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Role of Endocardial vs. Epicardial LAA isolation

Disclosures

SentreHeart/Atricure, Inc• Consultant• Equity holder

Life Signals, Inc• Consultant• Equity holder

Cornerstone of AF Ablation is PVI

Brooks AG, et al. Outcomes of long standing persistent AF: A systematic review. Heart Rhythm. 2010; 7:835-46

Additive Catheter Ablation Strategies

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Automaticity cells

identified in the

LAA that leads to

AT

Guo et al. Heart Rhythm 11:17–25, 2014 Reentrant

Circuits

LAA can fibrillate independently of the left atrium

Rostock…..Haissaguerre JCE 17:807-812, 2006

Localized reentry within the left atrial appendage:

arrhythmogenic role in patients undergoing

ablation of persistent atrial fibrillationHocini M, Shah AJ, Sanders P, Wright M, Narayan SM, Takahashi Y, Jais P, Matsuo S, Knecht S,

Sacher F, Lim KT, Clementy J, Haissaguerre M

Heart Rhythm. 2011 Dec;8(12):1853-61.

15 (19%) arose from LAA in patients with persistent AF for 17+/- 15 months

89% were entrained suggesting localized reentry within the LAAAll were successfully ablated within the LAA, targeting fractioned potentialsAt 18 +/- 7 months 13/15 (87%) remained in SR without AAD

Kim et al. JACC 36:1324-7, 2000

Chick et al., PACE 2014; 00:1–10)

Atrial Tachycardias Utilizing the

Ligament of Marshall

Region Following Single Ring

Pulmonary Vein Isolation for Atrial

Fibrillation

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Left Atrial Appendage : An Under recognized Trigger Site of Atrial Fibrillation

Di Biase et al., Circulation. 2010;122:109-118 Romero et al. Heart Rhythm 15: 1577-1582, 2018

- High recurrence rate

- LAA perforation

- Thrombus formation

Rilliing et al. Circ Arrhythm Electrophysiol, , 2016

• Restoration of sinus rhythm with PVI

• Stroke prevention without need for OAC therapy after LAA occlusion device

Combined PVI and LAA occlusion

Potential benefits:

PVI should be done before LAA closure with an LAA implant

**

- 20 of 22 pAF pts had successful acute LAA electrical isolation

- 17 of 20 pts (85%) had LAA reconnection- 20 of 20 pts underwent successful LAA occlusion- No complicaitons- 1 of 20 pts (5%) had > 5mm leak

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 patients.

• LAA Electrical isolation achieved in only 10 of 17 patients, 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 patients 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..

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Potential adverse consequences of performing PVI concomitantly or after an LAA implant

• LAA implants do not result in electrical isolation of the LAA

Heeger et al., Heart Rhythm 2015JCE 2017

Migration Significant Leaks >5mm Thrombus

JCE 28(2):139-146; 2017.

Restore MaintainProtect

Benefits of an epicardial approach of LAA closure

LA

LA

LAA

1 cmLAA Suture Endo

EndoLA

H

LAA ligation results in a permanent

transmural lesion

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

LAA

Can you improve Efficacy Rates of AF Ablation with LAA Exclusion?

LAA exclusion as adjunctive

therapy to PVI for the treatment of

Persistent and Longstanding

Persistent AF

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Arrhythmia Benefits of LAA ligation

Han et al, Heart Rhythm 2014

LAA Electrical Isolation

Decreased AF Burden

Afzal et al. Heart Rhythm 2015

Badhwar et al. Int J Card 2016

Spontaneous Conversion to SR

Atrial Fibrillation

Post-LARIATAcute to 30d

Electrical and Structural Remodeling

0%

10%

20%

30%

40%

50%

60%

70%

LARIAT +

Ablation

Ablation Only

Freedom from AF

At 1 year

Lakkireddy D., et al. JACC EP 2015

Baseline Post-LAA ligation Post-PVI

20

25

30

35

40

45

50

55

60

Pre-ligation Post-ligation Post-PVI 2 months after PVI

*

P wave dispersion

Recurrent-AF(n-1)

SR (n=9)**

Badhwar et al., JCE 2015

Lakkireddy et al., JACC EP 2015

• Multi-center, prospective randomized trial

• Superiority trial comparing LAA ligation

and PVI versus PVI in patients with

persistent and longstanding persistent AF

FDA IDE# G150107 / NCT02513797

Primary Endpoints

Primary

Effectiveness

Endpoint

(Superiority)

Freedom from episodes of AF > 30 seconds and no

requirement for new Class I or III AAD therapy at 12

months post PVI, measured by 24-hr holter or

symptomatic event monitoring*

Primary Safety

Endpoint

The incidence of significant LARIAT device or procedure-

related SAEs occurring within 30 days after the LAA

ligation procedure (Performance Goal)

*consistent with HRS 2012 Consensus Guidelines (Table 5)

Clinicaltrials.gov Identifier: NCT02517397

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• FDA IDE Approval: June 2015

• 1st Subject Enrolled: October 2015

• 560 Total Subjects Randomized (September 12th, 2019)

• 53 Activated Sites

• Stage 1-100 Subjects Enrolled: January 2017

• Stage 2 Approved: May 2017 (DMC / FDA Approval (100 subject safety & performance)

– 400th Enrollment: Aug 2018

– 450th Enrollment: Jan 2019

– 500th Enrollment: May 2019

– 550th Enrollment: August 2019

– 600th 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.

HRS 2017

Trial Status & Milestones

Clinicaltrials.gov Identifier: NCT02517397

LAA ligation enables a more complete ablation procedure

Arrhythmia post epicardial ablation Mitral isthmus flutter

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LAA ligation facilitates mitral isthmus lineActivation map

Voltage map

Case Presentation

• 55 yo gentleman

– Hx of longstanding AF

– CHADs score 1

– Refractory to medical therapy

– Failed 2 previous PV

• How do you treat this patient?

– Repeat PVI

– AVJ ablation and pacemaker

– 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

IV

C

MV

SVC

LAA isolation with catheter ablation is associated with:

A) High recurrence rates of LAA electrical activity

B) LAA thrombus despite OAC therapy

C) Improvement in efficacy with LAA focal ablation

D) A and B

E) All of the above

Concomitant RFCA and LAAC with an implant may cause:

A) Device migration

B) New device leaks

C) Device related thrombus

D) None of the above

E) All of the above

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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