LAmbre LAA closure:
Claudio Tondo, MD, PhD, FESC,FHRS
Heart Rhythm Centre
Monzino Cardiac Center, IRCCS
Dept. of Cardiovascular Sciences and Community Health
University of Milan, Milan, Italy
and
Texas Cardiac Arrhythmia Institute, Austin,Tx, USA
LIFETECH LAA OCCLUDER –
1. Double-membrane, Disc-type Device: Cover + Umbrella
2. Fully Recapturable Umbrella
3. Small Delivery Sheath: 8-10Fr, Sizes 16-36mm
4. Recessed hub
ConnectingSleeve
LAmbreTM Occluder - Material
LAmbreTM LAA Closure System
Membrane:PET
Cover Mess:Nitinol withTiN coated
Umbrella Frame: Nitinol
Connecting Sleeve: Nitinol
LAmbreTM Delivery system - Available in two types
LAmbreTM LAA Closure System
Delivery
Cable
Haemostatic
Valve LoaderDelivery
Sheath
Work assembly of the Delivery Cable, the Delivery Sheath, the Loader
and the Haemostatic Valve
Delivery
Cable
Haemostatic
Valve LoaderDelivery
Sheath
Work assembly of the Delivery Cable, the Delivery Sheath, the Loader
and the Haemostatic Valve
45°X 30°double curves
45°single curve
Safely stabilized anchoring mechanism
* 8 small hooks (engage into LAA walls)
* 8 individual U-shaped ends(trapped in trabeculations)
* Over-sized umbrella(pushing and stenting against the LAA)
Patented Anchor Design to Ensure Stable Device Fixation
Hook
U-shaped End
ANCHORING MECHANISMS FOR
•8 small distal hooks (engage into
LAA walls)
•Over-sized umbrella (pushing and stenting
against the LAA)
•8 bigger prox barbs (trapped in
trabeculations)
TWO TYPES OF
Standard
• 16-36mm
• Cover 4-6mm larger
Special• 16-26mm
• Cover 12-14mm larger
SPECIAL DEVICE
• Umbrella ranged from 16-28mm
• Cover 12-14mm larger
• Being used in about 7%
• of LAmbre implants
• Potential suitable anatomies
1. Bilobed or multi-lobed
2. Shallow
3. Extreme sizes (small or large)
4. Combinations of the above
landing zone landing zonelanding zone landing zone
landing zonelanding zonelanding zone
-> Opening up the umbrellaat proximal LAA (active roll-in of stabilizing hooks)
-> Distal positioning ofdelivery catheter is notrequired!
-> Less demanding on catheter alignment in perpendicular to ostial axis!!
Lam YY. A new left atrial appendage occluder (Lifetech LAmbreTM Device) for stroke prevention in atrial fibrillation.Cardiovasc Revasc Med 2013; 14:134-6
Occluder Deploy Procedural Steps
Umbrella PARTIALLYopened
Umbrella FULLYopened
LA coverdeployed
Umbrella Justopened
FLUROSCOPIC VS. EX-VIVO APPEARANCES
Imaginary line between nadir of the frames
Radio-opaquemarker
LAA ANGIOGRAM: BEST PRACTICES
1. Use 2 marks (10mm, leading-to-leading edge) at the tip of delivery sheath OR marked pigtail for calibration
2. Measure at RAO 20 caudal 20view
–Landing zone
–Ostium3. Should have good correlation with
TEE (in general angio 2-4mm larger)
Landing Zone
Ostium
10mm
SIZE SELECTION FOR
Landing zone
Ostium
10mm
RAO 20 Caudal 20 TEE 135
• Device Size (Diameter o Umbrella): 2-6mm (or 10-25%) larger than the measured landing zone
• Signs of Optimal Device Placement
1. Rectangular-shaped umbrella (indicates compression)2. Lowest frame level same as radio-opaque marker(indicates optimal opening of umbrella)
4. Concave-shaped cover 3. Umbrella deployed beyond the left circumflex arterylevel
SIZING/TYPE CONSIDERATIONS
1. In general 2-6mm (10-25%) larger than
measured landing zone
2. More oversizing:
– Large landing zone >26mm
– Large ostium
– Certain LAA morphologies (cauliflower or
chickenwing)
3. Special device in special anatomies
(bilobed, shallow etc.)
LAA SIZING – CASE EXAMPLE
Umbrella can be compressed up to 40% in bench testBoth LAA have same landing zone measurement (20mm) but differentostial size (28mm vs 23mm)1. Wide opening (28mm ostium): 26 (32) device2. Narrowing opening (23mm ostium): 22 (28) or 24 (30) device
DEVICE IMPLANTATION
1. Standard implantation technique
2. Modified technique for patients with dense
SEC in LAA
3. Sandwich technique for patients with chickenwing
morphology
Comparisons with other 2 devices
WATCHMAN ACP/AMULET LAmbre
Leak More likely Less likely Less likely
Dependence on LAA depth
YES No No
Delivery Sheath 14 Fr 9-13 Fr (13)/-14F 8-10 (9)
Deep seating of delivery catheter
Required Not required Not required
Backward bounce of the device
No Yes/no No
Recapture and Repositioning
Limited possible Full
* Cited from Dr. Jai-Wun Park presentation in CIT 2016
Modified implantation technique for patient with dense SEC
• This technique is recommended for patients with:– dense SEC
– Possible LAA thrombus
• Modified steps– No LAAangiogram
– No stiffwire, delivery sheath or pigtail in LAA (no touch technique)
– TEE for sizing and guidance during implantation
– Umbrella partially opens outside LAA
– Sheath rotation (usu counter-clockwise) to engage LAA to complete umbrella deployment
Standard vs. Modified Techniques
1. Device
Deployment in
proximal LAA
2. Partial Device
Deployment in LA
ard Ana om
• Gender: Male
• Age: 71
• CHA2DS2-VASc score: 3
• HASBLED score: 2
• Parox AFib
• LAmbre device size: 24/30
• Landing zone: 10
• Delivery sheath: 8F
• LAA lobe: 1
Patient: Single Lobe with Thrombus in LAA
Patient: Single Lobe with Thrombus in LAA
Patient: Single Lobe with Thrombus in LAA
Patient: Single Lobe with Thrombus in LAA
LAMBRE OCCLUDER: CONVENTIONAL APPROACH
LAMBRE OCCLUDER: CONVENTIONAL APPROACH
Comparisons with other 2 devices
Rates for Implant Success and severe procedural-related complications
* The only exclusion criteria was the presence of LAA thrombus, no other anatomical exclusion criteria (i.e. patients with small, large or shallow LAA all included)
** Cited from Dr. Jai-Wun Park presentation in CIT 2016
PROTECT-AF ACP Retrospective European Registry
LAmbre Global Study
No of patients(time of follow-up)
463(7 days within
procedure)
143(
0%
3%
6%
9%
12%
15%
18%
21%
24%
27%
30%
thrombus inFU Tamponade P effusion Minor leak (
EASY AND SAFE
TO USE✓ Adapt to various LAA anatomies
✓ Stable Anchoring
✓ Fully retrievable and
repositionable within LAA
✓ Low profile
✓ Rapid Endothelialization
LAmbreTM LAA Closure System
Combined Cryoablation and LAA Closure
Fassini G,…Tondo C, Europace 2016
Potential conflicts of interest
Speaker’s name:
▪ I have the following potential conflicts of interest to report:
Question
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