Transoral incisionless fundoplication (TIF) appears to be a safe long-term therapeutic option for selected patients with gastroesophageal reflux disease (GERD) who refuse lifelong medical therapy or surgery, are intolerant to proton pump inhibitors (PPIs), or have an increased surgical risk, according to a study in Endoscopy International Open.
Researchers conducted a literature search through May 2020 for studies that reported outcomes of TIF beyond 3 years. They pooled data regarding patient satisfaction, PPI daily consumption, PPI use reduction, GERD-Health-Related Quality of Life (GERD-HRQL) score, and normalization of heartburn and regurgitation scores.
A total of 8 studies (418 patients, 55.5% men) with a mean follow-up of 5.3 years (range, 3-10 years) were included in the analysis. Patients had a median and mean, respectively, age of 44.6 years (range, 19-79; 4 studies) and 47.1 years (±13.2; 3 studies), body mass index of 25.9 kg/m2 (range, 17.1-36.0) and 25.9 kg/m2 (± 4.1), and GERD duration of 4.8 years (range, 0.5-25 years) and 11.2 (±9.8 years).
Before and after the TIF procedure, the pooled rate of patient satisfaction was 12.3% (95% CI, 12.3-35.1, I2 = 87.4%) and 70.6% (95% CI, 51.2-84.6, I2 = 80%), respectively, corresponding with an odds ratio of 21.4 (95% CI, 3.27-140.5). Pooled rates of patients who were completely off PPIs or occasionally used PPIs were 53.8% (95% CI, 42.0-65.1) and 75.8% (95% CI, 67.6-82.6), respectively.
Participants’ pooled estimated mean GERD-HRQL scores off PPI before and after TIF were 26.1 and 5.9, respectively (P <.001). The overall pooled rates of heartburn and regurgitation scores normalization were 73.0% (95% CI, 0.62-0.82) and 86%, respectively (95% CI, 75.0-91.0).
“TIF resulted in long-term patient satisfaction rates of 74% to 86%, with interruption/reduction of PPI in about 75% of cases at 3 and 4 to 5 years, and with a significant and persistent improvement in GERD-related symptoms and quality of life in four-fifths and two-thirds of patients at 4 to 5 and 10 years, respectively,” stated the investigators. “These results are clinically relevant because they show that the satisfactory outcomes reported after TIF in the short term are maintained even in the long term, arguing in favor of TIF as an effective alternative to surgery in selected patients.”
Among several study limitations, the long-term follow-up in most included studies rarely included a complete clinical assessment, such as an endoscopic or functional evaluation. Also, the researchers observed a high heterogeneity across studies for patients’ reported overall satisfaction after TIF.
“This meta-analysis showed that pooled long-term post-TIF data seem sufficient to confirm that TIF appears to offer a therapeutic option as effective as surgery in the long term and safe for selected symptomatic patients with GERD, with a Hill grade I or II gastroesophageal valve, or a hiatal hernia no longer than 2.5 cm, who refuse life-long medical therapy or surgery, are intolerant to PPIs, or are at risk of persistent postsurgical side effects,” the study authors concluded.
Testoni S, Hassan C, Mazzoleni G, et al. Long-term outcomes of transoral incisionless fundoplication for gastro-esophageal reflux disease: systematic-review and meta-analysis. Endosc Int Open. 2021;9(2):E239-E246. doi: 10.1055/a-1322-2209