Patient info for TIF/endoscopic gastric fundoplication


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A new surgical technique for acid reflux
No incisions!

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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.
  • Patient info for TIF/endoscopic gastric fundoplication

    1. 1. <ul><li>No more pain. No more pills. </li></ul><ul><li>Get back to living! </li></ul>120308
    2. 2. Symptoms of GERD <ul><li>Heartburn </li></ul><ul><li>Acid regurgitation </li></ul><ul><ul><li>Sour or bitter taste in throat or mouth </li></ul></ul><ul><ul><li>Esp. after large, late meals </li></ul></ul><ul><li>Water brash </li></ul><ul><ul><li>Hot sensation in stomach </li></ul></ul><ul><ul><li>Excess salivation </li></ul></ul><ul><li>Dysphagia and Odynophagia </li></ul><ul><ul><li>Difficulty swallowing or painful swallowing </li></ul></ul>
    3. 3. Other Symptoms of GERD <ul><ul><li>Pulmonary </li></ul></ul><ul><ul><li>Asthma </li></ul></ul><ul><ul><li>Aspiration pneumonia </li></ul></ul><ul><ul><li>Chronic bronchitis </li></ul></ul><ul><ul><li>Other </li></ul></ul><ul><ul><li>Regurgitation </li></ul></ul><ul><ul><li>Chest pain </li></ul></ul><ul><ul><li>Dental erosion </li></ul></ul><ul><ul><li>ENT </li></ul></ul><ul><ul><li>Hoarseness </li></ul></ul><ul><ul><li>Laryngitis </li></ul></ul><ul><ul><li>Sore throat </li></ul></ul><ul><ul><li>Chronic cough </li></ul></ul><ul><ul><li>Frequent swallowing </li></ul></ul><ul><ul><li>Burning in the throat or mouth </li></ul></ul>Atypical symptoms
    4. 4. Causes of GERD DeMeester: Gastric pathology as an indicator and potentiator of gastroesophageal reflux disease. Dis Esophagus, 1997; 10(1):1-8 <ul><li>Overweight and Obesity </li></ul><ul><li>“ Modern” nutritional habits: coffee, chocolate, carbonized drinks, fatty foods, etc. </li></ul>Unfolding of Sphincter Distention Contributing factors:
    5. 5. <ul><li>Anatomical change and loss of natural antireflux valve </li></ul>Root Cause of Moderate/Severe GERD Normal Anatomy Fully Functional Valve Prevents Reflux Abnormal Dysfunctional Valve GERD
    6. 6. <ul><li>10 - 15% of adult population suffers from daily GERD (~ 15 MM) </li></ul><ul><li>Incidence of GERD rises rapidly after 40 years of age </li></ul><ul><li>Esophageal cancer is 8X more likely to occur in patients with weekly heartburn or regurgitation </li></ul>USA GERD Incidence
    7. 7. 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 Abnormal
    8. 8. Continued Reflux Symptoms on Medications Gallup Poll Reflux* 72% on Medication 79% Nighttime symptoms 50% Nighttime reflux worse than daytime reflux 63% Ability to sleep affected 40% Daytime function affected 70% Nighttime discomfort moderate to severe 75% Can not fall asleep or wakes them up 45% Medication does not relieve all symptoms *Gallup Poll 2000 for AGA N = 1000 American Journal of Gastroenterology 2003; vol. 98 Shaker et al 20-40% of patients dissatisfied with PPI medication
    9. 9. <ul><li>Young patients at risk for long-term complications with chronic drug therapy </li></ul><ul><ul><li>At risk for osteoporosis </li></ul></ul><ul><ul><li>Barrett’s and esophageal cancer risk increase </li></ul></ul><ul><ul><li>Drug-drug interaction issues </li></ul></ul><ul><ul><li>Adverse events from PPIs </li></ul></ul><ul><li>Patients who do not want to take drugs for life </li></ul><ul><li>Non Erosive Reflux Disease (NERD) </li></ul>Patients Needing a New Approach Long-term Implications
    10. 10. <ul><li>Limitations of Pharmaceuticals </li></ul><ul><ul><li>Treat only the symptoms – not the cause </li></ul></ul><ul><ul><li>Do not stop reflux </li></ul></ul><ul><ul><li>Do not treat non-heartburn symptoms (asthma, hoarseness, coughing…) </li></ul></ul>GERD Treatment Options <ul><li>Benefits of EsophyX </li></ul><ul><li>GEJ reconstructed </li></ul><ul><li>PPIs reduced or eliminated </li></ul><ul><li>Hiatal Hernia fixed < 2cm </li></ul><ul><li>Significant pH Normalization </li></ul><ul><li>Improved Quality of Life </li></ul><ul><li>Reduce/Eliminate reflux </li></ul><ul><li>Adjustment possible </li></ul>
    11. 11. EsophyX TIF TIF ( T ransoral I ncisionless F undoplication) <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>Unique Surgical Approach
    12. 12. EsophyX Animation Unique Surgical Approach
    13. 13. <ul><li>45 - 60 minute procedure </li></ul><ul><li>8 - 14 fasteners “SerosaFuse fasteners” (3.0 non-absorbable propylene sutures) </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>EsophyX Experience <ul><li>Reconstructs the natural primary barrier to reflux by creating a robust valve </li></ul>Unique Surgical Approach
    14. 14. Multi Center Trial (1 year) N=79 85% of Patients OFF daily PPIs <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>Clinically Safe & Effective
    15. 15. Phase 2 – Dietary Changes * P < 0.01 Patients can enjoy foods that caused reflux off PPIs
    16. 16. Phase 2 – Dietary Changes Patients can enjoy more foods than they could on PPIs without reflux
    17. 17. Multi Center Trial (2 years) N=79 Clinically Safe & Effective <ul><li>Minimal risk of adverse events </li></ul><ul><li>Patients satisfied with treatment 86% </li></ul><ul><li>Patients can consume reflux causing 60-80% foods without symptoms </li></ul>
    18. 18. <ul><li>EsophyX-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>Effectiveness - Conclusions