Alert: Patients with Lariat Device for Left Atrial Appendage Closure
By Steve S. Ryan, PhD, February 2015
If you’ve had your Left Atrial Appendage (LAA) closed off using the Lariat device from SentreHeart, Inc., you must schedule follow-up tests at 3 months and one year intervals to check for total LAA closure with no gaps or leakage. Talk to your doctor about a TEE (Trans-esophageal Echocardiogram) or preferably a 3-D TEE. In a small number of reported cases the Lariat failed to fully seal off the LAA allowing tissue remnants to loosen, enter the blood stream and cause clot and stroke. (See Shannon Dickson’s first-hand story below.)
The Lariat Device
When closing off the Left Atrial Appendage (LAA), surgeons may use the Lariat II device, a noose-like device which is slipped around this small pocket of heart tissue. The ‘lasso’ is then tightened, and eventually the tissue dies and shrivels up like a grape. In effect, the Lariat II chokes off the LAA and eliminates it as a source of A-Fib signals. (For more on the Lariat see my article: Tech & Innovations: Lariat II.)
The Problem: The ‘Gunny-Sack’ Effect
In what is described as “the gunny-sack effect”, the LAA heart tissue between the lariat lasso atrophies and becomes thinner. As with a gunnysack, the multiple tight folds begin to loosen and unravel slightly leaving a hole. If the hole is large enough, blood may flow into and out of the dead LAA possibly carrying with it dead (necrotic) tissue remnants into the blood stream. These dead tissue remnants can cause clots and strokes. Normal blood thinners don’t work on them. Any hole over 2mm can create such leaks. It’s estimated that holes greater than 2mm occur in 6% of Lariat cases, but not all cause clots and strokes. The number of clot/strokes (embolic events) reported so far is very small compared with around 2,500 total Lariat cases worldwide to-date.
Easily Fixed if Discovered
Once this hole or leak is discovered, it’s relatively easy for your surgeon to fix by closing it off with an Amplatzer Atrial Septal Occluder, an Amplatzer Duct Occluder II, or a Gore Helix Septal Occluder.
Lariat II – Should Include Short-Term Anticoagulation
And even when the LAA is completely closed off, there is still a small chance (around 2%) of clots forming inside the heart at the LAA closed off location primarily during the first 4-8 weeks. This is probably related to tissue inflammation and blood platelet “clumping” at the site. It’s therefore important for you and your doctor to consider short term anticoagulation for 6-8 weeks to reduce the risk of clot forming at the closure site. (For those patient who can not take oral anticoagulation or antiplatelet agents, there will be a small temporary risk of stroke at the LAA site while the area heals.)
Shannon W. Dickson: Tells of Clots and a Stroke After Lariat II Installed
If you’d like to read a well-written first-person account of someone who experienced clots and a stroke after having a Lariat occluder installed, Shannon W. Dickson published his experience in The AFIB Report, Number 133, August/September 2014.
(Shannon Dickson says he got the Lariat II because his A-Fib was producing loads of spots in his LAA. Even after an LAA isolation ablation a year earlier (effectively disconnecting electrically from the LAA), Shannon chose the added reassurance a successful Lariat ligation can bring. Permanently removing the LAA from the ‘AFIB/Flutter equation’ insures his LAA could never again reconnect and be a source of more arrhythmia.)
Shannon is the new managing editor of The AFIB Report; a one-year subscription to The AFIB Report is $29.00.
Don’t let this risk of a leak and stroke scare you away from having a Lariat device installed if you need it. If a hole or leak does form, and it’s discovered, it’s very easily fixed. Just make sure your doctors check for leaks!
Last updated: Friday, October 14, 2016