Karim S Trad, MD, Daniel S Turgeon, MD. Reston Hospital Center, Reston, Virginia
A retrospective study evaluated safety, symptom resolution, patient satisfaction and medication use after one to two years following transoral incisionless fundoplication (TIF) in patients with GERD and laryngopharyngeal (LPR) symptoms.
METHODS AND PROCEDURES:
Thirty-eight patients underwent TIF using EsophyX at our community-based hospital because they had persistent GERD and/orLPR symptoms, which were not controlled or only partially controlled on antisecretory medications, and were either dissatisfied with their current therapy or not willing to continue taking medication. The preoperative evaluation followed our routine protocol for surgical fundoplication patients and consisted of a complete history and physical, symptom assessment and gastroesophagael reflux evaluation by endoscopy, barium swallow, and manometry. Reflux measurement by pH testing was performed, if clinically required. The TIF procedure was considered appropriate as an alternative to laparoscopic fundoplication when the axial height of the hiatal hernia was ≤ 2 cm. Follow-up assessment consisted of symptom evaluation using three GERD-specific, validated questionnaires and was completed in 20 patients.
Median age was 59 (range 25-77) years, BMI was 25 (21-36) kg/m², and 50% were female. All patients had documented chronic GERD for a median 5 (1-15) years and refractory symptoms to proton pump inhibitors (PPIs). Hiatal hernia was present in 60% (12/20) of patients, and 20% (6/20) had erosive esophagitis (LA grade A or B). TIF was performed following a standardized TIF2 protocol and resulted in reducing hiatal hernia and restoring the natural anatomy of the GE junction (Hill grade I). There were no post-operative complications. At a median 14-month follow-up 85% (17/20) of patients were off daily PPIs (65% completely off PPIs), and 65% (13/20) were satisfied with their current health condition compared to 0% before TIF. Median GERD Health-related Quality of Life scores were significantly improved (reduced) to 6 (0-25) from 27 (0-45) before TIF (P < 0.001). Heartburn was eliminated in 68% (13/19) of patients and regurgitation in 80% (12/15). Atypical LPR symptoms such as hoarseness, coughing, and throat clearing were eliminated in 58% (11/19) of patients as measured by Reflux Symptom Index scores, which were significantly reduced to 4 (0-22) from 16 (3-42) pre-TIF (P < 0.001). High incidence of typical and atypical symptom resolution was also supported by GERD Symptom Scores [5 (0-25) vs. 24 (9-60) pre-TIF, P < 0.001].
Our preliminary outcomes are encouraging and document long-term symptomatic improvement of GERD and LPR symptoms following TIF and elimination of daily medication in 85% of patients.
Program Number: S004