Disclosures Role of Endocardial vs. Epicardial LAABenefits of an epicardial approach of LAA closure...
Transcript of Disclosures Role of Endocardial vs. Epicardial LAABenefits of an epicardial approach of LAA closure...
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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