TricValve Caval Valve Implantation
Dr Dawkins performs this procedure at Cleveland Clinic London and at the John Radcliffe Hospital in Oxford, where he is Clinical Lead for Structural Intervention.
The TricValve (P+F Products) is a transcatheter system that treats severe tricuspid regurgitation by implanting two self-expanding bioprosthetic valves into the venae cavae: one in the superior vena cava (SVC) and one in the inferior vena cava (IVC). Rather than replacing the tricuspid valve itself, the TricValve approach (also known as caval valve implantation, CAVI) prevents the backwards transmission of pressure into the venous system, reducing the symptoms caused by venous congestion. This is called heterotopic valve replacement, meaning the new valves sit in a different position from the valve being treated; valves such as EVOQUE, which replace the tricuspid valve in its own position, are called orthotopic.
How does it work?
Two valves are delivered on catheter systems through the femoral vein. Using a combination of x-ray and ultrasound guidance, the SVC valve is positioned and deployed first, followed by the IVC valve. Both valves are self-expanding and seat against the wall of each vena cava. When the right atrium contracts, the two caval valves close, preventing backwards transmission of pressure into the liver, abdomen and head, which addresses the most disabling symptoms of severe tricuspid regurgitation.
Who is TricValve recommended for?
TricValve is generally considered for patients with symptomatic severe tricuspid regurgitation who are unsuitable for tricuspid edge-to-edge repair (TEER) and unsuitable for direct tricuspid replacement (for example with the EVOQUE system), and for whom open-heart surgery is also not an option. It is often particularly considered when the dominant symptoms are from venous congestion (peripheral oedema, ascites, hepatic congestion) rather than primarily from forward heart failure. The selection process is careful and individualised: TricValve is typically chosen when other options are not feasible.
What is the process for deciding to treat someone with this technique?
Generally you would be referred by your GP or cardiologist. You would then be assessed in clinic by Dr Dawkins, which usually includes additional investigations, typically a transthoracic echocardiogram, a transoesophageal echocardiogram (TOE), and a cardiac CT scan to size the venae cavae. Once we have all the necessary information, we will discuss you at one of our regular structural valve meetings. These are attended by interventional cardiologists, cardiac surgeons, imaging experts and anaesthetists. If the consensus is that TricValve is the best option for you, and you would like to go ahead, we will offer you a procedure date.
What can I expect from the procedure?
The procedure is performed under general anaesthetic or deep sedation, with continuous TOE guidance. Both valves are delivered through the femoral vein. The procedure typically takes around an hour. Most patients stay in hospital for one night, although some need an extra day for monitoring. Dr Dawkins will see you in clinic a month or so after the procedure, but can be contacted in the interim if you have any queries or problems.
What are the benefits and risks?
A successful TricValve implant reduces venous congestion, which typically translates into significantly less leg and abdominal swelling, less liver congestion, and improved breathlessness and exercise tolerance over the following weeks. Like any procedure there are risks, including bleeding from the access site, valve mispositioning, the need for further intervention, and rarely significant heart-related complications. We will discuss your individual risk profile in detail at your consultation, both verbally and in writing.
What experience does Dr Dawkins have?
TricValve is generally considered when other tricuspid treatments are not suitable, so it helps to be assessed by someone who can offer all of them. Dr Dawkins is one of the highest-volume operators in the UK for transcatheter mitral and tricuspid intervention, and performed the first UK tricuspid edge-to-edge repairs with both Pascal and TriClip and the first UK EVOQUE tricuspid valve replacement. He is one of very few clinicians in the UK able to offer the full range of transcatheter tricuspid options: TEER, EVOQUE replacement and TricValve.
How to choose: TEER, EVOQUE or TricValveWhich tricuspid treatment suits which valve
Three transcatheter options
There are three ways to treat a leaking tricuspid valve without open-heart surgery: tricuspid edge-to-edge repair (TEER), EVOQUE valve replacement and TricValve. All three are carried out through a vein at the top of the leg, under general anaesthetic, and usually take about an hour.
Which one is right for you depends mainly on the anatomy of your tricuspid valve. This is assessed in detail with a transoesophageal echocardiogram and a CT scan, and every patient is discussed at a structural valve meeting before a procedure is offered.
Tricuspid edge-to-edge repair (Pascal or TriClip)
- How it works: clips hold the leaflets of your own valve together to reduce the leak.
- When it is used: it is usually the first choice when the leaflets can be brought together.
- Advantages: it is a very safe procedure, it keeps your own valve, and it rarely affects the heart’s electrical wiring. Most patients go home the same day or after one night.
- Limitations: some leak usually remains. Repair is less likely to work well when the gap between the leaflets is too wide, the leaflets are too short or tethered, or a pacemaker wire through the valve gets in the way.
EVOQUE valve replacement
- How it works: a new valve is placed inside your own tricuspid valve.
- When it is used: when repair is unlikely to reduce the leak enough.
- Advantages: it usually removes the leak almost completely.
- Limitations: there is a higher chance of needing a pacemaker. Blood-thinning medication is needed afterwards, so this technology may not be suitable for patients who have difficulties with bleeding or cannot tolerate oral anticoagulation (blood-thinning tablets). Not every valve is the right size or shape for EVOQUE. Most patients go home after one night.
TricValve Caval Valve Implantation
- How it works: two valves are placed in the large veins that bring blood back to the heart, to stop blood being pushed backwards into the liver, abdomen and legs.
- When it is used: when neither repair nor replacement is suitable, most often because the tricuspid valve is too large.
- Advantages: it can relieve swelling and congestion in patients who have no other transcatheter option, and it rarely affects the heart’s electrical wiring.
- Limitations: it does not reduce the leak in the tricuspid valve itself. Blood-thinning medication is needed afterwards, so this technology may not be suitable for patients who have difficulties with bleeding or cannot tolerate oral anticoagulation (blood-thinning tablets). Most patients go home after one night.
Is a procedure always the right choice?
Not always. Everyone continues their heart medication, and for some patients medication alone remains the best treatment. European guidelines recommend that transcatheter treatment should be considered for patients with severe symptoms despite medication, as long as the right side of the heart is not severely weakened and there is no severe lung-related high blood pressure [1]. Dr Dawkins will go through all of the options with you, including not having a procedure.
References
- Praz F, et al. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. European Heart Journal 2025;46:4635–4736. doi:10.1093/eurheartj/ehaf194
The evidence: key studiesPublished trial and registry results, with references
These summaries describe how TricValve Caval Valve Implantation was developed and tested, and the main published results. The figures are the results reported in those studies, not predictions for any individual patient. Where a study reports a P value, it is included. A P value shows how likely a difference of that size would be to arise by chance if there were really no change or difference. A value below 0.05 is usually taken to mean the difference is unlikely to be due to chance ("statistically significant"). Dr Dawkins is happy to go through these results with you.
How was TricValve developed?
- 2011: the first patient. In Germany, a custom-made valve was placed in the inferior vena cava of a patient with severe tricuspid regurgitation. The pressure in the vein fell and the patient’s symptoms improved [1].
- 2010s: early experience. Over the following years, small numbers of patients were treated, mostly with valves designed for other purposes and placed in the inferior vena cava only. Some of these valves moved out of position, and attention turned to a dedicated system with a valve in each vena cava: TricValve [2].
- TRICUS and TRICUS EURO. TricValve was tested in 9 patients in Lithuania and then in 35 patients at 12 centres in Spain and Austria [3].
- December 2020: FDA Breakthrough Device designation. The US Food and Drug Administration (FDA) gave TricValve Breakthrough Device status, which speeds up its review. It is not yet approved for routine use in the United States.
- May 2021: CE mark. On the strength of TRICUS EURO, TricValve became the first system of valves for both venae cavae to be approved in Europe.
- December 2025: a randomised trial in the United States. The FDA approved the start of TRICAV II, a randomised trial comparing TricValve plus medication with medication alone. Its results are not yet available.
What did the first studies show?
TRICUS and TRICUS EURO together followed 44 patients for a year. These patients had a severe leak and severe symptoms despite medication, and could not have surgery [3]:
- Symptoms: 62.2% had little or no breathlessness in everyday life at one year, compared with none before treatment (P<0.001).
- Quality of life: scores on a standard questionnaire (the Kansas City Cardiomyopathy Questionnaire, scored from 0 to 100) improved from a median of 36.5 to 65.6 (P<0.001).
- Walking distance: the distance walked in six minutes increased from 229 to 270 metres on average, but this was not statistically significant (P=0.285).
- Survival and admissions: 6.8% of patients died within the year, and 25.0% were admitted to hospital with heart failure at least once.
Are the results as good outside clinical trials?
The largest study so far, the TricBicaval registry, included 204 patients treated in 27 European hospitals and one in Brazil between 2020 and 2023. These patients were at high risk: 87.3% had a massive or torrential leak, and 71.1% had kidney problems [4]:
- Symptoms: at follow-up, 81.5% had little or no breathlessness in everyday life, compared with 19.8% before treatment (P<0.001).
- Swelling: leg swelling fell from 73.0% of patients to 22.1%, and fluid in the abdomen from 31.2% to 4.9% (both P<0.001).
- Hospital admissions: admissions with heart failure fell from 60.8 to 26.9 per 100 patients per year, compared with the year before treatment (P<0.001).
- Survival: 8.3% of patients died in hospital, although none died during the procedure itself. Within a year, 18.6% had died. This was 6.7% in patients whose risk score (the TRI-SCORE) was low, rising to 28.8% in those whose score was high (P=0.020). This is one reason not to put off assessment once symptoms develop.
What are the main risks?
In the TricBicaval registry [4]:
- Valve movement: the valve in the inferior vena cava moved out of position in 7.8% of patients. Some were treated with a second valve placed inside the first.
- Bleeding: 18.6% of patients had bleeding, which was life-threatening in 3.9%. Patients need blood-thinning medication after the procedure.
- Bleeding around the heart: 1.5% of patients (3 of 204) developed this some time after the procedure, and 2 of them died.
- Shoulder pain: mild shoulder pain after the procedure is quite common. 47.1% of patients had it, and it typically lasted about four days.
In the first studies, 4 of the 44 patients (9.0%) had a stroke within the year, and 20.4% had major bleeding, mostly from the stomach or bowel in patients taking warfarin-type blood thinners. There were no fractures of the valve frames and no significant clots on the valve leaflets [3].
What does TricValve not do?
TricValve does not reduce the leak in the tricuspid valve itself, which remains after the procedure. Its aim is to relieve the symptoms caused by the backflow into the veins. There have not yet been any completed randomised trials of TricValve. In 2025, European guidelines recommended that transcatheter treatment of the tricuspid valve should be considered for suitable patients with severe symptoms despite medication. The trials behind that recommendation tested edge-to-edge repair and valve replacement, and the guidelines do not make a specific recommendation about caval valves [5].
References
- Lauten A, et al. Heterotopic transcatheter tricuspid valve implantation: first-in-man application of a novel approach to tricuspid regurgitation. European Heart Journal 2011;32:1207–1213. doi:10.1093/eurheartj/ehr028
- Chen V, et al. Transcatheter caval implantation for severe tricuspid regurgitation. Current Cardiology Reports 2025;27:7. doi:10.1007/s11886-024-02190-8
- Blasco-Turrión S, et al. Bicaval TricValve implantation in patients with severe symptomatic tricuspid regurgitation: 1-year follow-up outcomes. JACC: Cardiovascular Interventions 2024;17:60–72. doi:10.1016/j.jcin.2023.10.043
- Sánchez-Recalde A, et al. Bicaval TricValve implantation in patients with severe tricuspid regurgitation: 1-year outcomes from the TricBicaval registry. JACC: Cardiovascular Interventions 2025;18:1913–1924. doi:10.1016/j.jcin.2025.06.023
- Praz F, et al. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. European Heart Journal 2025;46:4635–4736. doi:10.1093/eurheartj/ehaf194