Silzone coating and paravalvular leak: an independent, randomized study.

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Medical Device Technology

Background:

• Paravalvular leak (PVL) is a potential complication following mechanical heart valve replacement.
• Silzone coating was developed to potentially reduce thrombus formation and improve valve performance.
• Independent evaluation of Silzone-coated valves is crucial, separate from industry-sponsored trials like AVERT.

Purpose of the Study:

• To assess the impact of Silzone coating on paravalvular leak prevalence after mechanical valve replacement.
• To compare PVL rates between Silzone-coated and uncoated St. Jude Medical Masters valves in a randomized cohort.
• To evaluate plasma LDH levels as a marker of hemolysis or inflammation.

Main Methods:

• Randomized implantation of 95 patients with either Silzone-coated or uncoated St. Jude Medical Masters mechanical valves.
• Exclusion of patients with suspected or diagnosed infective endocarditis.
• Post-recall, control transthoracic echocardiography and plasma LDH determination were performed on surviving patients.

Main Results:

• No major paravalvular leaks were observed in either the Silzone-coated (5/51 minimal PVL) or uncoated (3/53 minimal/slight PVL) valve groups.
• The incidence of minimal paravalvular leak was not significantly different between the groups (p = 0.55).
• Plasma LDH levels showed no significant difference between the Silzone and control groups (p = 0.10).

Conclusions:

• Silzone coating did not demonstrate a significant impact on the incidence of paravalvular leak in this patient cohort.
• The observed incidence of major PVL in this study was lower than reported in the AVERT trial.
• Further investigation may be warranted, but initial findings suggest comparable PVL rates between coated and uncoated valves.