PARIS, May 21, 2019 /PRNewswire/ -- Abbott (NYSE:
ABT) today announced positive late-breaking data from its
TRILUMINATE study of the company's minimally invasive tricuspid
valve repair system. Results at 30 days demonstrated that the
investigational device is associated with a reduction of tricuspid
regurgitation (TR) symptoms – caused by a leaky tricuspid heart
valve – suggesting a possible treatment option for people suffering
from this difficult-to-manage structural heart disease. Abbott's
transcatheter tricuspid valve repair (TTVR) system builds on the
continued advances of the company's proven clip-based MitraClip
technology, which treats people with leaky mitral valves.
Results from the TRILUMINATE study were presented in a
late-breaking trial session at EuroPCR, the annual meeting of the
European Association of Percutaneous Cardiovascular Interventions
(EAPCI).
"Treating a leaky tricuspid heart valve has long presented a
significant challenge for cardiologists because it is an extremely
complex and difficult heart valve to treat," said Georg Nickenig, M.D., Ph.D., professor and
chief, Department of Cardiology, University Hospital, Bonn,
Germany, and lead investigator of
the study. "These data are extremely encouraging, and I am excited
about the potential of transcatheter tricuspid valve repair as a
minimally invasive treatment option for these very ill patients who
have no other options."
Tricuspid regurgitation is a condition in which the valve
between the two chambers on the right side of the heart does not
close properly, resulting in a backward flow of blood into the
right chamber of the heart, which can ultimately result in heart
failure and death if left untreated.i.ii.iii
Approximately one in 30 people over the age of 65 in the U.S. alone
have moderate or severe TR.iv Surgery is the only
definitive treatment but is rarely performed due to the high
mortality and morbidity rates associated with the procedure.
Currently, there are no approved non-surgical, minimally invasive
treatments for people with moderate or severe tricuspid
regurgitation.
TRILUMINATE is a prospective, single arm, multi-center study at
21 sites in Europe and
the United States evaluating the
safety and performance of the tricuspid valve repair system in 85
patients with symptomatic moderate or greater tricuspid
regurgitation who were determined to be good candidates for
percutaneous transcatheter intervention. Results show that at 30
days:
- 86.6% of patients saw a reduction in TR severity of at least
one grade (p < 0.0001).
- A significantly greater proportion of patients were categorized
as NYHA class I or II (80.5% at 30 days, compared to 25.6% at
baseline), an improvement that was statistically significant.
Doctors use the New York Heart Association (NYHA) classification
system (I-IV) to classify heart failure according to the severity
of a person's symptoms with class I causing little to no physical
limitations and discomfort.
- Patients also experienced a mean improvement in KCCQ score – a
self-assessment of social abilities, symptoms, and quality-of-life
– from 53.05 at baseline to 67.25 at 30 days, which was an increase
of 14.20 points (a five-point increase is considered clinically
significant).
Clinical follow-up will continue through six months and one, two
and three years.
"Abbott's experience in developing minimally invasive
technologies to help people with heart valve diseases avoid surgery
is unparalleled," said Michael Dale,
vice president of Abbott's structural heart business. "These data
show that our clip-based approach – for the first time ever – may
offer a proven treatment for an extremely difficult-to-treat
disease that is associated with high mortality."
Abbott's transcatheter tricuspid valve repair system
is an investigational device only.
For U.S. Important Safety Information about MitraClip,
visit:
https://www.structuralheartsolutions.com/us/mitraclip-isi.
About Abbott
Abbott is a global healthcare leader that
helps people live more fully at all stages of life. Our portfolio
of life-changing technologies spans the spectrum of healthcare,
with leading businesses and products in diagnostics, medical
devices, nutritionals and branded generic medicines. Our 103,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at
www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
i Singh JP , Evans JC , Levy D , et al . Prevalence
and clinical determinants of mitral, tricuspid, and aortic
regurgitation (the Framingham Heart Study). Am J Cardiol
1999;83:897–902.doi:10.1016/S0002-9149(98)01064-9.
ii Vassileva CM , Shabosky J , Boley T , et al .
Tricuspid valve surgery: the past 10 years from the Nationwide
Inpatient Sample (NIS) database. J Thorac Cardiovasc Surg
2012;143:1043–9.doi:10.1016/j.jtcvs.2011.07.004.
iii Stuge O , Liddicoat J . Emerging opportunities for
cardiac surgeons within structural heart disease. J Thorac
Cardiovasc Surg
2006;132:1258–61.doi:10.1016/j.jtcvs.2006.08.049.
iv Topilski Y. Tricuspid valve regurgitation:
epidemiology and pathophysiology. Minerva Cardioangiologica 2018
Mar 28 DOI: 10.23736/S0026-4725.18.04670-4).
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SOURCE Abbott