Long-Term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux

Robert A. Ganz, Steven A. Edmundowicz, Paul A. Taiganides, John C. Lipham, C. Daniel Smith, Kenneth R. DeVault, Santiago Horgan, Garth Jacobsen, James D. Luketich, Christopher C. Smith, Steven C. Schlack-Haerer, Shanu N. Kothari, Christy M. Dunst, Thomas J. Watson, Jeffrey Peters, Brant K. Oelschlager, Kyle A. Perry, W. Scott Melvin, Willem A. Bemelman, André J P M Smout & 1 others Dan Dunn

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

Background & Aims: Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device. Methods: We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. Results: Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. Conclusions: Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD + ClinicalTrials.gov no:. NCT00776997.

Original languageEnglish (US)
JournalClinical Gastroenterology and Hepatology
DOIs
StateAccepted/In press - 2015
Externally publishedYes

Fingerprint

Proton Pump Inhibitors
Gastroesophageal Reflux
Equipment and Supplies
Lower Esophageal Sphincter
Safety
Quality of Life
United States Food and Drug Administration
Deglutition Disorders
Netherlands
Gases
Prospective Studies
Acids

Keywords

  • Clinical Trial
  • Heartburn
  • Hiatal Hernia
  • Surgery

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Ganz, R. A., Edmundowicz, S. A., Taiganides, P. A., Lipham, J. C., Smith, C. D., DeVault, K. R., ... Dunn, D. (Accepted/In press). Long-Term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clinical Gastroenterology and Hepatology. https://doi.org/10.1016/j.cgh.2015.05.028

Long-Term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. / Ganz, Robert A.; Edmundowicz, Steven A.; Taiganides, Paul A.; Lipham, John C.; Smith, C. Daniel; DeVault, Kenneth R.; Horgan, Santiago; Jacobsen, Garth; Luketich, James D.; Smith, Christopher C.; Schlack-Haerer, Steven C.; Kothari, Shanu N.; Dunst, Christy M.; Watson, Thomas J.; Peters, Jeffrey; Oelschlager, Brant K.; Perry, Kyle A.; Melvin, W. Scott; Bemelman, Willem A.; Smout, André J P M; Dunn, Dan.

In: Clinical Gastroenterology and Hepatology, 2015.

Research output: Contribution to journalArticle

Ganz, RA, Edmundowicz, SA, Taiganides, PA, Lipham, JC, Smith, CD, DeVault, KR, Horgan, S, Jacobsen, G, Luketich, JD, Smith, CC, Schlack-Haerer, SC, Kothari, SN, Dunst, CM, Watson, TJ, Peters, J, Oelschlager, BK, Perry, KA, Melvin, WS, Bemelman, WA, Smout, AJPM & Dunn, D 2015, 'Long-Term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux', Clinical Gastroenterology and Hepatology. https://doi.org/10.1016/j.cgh.2015.05.028
Ganz, Robert A. ; Edmundowicz, Steven A. ; Taiganides, Paul A. ; Lipham, John C. ; Smith, C. Daniel ; DeVault, Kenneth R. ; Horgan, Santiago ; Jacobsen, Garth ; Luketich, James D. ; Smith, Christopher C. ; Schlack-Haerer, Steven C. ; Kothari, Shanu N. ; Dunst, Christy M. ; Watson, Thomas J. ; Peters, Jeffrey ; Oelschlager, Brant K. ; Perry, Kyle A. ; Melvin, W. Scott ; Bemelman, Willem A. ; Smout, André J P M ; Dunn, Dan. / Long-Term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. In: Clinical Gastroenterology and Hepatology. 2015.
@article{1ee22ae91e3c4b9c96083998017098a6,
title = "Long-Term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux",
abstract = "Background & Aims: Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device. Methods: We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. Results: Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3{\%} at 5 years. Moderate or severe regurgitation occurred in 57{\%} of subjects at baseline, but only 1.2{\%} at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5{\%} at baseline and in 6{\%} at 5 years. Bothersome gas-bloat was present in 52{\%} at baseline and decreased to 8.3{\%} at 5 years. Conclusions: Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD + ClinicalTrials.gov no:. NCT00776997.",
keywords = "Clinical Trial, Heartburn, Hiatal Hernia, Surgery",
author = "Ganz, {Robert A.} and Edmundowicz, {Steven A.} and Taiganides, {Paul A.} and Lipham, {John C.} and Smith, {C. Daniel} and DeVault, {Kenneth R.} and Santiago Horgan and Garth Jacobsen and Luketich, {James D.} and Smith, {Christopher C.} and Schlack-Haerer, {Steven C.} and Kothari, {Shanu N.} and Dunst, {Christy M.} and Watson, {Thomas J.} and Jeffrey Peters and Oelschlager, {Brant K.} and Perry, {Kyle A.} and Melvin, {W. Scott} and Bemelman, {Willem A.} and Smout, {Andr{\'e} J P M} and Dan Dunn",
year = "2015",
doi = "10.1016/j.cgh.2015.05.028",
language = "English (US)",
journal = "Clinical Gastroenterology and Hepatology",
issn = "1542-3565",
publisher = "W.B. Saunders Ltd",

}

TY - JOUR

T1 - Long-Term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux

AU - Ganz, Robert A.

AU - Edmundowicz, Steven A.

AU - Taiganides, Paul A.

AU - Lipham, John C.

AU - Smith, C. Daniel

AU - DeVault, Kenneth R.

AU - Horgan, Santiago

AU - Jacobsen, Garth

AU - Luketich, James D.

AU - Smith, Christopher C.

AU - Schlack-Haerer, Steven C.

AU - Kothari, Shanu N.

AU - Dunst, Christy M.

AU - Watson, Thomas J.

AU - Peters, Jeffrey

AU - Oelschlager, Brant K.

AU - Perry, Kyle A.

AU - Melvin, W. Scott

AU - Bemelman, Willem A.

AU - Smout, André J P M

AU - Dunn, Dan

PY - 2015

Y1 - 2015

N2 - Background & Aims: Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device. Methods: We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. Results: Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. Conclusions: Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD + ClinicalTrials.gov no:. NCT00776997.

AB - Background & Aims: Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device. Methods: We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. Results: Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. Conclusions: Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD + ClinicalTrials.gov no:. NCT00776997.

KW - Clinical Trial

KW - Heartburn

KW - Hiatal Hernia

KW - Surgery

UR - http://www.scopus.com/inward/record.url?scp=84945234828&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84945234828&partnerID=8YFLogxK

U2 - 10.1016/j.cgh.2015.05.028

DO - 10.1016/j.cgh.2015.05.028

M3 - Article

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

SN - 1542-3565

ER -