Tricuspid Valve and much more

Question 1

Tricuspid Valve Leaflets

Answer 1

The tricuspid valve has three leaflets: the anterior, posterior and medial or septal leaflets. Together, these separate the right atrium from the right ventricle.

Question 2

Tricuspid Valve Systole and Dyastole

Answer 2

During systole, or muscle contraction, the tricuspid valve closes, and during diastole, or heart relaxation, the tricuspid valve opens and lets blood fill the right ventricle.

Question 3

Tricuspid valve regurgitation happens when…

Answer 3

Tricuspid valve regurgitation happens when the tricuspid valve doesn’t close completely and blood leaks back from the right ventricle into the right atrium.

Question 4

Tricuspid valve stenosis happens if…

Answer 4

Tricuspid valve stenosis happens if the tricuspid valve can’t open completely, making it difficult to fill the right ventricle.

Question 5

Tricuspid Valve Regurgitation causes

Answer 5

Often, regurgitation is due to pulmonary hypertension which causes an increase in right ventricular pressure. This pressure then dilates the tricuspid valve, allowing blood to go backward.

Another well-known cause of regurgitation is rheumatic heart disease, an autoimmune reaction that involves the valve leaflets and causes inflammation. This chronic inflammation leads to leaflet fibrosis, which makes it so that they don’t form a nice seal and instead let blood leak through.

Still another cause of tricuspid regurgitation is damage to the papillary muscles from a heart attack. If these papillary muscles die, they can’t anchor the chordae tendineae, which then allows the tricuspid valve to flop back and allows blood to flow backward from the right ventricle into the right atrium.

There are also congenital causes for this condition, like Ebstein’s anomaly, which is when a person is born with leaflets that are located too low, i.e., in the ventricle rather than between the atria and the ventricle, and this makes it hard for the leaflets to form a nice seal.

Question 6

When blood flows back into the right atrium during systole, ….

Answer 6

This movement of blood can be heard as a holosystolic murmur, because it’s possible to hear blood flowing through the valve for the duration of systole.

Another possible effect is Carvallo’s sign, which is when the murmur gets louder with inspiration, or inhalation. This happens because the negative pressure in the chest brings more blood back up into the heart, and more blood makes the murmur even noisier.

Question 7

When extra blood that flowed backward into the atrium during systole ends up draining right back into the ventricle during diastole, …..

Answer 7

This means there’s an increase in right ventricular preload. It’s kind of like if you were digging a hole and every time you shoveled some dirt out, half of it fell back in; that’s a lot of wasted work.

Eventually, to deal with this extra blood and the extra work required to pump it out, the right ventricle grows larger, a process called eccentric ventricular hypertrophy. In this situation, new sarcomeres are added in series to existing ones. This remodeling, or structural change, in the heart stretches the annulus, or ring of the valve, letting more blood leak back into the atrium and actually therefore worsening the regurgitation.

Question 8

The right ventricle might not be able to keep up with the backflow of blood, this leads to…

Answer 8

This can lead to right-sided heart failure, which causes symptoms like distended neck veins, swelling of the ankles and feet, and blood backed up to the liver, which causes hepatosplenomegaly, or swelling of the liver and spleen. Diagnosis is usually done with an echocardiogram, and treatment for tricuspid regurgitation is usually aimed at maintaining good fluid balance. Only rarely is valve repair or replacement needed.

Question 9

What is the main cause of Tricuspid Valve Disease?

Answer 9

The main cause of tricuspid regurgitation is an enlarged right ventricle. This may be caused by any disorder that causes right ventricular failure, such as increased pressure in the pulmonary artery. Damage to the tricuspid valve may be caused by rheumatic fever.

Question 10

What happens if the tricuspid valve fails?

Answer 10

Tricuspid regurgitation occurs when this valve doesn’t properly close. This can cause blood to flow back up into the right atrium when the right ventricle contracts. Over time, this condition can weaken your heart. Tricuspid regurgitation is also known as tricuspid valve insufficiency.

Question 11

What is the treatment for tricuspid valve regurgitation?

Answer 11

The tricuspid valve may be repaired during surgery to correct other leaky heart valves. Surgical repair of the tricuspid valve generally works better than replacing it. Surgery to replace the tricuspid valve by itself (not along with the mitral or aortic valve) is only recommended in rare cases.

Question 12

Does tricuspid regurgitation get worse?

Answer 12

When tricuspid regurgitation is severe it can lead to right sided heart failure and right-sided congestion. The degree of symptoms generally depends on how badly the right side of the heart is failing. In addition to shortness of breath, there can be weakness, swelling, liver dysfunction, fatigue and weight loss.

Question 13

Can you live without your tricuspid valve?

Answer 13

In fact you can do without a tricuspid valve and live; there was a surgeon that used to do tricuspid valvectomies for endocarditis. You don’t live well; you’ll eventually have to have the tricuspid valve replaced.

Question 14

What are the symptoms of a leaky tricuspid valve?

Answer 14

Tricuspid valve regurgitation often doesn’t cause signs or symptoms until the condition is severe. You may be diagnosed with this condition when having tests for other conditions.

Noticeable signs and symptoms of tricuspid valve regurgitation may include:

Fatigue
Declining exercise capacity
Swelling in your abdomen, legs or veins in your neck
Abnormal heart rhythms
Pulsing in your neck
Shortness of breath with activity
You may also notice signs or symptoms of the underlying condition that’s causing tricuspid valve regurgitation, such as pulmonary hypertension. Pulmonary hypertension symptoms may include fatigue, weakness, difficulty exercising and shortness of breath

Question 15

Does tricuspid regurgitation cause shortness of breath?

Answer 15

You may also notice signs or symptoms of the underlying condition that’s causing tricuspid valve regurgitation, such as pulmonary hypertension. Pulmonary hypertension symptoms may include fatigue, weakness, difficulty exercising and shortness of breath.

Question 16

What is the function of tricuspid valve?

Answer 16

The tricuspid valve is located between the right atrium (top chamber) and right ventricle (bottom chamber). Its role is to make sure blood flows in a forward direction from the right atrium to the ventricle

Question 17

Ebstein’s anomaly

Answer 17

In this rare condition, the malformed tricuspid valve sits lower than normal in the right ventricle, and the tricuspid valve’s leaflets are abnormally formed. This can lead to blood leaking backward (regurgitating) into the right atrium.

Tricuspid valve regurgitation in children is usually caused by heart disease present at birth (congenital heart disease). Ebstein’s anomaly is the most common congenital heart disease that causes the condition. Tricuspid valve regurgitation in children may often be overlooked and not diagnosed until adulthood.

Question 18

Infective endocarditis

Answer 18

The tricuspid valve may be damaged by an infection of the lining of the heart (infective endocarditis) that can involve heart valves.

Question 19

Carcinoid syndrome

Answer 19

In this rare condition, tumors that develop in your digestive system and spread to your liver or lymph nodes produce a hormonelike substance that can damage heart valves, most commonly the tricuspid valve and pulmonary valves.

Question 20

Implantable device wires (leads)

Answer 20

Pacemaker or implantable cardioverter-defibrillator wires can sometimes cause injury to the tricuspid valve during placement or removal of the implantable device.

Question 21

Endomyocardial biopsy

Answer 21

In an endomyocardial biopsy, a small amount of heart muscle tissue is removed and tested for signs of inflammation or infection. Valve damage can sometimes occur during this procedure.

Question 22

Blunt chest trauma

Answer 22

Experiencing trauma to your chest, such as in a car accident, can lead to tricuspid valve regurgitation.

Question 23

Rheumatic fever

Answer 23

Rheumatic fever is a complication of untreated strep throat that can damage heart valves, including the tricuspid valve, leading to tricuspid valve regurgitation later in life.

Question 24

Congenital heart defects

Answer 24

Some heart defects present at birth (congenital) may affect the tricuspid valve. Most commonly this is Ebstein’s anomaly.

Question 25

Marfan syndrome

Answer 25

Marfan syndrome, a genetic disorder of connective tissue present at birth, is occasionally associated with tricuspid valve regurgitation.

Question 26

Radiation

Answer 26

Chest radiation may damage the tricuspid valve and cause tricuspid valve regurgitation.

Question 27

How the heart works

Answer 27

Your heart, the center of your circulatory system, is made up of four chambers. The two upper chambers (atria) receive blood. The two lower chambers (ventricles) pump blood.

Four heart valves open and close to let blood flow in one direction through your heart. The tricuspid valve — which lies between the two chambers on the right side of your heart — consists of three flaps of tissue called leaflets.

The tricuspid valve opens when blood flows from the right atrium to the right ventricle. Then the flaps close to prevent the blood that has just passed into the right ventricle from flowing backward.

In tricuspid valve regurgitation, the tricuspid valve doesn’t close tightly. This causes the blood to flow back into the right atrium during each heartbeat.

Question 28

Several factors can increase your risk of tricuspid valve regurgitation…

Answer 28

• Infections such as infective endocarditis or rheumatic fever. These infections can cause damage to the tricuspid valve.
• A heart attack. A heart attack can damage your heart and affect the right ventricle and function of the tricuspid valve.
• Heart failure. Heart failure can increase your risk of developing tricuspid valve regurgitation.
• Pulmonary hypertension. High blood pressure in the arteries in your lungs (pulmonary hypertension) can increase your risk of tricuspid valve regurgitation.
• Heart disease. Several forms of heart disease and heart valve disease may increase your risk of developing tricuspid valve regurgitation.
• Congenital heart disease. You may be born with a condition or heart defect that affects your tricuspid valve, such as Ebstein’s anomaly.
• Use of certain medications. If you’ve used stimulant medications such as fenfluramine (no longer sold on the market) or some medications for Parkinson’s disease, such as pergolide (no longer sold in the United States) or cabergoline, or certain migraine medications (ergot alkaloids), you may have an increased risk of tricuspid valve regurgitation.
• Radiation. Chest radiation may damage the tricuspid valve and cause tricuspid valve regurgitation.

Question 29

If tricuspid valve regurgitation lasts, it can lead to:

Answer 29

Heart failure. In severe tricuspid valve regurgitation, pressure can rise in your right ventricle due to blood flowing backward into the right atrium and less blood flowing forward through the right ventricle and into the lungs. Your right ventricle can expand and weaken over time, leading to heart failure.
Atrial fibrillation. Some people with severe tricuspid valve regurgitation also may have a common heart rhythm disorder called atrial fibrillation.

Question 30

Tricuspid valve disease refers to abnormal function of the tricuspid valve. Two types of tricuspid disease include

Answer 30

Tricuspid regurgitation - the valve is leaky or doesn’t close tight enough, causing blood to leak backwards across the valve

Tricuspid stenosis - the valve leaflets are stiff and do not open widely enough, causing a restriction in the forward flow of blood. Your physician may refer to this as an increased pressure gradient
across the valve, found by echocardiogram or cardiac catheterization.

Question 31

Edwards Cardioband Tricuspid Valve is a …

Answer 31

Edwards Cardioband Tricuspid Valve Reconstruction System is a transcatheter device designed to reduce tricuspid regurgitation through annular reduction via transfemoral access

Question 32

Tricuspid regurgitation is frequent but rarely treated

Answer 32

1.6M Moderate to severe TR prevalence

<8k Surgical procedures annually

Question 33

Tricuspid regurgitation is associated with increased

mortality

Answer 33

5,223 patients Study shows that moderate to severe TR increases mortality*

*Independent of PASP, LVEF
Topilsky Y et al. JACC Cardiovasc Imaging 2018 Aug 6. Epub 2018 Aug 6
Nath J et. al. Journal of the American College of Cardiology. 2004 Feb 4;43(3):405-9

Question 34

Functional tricuspid regurgitation is caused by…

Answer 34

Functional tricuspid regurgitation is predominantly a consequence of RV enlargement and annular dilatation

Question 35

3 key facts about Cardioband TR

Answer 35

3 key facts about Cardioband TR

▪ First CE-mark approved transcatheter device for the treatment of tricuspid regurgitation
▪ A dedicated technology to treat TR through annular reduction
▪ Expected shortened learning curve for Cardioband mitral system users

Question 36

Cardioband Tricuspid System addresses the main

cause of tricuspid regurgitation – annular dilatation because..

Answer 36

Cardioband Tricuspid System addresses the main cause of tricuspid regurgitation – annular dilatation

Restores valve to a more functional state – facilitating leaflet coaptation
Enables annular reduction based on each patient’s anatomy
Allows real-time adjustment and confirmation of procedural results

Question 37

Cardioband Tricuspid System has a reproducible and

standardised procedure

Answer 37

1. ACCESS - Insert Cardioband tricuspid delivery system into the right atrium using a transfemoral approach.
2. DEPLOY - Deploy implant via a steerable catheter to navigate around the tricuspid annulus, securing the implant with stainless steel anchors.
3. ADJUST AND REDUCE - Introduce the sizeadjustment tool over a wire and rotate the adjustment knob
   clockwise for implant contraction

Question 38

TRI-REPAIR study

Answer 38

▪ Single arm, multi-center, prospective study to evaluate the performance and safety of the Cardioband tricuspid system for reconstruction of pathological tricuspid valves.

Question 39

TRI-REPAIR study Participating sites

Answer 39

Heart Center, University Hospital Bonn
LMU Klinikum der Universität München,
Campus Großhadern
Universitätsmedizin der Johannes Gutenberg
Universität Mainz
Universitäres Herzzentrum Hamburg GmbH
(UHZ), Hamburg
Asklepios, St. Georg Hospital
Heart Center University of Cologne
Bichat Hospital
San Raffaele Institute
Zurich University Hospital*

Question 40

TRI-REPAIR study Conclusions

Answer 40

Patients with functional tricuspid regurgitation have a large unmet need
with limited treatment options. The TRI-REPAIR study demonstrated:
▪ Use of the Cardioband tricuspid system for tricuspid regurgitation is safe and feasible
▪ Significant reduction in EROA through annular reduction that is sustained at 6 months
▪ Clinically significant improvements in functional status, quality of life and exercise
sustained at 6 months
▪ Successful access, deployment and positioning of the Cardioband tricuspid implant in
100% of patients
▪ Further studies are warranted to validate these initial promising results

Question 41

Edwards’ CardiobandTM Tricuspid Valve Reconstruction System: A new option for under-treated patients. Why?

Answer 41

The granting of the CE mark to Edwards Lifesciences for its Cardioband Tricuspid System was an important development for patients with tricuspid regurgitation.

As well as becoming the first—and only—approved percutaneous treatment option for tricuspid repair on the European market, the device represents a new option for a condition that historically has been under-treated because, at least in part, the number of suitable treatments are limited.

in the USA, 1.6 million people have moderate-to-severe tricuspid regurgitation and most of them have functional tricuspid regurgitation. According to Dr. Stephan von Bardeleben (Heart Valve Center Mainz—Cardiology I, University Medicine Mainz, Mainz, Germany), 80% of his patients have functional tricuspid regurgitation, and he explains that “functional means secondary to left heart disease, both ventricular and valvular in origin, or secondary to any pressure load such as lung disease”.

However, despite its relatively high prevalence, tricuspid regurgitation has historically been under-diagnosed and under-treated. Dr. von Bardeleben reports that less than 1% of patients with moderate-to-severe tricuspid regurgitation will undergo surgical or interventional repair this year, which supports similar statistics reported in American studies.

Question 42

Why Cardioband TR?

Answer 42

Treatment of tricuspid regurgitation, provided it is successful and performed early enough, can improve cardiac output, decrease venous pressure, and improve leg oedema among other benefits. However, a key issue—and the main reason for the under-treatment of patients with tricuspid regurgitation—is a lack of available therapeutic options. While isolated surgery can be used for some patients, according to Dr. von Bardeleben, it is associated with substantial in-hospital mortality (8–10%). The only non-surgical option—prior to the Cardioband tricuspid system receiving the CE mark—was palliative medical therapy with diuretics. Therefore, there is a definite need for a less invasive therapeutic option in patients with this condition.

The Cardioband tricuspid system has been designed to address this need. Dr. von Bardeleben explains that it reduces the septolateral, as well as the anterior-posterior, diameter of the tricuspid valve. Although a similar device is used to treat mitral regurgitation (Cardioband Mitral System, Edwards Lifesciences), there are different considerations when treating patients with tricuspid regurgitation. He comments, “The stiffness of the tricuspid annulus is less than that in the mitral space. The proximity of the right coronary artery—as well as the limited thickness of the basal right ventricular wall—has to be respected when using the system in the tricuspid valve. In the mitral space, the circumflex artery is the artery with the closest relation to the Cardioband anchors.”

Question 43

Why does only a relatively small percentage of patients with tricuspid regurgitation receive treatment?

Answer 43

One of the reasons why a relatively small percentage of patients with tricuspid regurgitation receive treatment is the misconception that tricuspid regurgitation does not require treatment; this has led to the under-recognition of the clinical impact of tricuspid regurgitation on morbidity and mortality. In fact, tricuspid regurgitation is both a significant marker and cause of increased mortality. The increased risk of mortality correlates to the severity of tricuspid regurgitation. Dr. von Bardeleben states, “Patients with severe tricuspid regurgitation have the worst prognosis, with the survival rate being less than 50% by five years.” He adds that patients “complain about an inability to exercise, experience fatigue, have liver dysfunction, and have leg oedema,” meaning that their quality of life “is severely impaired”.

Question 44

TRI-REPAIR study 6 months data

Answer 44

Data for the Cardioband tricuspid system shows that it is a reasonable option for managing tricuspid regurgitation. The TRI-REPAIR study was a single-arm, prospective, study in which 30 patients with functional tricuspid regurgitation received the Cardioband tricuspid system.6 The primary endpoint was the rate of major serious adverse events at hospital discharge and at 30 days (safety endpoint) and the successful access, deployment, and positioning of the device (technical success endpoint). Other endpoints included reduction in tricuspid regurgitation grade, effective regurgitant orifice area (EROA), and volume and functional tests.

Technical success was achieved in all patients and, overall, there was a 16% reduction in septolateral diameter at discharge: 37±4.5mm vs. 44.4±4.4mm at baseline (paired t-test p<0.001). This reduction was sustained at 30 days and at six months. Furthermore, at 30 days, there was a 51% reduction in EROA, 31% reduction in vena contracta, and a 9% improvement in left ventricular stroke volume. These results were again sustained at six months (interim report).

In terms of functional improvements, at 30 days, there were significant improvements in Kansas City Cardiomyopathy Questionnaire scores (p<0.01), New York Heart Failure Association (NYHA) class (p<0.01), and oedema (p=0.01). By six months (interim report), not only were these improvements sustained but there was also a significant improvement in the six-minute walk test compared with baseline levels.

Question 45

Cardioband TR at EuroPCR 2018

Answer 45

Presenting the data at EuroPCR 2018 (21–24 May, Paris, France), Prof. Francesco Maisano (Heart Valve Clinic, University Hospital of Zurich, University of Zurich, Zurich, Switzerland) said: “In an early experience, the Cardioband tricuspid system provides a significant reduction in EROA through annular reduction,” adding that the study had given “valuable learnings”.

For Dr. von Bardeleben, the key to achieving good outcomes with the system is “optimal patient selection”. Therefore, he thinks that the patients who will benefit the most are those with annular septolateral dilatation that is intermediate (4–5cm), rather than severe, and those with moderately impaired, right ventricular function. He adds: “Patients should have NYHA Class II or III with symptoms but still have residual ability to walk so that they can be mobilised after the procedure.” Dr. von Bardeleben also believes that patients, prior to the procedure, should also have a life expectancy of more than one year and systolic pulmonary artery pressures of less than 60mmHg.

Summing up the available evidence for the Cardioband tricuspid system, alongside what is known about the optimal management of patients with tricuspid regurgitation, Dr. von Bardeleben says that the system is “the beginning of a new ‘microinvasive’ generation of transcatheter tools to address both “a forgotten valve and forgotten patient population”. He adds: “The Cardioband system has shown feasibility and safety, but there still is a journey of learning and understanding as well as sub differentiating the haemodynamics and pathophysiology of tricuspid and right heart disease. At the Heart Valve Center Mainz, we are happy and proud to be part of this journey.”