PN: C00771-01 B
Current Indications for
Endoscopic Transoral Incisionless Fundoplication - TIF
Stefan J.M. Kraemer, [email protected]
July 24, 2008
Topics
• Key Aspects of GERD?
• Scope of the Disease
• Current Treatments and Surgical Options
• Surgery –TIF (Natural Orifice Surgery)– Transoral Incision-less Fundoplication (EsophyX)
• Patient Profile and Patient Experience
What Causes GERD?
• Esophageal dysmotility
• Inadequate saliva production
– Saliva normally “buffers” any acid
• Impaired resistance of esophageal lining against acid
• Lower Esophageal Sphincter (LES) dysfunction
– Poorly functioning sphincter muscle
• Gastroesophageal Junction (GEJ) incompetent
– Gate between stomach and esophagus allows acid to wash up into esophagus
What Causes GERD?
• Delayed emptying of stomach– Poor motor function of
stomach allows acid to “pool” in stomach
• Hiatal hernia – Allows acid to reflux up into
the esophagus
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 AnatomyGERD
Mechanism and Progression of GERD
Mild Severe
Reflux Affects Lifestyle
• 40% of population suffers from heartburn at least once a month
• Incidence of GERD rises rapidly over age 40
• Sleep Deprivation– Daytime Sleepiness
– Auto Accidents, Productivity
• Progressive Disease if left untreated:– Herniation
– Barrett’s Esophagus
– Esophagial Cancer 15 Million Patients suffer from GERD Daily
Patients Dissatisfied with PPIs > 20-40% * of patients are not satisfied with PPI
medication> Patients not responsive to PPIs (Non-responders)> Patients on PPIs but lifestyle is still impacted
• Night time symptoms still persist*> Patients with small hiatal hernia aggravating
GERD> Persistent regurgitation> Patients with extraesophageal manifestation
of GERD• Asthma, Cough, Hoarseness, Dental, ENT problems
*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 efficacyLoss of efficacySide-effects such as dry mouthSide-effects such as dry mouthCalcium and Iron absorption Calcium and Iron absorption
Gastric polypsGastric polypsBacterial gastroenteritisBacterial gastroenteritis
Unclear cancer riskUnclear cancer riskOnly short-term indication clearedOnly 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 symptomsof chronic GERD, but specific post-fundoplication complaints remained a problem.
With Clinical Data of TIF Approaching Reported Data on With Clinical Data of TIF Approaching Reported Data on LARS…LARS…
· EsophyX allows surgeon to operate remotely enabling incisionless surgery.
The EsophyX Approach
Transoral Surgery> No incisions
> No scarring
> No incisional herniation
> Less potential for infection - nosocomial infection minimized
> Patient friendly – easier to market
> Natural Orifice Surgery is the future
Unique Surgical Approach
· TIF2 Reconstructs the primary components of the GEJ impacting the entire ARB
TIF 2Transoral Incisionless Fundoplication
> 3rd generation in reflux surgery
> An evolution of current surgical procedures
> Based upon long standing surgical principles
> Physiological less invasive
> Surgical reconstruction transoraly
> Future options open – adjustable
> Adaptive to patients anatomy
Unique Surgical Approach
The EsophyX Approach
PharmaceuticalSurgical
“Front Line Surgical Management”
Lifestyle change
Severe GERD
Mild GERD
CHALLENGES:Large Hiatal Hernias
Risk Low
BENEFITS: GEJ reconstructed
PPIs reducedCan correct EsophagitisHiatal Hernia fixed < 2cm
Significant pH NormalizationImproved Quality of LifeReduce/Eliminate reflux
Adjustment possibleBenefit Med/High
*Gallup Poll 2000 for AGA N=1000 American Journal of Gastroenterology 2003; vol. 98 Shaker et al
>20-40% of patients are not happy with PPI medication*
Limitations of Rx• Do not stop reflux • Do not treat Atypical Symptoms
GERD Treatment Options
EsophyX
Functional Change Anatomic Change
EsophyX Animation
Unique Surgical Approach
Pre-TIF 2.0Post- TIF 2.0
NissenFundoplication
EsophyXFundoplicatio
nRecreates Angle of HIS Yes YesInvolves multiple sutures/fasteners
Yes Yes
Reduces Hiatal Hernia Yes YesCreates a substantive nipple valve
Yes Yes
Lengthens Intraabdominal Esophagus
Yes Yes
Tighten LES/high pressure zone
Yes Yes
GEV anchored Yes YesCrura closed Yes NoUndone/redone** Yes
**Avoided -Invasive/complicated
Yes
Can be revised (adjusted) No Yes
Incisionless No YesNoninvasive no dissection No Yes
>Serosa-to-Serosa fusion
Transoral Surgery – “internal” – truly noninvasive
Based upon the surgical repair principles
of the gastroesophageal junction
Unique Surgical Approach
NEXT generation NEXT generation in surgery NOSin surgery NOS
Multi Center Trial (1year) N=79
Clinically Safe & Effective
85% of Patients OFF daily PPI’s
> Comparable efficacy & better tolerated then LNF
> No significant dysphagia, diarrhea, gas bloat
> Excellent QOL improvement 73%
> Elimination of PPI use 85%
> Esophagitis resolution 59%
> Hiatal hernia reduction 71%
> pH normalization 48% (Hill
grade one)
Phase 2 – Dietary Changes Favor ELF Over PPIs
• Benefit of ELF over PPIs are supported by increased consumption of reflux-inducing food items without GERD symptoms
• Patients’ tolerance for dietary challenging food items12 mo. after ELF exceeds benefits patients experienced on PPIs
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
*P < 0.01
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 ON PPIs
Clinical Effectiveness
ELF1.0 ELF1.0 TIF 2.0 PPIs LNF Toupet
Hill I Tight
GERD-HRQL improved by ≥ 50%
73% 75% 88% 68-91% 61-97% 61-97% (from Nissen)
Off daily PPIs 85% 86% 70% 0% 79-100% 65-92%
Normal acid exposure
37% 48% 67% 50-92% 88-97% 49-94%
Esophagitis reduced
62% 80% 67% 84-94% 86-95% 82-89%
Hiatal hernia reduced
60% 89% 89% 0% 87-99% 95%
TIF Evolution Yields Surgery-Like Results
EsophyX Experience
• 45 - 60 minute procedure• Proven 3rd Generation Technology• Overnight stay (general anesthesia)• Rapid Recovery• Incisionless• Reversible, Revisable, Re-doable
Unique Surgical Approach
Patients with gastroesophageal reflux disease (GERD) that is unresponsive to daily proton pump inhibitor (PPI) therapy
Patients with ARB deterioration
Patients not satisfied with their current medical management
Young patients with a long-term future of medication
Patients with GERD who want to discontinue daily PPI use
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.
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
PN: C00771-01 B
EsophyX Getting it Right