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 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 • • Grant/Research Support St Jude Medical, Boston Scientific, Medtronic, Gore, Abbott, Occlutech, • Consulting Fees/Honoraria Edwards, Terumo

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 Disc • Completely seal Stabilizing Wires at the orifice § Engage with LAA wall § Help hold the device in place Waist § Maintains tension between lobe and disc § Allows device to self-orient

Amplatzer ™ Amulet ™ Device Implant Procedure 2 1 Measure LAA orifice, landing zone, depth Deploy LOBE in landing zone 4 3 Deploy the DISC, to cover the ostium Release

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 1073 patients enrolled between Jun 2015 Design and Sept 2016 in 64 clinical sites in Europe, Middle East, Asia, Australia, South America • DESIGN: Prospective, multicenter, 13 patients international observational study Device not implanted* of the AMPLATZER™ Amulet™ LAA occluder. 1060 patients with AMPLATZER Amulet • OBJECTIVES: LAA Occluder implanted • Assess acute serious adverse events (0 - 7 days post procedure) Not completed 1 st F/U @ • Assess late serious adverse events database lock** (N=349) (> 7 days post-procedure through 2 years) • Report ischemic stroke, systemic embolism and cardiovascular death 1-3 Month Follow Up Completed (through 2 years) (N = 711) • Report bleeding events (through 2 years) * Device Not Implanted N • PRINCIPAL INVESTIGATOR Evidence of intracardiac David Hildick-Smith, Brighton, UK 7 thrombus in LA Anatomical/Sizing 6 Considerations ** Database lock: October 3, 2016

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 patients

Stroke and Bleeding Risk Stroke Risk Assessment Bleeding Risk Assessment CHA2DS2-VASc Score HAS-BLED Score 30% 40% 36% 25% 30% 30% 20% 20% 20% CHA2DS2-VASc= 4.2 ± 1.6 HAS-BLED = 3.3 ± 1.1 20% 18% 12% 11% 10% 10% 9% 5% 3% 4% 2% 3% 1% 0.2% 0% 0% 1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8

Results: Indication for Procedure (N = 610) 90% 85% 80% 70% 60% 50% 40% 30% 20% 9% 10% 5% 0% Contraindication to OAC Ischaemic stroke despite OAC Patient Choice 18% of patients on (N)OAC at time of consent 9

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 1060/1073 98.8% Defined as successful implantation of the Amulet device in the LAA.

Major Adverse Events Device/Procedure Related MAE No. % Death 3 0.3% 1 0.1% Related to Cardiac Perforation 1 0.1% Related to Myocardial Infarction 1 0.1% Related to Cardiorespiratory Arrest Stroke 3 0.3% Pericardial Effusion 5 0.5% 4 0.4% Resulted in Pericardiocentesis 1 0.1% Resulted in Surgical Intervention 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 Discharge 1-3 Month F/U N = 1073 N = 1058 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 1.5% 1.9% 1.3% Antiplatelet Triple Therapy 0.7% 2.2% 2.4%

TEE verified LAA Closure Rate ) 100% 99% 99% 75% % Subjects 50% Implant First follow-up 25% 1% 1% 0% 0% 0% No residual flow Flow 3-5 mm Flow > 5 mm _x000d_or flow < 3 mm Independent Echo Core lab utilized for analysis 14

Comparison to Other Studies ACP Watchman Amulet Registry 1 EWOLUTION 2 (Current Study) Implant Success 97.3% 98.5% 98.8% LAA Closure Rate 98.1% 99.3% 100.0% (1-3 months) < 5 mm Device or Procedure- 5.0% 2.7% 2.7% Related Complications 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 Hong Kong Anna Chan Australia Vincent Paul Simon Lam Dabit Arzamendi Jason Sharp Armando Bethencourt Tony Walton Ireland Kevin Walsh Ignacio Cruz Glenn Young Thomas Eul Israel Michael Glikson Spain Xavier Freixa Germany Sven Fischer Ignacio Garcia Bolao Austria Günter Stix Volker Geist J.R. Lopez Minguez Christoph Geller Rafael Ruiz Salmeron Belgium Adel Aminian Italy Sergio Berti Ulf Landmesser Werner Budts Francesco Caprioglio Thorsten Lewalter Antonio Colombo Kai Magnusson Chile Daniel Aguirre Jacob Odenstedt Paolo Della Bella Sweden Thomas Massa Magnus Settergren Paolo Golino Denmark J.E. Nielsen-Kudsk Heyder Omran Paolo Magnavacchi Lars Søndergaard Jai-Wun Park Switzerland Christian Sticherling Jacopo Oreglia Christopher Giuseppe Tarantini Piorkowski Finland Juha Lund Claudio Tondo Boris Schmidt Juha Sinisalo Horst Sievert Saila Vikman Robert Butler Jochen Woehrle United Brian Clapp Tobias Zeus Jean-Sylvain Hermida Kingdom Dhiraj Gupta Didier Klug David Hildick-Smith France Luc Lorgis Netherlands Rob de Winter Emmanuel Teiger Jean-Benoit Thambo