In this podcast, Luigi Bonavina, MD, talks about his team's latest study that investigated a novel approach, called magnetic sphincter augmentation with the LINX system, to reducing gastroesophageal reflux disease (GERD) symptoms and the need for proton-pump inhibitor therapy.
Additional Resource:
- Longest study of magnetic sphincter augmentation shows durable efficacy of linx® reflux management system. News release. Ethicon. Cincinnati, Ohio. November 10, 2020. https://www.jnjmedicaldevices.com/en-US/news-events/longest-study-magnetic-sphincter-augmentation-shows-durable-efficacy-linx-reflux
Luigi Bonavina, MD, is a professor of surgery at the University of Milan and chief of general and foregut surgery at the Policlinico San Donato in Milan, Italy.
TRANSCRIPT:
Amanda Balbi: Hello everyone, and welcome to another installment of Podcasts360—your go-to resource for medical news and clinical updates. I’m your moderator, Amanda Balbi with Consultant360 Specialty Network.
Gastroesophageal reflux disease (or GERD) is one of the most common gastrointestinal disorders worldwide, with an estimated prevalence of 20% of adults in the Western World. A new study has found that a novel procedure, called the LINX Reflux Management System, can provide effective, long-term control of GERD and can remove the need for daily reflux medication in up to 79% of patients.
My guest today is the lead author of the study, Dr Luigi Bonavina, who is a professor of surgery at the University of Milan and chief of general and foregut surgery at the Policlinico San Donato in Milan, Italy.
Thank you for joining me today, Dr Bonavina. To start, what are the key results of your study and what are their significance?
Luigi Bonavina: Well, our study was a 6- to 12-year follow-up report of patients with proven GERD who received an MSA implant between 2007 and 2014. All these patients were carefully selected by strict criteria, including a hiatus hernia less than 2 cm, esophagitis less than GRADE B, normal esophageal motility, and a BMI less than 35 m/kg2.
The mean GERD-HRQL score significantly improved, and 79% of these patients discontinued PPI use. In addition, the mean total percent time with pH below 4 significantly decreased over time in sequential studies, and 89% of patients achieved pH normalization.
What is interesting is that independent predictors of a favorable outcome were age less than 40 years and a GERD-HRQL score greater than 15.
So, taken together, the significance of these are results is that the magnetic sphincter augmentation is an ideal antireflux procedure for young patients with an early-stage disease.
Amanda Balbi: How does magnetic sphincter augmentation with the LINX system work, and what are the risks and benefits?
Luigi Bonavina: Well, the device is a flexible ring, like a small collar of titanium made by single beads that are linked together. Each bead contains a magnetic core. The system produces a magnetic force that augments the LES by keeping it closed. In fact, in the resting position, the magnetic sphincter augmentation device does resist the challenges of intragastric pressure and remains closed. When an individual swallows, the force of the bolus wins the magnetic resistance of the beads. And so, the bolus can proceed into the stomach.
Regarding the risks and benefits, the intraoperative risk is virtually zero. This is a simple laparoscopic operation. Postoperatively, about 3 to 6 weeks after the implant, some patients can complain of dysphagia. And this dysphagia is usually a transient phenomenon.
Another risk, which is rare, is the possibility of erosion of this foreign body into the GI lumen, and this will require a laparoscopic operation. The incidence is very low, around 0.1%.
Regarding the benefits, we should compare the possible and the potential effects of the MSA in comparison to proton-pump inhibitor therapy and fundoplication. Of course, having this simple laparoscopic operation avoids the need for long-term PPI therapy.
And also compared to fundoplication we should admit that this is a much simpler operation that must be done very carefully anyway. Compared to fundoplication, this is what we call a gastric-sparing operation. It means that we do not have to divide the short gastric vessels. So, we just focus our operative field on the esophago-gastric junction. It's a real super-focused surgical procedure.
Amanda Balbi: What kind of patients qualify for this procedure?
Luigi Bonavina: To me, the best candidates for magnetic sphincter augmentation are patients with proven GERD. This GERD must be absolutely proven in patients who complain of typical symptoms. Those typical symptoms are generally heartburn associated with food regurgitation.
Again, our study shows that patients who are less than 40 years of age are the ideal candidates. And since magnetic sphincter augmentation significantly reduces esophageal acid exposure and the need for long-term PPIs, it's likely that this operation can stop the progression of GERD toward complicated scenarios of the disease like Barrett’s esophagus and even, unfortunately, the lethal disease such as adenocarcinoma of the esophagus.
Amanda Balbi: Can you talk about why MSA is not more widely used in GERD patients? What are the barriers to treatment?
Luigi Bonavina: Well, the current limitation to use MSA in Italy—I'm just telling about my experience—is the lack, for example, in Italy of a specific DRG code for this procedure and the fact that we have a national health care system. So, hospitals don't like to pay for the device.
But as far as I know, limitations exist also elsewhere in other countries where there is no national system, and the main barrier may be represented by the insurance companies. However, let me say going into the clinical field that an important barrier to the use of the MSA is the bad publicity that surrounds, in general, surgery for GERD.
That has caused a decline in antireflux surgery utilization around the world. This is really an unfortunate problem. Patients are afraid of side effects like dysphagia, bloating, flatulence, ability to purge, and vomiting. Therefore, many patients refuse surgery for this reason, and many clinicians keep the patients away from surgery because they don't believe that surgery nowadays is a standard and effective procedure unless it is performed well in centers where there is an expertise to handle these kinds of patients.
Amanda Balbi: What are the key takeaways for clinicians and patients with GERD?
Luigi Bonavina: Well, first of all, GERD should not be underestimated. It's a very highly prevalent disease in the Western world and may cause troublesome complications. Even, again, adenocarcinoma arising from Barrett's esophagus.
So, I think that the paradigm that PPIs are the only most-effective and safest therapeutic option should change now that we know many side effects of those medications. Again, we know that that are and better surgical options.
MSA is less invasive in comparison to fundoplication, again, because we can spare the stomach from dissection. It's a standardized procedure and can be easily mastered and easily reproducible procedure.
What is important is a multidisciplinary approach to this disease, consisting of proper diagnosis, proper patient education before and after surgery, and, of course, proper treatment.
Amanda Balbi: Great. Thank you again for speaking with me today.
Luigi Bonavina: It was a pleasure, thanks.