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Updated: May 9, 2025
Four-Dimensional Computed Tomography-Guided Valve Sizing for Transcatheter Pulmonary Valve Replacement
Published on: January 20, 2022
Safety of Direct Oral Anticoagulants in Transcatheter Pulmonary Valves: A Pediatric Institution's Experience
Daniela Barisano1, Gwen Nance1, Ashish Saini2
1Department of Pharmacy, Children's Healthcare of Atlanta, Atlanta, GA, 30345, USA.
Insights
Direct oral anticoagulants (DOACs) show promise for thromboprophylaxis in pediatric patients following transcatheter pulmonary valve replacement (TPVR). This study found no major bleeding events, suggesting DOACs may be a safe option for this population.
Area of Science:
- Cardiology
- Pediatric Medicine
- Pharmacology
Background:
- Transcatheter pulmonary valve replacement (TPVR) carries a risk of valve thrombosis and dysfunction, necessitating thromboprophylaxis.
- Current use of direct oral anticoagulants (DOACs) in pediatric patients post-TPVR is off-label, lacking safety and efficacy data.
Purpose of the Study:
- To evaluate the safety and efficacy of DOACs for thromboprophylaxis in pediatric patients after TPVR.
- To assess a composite safety endpoint including bleeding events and medication discontinuation.
Main Methods:
- A single-center, retrospective study included pediatric patients (<18 years) receiving DOACs plus low-dose aspirin post-TPVR.
- Data collected included bleeding events (major and non-major), re-admissions, and valve-related complications.
Main Results:
- Of 31 patients, 4 (13%) met the composite outcome, all due to minor bleeding.
- One patient (3.2%) required readmission for minor bleeding; no major bleeds or bleeding-related deaths occurred.
- No instances of valve thrombosis or re-intervention for valve complications were reported.
Conclusions:
- DOACs appear to be safe for pediatric patients undergoing TPVR, with a low incidence of minor bleeding.
- Further research is warranted to determine optimal pediatric DOAC dosing and long-term benefits in TPVR thromboprophylaxis.
Abstract:
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.
