Cerrahtan hastaya EsophyX TIF PowerPoint Sunumu
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® No more pain. No more pills. Get back to living! 120308
Transcript of Cerrahtan hastaya EsophyX TIF PowerPoint Sunumu
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No more pain. No more pills.Get back to living!
120308
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Symptoms of GERD
• Heartburn• Acid regurgitation
– Sour or bitter taste in throat or mouth
– Esp. after large, late meals
• Water brash – Hot sensation in stomach
– Excess salivation • Dysphagia and Odynophagia
– Difficulty swallowing or painful swallowing
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Other Symptoms of GERD
PulmonaryAsthma
Aspiration pneumonia
Chronic bronchitis
OtherRegurgitation
Chest pain
Dental erosion
ENTHoarseness
Laryngitis
Sore throat
Chronic cough
Frequent swallowing
Burning in the throat or mouth
Atypical symptoms
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Causes of GERD
DeMeester: Gastric pathology as an indicator and potentiator of gastroesophageal reflux disease. Dis Esophagus, 1997; 10(1):1-8
• Overweight and Obesity
• “Modern” nutritional habits: coffee, chocolate, carbonized drinks, fatty foods, etc.
Unfolding of Sphincter
Distention
Contributing factors:
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Root Cause of Moderate/Severe GERD
Normal AnatomyFully Functional Valve Prevents Reflux
Anatomical change and loss of natural antireflux valve
Abnormal Dysfunctional ValveGERD
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• 10 - 15% of adult population suffers from daily GERD (~ 15 MM)
• Incidence of GERD rises rapidly after 40 years of age
• Esophageal cancer is 8X more likely to occur in patients with weekly heartburn or regurgitation
USA GERD Incidence
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PPIs are not the solution for severe or chronic reflux
Does not stop • Reflux • Non Erosive Reflux
Disease (NERD)• Regurgitation
ANATOMICAL CHANGES NEED ANATOMICAL REPAIRS
Severe and Chronic GERD
Normal
Abnormal
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Continued Reflux Symptoms on Medications
Gallup Poll Reflux*72% on Medication
79% Nighttime symptoms50% Nighttime reflux worse than daytime reflux63% Ability to sleep affected40% Daytime function affected70% Nighttime discomfort moderate to severe75% Can not fall asleep or wakes them up45% 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
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• Young patients at risk for long-term complications with chronic drug therapy
• At risk for osteoporosis• Barrett’s and esophageal cancer risk increase• Drug-drug interaction issues• Adverse events from PPIs
• Patients who do not want to take drugs for life
• Non Erosive Reflux Disease (NERD)
Patients Needing a New Approach
Long-term Implications
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Limitations of Pharmaceuticals• Treat only the symptoms – not the
cause
• Do not stop reflux
• Do not treat non-heartburn symptoms (asthma, hoarseness, coughing…)
GERD Treatment Options
Benefits of EsophyX• GEJ reconstructed
• PPIs reduced or eliminated
• Hiatal Hernia fixed < 2cm
• Significant pH Normalization
• Improved Quality of Life
• Reduce/Eliminate reflux
• Adjustment possible
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EsophyX TIF
TIF (Transoral Incisionless Fundoplication)
No incisions• No scarring• No incisional herniation• Less potential for infection -
nosocomial infection minimized
Patient friendly • Rapid return to work and normal
activities
Unique Surgical Approach
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EsophyX Animation
Unique Surgical Approach
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EsophyX Experience
Reconstructs the natural primary barrier to reflux by creating a robust valve
• 45 - 60 minute procedure• 8 - 14 fasteners “SerosaFuse fasteners”
(3.0 non-absorbable propylene sutures)• Overnight stay (general anesthesia)• Post-op discomfort minimal• Rapid recovery – Most patients are back to
work and most activities in a couple of days
Unique Surgical Approach
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Multi Center Trial (1 year) N=79
85% of Patients OFF daily PPIs
• Minimal risk of adverse events
• Excellent QOL improvement 73%
• Elimination of PPI use 85%
• Esophagitis resolution 59%
• Hiatal hernia reduction 71%
• pH normalization 49% (Hill grade
one)
Clinically Safe & Effective
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0%
20%
40%
60%
80%
100%
Citrus*
Strawberries*
Tomatoes*
Chocolate*
Fatty Foods*
Deep-Fried Foods*
Spicy Foods*
Carbonated Drinks*
Tea*
Coffee*
Caffeinated Drinks*
Alcohol*
12 mo Post-TIF Pre-TIF OFF PPIs
Phase 2 – Dietary Changes
*P < 0.01
Patients can enjoy foods that caused reflux off PPIs
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Phase 2 – Dietary Changes
Patients can enjoy more foods than they could on PPIs without reflux
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Multi Center Trial (2 years) N=79
Clinically Safe & Effective
• Minimal risk of adverse events
• Patients satisfied with treatment 86%
• Patients can consume reflux causing 60-80% foods without symptoms
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• 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.
• The results at 12 and 24 mo supported a
long-term maintenance of the
anatomical integrity of TIF valves.
Effectiveness - Conclusions
