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PARTNER I: TAVR vs. SAVR Valve Performance at 5 Years
Study Questions:
What are the functional characteristics of the SAPIEN transcatheter aortic valve replacement (TAVR) after 5 years in patients from the PARTNER (Placement of AoRTic TraNscathetER Valve Trial) I trial?
Methods:
All patients undergoing TAVR or SAVR with both first post-implant and 5-year echocardiograms were analyzed for aortic valve (AV) peak velocity, mean gradient, and effective orifice area; peak left ventricular (LV) outflow tract and in-stent velocities; Doppler velocity index; aortic regurgitation (AR); and LV mass index, stroke volume index, and cardiac index. First post-implant and 5-year data were compared.
Results:
There were 86 TAVR and 48 SAVR patients with paired first post-implant and 5-year echocardiograms. Baseline characteristics were similar between groups. There were no significant changes between first post-implant and 5-year echocardiograms in terms of AV area (1.62 ± 0.5 to 1.56 ± 0.5 cm2, p = 0.35) and AV mean gradient (11.5 ± 5.4 mm Hg to 11.0 ± 6.3 mm Hg at 5 years, p = 0.41). Peak AV and LV outflow tract velocities decreased (2.28 ± 0.54 to 2.13 ± 0.50 m/s, p = 0.03; and 1.09 ± 0.25 to 0.99 ± 0.26 m/s, p = 0.008; respectively), as did in-stent velocity (p = 0.015). Correspondingly, the TAVR Doppler velocity index was unchanged (0.53 ± 0.20 to 0.50 ± 0.10, p = 0.07). Among TAVR patients, there was no significant change in total AR (p = 0.40), transvalvular AR (p = 0.37), or paravalvular AR (p = 0.26); stroke volume index (36.8 ± 10.9 to 38.8 ± 12.6 ml/m2, p = 0.16), or cardiac index (2.6 ± 0.8 to 2.8 ± 0.9 L/min/m2, p = 0.25). LV mass index decreased significantly between first post-implant and 5-year echocardiograms (151 ± 35 g/m2 to 121 ± 38 g/m2, 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:
Among patients in the PARTNER I trial who are alive at 5 years, valve performance and cardiac hemodynamics were stable 5 years after implantation of both SAPIEN TAVR and SAVR valves.
Perspective:
These data from the PARTNER I trial suggest that the function of the SAPIEN transcatheter valve remains stable for up to 5 years after implantation. Patients who might have suffered a valve-related complication would have been excluded from analysis though. As TAVR is used in progressively lower-risk patients, truly long-term (not 5-year) data will be of interest.
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Cardiac Surgical Procedures, Diagnostic Imaging, Echocardiography, Echocardiography, Doppler, Heart Valve Diseases, Stents, Stroke Volume, Transcatheter Aortic Valve Replacement
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