Disclosure The Role of LAA Closure in Atrial Fibrillation - - PowerPoint PPT Presentation

9/8/2012 1

The Role of LAA Closure in Atrial Fibrillation

Disclosure SentreHeart, Inc

• Consultant
• Equity holder

A cardiac disease that kills by producing emboli The most severe consequence of AF is potentially life threatening embolic events

SETTING # THROMBI IN LA/LAA # IN LAA % IN LAA REFERENCE TEE 67 66 99% Stoddard, JACC 1995 TEE 35 34 97% Manning, Circulation 1994 Autopsy 47 35 74% Aberg, Acta. Med. Scan. 1969 TEE 4 2 50% Tsai, JFMA 1990 TEE 13 12 92% Klein, Int J Card Imaging 1993 TEE & Operation 11 8 73% Manning, Circulation SPAF III & TEE 20 19 95% Klein, Circulation 1994 TEE 19 19 100% Leung, JACC 1994 TEE 6 6 100% Hart, Stroke 1994 TOTAL 222 201 91%

AF MECHANISM FOR STROKE

Irregular Heartbeat

Pumping of Blood Disrupted

Blood Stagnates in LAA

Incubator for Thrombus

Clot dislodges from LAA

Next Stop: BRAIN

Location of Thrombus in Patients with AF

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PROTECT AF STUDY

Provided Proof of Principle

0.0% 0.5% 1.0% 1.5% 2.0% 2.5% 3.0% 3.5% DEVICE CONTROL 2.4% 1.6% 0.2% 1.9% 2.6% 3.5% ISCHEMIC HEMORRHAGIC ALL

Device is non-inferior to warfarin in stroke May provide an alternative to warfarin Conclusions:

STROKE RATES (95% CI)

Endocardial vs Pericardial

No LA foreign body Ease of Use Closure Efficacy Complications The Watchman Device

Endocardial Devices

PROTECT AF STUDY

0.00% 2.00% 4.00% 6.00% 8.00% 10.00% DEVICE CONTROL

COMPLICATION RATES

• Pericardial Effusion
• Air Embolism
• Cardiac Tamponade
• Migration
• Bleeding
• Thrombus

Pericardial Devices

Surgical (Direct visualization) Devices

Atriclip (FDA approved) Cardioblate TigerPaw System

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Catheter - Based Surgery

• Open Chest
• Cardiopulmonary Bypass
• Technique Variability Closure
• Performed with another open

procedure

• Percutaneous & Image Guided
• Immediate, Complete, Permanent
• Training Required on New Techniques

Performed in OR Performed in cath lab Epitek

Pericardial Devices

AEGIS Medical

Friedman PA, et al. J Cardio Electrophysiol, Aug 2009 Vol. 20, 908-15

LARIAT Suture Delivery Device

Patients with AF and high risk for embolic events that have limited to no options due to contraindications or intolarnace to OAC.

LAA ligation with the LARIAT Suture Delivery Device

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Non-randomized, single center, observational study Objective: Assessing Safety and Efficacy of LAA Closure Dec 2009 through Dec 2010 Patients with AF, CHADS2 >1 & Ineligible to Coumadin

Objectives of PLACE II

JACC In Press

Capture / Closure

Acute Closure 85 Complete <1mm 82 (96%) <2mm 2 ( 3%) <3mm 1 ( 1%) 1d Closure 85 Complete <1mm 81 (95%) <2mm 3 ( 4%) <3mm 1 ( 1%) >30d Closure 85 Complete <1mm 81 (95%) <2mm 3 ( 4%) <3mm 1 ( 1%) >90d Closure > 1 year 81* 65 Complete <1mm 60 (97%) <2mm 2 ( 3%) <3mm 0 ( 0%) Complete < 1 mm 64 (98%) < 2 mm 1 (2%)

* Four pts had 60d follow up and refused to have 90 d follow up

JACC In Press

Adverse Events

1) Access related complications (2 pericardial access related, 1 transseptal related) - 3 (3.5%) 2) No device complications 3) Chest pain due to pig tail catheter - 20 (24%) 3) Pericarditis - 2 (2.4%) 4) Late pericardial - 1 (1.2%) 5) Thrombus – 1 (1.2%) 6) Strokes – 2 non-embolic strokes (1 hemorraghic and one lacunar). Both > 6 mos after the procedure 7) Deaths – 2 that were > 6 mos after the procedure

Percutaneous LAA Ligation

• Feasible
• Effective LAA closure
• Acceptably low access complications and peri-

procedural adverse events

• Future outcome studies needed

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Rationale for LAA exclusion during AF Ablation

• Will it allow patients to stop Coumadin?
• Will it improve ablation outcomes?

HRS/EHRA/ECAS Expert Consensus Statement

• n Catheter and

Surgical Ablation of Atrial Fibrillation

• 1. Decisions regarding the use of warfarin more than

two months following ablation should be based on the patient’s risk factors for stroke and not on the presence or type of AF

• 1. Discontinuation of warfarin therapy post ablation is

generally not recommended in patients who have a CHADS score > 2

LAA Exclusion at the time of AF Ablation

Strategy of performing AF ablation for the treatment

• f AF and exclusion of the LAA for stroke prevention

Ablation for Atrial Fibrillation in Combination With Left Atrial Appendage Closure: First Results of a Feasibility Study

Swaans et al., J Am Heart Assoc. 2012;1:e002212

• 30 patients were treated with PVI and Watchman device
• 30% rate of documented recurrence of AF at 1 year.
• A repeated pulmonary vein isolation was performed

successfully in 4 patients, without interference of the LAA closure device.

• No thromboembolic events occurred during 1-year follow-

up. Conclusion: LAA occlusion with the Watchman device and AF ablation can be combined successfully and safely in a single procedure. The Watchman does not interfere with a repeated ablation.

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

LAA Isolation Improves Ablation Outcomes

Left Atrial Appendage : An Underrecognized Trigger Site of Atrial Fibrillation

Luigi Di Biase, J. David Burkhardt, Prasant Mohanty, Javier Sanchez, Sanghamitra Mohanty, Rodney Horton, G. Joseph Gallinghouse, Shane M. Bailey, Jason D. Zagrodzky, Pasquale Santangeli, Steven Hao, Richard Hongo, Salwa Beheiry, Sakis Themistoclakis, Aldo Bonso, Antonio Rossillo, Andrea Corrado, Antonio Raviele, Amin Al-Ahmad, Paul Wang, Jennifer E. Cummings, Robert A. Schweikert, Gemma Pelargonio, Antonio Dello Russo, Michela Casella, Pietro Santarelli, William R. Lewis and Andrea Natale

• Circulation. 2010;122:109-118

Consequences of Electrical Isolation

• f LAA with RFCA
• Mechanical standstill
• Thrombus formation

LAA thrombus

Electrical Isolation of LAA with the LARIAT Suture Delivery Device

11.0 mV 3.2 mV 2 4 6 8 10 12 14 16 18 Baseline LAA ligation

Mean Unipolar LAA Voltage

P < 0.001

10 of 30 patients had complete abolition of LAA electrical activity after acute ligation.

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Holter Data

• 28 of 29 patients did not have atrial fibrillation

at FU holter at 1 year.

• Subjectively all patients felt better

LAA ligation and PVI in Patients with Persistent AF

Cox Maze III

Feasibility Study of Concominant LAA Ligation and PVI

• UCSF, KUH
• 8 patients at each site have had LAA

ligation/PVI

• Persistent AF patients
• UCSF: 5 of 10 in sinus rhythm. All feel better.
• 1 additional patients who enrolled in study did

not proceed to PVI due to feeling better. Pt is in atrial flutter.

Conclusion

• There is rationale for LAA exclusion as part of

the AF treatment strategy.

• Which LAA exclusion device used will be

dependent on LAA closure efficacy and associated complications

• Studies will be needed to determine if LAA

exclusion improves stroke and AF ablation

• utcomes.