JIM Today 2018 - Friday - page 11

Issue 2 
 23 February 2018 
JIM today
MANTA device closes
the gap in large-bore access
ext-generation large-bore closure devices
are the order of business this afternoon
during the ‘TAVI 2’ session, held in Room
Foscolo. One such device is the MANTA (Essential
Medical, USA) – used to seal femoral punctures fol-
lowing vascular access procedures requiring cardiac
MANTA employs ‘anchor’ or ‘plug’
sealing, with the advantage of X-ray visibility and
improved deployment control.
Compared to surgical cut-down, vascular clo-
sure devices have been shown to reduce procedur-
al time to ambulation, as well as lowering the risk
of post-procedural infections. “All of these factors
are associated with prolonged hospitalisation and
poorer outcomes,” Herbert Kroon, from the De-
partment of Cardiology, Erasmus Medical Center,
Rotterdam, the Netherlands, told
JIM Today
“Another important advantage of closure de-
vices is that no general anaesthesia is required, and
patients are awake during procedures, which may
result in shorter times to (safe) discharge.”
Vascular closure devices are not without their
limitations, however. Dr Kroon noted that suture-
based closure devices like the Perclose ProGlide
and Prostar XL (Abbott Vascular, USA) may require
the pre-closure technique, which may be techni-
cally demanding and time consuming – although
implementation will get faster after practice.
“Having said that, recent trials on transcath-
eter aortic valve implantations still report a major
vascular complication rate of 5-8%, and up to two-
thirds of them are related to vascular closure device
failures,” said Dr Kroon.
Turning to MANTA specifically, Dr Kroon
relayed that the closure device is intended for all
patients with large-bore arteriotomies.
He went on: “MANTA consists of an endolu-
minal bioresorbable toggle and a collagen pad
on the outside, between which the vessel wall
is sandwiched. When pulling the delivery device
back, a green to red scale will inform you about
the level of pulling force that is applied. This may
be advantageous in situations where less pulling
force is allowed, like severely calcified femo-
ral arteries.”
Dr Kroon also outlined some of the important
procedural considerations. “There is no specifical-
ly required time to wait for sealing to take place;
just follow the step-by-step deployment,” he said.
“However, some important considerations must be
kept in mind. Firstly, one should always measure
the arteriotomy depth before using the large-bore
sheath. Secondly, a large subcutaneous haemato-
ma could alter the arteriotomy distance, thus needs
to be ruled out before proceeding with MANTA.
“Last but not least, an activated clotting time
<250 seconds and a systolic blood pressure <160
mmHg prior to closure are required.”
MANTA’s CE-mark approval trial showed excel-
lent results, noted Dr Kroon, with a 94% success
rate and median time to haemostasis (TTH) of 23
seconds in 50 patients. Currently, 60-day follow-
up of 341 patients in the IDE approval trial in the
United States has been completed, and results are
expected later in 2018.
Speaking more of the available data, he con-
tinued: “To date, more than 1,500 MANTA closure
devices have been used throughout centres in the
Netherlands, Norway, Sweden, Finland and Den-
mark, with good results. Post-market surveillance
reports a 100% reorder rate, with a median TTH as
low as 10 seconds, and a major vascular complica-
tion rate of 1.9% in 700+ commercial cases.
“Furthermore, I am excited to inform you
that at the moment people are reading this, the
first patients are most likely being enrolled in the
500-patient, European post-market MARVEL regis-
try, which will evaluate the effectiveness of MANTA
in real-world conditions. This is a multicentre,
single-arm study with approximately 20 participat-
ing centres throughout Europe and Canada.”
Given the positive experiences and results using
MANTA thus far, does Dr Kroon believe that the
device will become commonplace in practice? “The
mechanism of MANTA is a proven concept with
plug-based closure,” he said. “Initial study data
and early commercial experience show excellent
results regarding haemostasis success, time to hae-
mostasis and vascular complications. The learning
curve is steep, so adoption should be fast.
“But as always, it is up to the long-term data
that is evaluating the effect of the collagen pad on
the femoral arteries – as well as the randomised
trials – to determine whether MANTA will truly
revolutionise large-bore access closure.”
1. Essential Medical. When The Problem Is Large, The Solution Is
Simple… MANTA™.
“The mechanism of MANTA is
a proven concept with plug-
based closure. Initial study
data and early commercial
experience show excellent
results regarding haemostasis
success, time to haemostasis
and vascular complications.”
Herbert Kroon
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