番茄社区

PARIS -- The novel Lotus transcatheter aortic valve replacement (TAVR) device reduced paravalvular leak and disabling strokes compared with CoreValve devices but with a high pacemaker rate, according to the first large trial to compare the two.

The repositionable, mechanically-expanded Lotus valve bested CoreValve for effectiveness at 1 year, with lower rates of all-cause death, disabling stroke, and moderate-or-worse paravalvular leak (16.7% versus 29.0%, P<0.001) in REPRISE III data presented by Ted Feldman, MD, of Evanston Hospital, Ill., here at

When looking only at patients who actually got the valve they were assigned, Lotus met its primary safety endpoint of non-inferiority on a 30-day composite of all-cause death, stroke, major bleeding, major vascular complications, and acute kidney injury/failure (20.3% versus 17.2% for CoreValve, P=0.003).

The 1-year intention-to-treat analysis showed fewer disabling strokes (3.6% versus 7.1%, P=0.02), paravalvular leaks that were moderate or worse (2.0% versus 11.1%, P<0.001) and repeat procedures (0.2% versus 2.0%, P=0.007).

Moreover, no valve-in-valve procedures were needed in this group and operators observed no cases of valve malpositioning, unlike the CoreValve experience (3.0% and 2.6%, respectively, P<0.001 for both).

However, valve thrombosis was absent in the CoreValve cohort but occurred in 1.5% of Lotus recipients (P=0.03). Also Lotus had a whopping 35.5% 30-day new pacemaker rate compared with 19.6% in the CoreValve group (P<0.001).

A panelist at the late-breaking trial session concluded that the two devices are on par with one another but brought up the new pacemaker issue.

"We've seen with commercially-approved TAVR that after time, permanent pacemakers go down. This is a first-gen device," responded Feldman, adding that the trial was early experience for the majority of implanters.

What is different in the second iteration of the Lotus is the engineering to make it shorten top-down instead of from both sides to the middle, he continued, explaining that this provides less left ventricular outflow tract interaction.

Indeed, the newer generation Lotus reportedly had a 16% rate of permanent pacemakers implanted at 30 days.

REPRISE III included extreme- and high-risk patients who got transfemoral TAVR at 55 centers. Participants (n=912) were randomized 2:1 to Lotus and Corevalve (classic or Evolut R) devices.

Baseline characteristics were well-matched, albeit with a slightly lower Doppler velocity index in the Lotus arm. Lotus valves were size 23, 25, and 27 mm; CoreValve sizes were bigger, at 26, 29, and 31 mm.

Lotus devices were recalled by Boston Scientific earlier this year due to the premature release of a pin connecting the valve to its delivery system.

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