JIM Today 2018 - Saturday - page 4

JIM today
Issue 3 
 24 February 2018
ACURATE and Lotus: A tale of two valves
hursday’s TAVI 1 session welcomed a range
of cutting-edge reports from invited experts,
with a number of key technologies placed
under the spotlight.
Lars Søndergaard (Rigshospitalet, Copenhagen,
Denmark) stepped up to the podium to discuss the
Lotus and ACURATE family of transcatheter aortic
valves (Boston Scientific, USA), touching on their
place in contemporary TAVI.
Speaking to
JIM Today
prior to his talk,
Professor Søndergaard outlined the potential of
both technologies.
How important is it to tailor a particular TAVI
valve to patient, and what specific challenges
is the Lotus valve hoping to address?
In a subset of patients undergoing TAVI, specific
transcatheter heart valves may be related to better
outcomes. One example is bicuspid aortic valves,
which are often a challenge. Due to the anchor-
ing on the leaflets, rather than annulus – as well
as severe calcification – a high rate of paravalvular
leakage, valve embolisation and conduction abnor-
malities are common.
However, the experience at many TAVI centres
is that this can be overcome with the Lotus valve.
Due to the controlled deployment, possibility for
re-capturing the fully deployed valve prosthesis,
and its adaptive sealing, Lotus valves have very
similar procedural outcomes in bicuspid as in tricus-
pid aortic valves.
How does the newer Lotus Edge valve build
on the technology?
The Lotus Edge adds several features to the previ-
ous Lotus platform. Firstly, the introducer sheath
will be expandable with a profile of 14 or 15
F, which will allow more patients to undergo a
transfemoral procedure. This is important, firstly
because it has been shown that the transfemoral
approach is related to better outcomes for the
patient, as well as a shorter hospital stay. Secondly,
the shaft of the delivery system is smaller, which
makes the system more flexible, with improved
safety when used in tortuous vessels.
Thirdly, the mechanical features of the valve
deployment have been modified, and now include
the Depth Guard. This means that the valve frame
will extend less into the left ventricle outflow tract
during deployment, and
therefore potentially
reduce the risk of conduc-
tion abnormalities and
the need for permanent
pacemaker. Fourthly, add-
ing radiopaque markers
to the locking system
makes it easier to check
for complete locking of
the frame during deploy-
ment. Finally, two new
valve sizes (21 mm and
29 mm) will be added
to the portfolio, which will now cover all aortic
annulus sizes.
Lotus Mantra takes this a step further, with
a shorter design that should reduce pace-
maker use?
That is correct. The current height of the Lotus
valve frame will be reduced. This means that it will
be possible to implant the prosthesis in a higher
position without jeopardising the access to the
coronary arteries. And since high-position prosthe-
sis implantation is the key in reducing conduction
disturbance, this new valve design may potential
reduce pacemaker rate.
The ACURATE valve has now been incorpo-
rated into the Boston Scientific valvular fam-
ily. What unique aspects or benefits does the
technology bring to the fore?
The ACURATE valve is a different concept than
Lotus. It is a self-expanding technology with supra-
annular position of the leaflets. Furthermore, it is a
simple two-step deployment and therefore an at-
tractive valve prosthesis for many interventionalists.
What trials, either ongoing or upcoming, are
important for Lotus (e.g. REPRISE III)?
REPRISE III is a global, prospective, multicentre,
randomised controlled trial to compare safety and
effectiveness with the Lotus valve (N=607) versus
a self-expanding CoreValve (N=305; Medtronic) in
patients at extreme or high surgical risk. The trial
shows that Lotus is non-inferior to CoreValve with
regards to the 30-day primary composite safety
endpoint of all-cause mortality, stroke, life-threat-
ening/major bleeding, stage 2/3 AKI and major
vascular complications.
Furthermore, Lotus is superior to CoreValve for
the primary combined effectiveness endpoint of
all-cause mortality, disabling stroke and moderate
or greater paravalvular leak. So, REPRISE III confirms
that Lotus is an attractive alternative to the ‘estab-
lished’ TAVI systems on the market.
Similarly, what can you tell us about the ACU-
RATE data?
The SAVI TF registry included 1,000 patients with
severe aortic stenosis treated with ACURATE.
Despite a mean age of 81 years and STS score
of 6.0%, the 30-day mortality was only 1.4%,
and disabling stroke rate 1.2%. Furthermore, the
reported pacemaker rate of 8.3% and more than
mild paravalvular leakage in 4.1% of the patients is
among the best in class.
In your opinion, do you think the two valves
will indeed build a new and promising chapter
in TAVI?
I believe the Lotus and ACURATE platforms
offer an attractive solution for most patients with
aortic stenosis. This will be even better with the
next generation devices such as Lotus Mantra and
ACURATE with advanced sealing.
“I believe the Lotus and
ACURATE platforms offer an
attractive solution for most
patients with aortic stenosis.
This will be even better with
the next generation devices.”
Lars Søndergaard
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