Current Treatment Options and Controversies in GERD

1
Current Treatment Options and Controversies in
GERD

• James R Korndorffer Jr MD FACS
• Professor, Department of Surgery
• Director, Surgery Residency
• Medical Director, Tulane Simulation Center

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Presentation objectives

• Review current treatment options
• Medical treatment
• Surgical treatment
• Endoscopic treatment
• Identify existing controversies
• Evidence-based
• Keep you awake!

3
Why care?

• 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 McDonalds, Burger
  King, Taco Bell, Pizza Hut and Kentucky Fried
  Chicken)

4
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

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History

• What other points of the history do you want to
  know?

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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

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History Mr. Burns

• Characterization of Symptoms
• Pain is burning in nature, radiates to back
• Temporal sequence
• More frequent after meals, especially spicy
• Alleviating / Exacerbating factors
• Gets worse when lying down, especially at night,
  worse after he drinks alcohol or smokes
• Pain improves with antacids

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History Mr. Burns

• 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

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History Mr. Burns

• 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

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What is your Differential Diagnosis?
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Differential DiagnosisBased on History and
Presentation

• GERD
• Esophagitis
• Esophageal Dysmotility
• Gastroparesis
• Esophageal Cancer

• Achalasia
• PUD
• Esophageal Diverticulum
• Paraesophageal Hernia
• Gastric outlet obstruction

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Physical Examination

• What specifically would you look for?

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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
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Studies (Labs, X-rays, Diagnostics)

• What would you obtain?

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Studies ordered Mr. Burns

• CBC
• Electrolytes
• LFTs
• PT/APTT
• Chest X-ray
• EKG
• EGD/Colonoscopy

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EGD images
Normal GE junction with regular Z-line (arrows)
Mr. Burns EGD showing erosive esophagitis
(erosions indicated by arrows)
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Interventions at this point?

• Educate about lifestyle modifications that may
  alleviate symptoms
• 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

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Medical Therapy

• 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

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Histamine blockers

• 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

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Proton Pump Inhibitors (PPI)

• 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

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Indications for Surgical Referral
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Indications for surgery

• 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

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You are the Surgeon

• Any more tests?

24
Mr. Burns pH study note multiple episodes of
pHlt4 (arrows)
Normal 48h pH study
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Predictors of Successful Outcome

• 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 19993292-300.
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Surgery

• 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

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Goals of surgery

• Prevent significant reflux
• Improve quality of life
• Minimize complications (dysphagia)

Principles of operation

• Adequate mobilization of distal esophagus and
  gastric cardia
• Restoration of 2-3 cm of intraabdominal
  esophageal length
• Crural reapproximation
• Creation of a wrap

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Operative findings - Hiatal Hernia
On the right a small hiatal hernia is
demonstrated. On the left a moderate size
paraesophageal hernia is seen.
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Hiatal Closure
Esophagus
Esophagus
Left Crus
Crural Closure
Right Crus
On the right the crura have been dissected out
and on the left they are approximated with
permanent sutures over a Bougie
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Nissen fundoplication
Esophagus
Fundoplication
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Mr Burns Endoscopic Images
Preoperative retroflexed view of GE junction with
patulous hiatus (arrow)
Retroflexed view of GE junction after Nissen
fundoplication
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Complications

• 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, lt1 lap)
• 3 reoperation rate (wrap herniation, tight wrap)
• Mortality 0-0.8
• Complication rates differ substantially and
  appear to be related to surgeons experience

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Surgery
or

• Medical treatment?

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Comparison of Medical and Surgical Therapy for
Complicated GERD in Veterans

• 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 gt 2 years (176 _at_1 yr, 106_at_ 2yr
• Outcome better in surgery group
• Lower mean activity index
• Lower mean grade of esophagitis
• Lower time pH lt4

Spechler SJ, and the Department of Veterans
Affairs GERD Study Group 1992
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Long-term Outcome of Medical and Surgical
Therapies for Gastroesophageal Reflux
DiseaseFollow-up of a Randomized Controlled Trial

• 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

JAMA, Volume 285(18).May 9, 2001.2331-2338
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Long-term Outcome of Medical and Surgical
Therapies for Gastroesophageal Reflux
DiseaseFollow-up of a Randomized Controlled Trial

• Statement Need for medical therapy in 62 of
  the surgical patients

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Long-term Outcome of Medical and Surgical
Therapies for Gastroesophageal Reflux
DiseaseFollow-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 .

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Flaws in the Spechler VA Study

• 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
• Follow-up was available in lt 50 of surgical
  patients

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Spechler VA StudyNeed 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

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Laparoscopic Antireflux SurgeryFive-Year Results
and Beyond in 1340 Patients

• 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.
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Laparoscopic Antireflux SurgeryFive-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.
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Laparoscopic Antireflux SurgeryFive-Year Results
and Beyond in 1340 Patients

• 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.
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Laparoscopic Antireflux SurgeryFive-Year Results
and Beyond in 1340 Patients

• 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.
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Laparoscopic Antireflux SurgeryFive-Year Results
and Beyond in 1340 Patients
Pessaux P, Arnaud J, Delattre J, Meyer C,
Baulieux J, Mosnier H.
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Laparoscopic Antireflux SurgeryFive-Year Results
and Beyond in 1340 Patients

• 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.
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Laparoscopic Antireflux SurgeryFive-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.
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Symptoms are a poor indicator of reflux status
after fundoplication for GERD

• 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 138514-518.
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Does fundoplication halt the progression of
Barretts esophagus or even lead to its
regression?

• and does that lead to decreased incidence of
  adenocarcinoma?

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Barretts esophagus can and does regress after
antireflux surgery a study of prevalence and
predictive factors

• Retrospective review
• 91 patients with symptomatic Barretts
• 77 had surgery, 14 on PPI
• Histopathologic regression occurred in 36
  (surgery) vs. 7 (PPI plt0.03)
• 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.
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Does a surgical antireflux procedure decrease the
incidence of esophageal adenocarcinoma in
Barretts esophagus?

• 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 p0.29)
• 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.
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Summary

• 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

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Summary

• 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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