Reginald Bell, MD, Katherine Freeman, MSN, FNP, Rachel Heidrick, RN
Institute of Esophageal and Reflux Surgery, Englewood, CO
Introduction: Transoral Fundoplication (TIF 2.0) has become an accepted procedure to treat GERD. Long-term data on clinical success has been limited. We report results on 154 patients followed up to 9 years.
Methods: IRB approved retrospective study of prospective registry patients undergoing TIF 2.0 (without hernia repair) at single institution between 1/2008 and 7/2015. Perioperative complications, need for reintervention, and clinical response measured by GERD-HRQL and Regurgitation scores used in prior TIF studies, and changes in pH parameters were primary outcome measures.
Results: 154 patients with objectively documented GERD (88 F, mean age 54 (17-81), mean BMI 27 (19.6-38) underwent TIF 2.0 with the EsophyX-2 device. Using a combination of a caudal helical retractor, caudally-directed external advancement of the device to which the esophagus was adherent by suction, and a rotational movement of the tissue mold around one single helix engagement at 12o’clock position, the fundus of the stomach was partially rotated around the distal esophagus and secured with multiple 6.5mm H-shaped polypropylene fasteners.
131 (85%) patients were available for clinical follow-up at up to 9 years (0.7-9.7, Med 4.7, IQR 2-6.7); 75 (49%) were followed > 5 years. 29 (19.3%) patients underwent laparoscopic fundoplication at median of 465 days after TIF (93-2643). QOL results were similar in this group. (Figure 1).
At a median of 4.7 years after TIF, GERD-HRQL and Regurgitation scores decreased by >50% in 70% and 78%. Figure 2 shows GERD-HRQL scores by year.
Bloating by GERD-HRQL (score >2) decreased from 46% (58/126) preop to 18% (23/127) of patients postop.
89% (137/154) presented with medically refractory GERD. 72% of patients not undergoing reoperation were not using PPIs and 2 (2%) prn PPI at follow-up.
101 patients had pH testing at a mean of 20 months [1-94 R] post-procedure. Worst day DeMeester score decreased from a median of 32.7 [IQR 23.5-50] to 19.7 [IQR 7.4-35], p< 0.001, with 41/101 (41%) normalized.
3 complications required re-intervention: a GI bleed clipped endoscopically, an immediate laparoscopic repair of an esophageal leak, and an abscess at 5 days requiring laparoscopic drainage, repair, and fundoplication.
Discussion: Primary TIF 2.0 technique is durable with stable improvement in QOL and PPI use at up to 9 years, including 76/150 (51%) of patients followed >5 years. 72% non-reoperated TIF patients remained off PPI at up to 9 years of follow-up.
Citation: Reginald Bell, MD, Katherine Freeman, MSN, FNP, Rachel Heidrick, RN. P1166 - DURABILITY OF TRANSORAL FUNDOPLICATION (TIF 2): 154 PATIENTS FOLLOWED UP TO 9 YEARS. Program No. P1166. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.