User login
SEATTLE –
The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.
Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”
Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.
Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.
The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.
“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.
Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.
At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.
Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.
Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).
There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.
Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.
The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m2, but BMI ranged as high as 44.3.
Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.
Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).
About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.
Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.
The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
SOURCE: Alicuben E et al. WCE 2018, Abstract S095.
The enthusiasm and reservation surrounding the presented results supporting relatively high rates of regression of Barrett’s esophagus in patients undergoing LES magnetic sphincter augmentation are both well founded. Barrett’s regression, which has been observed to occur spontaneously as well as following antireflux interventions, is always a rich topic for debate. The reported rate of regression in this study being higher than that of complete fundoplication (Nissen fundoplication) is perplexing. The premise for the development of magnetic sphincter augmentation at a focal site was based on the theory that complete fundoplication is supraphysiologic, resulting in desired resolution of regurgitation with unwanted sequelae of dysphagia and bloat in a substantial number of patients. The development of magnetic sphincter augmentation was inspired by the concept that it would provide very reproducible control of regurgitation nearing that of complete fundoplication in a permanent fashion and do so at a focal point (< 1 cm) at the level of the lower esophageal sphincter, minimizing dysphagia and bloat. Since the design is one to replicate appropriate physiology without over treating the targeted reflux disease, theoretically any regression of Barrett’s esophagus should likewise approach but not exceed that of complete fundoplication.
I anticipate further studies will add to this rich debate. Any reservations about the results of this study should not overshadow the inherent advantages of magnetic sphincter augmentation. Its implantation is fairly straightforward to teach to surgeons who have a practice focused on antireflux surgery and due to the limited dissection/tissue mobilization required, most patients can return home a few hours after surgery and immediately resume a diet of solid foods.
Dr. Alicuban and colleagues discuss the small but real concern of erosion, however, another point of inherent concern is the binary function of the device. It is either implanted or not, there is no ability beyond endoscopic dilation to treat relative outflow obstruction and no means to convert the device to a “partial wrap.”
As we forge ahead with increasingly creative ways to address reflux disease the lessons we learn will contribute to the development of better medical, endoscopic and minimally invasive surgical technologies and the robust, civil debate seen here is something we can all enthusiastically anticipate.
Kevin M. Reavis, MD, FACS, is with the Division of Gastrointestinal and Minimally Invasive Surgery The Oregon Clinic; associate professor, Oregon Health & Science University, Portland, and President, Oregon Medical Society.
The enthusiasm and reservation surrounding the presented results supporting relatively high rates of regression of Barrett’s esophagus in patients undergoing LES magnetic sphincter augmentation are both well founded. Barrett’s regression, which has been observed to occur spontaneously as well as following antireflux interventions, is always a rich topic for debate. The reported rate of regression in this study being higher than that of complete fundoplication (Nissen fundoplication) is perplexing. The premise for the development of magnetic sphincter augmentation at a focal site was based on the theory that complete fundoplication is supraphysiologic, resulting in desired resolution of regurgitation with unwanted sequelae of dysphagia and bloat in a substantial number of patients. The development of magnetic sphincter augmentation was inspired by the concept that it would provide very reproducible control of regurgitation nearing that of complete fundoplication in a permanent fashion and do so at a focal point (< 1 cm) at the level of the lower esophageal sphincter, minimizing dysphagia and bloat. Since the design is one to replicate appropriate physiology without over treating the targeted reflux disease, theoretically any regression of Barrett’s esophagus should likewise approach but not exceed that of complete fundoplication.
I anticipate further studies will add to this rich debate. Any reservations about the results of this study should not overshadow the inherent advantages of magnetic sphincter augmentation. Its implantation is fairly straightforward to teach to surgeons who have a practice focused on antireflux surgery and due to the limited dissection/tissue mobilization required, most patients can return home a few hours after surgery and immediately resume a diet of solid foods.
Dr. Alicuban and colleagues discuss the small but real concern of erosion, however, another point of inherent concern is the binary function of the device. It is either implanted or not, there is no ability beyond endoscopic dilation to treat relative outflow obstruction and no means to convert the device to a “partial wrap.”
As we forge ahead with increasingly creative ways to address reflux disease the lessons we learn will contribute to the development of better medical, endoscopic and minimally invasive surgical technologies and the robust, civil debate seen here is something we can all enthusiastically anticipate.
Kevin M. Reavis, MD, FACS, is with the Division of Gastrointestinal and Minimally Invasive Surgery The Oregon Clinic; associate professor, Oregon Health & Science University, Portland, and President, Oregon Medical Society.
The enthusiasm and reservation surrounding the presented results supporting relatively high rates of regression of Barrett’s esophagus in patients undergoing LES magnetic sphincter augmentation are both well founded. Barrett’s regression, which has been observed to occur spontaneously as well as following antireflux interventions, is always a rich topic for debate. The reported rate of regression in this study being higher than that of complete fundoplication (Nissen fundoplication) is perplexing. The premise for the development of magnetic sphincter augmentation at a focal site was based on the theory that complete fundoplication is supraphysiologic, resulting in desired resolution of regurgitation with unwanted sequelae of dysphagia and bloat in a substantial number of patients. The development of magnetic sphincter augmentation was inspired by the concept that it would provide very reproducible control of regurgitation nearing that of complete fundoplication in a permanent fashion and do so at a focal point (< 1 cm) at the level of the lower esophageal sphincter, minimizing dysphagia and bloat. Since the design is one to replicate appropriate physiology without over treating the targeted reflux disease, theoretically any regression of Barrett’s esophagus should likewise approach but not exceed that of complete fundoplication.
I anticipate further studies will add to this rich debate. Any reservations about the results of this study should not overshadow the inherent advantages of magnetic sphincter augmentation. Its implantation is fairly straightforward to teach to surgeons who have a practice focused on antireflux surgery and due to the limited dissection/tissue mobilization required, most patients can return home a few hours after surgery and immediately resume a diet of solid foods.
Dr. Alicuban and colleagues discuss the small but real concern of erosion, however, another point of inherent concern is the binary function of the device. It is either implanted or not, there is no ability beyond endoscopic dilation to treat relative outflow obstruction and no means to convert the device to a “partial wrap.”
As we forge ahead with increasingly creative ways to address reflux disease the lessons we learn will contribute to the development of better medical, endoscopic and minimally invasive surgical technologies and the robust, civil debate seen here is something we can all enthusiastically anticipate.
Kevin M. Reavis, MD, FACS, is with the Division of Gastrointestinal and Minimally Invasive Surgery The Oregon Clinic; associate professor, Oregon Health & Science University, Portland, and President, Oregon Medical Society.
SEATTLE –
The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.
Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”
Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.
Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.
The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.
“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.
Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.
At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.
Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.
Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).
There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.
Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.
The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m2, but BMI ranged as high as 44.3.
Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.
Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).
About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.
Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.
The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
SOURCE: Alicuben E et al. WCE 2018, Abstract S095.
SEATTLE –
The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.
Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”
Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.
Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.
The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.
“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.
Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.
At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.
Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.
Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).
There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.
Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.
The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m2, but BMI ranged as high as 44.3.
Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.
Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).
About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.
Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.
The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
SOURCE: Alicuben E et al. WCE 2018, Abstract S095.
REPORTING FROM WCE 2018
Key clinical point: Magnetic lower esophageal sphincter augmentation might offer an easier and more effective fix for gastroesophageal reflux than the current standard, Nissen fundoplication.
Major finding: The overall regression rate of Barrett’s esophagus topped 70%.
Study details: Review of 67 patients
Disclosures: There was no industry funding, and the presenter had no disclosures. Two authors are consultants for Torax Medical, the company that makes the device.
Source: Alicuben E et al. WCE 2018, Abstract S095
