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1. About GERD

If you have heartburn twice a week or more, you may have acid reflux disease, also known as Gastroesophageal Reflux Disease (GERD). Heartburn is the most common symptom, but you may also experience:

  • Regurgitation
  • Hoarseness or sore throat
  • Frequent swallowing
  • Asthma or asthma-like symptoms
  • Pain or discomfort in the chest
  • Reflux-related sleep disorders
  • Yellow fluid or stains on pillow after sleep
  • Excessive clearing of the throat
  • Persistent cough
  • Burning in the mouth or throat
  • Intolerance of certain foods
  • Bloating
  • Dental erosions or therapy-resistant gum disease or inflammation

2. What is GERD?

Gastroesophageal Reflux Disease (GERD),  is reflux and regurgitation of the contents of the stomach into the esophagus that is frequent and severe enough to impact daily life. This reflux is not only painful and uncomfortable, but can burn the esophagus, cause chronic inflammation, and can lead to major damage and possibly even cancer of the esophagus. GERD is one of the most common diseases, with millions of people worldwide experiencing symptoms at least once a month. Over 60% of the elderly have frequent GERD, and several million have GERD symptoms every single day.

3. What causes GERD?

In a normal, healthy person, after swallowing, a valve between the esophagus and stomach opens to allow food to pass, then it closes to prevent stomach contents from refluxing into the esophagus.

 

Fully functional valve closes to prevent reflux of stomach acid into the esophagus.

Dysfunctional valve is unable to close to prevent stomach acid from refluxing into the esophagus.

For people with GERD, this valve has become dysfunctional and cannot close allowing stomach fluids to come up into the esophagus. 

The Transoral Incisionless Fundoplication (TIF) procedure, performed using the EsophyX device, reconstructs the antireflux valve mechanism, restoring it to what is believed to be its natural anatomic geometry, effectively stopping GERD.

4. What are the consequences of GERD?

With moderate to severe chronic GERD, regurgitation occurs regularly, spilling acid, bile, and other stomach contents not only into the esophagus but in some people also into the lungs, mouth, pharynx and/or nose.

The complications associated with untreated GERD are well documented and can have a significant impact on quality of life and, in extreme cases, life expectancy. Esophagitis can quickly become a chronic condition, and if the damage is severe, esophageal ulcers can form.

Esophageal ulcers can cause bleeding, sometimes severe, and can result in narrowing of the esophagus, which can make swallowing difficult and painful.

If GERD is left untreated, a potentially premalignant condition, Barrett’s esophagus, can develop and in a percentage of patients can progress to esophageal cancer.

5. What GERD treatment options are available?

The initial GERD treatment algorithm typically involves a combination of lifestyle changes, over-the-counter medications (OTC), and prescription drug regimens. For GERD sufferers who are dissatisfied with their medications, continue to have manifestations and/or complications, or are dissatisfied with the impact traditional treatment regimens have on their lifestyle, an anatomical solution is available.

 

 

5.1 Lifestyle:

For many, lifestyle modifications such as dietary and sleeping position changes can significantly decrease the frequency and severity of GERD and are usually the appropriate first step in the treatment process.

5.2 Drugs:

Drug therapies such as proton pump inhibitors (PPI) and H2 (H2RA) blockers reduce ‘typical' GERD symptoms caused by acid exposure, but they are not effective in treating non-acidic or alkaline reflux and ‘atypical symptoms' like asthma, or chronic cough, since these symptoms result from the presence of reflux contents, regardless of the acidity. Even if drug therapy is effective, it may be needed for life, since symptoms and disease return as soon as medication is stopped.

5.2.1 OTC:

OTC medications such as antacids, lower dosage H2 receptor antagonists (H2RA), and proton pump inhibitors (PPIs) are an easily accessible pain-reducing option for people who suffer from occasional mild-to-moderate GERD. Many OTC treatments work to neutralize the acid, reduce gas, and coat the lining of the esophagus and stomach, thereby providing short-term relief from symptoms.

5.2.2 PPIs and H2RAs:

Prescription doses of Proton Pump Inhibitors (PPIs) and/or H2RAs are effective pain reducing treatment options for moderate and recurrent heartburn because they reduce the amount of acid produced in the stomach. These medications, however, do not prevent neutralized acid from refluxing up into the esophagus, lungs, mouth, and/or nasal cavities. They also do not prevent reflux of other caustic agents, including bile, pepsin and digestive enzymes. In other words, medication treats the symptoms of GERD without addressing the root cause of GERD, reflux and regurgitation.

About 10-20% of patients do not respond to these prescription medications and symptoms remain. Even on prescription medication, some patients are not able to eat large meals, eat late at night, drink alcohol, coffee, and carbonized drinks, eat fatty foods, chocolate, strawberries, or spicy foods without having symptoms return. Some patients may also have breakthrough symptoms at night and regurgitate while sleeping. Some even find a pool of yellow fluid (bile) on their pillow when experiencing reflux at night. So-called "silent aspiration" is often cited as the reason for GERD-related asthma. Raising the head of the bed is one option to help in reducing nighttime reflux.

GERD is a progressive disease, prescription medications do nothing to slow or prevent this progression.  Some patients who respond well to prescription medication may find they require increasing dosage of the medication over time or that they need to switch to a new medication to maintain symptom control. 

6. What surgical solutions are available:

Open and laparoscopic surgical procedures have been used to treat GERD effectively for over 50 years. Laparoscopic repair has been shown to be effective in 75-90% of patients in alleviating heartburn and 50-75% in alleviating cough, asthma, and laryngitis[11]. Studies and years of clinical use prove that an anatomical correction is key to long-term prevention of GERD and disease progression. Unfortunately, even laparoscopic surgical repair can be invasive and typically has a high incidence of side effects like gas bloat and difficulty swallowing. For this reason, less than 1% of GERD patients currently choose invasive surgical therapy to treat their condition.

7. What is TIF (Transoral Incisionless Fundoplication)?

The TIF procedure, performed with the EsophyX device, is the latest advancement in the evolution of surgical procedures for the treatment of GERD and builds upon the principles of proven open and laparoscopic procedures used to effectively treat the disease. The key differences are that EsophyX TIF is performed through the mouth, does not require any incisions, and does not dissect any part of the natural internal anatomy. Benefits include reduced recovery time and discomfort and most patients are able to return to work and normal activities within a couple of days after the procedure.

 

Citations:

[1] Reappraisal of the Flap Valve Mechanism in the Gastroesophageal Junction: A Study of a New Valvuloplasty Procedure in Cadavers, Thor, B.A., Hill Lucius D, Mercer, Dale D., and Kozarek, Richard D.; Acta Chir Scand 153: 25-28, ©1987

[2] Practice guidelines on the diagnosis, surveillance, and therapy of Barrett's esophagus. Sampliner R., Am J Gastroenterol 1998; 93: 1028-1032

[3] Efficacy of Medical Therapy and Antireflux Surgery to Prevent Barrett's Metaplasia in Patients With Gastroesophageal Reflux Disease, Gerold J. Wetscher, MD, Michael Gadenstaetter, MD, Paul J. Klingler, MD, Helmut Weiss, MD, Peter Obrist, MD, Heinz Wykypiel, MD, Alexander Klaus, MD, and Christoph Profanter, MD, Annals of Surgery Vol. 234, No. 5, 627-632 ©2001 Lippincott Williams & Wilkins, Inc.

[4] The Burden of Gastrointestinal Diseases, The American Gastroenterological Association, ©2001

[5] Cost-of-disease analysis in patients with gastro-oesophageal reflux disease and Barrett's mucosa. S. N. WILLICH, M. NOCON, M. KULIG*, D. JASPERSEN_, J. LABENZ, W. MEYER-SABELLEK, M. STOLTE-, T. LIND & P. MALFERTHEINER, Aliment Pharmacol Ther 23, 371-376. ©2006 The Authors 371Journal compilation 2006 Blackwell Publishing Ltd doi:10.1111/j.1365-2036.2006.02763.x

[6] The economic impact of GERD and PUD: examination of direct and indirect costs using a large integrated employer claims database. Vijay N Joish, Gary Donaldson, William Stockdale, Gary M Oderda, Joseph Crawley, Rahul Sasane, Sandra Joshua-Gotlib, Diana I Brixner. Curr Med Res Opin. 2005 Apr; 21:535-44.

[7] Quality of life for patients with gastroesophageal reflux disease 2 years after laparoscopuc fundoplication. S. Contini, A. Bertele, G. Nervi, R. Zinicola, C.Scarpignato. Surg. Endosc (2002) 16: 1555-1560.

[8] Surgery of Gastroesophageal Reflux Disease: A Competative or Complementary Procedure?, Lundell, Lars, Division of Surgery, Karolinska University Hsopital, Dig Dis 2004; 22: 161-170

[9] Laparoscopic Nissen Fundoplication, Glyn G. Jamieson, M.S., F.A.C.S., F.R.A.C.S., David I. Watson, M.B., B.S., F.R.A.C.S., Robert Britten-Jones, M.B., B.S., F.R.C.S., F.R.A.C.S., Philip C. Mitchell, M.D., F.R.C.S.C., and Mehran Anvari, M.B., B.S., F.R.C.S.C. From the University Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia; ANNALS OF SURGERY Vol. 220, No. 2, 137-145 ©1994 J. B. Lippincott Company

[10] Clinical Results of Laparoscopic Fundoplication at Ten Year After Surgery, Dallemagne, Bernard; CHC-Les Cliniques Saint Joseph, Digestive Surgery, Surg End

[11] Management of Gastroesophageal Reflux Disease, Joel J. Heidelbaugh, M.D., Timothy T. Nostrant, M.D., Clara Kim, M.D., and R. Van Harrison, PH.D., University of Michigan Medical School, Ann Arbor,Michigan, Am Fam Physician 2003;68:1311-8,1321-2. ©2003 American Academy of Family Physicians

[12] Efficacy of Medical Therapy and Antireflux Surgery to Prevent Barrett's Metaplasia in Patients With Gastroesophageal Reflux Disease. Wetscher, Gerold J. MD *; Gadenstaetter, Michael MD *; Klingler, Paul J. MD *; Weiss, Helmut MD *; Obrist, Peter MD +; Wykypiel, Heinz MD *; Klaus, Alexander MD *; Profanter, Christoph MD *. Annals of Surgery. 234(5):627-632, November 2001.

[13] Mixed Reflux of Gastric and Duodenal Juices Is More Harmful to the Esophagus than Gastric Juice Alone: The Need for Surgical Therapy Re-Emphasized. Werner K. H. Kauer, M.D., Jeffrey H. Peters, M.D., Tom R. DeMeester, M.D., Adrian P. Ireland, M.D., Cedric G. Bremner, M.D., and Jeffrey A. Hagen, M.D. Annals of Surgery Vol. 222, No. 4, 525-5333 ©1995 Lippincott-Raven Publishers

[14] The Cost of Long Term Therapy for Gastro-Oesophageal Reflux Disease: A Randomized Trial Comparing Omeprazole and Open Antireflux Surgery, Julkunen, K Levander, M Lamm, C Mattson, J Carlsson, N O Ståhlhammar and H E Myrvold, L Lundell, P Miettinen, S A Pedersen, B Liedman, J Hatlebakk, R, doi:10.1136/gut.49.4.488 Gut 2001;49;488-494.

[15] Short-term cost effectiveness and long-term cost analysis comparing laparoscopic Nissen fundoplication with proton-pump inhibitor maintenance for gastro-oesophageal reflux disease, R. Cookson1, C. Flood1, B. Koo, D. Mahon, and M. Rhodes, British Journal of Surgery 2005; 92: 700-706 Published by JohnWiley & Sons Ltd, ©2005 British Journal of Surgery Society Ltd

[16] Endoscopic treatment modalities for gastroesophageal reflux disease (GERD), B. H. A. von Rahden and H. J. Stein Department of Surgery, University Hospital, Paracelsus Private Medical University (PMU), Salzburg, Austria Received April 21, 2006; accepted July 17, 2006 © Springer-Verlag 2006, European Surgery.

 

 

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