Transcatheter LAA Occlusion

Ahmed A. KhattabCardiology

Bern – Switzerland

Patients with AF have a 5-fold higher risk of stroke

>87% of strokes are thromboembolic

>90% of thrombus originates in the Left Atrial Appendage (LAA)

Thrombus in LAA

Background -1

Background -2

• Simultaneous surgical closure during cardiac surgery has been common practice since many years and is recommended in current guidelines.

• Thoracoscopic epicardial occlusion under general anaesthesia is an option.

• Non-surgical transcatheter LAA exclusion was first introduced in 2001.

Bonow RO, et al. JACC, 2006.Blackshear JL, et al. JACC, 2003.Sievert H, et al. Circulation, 2002.

First randomized trial using WATCHMAN Device

Holmes DR, et al. Lancet, 2009.

900 patient-year cohort

LobeHooks

Waist

Disc

• Flexible braided nitinol • Filled with polyester tissue• Double curved 9-13F sheath

Pacifier Principle

LAA

LA

The Amplatzer Cardiac PlugTM

St. Jude - AGA

Currently available devices

Khattab AA and Meier B. EHJ, 2010.

Khattab AA and Meier B. EHJ, 2010.

Amplatzer LAA Cardiac Plugs in Bern: 95 cases

CHADS2 Score (n)mean 2.5±1.3

Results: indications for LAA occlusion• 98% procedural success• ACPs 16-30mm• In 94% first selected device implanted

N = 95

LAA Closure with Amplatzer Cardiac Plug: Bern Experience

Combined procedures (75/95 or 79%)N = 95

64%

10%7%

25%

35%

21%

LAA Closure with Amplatzer Cardiac Plug: Bern Experience

Schneiter Elisabeth, 29.11.1926, 28.09.2010, Khattab, Windecker

Amplatzer Cardiac Plug24 mm

Medtronic CoreValve26 mm

Amplatzer Septal Occluder14 mm

Termporary Pacemaker LeadAmplatzer TorqueVue Sheath

13 French

Biomatrix Stent3.0 x 18 mm

LAD Stenting + LAA Occlusion + ASD Closure + TAVI(Female, 84 years, LAD stenosis, atrial fibrillation, ASD, aortic stenosis)

September 28, 2010, A. Khattab, MD, S. Windecker, MD

One Stop Shop

Three-month clinical overall complications • 2 device embolizations, 1 with surgery• 2 pericardial effusions, treated conservatively• 1 stroke - 1st day after procedure - reversible• No myocardial infarction

N = 95

* 1 Mobile thrombus3 Nonmobile thrombi8 Questionable thrombi

LAA Closure with Amplatzer Cardiac Plug: Bern Experience

Complete LAA Occlusion65/68 with FU TEE (96%)

95%

2%

1%1%

2%

2.3Even

ts1.0

Event

FU 6.0 ± 1.2 years: 231 patient-years CHADS2 2.2±1.2 5 deaths (nonrelated to device)

Thromboembolic events: expected and observed

Amplatzer LAA Occlusion in Bern

6.5Even

ts

1.0Event

AMPLATZER® Cardiac Plug• CE Mark 2008

– Implanted since December 2008

• Several physician initiated studies– Pre-registry data – Park et al. (2008-2009)– Italian Registry – Santoro et al. (2008-

2010)– Dual Center – Park, Meier (2010-2011)

• EU Post-Marketing Registry– First patient enrolled August 2009– Enrollment completed September 2011

• US FDA Randomized Trial– Completed enrollment in feasibility phase

(45 patients)– Up to 2000 patients to be enrolled in pivotal

phase – expected start: Q1 2012

Paroxysmal28%

Persistent12%

Permanent60%

History of Atrial Fibrillation

N= 148

- Only 3.3% on anticoagulation at enrollment

ACP Post Marketing RegistryBaseline Demographics

13 European Centers

History Indication

ACP RegistryImplant Success

Implant/Technical Success*• 140/145 (96.5%)• No device embolizations

during implant procedure

LAA Closure Rates (TEE/ TTE)

Implant D/C 1 M 6 M0%

20%

40%

60%

80%

100%

Large (> 3 mm)Small (≤ 3 mm)No Residual Flow

N=140 N=140 N=129 N=87

*Success: Devices implanted in those attempted

ACP Results Across Series*ACPInitial European Registry1

ACPItalian registry2

Dual Center experience3

ACP Post Marketing Registry

N = 143 N = 100 N = 131 N = 145

Enrollment period December 2008 -November 2009

December 2008 –November 2010

2010 - 2011 August 2009-May 2011 (interim)

Serious Pericardial Effusion

N = 5 (3.5%) N = 2 (2.0 %) N = 0 N = 3

Device Embolization

N = 2 (1.4%) N = 0 (0%) N = 0 N= 2

Ischemic Stroke N = 3 (2.1%) N = 0 (0%) N = 0 N = 0

Total reported safety events

N = 10 (7%) N = 2 (2%) N = 0 (0%) N = 5 (3.4%)

1. Park, J.-W. et al. (2011), Left atrial appendage closure with Amplatzer Cardiac Plug in Atrial Fibrillation: Initial European experience. Catheterization and Cardiovascular Interventions, 77: 700–706. doi: 10.1002/ccd.22764

2. G. Santoro (presented at the Progress In Clinical Pacing Congress in Rome) December 2010.3. Park, J.W., Leithauser, B., Schmid, M., Khattab, A., Gloeckler, S., Sperl, T., Kasch, F. and Meier, B. (2011) Dual Center Experience with Different Strategies of Left Atrial Appendage Closure with

Amplatzer Cardiac Plug for Prevention of Stroke in Atrial Fibrillation. Presented at UHK_Mayo Clinic Asia cardiovascular summit. 26-7 March (Hong Kong).

* Hospital discharge ≤ 24 hrs.

Indications for LAA occlusionPatients with AF and....

• Bleeding under OAC• Embolism under OAC• Difficult adjustment of INR• Patient‘s wish to discontinue OAC• Elderly patients liabe for repeated falls• Patients subject to repeated injuries (e.g.

butcher, etc.)