Electrical Stimulation Therapy (est) of the Lower Esophageal Sphincter (LES) – Emerging Treatment for Preventing GERD in Achalasia Patients Treated With Les Mytomy

Objective of the technology or device – EST of LES is an effective treatment for GERD (Am J Gastro 2011; 106: S6). Chronic LES-EST improves LES pressure, reduces esophageal acid exposure and improves symptoms in GERD patients. Our objective was to see if LES-EST can control GERD in a patient treated with Heller myotomy who developed severe GERD due to failed fundoplication.

Description of the technology and method of its use or application – EndoStim LES stimulation system (EndoStim BV, The Hague, Netherlands) consists of bipolar stitch electrodes, an implantable pulse generator (IPG) and a programmer for wireless programming of the device. Patient was a 32 y/o Caucasian female with 15 year history of achalasia, treated 10 years ago with Heller myotomy with partial fundoplication. For the last 5 years patient had significant reflux due to the failure of her wrap that was uncontrolled with supramaximal medical therapy (Omeprazole 80-100mg in divided doses). Esophageal manometry showed Type-II achalasia and pH testing showed free reflux with poor clearance. After IRB approval for humanitarian use, the patient underwent EndoStim implant . Laparoscopy revealed loose fundoplication with visible sutures. The wrap was carefully dissected exposing the right anterior surface of the LES. Bipolar stitch electrodes were laparoscopically placed in the muscularis propria of the LES and the IPG was placed subcutaneously in the anterior abdominal wall. EST at 20 Hz, 215usec, 5 mAmp in 30 minutes sessions was delivered in cyclic mode every 2 hours starting on day 1 post-implant. The patient was evaluated using GERD-HRQL, symptom diaries, esophageal pH and high resolution manometry at baseline and follow-up.

Preliminary results– The patient had an uneventful recovery and was discharged home on post-op day 2 on omeprazole 20mg qd. At 3-weeks follow-up patient reported significant improvement, with her GERD symptoms controlled on PRN antacids without the need for omeprazole. GERD-HRQL at 3-week follow-up was 11 (baseline HRQL on PPI=31 and off-PPI=42); 4 points on her GERD-HRQL were attributable to her dysphagia due to achalasia (no change in GERD-HRQL dysphagia score compared to baseline). Patient’s high-resolution manometry at 3-week follow-up revealed LES end-expiratory pressure of 7.7mm Hg (baseline 2.8) and mean pressure of 14mm Hg (baseline 5.8). There was no change in body manometry with100% aperistaltic swallows both at baseline and 3-week follow-up. Patient’s esophageal pH<4.0 measured using tube pH improved from 39% at baseline to 0% at 3 week follow-up.

Conclusions / future directions – These very preliminary results suggest that LES-EST may be effective in preventing post-myotomy GERD in patients with Achalasia. LES-EST may have an important role in both primary treatment of Achalasia in combination with an LES myotomy and those that develop GERD post-myotomy due to failure of their fundoplication. This patient also establishes the technical feasibility of EndoStim lead implant in patient with fundoplication failure and maybe a less invasive option for GERD patient needing redo-fundoplication. Additional patients with these conditions will be studied to conclusively establish the role of LES-EST in patients with Achalasia and fundoplication failure.

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