Appendage Closure
Jason Rogers, MD
Director, Interventional Cardiology
UC Davis Medical Center
Sacramento, California
Left Atrium: Atrial Fibrillation
Left Atrial Appendage
Left Atrium
Incidence of Atrial Fibrillation
Increases with Age
Adapted from Feinberg WM. Arch Intern Med. 1995;155:469-43
Left Atrial Appendage
Courtesy Mark Reisman MD
Cardioembolic Stroke
>90% of strokes in AF are caused by LAA Thrombi
Thrombus in
the LAA
1
Blackshear JL. Odell JA., Annals of Thoracic Surgery. 1996;61:755-759
Major Bleeding Rates With Newer Anticoagulants
Study
RE-LY1
Treatment
Major Bleeding
Hemorrhagic
Stroke
Dabigatran (110 mg)
2.71%
0.12%
Dabigatran (150 mg)
3.11%
0.10%
Warfarin
3.36%
0.38%
Rivaroxaban
3.6%
0.5%
Warfarin
3.4%
0.7%
Apixaban
2.13%
0.24%
Warfarin
3.09%
0.47%
ROCKET-AF2
ARISTOTLE3
1.  Connelly SJ et al, NEJM 2009;361:1139-51
2.  Patel MR et al, NEJM 2011;365:883-91
3. Granger J. et al, NEJM 2011;365:981-92
Percutaneous LAA Occlusion Devices
Watchman
Cardiac Plug
LARIAT
WATCHMAN Device
Nitinol Frame
160 Micron
Membrane
• Radially expands to maintain position
in LAA
• Available sizes:
•
21, 24, 27, 30, 33 mm (diameter)
• 10 Active fixation anchors around
device perimeter engage LAA tissue
for stability and retention
• Contour shape accommodates most
LAA anatomies
160 Micron Membrane
Anchors
• Polyethyl terephthalate (PET) cap
• Blocks emboli from exiting the LAA
• Promotes healing process
Case
•  71 year old
•  Chronic atrial fibrillation
•  h/o lung cancer
•  Recurrent nosebleeds
•  CHADS2 = 3
•  CHA2DS2Vasc = 5
Pre
Post
PROTECT AF Trial
•  707 coumadin-eligible patients (CHADS2 ≥ 1)
randomized 2:1 device vs. warfarin
•  Efficacy: CVA, CV Death, Systemic Embolism
•  Safety: Bleeding, Procedure Complications
Holmes DR et al. Lancet .2009;374:534–42
PROTECT-AF:
Adapted from HRS LBCT 2013 by Dr. Vivek Reddy
SH-158101-AB- MAY 2013
Patient Demographics
Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and
investigational use only. Not for sale in the US. Prior to use please review device indications,
contraindications, warnings, precautions, adverse events, and operational instructions. Only available
according to applicable local law. CE Mark received in 2005
PROTECT-AF:
Adapted from HRS LBCT 2013 by Dr. Vivek Reddy
SH-158101-AB- MAY 2013
Patient Demographics
Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and
investigational use only. Not for sale in the US. Prior to use please review device indications,
contraindications, warnings, precautions, adverse events, and operational instructions. Only available
according to applicable local law. CE Mark received in 2005
PROTECT-AF:
Adapted from HRS LBCT 2013 by Dr. Vivek Reddy
SH-158101-AB- MAY 2013
Primary Efficacy Endpoint
Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and
investigational use only. Not for sale in the US. Prior to use please review device indications,
contraindications, warnings, precautions, adverse events, and operational instructions. Only available
according to applicable local law. CE Mark received in 2005
PROTECT-AF:
Adapted from HRS LBCT 2013 by Dr. Vivek Reddy
SH-158101-AB- MAY 2013
Primary Efficacy Endpoint
Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and
investigational use only. Not for sale in the US. Prior to use please review device indications,
contraindications, warnings, precautions, adverse events, and operational instructions. Only available
according to applicable local law. CE Mark received in 2005
PROTECT-AF:
Adapted from HRS LBCT 2013 by Dr. Vivek Reddy
SH-158101-AB- MAY 2013
Primary Efficacy Endpoint
Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and
investigational use only. Not for sale in the US. Prior to use please review device indications,
contraindications, warnings, precautions, adverse events, and operational instructions. Only available
according to applicable local law. CE Mark received in 2005
PROTECT-AF:
Adapted from HRS LBCT 2013 by Dr. Vivek Reddy
SH-158101-AB- MAY 2013
Primary Efficacy Endpoint
Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and
investigational use only. Not for sale in the US. Prior to use please review device indications,
contraindications, warnings, precautions, adverse events, and operational instructions. Only available
according to applicable local law. CE Mark received in 2005
Intention-to-Treat:
All-Cause Mortality
P = 0.0379
Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and
investigational use only. Not for sale in the US. Prior to use please review device indications,
contraindications, warnings, precautions, adverse events, and operational instructions. Only available
according to applicable local law. CE Mark received in 2005
Adapted from HRS LBCT 2013 by Dr. Vivek Reddy
SH-158101-AB- MAY 2013
Hazard Ratio with Watchman, 0.66
(95% CI, 0.45 – 0.98)
PROTECT AF:
Adapted from HRS LBCT 2013 by Dr. Vivek Reddy
SH-158101-AB- MAY 2013
Primary Safety Endpoint
Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and
investigational use only. Not for sale in the US. Prior to use please review device indications,
contraindications, warnings, precautions, adverse events, and operational instructions. Only available
according to applicable local law. CE Mark received in 2005
Pericardial Effusions Requiring Intervention
3.0%
2.0%
1.0%
P = 0.318
p = 0.027
2.4%
1.6%
n=7 0.0%
1.2%
1.5%
0.2% 0.4%
n=1 n=1 n=11 n=7 n=4 Cardiac perforation requiring Pericardial effusion with cardiac
surgical repair
tamponade requiring
pericardiocentesis or window
PROTECT AF
PROTECT-AF and CAP data from Reddy VY et al.
Circulation. 2011;123:417-424
CAP
PREVAIL
Adapted from a presentation by David R. Holmes, Jr., M.D.
SH-146002-AA MAR2013
% of Patients
4.0%
Caution: In the United States, WATCHMAN is an investigational device limited by Federal law
and investigational use only. Not for sale in the US. Prior to use please review device
indications, contraindications, warnings, precautions, adverse events, and operational
instructions. Only available according to applicable local law. CE Mark received in 2005
Stroke and Device Embolization
p = 0.007
2.0%
1.1%
1.0%
0.0%
n=5 0.0%
n=0 0.4%
n=1 Procedure/Device Related Strokes
% of Patients
PROTECT AF
CAP
PREVAIL
p = 0.364
2.0%
1.0%
0.4%
0.0%
n=2* 0.2%
n=1 0.8%
n=2 Device Embolizations
PROTECT AF
CAP
PREVAIL
Procedure related strokes were reduced
Device embolizations remained low
*1 additional device embolization was reported at 45 days
PROTECT-AF and CAP data from Reddy VY et al. Circulation.
2011;123:417-424
Adapted from a presentation by David R. Holmes, Jr., M.D.
SH-146002-AA MAR2013
% of Patients
3.0%
Caution: In the United States, WATCHMAN is an investigational device limited by Federal law
and investigational use only. Not for sale in the US. Prior to use please review device
indications, contraindications, warnings, precautions, adverse events, and operational
instructions. Only available according to applicable local law. CE Mark received in 2005
LARIAT® LAA Closure
Coumadin Ineligible Subjects
Case
•  81 year old
•  Chronic atrial fibrillation
•  h/o UGI Bleed
•  HASBLED=9.1% yearly risk of bleeding
•  CHADS2=4
•  CHA2DS2Vasc=6
LAA Baseline
LA Appendage Appearance
Baseline
6 week Follow Up
Lariat PLACE Study
•  Permanent Ligation Approximation Closure and Exclusion
•  Single center, non-randomized study
•  85 patients underwent closure of their left atrial appendage
•  Follow up was 1 day, 30 days, 90 days and 1 year with transesophageal
echocardiography
Intent-to-Treat
85/89 (96%)
Adverse Events
(defined as access
related or device
failure)
3/89 (3.3%)**
Access 3/89 (3.3%)
Device 0/89 (0.0%)
Closure (defined
as < 1mm residual
flow)
1 day 81/85 (95%)
30 day 81/85 (95%)
90 day 77/81 (95%)
1 year 65/66 (98%)
* Bartus, Krzysztof, et al. “Percutaneous Left Atrial Appendage Suture Ligation Using the
LARIAT in Patients with Atrial Fibrillation: Initial Clinical Experience.” J Am Coll Cardiol.
** All non-serious: 2 pericardial access related. 1 transseptal access related.
Thank You