The Hancock® Valved Conduit for Right Ventricular Outflow Tract Reconstruction in Sheep for Assessing New Devices

Area of Science:

• Biomedical Engineering
• Cardiovascular Surgery
• Veterinary Medicine

Background:

• Xenograft conduits are used for congenital heart defect repair but can fail over time.
• Improved xenografts are needed to enhance patient outcomes.
• Evaluating new conduits requires comparison with a clinically available control in large animal models.

Purpose of the Study:

• To assess the performance and safety of a clinically available xenograft conduit.
• To evaluate the Medtronic Hancock® Bioprosthetic Valved Conduit in a sheep model for right ventricular outflow tract (RVOT) reconstruction.

Main Methods:

• RVOT reconstruction was performed in 13 sheep using the Hancock conduit.
• Animals were monitored for 70 to 140 days.
• Evaluations included echocardiography, pressure measurements, angiography, and necropsy.

Main Results:

• 11 out of 13 sheep survived the study term with few complications.
• Increased transvalvular pressure gradients were observed postoperatively.
• Seven conduits remained patent with mild pseudointimal proliferation and functional leaflets.

Conclusions:

• Hancock conduit RVOT reconstruction was successful in sheep, demonstrating durable and efficient performance.
• The conduit's clinical use and long-term viability in sheep support its role.
• The Hancock conduit is suitable as a control device for preclinical evaluation of novel xenografts.