Safety and Efficacy of Zero Fluoroscopy Patent Ductus Arteriosus Closure in Comparison to the Standardized Fluoroscopy-Guided Procedure:
A Systematic Review and Meta-Analysis
Authors: Mendel Brian , Kohar Kelvin , Djiu Richie Jonathan , Yumnanisha Defin Allevia , Vidya Ananda Pipphali , Winarta Justin , Arifin Karunia Hafifah , Mumtaz Muhammad Dzaky Erlangga , Nugroho Aqilla Katrita Zaira , Jagannatha Gusti Ngurah Prana , Siagian Sisca Natalia , Prakoso Radityo 
Published: February 2025

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.