9/14/2019 Disclosures Role of Endocardial vs. Epicardial LAA SentreHeart/Atricure, Inc isolation • Consultant • Equity holder Life Signals, Inc • Consultant • Equity holder Cornerstone of AF Ablation is PVI Additive Catheter Ablation Strategies Brooks AG, et al. Outcomes of long standing persistent AF: A systematic review. Heart Rhythm . 2010; 7:835-46 1
9/14/2019 Automaticity cells identified in the LAA can fibrillate independently of the left atrium LAA that leads to AT Guo et al. Heart Rhythm 11:17 – 25, 2014 Reentrant Circuits Rostock….. Haissaguerre JCE 17:807-812, 2006 Localized reentry within the left atrial appendage: arrhythmogenic role in patients undergoing Atrial Tachycardias Utilizing the ablation of persistent atrial fibrillation Ligament of Marshall Hocini M, Shah AJ, Sanders P, Wright M, Narayan SM, Takahashi Y, Jais P, Matsuo S, Knecht S, Region Following Single Ring Sacher F, Lim KT, Clementy J, Haissaguerre M Pulmonary Vein Isolation for Atrial Fibrillation Kim et al. JACC 36:1324-7, 2000 15 (19%) arose from LAA in patients with persistent AF for 17+/- 15 months 89% were entrained suggesting localized reentry within the LAA All were successfully ablated within the LAA, targeting fractioned potentials At 18 +/- 7 months 13/15 (87%) remained in SR without Chick et al., PACE 2014; 00:1 – 10) AAD Heart Rhythm. 2011 Dec;8(12):1853-61. 2
9/14/2019 Left Atrial Appendage : An Under recognized Combined PVI and LAA occlusion Trigger Site of Atrial Fibrillation - High recurrence rate - LAA perforation Potential benefits: - Thrombus formation • Restoration of sinus rhythm with PVI • Stroke prevention without need for OAC therapy after LAA occlusion device Di Biase et al., Circulation . 2010;122:109-118 Romero et al. Heart Rhythm 15: 1577-1582, 2018 Rilliing et al. Circ Arrhythm Electrophysiol, , 2016 PVI should be done before LAA closure with an Catheter Ablation for Atrial Fibrillation in Patients With Watchman Left Atrial Appendage Occlusion Device: LAA implant Results from a Multicenter Registry MOHIT K. TURAGAM, M.D., ∗ MADHAV LAVU, M.D.,† MUHAMMAD R. AFZAL, M.D.,† VENKAT VUDDANDA, M.D.,† MOHAMMAD -ALI JAZAYERI, M.D.,† VALAY PARIKH, M.D., ∗ DONITA ATKINS, B.S.,† SUDHARANI BOMMANA, M.Phil.,† LUIGI DI BIASE, M.D.,‡ RODNEY HORTON, M.D., § RONG BAI, M.D.,¶ VIJAY SWARUP , M.D.,# JIE CHENG, M.D., ∥ ANDREA NATALE, M.D.,§ and DHANUNJAYA LAKKIREDDY, M.D., F.H.R.S.† • All 60 patients had successful pulmonary vein isolation (PVI). • AF triggers originating from the LAA were seen in 17 patients. - 20 of 22 pAF pts had successful acute LAA electrical • LAA Electrical isolation achieved in only 10 of 17 patients, with isolation high recurrence of AT/AF. - 17 of 20 pts (85%) had LAA reconnection • New peri-device leaks in 30% (12/40) of patients with no leak - 20 of 20 pts underwent successful LAA occlusion * previously. - No complicaitons - 1 of 20 pts (5%) had > 5mm leak • * New significant peri-device leaks ( >5 mm) were noted in 10% (4/40) of patients after RFA and 29% (5/17) of patients after LAAEI, respectively, requiring continuation of oral anticoagulation. J Cardiovasc Electrophysiol. 2017;28(2):139-146. . 3
9/14/2019 Potential adverse consequences of performing PVI Benefits of an epicardial approach of LAA closure concomitantly or after an LAA implant • LAA implants do not result in electrical isolation of the LAA Migration Significant Leaks >5mm Thrombus Maintain Restore Protect JCE 2017 Heeger et al., Heart Rhythm 2015 JCE 28(2):139-146; 2017. LAA ligation results in a permanent LAA exclusion as adjunctive transmural lesion therapy to PVI for the treatment of Persistent and Longstanding LAA Persistent AF LA Can you improve Efficacy Rates of AF Ablation with LAA Exclusion? 1 cm Suture Endo LAA LAA H LA Endo LA Bartus et al., Circ Arrhythmia 7:764-767, 2014 4
9/14/2019 Electrical and Structural Remodeling Arrhythmia Benefits of LAA ligation LAA Electrical Isolation 60 Spontaneous Conversion to SR 55 50 Recurrent-AF(n-1) 45 40 Freedom from AF * * 35 SR (n=9) * At 1 year 70% 30 P wave dispersion 60% 25 Post-LARIAT 20 50% Han et al, Heart Rhythm 2014 Acute to 30d Atrial Fibrillation Pre-ligation Post-ligation Post-PVI 2 months after PVI 40% Decreased AF Burden Badhwar et al., JCE 2015 30% 20% 10% 0% LARIAT + Ablation Only Badhwar et al. Int J Card 2016 Ablation Baseline Post-LAA ligation Post-PVI Lakkireddy D., et al. JACC EP 2015 Afzal et al. Heart Rhythm 2015 Lakkireddy et al., JACC EP 2015 Primary Endpoints • Multi-center, prospective randomized trial Primary • Superiority trial comparing LAA ligation Freedom from episodes of AF > 30 seconds and no Effectiveness requirement for new Class I or III AAD therapy at 12 Endpoint and PVI versus PVI in patients with months post PVI, measured by 24-hr holter or (Superiority) symptomatic event monitoring* persistent and longstanding persistent AF Primary Safety The incidence of significant LARIAT device or procedure- Endpoint related SAEs occurring within 30 days after the LAA ligation procedure (Performance Goal) *consistent with HRS 2012 Consensus Guidelines (Table 5) FDA IDE# G150107 / NCT02513797 Clinicaltrials.gov Identifier: NCT02517397 5
9/14/2019 Trial Status & Milestones LAA ligation enables a more complete ablation procedure • FDA IDE Approval: June 2015 1 st Subject Enrolled: October 2015 • • 560 Total Subjects Randomized (September 12 th , 2019) • 53 Activated Sites • Stage 1-100 Subjects Enrolled: January 2017 • Stage 2 Approved: May 2017 (DMC / FDA Approval (100 subject safety & performance) 400 th Enrollment: Aug 2018 – 450 th Enrollment: Jan 2019 – 500 th Enrollment: May 2019 – – 550 th Enrollment: August 2019 600 th Enrollment: by YE 2019 – • 20 quarters of independent DMC reviews with no cited safety concerns The DMC’s unanimous recommendation is to continue to enroll patients with no safety concerns or observations. Clinicaltrials.gov Identifier: NCT02517397 HRS 2017 Mitral isthmus flutter Arrhythmia post epicardial ablation 6
9/14/2019 LAA ligation facilitates mitral isthmus line Case Presentation Activation map • 55 yo gentleman – Hx of longstanding AF SVC – CHADs score 1 – Refractory to medical therapy – Failed 2 previous PV • How do you treat this patient? – Repeat PVI MV Voltage map – AVJ ablation and pacemaker IV C – Surgical MAZE – Rate control and OAC therapy; and live with your symptoms • LAA ligation, PVI, LAPWI, CTI 5/2011 (Percutaneous “MAZE”) – Remains in sinus rhythm LAA isolation with catheter ablation is Concomitant RFCA and LAAC with an associated with: implant may cause: A) High recurrence rates of LAA electrical A) Device migration activity B) New device leaks B) LAA thrombus despite OAC therapy C) Device related thrombus C) Improvement in efficacy with LAA focal D) None of the above ablation E) All of the above D) A and B E) All of the above 7
9/14/2019 Epicardial LAA closure may lead to: A) Electrical remodeling B) Decrease in AF burden C) Spontaneous conversion to sinus rhythm D) All of the above E) None of the above 8
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