Archive for the ‘Pulmonary Valve Replacement and Repair’ Category

TricValve Transcatheter Bicaval Valves System – Interventional cardiologists at Cleveland Clinic have successfully completed the first implantation in North America

Reporter: Aviva Lev-Ari, PhD, RN

The Patient for this historic procedure:

An 82-year-old man presenting with severe symptomatic tricuspid regurgitation (TR) and right heart failure (RHF).

Expert Opinion: The Voice of Dr. Justin D. Pearlman, MD, PhD, FACC

The TricValve addresses the problem of severe ìncompetance of the tricuspid valve with a relatively simple procedure.

Instead of the challenge of replacing the defective valve, a catheter procedùre places valves at the two venous intake locations, the superior and ìnferior vena cava. A valve at the superior vena cava entrance to the right atrium occurs occasionally in nature, but is usually absent or fenestrated, covering the medial end if the crista supraventricularis.

A similar termed valve is occasionally found in nature on the inferior vena cava. These supernumerary valves can arrest back flow of pressure and volume from the right atrium to the upper and lower venous systems, and alleviate in particular congestion of the liver.

Normally the right atrial pressure is low, in which case this would offer no significant advantage for reproductive success natural selection to offset potential interference with blood flow into the right atrium that might promote thrombosis [Folia Morphology Morphology 66(4):303-6, MRuso].

However, in a setting of right heart failure, such as occurs from pulmonary hypertension, the tricuspid valve often becomes incompetent, and placement of the pair of vena cava valves can alleviate upstream consequences, albeit at the cost of risk of thrombosis and future impediment to other future procedures such as ablation of supraventricular arrhythmia.

The vena cava valves placed by catheter at the Cleveland Clinic helped an 80 year old man alleviate his pressing issue of hepatic congestion. Unlike a replacement tricuspid valve this procedure does not alleviate high pressures dilatìng the right atrium. Instead, it can worsen that problem.

The CLASP II TR trial is investigating the Edwards PASCAL transcatheter repair system [CLASP II TR, Edwards Lifesciences Corp, NIH NCT 0497145]

Survival data for surgìcal tricuspid valve replacements reported 37+-10 percent ten year survival, with average all cause survival of just 8.5 years [Z HIscan, Euro J CT Surgery 32(2) Aug 2007]. None-the‐less,  comparison of patients with vs without intervention for incompetance of the trìcuspid valve favored mechanical intervention [G Dreyfus Ann Thorac Surg 49:706-11,1990, D Adams, JACC 65:1931-8, 2015]. Time will tell which interventìon will prevail, and when these catheter alternatives to open chest surgery should be deployed.

The first implantation in North America: TricValve Transcatheter Bicaval Valves System

The structural heart procedure occurred in February 2022.

Rishi Puri, MD, PhD, an interventional cardiologist with Cleveland Clinic, and Samir Kapadia, MD, chair of cardiovascular medicine at Cleveland Clinic, performed the procedure. Puri has years of experience with the TricValve system, participating in a thorough analysis of its safety and effectiveness in 2021.

The TricValve system features two biological valves designed to be implanted via femoral vein access into the patient’s superior vena cava and inferior vena cava. This allows a therapy without impacting the patient’s native tricuspid valve. It is available in multiple sizes, allowing cardiologists to choose the best option for each individual patient.

Cleveland Clinic’s statement detailing the successful procedure notes that patients with severe TR and RHF have typically had limited treatment options. Tricuspid valve surgery is associated with significant risks, for instance, and prescribing diuretics is problematic when the patient also presents with kidney problems.

“TricValve can potentially provide an effective and low-risk solution for many patients who currently have no treatment options,” Puri said, adding that the workflow is quite similar to transcatheter aortic valve replacement.

The TricValve Transcatheter Bicaval Valves System was developed by P+F Products + Features GmbH, a healthcare technology company based out of Vienna, Austria. The solution was granted the FDA’s Breakthrough Device designation in December 2020, but it has still not gained full FDA approval.

This procedure was completed under a compassionate-use clearance from the FDA.

Image Source:


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VIDEO: MitraClip vs. surgical mitral valve replacement

Older LAAO patients, especially women, face a higher risk of complications




Other related articles published in this Open Access Online Scientific Journal include the following:


The LINK, above will take the e-Reader to:

  • 247 articles on HUMAN HEART VALVE-RELATED REPAIR Procedures


Our book on Cardiac Repair Procedures




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Pulmonary Valve Replacement and Repair: Valvuloplasty Device – Tissue (bioprosthetic) or mechanical valve;  Surgery type – Transcatheter Pulmonary Valve Replacement (TPVR) vs Open Heart, Valve Repair – Commissurotomy, Valve-ring Annuloplasty


Reporter: Aviva Lev-Ari, PhD, RN

Outcomes of Pulmonary Valve Replacement in 170 Patients With Chronic Pulmonary Regurgitation After Relief of Right Ventricular Outflow Tract Obstruction
Implications for Optimal Timing of Pulmonary Valve Replacement


Objectives The objectives of this study were to evaluate outcomes of pulmonary valve replacement (PVR) in patients with chronic pulmonary regurgitation (PR) and to better define the optimal timing of PVR.

Background Although PVR is effective in reducing right ventricular (RV) volume overload in patients with chronic PR, the optimal timing of PVR is not well defined.

Methods A total of 170 patients who underwent PVR between January 1998 and March 2011 for chronic PR were retrospectively analyzed. To define the optimal timing of PVR, pre-operative and post-operative cardiac magnetic resonance imaging (MRI) data (n = 67) were analyzed.

Results The median age at the time of PVR was 16.7 years. Follow-up completeness was 95%, and the median follow-up duration was 5.9 years. Overall and event-free survival at 10 years was 98% and 70%, respectively. Post-operative MRI showed significant reduction in RV volumes and significant improvement in biventricular function. Receiver-operating characteristic curve analysis revealed a cutoff value of 168 ml/m2 for non-normalization of RV end-diastolic volume index (EDVI) and 80 ml/m2 for RV end-systolic volume index (ESVI). Cutoff values for optimal outcome (normalized RV volumes and function) were 163 ml/m2 for RV EDVI and 80 ml/m2 for RV ESVI. Higher pre-operative RV ESVI was identified as a sole independent risk factor for suboptimal outcome.

Conclusions Midterm outcomes of PVR in patients with chronic PR were acceptable. PVR should be considered before RV EDVI exceeds 163 ml/m2 or RV ESVI exceeds 80 ml/m2, with more attention to RV ESVI.

Key Words

Relief of right ventricular (RV) outflow tract obstruction in tetralogy of Fallot or similar physiology often results in pulmonary regurgitation (PR). The resultant chronic volume overload can lead to RV dilation, biventricular dysfunction, heart failure symptoms, arrhythmias, and sudden death (1–5). Pulmonary valve replacement (PVR) can lead to improvement in functional class and a substantial decrease or normalization of RV volumes (6,7). Other potential benefits of PVR are improvement in exercise capacity (8) and decrease in QRS duration (9). However, benefits of PVR have to be weighed against the risks of this procedure. Although operative mortality of PVR is low (6), post-operative morbidities are not negligible (10) and patients are exposed to the risk of repeat PVR (11–13). PVR is indicated when patients become symptomatic or at risk for life-threatening arrhythmias (14). For asymptomatic patients, there have been debates regarding the optimal timing of PVR (15–19). Magnetic resonance imaging (MRI) is a gold standard for evaluating RV volumes and function (20), and these MRI parameters can be used to decide the indications for PVR. Many studies dealing with changes in MRI parameters after PVR have been reported (7–9,21–26). However, most of them have a limitation of small patient numbers, and there are few studies suggesting the optimal timing of PVR (7–9). The objectives of this study were to evaluate outcomes of PVR performed in patients with chronic PR and to better define the optimal timing of PVR by analyzing MRI parameters.


Journal of the American College of Cardiology



Pulmonary valve repair and replacement at Mayo Clinic


Mayo Clinic’s approach


Why it’s done

Pulmonary valve disease treatment depends on the severity of your condition, whether or not you’re experiencing signs and symptoms, and if your condition is getting worse.

Many types of pulmonary valve disease are caused by heart conditions present at birth (congenital heart disease). Types of pulmonary valve disease that may require treatment with pulmonary valve repair or pulmonary valve replacement include:

Pulmonary valve regurgitation is a leaky pulmonary valve. The leaky valve allows blood to flow backward into the heart rather than directly to the lungs for oxygen.

The most common cause of pulmonary valve regurgitation is pulmonary hypertension. Other causes of pulmonary valve regurgitation are congenital heart disease (specifically, tetralogy of Fallot or congenital pulmonary valve stenosis), bacterial infection of the heart (infective endocarditis), complications after heart surgery, and rarely rheumatic fever.

Pulmonary valve stenosis occurs when the pulmonary valve becomes thickened or obstructed, which makes it harder for it to open properly and for the heart to pump blood into the pulmonary artery and to the lungs.

The cause of pulmonary valve stenosis is usually unknown. It often affects children and may be caused by congenital heart disease or an infection in the mother during pregnancy. It can also occur in adults as a result of a rare type of cancer that affects the heart (carcinoid heart disease).

Pulmonary atresia is a congenital heart defect in which a child is born without a well-defined pulmonary valve. In pulmonary atresia, blood can’t flow from the right ventricle into the pulmonary artery. The only blood flow to the lungs is through an open passageway between the pulmonary artery and the main artery supplying blood to the body (aorta).

The cause is usually unknown. Children born with pulmonary atresia may also have other heart defects.

For some people with mild pulmonary valve disease without symptoms, careful monitoring under a doctor’s supervision may be all that’s needed.

But in many cases, pulmonary valve disease and dysfunction progress in adulthood and get worse without medical treatment. Most pulmonary valve conditions are mechanical problems that cannot be adequately treated with medications alone and will eventually require surgery to reduce symptoms and the risk of complications, such as heart failure, or death due to advanced heart failure or sudden cardiac arrest.

The decision to repair or replace a damaged pulmonary valve depends on many factors, including:

  • The severity of your pulmonary valve disease
  • Your age and overall health
  • Whether you need heart surgery to correct another heart problem in addition to pulmonary valve disease, such as another valve surgery, for example, tricuspid valve repair or replacement, so both conditions can be treated at once

In general and whenever possible, heart valve repair is the preferred option because it is associated with a lower risk of infection, preserves valve strength and function, and eliminates the need to take blood-thinning medications, which may be necessary with valve replacement.

But not all valves can be repaired, and heart valve repair surgery is often harder to do than valve replacement. Your best option will depend on your individual situation as well as the expertise and experience of your health care team.

Pulmonary valve repair and pulmonary valve replacement may be performed via traditional open-heart surgery, which involves a cut (incision) in the chest (sternotomy), or via minimally invasive methods that involve smaller incisions in the chest (hybrid approach) or a catheter-based approach.

What type of procedure you have depends on the severity of your pulmonary valve disease, overall health and whether you need additional heart surgery to treat other issues.


Transcatheter Pulmonary Valve Replacement (TPVR) at Cleveland Clinic


A number of patients with congenital heart disease have problems with their pulmonary valve, either since birth, or after cardiac surgery. For many patients, a valve replacement may be recommended.

Until the last decade replacing a faulty pulmonary valve could only be done with open heart surgery. Because all surgically implanted valves have a limited life-span, patients faced many surgeries over the course of their life to replace the pulmonary valve. The percutaneous, non-surgical option to replace the pulmonary valve has revolutionized the care of these patients.

Image Source: Medtronic, 2017

Who can benefit from TPVR?

Patients who may benefit from a transcatheter pulmonary valve include those with:

  • Tetralogy of Fallot who have had prior surgery but now have a leaky or narrowed pulmonary valve, especially if they have undergone a prior surgical replacement.
  • Patients with other underlying diagnoses who also have a surgically implanted pulmonary valve (such as a homograft or a bioprosthetic valve) that is no longer working well; including patients with truncus arteriosus, patients with aortic valve disease who have had a Ross procedure, and some patients with pulmonary stenosis or atresia.

The goals of transcatheter pulmonary valve replacement is to replace the pulmonary valve non-surgically and decrease the number of heart surgeries a patient will need over their life-time.


To see if you are a possible candidate for treatment with the transcatheter pulmonary valve, you’ll have a comprehensive evaluation by a multidisciplinary team. The evaluation focuses on the patient’s condition, anatomy, and management options and will include:

  • Physical exam.
  • Diagnostic tests including an echocardiogram, cardiac MRI, or cardiac CT scan (the latter if you cannot have an MRI due to, for example, having a pacemaker).


There are 2 valves currently approved by the FDA for this indication, the Melody valve and the Edwards SAPIEN XT valve. Both are tissue valves that are sutured to a stent, which is a thin metal cylinder that is mounted on a balloon catheter.

TPVR Procedure

The procedure is performed in a pediatric and adult congenital cardiac catheterization lab by an interventional cardiologist with expertise in congenital cardiac interventions, utilizing fluoroscopy and angiography to see the anatomy and evaluate the function of the heart valves.

A catheter is placed through a small incision into the femoral vein (in the groin) or the jugular vein in the neck.

A compressed tissue heart valve is placed on a balloon catheter; advanced through the vein to the heart, and is positioned directly inside the diseased pulmonary valve. Once in position, the balloon is inflated expanding the stent and the valve is secured in place. The new valve immediately begins to work. The catheter is then removed.

Patients are observed overnight and discharged the following morning. Usually you can return to your normal activities in 7 days.

Physicians with expertise in catheter interventions for congenital heart disease have been performing this procedure at the Cleveland Clinic since 2010. Both the Melody valve and the Edwards SAPIEN valve have been used, depending on the size needed for a particular patient. No patient with underlying congenital heart disease has had a severe complication and no patient has required removal of the valve to date.




Pulmonary Valve Surgery at John Hopkins 

Why doesn’t my heart valve work properly?

Heart InteriorFrom The Illustrated Field Guide to Congenital Heart Disease and Repair – Second Edition courtesy of Scientific Software Solutions Inc.

The valves in your heart may be damaged due to infection, rheumatic heart disease or birth (congenital) defects. The affected valve leaflets (cusps) may grow thick and brittle from scar tissue or calcium deposits, or they may become thin and weak resulting in an inefficient valve.

There are several terms referring to valve disease.

  • Stenosis – the opening of the valve becomes smaller, thus allowing less blood to flow through.
  • Regurgitation/Insufficiency (leaky valve) – the valve does not close properly and allows blood to flow backward as well as forward in the heart.

How will I feel?

Due to the damaged valve, your heart must work harder to pump blood throughout the body.  You may tire easily and feel short of breath with less activity or exercise.  You may experience an irregular heartbeat due to over-stretching of the heart muscle as in mitral stenosis, or dizziness and near fainting due to decreased blood flow to the brain as in aortic stenosis.

How will my valve be fixed?

Depending on the extent of your valve disease, you may need to have the valve repaired or replaced.  To repair the valve, your surgeon may perform a commissurotomy or implant a valve ring.  A commissurotomy is performed for a tight valve (stenosis).  The valve leaflets are cut to loosen the valve slightly, allowing blood to pass easily.  Another type of valve repair is a valve ring annuloplasty, which is sewn in place when the valve is leaking (regurgitant or insufficient).  The valve leaflets are tucked in place with the ring.

Often the valve cannot be repaired and the surgeon must replace the damaged valve with a tissue (bioprosthetic) or mechanical valve.  Tissue valve are valves from animals (e.g., cow, pig).  They generally do not require long-term anticoagulation and are not as durable as mechanical valves.  Mechanical valves are made from materials such as plastic or metal.  They require long-term anticoagulation and are considered extremely durable, lasting longer than tissue valves.

Your surgeon will discuss the need for repair or replacement of the valve with you prior to surgery as well as the type of valve (tissue or mechanical) should replacement be necessary.

Annuloplasty RingAnnuloplasty Ring

Tissue ValveTissue Valve

Mechanical ValveMechanical Valve

Valve Replacement Surgery: What else should I know?

Prevention of Valve Infection

To prevent an infection (endocarditis) from occurring around the new heart valve or ring, you should receive antibiotics before having any procedures that could permit bacteria to enter your body.  Among these procedures are:

  • All dental procedures (cleaning, filling, removing teeth, root canals, gum or ulcer treatment). You may use dental floss, In fact, we encourage you to reduce tartar with any approved method.
  • Surgical procedures such as colonoscopy, cystoscopy, or other surgical procedures.



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