Safety of percutaneous patent ductus arteriosus closure: an unselected multicenter population experience

Abstract

Background: The technique and safety of transcatheter patent ductus arteriosus (PDA) closure have evolved during the past 20 years. We sought to report a multicenter experience of PDA closure with a focus on the rate of adverse events (AE) and a review of institutional practice differences.

Methods and results: Outcome data on transcatheter PDA closure were collected at 8 centers prospectively using a multicenter registry (Congenital Cardiac Catheterization Project on Outcome Registry). Between February 2007 and June 2010, 496 PDA closures were recorded using a device in 338 (68%) or coils in 158 (32%). Most patients had an isolated PDA (90%). Fifty percent of patients were between 6 months and 3 years old, with only 40 patients (8%) <6 months old. Median minimum PDA diameter was 2.5 mm (range 1 to 12 mm; IQR 2 to 3 mm) for device closure and 1 mm (range 0.5 to 6 mm; IQR 1 to 2 mm) for coil closure (P<0.001). A device rather than coil was used in patients <3 years, weight <11 kg, and with a PDA minimum diameter >2 mm (all P<0.001). Three of 8 centers exclusively used a device for PDAs with a diameter >1.5 mm. In 9% of cases (n=46), an AE occurred; however, only 11 (2%) were classified as high severity. Younger age was associated with a higher AE rate. Coil-related AEs were more common than device-related AEs (10% versus 2%, P<0.001).

Conclusions: PDA closure in the present era has a very low rate of complications, although these are higher in younger children. Technical intervention-related events were more common in coil procedures compared with device procedures. For PDAs ≤2.5 mm in diameter, institutional differences in preference for device versus coil exist.

Keywords: PDA; adverse events; complications; interventional catheterization; safety.

Figure 1.

Proportion of 2 PDA closure methods (coils vs devices) based on PDA internal diameter. PDA indicates patent ductus arteriosus.

Figure 2.

Average annual PDA cases for each institution. Shaded bars represent the average annual PDA cases, and strippled bars represent the PDA percentage of total cases. PDA indicates patent ductus arteriosus.

Figure 3.

Differences in the preferred PDA closure method (coils vs devices) based on PDA internal diameter in 8 institutions. Figure shows median minimum diameter, IQR, and range by device or coil for each institution. IQR indicates interquartile range; PDA, patent ductus arteriosus.

Figure 4.

Adverse event (AE) rates by institution shown as any event and subdivided showing rates of higher severity level 3 or 4 events.