© Springer International Publishing AG 2018Eytan Bardan and Reza Shaker (eds.)Gastrointestinal Motility Disorders doi.org/10.1007/978-3-319-59352-4_12
12. I Am Tired of Taking Pills for My Reflux, What Else Can I Do? Surgical and Endoscopic Treatment for GERD
Department of Surgery, Medical College of Wisconsin, Milwaukee, WI, USA
KeywordsAntireflux surgeryFundoplicationGERDMagnetic sphincter augmentationEndoscopic GERD treatment
Question: “I heard that laparoscopic Nissen fundoplication is only temporary—that the surgery eventually falls apart in most people and needs to be redone. I also heard that there are a lot of side effects and I won’t be able to belch or vomit. Is that true?”
Durability, side effects, and symptomatic outcomes of laparoscopic fundoplication for GERD.
Response to a patient: It is true that a fundoplication when performed for GERD can loosen or come apart in some people. In general, only about 5–10% of people who undergo a fundoplication eventually need to have another surgical procedure because their fundoplication failed. There are some known risk factors for fundoplication failure including vomiting in the first month after surgery and severe obesity. There is also a technical component, and experienced antireflux surgeons likely have lower rates of failure than surgeons who rarely perform this procedure. A good evaluation and workup prior to surgery are important to ensure good results and limit side effects. When done properly, in a patient who has had an appropriate preoperative workup, and by an experienced surgeon, the risk of severe side effects of a fundoplication is minimal. Contrary to what you may have heard, most patients retain their ability to belch and even vomit after a properly constructed fundoplication. Most patients who undergo laparoscopic fundoplication report high rates of satisfaction and a better quality of life than they had before surgery.
Brief Review of the Literature
Current estimates suggest that GERD affects around 10–20% of adults in Western countries on a daily or weekly basis . Up to 50% of patients with GERD may require chronic pharmacologic therapy . Long-term GERD pharmacotherapy is expensive with an estimated annual cost in the USA of $11 billion . Proton pump inhibitors (PPIs) have been linked via retrospective studies to increased risk of enteric infections including Clostridium difficile -associated diarrhea, community-acquired pneumonia, bone fracture, nutritional deficiencies, kidney failure, myocardial infarction, dementia, and interference with metabolism of antiplatelet agents [4–6]. It is estimated that as many as 40% of patients with GERD suffer from persistent symptoms despite aggressive acid suppression therapy [7–9]. As a result, 20–40% of patients are dissatisfied with medical GERD treatment and might ask “I am tired of taking pills for reflux—what else can I do?” .
Surgical procedures for GERD are typically considered in patients with symptoms despite optimal PPI therapy, in patients who don’t tolerate or don’t want to rely on medications, and in patients with severe GERD. Surgery is used, however in less than 1% of eligible GERD patients, and its usage has been decreasing over the last decade . Laparoscopic Nissen fundoplication is the most commonly performed antireflux operation. The laparoscopic approach to fundoplication was introduced and popularized in the 1990s. The surgical technique involves a complete hiatal dissection with mobilization of the esophagus and fundus, re-approximation of the diaphragmatic crura, and creation of a 360-degree wrap of fundus around the distal esophagus. Laparoscopic Nissen fundoplication can be accomplished in 2 h or less for uncomplicated cases. Most patients stay in the hospital for 1–2 days. Many surgeons have their patients gradually transition from a soft or pureed diet to a more solid diet over the course of 2–8 weeks. Relief of symptoms, especially esophageal symptoms such as heartburn and regurgitation, occurs in >90% of patients and has been demonstrated to be durable beyond 10 years for the majority of patients [12, 13]. Potential surgical side effects following Nissen fundoplication include difficulty swallowing, increased flatus, bloating, early satiety, and inability to vomit or belch [14, 15]. Anatomic failure of the fundoplication with recurrent GERD can occur in 2–17% of cases .
The published outcomes of antireflux surgery are not always replicated in the community, especially for surgeons who perform laparoscopic antireflux surgery infrequently [17, 18]. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has published a Guidelines for Surgical Treatment of Gastroesophageal Reflux Disease. According to this document “The standardization of antireflux surgery technique is highly desirable, as it has been shown to lead to good postoperative patient outcomes (Grade A). Like any other surgical procedure, laparoscopic antireflux surgery is subject to a learning curve, which may impact patient outcomes. Therefore, surgeons with little experience in advanced laparoscopic techniques and fundoplication in particular should have expert supervision during their early experience with the procedure to minimize morbidity and improve patient outcomes (Grade B)” . Concerns related to potential side effects, recurrent GERD, and repeat surgery following laparoscopic Nissen fundoplication likely play a role in the fact that most patients who meet indications for antireflux surgery never undergo this procedure.
The laparoscopic fundoplication will continue to play a major role in the surgical treatment of GERD. The current high prevalence of GERD across the USA is unlikely to change anytime soon. Patients and providers alike are increasingly aware of many of the drawbacks of long-term acid suppression with PPIs and are seeking alternative treatments. An increasing array of options for addressing medically refractory GERD including gastric bypass in the obese, magnetic sphincter augmentation, and even endoscopic treatments of GERD will likely paradoxically increase the incidence of fundoplication surgery in this author’s opinion. Treatment for GERD can be tailored to the patient’s individual physiology, symptom profile, and treatment goals in a way that will get patients, primary care providers, and gastroenterologists to consider something other than chronic and indefinite medical therapy, as is so often the case today.
With regard to fundoplication, new technologies such as the EndoFLIP (Endoluminal Functional Lumen Imaging Probe ) may help surgeons to create a more consistent fundoplication least likely to result in side effects. Fundoplication surgery in the modern era is still very much of a subjective art. A better understanding of the mechanisms of failure and the advanced technologies available prior to considering antireflux surgery in a given patient will also likely contribute to better and more durable outcomes.
Question: “What about the magnetic sphincter augmentation device for GERD? Is this a better choice than a fundoplication?
Response to Patient: Surgery to implant a magnetic sphincter augmentation device , also known as a LINX device, is an alternative to traditional antireflux surgery. The LINX device is an implantable medical device that is placed around the junction between the esophagus and the stomach to augment or increase the competence of the lower esophageal sphincter in patients with GERD. Surgery to implant the device is performed laparoscopically (small incisions) and generally takes less than an hour. Many surgeons send their patients home the same day. Compared to a Nissen fundoplication, placement of the LINX device is technically easier and less invasive. The magnetic sphincter augmentation (MSA) device has been shown to lead to very high rates of resolution of severe GERD symptoms and high rates of patient satisfaction. Compared to a Nissen fundoplication, patients who undergo placement of a MSA device preserve the ability to belch and report low rates of bloating. The LINX device has been demonstrated to be very safe as well. Since the FDA approved this device in 2012, very-long-term follow-up is still not available, although results in patients who have had the device in place for 5 years or more have been excellent. Some patients are not appropriate for the LINX device including patients with a body mass index well over 35 kg/m2 (obese), patients with very large hiatal hernias, and patients with very poor esophageal motility. For many patients, the LINX device is a better choice than a fundoplication, especially when they are concerned about developing bloating and difficulty belching as a result of antireflux surgery. The most commonly reported side effect of MSA is dysphagia—difficulty or discomfort in swallowing. While dysphagia is common immediately after surgery, it goes away in most MSA patients.
Brief Review of Literature
The LINX® Reflux Management System (Torax Medical, Inc., Shoreview, MN, USA) is comprised of a small expandable ring of linked magnetic beads. The device is laparoscopically implanted around the esophagus at the esophagogastric junction to mechanically augment the function of the lower esophageal sphincter for the treatment of GERD. The LINX Reflux Management System is based on the premise that a device placed around the lower esophageal sphincter (LES) can assist, or augment, an incompetent LES to maintain a closed position when challenged by gastric reflux. The LINX System is indicated for patients diagnosed with GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite medical therapy for the treatment of reflux. The LINX System is not intended for use in patients with suspected or known allergies to metals such as iron, nickel, titanium, or stainless steel. The current generation of the device is compatible and safe with an MRI up to 1.5 Tesla. The LINX device is currently not recommended in patients with a hiatal hernia greater than 3 cm, in patients with a body mass index greater than 35 kg/m2, in patients with inefficient esophageal motility, or in patients with moderate to severe baseline dysphagia.
Review of published studies suggests that magnetic sphincter augmentation is safe with no reported deaths and a 0.1% rate of intra/perioperative complications . Long-term efficacy of LINX appears good for typical GERD symptoms with reduced acid exposure, improved GERD symptoms, and freedom from PPI in 85–88% at 3–5 years [21–23]. The most common side effect is dysphagia, the rate of which likely differs based on definition and patient population. Early dysphagia within the first few weeks is common at about 70% . Dysphagia resolves in most patients and the incidence is roughly 10% at 1 year and 4% at 3 years . The need for endoscopic dilation ranges from 6 to 12% [20, 25] and the primary reason for explanation appears to be persistent dysphagia with a rate in larger series of about 3%. Erosion appears rare with one reported in the first 1000 patients , one additional published case report , and several additional reports in the FDA MAUDE dataset (true number unknown, as multiple entries in this dataset may be made for each patient). Based on limited literature, erosion can be successfully treated with explanation.
There are several publications comparing clinical outcomes of the LINX device to laparoscopic Nissen fundoplication. Perioperative outcomes, symptom control, side effects, adverse events, and pH studies were compared in 34 consecutive patients who underwent LINX to 32 consecutive patients who had laparoscopic Nissen fundoplication . Operative time was longer for fundoplication. At 6 months, scores on the Gastroesophageal Reflux Disease Health Related Quality of Life scale improved from 20.6 to 5.0 for LINX vs. 22.8 to 5.1 for fundoplication. Postoperative DeMeester scores (14.2 vs. 5.1, p = 0.0001) and the percentage of time pH was less than 4 (4.6 vs. 1.1; p = 0.0001) were normalized in both groups but statistically different. LINX resulted in improved gassy and bloated feelings (1.32 vs. 2.36; p = 0.59) and enabled belching in 67% compared with none of the fundoplication patients. The investigators determined that LINX results in similar GERD symptom control with an improved quality of life compared to fundoplication.
An analysis of a prospective, multicenter registry of patients to undergo LINX and laparoscopic fundoplication for GERD was also reported . There were 202 LINX and 47 fundoplication patients with 1-year follow-up data at the time of analysis. The fundoplication group was older with a greater frequency of large hiatal hernia and Barrett’s esophagus. GERD health-related quality-of-life score improved following surgery for both procedures. Moderate or severe regurgitation improved from 58.2 to 3.1% after LINX and 60.0 to 13.0% after fundoplication (p = 0.014).
Proton pump inhibitor medications were discontinued in 82% of LINX and 63% of fundoplication patients (p = 0.009). Excessive gas and abdominal bloating were reported by 10% of LINX and 32% of fundoplication patients (p ≤ 0.001). The authors of this study concluded that antireflux surgery should be individualized to the characteristics of each patient, taking into consideration anatomy and side effects. They felt that both LINX and fundoplication showed significant improvements in reflux control, with similar safety and reoperation rates.
In another comparative study, from a series of 62 LINX and 117 laparoscopic Nissen fundoplications, 50 patients in both groups were matched using the “best-fit” model incorporating numerous preoperative variables . At 1 year after surgery, both groups had similar GERD health-related quality-of-life scores and proton pump inhibitor use. There were no patients with severe gas and bloating in the LINX group compared with 10.6% in the fundoplication group (p = 0.022). More fundoplication patients were unable to belch (8.5% of LINX and 25.5% of fundoplication; p = 0.028) or vomit (4.3% of LINX and 21.3% of fundoplication; p = 0.004). The incidence of postoperative dysphagia was similar between the groups. The authors concluded that analogous GERD patients had similar control of reflux symptoms with a lower incidence of gas bloat in LINX.
A comparative, multi-institutional retrospective cohort study of patients with GERD undergoing either LINX or laparoscopic Nissen fundoplication was recently published . Comparisons were made at 1 year for the overall group and for a propensity-matched group. There were 201 LINX and 214 fundoplication patients that were similar preoperatively with regard to age, gender, and GERD-HRQL scores . Obesity, dysphagia, higher DeMeester scores , Barrett’s esophagitis, and hiatal hernias were more prevalent in the fundoplication patients. Propensity-matched cases showed similar GERD-HRQL scores and the differences in ability to belch or vomit, and gas bloat persisted in favor of LINX. Mild dysphagia was higher for LINX (44% vs. 32%). Resumption of daily PPIs was higher for LINX (24 vs. 12, p = 0.02) with similar patient-reported satisfaction rates.
The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee published a Safety and Efficacy analysis of the LINX device in 2013 . They concluded that the device is both safe and effective, and should be an option for patients suffering from medically refractory GERD. In fact, in November of 2015, the American Medical Association awarded the LINX device a new Category 1 CPT (Current Procedural Terminology ) code that will be effective from January 1, 2017. To be awarded a category 1 CPT code, a device and associated procedure must be performed often and by many physicians across the country. The published, peer-reviewed literature must support clinical efficacy of the procedure as well.
As mentioned in the previous section, surgery for GERD is performed on a small portion of patients who would qualify. Magnetic sphincter augmentation is gradually becoming a more commonly performed procedure. Part of the reason for a relatively slow ramp-up of this procedure since FDA approval in 2012 (estimated 4000–5000 devices implanted worldwide by 4 years after initial FDA approval) is poor insurance coverage for the procedure. The creation of a category 1 CPT code should greatly improve access to this technology for patients with GERD. It is likely that the proportion of patients with medically refractory GERD to opt for surgery will increase overall.
Currently the LINX device has not been carefully studied in patients with hiatal hernias greater than 3 cm in size and in patients with Barrett’s esophagus. It is likely that with increasing experience, the outcomes of LINX in these patients will be demonstrated to be acceptable and safe. Patients with medically refractory GERD after bariatric surgery (especially sleeve gastrectomy ) may also be able to attain relief from their GERD symptoms with magnetic sphincter augmentation. Further study in these areas and for these indications is ongoing.
Question: “What proven endoscopic treatments are available to treat my reflux?”
Response to patient: Endoscopic procedures to address medically refractory GERD have been around for many years—with the FDA approving the first endoscopic device for GERD in 2000. Many different devices have come and gone over this time. There are currently two devices available on the market with some data to support their safety and efficacy. One of these devices endoscopically creates a reflux barrier similar to a fundoplication and is known as the transoral incisionless fundoplication (EsophyX ; TIF, Endogastric Solutions). The other device delivers radiofrequency energy to the lower esophageal sphincter and is known as the Stretta Procedure (Mederi Therapeutics).
The Stretta procedure has been around for the longest period of time. The Stretta system delivers radiofrequency energy to the muscle between the stomach and esophagus. The procedure likely works by inducing scarring and fibrosis of the esophagus near the sphincter leading to an improved barrier function and fewer reflux events. According to the company website, Stretta has been proven safe and effective in more than 37 clinical studies and 18,000 procedures. Stretta received its initial FDA approval in 2000.