Abstract Introduction Transoral incisionless fundoplication (TIF) is FDA-approved for patients with hiatal hernia < 2 cm. The American Foregut Society (AFS) recommends TIF only for those with Hill Grade (HG) ≤ 2 and advises cruroplasty for HG ≥ 3, regardless of hernia size. However, many patients may decline or be unfit for surgery. We conducted a systematic review and individual patient data (IPD) pooled analysis to assess the efficacy of TIF 2.0 in patients with severe GERD and HG III anatomy. Method A systematic search of PubMed and EMBASE through May 2023 identified studies evaluating TIF 2.0. Studies involving cruroplasty (cTIF) or other endoscopic therapies were excluded. Authors of eligible studies were contacted to provide IPD for patients with HG III. The primary outcome was complete cessation of proton pump inhibitors (PPIs). Secondary outcomes included technical success, GERD metrics, HG classification post-TIF, adverse events, and need for reintervention. Results Twenty-three studies met inclusion criteria and 4 provided IPD for 28 patients with HG III anatomy. Mean age and BMI were 51.1 years and 26.5 kg/m², respectively. Technical success was 100%. At 6 months, PPI cessation rate was 13/27 (46.4%). PPI recidivism occurred in 5/27 patients. Mean esophageal pH improved significantly from 11.9 to 7.5 ( p = 0.024). GERD Health-related Quality of Life (GERD-HRQL) scores improved from 29.5 to 14.0 ( p = 0.097). Thirteen of 20 patients improved to HG I–II. One patient (3.7%) required surgical revision. Conclusions Our findings support AFS recommendations for preoperative HG assessment. TIF may remain a viable adjunct to PPI therapy in select non-surgical candidates with hernia < 2 cm.
Gao et al. (Tue,) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: