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

Srilakshmi Vallabhaneni,Marsel Matka,Stephen Olenchock,Mehdi Razzaghi,Vivek Modi,Christopher Sarnoski,Raymond Durkin,Jamshid Shirani,Matthew Carey

doi:10.7759/cureus.18044

Srilakshmi Vallabhaneni, Marsel Matka + Show 7 more

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https://doi.org/10.7759/cureus.18044

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Abstract

BackgroundSevere patient prosthesis mismatch (sPPM) after surgical aortic valve replacement is associated with worse outcomes. Limited data exists on the impact of sPPM on outcomes after transcatheter aortic valve replacement (TAVR), especially regarding the newer generation valves. The aim of this study was to evaluate the incidence, determinants, and outcomes of sPPM in patients undergoing TAVR with Edwards SAPIEN XT (ES XT) and Edwards SAPIEN 3 (ES3) valves (Edwards Lifesciences, Irvine, CA, USA).MethodsWe retrospectively reviewed 366 patients who underwent TAVR with ES XT (n = 114) or ES3 (n = 252) valves between July 2012 and June 2018. sPPM was defined as indexed effective orifice area (iEOA) <0.65 cm2/m2. Kaplan-Meier survival estimates were used to determine outcomes.ResultsMultivariate linear regression analysis was utilized to determine potential independent effects of PPM on outcomes. sPPM was present in 40 (11%) of the patients [8 (7%) ES XT and 32 (13%) ES3] and was associated with female sex, smaller left ventricular outflow tract (LVOT) diameter and aortic valve annular area, absence of prior coronary artery bypass graft (CABG) surgery, shorter height, higher body mass index, and smaller pre-TAVR valve area (all p < 0.05). Among those with ES3 valves, the incidence of sPPM was inversely proportional to the valve size (50%, 25%, 5% and 3% for 20-, 23-, 26- and 29-mm valve sizes, respectively; p < 0.001). At a mean follow-up period of 3.5 ± 1.5 years, there was no difference in all-cause mortality (22.5% vs. 25.6%, p = 0.89) or a composite endpoint of heart failure, arrhythmias, stroke, and myocardial infarction (30% vs. 34%, p = 0.24) in those with or without sPPM.ConclusionES3 was associated with a higher incidence of sPPM, particularly with smaller valve sizes. However, the presence of sPPM as defined by iEOA was not an independent predictor of adverse outcomes in patients undergoing TAVR within an intermediate follow-up period.

Highlights

Patient prosthesis mismatch (PPM) has been defined as a reduced indexed effective orifice area of an otherwise normally functioning prosthetic valve [1]
We retrospectively reviewed 366 patients who underwent transcatheter aortic valve replacement (TAVR) with Edwards SAPIEN XT (ES XT) (n = 114) or Edwards SAPIEN 3 (ES3) (n = 252) valves between July 2012 and June 2018. Severe patient prosthesis mismatch (sPPM) was defined as indexed effective orifice area
Multivariate linear regression analysis was utilized to determine potential independent effects of PPM on outcomes. sPPM was present in 40 (11%) of the patients [8 (7%) ES XT and 32 (13%) ES3] and was associated with female sex, smaller left ventricular outflow tract (LVOT) diameter and aortic valve annular area, absence of prior coronary artery bypass graft (CABG) surgery, shorter height, higher body mass index, and smaller pre-TAVR valve area. Among those with ES3 valves, the incidence of sPPM was inversely proportional to the valve size (50%, 25%, 5% and 3% for 20, 23, 26- and 29mm valve sizes, respectively; p < 0.001)

Summary

Introduction

Patient prosthesis mismatch (PPM) has been defined as a reduced indexed effective orifice area (iEOA) of an otherwise normally functioning prosthetic valve [1]. The reported incidence of PPM after TAVR with earlier generation valves has ranged from 25-45% for moderate and from 1-15% for severe cases [8,9,10]. Significant valvular and para-valvular aortic insufficiency, led to relatively unsatisfactory outcomes in the first-generation Edwards SAPIEN and Edwards SAPIEN XT (ES XT) (Edwards Lifesciences, Irvine, CA, USA) balloon-expandable valves [14]. Severe patient prosthesis mismatch (sPPM) after surgical aortic valve replacement is associated with worse outcomes. The aim of this study was to evaluate the incidence, determinants, and outcomes of sPPM in patients undergoing TAVR with Edwards SAPIEN XT (ES XT) and Edwards SAPIEN 3 (ES3) valves (Edwards Lifesciences, Irvine, CA, USA)

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