2 The procedure
2.1.1 Aortic coarctation is a congenital narrowing of part of the aorta, most commonly the aortic arch, usually close to the origin of the left subclavian artery. This results in high blood pressure in the upper body and arms and low blood pressure in the legs.
2.1.2 Standard treatment for native coarctation and recoarctation (see Section 2.2.1) involves open chest surgery. The type of surgery used depends on the anatomy of the lesion and preference of the surgeon, but may include resection of the coarctation site and end-to-end anastomosis repair, patch aortoplasty, left subclavian flap angioplasty, or bypass graft repair.
2.2.1 Balloon angioplasty of aortic coarctation is a minimally invasive procedure that involves inserting a catheter into a large blood vessel, usually in the groin, and passing it up to the narrowed area under radiological guidance. A balloon is then inflated within the narrowed area and a stent may be placed there to keep the area dilated. Balloon angioplasty and stenting may be carried out as a first treatment (in native coarctation) or if previous surgical or angioplasty fails and coarctation recurs (recoarctation).
2.3.1 One small randomised controlled trial (RCT) was identified, along with a non-randomised comparative study and several case series. The RCT reported an 86% reduction in peak systolic pressure gradient in both the balloon angioplasty group and the surgery group. The non-randomised study comparing balloon angioplasty with and without stent placement reported a statistically significant reduction in peak systolic gradient of 83% in the angioplasty alone group and 96% in the angioplasty with stent group (p < 0.001). For more details, refer to the Sources of evidence section.
2.3.2 One Specialist Advisor noted that results could be improved by concomitant stenting. Another considered residual stenosis to be an efficacy concern.
2.4.1 In the RCT, the main complications reported were: aneurysm in 20% (4/20) of the angioplasty group and 0% (0/16) of the surgery group; diminished pulse (in the leg through which angioplasty was performed) in 10% (2/20) of the angioplasty group and 0% (0/16) of the surgery group; bleeding in 5% (1/20) of the angioplasty group and 13% (2/16) of the surgery group; and hypertension in 5% (1/20) of the angioplasty group and 0% (0/16) of the surgery group. For more details, refer to the Sources of evidence section.
2.4.2 The Specialist Advisors considered the main potential adverse effects of the procedure to be death, aortic rupture, aneurysm, femoral artery damage, neurological damage and stroke. One Advisor noted that there were possible safety concerns if the procedure was performed for recoarctation after previous patch repair, but not for other types of surgery.