Anastomotic leaks and iatrogenic perforations of the upper gastrointestinal tract remain challenging complications associated with significant morbidity and mortality. Current endoscopic management relies mainly on fully covered self-expanding metal stents (SEMS) or endoscopic vacuum therapy (EVT). Although effective, SEMS are limited by high migration rate and lack of active drainage, whereas EVT with a polyurethane sponge may delay oral nutrition. The VACStent, a recent device that combines a fully covered SMES with a polyurethane sponge-cylinder connected to a vacuum pump, was developed to overcome these limitations. This system enables continuous drainage of purulent material and granulation tissue formation, while reducing the risk of migration and preserving lumen patency. Real-world data regarding its performance remains limited. This study aimed to assess the clinical efficacy and safety of VACStent therapy in the management of upper gastrointestinal defects. 

We conducted a retrospective study including all consecutive patients with upper gastrointestinal defects treated with the VACStent between July 2024 and October 2025 at the Digestive Endoscopy Unit of Hospital de Santa Luzia, Viana do Castelo, Portugal. Demographic characteristics, type of defect, procedural details, treatment duration, need for adjunctive therapies and adverse effects were collected using a database based on electronic medical records. The primary outcome was complete closure of the defect. A descriptive statistical analysis was performed, reporting categorical variables as percentages, and continuous variables as means or medians, as appropriate.

VACStent was used in 7 patients (mean age 71.7 ± 10.0 years; 71.4% female) for the management of anastomotic leaks (57.1%, all after total gastrectomy) and iatrogenic perforations (42.9%, all occurring during balloon dilation for achalasia treatment). The median time between the index procedure and diagnosis of the defect was 4 days, and the time from diagnosis to VACStent placement was 0 days. The mean defect size was 14.4 ± 6.9mm. VACStent was used as first-line therapy in 71.4% (n=5) of cases. Technical success was achieved in 100%. The mean duration of VACStent therapy was 8.9 ± 4.0 days, with a median of 2 exchanges per patient. Oral diet was resumed after a median of 4 days of VACStent placement. Complete closure of the defect was achieved in 71.4% of patients; 2 patients required adjunctive therapy (SEMS and EVT, respectively). Among patients in whom closure was not achieved, one presented with severe sepsis and had the largest defect (two with more than 20mm), while in the other case VACStent was removed due to bleeding from an ulcer at the site of the distal flange of the device; both cases occurred in context of anastomotic leaks in which VACStent was used as first-line therapy. Device-related adverse events occurred in 42.9% patients – bleeding (n=1), retrosternal pain (n=1) and stenosis (n=1) – all managed endoscopically. 

VACStent therapy proved to be a safe and effective minimally invasive option for managing upper gastrointestinal anastomotic leaks and perforations, achieving defect closure in most patients and enabling early oral nutritional resumption, with a favorable safety profile. It also demonstrated effectiveness in cases where it was not used as first-line therapy. Therefore, VACStent emerges as an alternative to surgery and other endoscopic methods in these settings, although larger studies are required to validate these findings.