Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial.
BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Bonavina
Luigi
L
IRCCS Policlinico San Donato, University of Milan, Via Morandi 30, 20097, San Donato Milanese, Milan, Italy. luigi.bonavina@unimi.it
Saino
Greta I
GI
Bona
Davide
D
Lipham
John
J
Ganz
Robert A
RA
Dunn
Daniel
D
DeMeester
Tom
T
D000328:Adult; D000368:Aged; D004869:Equipment Safety; D049630:Esophageal Sphincter, Lower / Q000000981:diagnostic imaging / Q000601:surgery*; D050782:Esophageal pH Monitoring; D004945:Esophagoscopy; D005240:Feasibility Studies; D005260:Female; D005764:Gastroesophageal Reflux / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D008280:Magnetics / Q000295:instrumentation*; D008297:Male; D008365:Manometry; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D011859:Radiography; D016896:Treatment Outcome