Current Treatment Options and Controversies in GERD

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Current Treatment
Options and
Controversies in GERD
James R Korndorffer Jr MD FACS
Professor, Department of Surgery
Director, Surgery Residency
Medical Director, Tulane
Presentation objectives
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Review current treatment options
• Medical treatment
• Surgical treatment
• Endoscopic treatment
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Identify existing controversies
Evidence-based
Keep you awake!
Why care?
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10% of US adults report heartburn daily and 40%
monthly
More than 18 million Americans suffer
More than 40,000 antireflux operations performed
yearly in the US
GERD is a strong risk factor for adenocarcinoma
of the esophagus
$ 6-13 billion annual sales for PPIs (up to 6 times
the yearly sales of McDonald’s, Burger King, Taco
Bell, Pizza Hut and Kentucky Fried Chicken)
Mr. Burns

52 year-old male presents to the
office with complaints of
retrosternal pain that he has been
experiencing for the past 2 years
History
What other points of the history
do you want to know?
History, Mr. Burns
Consider the following:
• Characterization
of Symptoms
• Temporal sequence
• Alleviating /
Exacerbating factors
• Associated
•
•
•
•
•
signs/symptoms
Pertinent PMH
ROS
MEDS
Relevant Family Hx
Relevant Social Hx
History Mr. Burns
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Characterization of Symptoms
•
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Pain is burning in nature, radiates to back
Temporal sequence
• More frequent after meals, especially spicy
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Alleviating / Exacerbating factors:
• Gets worse when lying down, especially at night,
worse after he drinks alcohol or smokes
• Pain improves with antacids
History Mr. Burns

•
•
•
•
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Associated signs/symptoms:
Brings up (regurgitates) partially digested
food
Reports acid taste in mouth
Had a negative workup in the past for a heart
attack
when he presented to the ER with
similar symptoms
Occasionally food is getting stuck behind
sternum
Wakes up at night with choking sensation
History Mr. Burns
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Pertinent PMH: hyperlipidemia, asthma, h/o
two prior pneumonias
PSH: laparoscopic cholecystectomy
ROS: feels bloated frequently, no weight loss,
avoids eating before bedtime, no vomiting, no
melena
MEDS : Lipitor, antacids
Relevant Family Hx: noncontributory
Relevant Social Hx: smoker, social drinker,
works at construction site
What is your Differential
Diagnosis?
Differential Diagnosis
Based on History and Presentation
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GERD
Esophagitis
Esophageal
Dysmotility
Gastroparesis
Esophageal Cancer
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Achalasia
PUD
Esophageal
Diverticulum
Paraesophageal Hernia
Gastric outlet
obstruction
Physical Examination
What specifically would you look for?
Physical Examination Mr. Burns
• Vital Signs: Height: 6 foot, Weight 190 lbs, T: 98.6, HR: 84,
BP: 146/82
• Appearance: well developed man in no distress
• Relevant Exam findings for a problem focused
assessment
HEENT: eroded enamel
Genital-rectal: no masses,
heme positive
Chest: mild bilateral
wheezing
Neuromuscular: non-focal
exam
CV: RRR, no murmurs, rubs
or gallops
Skin/Soft Tissue: no rashes,
no jaundice
Abd: soft, no masses, no
tenderness
Remaining Examination
findings non-contributory
Studies (Labs, X-rays,
Diagnostics)
What would you obtain?
Studies ordered Mr. Burns
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CBC
Electrolytes
LFT’s
PT/APTT
Chest X-ray
EKG
EGD/Colonoscopy
EGD images
Normal GE junction
with regular Z-line
(arrows)
Mr. Burn’s EGD showing
erosive esophagitis
(erosions indicated by arrows)
Interventions at this point?
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Educate about lifestyle modifications that
may alleviate symptoms
•
•
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•
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Smoking, alcohol and caffeine cessation
Avoid meals before bedtime
Elevate head of bed
Weight loss if patient obese
Start treatment with Proton Pump Inhibitors
Arrange for follow-up visit
Medical Therapy
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Acid suppression is the mainstay of GERD
treatment today
70-90% of patients will experience relapse
within12 months of healing of acute disease
without prophylactic medical treatment
Agents used
• Proton Pump Inhibitors
• Histamine blockers
• Prokinetic agents
Histamine blockers
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Reversible competitive blockade of H2
receptors of the parietal cell
Acid suppression by 70%
Esophagitis healing rates up to 70%
Healing rates dependent on dosage,
treatment duration and severity of disease
Ranitidine, cimetidine, famotidine,
nizatidine
Proton Pump Inhibitors (PPI)
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Most effective available pharmacologic
agent for GERD
Acid suppression by 99%
Esophagitis healing rates 80-100%
+ +
Inhibit H /K ATPase enzyme system on
parietal cells
Omeprazole, lansoprazole, rabeprazole,
pantoprazole, esomeprazole
Indications for Surgical
Referral
Indications for surgery
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Patients with incomplete symptom control or
disease progression on PPI therapy
Patients with well-controlled disease who do not
want to be on life-long antisecretory treatment
Patients with proven extra-esophageal
manifestations of GERD like cough, wheezing,
aspiration, hoarseness, sore throat, otitis media,
or enamel erosion.
The presence of Barrett esophagus is a
controversial indication for surgery
You are the Surgeon

Any more tests?
Normal 48h pH study
Mr. Burn’s pH study note multiple episodes of
pH<4
(arrows)
Predictors of Successful
Outcome
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Typical symptoms
Clinical response to acid suppression therapy
Abnormal 24-hour pH score
Factors Present
“Excellent” Outcome
3
97%
2
75% - 85%
1
50%
Campos et al. J Gastrointest Surg 1999;3:292-300.
Surgery
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Works by restoring the barrier function of the
LES
Careful selection of patients with well
documented GERD is imperative
Laparoscopic fundoplication is considered the
gold standard in antireflux surgery
Nissen and Toupet the most common
Number of cases risen exponentially
Goals of surgery
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Prevent significant reflux
Improve quality of life
Minimize complications (dysphagia)
Principles of operation
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Adequate mobilization of distal esophagus and
gastric cardia
Restoration of 2-3 cm of intraabdominal
esophageal length
Crural reapproximation
Creation of a wrap
Operative findings - Hiatal
Hernia
On the right a small hiatal hernia is
demonstrated. On the left a moderate size
paraesophageal hernia is seen.
Hiatal Closure
Esophagus
Right Crus
Left Crus
Esophagus
Crural Closure
On the right the crura have been dissected out and
on the left they are approximated with permanent
sutures over a Bougie
Nissen fundoplication
Esophagus
Fundoplication
Mr Burn’s Endoscopic Images
Preoperative retroflexed view of
GE junction with patulous
hiatus (arrow)
Retroflexed view of GE junction
after Nissen fundoplication
Complications
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Dysphagia up to 20% but only 2% require
intervention (dilation or surgery)
Gas bloating ~20%
Esophageal or gastric perforation ~1%
Pneumothorax ~1%
Splenectomy (3% open, <1% lap)
3% reoperation rate (wrap herniation, tight
wrap)
Mortality 0-0.8%
Complication rates differ substantially and
appear to be related to surgeon’s experience
Surgery
or
Medical treatment?
Comparison of Medical and Surgical Therapy
for Complicated GERD in Veterans
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RCT of 247 patients with complicated GERD
• 77 randomized to continuous H2RA
therapy
• 88 randomized to H2RA for symptoms
• 82 randomized to surgery
Median follow-up > 2 years (176 @1 yr, 106@
2yr
Outcome better in surgery group
• Lower mean activity index
• Lower mean grade of esophagitis
• Lower % time pH <4
Spechler SJ, and the Department of Veterans Affairs GERD Study Group 1992
Long-term Outcome of Medical and Surgical
Therapies for Gastroesophageal
Reflux Disease
Follow-up of a Randomized Controlled Trial
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JAMA, Volume 285(18).May 9, 2001.2331-2338
Follow-up study conducted from 1997-99
• 238 of patients randomized could be found
• 79 had died
• 31 refuse to participate in follow-up
• 129 (54%) participated in at least part of the
study
 91 “medical” group
 38 “surgical” group
Mean follow-up
• 7.3 years in “medical” group
• 6.3 years in “surgical” group
Long-term Outcome of Medical and Surgical
Therapies for Gastroesophageal
Reflux Disease
Follow-up of a Randomized Controlled Trial
Statement: “Need for medical
therapy” in 62% of the surgical
patients
Long-term Outcome of Medical and Surgical
Therapies for Gastroesophageal
Reflux Disease
Follow-up of a Randomized Controlled Trial
Conclusion:
This study suggests that anti-reflux
surgery should not be advised with
the expectation that patients with
GERD will no longer need to take
antisecretory medications ….
Flaws in the Spechler VA Study
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Results reported as intention to treat
• 24/82 (29.3%) of surgical arm never had surgery
• 16/165 (9.7%) of the medical arm crossed over to
surgery
• 10 (6%) additional medical patients had antireflux
surgery after initial study period
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Follow-up was available in < 50% of surgical
patients
Spechler VA Study
Need for Medical Therapy
Statement: “Need for medical therapy” in 62%
of the surgical patients
Truth: this figure is misleading!
 Only 37 “surgery” patients assessed
 Total of 23 “surgery” patients on medication
 Recall, 24 “surgery” patient never had surgery
Laparoscopic Antireflux Surgery
Five-Year Results and Beyond in 1340 Patients
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1992- 1998
2684 patients with GERD underwent Lap
Nissen
31 hospital centers
61 surgeons (minimum 20 cases)
Pessaux P, Arnaud J, Delattre J, Meyer C, Baulieux J, Mosnier H.
Laparoscopic Antireflux Surgery
Five-Year Results and Beyond in 1340 Patients
2684 patients
- 1091 less than 5 years of follow-up
1593 were for 5 or more years of follow-up
1116 Completed medical examination
+ 224 M.D. phone interview
1340 respondents (84% follow-up)
Pessaux P, Arnaud J, Delattre J, Meyer C, Baulieux J, Mosnier H.
Laparoscopic Antireflux Surgery
Five-Year Results and Beyond in 1340 Patients
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3 operations
711 Laparoscopic Nissen (360 degree wrap)
559 Toupet (180 degree wrap)
70 Anterior partial wrap
Pessaux P, Arnaud J, Delattre J, Meyer C, Baulieux J, Mosnier H.
Laparoscopic Antireflux Surgery
Five-Year Results and Beyond in 1340 Patients
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Visick Classification
Grade 1 – no symptoms
Grade 2 – minimal symptoms, no lifestyle changes,
no need to see M.D.
Grade 3 – significant symptoms that require lifestyle
changes with M.D. help
Grade 4 – symptoms as bad or worse than
preoperatively
Pessaux P, Arnaud J, Delattre J, Meyer C, Baulieux J, Mosnier H.
Laparoscopic Antireflux Surgery
Five-Year Results and Beyond in 1340 Patients
Pessaux P, Arnaud J, Delattre J, Meyer C, Baulieux J, Mosnier H.
Laparoscopic Antireflux Surgery
Five-Year Results and Beyond in 1340 Patients
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Reoperation for recurrence – 59 patients
(4.4%)
Overall satisfaction with results of
surgery (93%)
Willing to have surgery again (94%)
“Need for medical therapy” – 122
patients (9%)
• Only 55 underwent objective testing
• 34/55 had abnormal acid reflux
Pessaux P, Arnaud J, Delattre J, Meyer C, Baulieux J, Mosnier H.
Laparoscopic Antireflux Surgery
Five-Year Results and Beyond in 1340 Patients
Conclusion:
Laparoscopic antireflux surgery is an effective
long-term procedure, is well tolerated, and can
be properly used in the treatment of GERD
Pessaux P, Arnaud J, Delattre J, Meyer C, Baulieux J, Mosnier H.
Symptoms are a poor indicator of reflux
status after fundoplication for GERD
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Prospective study
124 patients with symptoms after lap fundo at
17 months postop had manometry and pH-probe
50% were taking acid reducing medications
Symptoms were unreliable indicators of
presence of reflux
Only 39% had symptoms due to reflux
68% of those taking medications had no
evidence of reflux
Galvani C et al. Arch Surg 2003; 138:514-518.
Does fundoplication halt the
progression of Barrett’s
esophagus or even lead to its
regression?
…and does that lead to decreased
incidence of adenocarcinoma?
Barrett’s esophagus can and does
regress after antireflux surgery: a study
of prevalence and predictive factors
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Retrospective review
91 patients with symptomatic Barrett’s
77 had surgery, 14 on PPI
Histopathologic regression occurred in 36%
(surgery) vs. 7% (PPI; p<0.03)
On multivariate analysis short segment BE and
type of treatment were significantly associated
with regression
Median time to regression 18.5 months
Gurski RR et al. J Am Coll Surg 2003; 196(5):706-712.
Does a surgical antireflux procedure
decrease the incidence of esophageal
adenocarcinoma in Barrett’s esophagus?
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Meta-analysis: 1247 abstracts reviewed published
1966-2001, 34 included
4678 (surgical) vs. 4906 (medical) patient-years
follow-up
Cancer incidence 3.8/ 1000 patient-years
(surgical) vs. 5.3/ 1000 (medical; p=0.29)
Also no significant difference in last 5 years
Antireflux surgery in the setting of BE should not
be recommended as an antineoplastic measure
Corey KE. Am J Gastroenterol 2003; 98(11):2390-2394.
Summary
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GERD is a very common disease in the US and
can be managed medically in most patients
PPI are the gold standard and should be the initial
treatment of choice in patients with
uncomplicated classic symptoms
Patients suspected to have complicated disease
(dysphagia, anemia, weight loss, GI bleeding) or
with atypical reflux symptoms (hoarseness,
asthma, sinusitis, recurrent pneumonias, enamel
erosions, severe nausea and vomiting) or do not
respond to PPI treatment should undergo further
evaluation
Summary
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Surgery is a very effective treatment of
GERD with symptom resolution in over 90%
of patients and excellent quality of life
Randomized studies document superior
efficacy of surgery compared to PPI in
controlling the disease in the short-term but
there are concerns that in the long-term
some patients may need to go back on PPI
therapy
Patients should be carefully selected for
surgery
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