Safety and Efficacy of Zero Fluoroscopy Patent Ductus Arteriosus Closure in Comparison to the Standardized Fluoroscopy-Guided Procedure: A Systematic Review and Meta-Analysis.

Abstract

Background: Patent Ductus Arteriosus (PDA) is a common condition in premature infants requiring intervention to avoid problems. Despite improvements in lowering radiation exposure and employing better contrast agents, fluoroscopy is still the most widely employed technique, which exposes interventional echocardiographers to radiation risks. Techniques, such as Transthoracic Echocardiography (TTE)-guided procedures or Transesophageal Echocardiography (TEE)-guided procedures, provide radiationfree options. This systematic review and meta-analysis aimed to evaluate the safety and effectiveness of fluoroscopy-guided versus non-fluoroscopy-guided PDA closure techniques with respect to the reduction in procedural risks and improved clinical decision-making when treating hemodynamically severe PDAs in premature newborns. As there is no specific age or cutoff for this procedure, it is crucial to perform it as early as possible to prevent complications, especially if symptoms are already present.

Methods: This systematic review has been registered in PROSPERO with registration number CRD42024516321. Three electronic databases (PubMed, Scopus, and Google Scholar) have been reviewed up to February 2024 to search the literature. The main outcome has been the procedural success rate. The additional outcomes have included procedural-related complications rate. We have performed a proportional meta-analysis using the random-effects model and the DerSimonian-Laird method. The risk of bias in all included studies has been evaluated using the STROBE guideline [1].

Results: A total of 85 (78 fluoroscopy and 7 zero-fluoroscopy) studies have been included in this study. Percutaneous PDA closure success rate has been significantly higher in zero-fluoroscopy group compared to fluoroscopy guidance [99.4% (95%CI: 98.1-100%) and 94.6% (95%CI: 92.3-97%, test for subgroup differences p < 0.01), respectively]. The complication rate has been similar in both groups [4% (95%CI: 0- 10%) in zero-fluoroscopy and 8.9% (95%CI: 6.5-11.3%) in fluoroscopy group, test for subgroup differences; p = 0.14]. Device embolization has been the most common complication reported in the fluoroscopy group [1.7% patients (95%CI: 1.1-2.3%)]. Meanwhile, the residual leak has been the only complication reported in the zero-fluoroscopy group [15.6% patients (95%CI: 0-37.5%)].

Conclusion: Patent Ductus Arteriosus (PDA) is common in preemies and requires intervention. While fluoroscopy is widely used with lower radiation and better contrast agents, it still carries radiation risks. Thus, this review has evaluated the safety and effectiveness of fluoroscopy versus zero-fluoroscopyguided PDA closures, aiming to reduce procedural risks and enhance clinical decisions for treating PDA. Zero fluoroscopy techniques for percutaneous PDA closure have been found to yield comparable success rates and procedural outcomes to fluoroscopy-guided procedures. Considering its reduced side effects, zerofluoroscopy is safe and can be the preferred method to guide closures. However, future randomized controlled trials are necessary to better understand the exact role of interventional echocardiography in PDA closures.