LAmbre LAA Occluder Updates 4 th Asia Pacific Congenital & Structural Interventional Symposium 6 th June, 2013 Hong Kong 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) 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.
Procedural Steps 5mm landing zone 5mm landing zone 5mm landing zone 5mm landing zone landing zone landing zone landing zone -> Opening up the umbrella at proximal LAA -> Distal positioning of delivery catheter is not required! Lam YY. A new left atrial appendage occluder (Lifetech LAmbre TM Device) for stroke prevention in atrial fibrillation. Cardiovasc Revasc Med 2013; 14:134-6
Umbrella Just opened Umbrella partially opened Umbrella fully opened LA cover deployed
Limitations of Current LAA occluders Device Design Dependence on LAA depth WATCHMAN ACP LAmbre Leak More likely Less likely Less likely YES No No Delivery Sheath 14 Fr 9-13 Fr (13) 8-10 (9) Procedural control Deep seating of delivery catheter Backward bounce of the device Recapture and Repositioning Required Not required Not required No Yes No 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 (GLPlike) 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
Day 1 1 Month 3 Months
Day 1 1 Month 3 Months
Oct 2012 May 2013 Hanoi (n=1), Jakarta (n=14), Beijing (n=3), Wuhan (n=1) Aged 64±10; 68% Male CHA 2 DS 2 -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
10.2mm 10.4mm
16-26mm Cover 12mm larger 10.4mm
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.