JIM Today 2018 - Friday - page 4

4
JIM today
Issue 2 
Friday
 23 February 2018
Evaluating new devices for
percutaneous LAA closure
J
ai-Wun Park, an interventional cardiologist
from Dietrich-Bonhoeffer Klinikum in Neu-
brandenburg, Germany spoke on Thursday
about his extensive experience with percutaneous
left atrial appendage closure (LAAC). “I have been
involved in various animal studies and initial clinical
studies of new occluders, including the Amplatzer
Cardiac Plug, AMULET, OCCLUTECH-LAA device,
LAmbre device and Ultraseal device,” he told
JIM
Today
before the symposium.
Professor Park spoke at
length about the history of these
percutaneous devices, starting
from their inception at the be-
ginning of the new millennium.
“The first percutaneous device,
PLAATO, became available so
that cardiologists could – the
first time – offer patients with
atrial fibrillation and high stroke
risk a real alternative to oral
anticoagulation, through sealing
of the LAA with a device,” he
explained. “Following this proof
of concept – that a mechanical
occlusion of LAA may reduce
stroke risk, and simultaneously
also the bleeding risk – a signifi-
cant number of new occluders
have been developed.”
Two significant randomised
controlled trials then
followed: PROTECT-
AF (Left Atrial Ap-
pendage System for
Embolic Protection
in Patients With
Atrial Fibrillation
1
)
and PREVAIL
(Prospective
Randomized
Evaluation of
the Watchman
LAAC Device in
Patients With AF
Versus Long-
Term Warfarin
Therapy
2
). “They
demonstrated the
feasibility, safety,
and clinical benefit
of the WATCHMAN
device [Boston
Scientific, USA] versus
warfarin,” he said. “In
particular, the trials dem-
onstrated less haemorrhagic stroke in the device
groups.” After a long wait, WATCHMAN has finally
been approved by the US FDA, he added.
Professor Park also described the Ultraseal
device (Cardia, USA), outlining the design, and how
components differ from other LAA occluders. “The
special beauty of the Ultraseal LAA occluder is the
softness of the bulb (fixation body),” he said. “The
soft bulb is made of independent modules, which
can expand independently
from each other, giving perfect
adaptation to the landing zone.
This may result in less risk of
pericardial effusion.”
In addition, the waist is
articulated, Professor Park
explained: “The Ultraseal device
adapts to varying LAA morphol-
ogy, because the bulb and the
disc can be oriented on different
planes. Furthermore, the device
delivery can be carried out using
forceps (another articulation).”
The device is currently under
evaluation in clinical registries,
including an ongoing multicen-
tre registry study that is being
carried out in collaboration
with Dr Josep Rodés-Cabau,
of the Quebec Heart and Lung
Institute, Canada.
Offering his conclu-
sions, Professor Park
noted: “The Left
atrial appendage
occlusion proce-
dure is one of the
most challenging
interventional
procedures. Every
device has its
advantages
and limitations.”
References
1. Holmes DR, et
al. Percutaneous
closure of the left
atrial appendage versus
warfarin therapy for
prevention of stroke
in patients with atrial
fibrillation: a randomised
non-inferiority trial. Lancet.
2009;374:534–542.
2. Reddy VY, et al. Percuta-
neous left atrial appendage clo-
sure vs warfarin for atrial fibril-
lation: a randomized clinical trial.
JAMA. 2014;312:1988–1998.
Structural heart 1 
Club 
Thursday 
12:45
Room Foscolo
TAVI 2
Room Porta
Structural Heart 2
Room Club
Innovative technologies
Room Parini
Clinical crossroads on
optimal antithrombotic therapy
in patients treated with pci
DES 2 AND NEW BRS - Room Manzoni
Chairpersons: Bernhard Reimers, Alan Yeung
12.45
Delivering ultimate bifurcation treatment
Goran Stankovic
12.55
The Synergy stent in high-risk patients:
why design matters?
Giulio Stefanini
13.05
Magmaris: the impact of scaffold design
and materials on lowering scaffold
thrombosis
Michael Haude
13.15
Magic Touch: preliminary clinical evidence
with a novel Sirolimus drug coated balloon
Bernardo Cortese
13.25
Complexity made simple: Resolute Onyx
the advanced workhorse
Fausto Castriota
13.35
MVD in STEMI patients: safe solutions on
challenging cases!
Jacopo Andrea Oreglia
13.45
Questions & Answers
TAVI 2- Room Foscolo
Chairpersons: Alberto Cremonesi,
Corrado Tamburino
12.45
When is a patient not a good candidate for
TAVI? Case example and general outline
Marco Barbanti
13.00
Prime time for “Protected TAVI”
Martin B. Leon
13.15
The EMBLOK embolic protection system
early feasibility and safety study:
preliminary results
Azeem Latib
13.30
Next generation large bore closure device:
PerQseal
Michael Laule
Manta
Herbert Kroon
14.00
Questions & Answers
STRUCTURAL HEART 2 - Room Porta
Chairpersons: Maurice Buchbinder, Horst Sievert
12.45
When to replace, when to repair
Hendrik Treede
13.00
Transcatheter therapies for
the forgotten valves
Teld Feldman
13.15
Mitral valve replacement: ready for
prime time!
Bernard Prendergast
13.30
The role of ventricular unloading
in heart recovery
Paul Christian Schulze
13.45
Mitral valve repair. Transeptal complete
ring delivery
Azeem Latib
14.00
The first Core Valve case of the world
Purshotam Lal
14.05
Questions & Answers
INNOVATIVE TECHNOLOGIES - Room Club
Chairpersons: Davide Capodanno, Ron Waksman
12.45
PiCSO to reduce infarct size:update
on clinical studies
Ajay Jain
13.00
Left ventricular support during
complex transradial PCI for complete
revascularization
Carlo Briguori
13.15
The evolution of Plaque Scoring: from
lesion preparation to lesion treatment
Sean Gallagher
13.30
DynamX: a novel metallic DES with
adaptive remodeling
Martin B. Leon
13.45
The role of intravascular Lithotripsy for
treatment of heavily calcified coronary
lesions
Todd J. Brinton
Continued from page 2
Continued on page 6
“Following this
proof of concept –
that a mechanical
occlusion of
LAA may reduce
stroke risk, and
simultaneously
also the bleeding
risk – a significant
number of new
occluders have
been developed.”
Jai-Wun Park
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