8/11/2016 Disclosure LARIAT Update SentreHeart, Inc • Consultant • Equity holder Merits of an Epicardial LAA Closure Catheter - Based Surgery Approach Performed in OR Performed in cath lab Restore Maintain Protect Electrical Isolation LAA Exclusion • • Open Chest Percutaneous & Image Guided • • Immediate, Complete, Permanent Cardiopulmonary Bypass • • Training Required on New Techniques Technique Variability Closure • Performed with another open procedure 1
8/11/2016 LAA ligation with the LARIAT Suture LARIAT System Delivery Device LARIAT TM Suture Delivery Device EndoCATH TM Occlusion Balloon TM FindrWIRZ Left Atrial Appendage Left Atrium Percutaneous, epicardial placement of pre ‐ tied suture loop LAA ligation results in a permanent LAA % Closure closure 100% 100% 98% 100% 94% 89% 45D Post CT Pre CT 90% 80% 70% 60% 50% 40% LAA No LAA 30% 20% 10% 0% Bartus Massumi Stone Pillarsetti Lakkireddy LAA Time to TEE follow ‐ up 1y 96d+77d 45d+15d 1yr 1yr LA Closure 64/65 17/17 22/22 230/259 449/480 Bartus et al., Circ AE 7:764-767, 2014 2
8/11/2016 Percentage of Leaks in Watchman and LARIAT LAA Closures Leak After LARIAT Pillarisetti et al., Heart Rhythm 2015 Soni et al., JACC Cardiovascular Interventions 2015 Treatment of Leak LAA ligation in patients with contraindications to OAC therapy 20% Event Rate (% patient ‐ years) National Registry of AF Stroke rate 18% National Registry of AF Stroke rate with ASA 16% 14% 6.2% Expected ER Observed ER: 1% 12% Reduction of 80% 10% 8% 6% 4% 2% CHADS2 score of the 0% LARIAT Population 0 1 2 3 4 5 6 N=139 patients CHADS2 score Mean F/U 2.9 +/- 1.1 years Soni et al., JACC Cardiovascular Interventions 2015 Sievert et al., JACC EP 2015 405 patient-years 3
8/11/2016 Adverse Events Kaplan-Meier Curves Adverse Events Requiring Intervention (3.6%) Stroke Survival B • Pulmonary embolus 1 (0.7%) A – Periprocedural death • Cardiac Perforation 2 (1.4%) – Surgery • Late Hemopericardium 1 (0.7%) • Late Pericardial effusion 1 (0.7%) Additional Adverse Events (8.6%) • Pericarditis (>2 days) 8 (5.8%) • LA thrombus 2 (1.4%) Next Generation LARIAT + LAA closure in patients with contraindication to OAC therapy Watchman ACP LARIAT Reddy et al JACC 2013 Tzikas et al EuroIntervention Sievert et al JACC EP 2015 2015 Number of patients 150 1,047 139 Snare width increased from Age 72.5 7.4 75±8 67 ± 11 40mm to 45mm Mean CHADs2 score 2.8 1.2 4.43 2.4 +1.2 • Allows treatment of patients with Platinum ‐ Iridium LAAs > 40mm “ L ” Marker “ L ” Marker Mean follow-up 14.4 + 8.6 months, 13 months 35 + 12 months Patient-years 176.9 1,349 401 Absolute # 4 (stroke) 9 (strokes), 9 (TIA) 4 (strokes) strokes/systemic 31 (systemic embolism) embolism Event rate (patient- 2.3% 0.7% stroke 1% Stainless Steel Wire Braid on Catheter Shaft years) 0.7% TIA Improved “ torque ‐ ability ” of catheter 2.3% systemic embolism 4
8/11/2016 Acute & Longterm Outcomes of Procedural Improvements Percutaneous Left Atrial Appendage Suture Ligation: Results From A United • Use of micro-puncture needle for pericardial access States Multicenter Evaluation • Post-procedural use of colchicine D. Lakkireddy MD, M. Afzal MD, R. Lee, MD PhD, H. Nagaraj MD, D Tschopp MD, B Gidney MD, C. Ellis MD,E. Altman MD, B Lee MD, S Kar MD, N. Bhadwar MD, M Sanchez MD, V Gadiyarum MD, R. Evonich MD, A. Rasekh MD, J. Cheng MD, F. Cuoco, S. Chandok MD, S.Gunda MD, M. Reddy MD, P. Cuculich MD, A. D. Gibson MD, J Nath MD, R. Ferrelll MD, E. Matthew MD, D. Wilber MD Lakkireddy et al. Heart Rhythm 13:1030–1036, 2016 Acute & Longterm Outcomes of LARIAT Acute & Longterm Outcomes with LARIAT Colchicine versus No-Colchicine 9.0% 6.0% 8.4% 8.0% 5.0% 7.0% No Colchicine n=332 W/ Colchicine n=380 4.0% 6.0% 5.0% 4.5% 3.0% 4.0% 2.0% 2.0% 3.0% 2.7% 2.0% 1.5% 1.0% 0.7% 1.2% 0.5% 0.5% 1.0% 1.0% 0.2% 0.2% 0.5% 0.0% 0.0% 0.0% 0.0% Procedural Related Pts requiring Cardiac Perfs (no Pts needing Peri ‐ procedural Structural Injury All Complications Pericarditis w >2wks w Late peri effusion Late pleural effusion Total Mortality surgery surgery) transfusion stroke NSAIDs Lakkireddy et al., Heart Rhythm 2016 Lakkireddy et al., Heart Rhythm 2016 5
8/11/2016 LARIAT RS Initial European Experience with a novel percutaneous epicardial suture delivery device for LAA exclusion (Retractable Snare) Enables complete retraction of snare Tilz RR 1 , Foran J 2 , Bartus K 3 , Gafoor S 4 , Wong T 2 , Rillig A 1 , Fink T 1 , Lin T 1 , Myc J 2 , Lee R 5 , Sievert H 4 , Karl ‐ Heinz Kuck post suture deployment and tightening 1 AK St. Georg, Hamburg 2 Royal Brompton, London, England 3 Department of Cardiovascular Surgery and Transplantology, Jagiellonian University, John Paul II Hospital in Krakow, Krakow, • Ease of use during removal of LARIAT Poland 4 CardioVascular Center Frankfurt • • 85 of 85 patients underwent successful completion of the LARIAT+ Minimal manipulation of suture that may lead to reduced leaks (Current procedure. complete closure success rate >93%) • 83 of 85 (98%) patients with acute complete LAA closure. • One serious adverse event due to a RV perforation due to a sheath. • Broader LAA anatomic compatibility, ie reverse “C”s • 89% LAA closure at 3 months Tilz Europace 2015 FDA and CE mark clearances in place LAA Isolation Improves Ablation Outcomes Effect of Empirical Left Atrial Appendage Isolation on Long- term Procedure Outcome in Patients with Long-standing Persistent AF undergoing Ablation: Results from the BELIEF Left Atrial Appendage : An Underrecognized Trigger Site of Atrial Randomized Trial Fibrillation ClinicalTrials.gov Identifier: NCT01362738 Luigi Di Biase, J. David Burkhardt, MD, Prasant Mohanty, Sanghamitra Mohanty, , Javier E. Sanchez, Chintan Trivedi, Mahmut Güne ş , Yalç ı n Göko ğ lan, Carola Gianni, Rodney P. Horton, G. Joseph Gallinghouse, Shane Bailey, Jason D. Zagrodzky, Steven C. Hao, Richard H. Hongo, Salwa Beheiry, Pasquale Santangeli, Michela Casella, Antonio Dello Russo, Amin Al-Ahmad, Patrick Hranitzky, Dhanujaya R. Lakkireddy, Claudio Tondo, Andrea Natale. Texas Cardiac Center, San Francisco, California, USA; University of KaArrhythmia Institute at St. David’s Medical Center, Austin, Texas, USA; California Pacific Medical nsas, Kansas City, USA; Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy; Di Biase et al., Circulation . 2010;122:109-118 6
8/11/2016 Kaplan–Meier curves: single procedure success rate AIM Assess whether in patients with Long Standing Persistent AF the EMPIRICAL ELECTRICAL ISOLATION of the left atrial appendage ( LAA) in addition to extensive PV antrum and triggers ablation could improve freedom from AF/AT at follow up in a in a multicenter randomized trial. At the 12 month follow-up, 48(56%) in group 1 and 25 (28%) in group 2 were recurrence-free off-AAD after a single procedure. (Log-rank p=0.001, unadjusted HR 1.92 [1.3 to 2.9]). Di Biase, Natale et al, LBT ESC 2015 Di Biase, Natale et al, LBT ESC 2015 Unexpectedly High Incidence of Stroke and Left Atrial Cumulative Overall Success After 1.3 Procedures Appendage Thrombus Formation after Electrical Isolation of the Left Atrial Appendage for Treatment of Atrial Tachyarrhythmias: An undescribed and under recognized complication of left atrial catheter ablation Andreas Rillig , MD, Roland R. Tilz, MD, Tina Lin, MD, Christian Heeger, MD, Anita Arya, PHD, Andreas Metzner, MD, Shibu Mathew, MD, Erik Wissner, MD, Hisaki Makimoto, MD, PHD, Peter Wohlmuth, Karl- Heinz Kuck, MD, Feifan Ouyang, MD Mechanical standstill Thrombus formation LAA The cumulative success after multiple procedures was 65 (76%) in group 1 thrombus and 49 (56%) in group 2 LAA thrombus in 21%, and three ALL THE PATIENTS UNDERWENT LAA ISOLATION patients had a stroke while on OAC (Log-rank p= 0.003, unadjusted HR 2.24 [95% CI 1.3-3.8]) Di Biase, Natale et al, LBT ESC 2015 Rillig et al., Circ EP 2016 (in press) 7
8/11/2016 When should you exclude the Feasibility and Safety of Combined LAA: Before or After PVI? PVI and LAA closure Ablation for Atrial Fibrillation in Combination With Left Atrial Appendage Closure: First Results of a Feasibility Study Martin J. Swaans, MD; Martijn C. Post, MD, PhD; Benno J.W.M. Rensing, MD, PhD; Lucas V.A. Boersma, MD, PhD J Am Heart Assoc. 2012 Combined catheter ablation and left atrial appendage closure as a hybrid procedure for the treatment of atrial fibrillation Calvo N, Salterain N, Arguedas H, Macias A, Esteban A, García de Yébenes M1, Gavira JJ, Barba J, García-Bolao I. Europace 2015 Sick et al., JACC 2007 PVI and LAA electrical isolation Does left atrial appendage closure improve the success of pulmonary vein isolation? Results should be done before LAA closure of a randomized clinical trial with an LAA implant Alexander Romanov, Evgeny Pokushalov, Sergey Artemenko, Akmal Yakubov, Ilya Stenin, Evgeny Kretov, Oleg Krestianinov, Igor Grazhdankin, Dejan Risteski, Alexander Karaskov, Jonathan S. Steinberg * Sick et al., JACC 2007 J Interv Card Electrophysiol 44:9-16, 2015 8
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