Introduction: Transoral incisionless fundoplication (TIF) is a minimally invasive procedure for treatment of gastroesophageal reflux disease (GERD). Although studies have reported long-term durability and resolution of symptoms, the procedure carries a wide range of adverse events from mild to life-threatening. This study aims to evaluate the short-term outcomes of consecutive TIF procedures in a tertiary academic center. Methods: This is a retrospective study of patients who underwent TIF procedure by a single experienced gastroenterologist at a tertiary center in the United States from January 2018 to December 2021. Clinical success was defined as the ability to create a >=270° partial wrap with estimated longitudinal length of >=2cm. Short-term outcomes including patient symptoms or procedure related adverse events immediately to two months post-op were collected retrospectively. Results: Overall, 68 patients underwent 77 consecutive TIF procedures. The average age of patients was 52.35 ± 15.74 years (67.6% female). Technical success was achieved in 100% of the patients. 10.3% of the patients had a history of prior anti-reflux surgery. Chronic GERD was the main indication for TIF procedure. The majority of patients underwent TIF for Hill grade II and III flap valves, present in 62.5% and 25%, respectively. 50.6% of patients had post-procedure symptoms up to 2 months post-procedure including abdominal pain (28%), nausea/vomiting (14.3%), chest pain (10.4%), dysphagia/odynophagia (6.5%). There was a positive correlation between number of fasteners used and immediate abdominal pain (p=0.003), sore throat (p=0.024), and nausea/vomiting (p=0.046). Two patients developed major adverse events: one developed pneumoperitoneum and the second aspiration pneumonia complicated by flash pulmonary edema. Of the 29 patients with follow-up EGDs, 62.1% had an intact wrap (Hill I). There was no significant difference in the average number of fasteners in those with intact or loose wrap on follow up EGD (21.67 ± 5.1 vs. 22.8 ± 5.2, p=0.57). 9 patients (13.2%) underwent redo TIF and 2 (2.9%) proceeded with surgical fundoplication for persistent symptoms. (Table) Conclusion: Outcomes of TIF performed on a heterogeneous population in a tertiary academic center are comparable to outcomes reported from original randomized trials of TIF. Immediate adverse effects are common after TIF, but typically improve on long-term follow-up. Table 1. - Baseline patient characteristics and short-term post-TIF outcomes Patient summary characteristics: Gender (Female) 67.6% (n=46) Age [mean ± SD 52.35 ± 15.74 Race White 79.41% (n=54) Non-Hispanic 67.65% (n=46) BMI [mean ± SD] 27.7 ± 5.1 ASA Score II 69.1% (n=47) III 29.4% (n=20) IV 1.5% (n=1) Prior history of Barrett’s ablation 4.4% (n=3) Prior esophageal surgical intervention Nissen Fundoplication 8.8% (n=6) POEM- Nissen Fundoplication 1.5% (n=1) POEM 2.9% (n=2) Indication for TIF GERD 83.82% (n=57) Chronic cough +/- GERD 16.17% (n=11) Hernia HILL grade (if available): 1 25% (n=14) 2 62.5% (n=35) 3 8.9% (n=5) 4 3.6% (n=1) PH impedance or Bravo test (uninterpreTable (n=1); not performed due to presence of BE/esophagitis (n=5)) Acid 82.26% (n=51) Non-acid 17.74% (n=11) Procedure characteristics: Number of fasteners [mean ± SD] 23.1 ± 6.2 Median Hospital LOS (days) [min, max] 1 [0,10] Immediate outcomes post procedure-2 months(%): Immediate adverse events 50.6% (n=39) Immediate abdominal pain 28.6% (n=22) Immediate chest pain 10.4% (n=8) Immediate dysphagia/odynophagia 6.5% (n=5) Immediate sore throat 7.8% (n=6) Immediate Nausea/vomiting 14.3% (n=11) Follow-up Procedural outcomes (%): Post-TIF EGD performed 42.6% (n=29) Time interval between TIF and Follow up EGD 269.8 ± 205.1 Days Esophagitis on post-TIF EGD 10.3% (n=3) Intact wrap on post-TIF EGD 62.1% (n=18) >95% SAP on follow up PH testing (out of 18) 50% (n=9) Post-TIF surgical fundoplication (n) 2.9% (n=2) Repeat TIF patient characteristics: Repeat TIF required (n) 13.2% (n=9) Female Gender (%) 66.7% (n=6) BMI at initial TIF [mean ± SD] 29.4 ± 3.7 Age at initial TIF (median) [min,max] 53 [25,65] ASA score at initial TIF (median) [min,max] 2 [2,3] Number of fasteners (median) [min, max] Initial TIF 20 [14,34] Re-Do TIF 22 [8,28] Procedure length (median) [min, max] Initial TIF 47 [36,89] Re-Do TIF 45 [29,56]
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