Research Article: Early versus newer generation transcatheter heart valves for transcatheter aortic valve implantation: Echocardiographic and hemodynamic evaluation of an all-comers study cohort using the dimensionless aortic regurgitation index (AR-index)

Date Published: May 31, 2019

Publisher: Public Library of Science

Author(s): Anja Stundl, Hannah Lucht, Jasmin Shamekhi, Marcel Weber, Alexander Sedaghat, Fritz Mellert, Eberhard Grube, Georg Nickenig, Nikos Werner, Jan-Malte Sinning, George C.M. Siontis.

http://doi.org/10.1371/journal.pone.0217544

Abstract

More than mild paravalvular aortic regurgitation (pAR) negatively impacts prognosis after transcatheter aortic valve implantation (TAVI). “Newer generation” transcatheter heart valves (THVs) including Direct Flow Medical, Medtronic Evolut R, Boston Lotus, and Edwards SAPIEN 3 valve system promise to improve outcome by reducing the rate of TAVI-related issues such as pAR. Aim was to evaluate and compare the hemodynamic performance with AR index of “early” vs. “newer generation” THVs and its impact on outcome.

In 805 patients undergoing TAVI, the degree of pAR was assessed using imaging modalities (angiography, echocardiography) and hemodynamic measurements (aortic regurgitation index, ARI ratio). Severity of pAR and outcome were assessed according to the VARC-2 criteria.

TAVI with use of “newer generation” THVs showed significantly reduced pAR and improved outcomes compared to “early generation” devices that could at least in part be explained by more favorable hemodynamics

Partial Text

Over the last decade, transcatheter aortic valve implantation (TAVI) has become an effective treatment alternative for patients suffering from severe symptomatic aortic stenosis at increased risk for surgical aortic valve replacement (SAVR) [1–3]. Among several aspects contributing to the procedural and clinical success of TAVI, appropriate patient selection, implementation of clinical best practices, and a continuous evolution in design of transcatheter heart valves (THVs) play a pivotal role to reduce the rate of TAVI-related complications, such as paravalvular aortic regurgitation (pAR). This is especially important since greater than mild pAR has been proven to have a negative impact on both short- and long-term mortality [4–5]. However, there is also evidence that mild pAR might have negative effects on survival after TAVI [5]. The heterogeneity of these data may be explained by the non-standardized clinical assessment of pAR. To address this issue, both a precise diagnosis and an accurate quantification of the severity of pAR are essential, which can be provided by a comprehensive multi-modal approach with angiographic, echocardiographic, and hemodynamic evaluation. The currently available so-called “newer generation” THVs including Direct Flow Medical, Medtronic Evolut R, Boston Lotus, and Edwards SAPIEN 3 valve system promise to facilitate the procedure itself and to further improve outcome by reducing the rate of TAVI-specific complications such as pAR due to new technology advances, which are characterized by technical improvements in design and implantation techniques (e.g. repositioning, recapturing, sealing mechanisms). Hence, the aim of the present study was to evaluate and compare the hemodynamic performance using the “AR index” and the “ARI ratio” of “early” vs. “newer generation” transcatheter heart valves and its impact on outcome.

In this study, we were able to show that, among the several aspects contributing to the improvement of procedural and clinical outcome of TAVI patients such as more appropriate patient selection with decreasing surgical risk, implementation of best clinical practices, and growing experience (the so-called “learning curve”), the use of “newer generation” THVs significantly reduces the occurrence of pAR and, thus, helps to further improve patient outcomes. Greater than mild pAR occurred significantly less frequently in patients undergoing TAVI with “newer generation” THVs and the post-procedural ARI was significantly higher with use of the Lotus THV compared to all other THVs. When categorized into quartiles, a post-procedural ARI in the lowermost quartile was significantly associated with increased all-cause mortality at 1 and 3 years. However, an ARI lower than 25 was only predictive for 1-year and 3-year mortality in “early generation”, but not in “newer generation” THVs, since the occurrence of more than mild pAR was significantly lower with these valve types. Taken together, this improvement in procedural success and patient outcome might also be explained to a certain extent by more favorable hemodynamics as assessed with the ARI and ARI ratio compared to “early generation” THVs.

TAVI with use of “newer generation” THVs significantly reduced pAR and improved outcomes compared to “early generation” devices that might at least in part be explained by more beneficial hemodynamics.

 

Source:

http://doi.org/10.1371/journal.pone.0217544