Disclosures Role of Endocardial vs. Epicardial LAA - - PDF document

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Disclosures Role of Endocardial vs. Epicardial LAA - - PDF document

Jun 21, 2023 457 likes •557 views

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

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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 fibrillation

Hocini 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 LAA All were successfully ablated within the LAA, targeting fractioned potentials At 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 2015 JCE 2017

Migration Significant Leaks >5mm Thrombus

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

Restore Maintain Protect

Benefits of an epicardial approach of LAA closure

LA

LA LAA

1 cm

LAA Suture Endo Endo LA

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-LARIAT Acute 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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9/14/2019 7 LAA ligation facilitates mitral isthmus line

Activation 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