MUSE procedure results in significant pH response


Patient Background
39 year old woman, 4’ 10”, BMI =23 suffered from severe daily GERD symptoms for approximately 10 years. The DeMeester score was 93.2 off PPI. High Resolution Manometry showed an elevated lower esophageal sphincter basal pressure of 46.5mmHg and no evidence of primary motility disorder. Pre-procedure medications: Ranitidine 150mg , Sucralfate 1 gram, Omeprazole 40mg all taken daily. Medical history includes resection of right vocal cord cyst, associated with prolonged acid reflux, and a deviated septum repair in 2008. The patient was initially placed on Zantac 150mg daily post vocal cord cyst resection. Subsequently in 2014, patient was found to have two new cysts, on the right and left vocal cords, despite anti-reflux medications.

A 48-hour pH study report on 4/21/2014 revealed a total fraction time of pH<4 of 24.1% (normal value 4.9%) with a total of 863 reflux episodes (normal value: 104). The patient had 16 episodes of reflux, which were longer than 5 minutes with the longest reflux duration being 36 minutes. The study was performed off PPI for 7 days and off H2 blockers for 3 days. The patient had high symptom association with regurgitation and chest pain.

Treatment
The procedure was conducted under general anesthesia. Patient was administered 10mg Decadron and 8mg Zofran to manage post-operative nausea. EGD inspection showed no evidence of esophagitis or hiatal hernia and GEJ valve estimated as Hill Grade II (esophageal mucosa could be seen around the endoscope in retrograde view).

The MUSE device was inserted through an over tube. The device was retroflexed to identify a suitable location for stapling. Using the built-in ultrasound and stapler, four quintuplets of staples were deployed to attach the fundus to the esophagus in a semi-circle.
Pre and Post MUSE procedure  



A gastroscope was used to examine the integrity of the staples deployed. The time from insertion of the device to the
completion of each staple quintuplet was progressively shorter, consistent with a relatively short learning curve: Stapling 1 -33 minutes; Stapling 2 – 20 minutes; Stapling 3 – 15 minutes; Stapling 4 – 10 minutes. The four quintuplets were deployed between 20 and 60 degrees apart, 2-3cm above the GEJ junction. The post procedure image demonstrates the anterior fundoplication. The patient experienced minimal self-limited asymptomatic post-operative pneumoperitoneum, which resolved completely within 48 hours. The patient was discharged home the next day. Upon discharge the patient diet was restricted to clear fluids for 48 hours, full liquids for one week, pureed foods for 10 days, soft foods for 2 weeks, at which point she was advanced to a regular diet. The patient experienced intermittent mild left shoulder and arm pain, treated with Tylenol with codeine elixir as needed. The left shoulder and arm pain spontaneously resolved two weeks post procedure.

Outcomes
MUSE procedure outcome
Pre-MUSE procedure 48-hour pH study report:
Pre-MUSE procedure 48 hour ph study report


Two months post-MUSE procedure 48 hour pH study report:
Two months post MUSE procedure 48 hours ph study report

MKTMUSE12 Rev B  Page 2 of 2