Lower Esophageal Sphincter (LES) Electrical Stimulation Improves Sleep Quality and Work Productivity in Patients with Refractory GERD.

Nicole Bouvy (1), Nicolaas F Rinsma (1), Alex Escalona (2), Jelle P Ruurda (3), Jose Conchillo (1), Arjan Bredenoord (4), Mark van berge Henegouwen (4), Philip Chiu (5), Michael Booth (6), Albis Hani (7), D N Reddy (8), Andre Smout (4), Justin Wu (5), Peter D Siersema (4). 1Maastricht Uni Med Ctr. 2Pontificia Uni Catolica de Chile. 3Uni Med Ctr Utrecht. 4Academic Med Ctr Amsterdam. 5Chinese Uni of Hong Kong. 6Waitemata Specialist Ctr Auckland NZ. 7Pontificia Uni Javeriana Bogota, COL. 8Asian Inst. of Gastro Hyderabad IN.

INTRODUCTION: Sleep-Quality and Work-Productivity are commonly affected in refractory GERD patients.

AIM: To evaluate Sleep-Quality and Work-Productivity in refractory GERD patients undergoing long-term electrical stimulation therapy (EST) of the LES using the EndoStim® LES Stimulation System (EndoStim BV, the Hague, Netherlands).

METHODS: We studied GERD patients (n=35) partially responsive to PPI with Off-PPI GERD HRQL>20 and at least 5 point improvement on PPI, LES end-expiratory pressures of >5 mmHg, % 24 hour esophageal pH<4 for >5%, hiatal hernia< 3cm and esophagitis< LA Grade-C. Bipolar stitch electrodes and a pulse generator were implanted laparoscopically. EST at 20 Hz, 220usec, 5 mAmp in 12, 30-minute sessions was initiated post-implant. Patients completed the Pittsburgh Sleep Quality Index (PSQI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem V2.0 (WPAI:SHP) On-PPI and Off-PPI at baseline, and at 6 and 12-month on LES-EST.

RESULTS: Subjects sleep-scores [PSQI; median (IQR)] at baseline On-PPI was 5.5(4-10), which worsened to 8(5.8-11) when Off-PPI. At 6-month, sleep scores improved to 5(3-6.8), which was significantly better that both On-PPI (p=0.04) and Off-PPI (p=0.02) scores at baseline. This improvement was sustained at 12-month follow-up; 5(2.8-7.2; p=0.2 vs. On-PPI and p=0.05 vs. Off-PPI). At baseline 50% and 75% of patients had abnormal sleep scores On and Off-PPI, respectively, which decreased to 41% on LES-EST at 6-months and 50% at 12-months.

Patients’ median %time missed from work due to GERD at baseline was 0(0-8.5)% On-PPI and 3.8(0-11.3)% Off-PPI. At 6-months, this improved to 0(0-0)% (n=14; p=0.04 vs. off-PPI) and was sustained at 12months 0 (0-0)% (n=7; p=0.10 vs. off-PPI). Median percent impairment while working due to GERD at baseline was 20 (0-50) % on-PPI and 60 (25-80)% off-PPI. At 6-months, this improved to 0 (0-7.5) (n=14; p=0.07 vs. On-PPI and p=0.006 vs. Off-PPI) and remained 0(0-5) at 12-months (n=8; p=0.3 vs. On-PPI, p=0.2 vs. Off-PPI).

Percent overall work impairment incorporates time missed and subjects’ perceived impairment at work. Median % of overall impairment due to GERD at baseline was 20(5-58)% On-PPI and 63(31-82)% Off-PPI. At 6-monthss, this improved to 0(0-7.5)% (n=14; p=0.05 vs. baseline On-PPI and p=0.006 vs. Off-PPI) and remained [0(0-0)%; n=8; p=0.04 vs. On-PPI, p=0.10 vs. Off-PPI] at 12-months.

Subjects reported a median % activity impairment due to GERD of 30(10-50)% On-PPI and 60(30-80)% Off-PPI at baseline. This improved to 0(0-20)% at their 6-month evaluation, (n=25; p=0.04 vs. On-PPI, p<0.001 vs. Off-PPI) and remained improved 5(0-32.5)% at the 12-month follow-up (n=16; p=0.05 vs. On-PPI, p=0.03 vs. Off-PPI).

There was concomitant improvement in all standard GERD outcomes.

CONCLUSION: LES-EST significantly improves sleep-quality, work-productivity and overall impairment of activity due to GERD in refractory GERD patients. These results were significantly better than baseline PPI therapy.