Implant success2a
a Percentage of patients who had study device implanted, deployed as intended and retrieved successfully.
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
T-TEER procedure
High levels of implant success and acute procedural success in the TriCLASP study
Acute procedural success2b
b 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 in patients with at least severe TR and not clinically significant TR at 1 year in a post-market setting.2
30 days
1 year
MAE: major adverse event.
T-TEER results in significant and sustained TR reduction at 1 year2
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
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.
T-TEER + medical therapy reduces annualised heart failure hospitalisations (HFH) over 2 years4
T-TEER combined with medical therapy significantly improved annualised HFH rates at 2 years compared to medical therapy alone in the TRILUMINATE pivotal trial.4
HFH: heart failure hospitalisation; T-TEER: tricuspid transcatheter edge-to-edge repair.
Relative risk reduction in HFH with T-TEER4
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
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, typically leading to shorter hospital stays, faster recovery and lower complication rates compared to conventional surgical approaches.3,6
<1 hour device time3
3 days length of stay3
TTVR procedure
TTVR demonstrates high implant success rates at 1 year3
Implant success3*
Implant success3*
*Twelve patients did not receive an EVOQUE valve due to challenging anatomy (n=7), imaging preventing confirmation of leaflet capture (n=4), or TR that was no longer severe on transoesophageal echocardiography (n=1).
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.7
30 days
Cardiovascular mortality
Stroke
New pacemaker / CIED implantation
31 to 365 days
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.
Consistent TR resolution
TTVR + medical therapy reduced TR to mild or less in 95.3% of patients at 1 year and eliminated TR in 72.6% of patients.7
GDMT: guideline-directed medical therapy; TTVR: transcatheter tricuspid valve replacement.
TTVR + medical therapy is superior to medical therapy alone
Patients in the TTVR group were twice as likely to have a clinical benefit than those treated with medical therapy alone.7
Events are shown in rank order, left to right.
6MWD: 6-minute walk distance; CI: confidence interval; GDMT: guideline-directed medical therapy; HFH: heart failure hospitalisation; KCCQ-OS: Kansas City Cardiomyopathy Questionnaire Overall Summary; NYHA: New York Heart Association; RVAD: right ventricular assist device; TTVR: transcatheter tricuspid valve replacement; TV: tricuspid valve.
Patients treated with TTVR + medical therapy 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.7,11
KCCQ-OS improvement11,12
NYHA functional class improvement12
6MWD improvement7,12
6MWD: six-minute walk distance; GDMT: guideline-directed medical therapy; KCCQ-OS: Kansas City Cardiomyopathy Questionnaire Overall Summary; NYHA: New York Heart Association; TTVR: transcatheter tricuspid valve replacement.
I am particularly impressed by the 1-year data on TTVR from the TRISCEND II pivotal trial*
-Dr Ali Vazir, consultant in cardiology and critical care, Royal Brompton Hospital, London, United Kingdom
*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
