Antireflux surgery has become a well-established therapy for gastroesophageal reflux disease (GERD) and its complications. The popularization of minimally invasive surgical techniques has brought about a revolution in the use of fundoplication for the long-term management of GERD. A reliable and objective understanding of the outcomes following fundoplication is important for all physicians treating GERD, so that informed decisions can be made regarding the optimal treatment strategy for a given patient. With ongoing study, the appropriate indications for surgical intervention among the array of potential antireflux therapies will continue to be elucidated.
Key points
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Antireflux surgery has become a well-established therapy for gastroesophageal reflux disease and its complications.
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Minimally invasive surgical techniques have revolutionized the use of fundoplication.
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Surgical outcomes are highly dependent on appropriate and thorough preoperative patient evaluation.
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Foregut diagnostics and surgical techniques continue to be refined.
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Laparoscopic fundoplication has compared favorably to medical therapy long term.
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Laparoscopic fundoplication remains the gold standard to which evolving endoscopic and surgical technologies for control of gastroesophageal reflux disease must be compared.
Introduction
Over half a century has passed since Rudolph Nissen first reported the use of fundoplication for the treatment of gastroesophageal reflux disease (GERD). In the ensuing years, antireflux operations by a variety of methods have proven effective and durable in the control of GERD and its various manifestations. Surgical therapy for GERD was subsequently revolutionized by the introduction and popularization of minimally invasive operative techniques in the early 1990s. Today, laparoscopic Nissen fundoplication (LNF) is the most commonly performed antireflux procedure (ARP) and remains the “gold standard” against which other operative interventions are compared.
The indications for surgery, preoperative evaluation, and techniques of fundoplication have been refined, leading to favorable outcomes as assessed by both subjective and objective parameters in most appropriately selected candidates. The availability of a laparoscopic approach to fundoplication, coupled with the excellent long-term control of symptoms afforded by such procedures, has made antireflux surgery an attractive alternative for the management of GERD. On the other hand, surgery has the potential for morbidity, is costly, and can be associated with a suboptimal outcome in a minority of patients. Recent data suggest that the peak use of antireflux surgery in the United States occurred in 1999, with an estimated 15.7 cases per 100,000 adults at that time. Since then, the frequency of antireflux surgery has declined, such that an estimated 11 ARPs were performed per 100,000 adults in 2003, a 30% reduction. In a separate analysis of the National Inpatient Sample database, the use of antireflux operations decreased 40% between 2000 and 2006. These declines may reflect the widespread use of prescription medications, over-the-counter proton pump inhibitors (PPIs) and other acid suppressive medications, as well as concerns about both the durability of surgical repair and the potential for long-term postoperative side effects. Given the various treatment options for GERD, each with their potential advantages and shortcomings, accurate and current data regarding outcomes of antireflux surgery are necessary as a basis against which other established and novel therapies must be judged. The purpose of this article is to review the contemporary literature regarding the optimal work-up and patient selection for antireflux surgery, as well as to assess the data regarding both short-term and long-term symptomatic and objective outcomes.
Introduction
Over half a century has passed since Rudolph Nissen first reported the use of fundoplication for the treatment of gastroesophageal reflux disease (GERD). In the ensuing years, antireflux operations by a variety of methods have proven effective and durable in the control of GERD and its various manifestations. Surgical therapy for GERD was subsequently revolutionized by the introduction and popularization of minimally invasive operative techniques in the early 1990s. Today, laparoscopic Nissen fundoplication (LNF) is the most commonly performed antireflux procedure (ARP) and remains the “gold standard” against which other operative interventions are compared.
The indications for surgery, preoperative evaluation, and techniques of fundoplication have been refined, leading to favorable outcomes as assessed by both subjective and objective parameters in most appropriately selected candidates. The availability of a laparoscopic approach to fundoplication, coupled with the excellent long-term control of symptoms afforded by such procedures, has made antireflux surgery an attractive alternative for the management of GERD. On the other hand, surgery has the potential for morbidity, is costly, and can be associated with a suboptimal outcome in a minority of patients. Recent data suggest that the peak use of antireflux surgery in the United States occurred in 1999, with an estimated 15.7 cases per 100,000 adults at that time. Since then, the frequency of antireflux surgery has declined, such that an estimated 11 ARPs were performed per 100,000 adults in 2003, a 30% reduction. In a separate analysis of the National Inpatient Sample database, the use of antireflux operations decreased 40% between 2000 and 2006. These declines may reflect the widespread use of prescription medications, over-the-counter proton pump inhibitors (PPIs) and other acid suppressive medications, as well as concerns about both the durability of surgical repair and the potential for long-term postoperative side effects. Given the various treatment options for GERD, each with their potential advantages and shortcomings, accurate and current data regarding outcomes of antireflux surgery are necessary as a basis against which other established and novel therapies must be judged. The purpose of this article is to review the contemporary literature regarding the optimal work-up and patient selection for antireflux surgery, as well as to assess the data regarding both short-term and long-term symptomatic and objective outcomes.
Indications
In the era of “open” surgery before 1990, the need for a laparotomy or thoracotomy limited the use of fundoplication to patients manifesting only the most severe complications of GERD, such as refractory esophagitis, esophageal stricture, or repetitive aspiration. The introduction of less invasive surgical approaches brought an expansion of the indications for operative repair to include patients with longstanding symptoms and no complications seeking an alternative to life-long acid suppression therapy. A medical position statement on the management of GERD published by the American Gastroenterological Association in 2008 recommended that antireflux surgery be considered an option (1) when a patient with an esophageal GERD syndrome is responsive to, but intolerant of, acid suppressive therapy (grade A recommendation); (2) for patients with an esophageal GERD syndrome who have persistent troublesome symptoms, especially troublesome regurgitation, despite PPI therapy (grade B recommendation); (3) for patients with an extraesophageal GERD syndrome with persistent troublesome symptoms despite PPI therapy (grade C recommendation).
The evaluation for antireflux surgery commences with a thorough history emphasizing the patient’s reflux symptoms and response to antisecretory and promotility therapy. The presence of both “typical” reflux symptoms, such as heartburn, regurgitation, or dysphagia, as well as “atypical” symptoms that might be attributable to GERD, such as cough, wheezing, hoarseness, shortness of breath, or sore throat, is noted. Because there are fewer potential mechanisms for their generation, typical symptoms are more likely to be secondary to pathologic gastroesophageal reflux than are atypical symptoms. The patient must be made aware of the relatively diminished probability of success of antireflux surgery when atypical symptoms are the primary factors driving intervention, in that other contributors may persist. Also relevant is the longer time frame anticipated for respiratory symptoms to improve after surgery compared with typical symptoms.
Symptomatic response to acid suppression medications is of importance as it can predict relief following surgery. A paradox of patient referral for an ARP is that patients well controlled on medical therapy, who may be among the best candidates for surgery, often are not sent for a surgical opinion. On the other hand, those patients who do not respond to medical therapy and, therefore, may not respond well to surgery, frequently are referred for surgical therapy. A detailed objective evaluation for the presence of pathologic gastroesophageal reflux is particularly important in the latter group, as well as a careful determination of whether the patient’s main complaints are reflux-related. The surgeon needs to be aware of primary symptoms, such as nausea, early satiety, epigastric pain or bloating, that may be indicative of foregut pathologic abnormality and may even occur in the presence of excessive esophageal acid exposure, although may not be caused by gastroesophageal reflux per se. Persistent symptoms despite PPI use, PPI dose escalation, young age with concerns over chronic PPI use, nocturnal regurgitation, and chronic cough are common reasons for surgical referral.
Other historical factors of interest include the presence of asthma, other pulmonary disease (eg, recurrent aspiration/pneumonia, “idiopathic” pulmonary fibrosis, or interstitial lung disease), concomitant cardiac disease, exercise tolerance, and prior surgical procedures involving the abdomen, chest, or neck. Physical examination should include the patient’s body habitus and weight, detailed assessment of the lungs, documentation of surgical scars, as well as an overall assessment of functional status. Obesity and extensive prior upper abdominal surgery are relative indications for a transthoracic approach to fundoplication in the hands of some surgeons, whereas a thoracotomy is generally avoided in elderly persons or in a patient of poor functional status. In the setting of morbid obesity, whether fundoplication or a bariatric procedure such as Roux-en-Y gastric bypass is the preferable operation to control reflux is a matter of ongoing study. Many surgeons favor the latter option because of the questionable durability of a fundoplication in the setting of morbid obesity as well as the multiple non-GERD-related health benefits derived from weight loss following gastric bypass.
Anatomic Factors
In addition to patients who are severely symptomatic from GERD, other individuals commonly referred for consideration of antireflux surgery are those with a paraesophageal hernia (PEH) and intrathoracic stomach. The traditional recommendation, dating back to a landmark article by Skinner and Belsey from 1967, had been to repair all such large hernias at the time of diagnosis. In that report, the risk of fatal complications from an untreated, minimally symptomatic PEH was found to be 29% over the patient’s lifetime, a rate thought high enough to justify operative intervention.
With increasing experience, however, the observation has been made that the risk of leaving asymptomatic or minimally symptomatic PEHs uncorrected is not nearly that high. In addition, the repair of such hernias is not without risk of morbidity or mortality, especially in light of the demographics of this condition. Patients presenting with PEH are commonly elderly, kyphotic and possessing significant comorbidities. Finally, the long-term success rate after repair of large hernias is not as good as following repair of smaller, sliding hiatal hernias or after operation for GERD without an associated hiatal hernia. This fact deserves emphasis, in that the outcomes of all patients undergoing fundoplication tend to be lumped together and, perhaps, has been a mitigating factor against referral of patients for fundoplication to control GERD. Many centers, including ours, are seeing an increasing proportion of patients with PEH referred for fundoplication, a trend that may negatively impact overall surgical outcomes.
Another point worthy of emphasis is that most studies of novel endoscopic or alternative minimally invasive therapies for GERD have excluded cohorts of patients with symptomatic, functional, or anatomic factors that might preclude effective reflux control through such approaches. Clinical trials of investigational antireflux therapies have, by and large, included only study subjects with uncomplicated GERD and typical symptoms of heartburn and regurgitation that have responded to medical therapy. Patients with severe anatomic derangements, such as esophageal strictures, persistent esophagitis, Barrett’s esophagus, or sizable hiatal hernias, as well as those with severe motility disorders or significant comorbidities, are excluded from such investigations. Similarly, patients who have demonstrated a poor response to medical therapy and those with primarily extraesophageal manifestations of GERD have not been studied. These factors must be kept in mind as one compares outcomes following a fundoplication to those reported for novel endoscopic or surgical therapies; the patients expected to have the worst outcomes generally are excluded from trials of the latter.
Preoperative evaluation
An appropriate and thorough evaluation of patients considered for antireflux surgery is of paramount importance. The proof of pathologic gastroesophageal reflux, as well as the characterization of associated abnormalities in foregut structure and function, is critical to a successful surgical outcome. Likewise, inadequate or inaccurate preoperative evaluation can be a major contributor to a poor outcome following an antireflux repair. Three factors have emerged as being most predictive of a successful symptomatic outcome after antireflux surgery: the presence of typical symptoms of GERD (heartburn or regurgitation), symptomatic improvement in response to acid suppression therapy before surgery, and an abnormal score on ambulatory esophageal pH monitoring, with an abnormal score on ambulatory esophageal pH monitoring being of greatest importance. Each of these factors helps to establish that GERD is, indeed, the cause of the patient’s symptoms, although they have little relationship to the severity of the underlying disease.
The goals of preoperative evaluation for potential antireflux surgery are provided in Box 1 . The most common preoperative diagnostic studies include the following:
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Video esophagography;
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Flexible upper gastrointestinal endoscopy;
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Stationary esophageal manometry;
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Ambulatory esophageal pH monitoring.
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Elucidation of all symptoms that might be attributable to GERD, as well as symptoms potentially attributable to associated foregut abnormalities;
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Assessment of comorbidities that might impact candidacy for surgery, the surgical approach, and perioperative complications;
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Objective confirmation of the presence of GERD;
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Appreciation of associated anatomic abnormalities (eg, Barrett’s esophagus, shortened esophagus, esophageal stricture, large sliding or paraesophageal hiatal hernia);
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Assessment of associated functional abnormalities of the foregut;
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Estimation of the probability of a successful symptomatic response to surgical therapy;
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Planning the type of fundoplication, the operative approach (laparoscopic, open transabdominal, or transthoracic), and the likelihood of needing to perform an esophageal lengthening procedure (Collis gastroplasty).
Further investigations, in particular, gastric-emptying scans or impedance monitoring, are added depending on the findings of standard testing and the presence of symptoms that warrant additional study.
Most of the preoperative studies have been well described and are established in common clinical practice. A few newer technologies have emerged that deserve emphasis in terms of their applicability to patients being considered for an ARP.
High-Resolution Manometry
The introduction of high-resolution manometry (HRM) into clinical practice in 2000 (ManoScan 360 ; Given Imaging, Duluth, GA), along with the development of sophisticated algorithms to display the expanded data set as esophageal pressure topography plots, has transformed conventional esophageal manometry from an analysis of wave tracings to an image-based paradigm assisted with color enhancements ( Fig. 1 ). Just as high-definition television has made standard-definition broadcasting seem antiquated, HRM has made conventional manometry (CM) seem obsolete.