Acid Reflux: New Treatment

Options Peter Janu, M.D.

Surgeon Calumet Medical Center

St. Elizabeth Hospital

Is This You?

Overview

• Understanding GERD •  Medical/Surgical Management •  Incisionless Surgical Therapy

•  > 40% of population suffers from heartburn at least once a month

•  10 - 15% of adult population suffers from daily GERD (~ 15 million)

•  Incidence of GERD rises rapidly after 40 years of age

•  6 million suffer from both GERD and asthma

•  Esophageal cancer is 8 X more likely to occur in patients with weekly heartburn or regurgitation

USA GERD Incidence

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 or painful swallowing

Other Symptoms of GERD Pulmonary Asthma Aspiration pneumonia Chronic bronchitis

Other Regurgitation Chest pain Dental erosion

ENT Hoarseness Laryngitis Sore throat Chronic cough Frequent swallowing Burning in the throat or mouth

Atypical symptoms

Normal Anatomy Normally, the lining of the esophagus and stomach are made of different types of cells. The cells which line the esophagus are not as resistant to acid as the cells which line the stomach.

There is normally a sphincter muscle (a “gate”) between the esophagus and stomach called the LES (lower esophageal sphincter) which serves as a barrier and protects the esophagus from acid.

Pathologic Anatomy Hiatus of the Diaphragm (colored area) – where the esophagus passes through the diaphragm to connect with the stomach. Muscular fibers of the diaphragm wrap around the esophagus as it passes into the abdomen. When this area is too loose or lax , the stomach can “slip” or “slide” through up into the chest. This creates a pressure differential which allows stomach acid to freely wash up into the esophagus. This condition is known as a hiatal hernia.

Causes of GERD

Hiatal hernia

– allows acid to wash up into the esophagus due to pressure differences between the abdomen and chest.

– Loose hiatus muscle fibers causes reflux even without a hiatal hernia.

Hiatal Hernia Classification

What causes GERD?

These can often be medically managed

Intrinsic Factors:

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? Extrinsic Factors: Deterioration of natural barrier to reflux; the Antireflux Valve

Dysfunctional Valve

Can’t close to prevent reflux of stomach contents

This requires surgical management

Dysfunctional Valve

Can’t close. Loose to the scope.

Consequences of GERD Reflux Esophagitis – Injury and inflammation of the inner lining of the esophagus from prolonged exposure to acid and digestive enzymes.

– This produces pain as well as sometimes painful swallowing (known as “dysphagia”), may cause bleeding.

Effect of GERD on the Esophagus •  Barrett’s esophagus - is one of the serious complications of GERD. It is a precancerous condition that can cause cancer of the esophagus. It is thought to be caused by ongoing injury, inflammation and damage to the lining of the esophagus.

Clinical Progression of GERD

Overview

•  Understanding GERD

• Medical/Surgical Management •  Surgical Therapy- New Procedures

Lifestyle/Behavior Modification •  Diet •  Weight loss •  No late night eating •  Bed position •  Sleeping in a chair…

•  Antacids –  Neutralize or buffer

stomach acid

•  H2 blockers (ranitidine, cimetidine) –  Blocks the body’s signal

to the stomach to produce acid

•  Proton Pump Inhibitors (PPIs) –  Blocks the secretion of

acid into the stomach

Types of Medications

*May be satisfactory for some patients

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

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

•  May be a significant risk for long-term complications with chronic drug therapy

•  At risk for osteoporosis •  At risk for gastric polyps •  Barrett’s and esophageal cancer risks increase •  Drug-drug interaction issues •  Adverse events from PPIs

•  Patients who do not want to take drugs for life

•  Non-Erosive Reflux Disease (NERD)

•  Expense

Long-Term PPIs

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…)

Tests for Surgery

•  Endoscopy •  Barium swallow •  pH monitoring •  Manometry

Patients might need one or more of the following tests:

Diagnostic Tests Upper Endoscopy – The most commonly used test to evaluate the esophagus and stomach. – This is a test that requires mild sedation (medication to make you comfortable) to perform. It is the most accurate way to evaluate damage to or inflammation of the upper gastrointestinal tract. – A flexible scope with a camera and light on the end is placed through the mouth and guided into the esophagus, stomach, and small intestine.

Diagnostic Tests • Upper endoscopy – The scope and

camera allow for clear and detailed viewing of the lining of the esophagus and stomach as well as the ability to take small biopsies to examine the cells if irregularities are noted.

Surgical Treatment Aims to recreate the natural valve that stops fluids from the stomach refluxing back to the esophagus.

Nissen Fundoplication

Laparoscopic Fundoplication Laparoscopic Fundoplication

Is performed using a telescopic camera, a TV monitor and five ½ inch incisions. Small instruments are placed through the incisions allowing surgeons to complete the surgery. Most patients are able to leave the hospital the day after their surgery is performed.

•  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

1,000 cases

Lap Nissen Fundoplication

Overview

•  Understanding GERD •  Medical/Surgical Management

•  Incisionless Surgical Therapy

Treatment Options

Lifestyle Change

Surgical

Mild GERD

Severe GERD Anatomical Changes

Pharmaceutical (Rx and OTC)

Today’s Approach

TIF with EsophyX®

“Front Line Surgical Management”

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

TIF and Principles of Antireflux Surgery

TIF Experience Reconstructs the natural primary barrier to reflux by creating a robust valve

•  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

Unique Surgical Approach

What Can Be Expected from Surgery

Laparoscopic Hiatal Hernia Repair

Nissen Fundoplication TIF

Recreates Angle of HIS Yes Yes

Involves multiple sutures/fasteners Yes Yes Reduces Hiatal Hernia Yes Yes

Creates a substantive nipple valve Yes Yes Lengthens Intraabdominal Esophagus Yes Yes Tighten LES/high pressure zone Yes Yes

GEV anchored Yes Yes

Crura closed Yes No Undone/redone** No Yes

Can be revised (adjusted) No Yes

Incisionless No Yes Noninvasive no dissection No Yes

TIF Meets Surgical Objectives

3D Manometry

Post-TIF manometry similar to both normal and Nissen

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%

Clinically Safe & Effective

Multi-Center Trial (2 years) N=79

Clinically Safe & Effective

•  Minimal risk of adverse events

•  Patients satisfied: 86%

•  Patients can consume reflux causing foods without symptoms: 60-80%

•  No long-term adverse events

•  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 months supported a long-term maintenance of the anatomical integrity of TIF valves.

Effectiveness - Conclusions

Incisionless Surgery •  Recognized as Future of

Surgery •  Offers patients improved

safety and recovery time

Surgical Society Support

Medical/Surgical Therapies

Incisionless TIF Fundoplication

Appropriate for Patients Who:

•  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 •  Are currently taking Plavix

Contraindications to Esophyx TIF

•  Hiatal hernia > 3X3 cm •  Previous surgery on the upper part of the

stomach, previous resection of the stomach, previous bariatric surgery

•  Morbid obesity with BMI>35 •  Barrett’s Esophagus with high grade dysplasia/

cancer of the esophagus/stomach •  High risk of general anesthesia due to advanced

heart or lung disease

Conclusions •  Medical treatment of GERD provides symptomatic relief to

majority of patients but does not address the cause of the disease.

•  Patients with moderate-to-severe GERD, atypical symptoms, resistant to therapy with medications or unwilling to continue taking them, may be candidates for surgical treatment.

•  Laparoscopic Fundoplication while being a “gold standard” of surgery might be effectively replaced by less invasive TIF procedure in patients with no or small hiatal hernia.

•  Current experience with TIF demonstrates good safety profile and efficacy comparable to Laparoscopic Fundoplication without potential side effects of that procedure.

•  Patients with hiatal hernia >3cm or more complex hernia would benefit from Laparoscopic Fundoplication.