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Current Indications  for Endoscopic  Transoral Incisionless  Fundoplication - TIF Stefan J.M. Kraemer, M.D . [email_address] July 24, 2008
Topics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What Causes GERD? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What Causes GERD? ,[object Object],[object Object],[object Object],[object Object]
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
Mechanism and Progression of GERD Mild Severe
Reflux Affects Lifestyle ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],15 Million Patients suffer from  GERD Daily
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],*Gallup Poll 2000 for AGA N=1000 American Journal of Gastroenterology 2003; vol. 98 Shaker et al Patients needing a new approach
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
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…
[object Object],[object Object],The EsophyX Approach Transoral Surgery ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Unique Surgical Approach
[object Object],[object Object],TIF 2 Transoral Incisionless Fundoplication  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Unique Surgical Approach The EsophyX Approach
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 ,[object Object],[object Object],[object Object],[object Object]
EsophyX Animation Unique Surgical Approach
Pre-TIF 2.0 Post- TIF 2.0
[object Object],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
Multi Center Trial (1year)   N=79 Clinically Safe & Effective 85%  of Patients OFF daily PPI’s ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Phase 2 – Dietary Changes Favor ELF Over PPIs ,[object Object],[object Object],* P  < 0.01
Clinical Effectiveness
TIF Evolution Yields Surgery-Like Results
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],EsophyX Experience Unique Surgical Approach
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Profiles for Referral
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
EsophyX  Getting it Right

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Overview of Endoscopic Gastric Fundoplication

  • 1. Current Indications for Endoscopic Transoral Incisionless Fundoplication - TIF Stefan J.M. Kraemer, M.D . [email_address] July 24, 2008
  • 2.
  • 3.
  • 4.
  • 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. Mechanism and Progression of GERD Mild Severe
  • 7.
  • 8.
  • 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. 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.
  • 12.
  • 13.
  • 14. EsophyX Animation Unique Surgical Approach
  • 15. Pre-TIF 2.0 Post- TIF 2.0
  • 16.
  • 17.
  • 18.
  • 20. TIF Evolution Yields Surgery-Like Results
  • 21.
  • 22.
  • 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. EsophyX Getting it Right

Editor's Notes

  1. 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.