Trends in procedural closure of patent ductus arteriosus among children from 2011 to 2022 in Japan.

BACKGROUND

Although surgery was traditionally the primary modality for definitive patent ductus arteriosus (PDA) closure, the indications for transcatheter closure have expanded with device advancements in recent decades. This study aimed to describe the trends in surgical and transcatheter closure for PDA in Japan.

METHODS

Patients aged <16 years who underwent procedural PDA closure between April 2011 and March 2023 were identified from the Diagnosis Procedure Combination database in Japan. Considering the redaction of the requirements for the Amplatzer Duct Occluder (age ≥6 months and weight ≥6 kg) in 2016, patients were stratified by this erstwhile weight threshold (6 kg) to evaluate the impact of this regulatory change. We analyzed data from consecutive 2-year periods. We examined the trend in the proportion of transcatheter closure among all procedural PDA closures using multivariable mixed-effects logistic regression models.

RESULTS

The study enrolled 5638 patients (3235 weighing <6 kg and 2403 weighing ≥6 kg). The proportion of transcatheter closure increased over time from 13/466 (2.8%) patients in 2011-2012 to 60/431 (13.9%) in 2021-2022 in patients weighing <6 kg (adjusted odds ratio 1.46, 95% confidence interval 1.29-1.67), and from 268/316 (84.8%; 2011-2012) to 392/416 (94.2%; 2021-2022) in patients weighing ≥6 kg (1.56, 1.38-1.76).

CONCLUSIONS

Although the proportion of transcatheter closure steadily increased in patients weighing <6 kg, its implementation was slow and surgical closure remained the primary treatment. Transcatheter closure has become the predominant option for patients weighing ≥6 kg.