Implant success2*
*Percentage of patients who had study device implanted, deployed as intended and retrieved successfully.
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


Implant success2*
*Percentage of patients who had study device implanted, deployed as intended and retrieved successfully.
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.
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
MAE: major adverse event.
Outcomes of the TriCLASP study at 1 year:2
Freedom from all-cause mortality
Relative reduction in annualised rate of HF hospitalisation
NYHA class I/II
Improvement in KCCQ score from baseline
HF: heart failure; KCCQ: Kansas City Cardiomyopathy Questionnaire; NYHA: New York Heart Association.
Lower heart failure (HF) rehospitalisation rate at 1 year8*
Significant improvements in liver function and stabilisation of kidney function9
Lower mortality rate8*
*Based on TriValve registry data.
HFH: heart failure hospitalisation; T-TEER: tricuspid transcatheter edge-to-edge repair.
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


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
*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*
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
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.


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.
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
OMT: optimised medical therapy; TTVR: transcatheter tricuspid valve replacement.
OMT: optimised medical therapy; TTVR: transcatheter tricuspid valve replacement.
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 time4
<1 hour device time4
Implant success4
Implant success4
Cardiovascular mortality
Stroke
New pacemaker / CIED implantation
Cardiovascular mortality
Stroke
New pacemaker / CIED implantation
CIED: cardiac implantable electronic device.

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.


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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