Original Research
Long-Term Valve Performance of TAVR and SAVR: A Report From the PARTNER I Trial

https://doi.org/10.1016/j.jcmg.2016.11.004Get rights and content
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Abstract

Objectives

The aim of this study was to evaluate the long-term performance of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) through longitudinal echocardiographic analysis.

Background

The long-term performance of the SAPIEN TAVR is not well-described. Therefore, we examined the hemodynamic and valvular profile of the SAPIEN TAVR over 5 years.

Methods

All patients receiving TAVR or SAVR with first post-implant (FPI) and 5-year echoes were analyzed for aortic valve (AV) peak velocity, AV mean gradient, AV area, peak left ventricular (LV) outflow tract and in-stent velocities, Doppler velocity index, aortic regurgitation (AR), LV mass index, stroke volume index, and cardiac index. The FPI and 5-year data were compared using a paired t test or McNemar’s analyses.

Results

There were 86 TAVR and 48 SAVR patients with paired FPI and 5-year echocardiograms. Baseline characteristics were similar between groups. The AV area did not change significantly 5 years after TAVR (p = 0.35). The AV mean gradient also remained stable: 11.5 ± 5.4 mm Hg at FPI to 11.0 ± 6.3 mm Hg at 5 years (p = 0.41). In contrast, the peak AV and LV outflow tract velocities decreased (p = 0.03 and p = 0.008, respectively), as did in-stent velocity (p = 0.015). Correspondingly, the TAVR Doppler velocity index was unchanged (p = 0.07). Among TAVR patients, there was no change in total AR (p = 0.40), transvalvular AR (p = 0.37), or paravalvular AR (p = 0.26). Stroke volume index and cardiac index remained stable (p = 0.16 and p = 0.25, respectively). However, there was a significant regression of LV mass index (p < 0.0001). The longitudinal evaluation among SAVR patients revealed similar trends. There was a low rate of adverse events among TAVR and SAVR patients alive at 5 years.

Conclusions

Longitudinal assessment of the PARTNER (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial) I trial demonstrates that valve performance and cardiac hemodynamics are stable after implantation in both SAPIEN TAVR and SAVR in patients alive at 5 years. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial [PARTNER]; NCT00530894)

Key Words

aortic stenosis
surgical aortic valve replacement
transcatheter aortic valve replacement

Abbreviations and Acronyms

AR
aortic regurgitation
AS
aortic stenosis
AV
aortic valve
AVA
aortic valve area
BSA
body surface area
DVI
Doppler velocity index
FPI
first post-implant
LV
left ventricle
LVOT
left ventricular outflow tract
SAVR
surgical aortic valve replacement
TAVR
transcatheter aortic valve replacement
TVI
time velocity integral

Cited by (0)

The PARTNER Trial was funded by Edwards Lifesciences.

Duke Clinical Research Institute and Columbia University Medical Center were the recipients of research grants from Edwards Lifesciences, Inc. Dr. Weissman has received grants from Edwards Lifesciences, Abbott Vascular, Medtronic, Sorin, Direct Flow Medical, Boston Scientific, and JenaValve. Dr. Hahn has received consultant fees from Edwards Lifesciences; and research support from Philips Healthcare. Dr. Pibarot holds the Canada research Chair in Valvular Heart Diseases, Canadian Institutes of Health Research, Ottawa, Ontario, Canada; and has received grant support from Edwards Lifesciences. Dr. Svensson holds equity in Cardiosolution and Valvexchange; and intellectual property with Postthorax. Dr. Kodali has received grants from Edwards Lifesciences and Medtronic; is a member of the PARTNER Trial Executive Committee; and holds equity in Thubrikar Aortic Valve, Inc. Dr. Szeto has received consulting fees/honoraria from Microinterventional Devices. Dr. Makkar has received grants from Edwards Lifesciences and St. Jude Medical; is a consultant for Abbott Vascular, Cordis, and Medtronic; and holds equity in Entourage Medical. Drs. Mack, Svensson, and Leon have received travel reimbursements from Edwards Lifesciences related to their work as unpaid members of the PARTNER Trial Executive Committee. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.