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.

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.

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

Umbrella partially opened

Umbrella fully opened

LA cover deployed

Umbrella Just opened

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

16-36mm

Cover 4-6mm larger

16-26mm

Cover 12mm larger

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

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

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)

All devices successfully implanted, retrieved and re-implanted in all dogs

Implant size 24±3mm (36±7% oversizing)

Complete LAA sealing at 3 months

Aggressive Tug Test !!!

3 Anchoring Mechanisms: • Hooks • Individual frames • Stenting effect of the over-sized umbrella

3 Months 1 Month Day 1

3 Months 1 Month Day 1

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

Routine case

Large Appendage

Isolated Disc Repositioning

Sandwich Technique

Small Appendage

30mm 35mm

30mm 35mm

Un-compressed umbrella

10.4mm

10.2mm

16-26mm

Cover 12mm larger

10.4mm

http://www.google.com.hk/url?sa=i&rct=j&q=baby+playing+a+ball&source=images&cd=&cad=rja&docid=nd6lTTfpcm98FM&tbnid=7UlnSyzwsaoWWM:&ved=0CAUQjRw&url=http://wallpapers-mobilewallpapers.blogspot.com/2010/10/kutties-hq-wallpapers-kutties-funny.html&ei=OPbLUdzjDMWbtAap1oFY&psig=AFQjCNGZMSa6RZCODab26i5csDhfH6zXXA&ust=1372407670114683

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.