U of L Update: June 2004
Cardiovascular Innovation Institute: New Treatments For The Heart
Dear Colleagues:
The Cardiovascular Innovation Institute is among our most exciting new initiatives and partnerships. Building on the internationally recognized work of Drs. Laman Gray and Rob Dowling, U of L physicians who implanted the worldÕs first totally implantable artificial hearts during surgeries at Jewish Hospital, the institute will advance the study of devices that save and improve lives. An added bonus is the economic benefit that will return to our community and state as the institute develops.
This issue of U of L Update discusses the need for the institute and how it will benefit heart patients as well as the economy. We also want to acquaint with you several other important happenings here on campus. I hope you share our excitement.
Sincerely,
James R. Ramsey
President
Inside the Report
- Heart Disease Is Leading Cause of Death In United States
- The Need Is Urgent
- The Vision
- Clinical Translation
- The Facility
- Economic Development
- The Benefits
Heart Disease is the leading cause of death
Heart disease is the leading cause of death in the United States, claiming more lives each year than the next seven causes of death combined. Along with loss of lives, the annual total cost of heart disease to our nation is $21 billion.
Unfortunately, Kentucky ranks fifth among the nation’s states for incidence of death from heart disease. The Cardiovascular Innovation Institute, a partnership of the University of Louisville, Jewish Hospital Heart and Lung Institute and Kentucky’s Office for the New Economy, with support from Sen. Mitch McConnell, has been created to bring new treatments for this devastating disease.
Our goal: Elevate the quality of life for heart failure patients by turning the results of our leading-edge research and technology into the highest quality health care.
The Need Is Urgent
According to the National Heart, Lung and Blood Institute an estimated 400,000 people are diagnosed with advanced heart failure in the United States each year.
Almost 5 million Americans currently suffer from heart failure, a number that is expected to increase due to our aging population.
75 percent of advanced heart failure patients dependent on medication alone die within one year.
Only 5 percent of patients with advanced heart failure survive five years.
Most heart failure patients require an array of therapies to sustain a reasonable quality of life. As they near the end stage of heart failure, simple activities that the rest of us take for granted such as being able to sit up, stand or speak for more than a few minutes often leaves them exhausted and breathless.
Heart assist devices can help heart failure patients in three ways: as temporary bridges for transplant patients awaiting a donor’s heart; as permanent implants in those who are not heart transplant candidates; and as a way to help the heart until it has time to recover.
These types of heart assist devices have been used to treat patients for nearly 20 years. But while the technology has sustained many lives, in most cases the size of the devices and the equipment needed to support them have limited their ability to enhance patients’ quality of life.
The new generation of heart devices are smaller and more energy-efficient, but they are still in the experimental stages. Researchers do not yet know their long-term effects on patients.
The Cardiovascular Innovation Institute will be uniquely qualified to test these devices both in the lab and in patients. The tests will help generate concrete data on the effect of heart assist devices on the native heart, patient survival and quality of life. Researchers at the institute will be able to build on their vast experience with patients and research models by developing the next generation of devices.
These next-generation devices will help physicians provide the best possible care for advanced heart disease patients, enabling them and their families to enjoy a better quality of life.
“In the end, it won’t matter how successful we’ve been at building nice buildings or running nice experiments in the lab,” says Dr. Laman Gray, the institute’s medical director and U of L’s director of thoracic and cardiovascular surgery. “We will only be truly successful if we can make patients’ lives better. That’s the bottom line.”
The Vision
Over the last 20 years Gray, fellow U of L surgeon Rob Dowling and their colleagues have built up a valuable knowledge base about heart assist devices. Now they want to use this information to help improve the performance of existing devices and develop the next generation of bio-adaptive heart innovations.
One of the most promising improvements will be to combine the heart devices’ electromechanical capabilities with those of miniature biofeedback sensors. Current heart devices are limited in their ability to meet the body’s changing metabolic demands. Biofeedback sensors could enable the devices to be much “smarter,” responding to physiological changes that occur throughout the day such as standing up, walking, sleeping or exercising.
The institute also will cultivate the tremendous advantages that come from enabling biologists, cardiologists, engineers, physiologists, surgeons and veterinarians to work together in one place. This multidisciplinary team will be singularly focused on improving the lives of advanced heart failure patients.
Design concept, prototyping and engineering, device testing, development and improvement, clinical trials, user training, surgical implantation and cardiac rehabilitation--all will be accomplished at the Louisville Medical Center. Once innovations have been proven in the lab and in clinical studies, new Louisville-based businesses can be developed around the core technologies.
Hank Wagner, president of Jewish Hospital HealthCare Services and vice chair of the institute’s board of directors, is confident that the institute’s combination of scientific, clinical and entrepreneurial expertise will offer new hope to patients in Louisville and beyond.
“The pioneering spirit that led to the success of the AbioCor replacement heart will be the guiding force at the Cardiovascular Innovation Institute,” he says.
Clinical Translation
The key to the institute’s success is to conceptualize, develop and test those devices and therapies that show the best potential for moving quickly from the laboratory to the clinic where they can have a positive impact on patients. All of the institute’s activities will be built on core clinical research strengths and directed toward this end.
These core “centers of competence” are:
Pediatric innovation, which involves assessing and developing better heart assist devices to meet the special needs of children.
Biosensor innovation, including the development of biofeedback sensors using the latest MEMS and nanotechnology to improve the performance of adult and pediatric devices.
Biomaterials innovation, focused on engineering biocompatible surfaces for devices to eliminate factors that cause clotting, a common problem in current devices.
Information management, in which national databases and registries of devices and heart failure patients are collected in an effort to identify device improvement opportunities and develop more informed recommendations for physicians and patients.
Medical education, including providing information to caregivers that speeds the adoption of new products as well as improves the quality of health care and reduces its costs.
Proteomics, which combines circulatory support with protein therapy to revitalize heart function and allow the eventual removal of medical implants and devices.
All of the institute’s work will be conducted under the FDA’s most stringent “good laboratory practices” (GLP), which require routine calibration of equipment and high standards for data acquisition and quality assurance. Only GLP laboratories meet the FDA’s requirements set for the approval of new devices and therapies.
The Facility
The Cardiovascular Innovation Institute will be a four-story expansion of the existing lab at the University of Louisville Health Sciences Center in the Louisville Medical Center.
The institute will consist of research labs, fabrication facilities, operating rooms, recovery rooms, diagnostic equipment, training facilities, mock circulation labs, administrative offices, conference rooms, sterile supply rooms and medical imaging areas.
The building’s design will make it easier for multidisciplinary teams to collaborate. It also will provide space for corporate partners who want their researchers to work on site with the institute’s scientists.
Funding for the facility will include $15 million from Jewish Hospital, $5 million from the Kentucky Office for the New Economy and the remainder from private contributions. Nearly $3 million in federal grants secured by Sen. Mitch McConnell will fund the facility’s state-of-the-art equipment.
Economic Development
The Kentucky Innovation Act of 2000 directed the commissioner for the new economy to develop a statewide strategic plan to drive Kentucky toward a new, technology-based economy that grows jobs and advances the state. The resulting New Economy Initiative was built on three pillars: a thriving research and development capacity, an entrepreneurial business climate and an educated workforce.
The Cardiovascular Innovation Institute was identified as one of the five special opportunity areas in the new economy strategic plan, and the Office of the New Economy (ONE) provided $5 million for facility construction.
"A focused investment in biomedical research infrastructure will make Kentucky one of the leaders in cardiovascular research and provide an engine to drive our economy,” William Brundage, commissioner of the Kentucky Office for the New Economy, says. “In time, we hope the institute will make us as well known for our pioneering contributions in heart innovations as we are for the Kentucky Derby.”
The Cardiovascular Innovation Institute has a strong plan that will foster commercialization of the technologies developed by its research team. Over the next decade the goal is to create a cluster of new businesses in Louisville based on the institute’s work.
The ONE Innovation Commercialization Center in Louisville is likely to be a key partner in this business development. The center was created to help evaluate the market potential for new ideas and research development business strategies and plans for bringing the most promising ideas to market. It also will secure venture capital funding to launch the projects.
The Benefits
The Cardiovascular Innovation Institute will enhance the reputation of Kentucky as a leader in the development, testing, improvement and clinical evaluation of heart assist devices. It will provide U of L researchers with the support and infrastructure needed to capture a greater number of research grants and contracts from the federal government and private industry. Each $1 million in federal grants the university receives generates $2.2 million for the local and state economies.
The institute also will help fuel the state’s new economy by establishing new business relationships, attracting medical device companies and developing start-up biomedical companies in Louisville.
Most important, however, is the promise that the work of the institute holds for the millions of heart failure patients in Kentucky and across the country. The institute will give them access to the latest heart devices and therapies that should both extend and improve their lives.
“The significance of such a lofty goal cannot be understated,” U of L President James R. Ramsey says. “This project has the potential to be one of the most significant and visionary undertakings in the history of the Louisville Medical Center.”