493. EFFECTIVENESS OF TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) WITHOUT OR WITH HIATAL HERNIA REPAIR (CTIF) IN PATIENTS WITH GERD AND CHRONIC COUGH
Authors: Swei Eric , Almario Jose Antonio , Dunbar Kerry , Yadlapati Rena , Parker Brett , Brewer-Gutierrez Olaya , Janu Peter , Murray Michael , Sohagia Amit , Diehl David , Khara Harshit , Abu-Dayyeh Barham , Sharaiha Reem , Zarnegar Rasa , Ihde Glenn , Kolb Jennifer , Nguyen Ninh , Chang Kenneth , Canto Marcia Irene 
Published: September 2024

Abstract

Background
GERD is a common cause of chronic cough. Although barrier therapy with laparoscopic fundoplication is highly effective for typical GERD symptoms, the response rates are variable for chronic cough. We hypothesized that transoral incisionless fundoplication (TIF) or TIF with hiatal hernia repair (cTIF) may be a suitable alternative for medically refractory cough associated with GERD.

Aim
We prospectively s studied the effectiveness and safety of TIF/cTIF in patients with chronic cough and proven GERD.

Methods
Patients with GERD and extra-esophageal symptoms from 10 academic and community medical centers (TIF Registry), elevated GERD-HRQL score +/- Reflux Symptom Index (RSI) &gt;13 and pathologic reflux by esophageal pH-metry, or erosive esophagitis/Barrett’s esophagus were evaluated before and after a minimum 6 months post TIF/cTIF performed by gastroenterologists and surgeons. Patients with history of prior foregut/bariatric surgery, chronic obstructive or interstitial lung disease, or prior lung transplant were excluded. The primary outcome was improvement in RSI score at last follow-up compared to baseline. Secondary outcomes were: 1) normalization of RSI (&lt;13), 2) improvement in cough sub-scores of RSI (decrease ≥ 2 points or to 0 on a 5-point scale), 3) GERD symptom improvement (&gt;50% decrease in GERD-HRQL, or &lt; 2 in all sub-scores) 4) discontinuation of proton pump inhibitor (PPI), and 5) overall patient satisfaction. We further analyzed response in patients with cough-predominant phenotype (chief complaint of cough and RSI troublesome cough subscore ≥2).

Results
198 patients with cough and GERD successfully underwent TIF/cTIF (Table 1) without serious adverse events. Greater than 6-month follow-up was available for 177 patients at a median of 12 months [IQR 6,12]. Median RSI score decreased from 18 [IQR 13, 27] to 5 [IQR 2, 11] (p &lt; 0.0001), median change 11 [IQR5,11]. 83% of patients with elevated baseline RSI normalized their scores. 75% of patients had improvement of cough when lying down (median: 1 point [IQR 0,3]), and 72% of patients had improvement of troublesome cough (median: 1 point [IQR 1,3]). 83% of patients successfully discontinued or decreased PPI to occasional use. Patient satisfaction improved from a baseline of 5.6% to 68.8% (p &lt;0.0001). Compared to patients without cough-predominant symptoms, cough-predominant patients (n=108) experienced an additional 4.2-point decrease in in RSI score (p = 0.01) and 1.5-point decrease in troublesome cough sub-scores (p&lt;0.0001). Patients with regurgitation phenotype were more likely to have a favorable cough response at 6 months (p&lt;0.0001). In appropriately selected patients, cTIF and TIF were comparable for cough, GERD-HRQL, RSI, and PPI responses.

Conclusion
TIF/cTIF are effective and safe alternative barrier therapies for patients with pH-positive cough-predominant GERD.