Transapical aortic valve implantation with a self-expanding anatomically oriented valve

Area of Science:

• Cardiovascular Surgery
• Medical Devices
• Bioprosthetics

Background:

• Aortic stenosis is a significant cause of morbidity and mortality.
• Transcatheter aortic valve implantation (TAVI) offers a less invasive treatment option.
• Novel bioprosthetic devices aim to improve TAVI outcomes.

Purpose of the Study:

• To evaluate the feasibility and initial outcomes of the self-expanding Medtronic Engager™ aortic valve bioprosthesis.
• To assess the anatomical positioning and early performance of the novel device in patients undergoing transapical implantation.

Main Methods:

• A prospective, first-in-human study (NCT00677638) included 30 patients with severe aortic stenosis.
• Transapical implantation of the self-expanding Engager™ valve was performed.
• Valve placement accuracy, hemodynamic performance, and complications were assessed.

Main Results:

• Accurate valve placement was achieved in 97% of patients.
• Post-implant gradients were acceptable, with predominantly mild paravalvular leakage (≤ Grade I in 80%).
• Complications included atrioventricular block (10%), dissections (13%), and significant 30-day mortality (20%).

Conclusions:

• The Medtronic Engager™ aortic valve bioprosthesis demonstrated feasibility for anatomically correct placement.
• Observed complications, including mortality, led to a complete redesign of the delivery system.
• Further studies are required to establish the safety and performance of the redesigned device.