Effectiveness and safety of a ventricular septal occluder device for the treatment of Gastro-tracheal fistula.

ABSTRACT

BACKGROUND: Gastro-tracheal fistula (GTF) is one of the most serious complications after esophagogastrostomy and radiotherapy, with very high disability and mortality rates. To evaluate the effectiveness and safety of ventricular septal occluder devices (VSOD) for the treatment of Gastro-tracheal fistula (GTF). METHODS: From January 2020 to May 2022, 14 patients with GTF underwent VSOD under real-time fluoroscopy. The technical success, complications, quality of life (QoL), Eastern Cooperative Oncology Group (ECOG) score, Karnofsky score, and median overall survival (mOS) were recorded and analyzed. RESULTS: Technical success, and major complication rates were 71.4%, and 14.3%, respectively. Both the ECOG and the Karnofsky score showed significant improvement at the 2-month evaluation compared with the pretreatment value (p<0.05). For QoL, general health, physical function, vitality, role physical, and social function all improved at the 2-month evaluation (p<0.05), but bodily pain, role emotion, and mental health showed no significant difference (P>0.05). During the mean follow-up of 9.6 months, eight patients were alive, and the mOS was 11.4 months (95% CI, 8.5-14.3). CONCLUSIONS: VSOD is a simple and safe technique for GTF treatment, but long-term observation is needed at multiple centers to confirm our findings.