PMID- 23073680
OWN - NLM
STAT- MEDLINE
DCOM- 20130923
LR  - 20211021
IS  - 1432-2218 (Electronic)
IS  - 0930-2794 (Print)
IS  - 0930-2794 (Linking)
VI  - 27
IP  - 4
DP  - 2013 Apr
TI  - Electrical stimulation therapy of the lower esophageal sphincter is successful in 
      treating GERD: final results of open-label prospective trial.
PG  - 1083-92
LID - 10.1007/s00464-012-2561-4 [doi]
AB  - BACKGROUND: Electrical stimulation of the lower esophageal sphincter (LES) 
      improves LES pressure without interfering with LES relaxation. The aim of this 
      open-label pilot trial was to evaluate the safety and efficacy of long-term LES 
      stimulation using a permanently implanted LES stimulator in patients with 
      gastroesophageal reflux disease (GERD). METHODS: GERD patients who were at least 
      partially responsive to proton pump inhibitors (PPI) with abnormal esophageal pH, 
      hiatal hernia </= 3 cm, and esophagitis </= LA grade C were included. Bipolar stitch 
      electrodes were placed in the LES and an IPG was placed in a subcutaneous pocket. 
      Electrical stimulation was delivered at 20 Hz, 215 mus, 3-8 mA in 30 min sessions. 
      The number and timing of sessions was tailored to each patient's GERD profile. 
      Patients were evaluated using GERD-HRQL, daily symptom and medication diaries, 
      SF-12, esophageal pH, and high-resolution manometry. RESULTS: 24 patients (mean 
      age = 53 years, SD = 12 years; 14 men) were implanted; 23 completed their 6-month 
      evaluation. Median GERD-HRQL scores at 6 months was 2.0 (IQR = 0-5.5) and was 
      significantly better than both baseline on-PPI [9.0 (range = 6.0-10.0); p < 
      0.001] and off-PPI [23 (21-25); p < 0.001] GERD-HRQL. Median% 24-h esophageal pH 
      < 4.0 at baseline was 10.1 and improved to 5.1 at 6 months (p < 0.001). At their 
      6-month follow-up, 91 % (21/23) of the patients were off PPI and had 
      significantly better median GERD-HRQL on LES stimulation compared to their on-PPI 
      GERD-HRQL at baseline (9.0 vs. 2.0; p < 0.001). There were no unanticipated 
      implantation- or stimulation-related adverse events or untoward sensation due to 
      stimulation. There were no reports of treatment-related dysphagia, and manometric 
      swallow was also unaffected. CONCLUSIONS: Electrical stimulation of the LES is 
      safe and effective for treating GERD. There is a significant and sustained 
      improvement in GERD symptoms, esophageal pH, and reduction in PPI usage without 
      any side effects with the therapy. Furthermore, the therapy can be optimized to 
      address an individual patient's disease.
FAU - Rodriguez, Leonardo
AU  - Rodriguez L
AD  - Department of Surgery, Centro Clinico de Obesidad (CCO), Obesidad Y Diabetes, 
      Estoril N degrees  120 Of. 814, Las Condes, Santiago, Chile. doctor@leonardorodriguez.cl
FAU - Rodriguez, Patricia
AU  - Rodriguez P
FAU - Gomez, Beatriz
AU  - Gomez B
FAU - Ayala, Juan C
AU  - Ayala JC
FAU - Saba, Jorge
AU  - Saba J
FAU - Perez-Castilla, Alberto
AU  - Perez-Castilla A
FAU - Galvao Neto, Manoel
AU  - Galvao Neto M
FAU - Crowell, Michael D
AU  - Crowell MD
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20121017
PL  - Germany
TA  - Surg Endosc
JT  - Surgical endoscopy
JID - 8806653
SB  - IM
CIN - Endoscopy. 2013;45(4):272-5. PMID: 23533074
MH  - *Electric Stimulation Therapy/adverse effects/instrumentation
MH  - *Esophageal Sphincter, Lower
MH  - Female
MH  - Gastroesophageal Reflux/*therapy
MH  - Humans
MH  - *Implantable Neurostimulators
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Treatment Outcome
PMC - PMC3599161
EDAT- 2012/10/18 06:00
MHDA- 2013/09/24 06:00
PMCR- 2012/10/17
CRDT- 2012/10/18 06:00
PHST- 2012/06/27 00:00 [received]
PHST- 2012/08/21 00:00 [accepted]
PHST- 2012/10/18 06:00 [entrez]
PHST- 2012/10/18 06:00 [pubmed]
PHST- 2013/09/24 06:00 [medline]
PHST- 2012/10/17 00:00 [pmc-release]
AID - 2561 [pii]
AID - 10.1007/s00464-012-2561-4 [doi]
PST - ppublish
SO  - Surg Endosc. 2013 Apr;27(4):1083-92. doi: 10.1007/s00464-012-2561-4. Epub 2012 
      Oct 17.