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Proven transcatheter therapies could rewrite your patient’s story.1–4

Transcatheter tricuspid valve interventions (TTVIs) present an opportunity to address symptomatic, severe tricuspid regurgitation (TR) and improve patients’ functional status and symptoms1–4

Repair or replace? Two emerging transcatheter options to treat severe or greater TR5

Tricuspid transcatheter edge-to-edge repair (T-TEER) fixes the native valve using leaflet approximation devices or annuloplasty, and transcatheter tricuspid valve replacement (TTVR) replaces the valve with a prosthetic one.5,6 Both present an opportunity to address symptomatic, severe TR and improve patients’ functional status and symptoms.2,7 

T-TEER

T-TEER is a minimally invasive procedure designed to address TR. It works by approximating the valve leaflets at the site of leakage, which also indirectly helps reduce the size of the valve annulus.5

Patient in Heart

T-TEER procedure

High levels of implant success and acute procedural success in the TriCLASP study

99% Implant success

Implant success2*

*Percentage of patients who had study device implanted, deployed as intended and retrieved successfully. 

86% Acute procedural success

Acute procedural success2†

Device deployment success with evidence of tricuspid regurgitation reduction ≥1 grade at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge.

T-TEER has low major adverse event rates at 30 days and 1 year2

Outcomes from the TriCLASP study confirm the sustained safety and effectiveness of T-TEER for up to 1 year in patients with clinically significant TR at baseline, in a post-market setting.2

TriCLASP study 1

30 days

TriCLASP study 2

1 year

MAE: major adverse event. 

T-TEER results in significant and sustained TR reduction at 1 year2

T-TEER results in significant and sustained TR reduction at 1 year
Outcomes from the TriCLASP study show that after 1 year, 87% of patients had moderate or less TR after T-TEER.2

Treating TR with T-TEER leads to benefits beyond the heart valve2

Outcomes of the TriCLASP study at 1 year:2

88% Freedom from all-cause mortality

Freedom from all-cause mortality 

72% rate of HF hospitalisation

Relative reduction in annualised rate of HF hospitalisation

75% NYHA class I II

NYHA class I/II

8pt Improvement in KCCQ from baseline

Improvement in KCCQ score from baseline

HF: heart failure; KCCQ: Kansas City Cardiomyopathy Questionnaire; NYHA: New York Heart Association. 

Lower HF rehospitalisation

Lower heart failure (HF) rehospitalisation rate at 1 year8*

Improvements in liver function

Significant improvements in liver function and stabilisation of kidney function9

Lower mortality rate

Lower mortality rate8*

*Based on TriValve registry data.

T-TEER + medical therapy reduces annualised heart failure hospitalisations (HFH) over 2 years3

T-TEER + medical therapy reduces annualised HFH over 2 years
T-TEER combined with medical therapy significantly improved annualised HFH rates at 2 years compared to medical therapy alone in the TRILUMINATE pivotal trial.3

HFH: heart failure hospitalisation; T-TEER: tricuspid transcatheter edge-to-edge repair.

28% Relative risk reduction in HFH with T-TEER
Relative risk reduction in HFH with T-TEER3

TTVR

TTVR involves delivering a replacement valve to the tricuspid position through either the transfemoral or more direct transjugular venous access, ideally using a fully percutaneous technique.10

Ed in heart

TTVR + optimised medical therapy (OMT) is superior to OMT alone4,11

For patients with the most severe TR, treatment with TTVR demonstrated a hard endpoint benefit versus OMT alone, with a number needed to treat of 7 at 18 months.4

For patients with massive/torrential TR, TTVR versus OMT alone demonstrated:4

TTVR versus OMT

*p=0.045; p=0.030; both at 18 months post TTVR. HFH: heart failure hospitalisation.

Patients in the TTVR + OMT group were twice as likely to have a clinical benefit than those treated with OMT alone.4,11* When stratified by TR severity, TTVR continued to demonstrate a greater likelihood of clinical benefit over OMT alone.4*

Win ratio outcomes

CI: confidence interval; TR: tricuspid regurgitation; TTVR: transcatheter tricuspid valve replacement. 

*Win ratio analysis of primary safety and effectiveness endpoint: a hierarchical composite that included death, durable right ventricular assist device/heart transplantation, tricuspid valve intervention, annualised HFH, and pre-specified improvements in quality of life, functional status and exercise capacity. 

Patients treated with TTVR + OMT had greater improvements in health status, including increase in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS), New York Heart Association (NYHA) class I/II and six-minute walk distance (6MWD) at 1 year.4,11

Patients table

Reported values correspond to changes from baseline to 1 year for TTVR vs OMT alone. *Kruskal-Wallis test.
6MWD: six-minute walk distance; KCCQ-OS: Kansas City Cardiomyopathy Questionnaire Overall Summary; NYHA: New York Heart Association; OMT: optimised medical therapy; TR: tricuspid regurgitation; TTVR: transcatheter tricuspid valve replacement. 

Prof Philipp Lurz

For patients with the most severe TR, treatment with TTVR demonstrated a hard endpoint benefit versus OMT
alone.*

-

Prof Philipp Lurz 
University Medical Centre of the Johannes Gutenberg University, Mainz, Germany 

*Expert opinions, advice and all other information expressed represent contributors' views and not necessarily those of Edwards Lifesciences.

Consistent TR elimination 

TTVR + OMT reduced TR to mild or less in 95.3% of patients at 1 year and eliminated TR in 72.6% of patients.11

Consistent TR resolution

OMT: optimised medical therapy; TTVR: transcatheter tricuspid valve replacement. 

TTVR is changing the narrative for the patients who need it most

TTVR provides a minimally invasive treatment option for patients with severe, symptomatic TR, which is associated with significant functional and quality of life improvements.6,12,13

_1 hour device time

<1 hour device time4

TTVR procedure

TTVR demonstrates high implant success rates at 1 year4

95% Implant success

Implant success4

Sustained safety of TTVR 

Outcomes from the TRISCEND II pivotal trial confirm the sustained safety of TTVR in patients with at least severe TR at 1 year.11

30 days

3% Cardiovascular mortality

Cardiovascular mortality

<1% Stroke

Stroke

25% New pacemaker - CIED implantation

New pacemaker / CIED implantation

31 to 365 days

6% Cardiovascular mortality

Cardiovascular mortality

1% Stroke

Stroke

4% New pacemaker - CIED implantation

New pacemaker / CIED implantation

CIED: cardiac implantable electronic device.

Dr med. Rahul Sharma

To be able to tell your patients, ‘You will feel better after this therapy’, is amazing.*

-

Dr med. Rahul Sharma, interventional cardiologist, Stanford University, California, USA

*Expert opinions, advice and all other information expressed represent contributors' views and not necessarily those of Edwards Lifesciences.

Refer your severe, symptomatic TR patients on medical therapy to the Heart Team 

grey heart

References

  1. Taramasso M. Expanding the tools for transcatheter tricuspid valve intervention: Transcatheter tricuspid valve repair. JACC Case Rep. 2020;2(8):1112–1114. doi:10.1016/j.jaccas.2020.05.056. 
  2. Hausleiter J. Transcatheter tricuspid valve repair: TriCLASP study 1-year results. PCR London Valves, 24–26 November 2024, London, UK. 
  3. Kar S, Makkar RR, Whisenant BK, et al. Two-year outcomes of transcatheter edge-to-edge repair for severe tricuspid regurgitation: The TRILUMINATE pivotal randomized trial. Circulation. 2025;0(0)doi:10.1161/CIRCULATIONAHA.125.074536. 
  4. Lurz P, Hahn RT, Kodali S, et al. Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial. Eur Heart J. 2025;doi:10.1093/eurheartj/ehaf676. 
  5. Maisano F, Hahn R, Sorajja P, et al. Transcatheter treatment of the tricuspid valve: Current status and perspectives. Eur Heart J. 2024;45(11):876–894. doi:10.1093/eurheartj/ehae082. 
  6. Edwards EVOQUE Tricuspid Valve Replacement System. Instructions for use (2024). 
  7. Eternal Hospital. Transcatheter tricuspid valve replacement (TTVR). Accessed 19 March 2025, https://drsamincardiology.com/services/transcatheter-tricuspid-valve-replacement-ttvr/. 
  8. Taramasso M, Benfari G, van der Bijl P, et al. Transcatheter versus medical treatment of patients with symptomatic severe tricuspid regurgitation. J Am Coll Cardiol. 2019;74(24):2998–3008. doi:10.1016/j.jacc.2019.09.028. 
  9. Karam N, Braun D, Mehr M, et al. Impact of transcatheter tricuspid valve repair for severe tricuspid regurgitation on kidney and liver function. JACC Cardiovasc Interv. 2019;12(15):1413–20. doi:10.1016/j.jcin.2019.04.018. 
  10. Hausleiter J, Stolz L, Lurz P, et al. Transcatheter tricuspid valve replacement. J Am Coll Cardiol. 2025;85:265–91.  
  11. Hahn RT, Makkar R, Thourani VH, et al. Transcatheter valve replacement in severe tricuspid regurgitation. N Engl J Med. 2024;392(2):115–26. doi:10.1056/NEJMoa2401918. 
  12. Sala A, Hahn RT, Kodali SK, et al. Tricuspid valve regurgitation: Current understanding and novel treatment options. J Soc Cardiovasc Angiogr Interv. 2023;2(5):101041. doi:10.1016/j.jscai.2023.101041. 
  13. Praz F, Borger MA, Lanz J, et al. 2025 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the task force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2025; doi: 10.1093/eurheartj/ehaf194. Epub ahead of print.
Medical device for professional use.

Medical device for professional use.

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

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