Antithrombotic Therapy in a Prospective Trial of a Pediatric Ventricular Assist Device

Area of Science:

• Pediatric Cardiology
• Cardiovascular Surgery
• Biomedical Engineering

Background:

• Efficacious ventricular assist device (VAD) support in pediatric patients necessitates optimal antithrombotic management.
• The EXCOR Pediatric VAD Investigational Device Exemption (IDE) study provides valuable experience in this area.

Purpose of the Study:

• To describe the antithrombotic management experience within the EXCOR Pediatric VAD IDE study.
• To review monitoring parameters, drug dosing, adverse events, and pump-related issues.

Main Methods:

• Analysis of 68 pediatric patients in North America enrolled in the EXCOR Pediatric VAD IDE study (May 2007–December 2010).
• Guidance provided by the Edmonton Anticoagulation and Platelet Inhibition Protocol.
• Review of monitoring, dosing, serious adverse events, and pump changes.

Main Results:

• Major bleeding occurred in 43% of subjects, with 24% related to antithrombotic management, primarily within 14 days postimplantation.
• Neurologic events occurred in 28% of subjects, with 9% related to antithrombotic therapy intensity, mostly between 4–30 days postimplantation.
• Pump replacement was necessary in 56% of subjects.

Conclusions:

• Implementing an antithrombotic protocol was feasible in this multicenter pediatric VAD study.
• The incidence of significant bleeding and thromboembolic events was deemed acceptable relative to the life-saving benefits of VADs.
• Further research is required to optimize antithrombotic strategies for pediatric VAD patients.