Comprehensive Echocardiographic Assessment of Normal Transcatheter Valve Function

Area of Science:

• Cardiovascular Medicine
• Biomedical Engineering
• Interventional Cardiology

Background:

• Transcatheter aortic valve replacement (TAVR) requires reliable methods to assess prosthetic valve function.
• Echocardiographic Doppler-derived hemodynamic data are crucial for pre- and post-implant evaluation of TAVR devices.
• Establishing normal hemodynamic parameters is essential for identifying structural valve dysfunction.

Purpose of the Study:

• To define normal hemodynamic function parameters for different iterations of balloon-expandable and self-expanding transcatheter aortic valves.
• To provide expected echocardiographic Doppler-derived hemodynamic data for TAVR devices.
• To inform pre-implant decision-making and post-implant monitoring of longitudinal valve function.

Main Methods:

• Collected echocardiography core lab data on mean gradients and effective orifice area (EOA) from discharge or 30-day echocardiograms.
• Analyzed data from randomized trials including PARTNER (balloon-expandable) and Medtronic CoreValve US Pivotal/Evolut R IDE studies (self-expanding).
• Examined relationships between valve size, annular anatomy, and post-implant EOA.

Main Results:

• Provided mean EOA and gradient values for SAPIEN, SAPIEN XT, SAPIEN 3, CoreValve, and Evolut R valves.
• SAPIEN 3 EOA increased with baseline annular area (p < 0.001).
• Evolut R EOA increased with baseline annular perimeter (p < 0.001).

Conclusions:

• Tables of expected transcatheter aortic valve hemodynamics by type and size are vital for function evaluation.
• Expected EOA data correlated with native annular anatomy, aiding pre-implantation decisions.
• Proposed criteria for defining structural valve dysfunction based on these hemodynamic parameters.