SAN DIEGO, March 15, 2015 /PRNewswire/ -- About three years
ago, Betty Vaughn of Golden Valley, Minn., started to feel
light-headed, fatigued and out of breath when she walked up and
down the stairs. After visiting her doctor, the 89-year-old was
diagnosed with degenerative mitral regurgitation (DMR), a heart
condition 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. After her diagnosis, Paul Sorajja, M.D., cardiologist at Abbott
Northwestern Hospital in Minneapolis, performed a transcatheter mitral
valve repair (TMVR) procedure on Vaughn, who was not a good
candidate for surgery, using Abbott's (NYSE:
ABT) MitraClip® in October
2014. Now, just months after the procedure, Vaughn has
resumed many of the activities she loves, like working in the yard
and playing cards with friends.
Vaughn's story shows how MitraClip can help people with a leaky
heart valve feel better and resume their active lives. It's one
example of the favorable outcomes from the initial commercial
experience of transcatheter mitral valve repair with MitraClip in
the United States, which were
presented today during the late-breaking clinical trial session at
the American College of Cardiology's (ACC) 64th Annual
Scientific Session & Expo.
Abbott's MitraClip treats people with DMR, which is a
condition involving a dysfunction of the heart's mitral valve. It
is a treatment option for people who are not good candidates for
surgery, the current standard of care, because of their advanced
age, frailty or other complicating factors. In the United States, mitral regurgitation (MR)
is the most common valve disease, affecting nearly one in 10 people
age 75 and older. People with MR often have difficulty with
everyday activities, such as climbing stairs, and may require long
periods of rest due to fatigue.
In the study, a transcatheter valve therapy (TVT) registry
formed from a partnership with the Society of Thoracic Surgeons
(STS) and ACC, researchers evaluated data from 564 people with TMVR
who were treated with MitraClip following FDA approval of the
device in October 2013 through
August 2014. The data continue to
support the use of MitraClip, with successful treatment for 93
percent of people in the study. The treated group's median
age was 83 years-old, and they were not candidates for surgery
because they were too frail or had other complicating factors. Dr.
Sorajja, the lead investigator for this study, shared the data at
today's ACC session.
"The results of this MitraClip study are very favorable and
consistent with the results we saw in studies prior to the
therapy's U.S. approval," Dr. Sorajja said. "The results show
clinically meaningful reduction in the severity of mitral
regurgitation and improvement in the overall health of very sick
people with prohibitive risk DMR who have no other meaningful
options to improve their lives."
In the ACC presentation, Dr. Sorajja concluded that treatment
with MitraClip for prohibitive risk patients with symptomatic MR is
durable in a real-world commercial setting. Key findings from the
564 patients treated with the MitraClip device demonstrated the
following:
- Prior to treatment, more than 90 percent of patients had a
mitral regurgitation grade of 3 or 4, indicating significant
leakage of the mitral valve. After treatment with MitraClip, 93
percent of patients achieved an MR grade of less than or equal
to 2, with 63.6 percent at a grade of less than or equal to 1,
demonstrating a significant decrease in leakage.
- Average length of stay in the hospital was 3 days, with 82
percent discharged home.
- Adverse events and procedural complications were low,
consistent with clinical trial experience.
Vaughn knows what it feels like to suffer from MR. After
receiving a MitraClip, however, her life has been
improved.
"[My doctor] said I would feel better, and I did," Vaughn said.
"That's the difference. I'm living now. I'm doing much better."
To learn more about mitral regurgitation click here for an
infographic. For more information about MitraClip visit
www.mitraclip.com.
About Mitral Regurgitation
Mitral regurgitation is a
debilitating, progressive and life-threatening disease in which a
leaky mitral valve causes a backward flow of blood in the heart.
The condition can raise the risk of irregular heartbeats, stroke,
and heart failure, which can be deadly. Mitral regurgitation is
common, affecting more than 4 million Americans – nearly one in 10
people aged 75 and above.i Open heart mitral valve
surgery is the standard-of-care treatment, but many people are at
prohibitive risk for an invasive procedure. Medications for the
condition are limited to symptom management and do not stop the
progression of the disease.
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 (ACC), 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 the MitraClip Device
Abbott's MitraClip repairs
the mitral valve without the need for an invasive surgical
procedure. The device is delivered to the heart through the femoral
vein, a blood vessel in the leg, and once implanted, allows the
heart to pump blood more efficiently, thereby relieving symptoms
and improving people's quality of life. People undergoing MitraClip
treatment typically experience short recovery times and short
hospital stays of two to three days.ii More than
20,000 people around the world have been treated with the MitraClip
device.
For more information, including important safety information,
please visit www.mitraclip.com.
About Abbott:
Abbott is a global healthcare company
devoted to improving life through the development of products and
technologies that span the breadth of healthcare. With a portfolio
of leading, science-based offerings in diagnostics, medical
devices, nutritionals and branded generic pharmaceuticals, Abbott
serves people in more than 150 countries and employs approximately
73,000 people.
Visit Abbott at www.abbott.com and connect with us on
Twitter at @AbbottNews.
i 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.
http://www.ncbi.nlm.nih.gov/pubmed/16980116
ii Data on file at Abbott; Rogers, JH, Franzen, O.
Percutaneous edge-to-edge MitraClip therapy in the management of
mitral regurgitation. European Heart Journal (2011) 32,
2350–2357.
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SOURCE Abbott