Transoral Incisionless FundoplicationJames K. Fullerton, MDDepartment of General Surgery
www.SpringfieldClinic.comwww.SpringfieldClinic.com
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Gastroesophageal Reflux Disease(GERD)
GERD Facts
• 10% of adults suffer daily heartburn
• Incidence increases after 40 yo
• 50% of patients require lifelong tx
• Most GERD gets worse with time
• Increased esophageal cancer risk with untreated severe GERD
Acid Reflux Symptoms
• Heartburn
• Dysphagia or odynophagia
• Hoarseness
• Cough, asthma
• Regurgitation
• Pneumonia
• Abdominal pain
Lower Esophageal Sphincter (LES)> Relaxes to allow
swallowing
Angle of HIS
Fundus
Gastroesophageal Flap Valve (GEV)> 180° flap valve, maintains closure against lesser curve of stomach > Is closed by pressure in the stomach to prevent reflux
Esophagus
Diaphragm
Gray’s Anatomy, 1997
Z Line> Marks where stomach and esophagus meet
Anatomy
GERD
• Acid reflux symptoms
• Injury to the esophagus
• Hiatal Hernia
Diagnosis
• Symptoms
• Response to treatment
• Tests– Endoscopy– Upper GI– 24 hour esophageal pH study– Esophageal manometry
Upper Endoscopy (EGD)
Intrinsic Factors: These can often be medically managed
Esophageal clearance of acid
Mucosal resistance to acid
Ability of the stomach to empty
Duodenal-gastric reflux
What causes GERD?
Normal Anatomy
Fully Functional Valve Prevents Reflux
Extrinsic Factors:Deterioration of natural barrier to reflux; the Antireflux Valve
Normal Anatomy
Antireflux Valve Tight to the Scope
What causes GERD
What causes GERD?
Extrinsic Factors:Deterioration of natural barrier to reflux; the Antireflux Valve
Dysfunctional Valve
Can’t close to prevent reflux of stomach contents
Dysfunctional Valve
Can’t close. Loose to the scope.
Reflux Complications
• Ulcers
• Bleeding
• Strictures
• Lung problems
• Barrett’s Esophagus
• Esophageal Cancer
Treatment: Lifestyle Changes
• Weight loss• Raise head of bed• Smoking• Avoid late meals• Avoid acid inducing foods
(caffeine, chocolate, alcohol)
Treatment: Medications
• Antacids
• H2 blockers
• Proton Pump Inhibitors (PPI)
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
Chronic GERD
Problems with Medical Tx
• Controlling symptoms not enough• High dose PPI failed to normalize pH in >1/3 pts
Sampliner RE, Am J Gastroenterol, 1994
• Not prevent biliopancreatic reflux
• Lifelong need for medication
• Does not cause regression or prevent development of dysplasia
Sharma et al, Sharma et al, Am J GastroenterolAm J Gastroenterol, 1997, 1997Shaffer et al, Shaffer et al, GastroenterologyGastroenterology, 1996, 1996
FDA Warnings
Vitamin B12 Deficiency
Increased Pneumonia Risk
Reduced GallbladderMotility
Osteoporosis RelatedFractures
Drug InteractionPlavix
Fundic Gland Polyps
Magnesium Deficiency
Bacterial Gastroenteritis
Small Intestinal Bacterial Overgrowth
PPI Complications
Indications for Surgery
• Esophagitis
• PPIs required for control
• Persistent symptoms despite medications
• Presence of Barrett’s esophagus
• Non-acid symptoms of reflux (asthma, chronic cough, laryngitis…)
Surgery
• Fundoplication• Open• Laparoscopic• Endoscopic
Antireflux Surgery
• Effectively alleviates GERD symptoms
• Abolishes reflux of gastric contents
• Cheaper than lifelong medication
• Studies have demonstrated that Antireflux surgery is better than medical tx in preventing progression to adenoCA
Hofstetter et al, Ann Surg, 2001Hofstetter et al, Ann Surg, 2001McCallum et al, McCallum et al, GastroenterologyGastroenterology, 1991, 1991Ortiz et al, Ortiz et al, Br J SurgBr J Surg, 1996, 1996Katz et al, Katz et al, Am J GastroenterologyAm J Gastroenterology, 1998, 1998
Aims to recreate the natural valve that stops fluids from the stomach refluxing back to the esophagus.
Surgical Treatment
Laparoscopic Nissen Fundoplication
• Average hospital stay 1.2 days• Resolution of symptoms at 1 year: 94%• Major complications: 2%• Long term complications: 2-62%
– Gas bloat– Difficulty swallowing
Hunter JG, et al. Surgical Endoscopy 2001Hunter JG, et al. Surgical Endoscopy 2001
Lap Nissen Fundoplication
Lifestyle
Change
Surgical
MildGER
D SevereGERD
Anatomical Changes
Anatomical Changes
Pharmaceutical(Rx and OTC)
Today’sApproachToday’s
Approach
A NEWA NEWAlternativAlternativ
ee
A NEWA NEWAlternativAlternativ
eeTIF with EsophyX®
“Front Line Surgical Management”
Treatment Options
Incisionless Surgery• Recognized as Future of
Surgery• Offers patients improved
safety and recovery time
Surgical Society Support
Medical TherapiesMedical Therapies
50
%5
0%
50%50%0%0%
••Medical Therapies PPI, H2 Blockers Medical Therapies PPI, H2 Blockers
•• Lap Lap FundoplastyFundoplasty
OpenOpen •• FundoplastyFundoplasty
••TIF TIF FundoplastyFundoplasty
10
0%
10
0%
100%100%
Incisionless TIFFundoplication
••Lifestyle/Behavior ModificationsLifestyle/Behavior Modifications
Medical and Surgical Therapies
• No incisions• No scarring• No incisional herniation• Less potential for infection -
nosocomial infection minimized
• Patient friendly • Rapid return to work and normal
activities
Transoral Incisionless Fundoplication (TIF)
TIF EsophyX
TIF
• Reconstructs the natural primary barrier to reflux by creating a robust valve
TIF
• 45 - 60 minute procedure• Overnight stay (general anesthesia)• Post-op discomfort minimal• Rapid recovery – Most patients are back
to work and most activities in a couple of days
Patient Selection
• Are on double-dose PPIs• Have nighttime symptoms even on medication• Have non-heartburn symptoms of reflux that
can’t be treated with medications• Are dissatisfied with current treatment• Are concerned about long-term use of PPIs
TIF
TIF EsophyX
TIF EsophyX
TIF meets surgical expectations
Nissen TIF
Recreates Angle Yes Yes
Multiple sutures Yes Yes
Reduces Hernia Yes Yes
Nipple valve Yes Yes
Tightens LES Yes Yes
Crura closed Yes No
Incisionless No Yes
Noninvasive No Yes
TIF Manometry
Multicenter Trial (1 Yr) n = 79
• 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)
85% of Patients OFF daily PPIs
Effective and Safe
• TIF was shown to be effective in treating TIF was shown to be effective in treating
chronic GERD as indicated by the chronic GERD as indicated by the
significantly improved significantly improved quality of lifequality of life and and
reduced dependency on daily PPIsreduced dependency on daily PPIs..
• The results at 12 and 24 mo supported a The results at 12 and 24 mo supported a
long-term long-term maintenance of the anatomical maintenance of the anatomical
integrityintegrity of TIF valves. of TIF valves.
• On double dose PPIs• Having nighttime symptoms even on your
medication• Having non-heartburn symptoms of reflux that
can’t be treated with medications• Dissatisfied with your current treatment
Please see our staff to schedule an evaluation
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