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

Abstract

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 PPM_THV) or native aortic annulus dimension (predicted PPM_CT).

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 PPM_THV, 12.0 and 0.1% according to PPM_CT, 21.6 and 0.2% according to flow status-based predicted PPM_THV, and 25.1 and 0.4% according to flow status-based predicted PPM_CT. 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.