The OhioHealth Structural Heart Disease Patient Evaluation and
Research Center has been awarded the Healthcare Achievement Award
for R&D Initiative of the Year by Columbus
The Structural Heart Disease Patient Evaluation and Research
Center at OhioHealth Riverside Methodist Hospital is on the leading
edge of life-saving technologies for patients with anatomical heart
The center works closely with the OhioHealth Research and
Innovation Institute to provide patients with access to trial-stage
devices and therapies that aren't available anywhere else. The
center's physicians and research team test devices, secure FDA
approval and move them into wider commercialization for use in
structural heart disease patients.
"We consider ourselves a leader in innovation, a site that has
extensive experience in clinical trials," says Dr. Steven Yakubov,
medical chief of OhioHealth Structural Heart Disease Program and
medical director of the OhioHealth Research and Innovation
Institute. "We have an extensive research organization that is
attractive to companies (for) the top drugs and devices that need
to be tested."
Hundreds of structural heart disease patients with an array of
problems go through the Patient Evaluation and Research Center
every month. Many of them are high-risk patients who have been
deemed inoperable. For them, the device trials at the center are
their last hope. The clinical work undertaken in the center
includes trials for valve-closure devices for stroke patients,
mitral valve clips for treatment, and minimally-invasive valve
The program focuses most prominently on the treatment of severe
aortic stenosis, a narrowing of the aortic valve that restricts
blood flow. The condition affects an estimated 100,000 people in
the United States, half of whom will die without treatment. Open
heart surgery is not an option for many of these patients. The
center's team successfully took a new treatment for the condition
from trial to market.
After three years of trials on the CoreValve replacement device
manufactured by Medtronic, the center received FDA approval for
CoreValve's commercial use on January 17, 2014. "It was very
exciting for us. We put a lot of hard work into this," says
Yakubov, who served on the FDA steering and screening committees
for that trial.
Moving the CoreValve from testing to commercial use solidified
the various aspects of the program under one umbrella, establishing
the center as its own entity within the structural heart program,
says Yakubov. He was the lead physician in developing the program.
Today, a number of independent companies approach the center to
conduct the clinical trials necessary to commercialize new
The Patient Evaluation and Research Center is an intense,
multi-disciplinary program. It depends on the skills of a variety
of medical professionals to execute innovative therapies within the
relatively young discipline of noninvasive structural heart disease
Yakubov worked very closely with co-primary investigator Dr.
Daniel Watson, a thoracic and vascular surgeon at Riverside, on the
CoreValve clinical trials. They saw and evaluated every patient as
a team and worked together to implant the CoreValve device in all
of the patients.
While that level of coworking is unusual between two physicians,
Yakubov says the new technologies require lots of thought and
expertise. "It's been rewarding to have multiple positions working
together," he says. The level of collaboration between specialties
has encouraged cooperation within the institution overall, he
There are 13 dedicated physicians on the center team. Greta
Robb, RN, is the clinical research manager for the center. The
research staff includes nurses and research coordinators whom
Yakubov calls the "backbone" of the program. Ancillary medical
professionals including anesthesiologists, cardiologists, surgeons
and radiologists are involved in the center's work. Dr. Bruce
Vanderhoff, senior vice president and chief medical officer of Ohio
Health, oversees this and all other programs within the Research
and Innovation Institute.
Even physicians from outside OhioHealth have approached the
research center to help patients with their innovative devices.
"Many physicians in outlying communities know that if there's a
patient with a particular problem, they can call us to say, 'Is
there something that's not currently commercially available that
you can offer to these patients?' because they're often very sick,"
Clinical trials cost money. The structural heart center's
clinical trials are not profitable for OhioHealth. The return on
investment is the reputation the work develops for the structural
heart program as a leader in innovative cardiac care.
"We're not there to make money. We try not to lose money, but we
also try to bring the current latest technology to patients,"
Yakubov says. The Centers for Medicare & Medicaid Services, a
federal Department of Health and Human Services agency, provides
funding support for FDA-approved technologies.
Many private insurers do not cover the cost of investigational
trials, a cost-cutting that represents an "irresponsible" limiting
of treatment options, Yakubov says.
"We're trying to offer these therapies in the best interest of
the patient, and once in a while we feel like they're withholding
the best available care to the patient," he says.
As long as OhioHealth continues to support the program, it will
strive to deliver better products and stay abreast of the latest
investigational trials. "Prov(ing) that these technologies work,
and transition(ing) them to commercial products so that all
physicians are able to deliver these technologies and this type of
care to their patients," is the long-term mission of Yakubov and
the Structural Heart Disease Patient Evaluation and Research Center
Top executives: Dr. Bruce Vanderhoff, senior vice president and
chief medical officer of Ohio Health; Dr. Steven Yakubov, medical
chief of OhioHealth Structural Heart Disease Program and medical
director of the OhioHealth Research and Innovation Institute; Greta
Robb, RN, clinical research manager of the OhioHealth Research and
Innovation Institute and Structural Heart Disease Patient
Evaluation and Research Center
Mission: Works with the OhioHealth Research and Innovation
Institute to provide patients timely access to clinical research
trials, offering innovative procedures and treatments; conducts the
necessary research to move devices and treatments through rigorous
FDA-approval processes, bringing them to the commercial market