Tricuspid Valve Replacement with EVOQUE (TTVR)
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.
Transcatheter tricuspid valve replacement (TTVR) with the EVOQUE system (Edwards Lifesciences) is a minimally invasive technique to replace a severely leaking tricuspid valve without open-heart surgery. The EVOQUE is a self-expanding bioprosthetic valve made of bovine pericardial leaflets mounted on a nitinol frame. It is delivered through a vein in the leg and deployed in the position of the native tricuspid valve.
How does it work?
The valve is delivered on a steerable catheter system through one of the femoral veins. Using a combination of x-ray and continuous transoesophageal echocardiogram (TOE) guidance, it is positioned across the native tricuspid valve. When deployed, the new valve seats within the native annulus, anchoring against the leaflets and chordae, and replaces the function of the leaking valve. After deployment we assess the valve carefully to confirm normal function and absence of significant leak around the implant.
Who is tricuspid valve replacement with EVOQUE recommended for?
EVOQUE tricuspid replacement is recommended for selected patients with symptomatic severe tricuspid regurgitation at increased risk for open-heart surgery, in whom transcatheter edge-to-edge repair (TEER) is not the best option, typically because of complex valve anatomy, large gaps between the leaflets, severe leaflet tethering, or features that make a clip-based repair unlikely to reduce the leak sufficiently. As with TEER, the right ventricle and the rest of the heart need to be functioning well enough for the procedure to translate into clinical benefit. The TRISCEND II trial showed substantial reductions in tricuspid regurgitation and improvements in symptoms in carefully selected patients.
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 valve and plan the procedure. 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 this would be a good treatment 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 carried out under general anaesthetic with continuous TOE guidance. Vascular access is via 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?
Successful tricuspid replacement with EVOQUE substantially reduces the severity of regurgitation, which usually translates into improved breathlessness, less leg and abdominal swelling, and better exercise tolerance over the following weeks and months. As with any structural intervention there are risks, including bleeding from the access site, conduction problems (sometimes requiring a pacemaker), the need for further intervention, and rarely stroke or 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?
Dr Dawkins performed the first EVOQUE transcatheter tricuspid valve replacement in the UK, and is one of the highest-volume operators in the UK for transcatheter mitral and tricuspid intervention. Clinicians visit Oxford from around the world to learn the EVOQUE procedure with him.
He also offers tricuspid edge-to-edge repair (TEER, with Pascal and TriClip) and caval valve implantation with TricValve, making him one of very few clinicians in the UK able to offer the full range of transcatheter tricuspid options. This means the treatment can be matched to your valve anatomy.
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 EVOQUE 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 the two treatments were really equal. 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 EVOQUE developed?
For a long time, the only way to replace or repair a leaking tricuspid valve was conventional open-heart surgery. Open-heart surgery on the tricuspid valve alone carries a high risk, partly because many patients are referred late, when the heart and other organs are already affected. In a US national study of more than 5,000 of these operations between 2004 and 2013 [1]:
- Death in hospital: 8.8% of patients died, and this didn’t improve over the decade. The figure was 5.9% after valve repair and 10.9% after valve replacement.
- Pacemaker: 35% of patients who had the valve replaced needed a pacemaker.
- Hospital stay: the typical stay was 11 days.
As a result, many patients with a severely leaking tricuspid valve were treated with water tablets alone. EVOQUE was designed to replace the valve through a vein in the leg instead.
- 2019 to 2020: the first patients were treated with EVOQUE, on compassionate grounds, at seven centres. Of the first 25 patients, the valve was implanted successfully in 92%. No patients died in the first month, and the leak was reduced to moderate or less in 96% [2].
- 2022 and 2023: the TRISCEND study followed. In the first 56 patients, the leak was mild or less in 98% at one month [3]. By one year, in 176 patients, the leak was mild or less in 98%, and 93% had little or no breathlessness in everyday life, compared with 26% before treatment [4].
- 19 October 2023: CE mark. On the strength of these results, EVOQUE received its CE mark in Europe. It was the first transcatheter valve replacement for the tricuspid valve approved anywhere in the world.
- 5 December 2023: first in the UK. Less than two months later, Dr Dawkins performed the first EVOQUE procedure in the UK.
- 1 February 2024: FDA approval. The US Food and Drug Administration (FDA) approved EVOQUE.
Does EVOQUE work better than medication alone?
TRISCEND II, published in 2025, was the first randomised trial of a transcatheter tricuspid valve replacement. 400 patients with severe tricuspid regurgitation, at centres in the United States and Germany, were allocated, two to one, to EVOQUE plus medication or to medication alone. After one year, patients who had EVOQUE did better overall (P<0.001), mainly because they felt better and could do more:
- 66% had a meaningful improvement in quality of life, compared with 37% on medication alone.
- 79% had improved by at least one class of breathlessness, compared with 24% [5].
In 2025, European guidelines recommended for the first time that transcatheter treatment of the tricuspid valve, by repair or replacement, should be considered for suitable patients with severe symptoms despite medication [6].
How well does it stop the leak?
EVOQUE produces substantial reductions in tricuspid regurgitation. In TRISCEND II, the leak was mild or less in 95% of EVOQUE patients at one year, compared with 2% of those on medication alone [5].
Does it help people live longer?
TRISCEND II was not designed to answer this question, and the numbers so far are small. Within the first year, 12.6% of EVOQUE patients died, compared with 15.2% on medication alone. Admission to hospital with heart failure was 20.9% and 26.1% respectively [5]. Longer-term results are awaited.
What are the main risks?
The two most important risks are bleeding and the need for a pacemaker [5]:
- Bleeding: severe bleeding occurred in 15.4% of EVOQUE patients, compared with 5.3% on medication alone (P=0.003).
- Pacemaker: the new valve sits close to the heart’s electrical wiring and can disturb it. Of the patients who did not already have a pacemaker, 27.8% needed one after EVOQUE, compared with 3.8% on medication alone (P<0.001).
Why EVOQUE rather than tricuspid edge-to-edge repair?
There are two main transcatheter options for a leaking tricuspid valve: repairing the patient’s own valve with clips (tricuspid edge-to-edge repair), or replacing it with EVOQUE. The choice depends mainly on the anatomy of the valve, which is assessed in detail with a transoesophageal echocardiogram and a CT scan.
- Edge-to-edge repair works best when the leaflets can be brought together. It keeps the patient’s own valve and rarely affects the heart’s electrical wiring. However, it often leaves some leak behind.
- EVOQUE can be used 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 of repair. It usually removes the leak almost completely. The trade-off is a higher chance of needing a pacemaker, and a need for blood-thinning medication afterwards.
Is everyone suitable for EVOQUE?
Not every tricuspid valve is suitable. Patients being considered for EVOQUE are invited for a screening day, with a detailed transoesophageal echocardiogram (TOE) and a CT scan. The results are reviewed by the team and also by the valve manufacturer to decide whether EVOQUE is suitable.
In a 2026 study from a large US centre, about 1 in 6 patients referred for tricuspid treatment (17%) were not suitable, most often because the valve was too large [7]. Early screening studies had found many more patients unsuitable. Where EVOQUE is not suitable, other options such as tricuspid edge-to-edge repair or TricValve may be.
Are the results as good outside clinical trials?
Results from routine practice since approval have been better than in the trials on several measures.
- United States: in the first 1,034 EVOQUE procedures after FDA approval, at 82 hospitals, the valve was implanted successfully in 98% of patients, and the leak was mild or less in 98% at one month. Slightly fewer patients died within 30 days than in TRISCEND II (3.1% compared with 3.5%). Far fewer of those without a pacemaker needed one (16% compared with 28%) [8].
- Europe: a series of 176 patients treated at 12 European centres after the CE mark found less severe bleeding (7%) and fewer new pacemakers (19% of those without one) than in the trials [9].
References
- Zack CJ, et al. National trends and outcomes in isolated tricuspid valve surgery. Journal of the American College of Cardiology 2017;70:2953–2960. doi:10.1016/j.jacc.2017.10.039
- Fam NP, et al. Transfemoral transcatheter tricuspid valve replacement with the EVOQUE system: a multicenter, observational, first-in-human experience. JACC: Cardiovascular Interventions 2021;14:501–511. doi:10.1016/j.jcin.2020.11.045
- Kodali S, et al. Transfemoral tricuspid valve replacement in patients with tricuspid regurgitation: TRISCEND study 30-day results. JACC: Cardiovascular Interventions 2022;15:471–480. doi:10.1016/j.jcin.2022.01.016
- Kodali S, et al. Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study. European Heart Journal 2023;44:4862–4873. doi:10.1093/eurheartj/ehad667
- Hahn RT, et al. Transcatheter valve replacement in severe tricuspid regurgitation (TRISCEND II). New England Journal of Medicine 2025;392:115–126. doi:10.1056/NEJMoa2401918
- 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
- Andrews T, et al. Real-world suitability of patients for transcatheter tricuspid valve replacement. American Journal of Cardiology 2026;264:1–6. doi:10.1016/j.amjcard.2026.01.002
- Makkar RR, et al. Real-world outcomes of transcatheter tricuspid valve replacement: analysis from the STS/ACC TVT Registry. JAMA 2026;335:1606–1615. doi:10.1001/jama.2026.3446
- Angellotti D, et al. Early outcomes of real-world transcatheter tricuspid valve replacement. JACC: Cardiovascular Interventions 2025;18:1896–1909. doi:10.1016/j.jcin.2025.06.002