A Multicenter Prospective Registry of the Amulet Left Atrial Appendage Closure Device for Stroke Prevention in Patients with Atrial Fibrillation David HildickSmith John Camm ID: 535890
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THE AMULET STUDY: A Multicenter, Prospective Registry of the Amulet Left Atrial Appendage Closure Device for Stroke Prevention in Patients with Atrial Fibrillation
David Hildick-Smith,
John
Camm,
Hans-Christoph
Diener
,
Ulf
Landmesser
,
Vincent
Paul,
Boris
Schmidt,
Magnus
Settergren
,
Emmanuel
Teiger,
Claudio
Tondo
On behalf of Amulet Observational Study InvestigatorsSlide2
Disclosure Statement of Financial Interest
Grant/Research Support
Consulting Fees/Honoraria
St Jude Medical, Boston Scientific, Medtronic, Gore, Abbott, Occlutech, Edwards, Terumo
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
CompanySlide3
BackgroundThe St Jude Medical AMPLATZER™ Amulet™ is a percutaneous transcatheter left atrial appendage occluder device, designed to prevent thromboembolism from the left atrial appendage (LAA) among patients with non-valvular atrial fibrillation (AF). The objective of this analysis is to report short-term outcome data on the use of AMPLATZER™ Amulet™
LAA
OccluderSlide4
AMPLATZER™ Amulet™ Device
Lobe
Inside
the LAA
neck
Designed to conform to LAA anatomy
Stabilizing Wires
Engage with LAA wall
Help hold the device in place
Waist
Maintains tension between
l
obe and disc
A
llows device to self-orient
Disc
Completely seal
at the orificeSlide5
Amplatzer™ Amulet™ Device Implant Procedure
Measure LAA orifice, landing zone, depth
Deploy
LOBE
in
landing
zone
Deploy the
DISC
, to
cover
the ostium
Release
1
2
3
4Slide6
Key MethodsPatients were consented to participate prior to the procedure.Study follow-up visits were at 1-3, 6, 12 and 24 months post implant. A transesophageal echocardiogram (TEE) at 1-3 months.An independent echocardiography core lab adjudicated all echo data Clinical Event Committee adjudicated all Serious Adverse Events (SAEs) reported in the study
.Slide7
Study Design and Flowchart
Design
DESIGN:
Prospective, multicenter, international observational study of the AMPLATZER™ Amulet™ LAA
occluder
.
OBJECTIVES:
Assess
acute serious adverse events
(0 - 7 days post procedure)
Assess late serious adverse events
(> 7 days
post-procedure
through 2
years)
Report
ischemic stroke, systemic embolism and cardiovascular
death
(through
2 years)
Report
bleeding
events
(through
2 years
)
PRINCIPAL INVESTIGATOR
David
Hildick
-
Smith, Brighton, UK
1073 patients enrolled between Jun 2015 and Sept 2016 in 64 clinical sites in Europe, Middle East, Asia, Australia, South America
13 patients
Device not implanted*
1060 patients
with
AMPLATZER Amulet LAA Occluder
implanted
1-3
Month Follow
Up
Completed
(N
= 711)
*
Device Not ImplantedNEvidence of intracardiac thrombus in LA7Anatomical/Sizing Considerations6
** Database lock: October 3, 2016
Not completed 1st F/U @ database lock** (N=349)Slide8
Results: Patient Population
Mean ± SD or %
n=1071*
Age (years)
75 ± 8
Gender - Female
35.6%
Prior Stroke
27.1%
Prior TIA
10.6%
Heart Failure
17.4%
Diabetes
31.4%
Hypertension
84.2%
Prior History of Major Bleeding
72.5%
CHA
2
DS
2
-VASc Score
>
4
65%
HAS-BLED
>
3
58%
*Baseline data unavailable in 2 patientsSlide9
Stroke and Bleeding Risk
8Slide10
Results: Indication for Procedure (N = 610)9
18% of patients on (N)OAC at time of consentSlide11
Implant Procedure
Imaging modality
% (n)
Intracardiac echo
10% (107)
Transoesophageal
echo
90% (966)
Device Selection
% (n)
First device selected implanted
93% (995)Slide12
Implant Success
Implant
No.
%
Implant Success
Defined as successful implantation of the Amulet device in the LAA.
1060/1073
98.8%Slide13
Major Adverse Events
Device/Procedure Related MAE
No.
%
Death
Related to Cardiac Perforation
Related to Myocardial Infarction
Related to Cardiorespiratory Arrest
3
1
1
1
0.3%
0.1%
0.1%
0.1%
Stroke
3
0.3%
Pericardial Effusion
Resulted in
Pericardiocentesis
Resulted in Surgical Intervention
5
4
1
0.5%
0.4%
0.1%
Embolization
1
0.1%
Bleeding
10
0.9%
Other
7
0.7%
TOTAL
29
2.7%Slide14
Antiplatelet and Anticoagulant therapy (1-3 months F/U)
Baseline
N = 1073
Discharge
N = 1058
1-3 Month F/U
N = 719
None
40.6%
14.7%
6.5%
Single Antiplatelet
20.5%
23.8%
31.3%
Dual Antiplatelet
14.4%
41.8%
45.6%
(N)OAC only
15.8%
7.3%
4.7%
(N)OAC plus Single Antiplatelet
1.5%
1.9%
1.3%
Triple Therapy
0.7%
2.2%
2.4%Slide15
TEE verified LAA Closure Rate)14Independent Echo Core lab
utilized for
analysisSlide16
Comparison to Other Studies
ACP
Registry
1
Watchman
EWOLUTION
2
Amulet
(Current Study)
Implant Success
97.3%
98.5%
98.8%
LAA Closure Rate
(1-3 months)
<
5 mm
98.1%
99.3%
100.0%
Device or Procedure-Related Complications
5.0%
2.7%
2.7%
Early Mortality
0.8%
(30-day)
0.7%
(30-day)
0.3%
(7-day)
1
Tzikas et al.
EuroIntervention
.
2015;10
3
Boersma
et al.
Eur
Heart J
. 2016 Aug;37(31):2465-74. Slide17
ConclusionsThe Amplatzer Amulet device has very high technical implant success ratesImplantation is associated with low rates of peri-procedural and early adverse eventsAmulet demonstrated high closure ratesAntiplatelet therapy is appears to be a reasonable treatment strategy post-implantation in the short-termAdditional long-term data will be collected to confirm these promising early findingsSlide18
Thank you! To all 64 participating sites
Country
PI
Country
PI
Country
PI
Country
PI
Australia
Vincent
Paul
Jason
Sharp
Tony Walton
Glenn
Young
Germany
Thomas
Eul
Sven Fischer
Volker Geist
Christoph Geller
Ulf Landmesser
Thorsten Lewalter
Kai Magnusson
Thomas Massa
Heyder
Omran
Jai-
Wun
Park
Christopher PiorkowskiBoris SchmidtHorst SievertJochen WoehrleTobias ZeusHong Kong Anna ChanSimon LamSpainDabit ArzamendiArmando BethencourtIgnacio CruzXavier FreixaIgnacio Garcia BolaoJ.R. Lopez MinguezRafael Ruiz SalmeronIrelandKevin WalshIsraelMichael GliksonAustriaGünter StixItaly
Sergio Berti
Francesco
Caprioglio
Antonio Colombo
Paolo Della Bella
Paolo
Golino
Paolo
Magnavacchi
Jacopo
Oreglia
Giuseppe
Tarantini
Claudio
Tondo
Belgium
Adel
Aminian
Werner
Budts
Chile
Daniel
Aguirre
Sweden
Jacob
Odenstedt
Magnus
Settergren
Denmark
J.E.
Nielsen-Kudsk
Lars
Søndergaard
Switzerland
Christian
Sticherling
Finland
Juha
Lund
Juha
Sinisalo
Saila
Vikman
United Kingdom
Robert Butler
Brian Clapp
Dhiraj
Gupta
David
Hildick
-Smith
France
Jean-Sylvain
Hermida
Didier Klug
Luc
Lorgis
Emmanuel
Teiger
Jean-Benoit
Thambo
Netherlands
Rob de Winter