Valvular performance and aortic regurgitation following transcatheter aortic valve replacement using Edwards valve versus CoreValve for severe aortic stenosis: A Meta-analysis




Abstract


Objectives


To compare incidence of aortic regurgitation (AR), paravalvular AR and valvular performance with Doppler hemodynamic parameters following transcatheter aortic valve replacement (TAVR) with Edwards valve (EV) versus CoreValve (CV). Currently, there are scarce data on post-TAVR echocardiographic outcomes comparing EV and CV.


Methods


PubMed and the Cochrane Center Register of Controlled Trials were searched through May 2015. Twenty studies (n = 11,244) comparing TAVR procedure that used EV (n = 6445) and CV (n = 4799) were included. End points were post-TAVR moderate to severe AR and paravalvular AR, effective orifice area (EOA), mean trans-aortic pressure gradient (MPG), peak trans-aortic pressure gradient (PPG) and left ventricular ejection fraction (LVEF). The mean difference (MD) or relative risk (RR) with 95% confidence interval (CI) was computed and p < 0.05 was considered as a level of significance.


Results


Moderate to severe AR and paravalvular AR were significantly lower in EV group (RR: 0.57, CI: 0.52–0.63, p < 0.00001 and RR: 0.40, CI: 0.25–0.63, p < 0.0001 respectively) compared to CV group . EOA and PPG were not significantly different between EV and CV groups. MPG was significantly lower among patients in CV group (MD: 1.08, CI: 0.05–2.10, p = 0.04). LVEF was significantly higher in patients in EV group (MD: 2.26, CI: 0.77–3.74, p = 0.03) .


Conclusions


This study showed CV is associated with higher incidence of post-TAVR moderate to severe paravalvular AR. Echocardiographic valvular performance measures (MPG, LVEF) showed minimal but significant difference, which may not be clinically significant.


Highlights





  • Incidence of post-TAVR moderate to severe AR and paravalvular AR is higher with CV compared to EV.



  • Post-TAVR MPG was lower with CV compared to EV.



  • Post-TAVR LVEF was higher with EV compare to CV.



  • EOA and PPG were not significantly different between EV and CV.




Introduction


Transcatheter aortic valve replacement (TAVR) has developed as an alternative to surgical aortic valve replacement for patients with severe aortic stenosis (AS) who are not candidates for surgery or at high surgical risk . Currently available Food and Drug Administration-approved devices in United States are balloon-expandable Edwards Valve (EV) and self-expandable CoreValve (CV). Architecture of valvular prosthesis may influence valve performance of post- implantation. CV is a trileaflet porcine pericardial tissue valve affixed to self-expandable Nitinol frame . EV is a trileaflet bovine pericardial tissue affixed to balloon expandable steel frame (first generation) or cobalt chromium frame (second generation) .


More than two-thirds of the patients undergoing TAVR experience post-procedural aortic regurgitation (AR) . Most of these patients have mild AR and about 12% to 16% have moderate to severe degree of AR as reported . Circumferential malapposition due to heavy annular calcification, mal-positioning of prosthesis and mal-sizing of prosthesis have been described as the most likely reasons for post-procedural AR . Type of device used for TAVR procedure may have significant implication on incidence of post-procedural AR . Valve architecture and implantation technique unique to each currently available transcatheter aortic valve is likely responsible for this difference. Currently, there are few data on echocardiographic outcomes comparing post-TAVR EV and CV. The objective of this meta-analysis was to compare post-TAVR valvular performance with Doppler hemodynamic parameters and incidence of post-TAVR AR and paravalvular AR between EV and CV. Recently, Food and Drug Administration has approved new generation valves including Edwards SAPIEN 3 and CoreValve Evolut. However, only initial experiences from few centers is available, and not enough data is available yet to provide insight into these two devices.


Another meta-analysis by Athappan et al. was performed on studies which either used EV or CV lacking the head to head comparison between EV to CV. The purpose of our study is to compare echocardiographic outcomes at 30 days post-TAVR on studies that assessed both valves.

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Nov 13, 2017 | Posted by in CARDIOLOGY | Comments Off on Valvular performance and aortic regurgitation following transcatheter aortic valve replacement using Edwards valve versus CoreValve for severe aortic stenosis: A Meta-analysis

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