PREDICTORS OF ADVERSE EVENTS FOLLOWING X-TACK USE: A CASE CONTROL ANALYSIS OF A POST-MARKETING REGISTRY

Introduction: The X-Tack system is a device used for soft-tissue approximation in minimally invasive endoscopic procedures, and for stent or enteral tube fixation. Since it is a relatively new device, sparse data exists on potential adverse events that may occur following its use. Our aim is to describe the rate and types of adverse events that may occur and attempt to analyze factors that may be associated with an increased risk for adverse events.
Methods: This is a retrospective multi-center registry that includes endoscopic procedures in which X-tack was used from January 2021 to September 2023. 100 patients and corresponding procedures are included. 30-day adverse events (AEs) were reported whether specifically linked to the use of X-tack or not. Demographics and procedural details were compared between those who experienced an AE and those who did not. Continuous variables were described as Median ± Interquartile Range (IQR), categorical variables were described as proportions or percentages. Proportions were compared using chi-squared or fisher-exact tests. Medians were compared using Man-Whitney U test.
Results: Median age at the time of procedure was 60 (48-73) years old, while median BMI (Body Mass Index) was 26.4 (22.3-32.8). 54% of patients were women. 19 patients (19%) experienced an adverse event within 30 days of the procedure. Of those, 12 required hospital admission, of which 3 required ICU (Intensive Care Unit) care. Three patients required an endoscopy, and four required surgeries. The most common AE was bleeding (26%), followed by stent or tube migration (16%) and perforation (5%). The rest were various adverse events including infection, pain and respiratory distress (Figure 1). Sixteen of 19 adverse events were deemed unlikely to be related to the X-tack device, and more likely to result from the overall condition of the patient and/or the rest of the endoscopic procedure. Patient and procedure characteristics including age, medication use, suture pattern and technical success were not significantly different between those who experienced AEs and those who did not. Only lower BMI was associated with a higher risk of AEs (p=0.038) (Table 1).
Conclusion: Adverse events may occur after X-Tack use, the most common of which is bleeding. Lower BMI was associated with a higher risk of adverse events, while ASA class, anticoagulation, immunosuppression, and age were not, suggesting that a wide spectrum of patients may benefit from its use.