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For patients with gastroesophageal reflux disease (GERD), endoscopic and minimally invasive surgical techniques may be viable alternatives to proton pump inhibitor (PPI) therapy, according to investigators.
Still, their exact role in the treatment process remains undetermined, reported Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues.
“The frequent incomplete response to PPI therapy, in addition to recent studies suggesting chronic complications with PPI therapy, have fueled discussion of alternative strategies for treating patients with GERD,” the investigators wrote in Gastroenterology. “For a substantial number of patients and providers with the above concerns who are unwilling to pursue the traditional surgical gastric fundoplication, endoscopic or less invasive surgical strategies have gained some traction.”
Dr. Vaezi and colleagues noted that they conducted the scoping review with intentions of being more descriptive than prescriptive.
“Our goal is not to recommend the utility of any of the discussed techniques in specific clinical scenarios,” they wrote. “Rather, it is to summarize the currently available evidence and identify where more research may be helpful.”
Across 22 randomized, controlled trials and observational studies, objective and symptomatic improvement varied between modalities. Measured outcomes also varied; most studies reported symptoms, health-related quality of life, and PPI use; fewer studies (but still a majority) reported intraesophageal acid exposure and/or lower esophageal sphincter (LES) pressure. Conclusions drawn by Dr. Vaezi and colleagues are summarized below.
Magnetic sphincter augmentation of the LES
In multiple trials, magnetic sphincter augmentation demonstrated a “high degree of efficacy” in the short or midterm, and a favorable safety profile. Dr. Vaezi and colleagues highlighted significant improvements in disease-related quality of life, with “a substantial proportion” of patients achieving normalization or at least 50% improvement in acid exposure. While some patients required esophageal dilation after the procedure, this was not needed any more frequently than after surgical fundoplication.
Radiofrequency ablation
Across five trials, radiofrequency ablation, which involves delivery of energy to the LES and gastric cardia, improved GERD-related quality of life, and reduced, but did not normalize, acid exposure. The technique lessened short-term need for PPIs, but long-term relief was not observed. Compared with observational studies, efficacy signals were weaker in randomized, controlled trials. The procedure was generally safe.
Surgical implantation of LES pacemaker
Limited data were available for LES sphincter stimulation among patients with GERD, and the most recent study, involving a comparison of device placement with or without stimulation, was terminated early. Still, available data suggest that the technique is generally well tolerated, with reduced need for PPIs, improved symptoms, and lessened acid exposure. Dr. Vaezi and colleagues noted that the manufacturing company, EndoStim, is in receivership, putting U.S. availability in question.
Full-thickness fundoplication
Endoscopic full-thickness fundoplication was associated with improvement of symptoms and quality of life, and a favorable safety profile. Although the procedure generally reduced PPI use, most patients still needed PPIs long-term. Reflux improved after the procedure, but not to the same degree as laparoscopic plication.
Transoral incisionless fundoplication
Based on a number of studies, including five randomized, controlled trials, transoral incisionless fundoplication appears safe and effective, with reduced need for PPIs up to 5 years. According to Dr. Vaezi and colleagues, variable results across studies are likely explained by variations in the technique over time and heterogeneous patient populations. Recent studies in which the “TIF 2.0 technique” has been performed on patients with hiatal hernias less than 2 cm have met objective efficacy outcomes.
Incisionless fundoplication with magnetic ultrasonic surgical endostapler
The magnetic ultrasonic surgical endostapler, which allows for incisionless fundoplication, had more limited data. Only two studies have been conducted, and neither had sham-controlled nor comparative-trial data. Furthermore, multiple safety signals have been encountered, with “substantial” complication rates and serious adverse events that were “noticeable and concerning,” according to Dr. Vaezi and colleagues.
Concluding their discussion, the investigators suggested that some endoscopic and minimally invasive approaches to GERD are “promising” alternatives to PPI therapy.
“However, their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially the durability of their effect, are understood,” they wrote.
The investigators reported no conflicts of interest.
SOURCE: Vaezi MF et al. Gastroenterology. 2020 Jul 1. doi: 10.1053/j.gastro.2020.05.097.
For patients with gastroesophageal reflux disease (GERD), endoscopic and minimally invasive surgical techniques may be viable alternatives to proton pump inhibitor (PPI) therapy, according to investigators.
Still, their exact role in the treatment process remains undetermined, reported Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues.
“The frequent incomplete response to PPI therapy, in addition to recent studies suggesting chronic complications with PPI therapy, have fueled discussion of alternative strategies for treating patients with GERD,” the investigators wrote in Gastroenterology. “For a substantial number of patients and providers with the above concerns who are unwilling to pursue the traditional surgical gastric fundoplication, endoscopic or less invasive surgical strategies have gained some traction.”
Dr. Vaezi and colleagues noted that they conducted the scoping review with intentions of being more descriptive than prescriptive.
“Our goal is not to recommend the utility of any of the discussed techniques in specific clinical scenarios,” they wrote. “Rather, it is to summarize the currently available evidence and identify where more research may be helpful.”
Across 22 randomized, controlled trials and observational studies, objective and symptomatic improvement varied between modalities. Measured outcomes also varied; most studies reported symptoms, health-related quality of life, and PPI use; fewer studies (but still a majority) reported intraesophageal acid exposure and/or lower esophageal sphincter (LES) pressure. Conclusions drawn by Dr. Vaezi and colleagues are summarized below.
Magnetic sphincter augmentation of the LES
In multiple trials, magnetic sphincter augmentation demonstrated a “high degree of efficacy” in the short or midterm, and a favorable safety profile. Dr. Vaezi and colleagues highlighted significant improvements in disease-related quality of life, with “a substantial proportion” of patients achieving normalization or at least 50% improvement in acid exposure. While some patients required esophageal dilation after the procedure, this was not needed any more frequently than after surgical fundoplication.
Radiofrequency ablation
Across five trials, radiofrequency ablation, which involves delivery of energy to the LES and gastric cardia, improved GERD-related quality of life, and reduced, but did not normalize, acid exposure. The technique lessened short-term need for PPIs, but long-term relief was not observed. Compared with observational studies, efficacy signals were weaker in randomized, controlled trials. The procedure was generally safe.
Surgical implantation of LES pacemaker
Limited data were available for LES sphincter stimulation among patients with GERD, and the most recent study, involving a comparison of device placement with or without stimulation, was terminated early. Still, available data suggest that the technique is generally well tolerated, with reduced need for PPIs, improved symptoms, and lessened acid exposure. Dr. Vaezi and colleagues noted that the manufacturing company, EndoStim, is in receivership, putting U.S. availability in question.
Full-thickness fundoplication
Endoscopic full-thickness fundoplication was associated with improvement of symptoms and quality of life, and a favorable safety profile. Although the procedure generally reduced PPI use, most patients still needed PPIs long-term. Reflux improved after the procedure, but not to the same degree as laparoscopic plication.
Transoral incisionless fundoplication
Based on a number of studies, including five randomized, controlled trials, transoral incisionless fundoplication appears safe and effective, with reduced need for PPIs up to 5 years. According to Dr. Vaezi and colleagues, variable results across studies are likely explained by variations in the technique over time and heterogeneous patient populations. Recent studies in which the “TIF 2.0 technique” has been performed on patients with hiatal hernias less than 2 cm have met objective efficacy outcomes.
Incisionless fundoplication with magnetic ultrasonic surgical endostapler
The magnetic ultrasonic surgical endostapler, which allows for incisionless fundoplication, had more limited data. Only two studies have been conducted, and neither had sham-controlled nor comparative-trial data. Furthermore, multiple safety signals have been encountered, with “substantial” complication rates and serious adverse events that were “noticeable and concerning,” according to Dr. Vaezi and colleagues.
Concluding their discussion, the investigators suggested that some endoscopic and minimally invasive approaches to GERD are “promising” alternatives to PPI therapy.
“However, their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially the durability of their effect, are understood,” they wrote.
The investigators reported no conflicts of interest.
SOURCE: Vaezi MF et al. Gastroenterology. 2020 Jul 1. doi: 10.1053/j.gastro.2020.05.097.
For patients with gastroesophageal reflux disease (GERD), endoscopic and minimally invasive surgical techniques may be viable alternatives to proton pump inhibitor (PPI) therapy, according to investigators.
Still, their exact role in the treatment process remains undetermined, reported Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues.
“The frequent incomplete response to PPI therapy, in addition to recent studies suggesting chronic complications with PPI therapy, have fueled discussion of alternative strategies for treating patients with GERD,” the investigators wrote in Gastroenterology. “For a substantial number of patients and providers with the above concerns who are unwilling to pursue the traditional surgical gastric fundoplication, endoscopic or less invasive surgical strategies have gained some traction.”
Dr. Vaezi and colleagues noted that they conducted the scoping review with intentions of being more descriptive than prescriptive.
“Our goal is not to recommend the utility of any of the discussed techniques in specific clinical scenarios,” they wrote. “Rather, it is to summarize the currently available evidence and identify where more research may be helpful.”
Across 22 randomized, controlled trials and observational studies, objective and symptomatic improvement varied between modalities. Measured outcomes also varied; most studies reported symptoms, health-related quality of life, and PPI use; fewer studies (but still a majority) reported intraesophageal acid exposure and/or lower esophageal sphincter (LES) pressure. Conclusions drawn by Dr. Vaezi and colleagues are summarized below.
Magnetic sphincter augmentation of the LES
In multiple trials, magnetic sphincter augmentation demonstrated a “high degree of efficacy” in the short or midterm, and a favorable safety profile. Dr. Vaezi and colleagues highlighted significant improvements in disease-related quality of life, with “a substantial proportion” of patients achieving normalization or at least 50% improvement in acid exposure. While some patients required esophageal dilation after the procedure, this was not needed any more frequently than after surgical fundoplication.
Radiofrequency ablation
Across five trials, radiofrequency ablation, which involves delivery of energy to the LES and gastric cardia, improved GERD-related quality of life, and reduced, but did not normalize, acid exposure. The technique lessened short-term need for PPIs, but long-term relief was not observed. Compared with observational studies, efficacy signals were weaker in randomized, controlled trials. The procedure was generally safe.
Surgical implantation of LES pacemaker
Limited data were available for LES sphincter stimulation among patients with GERD, and the most recent study, involving a comparison of device placement with or without stimulation, was terminated early. Still, available data suggest that the technique is generally well tolerated, with reduced need for PPIs, improved symptoms, and lessened acid exposure. Dr. Vaezi and colleagues noted that the manufacturing company, EndoStim, is in receivership, putting U.S. availability in question.
Full-thickness fundoplication
Endoscopic full-thickness fundoplication was associated with improvement of symptoms and quality of life, and a favorable safety profile. Although the procedure generally reduced PPI use, most patients still needed PPIs long-term. Reflux improved after the procedure, but not to the same degree as laparoscopic plication.
Transoral incisionless fundoplication
Based on a number of studies, including five randomized, controlled trials, transoral incisionless fundoplication appears safe and effective, with reduced need for PPIs up to 5 years. According to Dr. Vaezi and colleagues, variable results across studies are likely explained by variations in the technique over time and heterogeneous patient populations. Recent studies in which the “TIF 2.0 technique” has been performed on patients with hiatal hernias less than 2 cm have met objective efficacy outcomes.
Incisionless fundoplication with magnetic ultrasonic surgical endostapler
The magnetic ultrasonic surgical endostapler, which allows for incisionless fundoplication, had more limited data. Only two studies have been conducted, and neither had sham-controlled nor comparative-trial data. Furthermore, multiple safety signals have been encountered, with “substantial” complication rates and serious adverse events that were “noticeable and concerning,” according to Dr. Vaezi and colleagues.
Concluding their discussion, the investigators suggested that some endoscopic and minimally invasive approaches to GERD are “promising” alternatives to PPI therapy.
“However, their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially the durability of their effect, are understood,” they wrote.
The investigators reported no conflicts of interest.
SOURCE: Vaezi MF et al. Gastroenterology. 2020 Jul 1. doi: 10.1053/j.gastro.2020.05.097.
FROM GASTROENTEROLOGY