Prospective registry validating the reproducibility of mitral paravalvular leak measurements in a standardized real-time three-dimensional transesophageal echocardiography algorithm for optimal choice of the closure device

Introduction
Transcatheter paravalvular leak closure (TPVLC) has become a well-established method of treatment for patients with paravalvular leak (PVL) causing heart failure or significant hemolysis. Nonetheless, the method of optimal PVL sizing and subsequent device choice requires standardization. For this purpose a real-time three-dimensional transesophageal echocardiography (RT-3D TEE) algorithm was developed in our institution. It has proven clinically useful with results successfully translated into type, size, and number of occluding devices. Still, the reproducibility of measurements has not been previously verified.

Aim
To investigate the intra- and inter-observer variability of measurements in a RT-3D TEE algorithm developed for optimal choice of occluding devices during TPVLC.

Material and methods
Three echocardiographers, with RT-3D TEE clinical experience ranging from 1 to 8 years, analyzed recordings of 20 mitral PVLs according to our standardized protocol. PVL channel cross-sectional area (CSA), width (W) and length (L) were measured at the level of the vena contracta. Each echocardiographer performed the measurements twice on different days, individually and blinded to other participants’ results.

Results
Measurements of PVL CSA, W and L showed intra- and interobserver agreement of 0.98, 0.93, 0.92 and 0.95, 0.88, 0.87, respectively.

Conclusions
The presented algorithm enables standardized utilization of RT-3D TEE for appropriate TPVLC device choice with low intra- and inter-observer variability.