Nguyen, Ninh T.

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) >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 (<13), 2) improvement in cough sub-scores of RSI (decrease ≥ 2 points or to 0 on a 5-point scale), 3) GERD symptom improvement (>50% decrease in GERD-HRQL, or < 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 < 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 <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<0.0001). Patients with regurgitation phenotype were more likely to have a favorable cough response at 6 months (p<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.

Abstract Background and study aims Concomitant hiatal hernia (HH) repair with transoral incisionless fundoplication (TIF) is a therapeutic option for patients with HH > 2 cm and gastroesophageal reflux disease (GERD). Data comparing this approach with laparoscopic Nissen fundoplication (LNF) are lacking. We performed an exploratory analysis to compare these two approaches' adverse events (AEs) and clinical outcomes. Patients and methods This was a multicenter retrospective cohort study of HH repair followed by LNF versus HH repair followed by TIF in patients with GERD and moderate HH (2–5 cm). AEs were assessed using the Clavien-Dindo classification. Symptoms (heartburn/regurgitation, bloating, and dysphagia) were compared at 6 and 12 months. Results A total of 125 patients with HH repair with TIF and 70 with HH repair with LNF were compared. There was no difference in rates of discontinuing or decreasing proton pump inhibitor use, dysphagia, esophagitis, disrupted wrap, and HH recurrence between the two groups (P > 0.05). The length of hospital stay (1 day vs. 2 days), 30-day readmission rate (0 vs. 4.3 %), early AE rate (0 vs. 18.6 %), and early serious AE rate (0 vs. 4.3 %) favored TIF (all P < 0.05). The rate of new or worse than baseline bloating was lower in the TIF group at 6 months (13.8 % vs. 30.0 %, P = 0.009). Conclusions Concomitant HH repair with TIF is feasible and associated with lower early and serious AEs compared to LNF. Further comparative efficacy studies are warranted.

Background: The American Foregut Society (AFS) is dedicated to advancing patient care and digestive health within the realm of foregut disease. One of the most common and debilitating esophageal conditions is gastroesophageal reflux disease (GERD). The Hill grade is an endoscopic classification of the esophagogastric junction (EGJ) based on the appearance of the gastroesophageal flap valve from a retroflexed view of the hiatus. This endoscopic classification provides insight into the anatomic disruption of the EGJ which has been shown to correlate with GERD. However, clinical utilization of this classification by endoscopists has been limited due to the perceived relevance and subjectivity of the classification. With the advent of endoscopic treatment options for GERD, there is renewed enthusiasm to develop a grading system of the EGJ that can objectively define anatomical impairment and reduce interobserver grading variability. Methods: The AFS convened a 13-member working group tasked with reviewing the Hill grade classification and formulating a proposal for its revision utilizing a modified Delphi method. This white paper summarizes the output from this working group. Results: The working group concluded that all components of the antireflux barrier—the lower esophageal sphincter and its sling fibers, the crural diaphragm, and the gastroesophageal flap valve—contribute to EGJ integrity. Using defined objective parameters of extent of hiatal axial herniation and crural disruption and presence or absence of a flap valve, the new AFS classification stratifies EGJ integrity from normal (grade 1) to increasing degrees of EGJ disruption (grade 2-4) beginning with loss of the flap valve and progressing to increasing degrees of crural disruption and hiatus hernia. This AFS classification also stipulates appropriate endoscopic methodology to utilize in making the assessment and provides a basic nomenclature for communication among endoscopists. Conclusions: The AFS endoscopic classification of the EGJ expands on the Hill classification by including assessment of axial hiatal hernia length (L), hiatal aperture diameter (D), and presence or absence of the flap valve (F) making it more comprehensive - LDF components. Future directions include validation studies correlating the ability of the AFS classification in predicting the presence and severity of GERD.