The VACStent trial: combined treatment of esophageal leaks by covered stent and endoscopic vacuum therapy

Abstract

Background Endoscopic treatment of esophageal leaks, mostly by covered stents or endoscopic vacuum therapy (EVT), has largely improved the clinical outcome in the last decade. However, both techniques suffer from significant limitations. Covered stents are hampered by a high rate of migration and missing functional drainage, whereas endoluminal EVT devices are limited by obstruction of the GI tract. The new design of the VACStent makes it a fully covered stent within a polyurethane sponge cylinder, allowing EVT while stent passage is still open. Initial clinical applications have demonstrated the fundamental concept of the VACStent. Method A prospective multicenter open-label study was performed with the primary endpoint safe practicality, complete leak coverage, and effective suction-treatment of esophageal leaks. Secondary endpoints were prevention of septic conditions, successful leak healing, and complications, in particular stent-migration, local erosions and bleeding. Results Fifteen patients with different, mostly postoperative anastomotic leaks were enrolled in three centers. A total of 41 VACStents were implanted. The mean number of VACStents per patient was 2.7, with a mean duration of VACStent treatment of 15 days. The primary endpoint was met in all VACStent applications (41/41 implants), resulting in a leak healing rate of 80% (12/15 patients). Septic episodes were prevented in 93% (14/15 patients) and there was no mortality. There were no severe device-related adverse events (SADE) nor significant local bleeding or erosion. Minor stent-dislocation and migration, respectively, was observed in 7%. Oral intake of liquids or food was documented in 87% (13/15 patients). One anastomotic stenosis was seen during follow-up. Conclusions VACStent treatment is a safe and effective treatment in esophageal leaks which can be covered by the sponge cylinder. Its application was described as easy and resembling that of conventional GI stents, with an impressive clinical success rate comparable to EVT outcomes. The VACStent offers a new option for clinical treatment of critical situations in esophageal perforations and anastomotic sutureline failures.

Endoscopic vacuum therapy for anastomotic leakage after upper gastrointestinal surgery

“…Combined mortality was 8% (3/38, 95% CI [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21]). One patient deceased after 2 weeks of EVT treatment due to radiation pneumonitis, while improvement of the defect was observed.…”

The Use of Esophageal Stents in the Management of Postoperative Fistulas—Current Status, Clinical Outcomes and Perspectives—Review

“…The indications for VACStent installation are the following: spontaneous esophageal perforation, esophageal fistula and esophageal anastomosis fistula, occurring after surgical intervention [51]. According to a study by Lange et al that included 15 patients, the healing rate of anastomotic fistulas after VACStent installation was 80%, without the occurrence of severe complications such as bleeding at the end of the stent or perforation, and stent migration was the most common complication [52]. This promising method can be applied in the centers that approve this procedure, and this method may take over some of the indications currently held by the two major endoscopic methods already established in the treatment of anastomotic fistulas.…”

Refractory eso‐pleural fistula following Roux‐en‐Y gastric bypass: VacStent to the rescue!!

“…1 Leak management using VacStent, combining the benefit of a fully covered stent and vacuum therapy, has been recently described. [2][3][4] No data support the use of VacStent for chronic gastrointestinal fistula communicating with the pleural space. This case highlights the rapid solving of a chronic refractory eso-pleural fistula using the VacStent.…”