Marcia I. Canto, Olaya I. Brewer Gutierrez, Mohamad Dbouk, Vivek Kumbhari, Mouen A. Khashab, Anthony N. Kalloo
Published clinical trials of transoral incisionless fundoplication (TIF) in GERD patients using older devices and techniques reported symptom improvement, but with variable effectson proton pump inhibitor (PPI) cessation and esophageal acid exposure. There are limited data on the outcomes of modern TIF performed by a therapeutic endoscopist usingimproved devices and techniques.
Aim: We evaluated the safety and efficacy of TIF performed for treatment of GERD.
Methods: From September 2017, consecutive patients withrefractory GERD/LPRD were enrolled into a prospective cohort study conducted in an academic tertiary referral center. Baseline clinical data, GERD questionnaires (GERD-HQRLand Reflux Symptom Index or RSI), endoscopy, Bravo wireless or pH impedance testing were recorded. TIF 2.0 (creation of a gastroesophageal plication with at least 270 degreewrap function and a 3 cm high pressure zone) was performed by a therapeutic endoscopist using the EsophyxZ or EsophyxZ+(Endogastric Solutions) devices under generalanesthesia. Patients were observed then discharged when possible. We excluded patients with negative pH testing, > 2 cm hiatal hernia, Hill grade > 2, BMI > 35, jackhammeresophagus, moderate to severe ineffective esophageal motility, achalasia post per-oral endoscopy myotomy (POEM), and eosinophilic esophagitis. Patients with non-dysplasticBarrett’s esophagus (BE) had ablation and achieved complete eradication prior to TIF. Treatment response was assessed at a minimum 6 months (with GERD surveys, EGD andBravo pH testing) or last follow-up (GERD surveys). Efficacy was assessed by GERD phenotype.
Results: Of 257 patients screened for TIF, 51 patients met criteria and underwentTIF (Table 1). Technical success rate=50/51(98%). Median procedure time was 48 min (QR 36-61) after the first 20 cases. All patients were discharge home from the PACU or after23-hour observation. There were no treatment related serious adverse events. 3 (5.8%) patients had intra-procedural mild bleeding responding to endoscopic therapy. Median follow-up time was 11.5 months. In 31 evaluable patients with at least 6 months follow-up, symptom control in refractory GERD and LPRD was achieved in 90% (GERD-HQRL 90%) and95% (RSI), respectively. PPI use was eliminated or reduced in 94%. Esophageal acid exposure time was normalized or reduced in 72%. Overall response rates in patients with refluxchest pain syndrome (n=4, 100%),regurgitation-predominant GERD (n=10, 90%), LPRD (n=4,100%), BE (n=8, 88%), >= 30 fasteners (n=13, 92%), >=3cm valve length n=13, 94%),and >270 degree valve circumference (n=14,93%) were high. 6(12%) patients required repeat TIF(n=3) or surgery(n=3) within 1 year.
Conclusions: Our early experience suggeststhat TIF 2.0 is a viable, efficient, safe, and effective alternative intervention for selected patients with refractory GERD and LPRD.