- Left atrial appendage (LAA) closure devices provide a less invasive alternative to surgical LAA closure for stroke prevention in atrial fibrillation patients. The WATCHMAN and Amplatzer Cardiac Plug are the most widely used devices. - Major trials like PROTECT AF have demonstrated the efficacy and safety of LAA closure with the WATCHMAN device. FDA approval is pending for its use in warfarin-eligible patients. - Percutaneous LAA closure procedures involve transseptal access and deployment of self-expanding nitinol devices into the LAA orifice. Complete sealing of the LAA is confirmed prior to device release.

1. LA APPENDAGE CLOSURE DEVICES
SHYAM SASIDHARAN

2. FEATURING…
• Background and Rationale.
• Anatomy and physiology of LAA.
• Current status- various devices.
• WATCHMAN/AMPLATZER CARDIAC
PLUG/LARIAT.
• Major Trials/Recommendations.

3. BACKGROUND

5. CHALLENGES IN AF TREATMENT

6. MAJOR BLEEDING RATES
EuroIntervention 2014;10:497-504
Left atrial appendage closure for stroke prevention in non-valvular atrial fibrillation: rationale,
devices in clinical development and insights into implantation techniques

7. Rationale of LAA closure
• Stroke risk closely related to bleeding risk.
• In non-valvular AF, over 90 % of stroke-causing clots formed in LA
from LAA.
• Given the important role played by LAA in the pathogenesis of
embolic stroke, early attempts to reduce the risk by surgical removal
or more recently ligation during the cardiac surgery were made.
• Data on surgical LAA closure showed that such procedure is feasible
and safe . LAAOS (Left Atrial Appendage Occlusion Study)
• LIMITATIONS : need for major surgical procedure and a high rate
of incomplete occlusion of the LAA orifice which might contribute to
a high residual risk of stroke.
• Because of this a less invasive approach of percutaneous LAA
closure was translated from animal models into the clinical setting
and a growing body of evidence has shown its safety and feasibility.

8. ANATOMY OF LAA

9. ANATOMY OF LAA…

10. Distribution of number of lobes (1 to 4) of left atrial appendage
Fifty-four percent of LAAs had
two lobes, and the number
ranged between one and four
lobes . There were no age or
sex differencesVeinot J et al. Circulation
1997;96:3112-3115

11. 4 MORPHOLOGICAL TYPES
CACTUS CHICKEN WING
BROCCOLI WINDSOCK

12. PHYSIOLOGY AND PATHOLOGY IN AF
• LAA cardiocytes have high concentrations of
ANP but < RAA.
• LAA function measured by means of
echocardiographic Emptying fraction,peak
systolic strain and flow velocity.
• In AF ,LAA undergoes remodelling,size
increases – endocardial elastosis – depress LAA
function.

13. PREDICTORS OF THROMBOEMBOLISM
• Risk is 6 times higher in non-chicken wing LAA
compared to chicken wing type.
• Increase in chamber dimensions and LAA
volume.
• Smaller ostial size
• Shorter LAA length.
• LAA dysfunction- peak systolic strain<21%
Emptying fraction <21%
LAA velocity<20cm/s

14. DEVICES

15. PLAATO DEVICE
First percutaneous LAA occlusion device(1998)

16. • The PLAATO system (Appriva Medical), consists of an implant
and a delivery catheter.
• The implant ( is a self-expanding nitinol cage (range of from 15
to 32 mm) covered with an occlusive expanded
polytetrafluoroethylene (ePTFE) membrane,which is laminated
directly to the frame structure so that the perimeter has intimate
contact with the inner wall of the appendage.
• The purpose of the membrane is both to occlude the orifice of
the LAA and to allow tissue incorporation into the device.
• Small anchors along the struts and passing through the
occlusivemembrane assist with device anchoring and encourage
healing response.
• The device is delivered through a custom 14 Fr transseptal
sheath curved to point at the LAA

17. WATCHMAN LAAC
DEVICE
• Developed by Atritech medical in 2003.
• Largest published clinical data to date.
• PROTECT AF - seminal trial proving both the
efficacy of the device and concept of LAA
closure.
• CE mark in 2005.
• CAP registry (2010) and PREVAIL trial
• ASAP and EVOLVE trials.
• FDA approval for warfarin eligible patients
pending.

19. PROCEDURE
• Selecting appropriate size, according to TEE guided
measurement of ostial diameter.(0 & 135)
• GA/Consciuos sedation- fluoroscopic and TEE.
• Trans septal puncture and introduction of Access
sheath.
• Access into LAA with a pigtail catheter.
• Device loading of Access sheath.
• Device deployment and release.

20. DEVICE RELEASE CRITERIA

22. HEALING PROCESS

23. WATCHMAN - COMPLICATIONS
• Pericardial effusion – 4.8%
• Air embolism – 1.1%
• Cardiac perforation – 1.6%
• Device embolisation – 0.6%

25. AMPLATZER CARDIAC PLUG
• Amplatzer Cardiac Plug is a self-
expanding device made from nitinol
& dacron consisting of 3 parts
namely lobe, disk, & the middle
segment.
• 1ST human experience with this
device was published by Park et al in
2010 in Europe
• LAA closure in 132 of 137 (96.4 %)
pts,& development of serious
complications (ischemic stroke in 3,
device embolization in 2, and
clinically significant PE in 5
cases) in 10 (7.3 %) pts was
reported
• Doesnot require anticoagulation.

26. COHEREX WAVECREST LAA OCCLUDER
• Made of e-PTFE
• Anchored with 20 microtines
distributed circumferentially
at the distal device margin.
• Ideal for shallow LAA
• WAVECREST I trial
• CE approval in 2013.
• US pivotal WAVECREST II
trial started in 2014.

27. LARIAT DEVICE
• Endo-epicardial procedure
• Pericardial and transseptal
access.
• Placement of 2 magnet tipped
guidewires
• Connection of epicardial and
endocardial guidewires.
• Snare capture of the LAA and
release of the pretied suture for
LAA ligation.
• Serious pericardial effusion and
major bleeding.

29. EMERGING TECHNOL0GIES
• OCCLUTECH LAA OCCLUDER
• LIFETECH LAA OCCLUDER : Lambre
• CARDIA ULTRASEPT LAA OCCLUDER
• AEGIS –ECG guided LAA capture and ligation
system
• EPITEK- Fibreoptic endoscope mediated.

31. ACC/AHA/HRS 2014 AF GUIDELINES
• Class IIb - Surgical excision of the LAA may be
considered in patients undergoing cardiac
surgery. (Level of Evidence: C)
• WATCHMAN device and ACP device may be
used in patients with high risk of stroke and
contraindiactions for OACs.

32. TAKE HOME MESSAGE
• Device occlusion of LAA – impressive results.
• Currently recommended only for those patients
with high risk for stroke and contraindications
for OACs
• Further improvement expected with operator
experience and newer generation devices.
• Likely to be approved for use in warfarin eligible
patients in near future.

33. Thank you…