Background/Purpose: Gastrointestinal tract (GIT) symptoms impact up to 90% of individuals with SSc. Hiatal hernia, decreased esophageal contractility, and lower esophageal sphincter tone contribute to dysphagia and gastroesophageal reflux disease (GERD) reducing quality-of-life.Nissen fundoplication is often avoided in SSc due to risk of worsening dysphagia. Transoral incisionless fundoplication (TIF) with the EsophyX System (EndoGastric Solutions Redmond, WA, USA), in conjunction with hiatal hernia repair—termed cTIF—was employed to treat SSc patients with refractory GERD. The EsophyX System offers an alternative treatment option by enabling fasteners to be placed endoscopically at the gastroesophageal junction, resulting in partial recreation of the lower esophageal sphincter at less than or equal to 270 degrees. This approach avoids generating high distal esophageal pressures, which is important in SSc, where esophageal hypomotility increases risk of outflow obstructions and dysphagia. We present a case series highlighting effective use of cTIF for patients with SSc.

Methods: We retrospectively identified patients who fulfilled 2013 ACR/EULAR SSc Classification Criteria and underwent cTIF using the EsophyX System between February 2023 to March 2024. Esophagram, EGD with high-resolution manometry, 24-hour impedance testing, and functional luminal imaging probe plethysmography data were queried. At a mean (SD) post procedure follow-up of 23 (5) months, patients completed the GERD-HRQL survey, a 16-item questionnaire. Patients reported their current (post-procedure) symptoms and retrospectively assessed pre-procedure burden. Small sample sizes precluded formal statistical testing.

Results: Six patients with refractory GERD and/or dysphagia despite medical management who underwent cTIF were identified (Table 1). Esophagrams (n=6) revealed dysmotility in three, and narrowed GE junction in two, patients. Esophageal manometry (n=2) revealed ineffective esophageal motility in one patient and normal in another. pH impedance (n=2) revealed severe GERD per upright acid exposure time in both patients (Table 2). One patient had gastroesophageal intussusception that resolved post-cTIF (Figure 1).At follow-up, one patient had died of respiratory failure, and one patient did not complete, and four completed the GERD-HRQL. The mean (SD) GERD-HRQL pre- vs. post-procedure was 62(4.39) and 19.25(16.29), respectively. Improvement in scores ranged from 30% to 90%, exceeding the minimal clinically important difference.

Conclusion: cTIF appears to be a promising treatment for refractory GERD and dysphagia in SSc. No patient reported worsening dysphagia, and four patients reported overall improvement in symptoms. These outcomes suggest cTIF may safely and effectively fill a critical treatment gap for patients with refractory SSc-GERD.

pre and post cTIF endoscopy photos revealing improvement of the gastric contents intussuscepting through the esophagus

baseline characteristics

Summary of pre-procedure esophageal function testing, including esophagram findings, pH study results (acid exposure time), high-resolution manometry (Chicago Classification), and functional luminal imaging probe (FLIP) assessment, alongside procedural wrap degree following cTIF intervention.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/targeting-refractory-reflux-in-systemic-sclerosis-early-outcomes-following-a-novel-intervention/