WASHINGTON, March 18, 2017 /PRNewswire/ -- Abbott (NYSE: ABT)
today announced favorable one-year outcomes from the largest study
of real-world experience for the MitraClip system in transcatheter
mitral valve repair (TMVR) procedures in the United States. MitraClip treats people
with degenerative mitral regurgitation (DMR, also known as leaky
heart valve), a serious condition involving a dysfunction of the
heart's mitral valve, which regulates blood flow into the heart's
main pumping chamber.
The study analyzed data from the Transcatheter Valve Therapy
(TVT) registry involving nearly 3,000 DMR patients who were
high-risk for surgery. Following minimally invasive implantation
with MitraClip, patients had significant improvements, including
92.8 percent of patients achieving post-procedural mitral
regurgitation (MR) severity grade of less than or equal to 2 (acute
procedural success defined as MR ≤2). In addition, 80.0 percent of
MitraClip patients remained free from heart failure (HF)
re-hospitalization in the year after implantation. Most
patients—85.9 percent of people treated—were discharged to their
homes after an average hospital stay of only two days. The average
age of patients was 82.
The data were presented by Paul
Sorajja, M.D., director of the Center of Valve and
Structural Heart Disease at Minneapolis Heart Institute,
cardiologist at Abbott Northwestern Hospital in Minneapolis and principal investigator of the
study, during a late-breaking featured clinical research session of
the American College of Cardiology's (ACC) 66th Annual Scientific
Session.
"The consistent one-year results seen in this study validate
that treatment with MitraClip can provide meaningful reduction in
the severity of mitral regurgitation," said Dr. Sorajja. "The
consistency of data over time in this large patient registry
underscore the valuable impact MitraClip has on the overall health
of very sick people living with this silent killer."
Mitral regurgitation is a debilitating, progressive and
life-threatening disease in which the leaflets of the mitral valve
do not close completely, causing blood to flow backward and leak
into the left atrium of the heart during the cardiac cycle. The
condition can raise the risk of irregular heartbeats, stroke, and
heart failure, which can be deadly.
Nearly one in ten people over the age of 75 have moderate to
severe MR1 , which is frequently difficult to diagnose.
Patients often may not be eligible for the standard-of-care surgery
because of advanced age, frailty, multiple comorbidities or other
complicating factors. Until the regulatory approval of MitraClip,
these high surgical risk patients could only manage their symptoms,
such as shortness of breath and fatigue, with medications that did
not stop the progression of the disease.
"Abbott's goal is to improve health, and our MitraClip therapy
provides a much-needed solution for gravely ill people who have
very few options," said Michael
Dale, general manager of Abbott's structural heart business.
"The consistency in data across multiple trials reinforce the
nearly immediate impact that MitraClip has on people's quality of
life, allowing them to lead fuller, longer lives."
About the Transcatheter Valve Therapy (TVT)
Registry
The STS/ACC TVT Registry™ is a benchmarking tool
developed to track patient safety and real-world outcomes related
to transcatheter valve replacement and repair procedures and
emerging treatments for valve disease patients. Created by The
Society of Thoracic Surgeons (STS) and the American College of
Cardiology, the TVT Registry is designed to monitor the safety and
efficacy of these new technologies for the treatment of valve
disease. Through the capture and reporting of patient demographics,
procedure details, and facility and physician information, the TVT
Registry provides a data repository capable of delivering insight
into clinical practice patterns and patient outcomes.
About MitraClip
The MitraClip Clip Delivery System is
indicated for the percutaneous reduction of significant symptomatic
mitral regurgitation (MR > 3+) due to primary
abnormality of the mitral apparatus [degenerative MR] in patients
who have been determined to be at prohibitive risk for mitral valve
surgery by a heart team, which includes a cardiac surgeon
experienced in mitral valve surgery and a cardiologist experienced
in mitral valve disease, and in whom existing comorbidities would
not preclude the expected benefit from reduction of the mitral
regurgitation. The MitraClip System is available in the United States and in more than 50
countries around the world. More information, including important
safety information, can be found at
http://www.abbottvascular.com/docs/ifu/structural_heart/eIFU_MitraClip.pdf
About Abbott
At Abbott, we're committed to helping
you live your best possible life through the power of health. For
more than 125 years, we've brought new products and technologies to
the world -- in nutrition, diagnostics, medical devices and branded
generic pharmaceuticals -- that create more possibilities for more
people at all stages of life. Today, 94,000 of us are working to
help people live not just longer, but better, in the more than 150
countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
1 Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS,
Scott CG, Enriquez-Sarano M. Burden
of valvular heart diseases: a population-based study. Lancet. 2006
Sep 16;368(9540):1005-11.
https://www.ncbi.nlm.nih.gov/pubmed/16980116
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SOURCE Abbott