What may have seemed like science fiction, surgery without an incision, is now a reality that is making lives better for patients suffering from chronic acid reflux also known as gastroesophageal reflux disease (GERD). Peter Janu, MD, a general surgeon, provides basic information about GERD as well as common treatment options including the new TIF (transoral incisionless fundoplication) procedure for the treatment of GERD.

1. Acid Reflux:
New Treatment
Options
Peter Janu, M.D.
Surgeon
Calumet Medical Center
St. Elizabeth Hospital

2. Is This You?

3. Overview
• Understanding GERD
• Medical/Surgical Management
• Incisionless Surgical Therapy

4. USA GERD Incidence
• > 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

5. 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

6. Other Symptoms of GERD
Pulmonary ENT
Asthma Hoarseness
Aspiration pneumonia Laryngitis
Chronic bronchitis Sore throat
Chronic cough
Other
Frequent swallowing
Regurgitation
Burning in the throat or
Chest pain
mouth
Dental erosion
Atypical symptoms

7. 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.

8. 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.

9. 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.

10. Hiatal Hernia Classification

11. What causes GERD?
Intrinsic Factors:
Esophageal clearance of acid
Mucosal resistance to acid
Ability of the stomach to empty
Duodenal-gastric reflux
These can often be medically managed

13. What Causes GERD?
Extrinsic Factors:
Deterioration of natural barrier to reflux; the Antireflux Valve
Normal Anatomy Normal Anatomy
Fully Functional Valve Prevents Reflux Antireflux Valve Tight to the Scope

14. What Causes GERD?
Extrinsic Factors:
Deterioration of natural barrier to reflux; the Antireflux Valve
Dysfunctional Valve Dysfunctional Valve
Can’t close to prevent reflux of Can’t close. Loose to the scope.
stomach contents
This requires surgical management

15. 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.

16. 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.

17. Clinical Progression of GERD

18. Overview
• Understanding GERD
• Medical/Surgical Management
• Surgical Therapy- New Procedures

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

20. Types of Medications
• 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
*May be satisfactory for some patients

21. 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
20- 40% of patients dissatisfied with PPI medication
*Gallup Poll 2000 for AGA N = 1000
American Journal of Gastroenterology 2003; vol. 98 Shaker et al

22. Severe and Chronic GERD
PPIs are not the solution for severe
or chronic reflux
Does not stop
• Reflux
• Non Erosive Reflux
Disease (NERD) Normal
• Regurgitation
ANATOMICAL
CHANGES NEED
ANATOMICAL REPAIRS
Chronic GERD

23. Long-Term PPIs
• 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

24. 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…)

25. Tests for Surgery
Patients might
need one or more
of the following
tests:
• Endoscopy
• Barium swallow
• pH monitoring
• Manometry

26. 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.

27. 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.

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

29. Nissen Fundoplication

30. 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.

31. Lap Nissen Fundoplication
1,000 cases
• 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

32. Overview
• Understanding GERD
• Medical/Surgical Management
• Incisionless Surgical Therapy

33. Treatment Options
TIF with EsophyX®
“Front Line Surgical Management”
Mild Severe
Anatomical Changes
GERD GERD
Today’s Lifestyle Pharmaceutical Surgical
Approach Change (Rx and OTC)

34. 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

35. TIF and Principles of Antireflux Surgery

36. 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

37. What Can Be Expected from Surgery

38. Laparoscopic Hiatal Hernia Repair

39. TIF Meets Surgical Objectives
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

40. 3D Manometry
Post-TIF manometry similar to both normal and Nissen

41. 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

42. Multi-Center Trial (2 years) N=79
• Minimal risk of adverse events
• Patients satisfied: 86%
• Patients can consume reflux causing
foods without symptoms: 60-80%
• No long-term adverse events
Clinically Safe & Effective

44. Effectiveness - Conclusions
• 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.

45. Surgical Society Support
Incisionless Surgery
• Recognized as Future of
Surgery
• Offers patients improved
safety and recovery time

46. Medical/Surgical Therapies
Incisionless TIF
Fundoplication

47. 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

48. 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

49. 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.