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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