul><li>Gate between stomach and esophagus allows acid to wash up into esophagus </li></ul></ul>
    4. 4. What Causes GERD? <ul><li>Delayed emptying of stomach </li></ul><ul><ul><li>Poor motor function of stomach allows acid to “pool” in stomach </li></ul></ul><ul><li>Hiatal hernia </li></ul><ul><ul><li>Allows acid to reflux up into the esophagus </li></ul></ul>
    5. 5. But the Root Cause in Moderate/Severe GERD is Anatomical changes (LES) Angle of HIS Fundus Diaphragm Z - Line (LES) Angle of HIS Fundus Gastroesophageal Flap Valve (GEV) Esophagus Diaphragm Z - Line Lower Esophageal Sphincter Normal Anatomy GERD
    6. 6. Mechanism and Progression of GERD Mild Severe
    7. 7. Reflux Affects Lifestyle <ul><li>40% of population suffers from heartburn at least once a month </li></ul><ul><li>Incidence of GERD rises rapidly over age 40 </li></ul><ul><li>Sleep Deprivation </li></ul><ul><ul><li>Daytime Sleepiness </li></ul></ul><ul><ul><li>Auto Accidents, Productivity </li></ul></ul><ul><li>Progressive Disease if left untreated: </li></ul><ul><ul><li>Herniation </li></ul></ul><ul><ul><li>Barrett’s Esophagus </li></ul></ul><ul><ul><li>Esophagial Cancer </li></ul></ul>15 Million Patients suffer from GERD Daily
    8. 8. <ul><li>Patients Dissatisfied with PPIs </li></ul><ul><li>20-40% * of patients are not satisfied with PPI medication </li></ul><ul><li>Patients not responsive to PPIs (Non-responders) </li></ul><ul><li>Patients on PPIs but lifestyle is still impacted </li></ul><ul><ul><li>Night time symptoms still persist* </li></ul></ul><ul><li>Patients with small hiatal hernia aggravating GERD </li></ul><ul><li>Persistent regurgitation </li></ul><ul><li>Patients with extraesophageal manifestation of GERD </li></ul><ul><ul><li>Asthma, Cough, Hoarseness, Dental, ENT problems </li></ul></ul>*Gallup Poll 2000 for AGA N=1000 American Journal of Gastroenterology 2003; vol. 98 Shaker et al Patients needing a new approach
    9. 9. Excellent Results for Curing Esophagitis and Ulcer Loss of efficacy Side-effects such as dry mouth Calcium and Iron absorption  Gastric polyps Bacterial gastroenteritis Unclear cancer risk Only short-term indication cleared PPIs Under Increasing Pressure
    10. 10. Lundell et al. British Journal of Surgery 2007; 94: 198-203 Conclusion : After 7 years, surgery was more effective in controlling overall symptoms of chronic GERD , but specific post-fundoplication complaints remained a problem. With Clinical Data of TIF Approaching Reported Data on LARS…
    11. 11. <ul><li>EsophyX allows surgeon to operate remotely enabling </li></ul><ul><li>incisionless surgery. </li></ul>The EsophyX Approach Transoral Surgery <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 – easier to market </li></ul><ul><li>Natural Orifice Surgery is the future </li></ul>Unique Surgical Approach
    12. 12. <ul><li>TIF2 Reconstructs the primary components of the GEJ </li></ul><ul><li>impacting the entire ARB </li></ul>TIF 2 Transoral Incisionless Fundoplication <ul><li>3 rd generation in reflux surgery </li></ul><ul><ul><li>An evolution of current surgical procedures </li></ul></ul><ul><ul><li>Based upon long standing surgical principles </li></ul></ul><ul><ul><li>Physiological less invasive </li></ul></ul><ul><ul><li>Surgical reconstruction transoraly </li></ul></ul><ul><li>Future options open – adjustable </li></ul><ul><li>Adaptive to patients anatomy </li></ul>Unique Surgical Approach The EsophyX Approach
    13. 13. Pharmaceutical Surgical Lifestyle change CHALLENGES: Large Hiatal Hernias Risk Low GERD Treatment Options EsophyX Functional Change Anatomic Change “ Front Line Surgical Management” Severe GERD Mild GERD BENEFITS: GEJ reconstructed PPIs reduced Can correct Esophagitis Hiatal Hernia fixed < 2cm Significant pH Normalization Improved Quality of Life Reduce/Eliminate reflux Adjustment possible Benefit Med/High *Gallup Poll 2000 for AGA N=1000 American Journal of Gastroenterology 2003; vol. 98 Shaker et al <ul><li>20-40% of patients are not happy with PPI medication* </li></ul><ul><ul><li>Limitations of Rx </li></ul></ul><ul><ul><ul><li>Do not stop reflux </li></ul></ul></ul><ul><ul><ul><li>Do not treat Atypical Symptoms </li></ul></ul></ul>
    14. 14. EsophyX Animation Unique Surgical Approach
    15. 15. Pre-TIF 2.0 Post- TIF 2.0
    16. 16. <ul><li>Serosa-to-Serosa fusion </li></ul>Transoral Surgery – “internal” – truly noninvasive Based upon the surgical repair principles of the gastroesophageal junction Unique Surgical Approach NEXT generation in surgery NOS Yes Yes **Avoided -Invasive/complicated Undone/redone** Yes No Can be revised (adjusted) No Yes Crura closed Yes No Incisionless Yes Yes GEV anchored Yes No Noninvasive no dissection Nissen Fundoplication EsophyX Fundoplication Recreates Angle of HIS Yes Yes Involves multiple sutures/fasteners Yes Yes Reduces Hiatal Hernia Yes Yes Creates a substantive nipple valve Yes Yes Lengthens Intraabdominal Esophagus Yes Yes Tighten LES/high pressure zone Yes Yes
    17. 17. Multi Center Trial (1year) N=79 Clinically Safe & Effective 85% of Patients OFF daily PPI’s <ul><ul><li>Comparable efficacy & better tolerated then LNF </li></ul></ul><ul><ul><li>No significant dysphagia, diarrhea, gas bloat </li></ul></ul><ul><ul><li>Excellent QOL improvement 73% </li></ul></ul><ul><ul><li>Elimination of PPI use 85% </li></ul></ul><ul><ul><li>Esophagitis resolution 59% </li></ul></ul><ul><ul><li>Hiatal hernia reduction 71% </li></ul></ul><ul><ul><li>pH normalization 48% (Hill grade one) </li></ul></ul>
    18. 18. Phase 2 – Dietary Changes Favor ELF Over PPIs <ul><li>Benefit of ELF over PPIs are supported by increased consumption of reflux-inducing food items without GERD symptoms </li></ul><ul><li>Patients’ tolerance for dietary challenging food items12 mo. after ELF exceeds benefits patients experienced on PPIs </li></ul>* P < 0.01
    19. 19. Clinical Effectiveness
    20. 20. TIF Evolution Yields Surgery-Like Results
    21. 21. <ul><li>45 - 60 minute procedure </li></ul><ul><li>Proven 3 rd Generation Technology </li></ul><ul><li>Overnight stay (general anesthesia) </li></ul><ul><li>Rapid Recovery </li></ul><ul><li>Incisionless </li></ul><ul><li>Reversible, Revisable, Re-doable </li></ul>EsophyX Experience Unique Surgical Approach
    22. 22. <ul><ul><li>Patients with gastroesophageal reflux disease (GERD) that is unresponsive to daily proton pump inhibitor (PPI) therapy </li></ul></ul><ul><ul><li>Patients with ARB deterioration </li></ul></ul><ul><ul><li>Patients not satisfied with their current medical management </li></ul></ul><ul><ul><li>Young patients with a long-term future of medication </li></ul></ul><ul><ul><li>Patients with GERD who want to discontinue daily PPI use </li></ul></ul><ul><ul><li>Patients with atypical symptoms , including laryngopharyngeal reflux (LPR) indicated by chronic or intermittent hoarseness, chronic throat clearing, chronic cough, voice fatigue or changes, globus sensation, and sore throat. </li></ul></ul>Profiles for Referral
    23. 23. Pharmaceutical Palliation; treatment of esophagitis and ulcer Surgical Treatment of anatomical root cause Severe GERD Hiatal hernia Mild GERD Before EsophyX 12 mo after EsophyX Functional Change Anatomic Change Mechanism and Progression of GERD Tranoral Incsionless Fundoplication TIF2
    24. 24. EsophyX Getting it Right