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

2. 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 McDonald’s, 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

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

6. 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

7. History Mr. Burns Characterization of Symptoms Temporal sequence
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

8. 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

9. 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

10. What is your Differential Diagnosis?

11. Differential Diagnosis Based on History and Presentation
GERD
Esophagitis
Esophageal Dysmotility
Gastroparesis
Esophageal Cancer
Achalasia
PUD
Esophageal Diverticulum
Paraesophageal Hernia
Gastric outlet obstruction

12. What specifically would you look for?
Physical Examination
What specifically would you look for?

13. 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

14. Studies (Labs, X-rays, Diagnostics)
What would you obtain?

15. Studies ordered Mr. Burns
CBC
Electrolytes
LFT’s
PT/APTT
Chest X-ray
EKG
EGD/Colonoscopy

16. EGD images Normal GE junction with regular Z-line (arrows)
Mr. Burn’s EGD showing erosive esophagitis
(erosions indicated by arrows)

17. 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

18. 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

19. 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

20. Proton Pump Inhibitors (PPI)
Most effective available pharmacologic agent for GERD
Acid suppression by 99%
Esophagitis healing rates %
Inhibit H+/K+ ATPase enzyme system on parietal cells
Omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole

21. Indications for Surgical Referral

22. 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

23. You are the Surgeon
Any more tests?

24. Mr. Burn’s pH study note multiple episodes of pH<4 (arrows)
Normal 48h pH study
Mr. Burn’s pH study note multiple episodes of pH< (arrows)

25. Predictors of Successful Outcome
Typical symptoms
Clinical response to acid suppression therapy
Abnormal 24-hour pH score
Factors Present “Excellent” Outcome %
% - 85% %
Campos et al. J Gastrointest Surg 1999;3:

26. 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

27. Principles of operation
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

28. Operative findings - Hiatal Hernia
On the right a small hiatal hernia is demonstrated. On the left a moderate size paraesophageal hernia is seen.

29. 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

30. Nissen fundoplication
Esophagus
Fundoplication

31. Mr Burn’s Endoscopic Images
Preoperative retroflexed view of GE junction with patulous hiatus (arrow)
Retroflexed view of GE junction after Nissen fundoplication

32. 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, <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

33. Surgery or
Medical treatment?

35. 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 > 2 years yr, 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

36. Long-term Outcome of Medical and Surgical Therapies for Gastroesophageal Reflux Disease Follow-up of a Randomized Controlled Trial
Follow-up study conducted from
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,

37. 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

38. 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 ….

39. 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 < 50% of surgical patients

40. 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

41. Laparoscopic Antireflux Surgery Five-Year Results and Beyond in 1340 Patients
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.

42. Laparoscopic Antireflux Surgery Five-Year Results and Beyond in 1340 Patients
less than 5 years of follow-up
1593 were for 5 or more years of follow-up
1116 Completed medical examination
M.D. phone interview
1340 respondents (84% follow-up)
Pessaux P, Arnaud J, Delattre J, Meyer C, Baulieux J, Mosnier H.

43. Laparoscopic Antireflux Surgery Five-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.

44. Laparoscopic Antireflux Surgery Five-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.

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

46. Laparoscopic Antireflux Surgery Five-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.

47. 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.

48. 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; 138:

49. …and does that lead to decreased incidence of adenocarcinoma?
Does fundoplication halt the progression of Barrett’s esophagus or even lead to its regression?
…and does that lead to decreased incidence of adenocarcinoma?

50. Barrett’s esophagus can and does regress after antireflux surgery: a study of prevalence and predictive factors
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):

51. Does a surgical antireflux procedure decrease the incidence of esophageal adenocarcinoma in Barrett’s esophagus?
Meta-analysis: 1247 abstracts reviewed published , 34 included
4678 (surgical) vs (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):

52. 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

53. 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 53