COMMENTARY

Antireflux Surgery in the Era of Proton-Pump Inhibitors

Joel E. Richter, MD

Disclosures

December 15, 2003

Gastroesophageal reflux disease (GERD) is the most common disease in the United States, affecting approximately 20% of the American population.[1] Frequently it leads to complications such as esophagitis, peptic strictures, and ulcers; Barrett's esophagus and aspiration associated with asthma; or ear, nose, and throat complaints. Surgery offers the opportunity to cure the disease by reducing the hiatal hernia back into the abdomen, tightening the crural diaphragm, and improving lower esophageal sphincter (LES) function with a fundoplication using the proximal stomach. Antireflux surgery can now be done laparoscopically with minimal hospital stay and rapid return to work in 5-10 days. Therefore, there is increased enthusiasm among patients and the surgical community for the wider use of this operation. In fact, recent data suggest that nearly 80,000 operations a year are being done.[2] With the availability of 5 effective proton-pump inhibitors (PPIs) and now an over-the-counter PPI, how does the physician decide between long-term medical therapy and antireflux surgery?

The Table summarizes the most common indications for antireflux surgery since the widespread use and acceptance of the PPIs.

Truly "intractable" GERD cases are rare; PPI failure suggests that GERD is the wrong diagnosis, noncompliance with drug therapy may be the problem, or that one is dealing with the unusual patient who cannot metabolize drug and obtain adequate blood levels. Rather, the favorable response to PPIs helps identify the patients who will do best after antireflux surgery.[3] Furthermore, everyone treating these patients must realize that direct-comparison studies now find equal efficacy for both the PPIs and surgery in the long-term relief of symptoms, healing of esophagitis, need for stricture dilation, and control of Barrett's esophagus.[4] The skill of the physician treating the patient then becomes paramount. Obviously, no particular expertise is required for prescribing PPIs; morbidity associated with their use has proven trivial to nonexistent (ie, very rare side effects and no carcinoid tumors in humans after 15 years of follow-up), and their use has no irreversible attributes. Unfortunately, the same cannot be said about antireflux surgery. Dysphagia, gas bloat, excessive flatus, and diarrhea are frequent postoperative complications. Mortality is very rare, but occurs in 0.1% to 0.2% in large series. Recurrent symptoms and esophagitis occur in 10% to 60% of patients, after 5- to 20-year follow-ups.[2] Finally, the best surgical results are presented from academic centers with highly trained esophageal surgeons. In contrast, the majority of antireflux operations are being done by general surgeons in community hospitals.[5] Both sides of these arguments deserve discussion with our patients, as do concerns about cost, compliance with drug regimens, and fears about long-term safety issues with the PPIs, since we only have safety data up to 15 years.

Cost is frequently argued as a factor favoring antireflux surgery in the long-term management of healthy adults who will have to suffer with their disease for 20-50 years. Considering the current cost of prescription PPIs, maintenance medical treatment will eventually approach the initial cost of antireflux surgery ($10,000 -$15,000) in 5-10 years.[6] However, these analyses are far more complicated than they appear initially. There are numerous hidden costs for both medical and surgical therapy. For example, patients doing poorly on medical therapy will require further diagnostic tests and physician visits. Additionally, 20% to 25% of patients treated medically will require double- and triple-dose PPIs to control their symptoms and keep their esophagitis healed.[7] However, most patients having antireflux surgery should have a thorough preoperative evaluation, which medical patients do not require before beginning long-term medical therapy. This evaluation will usually include a barium esophagram, esophageal manometry, 24-hour pH testing, and, often, gastric function tests. Some patients do not respond to antireflux surgery, whereas others have the previously discussed complications. If the success of surgery is less than lifelong, which now appears to be the case in 20% to 50% of patients,[2,8] additional medical/surgical therapy will be necessary. Finally, none of these scenarios considers the impact of generic and over-the-counter PPIs, which have become a reality in 2003. For example, even some of the most favorable models for surgery find PPIs to be the preferred cost-effective approach when the price of medication falls below $30 per month.[9] Overall, cost comparisons of long-term medical vs surgical therapy for GERD are far too complicated and rapidly evolving to make a comprehensive statement in favor of either therapy. In reality, many of our patients decide for or against antireflux surgery depending upon the cost that they personally incur because of their insurance or healthcare plan, as well as their level of satisfaction with medical treatment based upon symptom relief, quality of life, and convenience of their medical regimen.

Over the last 15 years, increasing attention has focused on the supraesophageal presentations of GERD, including chest pain, asthma, aspiration pneumonia, and a variety of ear, nose, and throat symptoms and signs including hoarseness, globus, cough, sore throat, vocal cord granulomas and polyps, and even laryngeal cancer. These patients may be difficult to identify because 20% to 50% have "silent GER" without classic symptoms of heartburn and acid regurgitation, and barium radiographs and endoscopy are frequently normal. Prolonged 24-hour pH testing is the best method to identify the coexistence of GER with these supraesophageal complaints, but the pattern of reflux or symptom correlation scores do not guarantee causality. This is because these patients may have multiple triggers for their supraesophageal symptoms aside from acid reflux. These patients do not predictably respond to PPI therapy; therefore, it should not be surprising that antireflux surgery is less reliable for patients with supraesophageal symptoms than for patients with typical heartburn. For example, a recent series reported 150 consecutive patients undergoing laparoscopic antireflux surgery, of which 35 patients (23%) had primarily atypical symptoms.[10] Surgery relieved heartburn in 94% of patients whereas only 56% of patients had relief of their supraesophageal complaints. The only useful preoperative predictors of relief of supraesophageal symptoms were the response to aggressive acid suppression with PPIs and the presence of hypopharyngeal reflux on pH testing in patients with laryngeal complaints. Therefore, we should inform patients considering antireflux surgery for supraesophageal symptoms that their complaints may be no better after surgery than they are while taking high doses of PPIs.

Despite the use of PPIs, some patients continue to have volume reflux with aspiration symptoms after meals and at night. Many of these patients complain that the "fire is gone" but they still have intermittent reflux of fluid with a bitter taste in the mouth. These patients are usually found to have low LES pressures and sometimes coexisting gastroparesis, resulting in constant volume reflux unless the stomach is completely empty. Esophageal pH testing and the new impedance testing, which measures both acid and nonacid reflux, can be helpful in making this sometimes-difficult diagnosis. Only antireflux surgery can help these patients by reconstructing their weak LES sphincter.

Over the last 5-10 years, the surgical literature has been enthusiastic that antireflux surgery promotes regression of Barrett's esophagus and can therefore decrease the risk of dysplasia and cancer. How might antireflux surgery be protective against esophageal cancer? Both acid and bile reflux occur in increasing amounts across the spectrum of GERD, especially in patients with Barrett's esophagus.[11] Proponents of the "dangers of bile reflux" argue that medical therapy only reduces the acid component of reflux, while the barrier created by antireflux surgery prevents reflux of both acid and duodenal contents. However, recent studies found that omeprazole is equally effective in decreasing both acid and bile reflux, the latter measured by the new Bilitec system.[11,12] The protective effects of the PPIs likely results from 2 mechanisms: reducing the gastric volume available for reflux into the esophagus and raising intragastric pH causing the harmful conjugated bile acids to precipitate out of solution. Although several surgical series suggest that the incidence of Barrett's-related cancer is reduced by surgery, the topic is quite controversial. For example, the recent 10-year prospective VA study follow-up found no significant difference between cancer risk after medical or surgical treatments.[8] Additionally, a large population-based retrospective study from Sweden showed that antireflux surgery does not guarantee a decreased risk of adenocarcinoma.[13] In fact, more patients who had antireflux surgery developed adenocarcinoma (14.1%) than patients who only had medical treatment of their GERD (6.3%). At this time, the protective effects of antireflux surgery in Barrett's esophagus are only speculative, but this area deserves close observation, and studies are essential in which the 2 cohort groups are equally matched for risk factors and followed over extended periods of time. Until that time, the dangers of bile reflux seem a needless scare tactic to promote surgery while attempting to counterbalance widespread use of PPIs, when in reality the number of antireflux operations has markedly increased rather than decreased over the years.

How can we help our patients who have severe GERD choose between prolonged medical therapy and surgery? At the Cleveland Clinic, all patients with severe disease are evaluated by both gastroenterologists and surgeons. If acid reflux is causing the patient's symptoms, we are convinced that all of these patients can get symptomatic relief and healing of esophagitis with the currently available treatments. However, there are benefits and risks to both medical and surgical treatments, and long-term issues are unresolved for both therapies. Medical treatments, especially PPIs, can effectively treat all forms of GERD, and the efficacy of these medications does not wane over time in studies up to 15 years. However, many patients will require daily lifelong medications, which are expensive and whose long-term risks are, frankly, not known. Surgery offers a unique opportunity to "cure" this chronic disease; this is dependent upon the diagnosis being correct and the procedure being performed by an experienced surgeon. Paradoxically, the best surgical candidates are the patients who respond completely to PPIs -- I would encourage my surgical colleagues not to break this "golden rule." On the downside, aggravating postoperative complications may occur in up to 25% of patients, and the long-term durability of both open and laparoscopic antireflux surgery is now suspect.[13] This issue of surgical durability vs long-term safety of PPIs is especially a critical issue for young people with chronic GERD. We take the approach of openly discussing both options with our patients and allowing them to make informed decisions. This way, patients are proactive in their treatment, usually happy with the results, and are not surprised, disappointed, or angry if complications or relapses occur.

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