Endovascular closure of patent ductus arteriosus

The ductus arteriosus is a normal vessel in the fetus that connects the pulmonary artery and the aorta. It allows the fetal blood flow to bypass the lungs, which are not used in utero. The ductus arteriosus usually closes at or shortly after birth. Sometimes it fails to close on its own; this is called a patent (or persistent) ductus arteriosus. Blood can then pass from the aorta into the pulmonary artery, exposing the lungs to increased blood flow and pressure. A large patent ductus arteriosus (PDA) may cause symptoms such as poor weight gain and breathlessness. Without medical treatment, blood vessels in the lung may eventually become damaged by the raised blood pressure. This puts strain on the heart and can lead to heart failure. Persistent ductus arteriosus is also associated with an increased risk of endocarditis, a life-threatening infection of the lining of the heart chambers and valves.

Open surgery is the standard treatment. Access to the heart is gained via an incision in the chest and a stitch and/or clip is placed around both ends of the ductus arteriosus (ligation), which is then cut in half if there is enough length (ligation and division).

The endovascular procedure involves passing a catheter through a vein or artery into the heart. Pressure measurements and angiograms may be performed to assess the size and shape of the ductus. An occlusion device is then introduced into the ductus through the catheter under X-ray guidance. The choice of device depends largely on the size of the PDA. Coils are suitable for closing PDAs of small to moderate size. Other occlusion devices are used to close larger PDAs. Small residual shunts after the procedure often resolve as endothelial tissue grows over and around the device.

Three non-randomised controlled studies reported efficacy data. In two of them, immediate occlusion was reported in 68% (71 out of 105) and 77% (23 out of 30) of patients treated with endovascular closure, and in 89% (8 out of 9) and 96% (140 out of 146) of patients treated with open surgery. The third study reported that 94% (93 out of 99) of patients treated with endovascular closure had a successful outcome immediately after the procedure, compared with 99% (109 out of 110) of patients treated with open surgery. The four case series, with a total of 2,035 patients, reported rates of immediate complete occlusion between 44% (90 out of 205) and 98% (214 out of 218) following endovascular closure. In all studies, occlusion rates after a period of follow-up were higher than immediately after the procedure. In one case series of 1,258 patients, the occlusion rate was 96% at 2-year follow-up compared with an immediate occlusion rate of 59%. For more details, see the overview.

The Specialist Advisors noted that a small proportion of patients would have a residual shunt.

The most commonly reported complications were haemolysis (most commonly mild to moderate) and embolisation of the device. Rates of haemolysis varied from 0.3% (1 out of 316) to 9% (3 out of 34), and rates of embolisation varied from 0.6% (2 out of 316) to 7% (7 out of 105). A study of 316 patients reported one death as a result of the procedure. For more details, see the overview.

The Specialist Advisors considered that device embolisation, haemolysis, vascular injury and death were potential adverse events.

There is a potential for long-term adverse effects and clinicians should report these to the Medicines and Healthcare products Regulatory Agency (MHRA).

These recommendations were based on evidence on the use of the Amplatzer device and coil embolisation for patent (or persistent) ductus arteriosus. The Institute may review the procedure if further data relating to other devices become available.