Centers of Excellence in Interventional Cardiology and Radiology

INTERVENTIONAL CARDIOLOGY

Percutaneous Treatment of Mitral Regurgitation – MitraClip

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

Valves of the heart

The heart is a pump made of muscle tissue. The heart has four pumping chambers: two upper chambers, called atria, and two lower chambers, called ventricles. The right atrium pumps blood into the right ventricle, which then pumps the blood into the lungs where carbon dioxide is given off and oxygen is taken into the blood.

From the lungs, the blood flows back into the left atrium, is pumped into the left ventricle, and then is pumped through the aorta out to the rest of the body and the coronary arteries. When the atria are pumping, the ventricles are relaxed in order to receive the blood from the atria. Once the atria have pumped their entire blood load into the ventricles, they relax while the ventricles pump the blood out to the lungs and to the rest of the body.48

In order to keep the blood flowing forward during its journey through the heart, there are valves between each of the heart’s pumping chambers:

Tricuspid valve – located between the right atrium and the right ventricle

Pulmonary (or pulmonic) valve – located between the right ventricle and the pulmonary artery

Mitral valve – located between the left atrium and the left ventricle

Aortic valve – located between the left ventricle and the aorta

If the heart valves become damaged or diseased, they may not function properly. Conditions that may cause dysfunction of heart valves are valvular stenosis and valvular insufficiency (regurgitation). When one (or more) valve(s) becomes stenotic (stiff), the heart muscle must work harder to pump the blood through the valve.

Mitral regurgitation

Mitral regurgitation (MR) is a condition in which the heart’s mitral valve leaflets do not close tightly. When this happens, blood flows backward from the heart’s left ventricle into the left atrium. The heart must then work harder to push blood through the body, which can cause fatigue, shortness of breath and worsening heart failure. It is the most common type of heart valve insufficiency.

Causes:

The MR causes are broadly classified as ischemic (due to consequences of ischemic heart disease) and non-ischemic. Non-ischemic causes include degenerative (myxomatous disease, leaflet degeneration, and annular calcification), endocarditic, rheumatic, and less common miscellaneous causes (congenital, cardiomyopathy-related, inflammatory, drug-induced, and traumatic).

The common causes of mitral regurgitation are mitral valve prolapse (MVP), ischemic heart disease, Marfan syndrome and rheumatic fever.

There are two types of mitral regurgitation: degenerative and functional. Degenerative mitral regurgitation, also called primary mitral regurgitation, is caused by damage to the mitral valve leaflets. Functional mitral regurgitation, also called secondary mitral regurgitation, is caused by enlargement of the heart due to heart attack or heart failure.

Symptoms

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Patients may be asymptomatic or presented with signs and symptoms of congestive heart failure such as shortness of breath and pulmonary edema.

Presentation of symptoms such as decreased exercise tolerance and palpitations suggest low cardiac output status. In the long run, condition can lead to complications like left ventricle dilation, atrial fibrillation and heart failure.

Signs and symptoms of mitral valve regurgitation depend on its severity and how quickly the condition develops. Mitral valve regurgitation signs and symptoms can include:

Blood flowing turbulently through your heart (heart murmur)

Shortness of breath, especially with exertion or when you lie down

Fatigue, especially during times of increased activity

Lightheadedness

Cough, especially at night or when lying down

Heart palpitations — sensations of a rapid, fluttering heartbeat

Swollen feet or ankles

Excessive urination

Mitral valve regurgitation is often mild and progresses slowly. You may have no symptoms for decades and be unaware that you have this condition.

Mitral valve regurgitation is often first suspected when your doctor hears a heart murmur. Sometimes, however, the problem develops quickly, and you may experience a sudden onset of severe signs and symptoms.

Diagnosis

Your doctor will do a complete cardiac exam. Mitral valve regurgitation usually produces a heart murmur. The murmur is the sound of blood leaking backward through the mitral valve.

An EKG is a simple, painless test that records the heart’s electrical activity. An ECG gives information about heart rhythm and, indirectly, heart size. With mitral valve regurgitation, the left ventricle may be enlarged and you may have heart rhythm irregularities (arrhythmias).

A Holter monitor is a portable device that you wear to record a continuous ECG, usually for 24 to 72 hours. Holter monitoring is used to detect intermittent heart rhythm irregularities that may be associated with mitral valve regurgitation.

Transthoracic Echocardiography the diagnostic test of choice, is usually necessary and sufficient to confirm the diagnosis of mitral regurgitation; it shows the size and shape of your heart and how well your heart chambers and valves are working. In some cases, your doctor may indicate a transesophageal echocardiography (TEE), for a proper diagnostic, wich uses sound waves to take pictures of your heart through the esophagus. The esophagus is the passage leading from your mouth to your stomach. 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.

A chest X-ray – a chest X-ray allows your doctor to evaluate the size and shape of your heart to determine whether the left ventricle is enlarged. Mitral valve regurgitation may result in blood backing up into your lungs, which causes congestion that’s visible on an X-ray.

Various exercise tests can help measure your tolerance for activity and check your heart’s response to exertion (exercise).

Cardiac catheterization. In this procedure, a doctor threads a thin tube (catheter) through a blood vessel in your arm or groin into your heart. The catheter is used to deliver dye into the heart chambers and the blood vessels of your heart. The dye, appearing on X-ray images as it moves through your heart, gives your doctors detailed information about your heart and heart valves. Some catheters used in cardiac catheterization have miniature devices (sensors) at the tips that can measure pressure within heart chambers, such as the left ventricle.

Indications

Mitral regurgitation (MR) is common worldwide and is increasing in prevalence. The standard of care for the treatment of significant MR is presently surgery. If feasible, mitral valve repair, rather than replacement, is the preferred treatment, offering lower rates of thromboembolism and infection, excellent durability, and increased survival. Surgery, even when effective, can be associated with significant morbidity and mortality, especially in the presence of advanced age or significant comorbidity. There is, therefore, a clear need for less invasive approache.

Medical: There are no medications indicated to treat mitral regurgitation, but there are medications used to manage patient symptoms.

Surgical: For symptomatic patients diagnosed with moderate-severe or severe MR, surgery is generally recommended to repair or replace the mitral valve. This typically involves open-heart surgery with the patient on cardiopulmonary bypass. Patients recovering from mitral valve surgery may take several months to regain normal physical function and activity.

Percutaneous mitral valve repair: The MitraClip procedure is minimally invasive and uses catheter-based technology. This new treatment expands the options for selected patients with MR. The treatment is designed to reduce MR, which may allow the heart to recover from overwork and improve function, potentially halting the progression of heart failure and enabling patients to live a higher-quality life.

Indication for percutaneous treatment (MitraClip):

Case selection is probably the most important determinant of success for the MitraClip procedure. All patients should have:

moderate or severe MR, as assessed formally by echocardiography

anatomical suitability, determined by transesophageal echocardiography (TEE)

the origin of the MR jet should ideally be from the central portion of the valve, although there have been case reports of successful MitraClip implants with MR arising from the commissures.

regardless of underlying aetiology, degenerative or functional, important anatomical prerequisites for MitraClip are a sufficient leaflet tissue for mechanical coaptation and resting mitral valve effective orifice area over 4 cm2, as there is an inevitable but small reduction in valve area on the transformation to a double orifice

important exclusions include rheumatic MR and calcified leaflets.

Procedure

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The MitraClip procedure is a catheterization lab procedure using fluoroscopy and echocardiographic guidance. TEE, especially 3D TEE is the most important imaging tool to guide the procedure.

Devices

MitraClip® is a catheter-based system consisting of a steerable guide catheter and the clip delivery system, which carries the MitraClip® device to be deployed at its distal end. The clip has two arms and a ‘gripper’ adjacent to each arm. Arms and grippers can be opened and closed separately to enable capture of the mitral leaflets between them.

The procedure is be done under general anaesthesia in a catherisation laboratory.

The hair at the catheter insertion site (groin area) is clipped off. You will be connected to an ECG monitor that records the electrical activity of the heart and monitors the heart during the procedure using small, adhesive electrodes. Your vital signs (heart rate, blood pressure, breathing rate, and oxygenation level) will be monitored during the procedure.

Then, after local asepsy and proper anticoagulation, a small inguinal incision is made. Once the local anesthetic has taken effect, a sheath, or introducer, will be inserted into the femoral vein. This is a plastic tube through which the catheter will be inserted into the blood vessel and advanced into the right atrium. Fluoroscopy (a special type of X-ray that will be displayed on a TV monitor) may be used to assist in advancing the catheter to the heart. Once the catheter is in place, contrast dye will be injected through the catheter into the valve in order to look at the area.

Then a transseptal puncture is a performed. Optimal TEE imaging is fundamental to this. Following successful transseptal puncture, intravenous heparin is administered.

A 0.035-inch Super Stiff exchange length guidewire is advanced through the transseptal catheter to the left upper pulmonary vein. The transseptal catheter is then removed and exchanged for the guide catheter. The MitraClip is then advanced through the guide catheter into the left atrium. With the help of TEE, the MitraClip is then orientated appropriately over the mitral valve. The clip is then opened and the arms are positioned perpendicularly to the leaflets using the TEE projection.

Once properly oriented, the clip is advanced to the left ventricle, and the CDS is then pulled back and the leaflets are grasped by dropping the grippers. After confirmation of adequate grasping of leaflets, the arms are closed and reduction in MR is assessed. If there is no significant change in MR, the clip is repositioned. On the other hand, if the reduction is adequate, the clip is deployed.

In cases of some residual MR on one side, a second clip can be deployed along side the first. In addition to assessment of MR, mitral valve gradients are checked periodically throughout the procedure to ensure that there is no iatrogenic mitral stenosis.

Groin hemostasis is achieved by manual compression.

Is it painful?

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

How long does it take?

The procedure usually lasts about an 1-2 hours.

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 catheter insertion site

• blood clot or damage to the blood vessel at the insertion site

• minor bleeding at the vascular puncture site, haematoma

• significant blood loss that may require blood transfusion

• fever

• headache, migraine

• infection at the catheter insertion site

• cardiac dysrhythmias or arrhythmias (abnormal heart rhythms)

• gaseous embolism

• stroke – the risk of transient ischemic attack and or cerebrovascular accident is minimized with routine preprocedural TEE to exclude left atrial thrombus.

• iatrogenig mitral stenosis – although clinically significant iatrogenic mitral stenosis has not been observed this remains a possibility, particularly with the use of multiple clips

• an iatrogenic atrial septal defect

• there was a significant postprocedural increase in transmitral gradient

• mitral valve surgery was subsequently performed due to an unsatisfactory reduction in MR.

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. If the insertion was in the groin, you will not be allowed to bend your leg for several hours.

You will generally stay in bed for a few hours, until you have recovered when you will be allowed home.

You will be encouraged to drink water and other fluids to help flush the contrast dye from your body.

Since the procedure is minimally invasive, the postprocedural recovery is usually very fast. You will most likely spend the night in the hospital after your procedure. Depending on your condition and the results of your procedure, your stay may be longer. You will receive detailed instructions for your discharge and recovery period.

Once at home, you should monitor the insertion site for bleeding, unusual pain, swelling, and abnormal discoloration or temperature change at or near the injection site. A small bruise is normal. If you notice a constant or large amount of blood at the site that cannot be contained with a small dressing, notify your doctor.

It will be important to keep the insertion site clean and dry. Your doctor will give you specific bathing instructions.

You may be advised not to participate in any strenuous activities. Your doctor will instruct you about when you can return to work and resume normal activities.

After repair, it is recommended to give aspirin for six months and some operators also administer clopidogrel for one month. Infective endocarditis prophylaxis is recommended.

Animal histopathologic studies demonstrated encapsulation of the device 3 months after implantation.

Important!

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The MitraClip is the only percutaneous technology effective in both functional and degenerative MR.

All patients showed rapid clinical improvement within a few days.

In summary, it is safe and effective to use this technique in patients with advanced age and/or extensive multimorbidity and/or severe heart failure. This combination of a high safety profile and sufficient efficacy in reducing mitral valve regurgitation may lead to MitraClip implantations even in acute and critically ill conditions.

DOCTORS
that perform the procedure

X
Sună Mesaj