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Sapien 3 bested Sapien XT in hemodynamic outcomes
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The Sapien 3 transcatheter valve demonstrated improvements in paravalvular aortic regurgitation compared with the earlier-generation Sapien XT valve, according to recent findings.
The researchers noted that no data are available that compare the Sapien 3 valve (Edwards Lifesciences) — specifically the enhanced anti-paravalvular leak properties — with earlier transcatheter valve systems.
In the current case-matched study, the researchers compared the Sapien 3 valve with the Sapien XT valve (Edwards Lifesciences) in terms of hemodynamic performance.
The cohort included 27 patients who were treated with the Sapien 3 device and 50 patients treated with the XT device. Eligible participants in the study device group were matched with those in the XT group for prosthesis size (26 mm), aortic annulus area and mean diameter measured by CT, LV ejection fraction, body surface area and BMI.
Clinicians determined prosthesis size by oversizing the annulus area by 1% to 15%, according to the researchers. Experts in a central echocardiography core lab analyzed Doppler-echocardiography images collected at baseline and 1-month follow-up.
Twenty percent of patients in the XT group required post-dilation compared with 3.7% of those in the Sapien 3 group (P=.047). Similar mean residual gradient and effective orifice area were reported in the two arms (P>.05).
Mild paravalvular aortic regurgitation was greater in the XT group than in the Sapien 3 group (42% vs. 7.4%; P=.002), as was moderate regurgitation (8% vs. 0%).
The only factor associated with trace or no anti-paravalvular leak properties after transcatheter aortic valve replacement was implantation of the Sapien 3 device (P=.007).
“TAVR with the [Sapien 3 valve] was associated with a very low rate of paravalvular leaks and need for balloon post-dilation, much lower than that observed with the earlier generation of balloon-expandable valves,” the researchers concluded. “The confirmation of these results in a larger cohort of patients will represent a major step forward in the use of transcatheter valves for the treatment of aortic stenosis.”
Disclosure: The researchers report financial disclosures with Edwards Lifesciences and St. Jude Medical.
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