This article is based primarily on a Nail It With Nadira: The Next Wave of Tricuspid Valve Replacement, featuring Nadera Hamid. Comments reflect the views and clinical experience of the individual speakers and should be interpreted within the context of ongoing clinical investigation.

As VDyne, Topaz, Intrepid and Laplace advance through clinical development, experts discussing the next generation of TTVR argued that the future of tricuspid intervention will be defined by patient selection, RV physiology and platform-specific design features, with different devices potentially serving different anatomical and clinical needs.

Take-home Messages

• The field is moving beyond proving that transcatheter tricuspid valve replacement (TTVR) works and towards determining which patients are best served by specific platforms.
• Emerging devices are increasingly leaflet-independent, potentially expanding eligibility among patients excluded from current repair and replacement technologies.
• Complete elimination of tricuspid regurgitation (TR) remains the major advantage of TTVR, but questions remain regarding durability, antithrombotic management, leaflet thrombosis and long-term follow-up.
• Right ventricular (RV) function and afterload mismatch remain important unresolved clinical challenges.
• Operators increasingly foresee intracardiac echocardiography (ICE), conscious sedation and fluoroscopy-guided workflows replacing traditional imaging-intensive procedures.
• A recurring theme throughout the discussion was that future tricuspid programmes will likely require several complementary TTVR devices rather than one dominant platform.

A field entering a new phase

The latest episode of Nail It With Nadira: The Next Wave of Tricuspid Valve Replacement, hosted by Dr Nadira Hamid and Professor Nicolas Van Mieghem, brought together investigators involved in several emerging TTVR programmes to discuss where the field is heading and what questions remain unanswered.

Importantly, the discussion was not framed as a competition between devices. Instead, speakers repeatedly returned to a broader question: how should structural heart teams choose between an expanding range of replacement technologies, and how should TTVR fit alongside tricuspid edge-to-edge repair (T-TEER)?

"The real question now," Dr Hamid said, "is how do we utilise these TTVR platforms in our clinical practice? How do we choose cases in our heart valve team? How do we distinguish these patients and what valve is best for our patients?"

That perspective reflects the current state of the field. Following growing evidence supporting transcatheter intervention for severe symptomatic TR, attention is increasingly shifting from feasibility towards patient selection, procedural optimisation and long-term management (Kovács et al., 2024; Hahn et al., 2024).

VDyne seeks broader applicability through leaflet-independent design

Presenting the VDyne system, Dr Susheel Kodali focused on design features intended to overcome some of the limitations that continue to exclude patients from current tricuspid therapies.

The valve uses an elliptical design intended to conform more naturally to the tricuspid annulus and anchors within the right ventricular outflow tract (RVOT) and posterior annular region. Unlike some repair technologies, implantation does not depend on leaflet morphology or leaflet capture.

For Dr Kodali, this may become increasingly important as operators seek to simplify procedures and expand access.

"This is leaflet agnostic. You don't need the imaging and leaflet characteristics that have excluded patients in some trials."

The system is also fully repositionable and retrievable prior to final release, allowing operators to assess valve stability before committing to deployment. Another distinguishing feature is a dedicated "pop-off" channel that could potentially permit future pacemaker lead placement or controlled residual regurgitation if required.

While early procedural success rates reflected the learning curve typical of new structural technologies, Dr Kodali noted substantial improvements with experience and device iteration. More recent experience has been associated with high implantation success and lower pacemaker rates.

One particularly interesting aspect of the presentation involved RV physiology. Dr Kodali highlighted evidence suggesting that successful elimination of TR results in RV remodelling and improved forward stroke volume, even when conventional measurements of RV ejection fraction decline.

"As you eliminate TR, you're going to get a drop in RV function as you measure EF, but forward stroke volume, which is what we care about, does improve."

This observation aligns with growing interest in how clinicians should assess RV recovery after TTVR, as traditional RV metrics may not accurately reflect haemodynamic improvement (Lurz et al., 2024).

Intrepid evolves from a mitral platform to a dedicated tricuspid system

Presenting Medtronic's Intrepid programme, Dr Firas Zahr described a technology that has undergone significant evolution since its earliest tricuspid experience.

The first-generation system was adapted from the company's transcatheter mitral valve replacement platform. Subsequent iterations have introduced a softer frame, lower radial force, a reduced ventricular footprint and dedicated sizing options designed specifically for tricuspid anatomy.

These developments are intended to reduce conduction disturbances and minimise RV injury while improving suitability for larger annuli.

However, Dr Zahr repeatedly emphasised that selecting patients involves far more than anatomical measurements.

"The problem with TR is sometimes it is the disease, but many times it is the symptom."

His comments highlighted a growing recognition that severe TR encompasses multiple disease phenotypes, including atrial functional TR, lead-related TR, pulmonary hypertension-associated TR and left-heart disease-related TR.

According to Dr Zahr, understanding the cause of RV dysfunction may ultimately be as important as understanding annular anatomy when deciding whether replacement is appropriate.

That question remains particularly relevant because RV afterload mismatch following complete TR elimination continues to be one of the major uncertainties across all TTVR programmes (Hahn et al., 2025).

Laplace focuses on procedures that are simple, recapturable and anatomically inclusive

Among the emerging platforms discussed, the Laplace (LLAS) TTVR system generated considerable interest because of its focus on anatomies that are frequently excluded from existing technologies.

Presenting the early experience, Dr Kashish Goel described a system that anchors using two principal structures: an anterior flap positioned within the RVOT and a posterior anchoring shelf that provides the primary fixation point.

According to Dr Goel, successful engagement of the posterior shelf is the key step in the procedure.

"The posterior shelf is the most important thing. Once that is anchored, the rest of the procedure is a cakewalk."

The valve remains fully recapturable until final release through a multi-stage deployment process that allows repositioning if necessary.

One notable aspect of the Laplace experience was the nature of the patients treated.

"The majority of patients actually treated in the EFS were rejects for EVOQUE."

Dr Goel explained that many enrolled patients had anatomical characteristics traditionally associated with screening failure, including:

• Small right atria
• Small right ventricles
• Pacing leads
• Failed T-TEER procedures
• Severe leaflet tethering
• Flail leaflets
• Carcinoid valve disease

The ability to treat these patients contributed to a screen-pass rate of approximately 65%, despite the complexity of the population.

Procedural simplicity also emerged as a central theme. Unlike technologies that require extensive leaflet assessment, the Laplace system relies largely on confirming anchoring at the posterior shelf.

"It relies on imaging, but mostly for that one step, which is very easy to see."

In early experience, technical success exceeded 90%, pacemaker implantation remained within single digits and significant improvements in NYHA class, KCCQ scores and six-minute walk distance were observed.

As seen with other replacement platforms, CT follow-up demonstrated evidence of RV reverse remodelling and improvements in forward stroke volume following elimination of TR.

With the addition of Topaz, I would revise both the standfirst/first paragraph and the take-home messages because the story is no longer primarily about leaflet-independent, annular replacement systems. One of the most interesting new themes from Dr Fam's presentation is that platforms are beginning to differentiate themselves around conduction-system preservation, RV interaction and anatomical conformity, rather than simply TR elimination.

Topaz takes a different approach, prioritising anatomical conformity and conduction-system preservation

While several emerging TTVR platforms focus on annular anchoring and leaflet-independent implantation, Dr Neil Fam highlighted a different design philosophy with the Topaz system.

The device combines a very soft nitinol outer frame with a rigid inner valve stent. Rather than relying on substantial radial force, it conforms to native tricuspid anatomy and anchors using small atraumatic fixation elements attached to the subvalvular apparatus and chordae.

"If you hold it in your hand, you can basically squish it into whatever shape you want and it'll conform to that triangular shape of the tricuspid annulus."

The system can be delivered via either transfemoral or transjugular access through a 29 Fr steerable sheath and is now available in larger sizes capable of treating annular dimensions up to 57 mm.

According to Dr Fam, one of the most intriguing observations from the early clinical experience has been a consistently low rate of new pacemaker implantation.

Data from the 20-patient European TRIcURE first-in-human study demonstrated 100% achievement of none or mild residual TR at 30 days, while no permanent pacemakers were required. Similar findings have been observed in the Canadian experience, where only a single pacemaker has been implanted across nearly 20 treated patients, according to Dr Fam.

When asked why the pacemaker incidence appeared lower than reported with some other replacement systems, he pointed to the valve's minimal radial force and limited interaction with the conduction system.

"I think it just doesn't put pressure on the conduction system. You're not coming close to the membranous septum at all with this device."

The discussion highlighted an important emerging question for the field: whether different TTVR platforms may ultimately produce different conduction-system, RV remodelling and haemodynamic profiles.

Dr Fam also presented a compassionate-use case involving torrential functional TR, severe ventricular dysfunction and an ICD lead traversing the tricuspid valve. Following lead manipulation and Topaz implantation, complete elimination of TR was achieved without evidence of paravalvular leak, despite the retained lead.

However, he acknowledged that the device has its own anatomical limitations. Patients with very shallow right ventricles or moderator bands positioned close to the annulus may not provide adequate space for full expansion of the ventricular component.

"If you've got a shallow RV and a moderator band which is close to the annulus, then probably Topaz is not the best choice for that individual patient."

Importantly, Dr Fam's presentation reinforced what became a recurring theme throughout the session: future success in TTVR may depend less on identifying one superior valve and more on understanding which anatomical and physiological characteristics favour one platform over another.

Imaging may be evolving faster than expected

One of the most thought-provoking parts of the discussion centred on procedural imaging.

As an imaging specialist, Dr Hamid challenged the panel to consider whether TTVR procedures could eventually be performed using ICE and 3D ICE instead of routine transoesophageal echocardiography (TEE).

The response from operators was remarkably consistent.

Several reported performing commercial procedures under conscious sedation using ICE guidance alone.

"I think that will be the standard of care in the future," said Dr Neil Fam.

Because many emerging TTVR systems are increasingly leaflet-independent, operators believe future procedures may become primarily fluoroscopy-guided with more limited imaging requirements.

If realised, that transition could lower procedural complexity and facilitate broader adoption beyond highly specialised centres.

Repair versus replacement remains an open debate

The webinar concluded with a discussion of perhaps the most controversial question in contemporary tricuspid intervention: should replacement be preferred when both TTVR and T-TEER are technically feasible?

Audience polling revealed that 57% of participants favoured replacement, while only 14% selected T-TEER.

The result surprised some members of the panel.

Professor Van Mieghem cautioned against overlooking unresolved questions surrounding replacement technologies, including:

• Long-term durability
• Leaflet thrombosis
• Optimal anticoagulation strategies
• Long-term surveillance requirements

At the same time, several speakers highlighted limitations of repair.

"The longer you follow these patients, unless you got mild TR at the end of the procedure, if you have moderate, it gets worse," Dr Fam said.

Others pointed to the profound symptomatic improvements often observed after complete elimination of regurgitation.

"If we can develop a repair therapy that eliminates TR predictably, I'm for it. But right now we don't have it," Dr Goel said.

Notably, none of the panellists argued that replacement should completely replace repair. Instead, the consensus was that both approaches will likely remain necessary.

One of the most important messages: no one argued for a single valve

The speakers repeatedly argued that future practice will require multiple treatment options.

As TTVR evolves, distinctions in anchoring mechanisms, imaging requirements, access strategies, annular sizing ranges and interaction with pacing leads may make different platforms preferable for different patients.

"We don't need 10 valves, but we probably need two or three," Dr Fam concluded.

Similarly, Dr Goel suggested that ongoing randomised studies may help the field move towards a truly personalised approach to treating severe TR.

"These randomised trials are going to give us a humongous amount of data. We will be able to treat patients almost like personalised care."

For now, that may be the most important take-home message from the discussion. The era of proving that transcatheter tricuspid valve replacement is feasible appears largely complete. The next phase will be defining how different replacement technologies can be used most effectively, safely and appropriately in real-world practice.

References

Hamid N, Van Mieghem NM, Kodali SK, Zahr F, Fam NP, Goel K. Nail It With Nadira: The Next Wave of Tricuspid Valve Replacement. Radcliffe Cardiology webinar transcript, July 2026. (Primary source).

Grayburn PA, Kodali SK, Hahn RT, et al. (2024). TRISCEND II: Novel Randomized Trial Design for Transcatheter Tricuspid Valve Replacement. American Journal of Cardiology, 225, 171-177.

Hahn RT, Kodali SK, Smith RL, et al. (2024). Contemporary transcatheter tricuspid valve interventions: current evidence and future directions. JACC: Cardiovascular Interventions, 17, 1425-1440.

Kovács A, Praz F, Lurz P, et al. (2024). Management of severe tricuspid regurgitation in the transcatheter era. Nature Reviews Cardiology, 21, 657-672.

Lurz P, Fam NP, Zahr F, et al. (2024). Right ventricular remodelling following transcatheter tricuspid valve replacement: current evidence and unresolved questions. EuroIntervention, 20, e1024-e1033.

Hahn RT, Lurz P, Taramasso M, et al. (2025). Replacement versus repair for severe tricuspid regurgitation: emerging evidence and future directions. European Heart Journal, 46, 2214-2225.