Comparative Efficacy and Safety of Zero-Fluoroscopy and Standard Transcatheter VSD Closure: A Systematic Review and Meta-Analysis.

Abstract

Introduction: The Zero-Fluoroscopy (ZF) approach has emerged as an alternative technique for transcatheter ventricular septal defect (VSD) closure, eliminating radiation exposure by relying solely on echocardiographic guidance. This method is particularly beneficial for pediatric patients. However, its efficacy and safety compared to the standard fluoroscopy-guided approach remain uncertain.

Methods: A systematic review was conducted following PRISMA guidelines. Data were retrieved from four databases. Studies reporting procedural success, complications, or procedural outcomes were included. Meta-analysis was performed using RStudio with a 95% CI, and subgroup comparisons were assessed.

Results: A total of 62 studies, including 5,020 patients (mean age 11.11 years), were analyzed. Nine studies utilized the ZF approach. The success rate was 95.5% (91.7-98.3%) for the ZF group and 98.0% (97.1-98.8%) for the fluoroscopy group, with no statistically significant difference (p = 0.08), indicating non-inferiority. The early residual shunt rate was significantly lower in the ZF group (5.5%, 0.1-15.8%) compared to the fluoroscopy group (20.8%, 15.7- 26.4%) (p < 0.05). Other complications, including new-onset conduction block (p = 0.12) and new-onset valvular regurgitation (p = 0.29), showed no significant differences.

Discussion: ZF closure shows similar success and safety to the standard approach, with the added benefit of reduced residual shunt and radiation exposure.

Conclusions: ZF is a safe, effective alternative to fluoroscopy-guided VSD closure, particularly suited for reducing radiation risks in pediatric and vulnerable patients.