The Omni design: evolution of a valve

Area of Science:

• Biomedical Engineering
• Cardiovascular Surgery
• Materials Science

Background:

• The Lillehei-Kaster prosthesis engineering has evolved to improve clinical performance.
• The Omni design, including Omniscience titanium and omnicarbon Pyrolite cages, addresses the gap between engineering and clinical outcomes.
• Previous studies indicated anterior orientation of mitral Omniscience valves resulted in fewer thrombotic complications due to anatomical variations.

Purpose of the Study:

• To evaluate the clinical performance and safety of the evolved Omni cardiac valve prosthesis.
• To assess the outcomes of the Omniscience and Omnicarbon valve designs in a multi-center European study.
• To report on patient survival, functional improvement, and thromboembolic event rates following valve replacement.

Main Methods:

• A prospective study involving 354 patients undergoing atrial, mitral, or double valve replacement with Omniscience valves across five European centers.
• Data collection included patient demographics, surgical procedures, and clinical follow-up until June 1987.
• Actuarial analysis was used to determine survival probability and freedom from thromboembolic events.

Main Results:

• No structural failures or significant hemolysis were observed in any patient.
• 91% of patients experienced improvement in at least one functional class.
• Actuarial survival at 3 years was 92.5% for atrial, 97.9% for mitral, and 93.6% overall. Freedom from all thromboembolic events was 97.8% at 2.5 years.

Conclusions:

• The advanced Omni valve design demonstrates excellent clinical performance and safety.
• Close collaboration between surgeons and designers has led to a significantly improved cardiac valve prosthesis.
• The study confirms the efficacy of the Omniscience and Omnicarbon valves in reducing complications and improving patient outcomes.