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Cardiomems

About 5 million Americans suffer from Congestive Heart Failure, the leading cause of hospitalization for people 65 and older. It’s also a huge strain on medicare. In this segment of Bio On My Mind, Susan Mittleman looks a technology that could let doctors monitor your heart and manage your care — without cutting you open or putting you in the hospital.

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Patients hospitalized for heart failure often end up on a ventilator, with a catheter in their heart. The catheter is the only way for doctors to measure the pressure, or cardiac output- and then fine-tune the treatment.

“It’s the information that’s critical.”

Interventional Cardiologist, Dr. Jay Yadaff, wanted a way to get this information without the painful procedure and costly hospitalization.

“We have good treatments for most conditions, but the treatment comes a little too late. If treatment could come earlier, the patient can do better, the health care system will save money, and we’ll have better outcomes.”

Yadaff found a wireless sensor technology developed at Georgia Tech for the Defense Department, and put that same technology into ‘Medical Defense’.

The Cardiomems sensor is a tiny, wireless device, about the size of a Tylenol, that’s implanted into the body through a minimally invasive procedure. The patient is then able to transmit information to the doctor, by laying on a special pillow and pressing a button.

“The idea is the doctor has daily information which lets him then adjust medication, over a period of several weeks to months, pressures are brought into line and then maintained there.”

The sensor is FDA approved and commercially available for use in the aortic aneurism sac, and there are about six-thousand patients in the United States with the implant.

“We’ve had no complications from these patients with device. There’s been many many cases where a problem was picked up than it would’ve been picked up otherwise.”

That same device, designed by Florent Cros and his team of Cardiomems engineers, is being studied now, for use in the pulmonary artery.

“This is a direct input on what’s happening inside the ‘black box,’ the heart. Thanks to this device, we can have it interrogated every day in a completely harmless manner.”

(Wolpe) “Technology that’s implanted can be extraordinarily helpful. But it does raise some ethical concerns.”

Paul Root Wolpe is the director of Emory University’s Center for Ethics.

“When you know you depend on an object for your life, like a pacemaker, or device to keep you from dying- like this device might, there’s always that concern of how well it works. Can I trust it? I think that’s a very real part of this move toward incorporating technology into our bodies.”

There may also be concern, says Wolpe, of who, besides the doctor, and insurance companies, may gain access, to that information, and how would they use it?

“Not just the insurance company. Employers, they may or may not have a right to that info,but certainly, they may know just that the device was implanted. That may be enough for them to worry bout the impact of having that employee on insurance rolls.”

But, he says,

“If it enhances human judgement, it’s a wonderful thing and we’re all for it!”

Cardiomems founder, Dr. Jay Yadaff, says this technology does just that.

“I think in heart failure, I think we can make a big difference because until now there’s been no way to get this information. We’re really solving a big problem.”

And patients with the device, like 64-year old Dan Miller, who has congestive heart failure and has had the sensor two years now, report feeling empowered, and more confident.

“To me it’s a safeguard. It kind of gives you a piece of mind, because it’s always in the back of your head that you have a heart problem. It just gives you a sense of well-being that you can keep going.”

Cardiomems hopes to get FDA approval on the sensor for heart failure early next year, and for other applications after that.

For WABE News, I’M Susan Mittleman.