Prevalence and Significance of Patient Prosthesis Mismatch Following Edwards SAPIEN XT and SAPIEN 3 Transcatheter...

Area of Science:

• Cardiology
• Biomedical Engineering
• Prosthetic Valve Research

Background:

• Severe patient prosthesis mismatch (sPPM) after surgical aortic valve replacement is linked to poorer outcomes.
• Limited data exists on sPPM's impact after transcatheter aortic valve replacement (TAVR), especially with newer valves.

Purpose of the Study:

• To assess the incidence, determinants, and outcomes of sPPM in TAVR patients using Edwards SAPIEN XT (ES XT) and Edwards SAPIEN 3 (ES3) valves.
• To investigate the relationship between valve size and sPPM incidence with ES3 valves.

Main Methods:

• Retrospective review of 366 TAVR patients (114 ES XT, 252 ES3) between July 2012 and June 2018.
• sPPM defined as indexed effective orifice area (iEOA) <0.65 cm²/m².
• Kaplan-Meier survival estimates and multivariate regression analysis used for outcome assessment.

Main Results:

• sPPM was present in 11% of patients (7% ES XT, 13% ES3) and associated with female sex, smaller LVOT diameter, absence of prior CABG, shorter height, higher BMI, and smaller pre-TAVR valve area.
• For ES3 valves, sPPM incidence decreased with increasing valve size (50% for 20mm to 3% for 29mm).
• At a mean 3.5-year follow-up, no significant differences in all-cause mortality or a composite endpoint of major adverse cardiovascular events were observed between patients with or without sPPM.

Conclusions:

• The Edwards SAPIEN 3 valve is associated with a higher incidence of sPPM, particularly with smaller valve sizes.
• Despite higher incidence, sPPM, defined by iEOA, was not an independent predictor of adverse outcomes in TAVR patients within an intermediate follow-up period.