Tricuspid Transcatheter Therapies: Emerging Data and Clinical Applications

Tricuspid regurgitation (TR) is a progressive and highly prevalent valvular heart disease with an estimated incidence of 160,000-240,000 new cases per year in the United States.^1-3 Untreated severe TR is associated with substantial morbidity, progressive deterioration in quality of life (QOL), and heightened mortality risk.^4-6 Isolated tricuspid valve surgery is rarely performed due to high surgical risk, particularly for those with later-stage heart failure and end-organ dysfunction. Transcatheter tricuspid valve intervention has thus emerged as a novel therapeutic option, with > 25 devices currently undergoing preclinical or early feasibility testing.^3,7 Transcatheter tricuspid valve intervention approaches for patients with symptomatic severe TR include tricuspid transcatheter edge-to-edge repair (T-TEER), annuloplasty devices, orthotopic (ie, deployed at the level of the tricuspid valve) transcatheter tricuspid valve replacement (TTVR), and heterotopic bicaval valve implantation (CAVI).

There are currently only two devices approved in the United States for transcatheter tricuspid valve intervention: TriClip (Abbott) for T-TEER and Evoque (Edwards Lifesciences) for TTVR. In Europe, there are five devices with CE Mark approval: TriClip and Pascal (Edwards Lifesciences) for T-TEER, the Cardioband system (Edwards Lifesciences) for annuloplasty, Evoque for TTVR, and TricValve (P&F Products Features) for CAVI.

ASSESSMENT OF TR

Based on imaging findings, TR can be classified as primary (intrinsic leaflet or subvalvular abnormality), atrial secondary (atrial dilation often secondary to atrial fibrillation), ventricular secondary (right ventricular [RV] dysfunction and dilation leading to leaflet tethering), or cardiac implantable electronic device–related (lead interference with leaflet motion). Transthoracic echocardiography and transesophageal echocardiography remain the mainstay imaging modalities for the initial diagnosis, patient selection, procedural monitoring, and follow-up of patients being considered for transcatheter tricuspid valve intervention. Cardiac CTA is integral for preprocedural evaluation, and cardiac MR offers an adjunct modality that can be used in complex cases to assess RV structure and function, as well as to rule out other pathologies. Assessment of RV reserve (by cardiopulmonary exercise test with ventriculography, stress echo, or MRI) and pulmonary vascular function is also important, as treatment of TR will increase RV afterload. Preprocedural imaging should ideally be performed in a euvolemic and clinically compensated state on a stable diuretic regimen, as RV size and function are highly preload dependent. Management of TR and the optimal timing of referral for transcatheter tricuspid valve intervention is evolving, guided by growing insights into procedural risk and the potential benefits of earlier intervention. Staging and treatment options should be reviewed by a multidisciplinary heart valve team, including structural interventionalists, cardiac surgeons, structural/interventional echocardiographers, cardiac radiologists, and heart failure cardiologists.

CONTEMPORARY DATA ON APPROVED DEVICES

T-TEER With TriClip

The TRILUMINATE pivotal trial was the first randomized evaluation comparing T-TEER with TriClip versus optimal medical therapy (OMT) alone. The composite primary endpoint at 1 year was death, tricuspid valve surgery, heart failure hospitalization (HFH), and improvement in QOL, and it favored the T-TEER group. This was primarily driven by an improvement in QOL, as reflected by an absolute improvement in the mean Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score of 12.3 points (SD, 1.8), with no significant differences in the incidence of death, tricuspid valve surgery, or HFH. T-TEER demonstrated a favorable safety profile, with 98.3% of patients free from major adverse events at 30 days.⁸ Similar results were noted in the full randomized cohort of the TRILUMINATE pivotal trial (N = 572), with improvement in KCCQ and 6-minute walk distance (6MWD) and no significant difference in mortality, tricuspid valve surgery, or HFH at 1 year.⁹ Across the TRILUMINATE trials, improvements in KCCQ score and 6MWD correlated with the degree of TR reduction, with the greatest benefit seen in patients achieving ≥ 2 grades of reduction.^8,9

In the Tri.Fr trial, 300 patients were randomized to TriClip or OMT alone. T-TEER improved the primary composite endpoint of change in New York Heart Association (NYHA) class, change in patient global assessment (PGA), or occurrence of major cardiovascular events (death or HFH).¹⁰ This was driven by improvement in the NYHA class and PGA, with no difference in mortality or HFH at 1 year. Successful deployment was noted in 97.3% of patients, and the absolute difference in KCCQ score at 1 year was 14.5 (SD, 27.2).¹⁰ T-TEER also displayed an excellent safety profile, with a major adverse event rate of 0.7% at 30 days.¹⁰

TTVR With Evoque

In the prospective, single-arm, multicenter TRISCEND study, the safety and efficacy of the Evoque TTVR system were assessed in 176 patients in North America and Europe with moderate or greater symptomatic TR despite OMT.¹¹ Device and procedural success rates were 94.4% and 93%, respectively. The prespecified 30-day safety endpoint occurred in 18.6%, with cardiovascular death in 1.7% and severe bleeding in 16.9%. At 1 year, TR was reduced to mild or less in 97.6%, with all-cause mortality of 9.1%, HFH of 10.2%, and new pacemaker implantation in 13.3%.

In TRISCEND II—the first randomized trial of TTVR—400 patients with severe TR were randomized 2:1 to TTVR with Evoque or OMT alone.¹² The win ratio of 2.02 for the primary endpoint (composite of death, RV assist device implantation or heart transplant, tricuspid valve intervention, HFH, improvement in KCCQ ≥ 10 points, and NYHA ≥ 1 functional class) favored TTVR, driven predominantly by an improvement in KCCQ and NYHA functional class. At 30 days, reduction in TR to mild or less was achieved in 95.3% of patients in the TTVR arm compared with 2.3% in the OMT group. Within the TTVR cohort, major adverse events included mortality in 3.5%, severe bleeding in 10.4%, and new pacemaker implantation in 24.7% of patients at 30 days.

DEVICE SELECTION AND CLINICAL APPLICATION

Selecting the optimal device for transcatheter tricuspid valve intervention remains challenging given the uncertainties around indication and timing and the limited data on long-term outcomes. In contemporary practice, T-TEER remains the most commonly used transcatheter tricuspid valve intervention, largely due to its procedural safety, widespread accessibility, and lower costs.¹³ Several single-arm studies and the TRILUMINATE trial have demonstrated the safety of T-TEER and its efficacy in reducing TR.^8,14-17 Nonetheless, its ability to achieve substantial and durable reduction in TR is limited compared to TTVR, and residual moderate-to-severe TR has consistently shown to be associated with worse prognosis.¹⁸ This raises uncertainty as to whether T-TEER should remain the initial therapeutic approach or whether TTVR should be considered more broadly. Conversely, while TTVR achieves more complete elimination of TR, this comes at a higher incidence of new pacemaker implantations (13%-25%) and a potential detrimental effect on the RV from afterload mismatch, particularly in patients with preexisting moderate-to-severe RV dysfunction.^11,12 Further studies are needed to guide the choice between these strategies.

Tricuspid valve anatomy is inherently complex, with true three-leaflet morphology present in only approximately 60% of patients.¹⁹ Beyond leaflet variability, the right atrium and ventricle are highly sensitive to volume status, and the subvalvular apparatus adds further challenges for imaging, device delivery, and procedural success. Favorable anatomy for T-TEER includes an anteroseptal jet location, coaptation gap ≤ 7 mm, localized leaflet prolapse, bi- or trileaflet morphology, absence of pacemaker leads, and adequate echocardiographic leaflet visualization.

Selection for TTVR is typically guided by anatomic and clinical complexity. Features that limit the feasibility of TEER and make replacement more suitable include multiple valve leaflets (> 3), large coaptation gaps (> 8.5 mm), nonanteroseptal regurgitant jets, marked leaflet tethering, and presence of pacing or defibrillator leads. Additionally, TTVR can be considered when residual significant TR persists after a failed T-TEER attempt, in the case of single-leaflet detachment, or when imaging quality is inadequate for TEER guidance. Patients with advanced RV dysfunction and poor ventricular-arterial coupling may derive limited benefit from TTVR and may be better candidates for T-TEER, although the overall therapeutic effect of any tricuspid intervention may remain modest at best in this subgroup of patients.

EMERGING DATA

Several ongoing and recently completed studies have evaluated emerging transcatheter tricuspid therapies, providing important insights into their safety and efficacy. The CLASP TR study enrolled 65 patients and reported implant and clinical success rates of 91% and 77% respectively.²⁰ In PASTE—the largest real-world (retrospective and prospective) registry of T-TEER with the Pascal device—investigators noted implant and procedural success rates of 98% and 95%, respectively.²¹ TR was reduced to moderate or less in 87% and mild or less in 55% of patients.²¹ Notably, use of the clover technique (ie, concomitant treatment of the anteroseptal and posteroseptal lines of coaptation) was associated with superior echocardiographic outcomes, and both intraprocedural and clinical success at 30 days and 1 year were higher in centers with greater experience.²¹

The prospective TRI-REPAIR study assessed the safety and performance of the Cardioband tricuspid system. A 100% technical success was reported in the 30 enrolled patients, along with 82% improvement in NYHA to class I or II, improvement in 6MWD increase by 73 meters, and improvement in KCCQ score by 14 points at 2 years.²²

The prospective, single-arm TRICUS and TRICUS EURO studies had a combined cohort of 44 patients and reported improved QOL in 95% of patients undergoing CAVI with TricValve (improvement of KCCQ ≥ 15 points, increase in 6MWD ≥ 40 m, or improvement to NYHA class I or II).²³ At 1 year, there was a 6.8% mortality rate and 29.5% HFH rate.²³

The TRAVEL study of 126 patients treated with the LuX-Valve (Jenscare) demonstrated 98.4% procedural success, sustained reduction to mild or less TR in 95.2% patients, 10.3% mortality and 4% HFH at 1 year.²⁴

In a compassionate-use experience of 20 patients with the Cardiovalve TTVR system (Venus Medtech), device success was achieved in 90%, with 95% showing mild or lower TR at 30 days and 10% mortality.²⁵ Early feasibility has also been demonstrated with the VDyne (VDyne, Inc.) and MonarQ (Peijia Medical) valves in compassionate use cases.^26,27

Key Ongoing Trials

Key ongoing trials of transcatheter tricuspid valve intervention include TRICI-HF, a 2:1 randomized trial comparing transcatheter tricuspid valve intervention with Cardioband or TriClip to OMT; TRINITY, a prospective, single-arm study evaluating the LuX-Valve Plus TTVR system; TRICAV, a 1:1 randomized trial of TricValve versus OMT; and TRACE-NL, a 2:1 randomized study of TriClip or Pascal versus OMT. These studies highlight the expanding armamentarium of T-TEER, annuloplasty, orthotopic, and heterotopic transcatheter tricuspid valve intervention devices.

CONCLUSION

Transcatheter tricuspid valve intervention has transformed the treatment landscape of severe TR, offering safe and effective alternatives for patients at high surgical risk. T-TEER remains the most widely used approach due to its safety and accessibility, while TTVR provides more complete elimination of TR at the expense of higher procedural complexity and higher rates of pacemaker implantation. As device technologies evolve, careful patient selection and multidisciplinary evaluation will be critical to optimize outcomes and define the role of each therapy in clinical practice.

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