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L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI,...

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stroke prevention in AF SYSTEMIC ANTICOAGULATION VERSUS LAAO L. Bing Liem, DO, FACOI FHRS FACC CLINICAL PROFESSOR OF MEDICINE UNIVERSITY OF CALIFORNIA SAN FRANCISCO
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Page 1: L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV

stroke prevention in AFSYSTEMIC ANTICOAGULATION VERSUS LAAO

L. Bing Liem, DO, FACOI FHRS FACCCLINICAL PROFESSOR OF MEDICINE UNIVERSITY OF CALIFORNIA SAN FRANCISCO

Page 2: L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV

Improved success and procedural safety

confirmed with new and experienced operators

CAP Registry

566 pts, 26

sites

PREVAIL

400 pts, < 50

sites

Significantly improved safety results

PROTECT-AF

800 pts, 59

sites

Watchman device was non-inferior to warfarin

in preventing strokes; FDA concerned with

acute safety events

PROTECT-AF

Long-term F/USuperior to warfarin for primary efficacy, CV

death, and all-cause mortality at 4 years

Page 3: L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV

LAA and AF

Di Biasi L, JACC 2016; Yorgun H, Europace 2017

Page 4: L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV

LAA and AF

Effect of empirical left atrial appendage isolation on long-term procedure outcome in patients with persistent or long standing persistent atrial fibrillation (BELIEF) study

RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV triggers with and without LAAI

Freedom from AF

At 12 months:

25 (28%) of the control

48 (56%) of LAAI

At 24 months and repeat procedures:

49 (56%) in control

65 (76%) with LAAI

Di Biasi L, JACC 2016; Yorgun H, Europace 2017

Page 5: L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV

LAA and AF

Di Biasi L, JACC 2016; Yorgun H, Europace 2017

Page 6: L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV

Endocardial vs Epicardial LAAO

Page 7: L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV

Endocardial vs Epicardial LAAO

Page 8: L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV

Current FDA-approved LAA closure devices

EndocardialWatchman

EpicardialAtriClip (surgical) Lariat (percutaneous)

“occlusion” “exclusion”

Page 9: L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV

Catheter Ablation for Atrial Fibrillation in Patients

With Watchman Left Atrial Appendage Occlusion Device:Results from a Multicenter Registry

All 60 patients had successful pulmonary vein isolation (PVI).

AF triggers originating from the LAA were seen in 17 pts.

LAA electrical isolation achieved in 10 of 17 pts, with high recurrence of AT/AF.

New peri-device leaks in 30% (12/40) of patients with no leak previously.

New significant peri-device leaks (>5 mm) were noted in 10% (4/40) of pts

after RFA and 29% (5/17) of patients after LAAEI, respectively, requiring

continuation of oral anticoagulation.

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.†

J Cardiovasc Electrophysiol. 2017;28(2):139-146..

Page 10: L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV

LA

LAA

LAA Suture Endo

EndoLA

H

LAA ligation results in a transmural lesion

Bartus et al., Circ Arrhythmia 7:764-767, 2014

LAA

Page 11: L. Bing Liem, DO, FACOI FHRS FACC...persistent atrial fibrillation (BELIEF) study RCT of PVI, posterior wall isolation, roof and anterior septum ablation, SVC isolation and non-PV

Multi-center, prospective randomized trial

Trial comparing LAA ligation + PVI versus PVI alone in

patients with persistent and longstanding persistent AF

FDA IDE# G150107 / NCT02513797


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