Tricuspid Regurgitation (TR) affects over 70 million patients globally, including over 1.5 million in the United States. Despite this, less than 8,000 tricuspid valve surgeries are performed in the US annually [iii]. Patients with moderate or severe TR experience a mortality rate of over 10% at one year [iv].
Patients with TR experience a wide variety of symptoms that can significantly impact their quality of life. Symptoms include fatigue, shortness of breath (dyspnea), swelling (edema), abdominal fluid collection (ascites), and jaundice, which impair the physical and mental well-being of patients. TR can also be associated with life-threatening complications such as right heart failure, irregular beating of the heart (atrial fibrillation), pulmonary hypertension, and endocarditis. These conditions increase the risk of death (mortality) and sickness (morbidity).
VDyne offers patients with TR a minimally invasive procedure to implant a prosthetic valve with a view to eliminating TR and restoring normal blood flow.
[ii] Demir OM, Regazzoli D, Mangieri A, Ancona MB, Mitomo S, Weisz G, Colombo A, Latib A. Transcatheter Tricuspid Valve Replacement: Principles and Design. Front Cardiovasc Med. 2018 Sep 19;5:129. doi: 10.3389/fcvm.2018.00129. PMID: 30283790; PMCID: PMC6156134.
[iii] Kolte D, Elmariah S. Current state of transcatheter tricuspid valve repair. Cardiovasc Diagn Ther. 2020 Feb;10(1):89-97. doi: 10.21037/cdt.2019.09.11. PMID: 32175231; PMCID: PMC7044094.
[iv] Davidson, L., et al. The Tricuspid Valve: A Review of Pathology, Imaging and Current Treatment Options: A Scientific Statement from the American Heart Association. Circulation. 2024; 149.
[v]Welle GA, Hahn RT, Lindenfeld J, Lin G, Nkomo VT, Hausleiter J, Lurz PC, Pislaru SV, Davidson CJ, Eleid MF. New Approaches to Assessment and Management of Tricuspid Regurgitation Before Intervention. JACC Cardiovasc Interv. 2024 Apr 8;17(7):837-858. doi: 10.1016/j.jcin.2024.02.034. PMID: 38599687.
IMPACT OF TR
TRICUSPID REGURGITATION
Tricuspid regurgitation—or TR—is a common heart condition that affects the tricuspid valve, which is located between the atrium and the ventricle on the right side of the heart. TR occurs when the valve leaflets do not close properly and allow blood to flow backwards—or regurgitate—into the right atrium. TR reduces the heart's pumping efficiency and causes poor blood flow [i].
TR is often referred to as the "forgotten valvular disease" because of (1) the complexity of diagnosis, (2) historically high mortality and poor outcomes associated with surgical treatments, and (3) the incorrect perception that clinical interventions on the left side of the heart "heal" or correct TR.
Tricuspid Regurgitation
TYPES OF TR
The tricuspid valve is located between the right atrium (right upper heart chamber) and the right ventricle (right lower heart chamber) on the right side of the heart and opens and closes as the heart beats.
The main function of the right side of the heart is to receive de-oxygenated blood circulating in the body and then pump that blood to the lungs, where the blood is oxygenated and returned to the left side of the heart for re-circulation to the body.
Most importantly, the tricuspid valve must close fully to allow the heart to pump blood from the right ventricle to the lungs for re-oxygenation.
THE TRICUSPID VALVE
The VDyne Valve System is an investigational product only that is presently undertaking human (clinical) feasibility studies. The VDyne System is not approved for sale or use for the treatment of any health condition.
Sometimes, TR is caused by structural abnormalities to the tricuspid valve itself due to birth (congenital) defects, rheumatic disease, or previous life-threatening inflammation of the heart, known as endocarditis.
These abnormalities may also be found in the adjacent anatomy that supports the tricuspid valve, including the chordae tendineae or papillary muscles. This type of TR is known as “Primary TR” but only accounts for ~10% of TR patients [iii].
Primary - TR
Secondary - TR
The most common type of TR – known as “Secondary TR” – is abnormal functioning of the tricuspid valve caused by other factors, including left-side heart disease, enlargement (dilation) of the ventricles, or high blood pressure in the lungs (pulmonary hypertension) [ii].
Ventricular TR and Atrial TR
Ventricular Secondary TR (known as Ventricular - STR) is where the patient's left heart pumping capacity is less than 50%. Atrial Secondary TR (known as Atrial - STR) is where the patient's left heart pumping capacity is greater than 50%. Together, Ventricular - STR and Atrial - STR account for 80% of patients [v].
Some patients who have previously been implanted with a cardiac implantable electric device (CIED) to regulate the heart's rhythm or rate (e.g., pacemakers, defibrillators) experience resultant TR due to the placement of the associated leads. These patients account for approximately 10 -15% of the population [v].