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Meta-Analysis
. 2023 Mar;97(3):394-406.e2.
doi: 10.1016/j.gie.2022.11.002. Epub 2022 Nov 17.

Impact of second-generation transoral incisionless fundoplication on atypical GERD symptoms: a systematic review and meta-analysis

Muhammad Haseeb  1 , Jeremy R Glissen Brown  2 , Umar Hayat  3 , Camden Bay  4 , Paul A Bain  4 , Pichamol Jirapinyo  1 , Christopher C Thompson  1
Affiliations
Meta-Analysis

Impact of second-generation transoral incisionless fundoplication on atypical GERD symptoms: a systematic review and meta-analysis

Muhammad Haseeb et al. Gastrointest Endosc. 2023 Mar.

Abstract

Background and aims: Transoral incisionless fundoplication (TIF) using the EsophyX device (EndoGastric Solutions, Inc, Redmond, Wash, USA) is a minimally invasive endoscopic fundoplication technique. Our study aimed to assess the efficacy of TIF for atypical GERD symptoms in patients with chronic or refractory GERD.

Methods: A systematic search of 4 major databases was performed. All original studies assessing atypical GERD using a validated symptom questionnaire (the reflux symptom index [RSI]) were included. The RSI score was assessed before and after TIF at a 6- and 12-month follow-up. Data on technical success rate, adverse events, proton pump inhibitor (PPI) use, and patient satisfaction were also collected. Only TIF procedures currently in practice using the EsophyX device (ie, TIF 2.0) and TIF with concomitant hiatal hernia repair were included in the review.

Results: Ten studies (564 patients) were included. At the 6- and 12- month follow-up, there was a mean reduction of 15.72 (95% confidence interval, 12.15-19.29) and 14.73 (95% confidence interval, 11.74-17.72) points, respectively, in the RSI score post-TIF, with a technical success rate of 99.5% and a pooled adverse event rate of 1%. At both time intervals, more than two-thirds of the patients were satisfied with their health condition and roughly three-fourths of the patients were off daily PPIs.

Conclusions: Our study shows that TIF using the EsophyX device is safe and effective in reducing atypical GERD symptoms at 6 and 12 months of follow-up. It improves patient-centered outcomes and can be a minimally invasive therapeutic option for patients suffering from atypical GERD symptoms on chronic medical therapy.

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Conflict of interest statement

Conflict of Interest:

MH: None

JGB: None

UH: None

CB: None

PAB: None

PJ: has received research support from Apollo Endosurgery, Fractyl and GI Dynamics, has served as a consultant to Endogastric Solutions and GI Dynamics, has received an honorarium from Obalon Therapeutics, and has received in-kind support from USGI Medical.

CCT: is a consultant and received research support from Apollo Endosurgery, Boston Scientific, Fujifilm, GI Dynamics, Lumendi, Olympus, USGI Medical. Consultant for Medtronic and Fractyl. Institutional research grants from Aspire Bariatrics and ERBE. General partner for BlueFlame Healthcare. Founder/Consultant/Board Member for Envision Endoscopy, Enterasense and GI Windows.

Figures

Figure 1:
Figure 1:
PRISMA Flowchart
Figure 2:
Figure 2:
Forest plot of pooled Serious Adverse Event Rate: The pooled weighted average of adverse event rate was 0.01 (1%)
Figure 3:
Figure 3:
Effect Estimate of Reflux Symptom Index (RSI) score at 6 Month Post-TIF: The mean RSI score for each individual study post-TIF decreased below the normality threshold of 13 and the magnitude of their combined effect pre- and post-TIF was 15.72 on reduction of RSI score.
Figure 4:
Figure 4:
Effect Estimate of Reflux Symptom Index (RSI) score at 12 Month Post TIF: The mean RSI score for each individual study post-TIF decreased below the normality threshold of 13 and the magnitude of their combined effect pre- and post-TIF was 14.73 on reduction of RSI score.
Figure 5 (A-H):
Figure 5 (A-H):
Elimination of Daily Troublesome atypical GERD symptoms (%). 5A: Hoarseness 5B: Clearing Throat 5C: Excess Throat Mucus 5D: Cough 5E: Cough after eating or lying flat 5F: Globus sensation 5G: Breathing difficulty 5H: Difficulty Swallowing
Figure 5 (A-H):
Figure 5 (A-H):
Elimination of Daily Troublesome atypical GERD symptoms (%). 5A: Hoarseness 5B: Clearing Throat 5C: Excess Throat Mucus 5D: Cough 5E: Cough after eating or lying flat 5F: Globus sensation 5G: Breathing difficulty 5H: Difficulty Swallowing
Figure 5 (A-H):
Figure 5 (A-H):
Elimination of Daily Troublesome atypical GERD symptoms (%). 5A: Hoarseness 5B: Clearing Throat 5C: Excess Throat Mucus 5D: Cough 5E: Cough after eating or lying flat 5F: Globus sensation 5G: Breathing difficulty 5H: Difficulty Swallowing
Figure 5 (A-H):
Figure 5 (A-H):
Elimination of Daily Troublesome atypical GERD symptoms (%). 5A: Hoarseness 5B: Clearing Throat 5C: Excess Throat Mucus 5D: Cough 5E: Cough after eating or lying flat 5F: Globus sensation 5G: Breathing difficulty 5H: Difficulty Swallowing
Figure 5 (A-H):
Figure 5 (A-H):
Elimination of Daily Troublesome atypical GERD symptoms (%). 5A: Hoarseness 5B: Clearing Throat 5C: Excess Throat Mucus 5D: Cough 5E: Cough after eating or lying flat 5F: Globus sensation 5G: Breathing difficulty 5H: Difficulty Swallowing
Figure 5 (A-H):
Figure 5 (A-H):
Elimination of Daily Troublesome atypical GERD symptoms (%). 5A: Hoarseness 5B: Clearing Throat 5C: Excess Throat Mucus 5D: Cough 5E: Cough after eating or lying flat 5F: Globus sensation 5G: Breathing difficulty 5H: Difficulty Swallowing
Figure 5 (A-H):
Figure 5 (A-H):
Elimination of Daily Troublesome atypical GERD symptoms (%). 5A: Hoarseness 5B: Clearing Throat 5C: Excess Throat Mucus 5D: Cough 5E: Cough after eating or lying flat 5F: Globus sensation 5G: Breathing difficulty 5H: Difficulty Swallowing
Figure 5 (A-H):
Figure 5 (A-H):
Elimination of Daily Troublesome atypical GERD symptoms (%). 5A: Hoarseness 5B: Clearing Throat 5C: Excess Throat Mucus 5D: Cough 5E: Cough after eating or lying flat 5F: Globus sensation 5G: Breathing difficulty 5H: Difficulty Swallowing
Figure 6 (A-D):
Figure 6 (A-D):
Forest plots of PPI Use Pre and Post TIF at 6 and 12 Month. 6A: Pre-TIF PPI Use (For 6 Month) 6B: Post-TIF PPI Use (At 6 Month) 6C: Pre-TIF PPI Use (For 12 Month) D: Post-TIF PPI Use (At 12 Month)
Figure 6 (A-D):
Figure 6 (A-D):
Forest plots of PPI Use Pre and Post TIF at 6 and 12 Month. 6A: Pre-TIF PPI Use (For 6 Month) 6B: Post-TIF PPI Use (At 6 Month) 6C: Pre-TIF PPI Use (For 12 Month) D: Post-TIF PPI Use (At 12 Month)
Figure 7 (A & B):
Figure 7 (A & B):
Effect Estimate of Reflux Symptom Index (RSI) score of cTIF. 7A: At 6 Month 7B: At 12 Month
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