Safety of Direct Oral Anticoagulants in Transcatheter Pulmonary Valves: A Pediatric Institution's Experience.

Transcatheter pulmonary valve replacement (TPVR) is associated with an increased risk of valve leaflet thrombosis and leaflet dysfunction requiring thromboprophylaxis. The use of direct oral anticoagulants (DOACs) in pediatric patients with TPVRs is currently off-label without established data on safety and efficacy. The primary objective was a composite safety score consisting of clinically relevant non-major bleeding, major bleeding, bleeding-related re-admission, and medication discontinuation. The secondary objective consisted of the individual components of the composite score, in addition to valve thrombosis as represented by increasing transvalvular gradient by echocardiogram and valve complication requiring re-intervention. A single center, retrospective, descriptive study of pediatric patients who underwent TPVR placement. Patients were included in this study if they were less than 18 years old and received a DOAC in addition to low dose aspirin (standard of care) post procedure for thromboprophylaxis. Thirty-one patients were identified, of which 21 were males (68%) with a median age of 14 years (IQR: 13, 16) and median weight of 49 kg (IQR: 49, 60). Of the 31 patients, 4 (13%) met the composite outcome with all 4 patients having minor bleeding (13%), and one patient requiring hospital readmission for a minor bleed (3.2%). There were no major bleeds or bleeding-related deaths. No patients developed a valve thrombosis or valve complication requiring re-intervention. DOACs may be safe in pediatric patients after TPVR. No patients experienced major bleeding, and only one had clinically relevant non-major bleeding. Further evaluation of pediatric DOAC use, dosing, and long-term benefits of thromboprophylaxis in TPVR should be evaluated.