Flow Status-Based Predicted Prosthesis-Patient Mismatch in Patients Undergoing Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve.

BACKGROUND

Effective orifice area (EOA) is flow dependent. However, established methods for the assessment of predicted prosthesis-patient mismatch (PPM) do not consider flow status and therefore may underestimate the rate and impact of PPM in patients with abnormal flow status. This study aimed to investigate the clinical impact of flow status-based predicted PPM in patients undergoing transcatheter aortic valve replacement (TAVR).

METHODS

Patients undergoing TAVR in a prospective TAVR registry were stratified by the presence of moderate or severe PPM (EOA index to body surface area [EOAi]: 0.65-0.85 or ≤0.65 and 0.55-0.70 or ≤0.55 cm2/m2 if obese). PPM was defined according to echocardiographically measured EOAi (measured PPM) or predicted or flow status-based predicted EOAi. Predicted EOAs were based on reference values of EOA for each valve generation and size (predicted PPMTHV) or native aortic annulus dimension (predicted PPMCT).

RESULTS

Among 1510 patients included (August 2007-June 2022), rates of moderate or severe PPM differed according to method of assessment: 27.0 and 8.7% according to measured PPM, 11.3 and 1.2% according to predicted PPMTHV, 12.0 and 0.1% according to PPMCT, 21.6 and 0.2% according to flow status-based predicted PPMTHV, and 25.1 and 0.4% according to flow status-based predicted PPMCT. Five-year mortality was comparable in patients with and without flow status-based predicted PPM defined by either method. These results were consistent when patients were stratified by flow status.

CONCLUSIONS

Rates of PPM differ considerably when flow status is considered. There was no consistent signal of increased risk of adverse events up to 5 years in patients with flow status-based predicted PPM.

CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. NCT01368250.