Centers of Excellence in Interventional Cardiology and Radiology

INTERVENTIONAL CARDIOLOGY

Watchman procedure for Atrial Fibrillation

We are the only center in Romania that perform the procedure!

Our center has saved the lives of over 4,500 patients in the last 4 years

The most modern equipped angiography room , an exceptional medical team

We are the first center in our country that performed this procedure!

The only treatment without the need for open surgery!

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Generalities

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia affecting over 6 million people worldwide, mainly those ages 65 and older. As the population continues aging, that number is expected to rise. Atrial fibrillation is the irregular, chaotic beating of the upper chambers of the heart. Episodes of AF may last a few minutes or several days.

Atrial fibrillation is associated with medical conditions such as coronary artery disease, high blood pressure, or an overactive thyroid. Sometimes there is no identifiable cause.

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Atrial fibrillation is not itself life threatening. Treatment depends on the symptoms patients are experiencing and the underlying medical conditions. It may include rate or rhythm controlling drugs to stabilise the heart rate, electrical cardioversion to restore the normal heart rhythm, or ablation techniques that isolate the electrical circuits that may be triggering episodes of Atrial fibrillation.

The most serious consequence of AF is ischaemic stroke. It is estimated that up to 20% of all strokes are related to AF. Most AF patients, regardless of the severity of their symptoms or frequency of episodes, require treatment to reduce the risk of stroke.

In patients with AF, blood tends to pool and form clots in an area of the heart called the left atrial appendage (LAA). The LAA is a pouch-like extension located in the upper left chamber of the heart. A blood clot that breaks loose from this area may migrate through the blood vessels and eventually plug a smaller vessel in the brain or heart resulting in a stroke or heart attack. Clinical studies show that the majority of blood clots in patients with Atrial fibrillation are found in the LAA.

Because of this growing prevalence there is an increased urgency to the search for additional ways of preventing stroke, the most devastating complication of AF. The Watchman® Left Atrial Appendage (LAA) Closure Technology device may offer a new option for stroke prevention.

Symptoms49

The symptoms of AF vary from mild fatigue to dizziness to chest pain or difficulty breathing. Some patients feel their heart palpitating: while others are unaware of the change in heart rate.

Diagnosis

Atrial fibrillation (AF) is diagnosed based on your medical and family histories, a physical exam, and the results from tests and procedures.

Sometimes AF doesn’t cause signs or symptoms. Thus, it may be found during a physical exam or an electrocardiogram (EKG) test done for another purpose. If you have AF, your doctor will want to find out what is causing it. This will help him or her plan the best way to treat the condition.

Your doctor will do a complete cardiac exam. He will listen to the rate and rhythm of your heartbeat and take your pulse and blood pressure reading. Your doctor will likely check for any signs of heart muscle or heart valve problems, will listen to your lungs to check for signs of heart failure. Your doctor also will check for swelling in your legs or feet and look for an enlarged thyroid gland or other signs of hyperthyroidism (too much thyroid hormone).

Blood tests check the level of thyroid hormone in your body and the balance of your body’s electrolytes.

An EKG is a simple, painless test that records the heart’s electrical activity. It’s the most useful test for diagnosing AF. An EKG shows how fast your heart is beating and its rhythm (steady or irregular). A standard EKG only records the heartbeat for a few seconds. It won’t detect AF that doesn’t happen during the test. To diagnose paroxysmal AF, your doctor may ask you to wear a portable EKG monitor that can record your heartbeat for longer periods –Holter monitor wich records the heart’s electrical activity for a full 24- or 48-hour period). You wear the Holter monitor while you do your normal daily activities. This allows the monitor to record your heart for a longer time than a standard EKG.

Transthoracic Echocardiography shows the size and shape of your heart and how well your heart chambers and valves are working;it can also identify areas of poor blood flow to the heart, areas of heart muscle that aren’t contracting normally, and previous injury to the heart muscle caused by poor blood flow. It’s painless and noninvasive (no instruments are inserted into the body).

Transesophageal echocardiography (TEE) uses sound waves to take pictures of your heart through the esophagus. The esophagus is the passage leading from your mouth to your stomach.Your heart’s upper chambers, the atria, are deep in your chest. They often can’t be seen very well using transthoracic echo. Your doctor can see the atria much better using TEE. During this test, the transducer is attached to the end of a flexible tube. The tube is guided down your throat and into your esophagus. You’ll likely be given medicine to help you relax during the procedure. TEE is used to detect blood clots that may be forming in the atria because of AF.

A chest X-ray is a painless test that creates pictures of the structures in your chest, such as your heart and lungs. This test can show fluid buildup in the lungs and signs of other AF complications.

Indications

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Despite its proven efficacy, anticoagulation therapy is not well-tolerated or may be difficult to control in many patients. Recently, a device based alternative to the long term use of anticoagulants has been developed and studied.

In patients with AF, blood tends to pool and form clots in an area of the heart called the left atrial appendage (LAA). If a blood clot breaks loose it may migrate through the blood vessels and cause a stroke. Everyone has an LAA, it is a pouch-like extension located in the upper left chamber of the heart. The LAA is about the size of a thumb and has a narrow opening into the left atrium. Since the majority of blood clots are found in the LAA, by closing it off, it is believed that it may reduce the risk of stroke and potentially eliminate the need for long term anticoagulanttherapy.

The WATCHMAN LAA Closure Technology is a device alternative to anticoagulant therapy in patients with non-valvular atrial fibrillation. Patients with AF are at a significantly greater risk of having a stroke due to migration of clots that may form in the LAA. By closing off the LAA, the WATCHMAN Technology is designed to reduce the risk of stroke, cardiovascular death and systemic embolisation, potentially eliminating the need for long term anticoagulant therapy. The elimination of anticoagulation may result in a reduction of bleeding related events such as bruising, nose bleeds, gastrointestinal bleeding, or more importantly, haemorrhagic strokes.

Procedure

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The Watchman device is inserted through a minimally invasive catheterization procedure.

The device is meant to capture blood clots and prevent them from migrating into the circulation and causing a stroke.

The WATCHMAN LAA Closure Device placement procedure may be done under local or general anaesthesia in a catherisation laboratory setting using a standard transseptal technique.

Prior to starting the procedure, a transesophageal echocardiogram (TEE) is performed to document the absence of thrombi within the LAA and to determine the appropriate sized WATCHMAN device to be implanted. The recommended international normalized ratio should be ≥ 1.5 to perform the implantation procedure.

Thus, after local asepsy and proper anticoagulation, a small inguinal incision is made. Through this incision, the physician will introduce a small narrow tube into the femoral vein, then through this tube a guidewire and vessel dilator will be introduced directly to the the heart, under fluoroscopic control (X ray control).

The radiologist uses the X-ray equipment to make sure that the catheter and the guide-wire are moved into the right position. A small amount of special dye, called contrast medium, is injected down the catheter to check the right position. Using TEE, the mid to lower part of the posterior septum is identified. This is the optimal place for transseptal crossing. Serial angiograms are performed in main to check the right position.

After the inter-atrial septum is crossed using a standard transseptal access system, the WATCHMAN Access Sheath and Dilator are advanced over a guidewire into the left atrium. The Access Sheath is then carefully advanced into the distal portion of the LAA over a pigtail catheter. Select the appropriate sized WATCHMAN device based on the TEE measurements taken.

The WATCHMAN Delivery System is prepped, inserted into the Access Sheath, and slowly advanced under fluoroscopic guidance. The WATCHMAN Device is then deployed into the LAA. The device release criteria are confirmed via fluoroscopy and prior to releasing the Device. Once the device has been deployed, use fluoroscopy and TEE to confirm the device release criteria have been met. If there is a gap or jet around the device that is larger than 5 mm, the device should be repositioned or fully recaptured and replaced. After release, perform angiography with contrast dye to document that the device is still in place. Then, using TEE, recheck the size and seal. Remove the sheath assembly from the left atrium.

WATCHMAN Device is placed at the opening of the LAA

The Watchman Device

The WATCHMAN Device is a self-expanding nitinol frame structure with fixation barbs and a permeable polyester fabric that covers the atrial facing surface of the device. The device is preloaded within a delivery catheter. The WATCHMAN Device is available in 5 sizes to accommodate the unique anatomy of each patient’s LAA

Is it painful?

No, is not a painfull procedure, because it is done under local or general anaesthesia.

How long does it take?

The procedure usually lasts about an hour and the patient is typically in the hospital for 24 hours following the procedure.

Risks

The complications are reduced by the proper preparation and the continuous surveillance of the patient. Potential complications:

  • allergic reactions to administered substances, including renal disfunction
  • reactions to anesthetic compounds
  • arteriovenous fistulas at the vascular puncture site
  • minor bleeding at the vascular puncture site, haematoma
  • fever
  • headache, migraine
  • infection
  • gaseous embolism
  • device embolization
  • pericardial effusions.

Before procedure

The preoperative assessment will establish if the interventional treatment is the best option for you.

Tell your doctor yf you’re pregnant.

Prior to the intervention, your doctor must be prevented about any history of allergic reactions. Blood tests are taken including hemoglobin level, coagulation, renal function, and other specific tests.

Your doctor will explain the procedure to you and offer you the opportunity to ask any questions that you might have about the procedure. You will be asked to sign a consent form that gives permission to do the procedure.

Notify your doctor if you are sensitive to or are allergic to any medications, latex, iodine, tape, contrast dyes, and anesthetic agents (local or general).

Based on your medical condition, your doctor may give you other specific preparation instructions.

After procedure

You will be taken back to the recovery area on a trolley and be able to sit up. You will be given pain medication for incisional pain. The nurses will carry out routine observations, such as taking your pulse and blood pressure, to make sure that there are no untoward effects. They will also look at the skin entry point to make sure there is no bleeding from it. You will generally stay in bed for a few hours, until you have recovered when you will be allowed home.

Since the procedure is minimally invasive, the postprocedural recovery is usually very fast. The majority of patients can leave the hospital the following day. Indications about recovery and postprocedural treatment will be clearly specified to all patients.

Anticoagulation with Sintrom and antiagregant treatment with aspirin for a minimum of 45 days following the implant procedure (internal normalized ratio (INR) 2.0-3.0) are recommended. Antibiotic prophylaxis is also recommended when needed. (endocarditis prophylaxis for 6 months following implantation; e.g stomatologic procedures).

At 45 days, assess the WATCHMAN device placement using TEE. Cessation of anticoagulation is at physician discretion, if the LAA is closed completely and thrombus on the device was ruled out. If flow is noted around the device greater than 5 mm, consideration should be given to keep the patient on Sintrom until it has decreased to less than 5 mm.

Patients ceasing warfarin should begin clopidogrel 75mg and aspirin daily through 6 months post-implant and continue taking aspirin daily indefinitely.

Important!

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While a number of epicardial left atrial appendage closure devices are available, Watchman is unique because it is placed inside the left atrial appendage.

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