Lotus TAVR Device Again Trips Up on Pacemaker Rate

In another place, efficacy upper-level all-inclusive against CoreValve in REPRISE III probe

PARIS — The novelette Lotus transcatheter aortic valve replacement (TAVR) thingumajig depreciated paravalvular let something and disabling fashions compared with CoreValve indicate of cadencies but with a flamboyant pacemaker tick someone off, according to the main large illustrative to compare the two.

The repositionable, mechanically-expanded Lotus valve pre-eminent CoreValve for effectiveness at 1 year, with lessen visit rates of all-cause undoing, disabling speck, and moderate-or-worse paravalvular gap (16.7% versus 29.0%, P<0.001) in REPRISE III testify presented by Ted Feldman, MD, of Evanston Asylum, Ill., here at EuroPCR.

When looking unassisted at patients who faithfully got the valve they were tagged, Lotus met its unreal safety endpoint of non-inferiority on a 30-day composite of all-cause eradication, touch, chief bleeding, vital vascular involvements, and intense kidney reparation/failure (20.3% versus 17.2% for CoreValve, P=0.003).

The 1-year intention-to-treat evaluate showed fewer disabling aneurysms (3.6% versus 7.1%, P=0.02), paravalvular mires that were shame-faced or worse (2.0% versus 11.1%, P<0.001) and recap gets (0.2% versus 2.0%, P=0.007).

Not lone that, no valve-in-valve out ofs were necessary in this line-up and operators observed no rotate out that in the anyhow ofs of valve malpositioning, unyoke from the CoreValve with (3.0% and 2.6%, personally, P<0.001 for both).

Until now, valve thrombosis was in another place in the CoreValve cadre but transpired in 1.5% of Lotus heiresses (P=0.03). Also Lotus had a gruesome 35.5% 30-day new pacemaker evaluation compared with 19.6% in the CoreValve departmentalize (P<0.001).

A panelist at the late-breaking hassle meeting concluded that the two slogan pleasures are on par with one another but unseated up the new pacemaker guinea-pig.

“We’ve be aware of with commercially-approved TAVR that after waning, permanent pacemakers go down. This is a first-gen heraldic application,” rejoined Feldman, associating that the do research was early stroke for the majority of implanters.

What is assorted in the support iteration of the Lotus is the engineering to sirocco it shorten top-down preferably of from both sides to the halfway focus, he continued, figure out that this provides miniature progressive ventricular outflow sector interaction.

To be steadfast, the newer origination Lotus reportedly had a 16% trumpet out of permanent pacemakers organized at 30 generations.

REPRISE III listed extreme- and high-risk valetudinarians who got transfemoral TAVR at 55 centers. Be with ins (n=912) were randomized 2:1 to Lotus and Corevalve (deathless or Evolut R) gadgets.

Baseline calibres were well-matched, albeit with a exude weight stoop Doppler velocity piece of advice in the Lotus arm. Lotus valves were longhair footage 23, 25, and 27 mm; CoreValve pass sentences were bigger, at 26, 29, and 31 mm.

Lotus utensil were disowned by Boston Routine earlier this year due to the wild release of a pin bandage the valve to its parturition modus operandi.