LAmbre LAA Occluder Updates...LAmbre device is feasible with high success rate in healthy dogs and...
Transcript of LAmbre LAA Occluder Updates...LAmbre device is feasible with high success rate in healthy dogs and...
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Yat-yin LAM MBBS MRCP FHKCP FHKAM FESC FRCP FACC MD
Associate Professor, Prince of Wales Hospital, The Chinese University of Hong Kong (CUHK) President, Hong Kong Society of Congenital and Structural Heart Disease (HKCASH)
LAmbre LAA Occluder Updates
4th Asia Pacific Congenital & Structural Interventional Symposium
6th June, 2013 Hong Kong
Conflicts of Interest: Consultant/Proctor of SJM, Boston Sci. and Lifetech Sci.
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Characteristics 1. Two parts : LA Cover and Umbrella. “An Umbrella in LA Appendage ” 2. TiN-coated LA cover which promotes faster endothelialization. 3. Recessed hub to reduce delayed thrombus formation. 4. Specially-designed umbrella/hooks for multiple recapture and repositioning. 5. A distal membrane to seal the appendage if the cover fail to do so. 6. Only smaller sheaths (8-10Fr, Sizes 16-36mm) required.
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5mm
landing zone landing zone5m
m
landing zone5m
m landing zone5m
m
landing zonelanding zonelanding zone
-> Opening up the umbrella at proximal LAA -> Distal positioning of delivery catheter is not required!
Procedural Steps
Lam YY. A new left atrial appendage occluder (Lifetech LAmbreTM Device) for stroke prevention in atrial fibrillation. Cardiovasc Revasc Med 2013; 14:134-6
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Umbrella partially opened
Umbrella fully opened
LA cover deployed
Umbrella Just opened
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Limitations of Current LAA occluders WATCHMAN ACP LAmbre
Device Design
Leak More likely Less likely Less likely
Dependence on LAA depth
YES No No
Delivery Sheath 14 Fr 9-13 Fr (13) 8-10 (9)
Procedural control
Deep seating of delivery catheter
Required Not required Not required
Backward bounce of the device
No Yes No
Recapture and Repositioning
Limited Limited Full
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16-36mm
Cover 4-6mm larger
16-26mm
Cover 12mm larger
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The feasibility and safety of this device was initially tested in a canine model (June 2011 – Aug 2012, Lam YY et al, Int J Cardiol 2013 Epub )
19 human implants (Part of ongoing Asian Registry – China, Vietnam, Indonesia) were then performed successfully (Oct 2012 – May 2013)
New Centers for CE study (Hong Kong – Q3 2013; Germany – Q4 2013 or Q1 2014)
CFDA study in China - Q1 2014
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June 2011 to Aug 2012
Gateway Medical Innovation Center, Shanghai (GLP-like)
22 dogs (28±3kgs) with LAmbre implants
Procedure: Transseptal puncture, Antibiotics 1 week, Aspirin 4 weeks
Echo follow up: – Immediate post-implant, D3, before sacrifice
Sacrificed in groups: Day 1-3 (n=5), 1- (n=7), 3- (n=4) & 6-months (n=6) for gross and microscopic examinations
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Feasibility: Achievement of acute procedural success (proper and stable implant in LAA without peri-implant leakage or impingement on surrounding cardiac structures)
Safety: Occurrence of clinical events related to heparin/aspirin (bleeding events) or procedure (catheter-related thrombus formation, air embolism, pericardial effusion, implant embolization, procedural-related transient ischemic attack, stroke or death)
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All devices successfully implanted, retrieved and re-implanted in all dogs
Implant size 24±3mm (36±7% oversizing)
Complete LAA sealing at 3 months
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Aggressive Tug Test !!!
3 Anchoring Mechanisms: • Hooks • Individual frames • Stenting effect of the over-sized umbrella
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3 Months 1 Month Day 1
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3 Months 1 Month Day 1
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Oct 2012 – May 2013
Hanoi (n=1), Jakarta (n=14), Beijing (n=3), Wuhan (n=1)
Aged 64±10; 68% Male
CHA2DS2-VASc: 3.4±1.4
HAS-BLED: 2.2±1.3
Acute procedural success: 100%
Significant Peri-device leakage (color-Doppler width≥3mm): 0%
Procedural(min): 56±18; Fluoro(min): 11±3
LZ diameter(mm): 20.5±4.0; Device size(mm): 26.2±3.6
Complication(s): 1 air-embolism, no pericardial effusion or device embolization
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Routine case
Large Appendage
Isolated Disc Repositioning
Sandwich Technique
Small Appendage
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30mm 35mm
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30mm 35mm
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Un-compressed umbrella
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10.4mm
10.2mm
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16-26mm
Cover 12mm larger
10.4mm
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Our preliminary data suggested LAA occlusion with LAmbre device is feasible with high success rate in healthy dogs and 19 humans.
Main advantages of this device include small delivery system, ease of use and the ability to be fully retrievable and repositionable during implantation.
Human trials with this novel device are underway.