2021 Scientific Sessions

Initial Experience and Safety of Drug-Coated Balloons in the Treatment of Congenital Heart Disease

Presenter

Neil C Tailor, M.D., Le Bonheur Children's Hospital, Memphis, TN
Neil C Tailor, M.D.1, Mariel E. Turner, M.D., FSCAI2, Oliver M Barry, MD, FSCAI3, Alejandro J. Torres, M.D., FSCAI4 and Matthew A. Crystal, M.D., FSCAI3, (1)Le Bonheur Children's Hospital, Memphis, TN, (2)Columbia University Irving Medical Center, New York, NY, (3)NewYork-Presbyterian Morgan Stanley Children's Hospital, New York, NY, (4)NewYork-Presbyterian Morgan Stanley Children's Hospital, Larchmont, NY

Keywords: Congenital Heart Disease (CHD), Drug-coated Balloon (DCB) and Drug-eluting Stent (DES)

Background:
Drug-coated balloons (DCB) have shown efficacious and safe use in the treatment of coronary stent re-stenosis and peripheral artery disease. Balloon length (4-8cm) and required dilation time (minimum 3 minutes for drug tissue deposition) has limited the use of DCB for patients with congenital heart disease (CHD). We describe our initial experience with DCB in the treatment of native and in-stent stenosis in CHD.

Methods:
Single center review of all CHD patients with native or in-stent stenosis treated with DCB from 2015 to 2020.

Results:
Eleven DCB (8 Bard Lutonix™, 3 Medtronic In.Pact™) were used in 9 patients with median age of 7 years (range 6m – 20y). Sites included pulmonary artery (6), pulmonary vein (3), systemic vein (2) and aorta (1). Nine dilations were performed in previously placed stents (5 drug-eluting stents, 4 bare-metal stents) and 2 in native vessels. Balloon angioplasty was performed with standard balloons followed by DCB or DCB alone. All DCB dilations were performed with 3 minute inflation time. There were no episodes of valve or cardiac injury, hypotension requiring inotropic support or balloon rupture. The use of long sheaths in select cases allowed for partial uncovering of long DCBs in the target region only. Acute procedural success was excellent with post-dilation vessel lumen reaching 105% ± 13% of the native distal vessel or stent diameter. Limited follow up data suggests benefit of DCB use for in-stent stenosis compared to native vessels.

Conclusions:
Use of DCB for native and in-stent stenosis in CHD patients is feasible with acute procedural success and low incidence of adverse events. Prohibitive length of DCB can be safely and effectively overcome using long sheaths. DCB may have a role in reducing re-interventions in select CHD patients. Further study of clinical outcomes is needed.