Two Real-World European Studies of Abbott's Minimally Invasive MitraClip®
Device Demonstrate Positive Outcomes for Patients with Mitral Regurgitation
ABBOTT PARK, Illinois, June 4, 2013
– Findings Published in the Journal of the American College of Cardiology
Demonstrate Significant Improvements in Day-to-Day Quality of Life
– Study in EuroIntervention Shows Similar Benefits in Both Elderly and
ABBOTT PARK, Illinois, June 4, 2013 /PRNewswire/ --Abbott today announced
publication of positive outcomes from two European post-approval studies of
the first-in-class catheter-based MitraClip® therapy for the treatment of
mitral regurgitation (MR). Results from ACCESS-EU, a European prospective
study that enrolled 567 patients at 14 sites, have been published in the
Journal of the American College of Cardiolog y. In addition, findings of the
investigator-sponsored German TRAnscatheter Mitral Valve Interventions (TRAMI)
registry, which enrolled 1,064 patients at 20 German sites, were recently
published in EuroIntervention .
Abbott's MitraClip System, which received CE Mark in 2008 and is commercially
available in Europe and other international markets, is an investigational
device in the United States. The device is delivered to the heart through the
femoral vein, a blood vessel in the leg, and is designed to reduce MR by
clipping together a portion of the leaflets of the mitral valve to allow the
heart to more efficiently pump blood.
Data from ACCESS-EU demonstrated that in real-world, post-approval experience
in Europe, patients undergoing the MitraClip therapy are predominantly high
surgical risk, elderly patients who are mainly affected by functional MR, a
type of MR in which a damaged heart impairs the performance of a normal mitral
valve. ACCESS-EU showed that in this patient population, the MitraClip
procedure demonstrated low rates of hospital mortality and adverse events and
provided significant improvements in day-to-day quality of life at one year
"I am impressed by the excellent outcomes observed in real-world patients with
the MitraClip therapy. The procedure proved safe and effective even in
patients who are at high risk for complications from mitral valve surgery,"
said Francesco Maisano, M.D., director of Transcatheter Valve Therapies at San
Raffaele Hospital in Milan, Italy, lead author of the ACCESS-EU data
publication and co-principal investigator of the study. "In my experience, the
MitraClip therapy has a definite role for patients who are not candidates for
surgery. I have treated many patients who have experienced a dramatic
improvement in quality of life. Relief from the symptoms of mitral
regurgitation has allowed many bedridden patients to return to normal
"The data from these studies, which together evaluated more than 1,600
patients, add to the clinical evidence confirming positive results for
treatment with MitraClip in high surgical risk patients suffering from the
debilitating symptoms of significant mitral regurgitation," said Charles A.
Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and
chief medical officer, Abbott Vascular. "The MitraClip device represents a
true advance for these patients, who suffer from poor quality of life and have
no satisfactory options to reduce their significant mitral regurgitation."
Findings of the ACCESS-EU study showed:
*Most patients currently treated in Europe are high surgical risk. The mean
age was 74 years, with 45 percent of patients older than 75 years. Most
patients had secondary or functional mitral regurgitation (FMR), a type of
MR in which a damaged heart impairs the performance of a normal mitral
valve; low ejection fraction (most 40 percent or lower); and presented
with multiple comorbidities, including coronary artery disease (63
percent), hypertension (76 percent), atrial fibrillation (68 percent) and
renal disease (42 percent).
*An implant success rate of 99.6 percent.
*No incidence of death or stroke during the MitraClip procedure and in the
immediate post-operative period.
*A majority of patients (91.2 percent) achieved MR reduction to MR grade of
2+ or less (on a scale of 1+ [mild MR] to 4+ [severe MR]) at discharge
*At one year following the procedure, 78.9 percent of patients were free
from MR severity of 2+ or more (p<0.0001), and 71.4 percent of patients
were in NYHA Functional Class II or Class I compared to 15 percent at
*A large majority of patients (79.2 percent) were discharged to home rather
than to a skilled nursing facility.
*Significant improvements in quality of life. At one year, Six-Minute Walk
Test results, which measure distance walked on a flat, hard surface in a
six-minute period, improved by a mean of 59.5 meters(p<0.0001). Minnesota
Living With Heart Failure results, which measure the effects of symptoms,
functional limitations and psychological distress on an individual's
quality of life, improved by a mean 13.5 points (p<0.0001).
Results of the TRAMI registry showed similar benefits for the MitraClip
therapy in both elderly and younger patients. To evaluate the influence of
age, patients were divided into two subgroups: patients 76 years old and
above, and patients younger than 76 years of age. The procedure proved to be
safe in both groups. Hospital mortality was 2.9 percent in elderly patients
and 2.8 percent in younger patients (p=0.96). Major adverse cardiovascular or
cerebrovascular events (MACCE), defined as a composite endpoint of death,
myocardial infarction or stroke, was 3.5 percent vs. 3.4 percent (p=0.93)
respectively. The majority of patients – 81.8 percent of elderly patients and
86.2 percent of younger patients (p=0.06) – fully recovered from the MitraClip
procedure and were discharged without the need for nursing care. There was
substantial relief of heart failure symptoms for themajority of patients,
with comparable proportions of patients in NYHA Functional Class II or Class I
(69.5 percent and 61.4 percent, respectively; p=n.s.).
About Mitral Regurgitation Mitral regurgitation (MR) is the most common type
of heart valve insufficiency, affecting approximately one in 10 people aged
75 years and older. The condition occurs when 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. To maintain an adequate forward
flow of blood throughout the body, the heart compensates by increasing the
size of the left ventricle, the main pumping chamber of the heart. This
requires the heart to work harder, and may ultimately lead to irregular
heartbeats, stroke, heart attack or death. MR may also lead to heart failure,
a potentially deadly condition that occurs when the heart is unable to pump
sufficiently to distribute blood flow to meet the needs of the body.
About the MitraClip ® Device Abbott's MitraClip therapy is designed to reduce
MR and provide clinical and quality-of-life benefits for patients suffering
from the debilitating symptoms of significant MR by clipping together a
portion of the leaflets of the mitral valve. The device is delivered to the
heart through the femoral vein, a blood vessel in the leg. The heart beats
normally during the procedure, and a heart-lung bypass machine is not
required. By reducing MR, the therapy may allow the heart to recover from
overwork and improve function, potentially halting the progression of heart
failure and enabling patients to live a higher-quality life.
The device received CE Mark in 2008 and is commercially available in
approximately 30 countries, with more than 9,000 patients treated to date. The
European Society of Cardiology (ESC) 2012 heart failure guidelines and the
ESC/European Association for Cardio-Thoracic Surgery 2012 guidelines for the
management of valvular heart disease specify the MitraClip device as a
treatment option for high surgical risk patients with MR.
About Abbott Vascular Abbott Vascular is the world's leader in drug eluting
stents. Abbott Vascular has an industry-leading pipeline and a comprehensive
portfolio of market-leading products for cardiac and vascular care, including
products for coronary artery disease, vessel closure, endovascular disease and
structural heart disease.
About Abbott Abbott ( NYSE: ABT ) 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 70,000 people.
Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.
 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.
CAUTION: Investigational device. Limited by Federal (or United States) law
to investigational use.
Contact: Media, Steve Kelly, +1-408-845-3427, or Financial, Tina Ventura,
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