Promising Pipeline: Predicting Solutions for Healthcare’s Big Challenges

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Robert Califf, MD, Duke Health, Raleigh-Durham, N.C.

Ask cardiologists to name the big advances of the past decade, and many point to transcatheter aortic valve replacement (TAVR) and other breakthroughs that are allowing cardiologists to treat structural heart disease with minimally invasive procedures. Looking ahead, some believe that even bigger, broader changes are coming.

Plenty of progress

In the 17 years since Ehtisham Mahmud, MD, began his career as a cardiologist, he has seen advances in technologies, medications and devices transform the industry. Now the chief of cardiovascular medicine at UC San Diego Health, Mahmud says structural heart interventions such as TAVR, transcather mitral valve repair and left atrial appendage closure have been particularly helpful in improving health outcomes.

“I would say TAVR has been the most dramatic and life-saving, life-altering therapy that did not exist when I first started practicing and now does,” Mahmud says. To the list, he adds percutaneous hemodynamic support with devices such as intra-aortic balloon pumps, ventricular assist devices and enhanced extracorporeal membrane oxygenation, which have allowed physicians to offer more therapies to sicker patients.

Other cardiologists name the Food and Drug Administration (FDA) approvals of new pharmaceuticals as transforming care. For example, they point to proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors for their potential to reduce low-density lipoprotein (LDL) cholesterol in patients with familial hypercholesterolemia and angiotensin receptor-neprilysin inhibitors for heart failure.

Peter Fitzgerald, MD, PhD, Stanford University Center for Research in Cardiovascular Interventions
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Long way to go

While many patients have benefited from the progress of the last decade, data suggest there’s still a long way to go to knock cardiovascular disease from its perch as the top cause of death and disability in the U.S. On the one hand, annual death rates attributable to heart disease and stroke declined 35.5 percent and 28.7 percent, respectively, between 2004 and 2014, according to the American Heart Association (AHA). On the other hand, gains have been offset by a finding, also from the AHA, that cardiovascular disease accounts for nearly 801,000 deaths in the U.S. annually, amounting to about one-third of all deaths. Meanwhile, the Centers for Disease Control and Prevention announced last December that U.S. life expectancy declined for the first time in decades, from 78.9 years in 2014 to 78.8 years in 2015.

At the same time, healthcare spending remains higher in the U.S. than in any other developed country. Data from the Centers for Medicare & Medicaid Services showed that the U.S. spent $3.2 trillion on healthcare in 2015, a 5.8 percent increase from the previous year. The AHA estimates that cardiovascular disease was associated with $555 billion in costs in 2016.

“We wait until people get a disease, and then we offer them all this expensive technology,” says Peter Fitzgerald, MD, PhD, co-director of Stanford University’s Center for Research in Cardiovascular Interventions in Stanford, Calif. “I think that in the future, it will have to be patient adherence, compliance, reminders, and we have to figure out how to utilize technology to provide more cost-effective care.”

Getting around human behavior

Robert Califf, MD, vice chancellor for health data science at Duke Health in Raleigh-Durham, N.C., and former FDA commissioner, predicts that in the next few years wearable sensors and monitoring devices will have the biggest impact on the care of patients with atherosclerosis, heart failure, atrial fibrillation and other cardiovascular diseases.

The FDA has already approved a few such devices and recently launched a pilot program aimed at speeding up approvals of healthcare apps and services. Patients can now stream their health data to the cloud through wearable technology, which allows them and their clinicians to track information on a continuous basis. Evaluating and accessing such data could help identify warning signs and lead to faster diagnoses.

As more people own smart devices and technology improves, wearable technology will likely become more common, Califf says. He foresees wristwatches determining whether patients have atrial fibrillation or other cardiac conditions. Innovations like this one will be “a big change from putting on a Holter monitor or implanting some cumbersome device,” he explains. “Sensors are becoming very inexpensive. I don’t think the cost is really going to be the issue.”

Still, Califf is discouraged by the increases in age-adjusted death rates for heart disease and stroke and the decline in life expectancy. In many cases, he says, the main culprits are diet, exercise and medication adherence.

Fitness trackers and smartphone health applications are becoming more popular and have shown promise. More companies are developing technology that alerts people when they should take their medications and allows them to track food intake and exercise routine. Still, convincing people to make lifestyle changes and stick with them is “a lot harder than developing a pill,” Califf says.

“The availability of sensors and interaction on cell phones should help, but we need to develop the most effective ways to do it and to interface between machines and people,” he says. “That’s really where the big challenge is.”

Removing hindrances

Cardiology faces other challenges when it comes to adopting innovations. Too often, Fitzgerald says, advances that are “truly revolutionary or innovative come to the United States in a delayed form.” For example, TAVR was available in 41 countries before the FDA approved the first device (the Sapien valve from Edwards Lifesciences) in 2011. He blames the agency’s conservative nature as well as legislation, regulation, litigation and infrastructure issues as “things that sometimes get in our way.”

He’s encouraged, though, by changes the FDA has undertaken, including its early feasibility study program, which now allows companies to enroll a small number of patients in U.S.-based trials, evaluate their devices early in the approval process and work with FDA staff and clinicians to gain constructive feedback.

The FDA also is increasingly using real-world evidence when it makes approval decisions, which has led to devices coming to the market sooner than before. For instance, in June, the U.S. became the first country to approve the Sapien 3 valve as a valve-in-valve treatment for high-risk patients whose old valves had degraded. The approval was based on data from the Transcatheter Valve Therapy Registry, which is sponsored by the American College of Cardiology and the Society of Thoracic Surgeons.

Reducing variation, decreasing costs

Fitzgerald is eager for technologies that will enable physicians to more effectively and efficiently evaluate people who are at risk for cardiovascular disease so health professionals can intervene earlier, perhaps reducing the need for costly treatments later. Such tools and other strategies for tackling care variations will help to rein in some of the country’s excessive healthcare spending.

To tackle huge challenges, healthcare will need big disruptors, or a composite of intersecting disruptors, what Fitzgerald calls “BDASH,” or Big data, smart Devices, Augmented (“not necessarily artificial”) intelligence and Security in Healthcare. It’s much more than a device, he says. “It’s where we’re all moving to in a very accelerated manner.”

The most significant advances in the pipeline today will affect “the whole way medicine is delivered to patients either before they get sick or when they get sick,” Fitzgerald predicts. “If you’re looking for something that’s going to be incredibly meaningful, it’s that, not another iteration of a stent or an iteration of a valve.”

When he speaks at medical conferences and industry events, he discusses changes in reimbursement, healthcare delivery and technology. Afterward, physicians often line up to share that they are concerned about emerging technologies replacing them. He tells them not to worry. “They’re going to be able to do things quicker, they’ll probably be able to charge the same and they’re not going to work as hard.”

His advice: “Embrace this because your life is going to be better.”

Source: Centers for Disease Control and Prevention.
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