The iValve prototypes reduced regional backflow velocity spikes, indicating the potential to lessen the need for lifelong anticoagulation therapy, according to a recent study. 

In the in vitro study, published in the Journal of Biomechanics, researchers evaluated the performance of a novel mechanical heart valve (MHV), known as the iValve, designed to combine the durability of traditional MHVs with the hemodynamic advantages of bioprosthetic valves while potentially eliminating the need for anticoagulation. Although durable, current MHVs require lifelong anticoagulation therapy because of nonphysiological flow patterns, posing risks of bleeding and thromboembolism. Conversely, bioprosthetic valves offer superior hemodynamic performance but are prone to structural deterioration within 7 to 8 years. 

The iValve incorporated a saddle-shaped housing and eye-like leaflets, optimizing blood flow and reducing thrombotic risk. Twelve iterations of the iValve were fabricated using 6061-T6 aluminum and polyether ether ketone and were tested for hemodynamic performance, including opening and closing dynamics. The iValve prototypes demonstrated a reduction in regional backflow velocity (RBV) spikes, which are associated with thromboembolic events, and exhibited a 7% to 10% decrease in closing time compared with standard MHVs.

In the study, the top-performing prototypes of the iValve achieved a mean RBV of −4.34 m/s without significant spikes, outperforming existing MHVs and closely matching the performance of bioprosthetic valves. The findings suggested that the iValve may reduce the need for lifelong anticoagulation therapy while providing enhanced durability.

Full disclosures can be found in the published study.