Pittsburgh's Allegheny General
Hospital Serves as Landmark Clinical Trial's Top Enrolling Site in
the United States
PITTSBURGH, April 17,
2024 /PRNewswire-PRWeb/ -- Allegheny Health Network's
(AHN) Allegheny General Hospital (AGH) was the top U.S. enrollment
site for a landmark international clinical trial comparing the
performance and durability of self-expanding and balloon-expandable
transcatheter aortic valve replacements (TAVRs) in patients
diagnosed with aortic stenosis and small aortic annulus – a ring at
the base of the aorta, the main artery that pumps oxygenated blood
from the heart to the rest of the body.
"Women comprised nearly 90 percent of the
study population. This is incredibly important and a tremendous
accomplishment as women have been historically underrepresented in
clinical trials investigating cardiovascular disease," said Dr.
Stephen Bailey, Chair of AHN
Cardiovascular Institute.
The study, reported in the latest New England Journal of
Medicine (doi: 10.1056/NEJMoa2312573) reported that self-expanding
valves had better hemodynamic (blood flow) results than
balloon-expandable valves after one year, hypothesizing that
self-expanding valve replacements could end up being the preferred
therapy going forward for this subset of stenosis patients.
Aortic valve stenosis is a progressive disease caused by calcium
buildup narrowing the heart's aortic valve, which in turn leads to
restricted blood flow. According to the American Heart Association
(AHA), more than 20 percent of older Americans and 7 percent of
those older than 65 years suffer from aortic stenosis, making it
one of the most common and serious heart valve diseases in the
country.
A common surgical intervention for aortic valve stenosis is the
TAVR procedure, using one of the two designs reviewed in the AGH
study.
Small aortic annulus – the fibrous ring at the base of the
aorta, where the ventricle and aorta meet – can further complicate
the TAVR procedure because the narrow openings make it more
difficult to put new valves into place. The "ring" is like a small
door that blood can flow through – if the door is too small, blood
can have a hard time passing through to the rest of the body.
Furthermore, patients with this specific condition, if left
untreated, have an expected survival of just two to three
years.
Results from the "Small Annuli Randomized To Evolut or SAPIEN
(SMART) Trial" demonstrated that among the patients who underwent
TAVR, self-expanding and balloon-expandable devices realized
similar health outcomes in the patient population after one year.
The self-expanding valve, however, saw a dramatically better
performance when it came to hemodynamic valve function.
The SMART trial was formally presented at the 2024 American
College of Cardiology annual conference. Stephen Bailey, MD, cardiothoracic surgeon and
Chair of the AHN Cardiovascular Institute, serves as the co-lead
investigator of the study at AGH alongside Ramzi Khalil, MD, AGH interventional
cardiologist.
"Patient populations were tracked over the course of 12 months
for disabling stroke, rehospitalization for heart failure, and
death – and, as expected, both valves saw equivalent, successful
health outcomes, with a low rate of adverse events," explained Dr.
Bailey.
Patients enrolled in the head-to-head trial were all diagnosed
with symptomatic aortic stenosis with a small aortic annulus. Small
aortic annulus is most often seen in women; of the 716 patients
enrolled in SMART – across 83 sites spanning Europe, the Middle
East, and the United States
- about 87 percent were female, with an average age of 80.
"Women comprised nearly 90 percent of the study population,"
said Dr. Bailey. "This is incredibly important and a tremendous
accomplishment as women have been historically underrepresented in
clinical trials investigating cardiovascular disease. As a field,
we recognize significant differences between presentations of heart
disease in men and women, and this work begins to further explore
and address this issue."
Patients enrolled in the trial will be followed closely for five
years to determine long-term outcomes of both TAVR devices.
TAVR was first approved by the Food and Drug Administration in
2011 for high-risk patient populations and to low-risk patients in
2019. Two years prior to the low-risk patient approval, AGH was the
only local medical center in the greater Pittsburgh area to participate in clinical
trials to prove the procedure's safety and efficacy, contributing
to its ongoing success and use today.
Self-expanding valves and balloon-expandable valves are both
animal valves encased mesh stents. Balloon-expandable valves, as
the name suggests, are expanded into place by a balloon that is
inserted into the patient's femoral artery then threaded into the
patient's new aortic valve. In a self-expanding valve, the valve is
made of nitinol – a metal alloy that expands when it gets warmer.
After the valve is put in place, it warms to the temperature of the
patient's body and expands to the proper size.
"These are two of the most commonly used TAVR prostheses and few
randomized comparisons have been performed to date," said Dr.
Bailey. "Our long-term results will help guide multidisciplinary
heart teams around the world design the best individualized care
plans, including surgical interventions, for patients diagnosed
with aortic stenosis."
The SMART trial was funded through a grant from Medtronic.
About the Allegheny Health Network:
Allegheny Health Network (AHN.org) is an integrated healthcare
delivery system serving the greater Western Pennsylvania region. The Network is
composed of 14 hospitals, ambulatory surgery centers, Health +
Wellness Pavilions, multiple employed physician organizations, home
and community based health services, a research institute, and a
group purchasing organization. The Network provides patients with
access to a complete spectrum of advanced medical services,
including nationally recognized programs for primary and emergency
care, trauma care, cardiovascular disease, organ transplantation,
cancer care, orthopedic surgery, neurology and neurosurgery,
women's health, diabetes, autoimmune disease and more. AHN employs
approximately 22,000 people, has more than 2,600 physicians on its
medical staff and serves as a clinical campus for Drexel University College of Medicine and the
Lake Erie College of Osteopathic
Medicine.
Media Contact
Nikki Buccina, Allegheny Health
Network, 412-596-2679, dominique.buccina@highmarkhealth.org,
www.ahn.org
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SOURCE Allegheny Health Network