This is half of a two-part debate — read the opposing argument.
Gastroesophageal reflux disease (GERD) is one of the most common disorders in the U.S., affecting more than 25 million people. Despite the high prevalence of this disease, not much progress has been made in treating it in the last 30 to 70 years. Einstein has been quoted as saying that the definition of insanity is doing the same thing over and over again and expecting a different result. We have had the same medications for the last 30+ years and the same surgery — Nissen fundoplication — for the last 70-plus years, but somehow, we believe that this time our treatment approach will result in better outcomes. I would argue that our treatment of this disease has been an abject failure and borders on insanity.
Admittedly, the surgical treatment of this disease has been fraught with problems and the reputation has been consequently poor. Surgeons, including myself, have been hesitant to acknowledge the complications and side effects associated with our one and only surgery. Richter et al. published a summary of the literature on Nissen showing that mortality rates were reported to be as high as 1 percent in some series with complications such as bowel perforation, bleeding and pneumothorax occurring in up to one to 10 percent of patients. He also reported that as many as 85 percent of patients experienced gas and bloating issues, 24 percent had persistent dysphagia and 62 percent had persistent heartburn despite surgery. Other studies have shown that recurrence rates after Nissen are as high as 20 to 40 percent by 10 years. I must admit that this doesn’t sound like a very attractive option to treat heartburn. I would, however, argue that part of the reason for the poor outcomes with Nissen are due to a lack of specialization in Foregut surgery. Many studies have shown significantly better results when Nissen is performed at specialized centers with high volume in Foregut procedures.
The mainstay of GERD treatment over the years has been medical therapy, but I would argue that this has not impacted this disease either. Despite medical therapy, up to 40 percent of patients will continue to have symptoms mainly due to the medication’s inability to control the regurgitative symptoms. Additionally, patients are increasingly concerned about the long-term safety of proton pump inhibitors (PPIs). Whether or not there is any validity to these concerns is immaterial because patients have access to these reports/publications on the possible long-term side effects, and they are concerned. Lastly, and maybe most importantly, the incidence of Barrett’s has been increasing over the decades, and a recent abstract from ACG showed that the incidence of esophageal adenocarcinoma has increased by 733 percent since 1975. It is the fastest rising cancer of any cancer out there and, at best, there are conflicting data on whether or not PPIs decrease the risk of developing esophageal cancer. Surgery has not impacted this either, but to be honest, nobody is getting surgery for GERD. It is estimated that only 0.4 percent of GERD patients get surgical treatment. With this, and combined with a 20 to 40 percent recurrence rate of reflux after surgery, it will be hard to show any impact on this disease.
So, at the end of the day after doing the same thing for 30 to 70 years, we have one surgery that not many patients want, and medications that patients are increasingly concerned about that don’t control all their symptoms and haven’t impacted this “epidemic” increase in esophageal cancer. It’s time to rethink how we treat this disease, and with Magnetic Sphincter Augmentation (MSA), we finally have another option. MSA is a ring of magnetic beads that is placed around the esophagus at the lower esophageal sphincter (LES) through a minimally invasive surgery that does not disrupt the native anatomy. The force of attraction of the magnetic beads keeps the LES closed, but the force of a swallow, belching or vomiting causes the beads to spread apart, allowing for normal physiologic functions.
“Despite medical therapy, up to 40 percent of patients will continue to have symptoms mainly due to the medication’s inability to control the regurgitative symptoms.”
The MSA received FDA approval over six years ago based on two prospective clinical trials and now has more than 80 publications demonstrating its safety and efficacy, including a randomized control trial (RCT) comparing MSA to PPIs for the control of regurgitative symptoms. In this study, MSA was shown to be significantly better at controlling regurgitative symptoms, with approximately 90 percent improvement with MSA versus 10 percent with PPIs. Additionally, 90 percent of MSA patients had normalization of their impedance pH parameters and significantly better improvement in GERD-Health Related Quality of Life (HRQL) scores than PPIs. It has also been shown in a recent meta-analysis to have equal efficacy to Nissen with significantly less gas and bloat issues and increased ability to belch and vomit.
The safety profile of the procedure has been well studied and MSA appears to have a low complication rate and side effect profile. The most feared complication is that of erosion, but in multiple studies, the erosion rate has consistently been low at 0.4 percent. When it has eroded, the treatment has been to take the device out either endoscopically or laparoscopically. No patient has needed anything more than simple removal. MSA does create dysphagia in the early recovery period in most patients. The dysphagia is self-limiting and usually resolves by three to four months post-operation. Less than 3 percent of patients have needed device removal for persistent dysphagia.
MSA has also been studied in patients with large hiatal hernias and Barrett’s esophagus. These are the patients that probably benefit the most from surgical treatment of their reflux. The barrier to GERD is both the LES function as well as the integrity of the crural diaphragm — the two sphincter hypothesis. So long as the hiatal hernia is repaired, MSA has been shown to control reflux and even induce regression of Barrett’s in some patients with short segment disease.
In conclusion, MSA has been shown to be both safe and effective at restoring the GERD barrier without the side effects of Nissen fundoplication. In my opinion, it is the first-line choice for patients needing surgical treatment of GERD. It is less invasive, does not alter anatomy and is reversible. It clearly normalizes reflux as opposed to simply masking the symptoms as with medical therapy. GERD is a mechanical problem that frequently needs a mechanical solution, and patients should be offered the option of MSA. We can’t keep doing the same thing over and over again expecting a different result. The increase in esophageal cancer confirms that this is not a good approach. Lastly, if we really want to impact this disease and its sequelae, then we need to position this as a specialty and work collaboratively to treat GERD. There are clearly benefits to the patient from a multidisciplinary center of excellence approach to managing this disease.
- The incidence of GERD complications such as esophageal cancer continues to rise despite current treatment options.
- MSA is a safe and effective minimally invasive surgical treatment option for patients with GERD that has less side effects than Nissen Fundoplication.
- MSA can be used in patients with hiatal hernias and Barrett’s as long as the hiatal hernia is repaired.
Disclosures: Dr. Lipham has consulted for Torax Medical Inc.