THE AMULET STUDY: A Multicenter, Prospective Registry of the Amulet - - PowerPoint PPT Presentation

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 Investigators

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 Company

Background

• The 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 Occluder

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 lobe and disc § Allows device to self-orient

Disc

• Completely seal

at the orifice

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 4

Key Methods

• Patients 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.

Study Design and Flowchart

Design

• DESIGN:

Prospective, multicenter, international observational study

• f 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 Implanted N

Evidence of intracardiac thrombus in LA 7 Anatomical/Sizing Considerations 6

** Database lock: October 3, 2016

Not completed 1st F/U @

database lock** (N=349)

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% CHA2DS2-VASc Score > 4 65% HAS-BLED > 3 58%

*Baseline data unavailable in 2 patients

Stroke and Bleeding Risk

8

4% 18% 36% 30% 9% 3% 1%

Bleeding Risk Assessment HAS-BLED Score

1 2 3 4 5 6 7

0% 10% 20% 30% 40% HAS-BLED = 3.3 ± 1.1

3% 11% 20% 25% 20% 12% 5% 2% 0.2%

Stroke Risk Assessment CHA2DS2-VASc Score

1 2 3 4 5 6 7 8 9

0% 10% 20% 30% CHA2DS2-VASc= 4.2 ± 1.6

Results: Indication for Procedure (N = 610)

9 85% 9% 5%

Contraindication to OAC Ischaemic stroke despite OAC Patient Choice

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

18% of patients on (N)OAC at time of consent

Implant Procedure

Imaging modality % (n) Intracardiac echo 10% (107) Transoesophageal echo 90% (966) Device Selection % (n) First device selected implanted 93% (995)

Implant Success

Implant No. % Implant Success

Defined as successful implantation of the Amulet device in the LAA.

1060/1073 98.8%

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%

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%

TEE verified LAA Closure Rate

)

14 Independent Echo Core lab utilized for analysis 99% 1% 0% 99% 1% 0%

No residual flow _x000d_or flow < 3 mm Flow 3-5 mm Flow > 5 mm

0% 25% 50% 75% 100%

% Subjects Implant First follow-up

Comparison to Other Studies

ACP

Registry1

Watchman

EWOLUTION2

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.

Conclusions

• The Amplatzer Amulet device has very high

technical implant success rates

• Implantation is associated with low rates of

peri-procedural and early adverse events

• Amulet demonstrated high closure rates
• Antiplatelet therapy is appears to be a

reasonable treatment strategy post- implantation in the short-term

• Additional long-term data will be collected to

confirm these promising early findings

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 Piorkowski Boris Schmidt Horst Sievert Jochen Woehrle Tobias Zeus Hong Kong Anna Chan Simon Lam Spain Dabit Arzamendi Armando Bethencourt Ignacio Cruz Xavier Freixa Ignacio Garcia Bolao J.R. Lopez Minguez Rafael Ruiz Salmeron Ireland Kevin Walsh Israel Michael Glikson Austria Günter Stix Italy 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