Interventional procedure overview of transcatheter tricuspid valve implantation for tricuspid regurgitation

Abushouk A, Layoun H, Harb SC et al. (2024) Real-World Patient Eligibility and Feasibility of Transcatheter Edge-to-Edge Repair or Replacement Interventions for Tricuspid Regurgitation. Journal of cardiac failure 30: 1265–72

Observational study

n=128

Follow-up: 1 year

A total of 11% of the population were deemed eligible for investigative therapies, 20% were offered off-label clipping, 20% were offered surgery and 49% had medical treatment.

At 1 year, there was a statistically significant reduction in TR severity in the investigative group (p<0.001) in comparison with the medical treatment group. However, the results were comparable to off-label clipping (p=0.60) and inferior to surgery (p=0.04). Current real-world eligibility for emerging transcatheter TR therapies remains limited, underscoring the need for continued innovative efforts to offer device therapies to a broader TR cohort.

Observational study focusing on the eligibility of people for transcatheter TR treatments.

Barreiro-Perez M, Gonzalez-Ferreiro R, Caneiro-Queija B et al. (2023) Transcatheter Tricuspid Valve Replacement: Illustrative Case Reports and Review of State-of-Art. Journal of Clinical Medicine 12(4), 1371

Review and case series (n=3)

Cardiovalve (n=2) and LuX-Valve Plus (n=1)

Transcatheter TV interventions are an appealing treatment option for a common disease in a group of people often with comorbidities, high surgical risk, and poor surgical outcomes when not addressed at an early stage. Particularly, TTVR with orthotopic prosthetic valves offers a definitive treatment maintaining the physiological functions of right heart chambers (as opposed to heterotopic prosthesis) and the possibility of treatment of people with contraindications to other percutaneous interventions such as edge-to-edge repair or annuloplasty devices.

The paper describes a small case series and a non-systematic review.

Cannata F, Sticchi A, Russo G et al. (2025) Mitral regurgitation evolution after transcatheter tricuspid valve interventions - A sub-analysis of the TriValve registry.

European Heart Journal Cardiovascular Imaging 26: 135

Subanalysis of TriValve registry

n=359 (12 TTVR)

Most cases of 'evolving mitral regurgitation' showed an improvement, above all if transcatheter tricuspid valve intervention is successful and if baseline characteristics associated with a ventricular functional mitral regurgitation subtype are present. Moreover, an effective transcatheter tricuspid valve intervention with significant TR reduction may prevent mitral regurgitation worsening and possibly trigger an improvement.

Most people had transcatheter edge-to-edge repair and only a small proportion had TTVR.

Chen Y, Cai C, Qiao F et al. (2022) Preoperative 6-minute walk test predicts prolonged hospitalization after transcatheter tricuspid valve replacement. Medicine 101: e32379

Retrospective cohort study

n=41

Preoperative decreased 6MWT distance was an independent risk factor for prolonged hospitalisation in high-risk TR patients after TTVR.

Larger studies are included.

Dershowitz L, Lawlor MK, Hamid N et al. (2024) Right ventricular remodeling and clinical outcomes following transcatheter tricuspid valve intervention. Catheterization and Cardiovascular Interventions 103: 367–75

Single-centre retrospective cohort study

n=61 (25 TTVR)

Follow-up: 147 days

Greater TR reduction was achieved by TTVR versus transcatheter tricuspid valve repair, which was in turn associated with RV reverse remodelling. RV dimension in follow-up was associated with increased risk of a composite outcome of death, heart failure hospitalisation, or redo tricuspid valve intervention.

Small retrospective study with mixed interventions.

Fam NP, von Bardeleben RS, Hensey M et al. (2021) Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience. JACC. Cardiovascular interventions 14: 501–11

Observational single arm study

n=25

Follow-up: 30 days

EVOQUE system (Edwards Lifesciences, US)

There were statistically significant improvements in NYHA functional class, signs of right-sided heart failure, and biochemical indexes of hepatic congestion, with a subset of people needing fewer diuretic agents at

30-day follow-up. As expected, right ventricular function was slightly reduced at follow-up, but this was offset by significant reductions in pre-load and right ventricular volumes with evidence of reverse remodelling by echocardiographic and CT assessment.

The main complications were valve reintervention (4%), new conduction abnormalities requiring permanent pacemaker implantation (8%), and major bleeding (12%).

36% of people had pacemaker leads, and all had successful TTVR with either no or mild paravalvular TR at the site of the lead, with no change in pacemaker function, including patients who were pacemaker dependent at baseline.

Larger studies are included.

Hagemeyer D, Merdad A, Sierra LV et al. (2024) Clinical Characteristics and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement: The TriACT Registry.

JACC. Cardiovascular interventions 17: 552–60

Multicentre observational study (TriACT registry)

n=38

Follow-up: 30 days

EVOQUE (Edwards Lifesciences), Cardiovalve (Cardiovalve), Topaz (TRiCares) and VDyne (VDyne)

A total of 149 people with TR were screened but only 38 were eligible for TTVR.

There were statistically significant functional improvements (NYHA functional class 1 or 2 from 21% to 68%, p<0.001), with TR 1 or less in 97% at 30-day follow-up (p<0.001 from baseline). Technical success was 91%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 8%, heart failure hospitalisation 5%, major bleeding 18%, and reintervention 9%.

Larger studies are included.

Hahn RT, George I, Kodali SK et al. (2019) Early Single-Site Experience With Transcatheter Tricuspid Valve Replacement. JACC. Cardiovascular Imaging 12: 416–29

Single centre case series

n=5

Follow-up: 30 days

GATE System (NaviGate

Cardiac Structures, Inc., US)

In this series of people with symptomatic, very severe functional TR, TTVR was feasible with short-term improvement in RV remodelling and cardiac output. Comorbidities, particularly right ventricular function, might be important determinants of outcomes.

Larger studies are included.

Hahn RT, Kodali S, Fam N et al. (2020) Early Multinational Experience of Transcatheter Tricuspid Valve Replacement for Treating Severe Tricuspid Regurgitation. JACC. Cardiovascular Interventions 13: 2482–93

Multicentre case series

n=30

Mean follow-up: 127 days

GATE System (NaviGate

Cardiac Structures, Inc., US)

Device malpositioning happened in 4 people, with conversion to open heart surgery in 2 (5%). Of those who had the device, 100% had reductions in TR of 1 or more, and 75% had reductions of 2 or more grades. In most people (79%), there was continued improvement in TR grade between discharge and 30 days.

Larger studies are included.

Hausleiter J, Stolz L, Lurz P et al. (2025) Transcatheter Tricuspid Valve Replacement. Journal of the American College of Cardiology; 85: 265–91

Review

Clinical outcomes from initial studies and compassionate use cases highlight the effectiveness of TTVR in reducing TR, inducing reverse right ventricular remodelling, and enhancing patients' quality of life.

There are still uncertainties about the effect of TTVR on hard clinical endpoints such as mortality and heart failure hospitalisation.

Potential complications and challenges associated with TTVR include new-onset conduction disturbances, bleeding complications, and afterload mismatch.

TTVR is currently mainly done when transcatheter edge-to-edge repair is unsuitable, but it may expand to include the situation when expected TR reduction from repair is suboptimal.

Future research will address whether there are differences between the available devices.

A systematic review and meta-analysis is included.

Khan MS, Baqi A, Tahir A et al. (2024) National Estimates for the Percentage of All Readmissions With Demographic Features, Morbidity, Overall and Gender-Specific Mortality of Transcutaneous Versus Open Surgical Tricuspid Valve Replacement/Repair. Cardiol Res. 15: 223–32

Retrospective observational study (data from a US Nationwide Readmissions Database)

n=10,506 (429 TTVR)

TTVR is an emerging alternative to open TVR in people with TV disease, especially high-risk populations with severe TR to improve the quality of life. Analysis of a large pool of NRD data has shown promising trends towards lower morbidity and mortality and lower overall healthcare cost burden with TTVR compared to open TVR.

Limited data, which includes both transcatheter repair and replacement.

Kodali S, Hahn RT, George I et al. (2022) Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. JACC. Cardiovascular Interventions 15: 471–80

Prospective, single-arm, multicentre study (TRISCEND)

n=56

Follow-up: 30 days

EVOQUE system (Edwards Lifesciences, US)

At 30 days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 27% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolisation, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. NYHA significantly improved to functional class 1 or 2 (79%; p<0.001), 6-minute walk distance improved 49.8 m (p<0.001), and KCCQ score improved 19 points (p<0.001).

A more recent publication of the same study with longer follow-up is included.

Lawlor MK, Ng V, Ahmed S et al. (2023) Baseline Characteristics and Clinical Outcomes of a Tricuspid Regurgitation Referral Population. American Journal of Cardiology 196: 22–30

Retrospective observational study

n=408

(77 had transcatheter tricuspid valve interventions)

Advanced regurgitation severity and right-sided cardiac remodelling with haemodynamic decompensation portend poor prognosis in TR, and late referral for surgical therapy with advanced disease is associated with high rates of morbidity and mortality.

People who had transcatheter tricuspid valve interventions were at greater preoperative risk than were those who had surgery. Further study is warranted to investigate risk stratification and selection for and timing of procedural intervention in people with TR.

It is unclear what the transcatheter interventions were and the aim of the study was to characterise the natural history of the highly selected TR referral population.

Lawlor MK, Hamid N, Kampaktsis P et al. (2022) Incidence and predictors of cardiogenic shock following surgical or transcatheter tricuspid valve intervention. Catheterization and Cardiovascular Interventions 99: 1668–78

Retrospective single centre observational study

n=122 (28 TTVR)

In people who have TV intervention for TR, surgery versus transcatheter tricuspid valve intervention and elevated central venous pressure are associated with advanced postprocedural cardiogenic shock. Patients developing advanced CS are at increased risk of in-hospital mortality.

Only a small proportion of the study population had TTVR.

Liu J, Tan T, Huang H et al. (2023) Outcomes of minimally invasive isolated tricuspid valve reoperation after left-side valve surgery: A single-center experience. Frontiers in Cardiovascular Medicine 10: 1033489

Retrospective single-centre cohort study

n=21 (5 TTVR)

Median follow-up: 16.8 months

LuX-Valve

Minimally invasive procedures were successfully done without any perioperative mortality, sternotomy conversion, or reoperation. NYHA class improved from baseline (p=0.004). TR severity was significantly improved during postoperative and follow-up period (both p<0.001). Compared with the endoscopic group, the TTVR group had a higher clinical risk score (8.00 versus 5.00, p=0.001), but a higher success rate in reducing TR to less than grade 1+ (100 versus 44%, p=0.045) at follow-up.

Only a small proportion of the study population had TTVR.

Lu F-L, An Z, Ma Y et al. (2021) Transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation. Heart 107: 1664–70

Multicentre cohort study

n=46

Follow-up: 6 months

LuX-Valve

Radial force-independent transcatheter bioprosthetic tricuspid valve replacement in high-risk patients with severe TR is feasible, safe and with low complication rates.

Larger studies are included.

Lu F-L, Ma Y, An Z et al. (2020) First-in-Man Experience of Transcatheter Tricuspid Valve Replacement With LuX-Valve in High-Risk Tricuspid Regurgitation Patients. JACC. Cardiovascular Interventions 13: 1614–16

Prospective case series

n=12

LuX-Valve

Transthoracic echocardiography at 30 days showed none-to-mild residual TR was documented in all but 1 patient (91%). Significant symptomatic improvement was observed with improved 6-minute walk tests (377 versus 277.5 metres, p<0.05) and NYHA functional status (54.5% at NYHA functional class 2; p<0.05).

Larger studies are included.

Mao Y, Li L, Liu Y et al. (2022) Safety, efficacy, and clinical outcomes of transcatheter tricuspid valve replacement: One-year follow-up. Frontiers in Cardiovascular Medicine 9: 1019813

Single-centre observational study

n=15

Follow-up: 1 year

LuX-Valve

TR was significantly reduced to 2+ or less. One person died on postoperative day 12 of a pulmonary infection that was considered unrelated to the procedures or the devices. The remaining 14 people reached the primary end point. One person was rehospitalised during 1-year follow-up because of device thrombosis. 79% of people had NYHA functional class 2 at 1 year. Rates of peripheral oedema and ascites decreased from 100% and 47% at baseline to 29% and 14% at 1 year, respectively.

Larger studies are included.

Mao Y, Liu Y, Meng X et al. (2023) Treatment of severe tricuspid regurgitation induced by permanent pacemaker lead: Transcatheter tricuspid valve replacement with the guidance of 3-dimensional printing. Frontiers in Cardiovascular Medicine 10: 1030997

Single-centre observational study

n=6

Follow-up: 2 years

LuX-Valve

All people showed significant improvement in symptoms at 6 months. TR severity measured by TTE decreased from 100% for severe regurgitation to 100% for no or trace regurgitation.

At 2 years, 2 people had NYHA functional class 1, 4 had NYHA functional class 2, and there were no device-related complications. The 6-minute walking test improved from 200 to 342.5 metres. KCCQ scores improved from 30.5 to 62.0.

Larger studies are included.

Miura M, Alessandrini H, Alkhodair A et al. (2020) Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention. JACC. Cardiovascular Interventions 13: 1999–2009

Multicentre registry data (TriValve)

n=333 transcatheter tricuspid valve interventions

Median follow-up: 237 days

Baseline massive or torrential TR was associated with an increased risk for 1-year death of any cause or rehospitalisation for heart failure after transcatheter tricuspid valve interventions compared with patients with severe TR. Procedural success was related to better outcomes, even in the presence of baseline massive or torrential TR.

Most procedures were valve repairs rather than replacements.

Ning X, Cao J, Wang W et al. (2023) Impact of transcatheter tricuspid valve replacement for tricuspid regurgitation on hepatic, cardiac, and venous structure. International Journal of Cardiology 372: 33–39

Case series

n=22

Follow-up: 6 months

LuX-Valve

TR elimination was associated with the reverse remodelling of liver, heart, and veins. LuX-Valve is a promising alternative for severe TR.

Larger studies are included.

Sazzad F, Zhu Y, Leo HL et al. (2023) A Systematic Review of the Design, Method of Implantation and Early Clinical Outcomes of Transcatheter Tricuspid Prostheses. Reviews in Cardiovascular Medicine 24: 231

Systematic review

11 articles

Of the 4 studies that reported NYHA class at follow-up, EVOQUE (79%) (Edwards Lifesciences, US), GATE (72%) (NaviGate Cardiac Structures Inc., US), and TricValve (53%) (P+F Products + Features, Austria) showed that most people were NYHA class 1 or 2 at follow-up, as compared to class 3 or 4 preoperatively. The remaining study, Edwards Sapien XT (Edwards Lifesciences, US) reported that 63% of people improved by 1 NYHA class.

Most devices are circular and are inserted and secured using radial forces.

Review included studies on caval valve implantation as well as TTVR, and there was no meta-analysis.

Scotti A, Coisne A, Taramasso M et al. (2023) Sex-related characteristics and short-term outcomes of patients undergoing transcatheter tricuspid valve intervention for tricuspid regurgitation. European Heart Journal 44: 822

Multicentre registry data (TriValve)

n=556 (13 TTVR)

Follow-up: 1 year

In the TriValve registry, after transcatheter tricuspid valve intervention in high-risk people with significant TR, there were no sex-related differences in terms of survival, heart failure hospitalisation, functional status, and TR reduction up to 1 year. The inverse probability of treatment weighting analysis suggests that transcatheter tricuspid valve intervention may be associated with a substantial and consistent increase in survival in both women and men compared with medical therapy alone. Future studies are needed to assess whether sex-related differences in outcomes may emerge at longer term follow-up.

Only a small proportion of the study population had TTVR.

Sun Z, Li H, Zhang Z et al. (2021) Twelve-month outcomes of the LuX-Valve for transcatheter treatment of severe tricuspid regurgitation. EuroIntervention 17: 818–26

Single centre case series

n=6

Follow-up: 12 months

LuX-Valve

All people had successful implantations of LuX-Valves through the right atrium with a substantial reduction in the degree of TR. Although 1 person with moderate paravalvular leakage died because of right heart failure during 3-month follow-up, the other 5 had no significant paravalvular leakage, and displayed significant improvements in mean transvalvular gradient, right heart sizes, conventional right ventricular function indices, and a reduction in NYHA functional class during 12-month follow-up.

Larger studies are included.

Taramasso M, Alessandrini H, Latib Azeem et al. (2019) Outcomes After Current Transcatheter Tricuspid Valve Intervention: Mid-Term Results From the International TriValve Registry. JACC. Cardiovascular Interventions 12: 155–65

Multicentre registry data (TriValve)

n=312

Procedural success (defined as the device successfully implanted and residual TR 2+ or less) was 73%. 30-day mortality was 4% and was lower among patients with procedural success (2% versus 7%; p=0.04); Actuarial survival at 1.5 years was 83% and was higher among patients who had procedural success.

Only a small proportion of the study population had TTVR.

Wang Y, Zhai M, Mao Yu et al. (2024) Transcatheter tricuspid valve replacement for functional tricuspid regurgitation after left-sided valve surgery: A single-center experience. Catheterization and Cardiovascular Interventions 103: 626–36

Single centre case series

n=20

Follow-up: 6 months

Lux-Valve

All people moderate or less TR immediately after the procedure. 1 person had a procedure-related major adverse event, leading to in-hospital mortality because of pulmonary infection. At the 6-month follow-up, 90% improved to NYHA functional class 1 to 2 (p<0.001). The overall KCCQ score improved from 35.9 points to 58.9 points, p<0.001.

Larger studies are included.

Webb JG, Chuang AM-Y, Meier D et al. (2022) Transcatheter Tricuspid Valve Replacement With the EVOQUE System: 1-Year Outcomes of a Multicenter, First-in-Human Experience. JACC. Cardiovascular Interventions 15: 481–91

Multicentre cohort study

n=27

Median follow-up: 379 days

EVOQUE system

At baseline, all people were at high surgical risk (mean STS score=8.6%) with 89% NYHA functional class 3 or 4. TR was predominantly functional in aetiology (70%). At 1 year, mortality was 7% (2/27), 70% of patients were NYHA functional class 1 or 2, and 96% and 87% of patients had a TR grade 2+ or less and 1+ or less, respectively. Between 30 days and 1 year, there were 2 heart failure hospitalisations, and 1 person needed a new pacemaker implantation.

Larger studies are included.

Wei W, Ning Li, Xiaoping N et al. (2022) Haemodynamics of transcatheter tricuspid valve replacement with Lux-Valve. Frontiers in Cardiovascular Medicine 9: 1007888

Prospective case series

n=30

Follow-up: 6 months

Lux-Valve

The surgical success rate was 100%. The cardiac index and stroke volume increased sharply from 2.42 and 47.8 to 3.04 and 57.2, respectively. The right atrium pressure difference dropped from 9.0 to 5.0. There was no significant change in the pulmonary artery pressure.

Larger studies are included.