Left Atrial Appendage Closure

Stroke is a serious risk for patients with atrial fibrillation, atrial fibrillation is an
irregular heart rhythm arising from the upper chambers of the heart called the
Atria. Normally, the atria act as priming chambers for the pumping of the
heart. When functioning normally, the atria contract at the normal rate of 60-90
beats a minute and work in sync with the lower chambers to fill the lower chambers.

When Atrial Fibrillation develops this normal synced contraction patter goes afoul.
The upper chambers no longer have a well-developed contraction process. They
shake and quiver chaotically at rates up to 600 per minute.

Blood flow in the upper chambers stagnates. Rather than moving forward quickly,
the blood swirls about and often moves much like a slow moving cloud of smoke.

Indeed this is what cardiologists have named this slow flow. We call it "smoke"• or
the more precise medical term is "Spontaneous Echo Contrast."• The red blood
cells are moving so slowly that they can actually be visualized by the ultrasound
machine on a Trans-esophagel Echocardiogram (TEE). Blood often tends to swirl,
clump, and clot in this chamber. Indeed, it is commonly the source of a blood clot
that forms a stroke.

In the majority of cases, the clots form in the left atrial appendage (LAA), a small,
pouch like sac in the top left chamber of the heart. If the clots travel through the
arteries in the heart, they can cause a stroke. People with atrial fibrillation are 5 to 7
times more likely to have a stroke than the general population.

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Taking a blood thinner, such as warfarin (Coumadin), reduces the risk of stroke in
patients with atrial fibrillation. Many patients have concerns about, or dislike, taking
warfarin. Some of the reasons for this are:

• Frequent blood draws are needed to measure the patient’s international

normal ratio (INR), or clotting time. The tests are needed to make sure the
patient takes the right amount of medication.
• While taking warfarin, patient needs to limit intake of certain foods that contain
vitamin K.
• The risk of bleeding is higher while taking warfarin.
• Some patients do not tolerate warfarin or have trouble maintaining a normal
INR.

New medications are available for patients with atrial fibrillation who do not have
heart valve disease. These medications are dabigatran (Pradaxa) and rivaroxaban
(Xarelto). However, like warfarin, some patients have concerns and problems with
these medications, such as:

• Patients who cannot take anticoagulants cannot tolerate these medications.

• Some patients are concerned about the cost of the medication.
• These medications also increase the risk of bleeding.

Studies have shown that, among patients who do not have valve disease, the
majority of blood clots that occur in the left atrium start in the LAA.

Who is likely to form a blood clot?

Cardiologists assign risk using something called the C.H.A.D.S. Score. If patient
has any history of congestive heart failure, has high blood pressure (hypertension),
age greater than 75 years old, diabetes, or if patient has a history of previous stroke,
transient ischemic attack, or has had an embolism- patient is at increased risk.

- C- Congestive heart failure (any history)- 1pt.

- H- Hypertension (prior history)- 1 pt.
- A- Age > 75 years- 1 pt.
- D- Diabetes- 1 pt.
- S- Secondary prevention in patients with ischemic stroke, TIA, or systemic
embolic event- 2 pts

The risk of an abnormal CHADS score in Atrial Fibrillation is the following:

1. 0 Score: low risk for ischemic stroke or peripheral embolization. Can be

managed with aspirin.
2. 1-2: are at intermediate risk (1.5-2.5 % risk of stroke per year) If prior
ischemic stroke, TIA, or systemic embolization to be at high risk
recommended to be on warfarin.
3. >2 or = 3: are at high risk (5.3-6.9% risk of stroke per year) and should in
treated with warfarin, unless there is a specific reason
not to be on these medications- such a bleeding, or prior
hemorrhagic stroke.

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Closure of Left Atrial Appendage

There are at risk of developing clots in the left atrium/LAA, the doctor may
recommend a procedure to seal off the LAA. This can reduce the risk of stroke and
eliminate the need to take blood-thinning medication.

There are several options and devices available for closure of the LAA.

WATCHMAN Device

WATCHMAN offers an alternative to the lifelong use of warfarin for people with atrial
fibrillation not caused by a heart valve problem (also known as non-valvular AFib).

This permanent heart implant effectively reduces the risk of stroke—without the risk
of bleeding that can come with the long-term use of warfarin (the most common
blood thinner). In addition, WATCHMAN can eliminate the regular blood tests and
food-and-drink restrictions that come with warfarin.

The WATCHMAN Device is a parachute-shaped, self-expanding device that closes

the LAA. It was tested in several studies that showed the device was a good
alternative treatment for patients who cannot tolerate treatment with warfarin.

The WATCHMAN device is implanted percutaneously (through the skin) in the

electrophysiology (EP) lab. The implant procedure does not require surgery;
however, general anesthesia may be used during the procedure. A catheter sheath
is inserted into a vein near the groin and guided across the septum (muscular wall
that divides the right and left sides of the heart) to the opening of the LAA. The
device is placed in the opening of the LAA. This seals off the LAA and keeps it from
releasing clots.

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Some important information about the WATCHMAN procedure:

• in the hospital overnight after the procedure.

• need to take aspirin and warfarin until the next follow-up appointment.
• have a transesophageal echo (TEE) within 48 hours of the procedure.
• first follow-up appointment is 45 days after the procedure. During this time,
heart tissue will grow over the implant to form a barrier against blood clots.
Another TEE will be done at this appointment. If the TEE shows that the LAA
is blocked, stop taking warfarin and start taking clopidogrel (Plavix) for 6
months. After 6 months, stop taking clopidogrel, unless need to take it for
another reason. To continue daily treatment with aspirin.
• If the TEE shows that the LAA is not blocked, continue taking warfarin and
have another TEE and follow-up appointment after 6 months.
• once the LAA is blocked, yearly follow-up appointment in the clinic.
• an echocardiogram (echo) within 60 days of the procedure.

LARIAT procedure

The LARIAT procedure is a percutaneous approach to immediate and complete left

atrial appendage (LAA) closure without the need to leave an implant inside of the
heart. Using an innovative approach to remote suture delivery, the LARIAT is
precisely placed around the base of the LAA through a 13F SofTIP guide cannula
using standard imaging techniques. There is no grasping or manipulation of the
fragile LAA tissue and the closure location may be optimized with the ability to re-
open the LARIAT snare as often as needed without deployment of the suture.

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HOW IT WORKS

1. During the procedure, you will be under anesthesia or sedation. Using x-ray
guidance, two small catheters will be positioned at the LAA. One will be on the inside
and the other on the outside to ensure ideal placement of the LARIAT suture.

2. Using small guide wires that are connected with magnets, the LARIAT will be
advanced to the base of the LAA from the outside. Once in position, your
doctor will close the LARIAT and release the suture that will tighten and close
off the LAA.

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 3. After closure of the LAA, the LARIAT and the guide wires will be removed,
leaving nothing behind inside of your heart. Only a small piece of suture will
remain at the base of the LAA on the outside. Closure will be immediate and
complete at the end of the procedure.

4. Over time, the LAA will shrink away and disappear due to the closure
eliminating blood flow to the LAA. As a result, the LAA will no longer ever be a
risk as a source of blood clots.

Benefits of the Lariat Procedure

For patients who qualify for the procedure based on their inability to take blood
thinners, the Lariat procedure offers many benefits. First and foremost is the drastic
reduction in blood clot and stroke risk. However, patients can also expect additional
benefits such as:

• A permanent, one-time solution for AFib-related blood clots

• A minimally invasive procedure posing little to no risk
• Minimal post-procedure discomfort
• No need for the frequent follow-ups or tests associated with blood thinner
medications

Complications:

Although the risk of device embolization is averted with epicardial LAA ligation,
obtaining pericardial access for the LARIAT procedure is associated with its own
inherent risks, including

• Chest pain
• Pericarditis
• Pericardial effusion
• Right ventricular puncture
• Epicardial vessel injury
• Sheath-related trauma

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