Preclinical evaluation of a new left atrial appendage occluder (Lifetech LAmbre (TM) Device) in a canine model


Lam Y., Yan B. P. , Doshi S. K. , Lİ A., Zhang D., KAYA M., ...Daha Fazla

INTERNATIONAL JOURNAL OF CARDIOLOGY, cilt.168, ss.3996-4001, 2013 (SCI İndekslerine Giren Dergi) identifier identifier identifier

  • Cilt numarası: 168 Konu: 4
  • Basım Tarihi: 2013
  • Doi Numarası: 10.1016/j.ijcard.2013.06.083
  • Dergi Adı: INTERNATIONAL JOURNAL OF CARDIOLOGY
  • Sayfa Sayıları: ss.3996-4001

Özet

Objectives: The study evaluated the feasibility and safety of a novel left atrial appendage (LAA) occluder (LAmbre (TM), Lifetech Scientific Corp., China) in canines.

Objectives:

 

The study evaluated the feasibility and safety of a novel left atrial appendage (LAA) occluder (LAmbre,

Lifetech Scienti

 

fic Corp., China) in canines.

Background:

 

Transcatheter LAA occlusion is comparable towarfarin in preventing atrial fibrillation-related strokes.

Methods:

 

Twenty-two healthy dogs (28 ± 3 kg) received LAmbre implants. The device is delivered by an

8

 

10 French sheath and has full recapture and repositioning capabilities. All dogs received 1-week antibiotics

and 4-week aspirin (80 mg daily) after implants and they were sacri

 

ficed in groups at Days 13

(n = 5), 1- (n = 7), 3- (n = 4) and 6-months (n = 6) for pathological examinations. Transthoracic

echocardiography (TTE) was performed immediately after implant, at Day 3 and before sacri

 

fice.

Results:

 

The LAmbre was successfully implanted, retrieved, repositioned and re-implanted in all dogs. The

mean implant size was 24 ± 3 mm and the device chosen was 36 ± 7% larger than the measured landing

zone diameter. Improper device selection (only 21% oversizing) resulted in dislodgement and death of 1

dog on Day 3. Post-implant angiography and TTE showed well-positioned device without pericardial

effusion or impingement on surrounding structures. Late complications included device-related thrombus at

1 month (n = 1) and clinically insigni

 

ficant pericardial effusion at Day 3 (n = 1). Complete healing on the atrial

facing surface with optimal LAA obliteration was con

 

firmed by gross andmicroscopic examinations in dogs that

have been followed up

 

3 months (n=10). No infarctwas detected inmajor organs.

Conclusions:

 

Our preliminary data suggested the LAmbredevice is feasible with high success rate in canines.

Further studies are needed to evaluate its safety and ef

 

ficacy.