NEWPORT BEACH, Calif., March 18, 2019 --- The
Jeffrey M. Carlton Heart & Vascular Institute at Hoag, the largest volume cardiovascular program in Orange County, was
the first hospital to bring
transcatheter aortic valve replacement (TAVR) to the community. Today, the American College of Cardiology (ACC) released
data from two trials showing that select patients who were at low-risk
for surgical complications still benefited from a minimally invasive,
transcatheter aortic valve replacement.
Hoag contributed to what the ACC referred to as “eye-popping”
data at its annual meeting in New Orleans. As part of the PARTNER 3 trial,
the Hoag TAVR team participated in research that included 1,000 low-surgical-risk
patients. Participants were randomized to minimally invasive TAVR with
the Edwards Lifesciences Sapien 3 valve or to open surgical
aortic valve replacement, the standard procedure for aortic stenosis.
“Currently, TAVR is only offered to high-risk or intermediate-risk
patients for open-heart surgery. These results are expected to expand
TAVR as an option for select patients who are at low risk for surgical
aortic valve replacement, allowing them to reap the benefits of valve
replacement without undergoing open heart surgery,” said
Anthony Caffarelli, M.D., Hoag co-principle investigator for the PARTNER 3 Trial, director of Hoag
Cardiovascular Surgery and Newkirk Family Endowed Chair in Aortic Care.
More than 1.5 million people in the U.S. suffer from
aortic stenosis, a condition that can progress to restrict every day activities, including
walking short distances. Without an operation, most aortic stenosis suffers
die within two years.
PARTNER 3 included 1,000 patients with severe aortic stenosis at 71 centers
in the U.S. and several other countries with over 95 percent of patients
enrolled at U.S. sites. Participants were carefully screened to be low
risk for either TAVR or surgery and were randomly assigned to receive
the SAPIEN 3 TAVR valve, the newest generation technology, or surgical
valve replacement. Compared with the earlier PARTNER trials with intermediate-
and high-risk surgical patients, this low-risk group was younger (73 years
on average), had fewer co-morbid conditions and had fewer symptoms. There
were also more men than women enrolled (67.5 percent vs. 32.5 percent,
respectively). A total of 16 patients died during follow up. Of these,
11 were in the surgery group and five were in the TAVR group, so the one-year
mortality rate was 1 percent for TAVR and 2.5 percent for surgery. Twenty
patients suffered a stroke, 14 of which occurred in the surgery group
(3.1 percent) and six in TAVR (1.2 percent). Patients in the surgical
group were also more likely to go back to the hospital compared with those
in the TAVR group (11 percent and 7.3 percent, respectively).
Hoag became a site for the PARTNER 3 trial in 2016 and is a leader in performing
these procedures. In 2012, Hoag began offering TAVR, an innovative percutaneous
procedure that offered hope to individuals at high risk for surgery. Since
then, the implications for TAVR have grown to include moderate risk patients,
and now low risk patients, as evaluated in the PARTNER 3 Trial.
“Hoag not only is helping guide research for these procedures, but
we are able to provide it directly to our community. Hoag and a
dedicated physician and clinical team have made a significant investment into Hoag’s TAVR Program to provide
this care people go out of county to seek,” said
Richard Haskell, M.D., one of the founding physicians for Hoag’s TAVR Program and interventional
cardiologist. “Our commitment to incorporating the most innovative
technology available is one reason Hoag cardiac patients achieve some
of the highest clinical outcomes in the nation.”
Transcatheter aortic valve replacement is a minimally invasive procedure
where a collapsible artificial valve is guided into the heart using a
catheter through a blood vessel in the leg or alternate site by an interventional
cardiologist and cardiac surgeon. The artificial heart valve is then inserted
across the patient’s own aortic valve where it immediately goes to work.
“These results are a game changer for the treatment of
aortic stenosis. We are excited that the Hoag team was able to contribute to this study
and advance the science and innovation in cardiac care,” said Dr.
Caffarelli. “We are proud that the Hoag team will continue to provide
the most expert, state-of-the-art care available to our community.”
For individuals with aortic stenosis, who have additional heart conditions,
standard surgical aortic valve replacement is still recommended. Hoag’s
cardiac surgery program has received a 3-star rating – which is
the top 5% in the country – the highest rating awarded by The Society
of Thoracic Surgeons – one of the most sophisticated and highly
regarded organizations that measures quality and compares cardiothoracic
surgery programs across the U.S. and Canada.
ABOUT HOAG MEMORIAL HOSPITAL PRESBYTERIAN
Hoag is an approximately $1 billion nonprofit, regional health care delivery
network in Orange County, California, that treats more than 30,000 inpatients
and 450,000 outpatients annually. Hoag consists of two acute-care hospitals
– Hoag Hospital Newport Beach, which opened in 1952, and Hoag Hospital
Irvine, which opened in 2010 – in addition to eight health centers
and 11 urgent care centers. Hoag is a designated Magnet® hospital by the American Nurses Credentialing Center (ANCC). Hoag offers
a comprehensive blend of health care services that includes five institutes
providing specialized services in the following areas:
cancer,
heart and vascular,
neurosciences,
women’s health, and orthopedics through Hoag’s affiliate,
Hoag Orthopedic Institute, which consists of an orthopedic hospital and two ambulatory surgical centers.
Hoag has been named one of the Best Regional Hospitals in the 2018 - 2019
U.S. News & World Report, andBecker’s Healthcare named Hoag as one of the 2018 “100 Great Hospitals in America”
– a designation Hoag has received five times. For an unprecedented
23 years, residents of Orange County have chosen Hoag as one of the county’s
best hospitals in a local newspaper survey. Visit
www.hoag.org for more information.
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To download the official press release, please click
here.