Who are the PPI non-responders?

Paul D Colavita, MD1, Christy M Dunst, MD1, Maria A Cassera, BS1, Kristin W Beard, MD1, Ahmed M Sharata, MD1, Radu Pescarus, MD2, Kevin M Reavis, MD1, Valerie J Halpin, MD3, Lee L Swanstrom, MD1. 1Gastrointestinal and Minimally Invasive Surgery Division, The Oregon Clinic, 2Department of General Surgery, Hopital Sacre-Coeur, Montreal, QC, 3Legacy Weight and Diabetes Institute, Portland, OR

Objective: Proton pump inhibitor (PPI) response is often considered a diagnostic strategy for gastroesophageal reflux disease (GERD).  Patients who do not respond to PPI are often left with an uncertain diagnosis and untreated symptoms.  The aim of this study was to evaluate these patients with GERD symptoms refractory to PPI to determine diagnosis, GERD or otherwise, and to determine treatment efficacy.

Methods: A prospective database was queried for all patients referred for GERD from 2005-2013.  PPI non-responders were defined by daily heartburn and/or regurgitation despite daily PPI use.  All patients underwent evaluation with pH-MII, manometry, upper GI contrast study, and EGD per protocol with selective gastric emptying study. Objective and subjective data were collected from 1-24 months postoperatively.

Results: Of 1776 patients referred for GERD, 628 met criteria as non-responders.  Ten did not complete their work-up, and 6 were lost to follow-up, leaving 612 in the final cohort.  The following disorders were identified in non-responders: isolated GERD (359), paraesophageal hernia (PEH) (114), gastroparesis (80), achalasia and other isolated motility disorders (14), symptomatic cholelithiasis (2), and others (17).  Twenty-six patients had a negative work-up.

Surgical procedures were performed on 520 (85%) non-responders.  GERD patients underwent 310 anti-reflux procedures, 9 subtotal gastrectomies, and 6 anti-reflux procedures with cholecystectomy.  One-hundred and twelve additional patients had PEH repairs with fundoplication.  Patients with gastroparesis underwent 50 pyloroplasties with anti-reflux procedures, 6 isolated pyloroplasties, 1 gastric stimulator placement, and 8 subtotal gastrectomies.  Seven Heller myotomies and 5 peroral endoscopic myotomies were performed for isolated gastroesophageal outflow obstruction. Six patients with other diagnoses underwent procedures.

For GERD patients, 98% had substantial improvement or complete resolution of their heartburn and regurgitation, with average symptom score follow-up of 7.3 months.  All patients with gastroparesis who underwent procedures had substantial improvement or complete resolution of their heartburn and regurgitation, with average follow-up of 7.1 months.  There was no 30 day mortality.

Conclusions: Fifty-nine percent of patients who present with GERD symptoms refractory to PPI therapy have objective isolated GERD while only 4.2% have a negative comprehensive evaluation. Twenty-eight percent have GERD and PEH or concurrent gastroparesis, which may explain the poor PPI response. After careful evaluation, 94% of non-responders will have a surgical diagnosis identified. Importantly, patients with objectively confirmed PPI refractory GERD enjoy excellent results with surgical therapy. Overall, the lack of PPI response should not exclude patients from further foregut evaluation as most will have a treatable disorder.

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