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

Melissa A Daubert; Neil J Weissman; Rebecca T Hahn; Philippe Pibarot; Rupa Parvataneni; Michael J Mack; Lars G Svensson; Deepika Gopal; Samir Kapadia; Robert J Siegel; Susheel K Kodali; Wilson Y Szeto; Raj Makkar; Martin B Leon; Pamela S Douglas

doi:10.1016/j.jcmg.2016.11.004

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

JACC Cardiovasc Imaging. 2016 Dec 8:S1936-878X(16)30895-6. doi: 10.1016/j.jcmg.2016.11.004. Online ahead of print.

Authors

Affiliations

¹ Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina. Electronic address: melissa.daubert@duke.edu.
² MedStar Health Research Institute, Washington, DC.
³ Columbia University Medical Center, New York, New York.
⁴ Quebec Heart and Lung Institute, Quebec, Ontario, Canada.
⁵ Cardiovascular Research Foundation, New York, New York.
⁶ Baylor Scott & White Healthcare, Plano, Texas.
⁷ Cleveland Clinic, Cleveland, Ohio.
⁸ Cedars-Sinai Medical Center, Los Angeles, California.
⁹ University of Pennsylvania Medical Center, Philadelphia, Pennsylvania.
¹⁰ Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina.

PMID: 28017714
DOI: 10.1016/j.jcmg.2016.11.004

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 I trial (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve 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; NCT00530894).

Keywords: aortic stenosis; surgical aortic valve replacement; transcatheter aortic valve replacement.

Associated data

ClinicalTrials.gov/NCT00530894