Transjugular Pulmonary Valve Implantation—Comparison of the LifeValve Catheter with Established Systems

Introduction: In the scope of the LifeValve-project, a new delivery system for transvenous pulmonary valve implantation was developed. Both decellularized tissue-engineered (n = 35) or pericardial valves (n = 13) sewn into self-expandable Nitinol-stents were used. Sheep anatomy required a jugular access for the implantation of these valves.

Methods: The path from the V. jugularis to the pulmonary valve requires a flexible delivery system. Unlike balloon-expandable stents, self-expandable Nitinol-stents necessitate a stiff catheter to enable the delivery of the stented valve. Thus, the sheath of the delivery system consists of a soft outer tube combined with an inner coiled spring. A capsule housing the stented valves was glued to the distal end allowing great flexibility regarding the diameter of the crimped implant. Angiographies of the implantations were compared with patients with congenital heart disease who received Melody® (Medtronic, Minneapolis, MN) or SAPIEN-3® valves (Edwards Lifesciences Inc., Irvine, CA, USA) via the jugular approach.

Results: 48 pulmonary valves were successfully implanted in sheep. Problems arose from the difficult mechanical requirements, the length of the stented valves and the crimping ratio. The relatively stiff capsule complicates reaching the implantation site. Compared with the Medtronic an Edwards delivery systems, the LifeValve catheter shows much better mechanical behavior and greater flexibility without buckling during turns. It is available in different sizes according to sheep anatomy and crimpability of the valve.

Conclusion: The new designed LifeValve catheter has superior properties compared with available systems. Integration of the capsule into the sheath can further optimize the mechanical behavior of this delivery system.