Hemolysis After TAVR Using the Fifth-Generation Balloon-Expandable Valve: Comparison With the Third-Generation Valve | JACC: Asia

0:00Thank you for the opportunity to discuss this important work. My name is Mateo Sterla. I'm a cardiology researcher at Montefere Medical Center and the Albert Einstein College of Medicine in New York. I'm joined on this editorial by my co-author is Pierre Pasquale-Leone and my mentor, Dr. Azim Lateeb. I will be discussing the study by Khrushima and colleagues, published in Jack Asia, entitled Timals is after Tavi using the fifth generation blue and expandable valve, comparison with the third generation valve, which examines himals as following trans-catheter aerodic valve implantation with the Sapien 3 Ultra-Razilia valve, compared with the third generation platform. In this study, the authors address it increasingly, recognize it but still under appreciated complication, clinically relevant hemolytic anemia following trans-catheter aerodic valve implantation with the fifth generation Sapien 3 Ultra-Razilia valve. Himals has traditionally been considered rare with contemporary blue and expandable valves and has not been systematically

1:02evaluated in major Tavi trials. However, read accumulating reports, particularly from Japan, suggest this assumption may no longer be valid. Khrushima and colleagues perform the retrospective single-center analysis of 230 consecutive patients undergoing trans-femoral Tavi with either the third generation Sapien 3 or the fifth generation Sapien 3 Ultra-Razilia valve. They use a strict and clinically meaningful definition of hemolytic anemia, where laboratory values were assessed serially from the peripersidial period through 30-day follow-up following identification of both overt and evolving hemolysis. Clinically relevant hemolysis occurred in 8.5% of patients treated with the Sapien 3 Ultra-Razilia valve, compared with less than 1% of those treated with the third generation Sapien 3 valve. In univariable analysis, implantation of the Sapien 3 Ultra-Razilia valve was associated with roughly a 10-fold higher odds of hemolysis. Additional correlates included

2:04small valve size, particularly the 20-millimeter valve, elevated residual vascular gradients, severe annual calcifications, and presence of trays, or more peripersidial leak. From a mechanistic perspective, these findings suggest a multifactorial process. Under expansion of smaller bluenic expandable valves may lead to higher velocities in shear stress, magnifying the hemodynamic impact of even mild periparavular regurgitation. Device-specific features of the Sapien 3 Ultra-Razilia valve, including its textured outer skirt and size-specific leaflet suspension design, may further influence local flow patterns, although these hypotheses remain speculative and require dedicated investigation. Clinically, this study has several important implications. First, it challenges the assumption that trays or mild periparavular leak is always benign, particularly in Sapien 3 Ultra-Razilia area. Second, it underscores the importance of careful valve expansion and grain optimization.

3:07Especially in patients with small anule, and third, it suggests that targeted biochemical surveillance may be a reasonable and higher-risk patients as he molasses can evolve after discharge before overt anemia becomes clinically apparent. While this study is limited by its retrospective design and small number of events, it contributes a credible and mechanistically plausible signal that aligns with emerging registry data, and it warrants further evaluation. In summary, this work highlights a complication that may be more prevalent than previously appreciated, and emphasizes the need for vigilance, thoughtful procedure optimization, and continued mechanistic research as trans-catheter valve technology continues to evolve.