PMID- 25726315
OWN - NLM
STAT- MEDLINE
DCOM- 20150429
LR  - 20160106
IS  - 1532-7361 (Electronic)
IS  - 0039-6060 (Linking)
VI  - 157
IP  - 3
DP  - 2015 Mar
TI  - Two-year results of intermittent electrical stimulation of the lower esophageal 
      sphincter treatment of gastroesophageal reflux disease.
PG  - 556-67
LID - S0039-6060(14)00708-9 [pii]
LID - 10.1016/j.surg.2014.10.012 [doi]
AB  - BACKGROUND: Lower esophageal sphincter (LES) electrical stimulation therapy (EST) 
      has been shown to improve outcome in gastroesophageal reflux disease (GERD) 
      patients at 1 year. The aim of this open-label extension trial (NCT01578642) was 
      to study the 2-year safety and efficacy of LES-EST in GERD patients. METHODS: 
      GERD patients responsive partially to proton pump inhibitors (PPI) with off-PPI 
      GERD health-related quality of life (HRQL) of >/=20, 24-hour esophageal pH </=4.0 for 
      >5% of the time, hiatal hernia </=3 cm, and esophagitis LA grade C or lower 
      participated in this trial. Bipolar stitch electrodes and a pulse generator 
      (EndoStim BV, The Hague, The Netherlands) were implanted laparoscopically. 
      LES-EST at 20 Hz, 215 mus, 3-8 mAmp was delivered over 30-minute sessions, 6-12 
      sessions per day, starting on day 1 after implantation. Patients were evaluated 
      using GERD-HRQL, symptom diaries, Short Form-12, and esophageal pH testing at 
      regular intervals. Stimulation sessions were optimized based on residual symptoms 
      and esophageal pH at follow-up. RESULTS: Twenty-five patients (mean age [SD] = 52 
      [12] years; 14 men) were implanted successfully; 23 patients participated in the 
      2-year extension trial, and 21 completed their 2-year evaluation. At 2 years, 
      there was improvement in their median GERD-HRQL on LES-EST compared with both 
      their on-PPI (9 vs 0; P = .001) and off-PPI (23.5 vs. 0; P < .001) baseline 
      scores. Median 24-hour distal esophageal acid exposure improved from 10% at 
      baseline to 4% (per-protocol analysis; P < .001) at 2 years with 71% 
      demonstrating either normalization or a >/=50% decrease in their distal esophageal 
      acid exposure. All except 5 patients (16/21) reported complete cessation of PPI 
      use; only 2 patients were using a PPI regularly (>/=50% of days). There was 
      significant improvement in sleep quality and daily symptoms of heartburn and 
      regurgitation on LES-EST. At baseline, 92% of the subjects (22/24) reported that 
      they were "unsatisfied" with their condition off-PPI and 71% (17/24) on-PPI 
      compared with 0% (0/21) "unsatisfied" at the 24-month visits on LES-EST. There 
      were no device- or therapy-related serious adverse events and no untoward 
      sensation or dysphagia reported with LES-EST. CONCLUSION: LES-EST is safe and 
      effective for treating patients with GERD over a period of 2 years. LES-EST 
      resulted in a significant and sustained improvement in GERD symptoms, and 
      esophageal acid exposure and eliminated PPI use in majority of patients (16 of 
      21). Further, LES-EST was not associated with any gastrointestinal side effects 
      or adverse events.
CI  - Copyright (c) 2015 Elsevier Inc. All rights reserved.
FAU - Rodriguez, Leonardo
AU  - Rodriguez L
AD  - Department of Surgery, CCO Obesidad y Diabetes, Santiago, Chile. Electronic 
      address: doctor@leonardorodriguez.cl.
FAU - Rodriguez, Patricia
AU  - Rodriguez P
AD  - Department of Surgery, CCO Obesidad y Diabetes, Santiago, Chile.
FAU - Gomez, Beatriz
AU  - Gomez B
AD  - Department of Surgery, CCO Obesidad y Diabetes, Santiago, Chile.
FAU - Ayala, Juan C
AU  - Ayala JC
AD  - Department of Gastroenterology, Clinic Indisa, Santiago, Chile.
FAU - Oxenberg, Danny
AU  - Oxenberg D
AD  - Department of Gastroenterology, Clinic Indisa, Santiago, Chile.
FAU - Perez-Castilla, Alberto
AU  - Perez-Castilla A
AD  - Department of Gastroenterology, Clinic Indisa, Santiago, Chile.
FAU - Netto, Manoel G
AU  - Netto MG
AD  - Department of Surgery, Gastro Obeso Center, Sao Paulo, Brazil.
FAU - Soffer, Edy
AU  - Soffer E
AD  - University of Southern California, Los Angeles, CA.
FAU - Boscardin, W John
AU  - Boscardin WJ
AD  - University of San Francisco, San Francisco, CA.
FAU - Crowell, Michael D
AU  - Crowell MD
AD  - Mayo Clinic in Arizona, Scottsdale, AZ.
LA  - eng
SI  - ClinicalTrials.gov/NCT01578642
PT  - Clinical Trial
PT  - Journal Article
DEP - 20141106
PL  - United States
TA  - Surgery
JT  - Surgery
JID - 0417347
RN  - 0 (Proton Pump Inhibitors)
SB  - IM
CIN - Surgery. 2015 Nov;158(5):1448. PMID: 25912380
MH  - Adult
MH  - Aged
MH  - *Electric Stimulation Therapy/adverse effects
MH  - Esophageal Sphincter, Lower/*physiology
MH  - Female
MH  - Gastroesophageal Reflux/psychology/*therapy
MH  - Humans
MH  - Hydrogen-Ion Concentration
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Proton Pump Inhibitors/therapeutic use
MH  - Quality of Life
EDAT- 2015/03/03 06:00
MHDA- 2015/04/30 06:00
CRDT- 2015/03/02 06:00
PHST- 2014/07/29 00:00 [received]
PHST- 2014/10/22 00:00 [revised]
PHST- 2014/10/28 00:00 [accepted]
PHST- 2015/03/02 06:00 [entrez]
PHST- 2015/03/03 06:00 [pubmed]
PHST- 2015/04/30 06:00 [medline]
AID - S0039-6060(14)00708-9 [pii]
AID - 10.1016/j.surg.2014.10.012 [doi]
PST - ppublish
SO  - Surgery. 2015 Mar;157(3):556-67. doi: 10.1016/j.surg.2014.10.012. Epub 2014 Nov 
      6.