Reduced medication dependency and improved symptoms and quality of life 12 months after enteryx implantation for gastroesophageal reflux.
BACKGROUND
The need is well recognized for additional data on endoluminal therapies for gastroesophageal reflux disease (GERD). This prospective multicenter clinical trial was designed to assess safety and effectiveness of Enteryx, a nonresorbable copolymer implanted into the lower esophagus, in reducing usage of proton pump inhibitors (PPIs) and improving reflux symptoms and quality of life.


METHODS
Enteryx implantation was performed under fluoroscopic visualization without general anesthesia in 93 patients with symptomatic GERD responsive to and relapsing upon cessation of PPI therapy. Subjective and objective data were collected up to 12 months postprocedure. The criterion for treatment success was reduction in PPI dosage of > or =50%.


RESULTS
At 12 months, treatment success was attained in 86% (confidence interval, 77%-93%) of 74 evaluable patients and elimination of PPI therapy in 65% (confidence interval, 53%-76%). The treatment success rate by intent-to-treat analysis was 69% (confidence interval, 58%-78%). Reflux-related heartburn (P < 0.0001), regurgitation symptoms (P = 0.0005), and physical (P < 0.0001) and mental quality of life (P = 0.0012) scores improved. The most frequent complications were chest pain (77%), dysphagia/odynophagia (27%), and sensation of fever (26%).


CONCLUSIONS
Enteryx implantation provides an effective and safe alternative for management of gastroesophageal reflux, reducing medication dependency and symptoms and enhancing quality of life.
Schumacher
Brigitte
B
Medizinische Klinik, Evangelisches Krankenhaus Düsseldorf, Kirchfeldstrasse 40, 40217 Düsseldorf, Germany. BrgSchumacher@aol.com
Neuhaus
Horst
H
Ortner
Marianne
M
Laugier
René
R
Benson
Martin
M
Boyer
Jean
J
Ponchon
Thierry
T
Hagenmüller
Friedrich
F
Grimaud
Jean-Charles
JC
Rampal
Patrick
P
Rey
Jean-François
JF
Fuchs
Karl-Hermann
KH
Allgaier
Hans-Peter
HP
Hochberger
Jürgen
J
Stein
Hubert J
HJ
Armengol
Juan Andrés Ramírez
JA
Siersema
Peter D
PD
Devière
Jacques
J
D005260:Female; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011145:Polyvinyls; D011446:Prospective Studies; D054328:Proton Pump Inhibitors; D011788:Quality of Life; D013997:Time Factors
D011145:Polyvinyls; D054328:Proton Pump Inhibitors; C020320:ethylene-vinyl alcohol copolymer