Clinical Trials

Cardiac Catheterization Laboratory

Title: Comparison Between Surgical vs Balloon Angioplasty vs Intravascular Stent Placement for Recurrent or Native Coarctation of the aorta
Principal Investigator:
Dennis Kim, M.D.

Coarctation (or narrowing) of the aorta is found as an isolated lesion, in addition to being associated with other heart abnormalities. Isolated coarctation of the aorta occurs in one out of 2,323 live births, and ranks 6th in frequency in all congenital heart lesions (1,2). Though, coarctation of the aorta may appear in isolation, it is also frequently associated with other intracardiac or extracardiac abnormalities. The most common defect associated with coarctation of the aorta is a bicuspid aortic valve. Unrepaired coarctation of the aorta carries a very high mortality, with approximately 90% mortality observed by age 50. The mean age of death was 35 years, with the primary causes of death being intracranial hemorrhage (11%), aortic rupture or dissection (23%), endocarditis (22%), and congestive heart failure (18%) (3,4,5).

The initial therapy for coarctation of the aorta was surgery, which was first performed back in 1944 by Drs. Crafoord and Nylin in Sweden (6). Techniques used to repair coarctation of the aorta, have included end-to-end anastomosis with resection of the coarctation segment (7), as well as use of the subclavian flap technique (8). Intraoperative and postoperative complications associated with surgical repair of coarctation of the aorta included: recurrent laryngeal nerve injury, phrenic nerve injury, chylothorax, spinal cord ischemia, post coarctectomy syndrome, paradoxical postoperative hypertension, and death, with mortality ranging from 1-3% (9,10,11). The most common reason for repeat intervention at intermediate follow-up is restenosis at the coarctation site or adjacent areas. The incidence of re-stenosis ranges from 3-11% for repairs performed before 2 years of age, to less than 5% in those performed after 2 years of age (11,12,13). Intermediate and long-term follow-up also has described a 10-33% incidence of aneurysms at site of repair of the coarctation segment. The majority of aneurysms occurred in procedures utilizing the patch technique, though aneurysm formation has also been associated with end-to-end resection and the subclavian flap technique (14,15,16,17). The etiology of aneurysms has been largely unknown, but has been associated with transverse arch hypoplasia (18).