Journal of Gastrointestinal Surgery

, Volume 12, Issue 12, pp 2133–2140 | Cite as

Magnetic Augmentation of the Lower Esophageal Sphincter: Results of a Feasibility Clinical Trial

  • Luigi BonavinaEmail author
  • Greta I. Saino
  • Davide Bona
  • John Lipham
  • Robert A. Ganz
  • Daniel Dunn
  • Tom DeMeester
2008 ssat quickshot presentation



The high prevalence of gastroesophageal reflux disease continues to encourage the development of treatment modalities to fill the gap between acid-suppression therapy and the laparoscopic Nissen fundoplication. The Magnetic Sphincter Augmentation device has been designed to augment the lower esophageal sphincter barrier using magnetic force. A multi-center feasibility trial was done to evaluate safety and efficacy.


Patients with typical heartburn (at least partially responding to proton-pump inhibitors), abnormal esophageal acid exposure, and normal esophageal peristalsis were enrolled. Patients with hiatal hernia >3 cm were excluded from the study. The device was implanted laparoscopically around the distal esophagus.


Over a 1-year period, 38 out of 41 enrolled patients underwent this procedure in 3 hospitals. No operative complications were recorded. A free diet was allowed since post-operative day one, and 97% of patients were discharged within 48 h. The mean follow-up was 209 days (range 12–434 days). The GERD-HRQL score decreased from 26.0 to 1.0 (p < 0.005). At 3 months post-operatively, 89% of patients were off anti-reflux medications, and 79% of patients had a normal 24-h pH test. All patients preserved the ability to belch. Mild dysphagia occurred in 45% of patients. No migrations or erosions of the device occurred.


Laparoscopic implant of the MSA device is safe and well tolerated. It requires minimal surgical dissection and a short learning curve compared to the conventional Nissen fundoplication.


Gastroesophageal reflux disease Lower esophageal sphincter Laparoscopic Nissen fundoplication Phrenoesophageal ligament Proton pump inhibitors 


  1. 1.
    Shaheen N, Hansen R, Morgan D, Gangarosa L, Ringel Y, Thiny M et al. The burden of gastrointestinal and liver diseases, 2006. Am J Gastroenterol 2006;101:2128–2138. doi: 10.1111/j.1572-0241.2006.00723.x.PubMedCrossRefGoogle Scholar
  2. 2.
    El-Serag HB. Time trends of gastroesophageal reflux disease: a systematic review. Clin Gastroenterol Hepatol 2007;5:17–26. doi: 10.1016/j.cgh.2006.09.016.PubMedCrossRefGoogle Scholar
  3. 3.
    Lagergren J, Bergstrom R, Lindgren A, Nyren O. Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med. 1999;340:825–831. doi: 10.1056/NEJM199903183401101.PubMedCrossRefGoogle Scholar
  4. 4.
    Iqbal A, Salinas V, Filipi C. Endoscopic therapies of gastroesophageal reflux disease. World J Gastroenterol. 2006;12:2641–2655.PubMedGoogle Scholar
  5. 5.
    Shaheen N. The rise and fall (and rise?) of endoscopic antireflux procedures. Gastroenterology. 2006;131:952–954. doi: 10.1053/j.gastro.2006.07.030.PubMedCrossRefGoogle Scholar
  6. 6.
    Velanovich V. Comparison of generic (SF-36) vs disease-specific (GERD-HRQL) quality of life scales for gastroesophageal reflux disease. J Gastrointest Surg. 1998;2:141–145. doi: 10.1016/S1091–255X(98)80004–8.PubMedCrossRefGoogle Scholar
  7. 7.
    Streets C, DeMeester T. Ambulatory 24-hour esophageal pH monitoring. Why, when, and what to do. J Clin Gastroenterol. 2003;37:14–22. doi: 10.1097/00004836–200307000–00007.PubMedCrossRefGoogle Scholar
  8. 8.
    Peters J, DeMeester T, Crookes P, Oberg S, deVos Shoop M, Hagen J, Bremner C. The treatment of gastroesophageal reflux disease with laparoscopic Nissen fundoplication. A prospective evaluation of 100 patients with “typical” symptoms. Ann Surg 1998;228:40–50. doi: 10.1097/00000658–199807000–00007.PubMedCrossRefGoogle Scholar
  9. 9.
    Dallemagne B, Weerts J, Markiewicz S, Dewandre J, Wahlen C, Monami B et al. Clinical results of laparoscopic fundoplication at ten years after surgery. Surg Endosc. 2006;20:159–165. doi: 10.1007/s00464–005–0174-x.PubMedCrossRefGoogle Scholar
  10. 10.
    Oelschlager B, Quiroga E, Parra J, Cahill M, Polissar N, Pellegrini C. Long-term outcomes after laparoscopic antireflux surgery. Am J Gastroenterol 2007;102:1–8. doi: 10.1111/j.1572–0241.2007.01057.x.CrossRefGoogle Scholar
  11. 11.
    Kelly J, Watson D, Chin K, Devitt P, Game P, Jamieson G. Laparoscopic Nissen fundoplication: clinical outcomes at 10 years. J Am Coll Surg 2007;205:570–575. doi: 10.1016/j.jamcollsurg.2007.05.024.PubMedCrossRefGoogle Scholar
  12. 12.
    Morgenthal C, Shane M, Stval A, Gletsu N, Milam G, Swafford V et al. The durability of laparoscopic Nissen fundoplication: 11-year outcome. J Gastrointest Surg 2007;11:693–700. doi: 10.1007/s11605–007–0161–8.PubMedCrossRefGoogle Scholar
  13. 13.
    Hunter J, Smith C, Branum G, Waring J, Trus T, Cornwell M et al. Laparoscopic fundoplication failures: patterns of failure and response to fundoplication. Ann Surg 1999;230:595–606. doi: 10.1097/00000658–199910000–00015.PubMedCrossRefGoogle Scholar
  14. 14.
    Vakil N, Shaw M, Kirby R. Clinical effectiveness of laparoscopic fundoplication in a US community. Am J Med 2003;114:1–5. doi: 10.1016/S0002–9343(02)01390–6.PubMedCrossRefGoogle Scholar
  15. 15.
    Finks J, Wei Y, Birkmeyer J. The rise and fall of antireflux surgery in the United States. Surg Endosc 2006;20:1698–1701. doi: 10.1007/s00464–006–0042–3.PubMedCrossRefGoogle Scholar
  16. 16.
    Ganz R, Gostout C, Grudem J, Swanson W, Berg T, DeMeester T. Use of a magnetic sphincter for the treatment of GERD: a feasibility study. Gastrointest Endosc 2008;67:287–294. doi: 10.1016/j.gie.2007.07.027.PubMedCrossRefGoogle Scholar
  17. 17.
    Kwok H, Marriz Y, Al-Ali S, Windsor J. Phrenoesophageal ligament re-visited. Clin Anat 1999;12:164–170. doi: 10.1002/(SICI)1098–2353(1999)12:3<164::AID-CA4>3.0.CO;2-N.PubMedCrossRefGoogle Scholar
  18. 18.
    DeMeester T, Wernly J, Bryant G, Little A, Skinner D. Clinical and in vitro analysis of gastroesophageal competence: a study of the principles of antireflux surgery. Am J Surg 1979;137:39–46. doi: 10.1016/0002–9610(79)90008–4.PubMedCrossRefGoogle Scholar
  19. 19.
    Bonavina L, DeMeester T, Mason R, Stein H, Feussner H, Evander A. Mechanical effect of the Angelchik prosthesis on the competency of the gastric cardia: pathophysiological implications and clinical perspectives. Dis Esophagus 1997;10:115–118.PubMedGoogle Scholar
  20. 20.
    Kahrilas P. Magnetic enhancement of the lower esophageal sphincter. Gastrointest Endosc. 2008;67:295–296. doi: 10.1016/j.gie.2007.08.032.PubMedCrossRefGoogle Scholar

Copyright information

© The Society for Surgery of the Alimentary Tract 2008

Authors and Affiliations

  • Luigi Bonavina
    • 1
    Email author
  • Greta I. Saino
    • 1
  • Davide Bona
    • 1
  • John Lipham
    • 2
  • Robert A. Ganz
    • 3
  • Daniel Dunn
    • 3
  • Tom DeMeester
    • 2
  1. 1.IRCCS Policlinico San DonatoUniversity of MilanMilanItaly
  2. 2.Department of Surgery Keck School of MedicineUniversity of Southern CaliforniaLos AngelesUSA
  3. 3.Abbott Northwestern HospitalMinneapolisUSA

Personalised recommendations