Structural Heart Center takes top honors

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 CEO magazine.

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 defects.

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 replacement devices.

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 devices.

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 treatment.

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 believes.

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," Yakubov says.

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 team.

Launched: 2011

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