J Lipham, MD, R Ganz, MD, Tr Demeester, MD, D Dunn, MD, W Bemelman, MD, G Saino, MD, D Bona, MD, P Fockens, MD, L Bonavina, MD. University Of Southern California, Abbott Northerwestern Hospital, Policlinico San Donato Milan Italy, Academic Medical Center Amsterdam
Introduction: The LINX device is intended for chronic reflux patients who have incomplete symptom relief from acid suppression therapy, confirmed pathologic reflux defined by standard pH testing and chose not to elect a Nissen fundoplication.
We have previously shown that the laparoscopic placement of the LINX device to augment the lower esophageal sphincter provides safe and effective GERD therapy on a short-term basis (Bonavina, 2008). We now extend those observations up to 4 years follow-up.
Methods: 44 patients were enrolled in a feasibility trial between February 2007 and October 2008. All patients had typical GERD symptoms of heartburn and regurgitation; confirmed pathologic reflux defined by standard pH testing, and were at least partially PPI responsive. All patients had laparoscopic implantation of the LINX™ device.
Results: There were no peri-operative complications, and no observed erosion or migration of the device. Follow-up data was available for 32 patients at a median of 3.2 years post-implant (range 2.6-4.0). The median % total time pH < 4 improved from 9.6% to 3.1%; the median GERD-HRQL total score improved from 26.5 to 2; and 88% were free of daily PPI use. No subjects reported the inability to belch and vomit and 87% were not bothered by bloating or gassy feelings.
Three patients had the device laparoscopically removed without complication; one patient received a Nissen fundoplication at the time of removal.
Conclusions: The treatment of chronic GERD with augmentation of the lower esophageal sphincter by the LINX device appears to be safe, effective and durable with a low side effect profile. The LINX procedure also appears to be safely reversible without preclusion of other treatment options.
Session Number: SS10 – Novel Technologies & Operations
Program Number: S066