David Hildick-Smith, John Camm, Hans-Christoph Diener, Ulf Landmesser, Vincent Paul, Boris Schmidt, Magnus Settergren, Emmanuel Teiger, Claudio Tondo

Transcription

1 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

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

3 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

4 AMPLATZER Amulet Device Lobe Inside the LAA neck Designed to conform to LAA anatomy Disc Completely seal at the orifice Stabilizing Wires Engage with LAA wall Help hold the device in place Waist Maintains tension between lobe and disc Allows device to self-orient

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

6 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.

7 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 Not completed 1 st database lock** (N=349) 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

8 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

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

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

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

12 Implant Success Implant No. % Implant Success Defined as successful implantation of the Amulet device in the LAA. 1060/ %

13 Major Adverse Events Device/Procedure Related MAE No. % Death Related to Cardiac Perforation Related to Myocardial Infarction Related to Cardiorespiratory Arrest % 0.1% 0.1% 0.1% Stroke 3 0.3% Pericardial Effusion 5 Resulted in Pericardiocentesis Resulted in Surgical Intervention % 0.4% 0.1% Embolization 1 0.1% Bleeding % Other 7 0.7% TOTAL %

14 Antiplatelet and Anticoagulant therapy (1-3 months F/U) Baseline N = 1073 Discharge N = Month F/U N = 719 None 40.6% 14.7% 6.5% Single Antiplatelet Dual Antiplatelet (N)OAC only 20.5% 23.8% 31.3% 14.4% 41.8% 45.6% 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%

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

16 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 Device or Procedure- Related Complications 98.1% 99.3% 100.0% 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 Aug;37(31):

17 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 postimplantation in the short-term Additional long-term data will be collected to confirm these promising early findings

18 Thank you! To all 64 participating sites Country PI Country PI Country PI Country PI Australia Austria Belgium Chile Denmark Finland France Vincent Paul Jason Sharp Tony Walton Glenn Young Günter Stix Adel Aminian Werner Budts Daniel Aguirre J.E. Nielsen-Kudsk Lars Søndergaard Juha Lund Juha Sinisalo Saila Vikman Jean-Sylvain Hermida Didier Klug Luc Lorgis Emmanuel Teiger Jean-Benoit Thambo 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 Ireland Israel Italy Kevin Walsh Michael Glikson Sergio Berti Francesco Caprioglio Antonio Colombo Paolo Della Bella Paolo Golino Paolo Magnavacchi Jacopo Oreglia Giuseppe Tarantini Claudio Tondo Netherlands Rob de Winter Spain Sweden Dabit Arzamendi Armando Bethencourt Ignacio Cruz Xavier Freixa Ignacio Garcia Bolao J.R. Lopez Minguez Rafael Ruiz Salmeron Jacob Odenstedt Magnus Settergren Switzerland Christian Sticherling United Kingdom Robert Butler Brian Clapp Dhiraj Gupta David Hildick-Smith