Focused Ultrasound

October 23, 2014
By Neal Kassell

The tides of health care delivery are turning. As the fee for-service structure shifts to a population based accountable care organization model, we expect to see the emergence of a more balanced, value-based health care ecosystem. Payors will seek ways to decrease cost, while patients will become active participants in their care, demanding improved outcomes that mean a quicker return to their daily lives. To meet these demands, individual hospitals mand larger systems alike will look to invest in diagnosis and treatment innovations to meet the future needs of our evolving medical system. However, many of these devices and associated procedures are stalled in various stages of research and development. We must find a way to accelerate the pace to commercial success as hospitals strive to achieve the ACO model’s population-based health goals.

One way to help achieve the goals of improving the quality of care and reducing costs is by minimizing complications associated with traditional/open surgery, which are estimated at up to $25 billion annually. Fortunately, there are a number of less invasive options offering fewer risks currently available or in development. The challenge is that there is a pervasive culture in our health care system that is adverse to innovation, resulting in a lagging adoption to new approaches that ultimately widens disparities in care delivered across the country. A Johns Hopkins University study recently published in the British Medical Journal reveals the under- utilization of minimally invasive surgery in the U.S. (Cooper et. al., 2014). In studying four common minimally invasive procedures (appendectomy, colectomy, hysterectomy, and lung lobectomy), they found that mean hospital utilization rates ranged from 71 percent to as low as 13 percent. The authors concluded that, despite reductions in pain, infections and risk of subsequent surgery, adoption of minimally invasive procedures is wildly inconsistent. Higher utilization is loosely associated with urban location, larger hospital size and teaching hospitals; however, no clear trends were apparent.

Learning the lessons of innovation
As one of the early champions of the Gamma Knife, I have witnessed the challenges of integrating a noninvasive treatment approach into patient care firsthand. Systemic barriers can slow adoption of new technology by health care professionals to a glacial pace. The Gamma Knife was invented in 1951 as a promising tool in noninvasive radiosurgery, yet wasn’t commercially available in the U.S. until 1987. That’s 36 years of painstaking research, regulatory hurdles and bureaucratic red tape; all the while patients were denied access to a better treatment. Now the Gamma Knife and other stereotactic radiosurgical technologies are mainstream in hospitals, being used to treat movement disorders, arteriovenous malformations, brain tumors, epilepsy, and many more conditions.

So when I became aware of a technology that could impact current practices to a far greater extent, I understood the challenges ahead. About eight years ago, I was searching for effective ways to treat brain tumors without needing to open the skull or use radiation, and I learned about a nascent technology with tremendous potential — focused ultrasound. As I delved deeper, I quickly learned that the company developing the technology was underresourced. Meanwhile, other companies and laboratories across the world were independently researching the technology without the benefit of collaboration. Determined not to see this innovative technology languish through the same long process from R&D to widespread utilization, we created what we believe is the first philanthropy in the U.S. dedicated to advancing a medical technology — the Focused Ultrasound Foundation. The Foundation’s mission is to accelerate the development and adoption of this noninvasive technology so that it can benefit patients in years rather than decades. And we believe that the technology will also be of tremendous benefit to the institutions and professionals providing care in the ACO model.

Focused Ultrasound – A non-invasive approach on the horizon
While focused ultrasound holds immense potential, the technology, for the most part, is in its infancy. Currently, it is approved by the Food and Drug Administration (FDA) for two indications – the treatment of symptomatic uterine fibroids and reducing the pain from bone metastases. This is merely the tip of the iceberg, with more than 40 potential applications that are in various stages of development in the U.S. and around the globe.

Focused ultrasound is steadily pushing its way to the forefront of noninvasive therapy. Two systems to treat prostate cancer are currently under FDA regulatory review. There is a pivotal trial ongoing at several U.S. centers using focused ultrasound to treat essential tremor, with earlier-phase clinical studies ongoing in brain tumors, Parkinson’s disease and OCD. There is great interest in using focused ultrasound to temporarily open the blood-brain barrier and allow drugs to penetrate the brain and treat tumors. Researchers have also noted its potential to enable localized and targeted drug delivery–releasing drugs in potent concentrations to a specific point anywhere in the body while minimizing systemic delivery and toxicity. Focused ultrasound could be pivotal to the future of health care. But, we have a long way to go.

The Foundation is working aggressively to overcome the hurdles focused ultrasound faces in becoming a standard of care. Within our various programs, we fund translational preclinical and early clinical research, foster collaboration to break down the silos that hinder innovation and help aggregate the evidence required for widespread reimbursement.

Value of non-invasive technologies
Hospital systems that want to thrive in the new environment will need to invest in the future. We will see an increased demand from payors and patients for noninvasive treatments, like focused ultrasound, that will shorten or eliminate hospital stays, reduce readmission rates, diminish infection rates and other risks, and ultimately lower the cost of care.

For patients, focused ultrasound offers the potential of less pain, reduced complications, and getting back to their lives faster. With treatments like focused ultrasound available, patients will come off the sidelines. As you eliminate the fear of complex surgery or radiation from the equation, I believe many patients with benign but nevertheless serious conditions will opt for treatment rather than simply toleration. This will help to decrease the cost of care and improve the overall health of the population — the ultimate goal of the ACO model.

Realizing the value of innovations like focused ultrasound requires investment and long-term vision. Early adapting academic medical centers are already vested in the technology. Hospital systems who want to maintain a competitive edge should continue to track the technology.

Think back 25 or 30 years, before anyone had heard of an MR. It promised to be the next big thing in diagnosis, but it was expensive and perhaps ultrasound imaging was sufficient. Imagine today’s clinical world without it. Now imagine a new technology that leverages the real-time imaging of MR coupled with power of sound waves, and the potential that exists to transform the future of therapy.

About the author: Neal F. Kassell, MD, is the founder and chairman of the Focused Ultrasound Foundation and a professor of neurosurgery at the University of Virginia, where he was co-chair until 2006. He has published more than 500 scientific papers and book chapters.