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The idea seems fairly simple: put a device inside the body that would help maintain normal sinus rhythm.

But is "cardiac resynchronization therapy device implantation" simple?

It isn't.

Three leads snake through the venous system and into muscle of the heart, then a lead wraps around the back end of the heart into the left ventricle.

Then you have implantable cardioverter defibrillators and another piece of whiz-bang technology.

What's the purpose of these devices?

"Well, two things, really," said Dr. Raj Chakka, a cardiologist who specializes in cardiac electrophysiology for Heart Clinic Arkansas in Little Rock. "The first is that you improve the patient's quality of life. The other is that you lower healthcare costs. It's really good all the way around."

Chakka gave an example of a patient.

"You have someone come in," he said. "They're complaining of shortness of breath … easily fatigued [with] an arrhythmia. They have this done and 70 percent of those patients are going to see a benefit in how they feel. It just improves their quality of life. They can go to the Wal-Mart, run their errands and not feel bad."

And depending on the device, the patient may not know that it kicked in.

"Depending on the device," Chakka said, "a patient may have an episode and [the device] could start pacing or send a small shock depending on the problem. And the patient might not even know.

"We'll get a record of it here, and we may ask them, 'how did you feel at this time?' and they might say that they felt a little dizzy or a little short of breath, or they might not have noticed anything. But that just means [the machine] was doing its job."

That's the cost-lowering aspect of these implantable devices: they have the ability to communicate with the physicians.

"It depends, some transmit the data to us when they come in for a checkup," Chakka said as he demonstrated how a wand passed over the area of the chest where the device was implanted would pick up the data and send it to the monitor for the physician and technician to view. "Others can send information wirelessly. Yes, like a BlackBerry."

But how does that cut healthcare costs?

"If a patient can be at home, and not have to come to the clinic for a checkup, it saves money," Chakka said. "If we can look at the data and make adjustments to a patient's medication and do that from the office, where the patient doesn't have to come in, that saves money."

Chakka added that Medicare thought so highly of the devices that it approved their usage before the clinical trials had been published.

The devices are also hugely popular for both cardiologists and the patients with an industry-wide estimation of 450,000 in use in America.

But the devices can differ greatly from each other.

One of the manufacturers is Medtronic, the Minnesota-based medical equipment company.

Medtronic offers two implantable devices, the Virtuoso, which is the ICD, and Concerto, which does cardiac resynchronization and also has a defibrillation capability.

Tracy McNulty, a spokeswoman for Medtronic, added that another device was still in clinical trials. It would be similar to the Concerto, but would feature "additional atrial therapy."

She added that since Concerto and Virtuoso were approved for use by the FDA in May 2006, roughly 20,000 are in use.

While new technology is already in clinical trials, more is on the horizon.

"It is very exciting," said Chakka, who was a mechanical engineer before going to medical school. "They keep coming out with better technology. Right now, we are in an evolution. The last 20 years have seen some major advances, the possibility of what could happen in the next 20 years is what makes it so exciting."

The biggest challenge to the promise of new technology might be making them work, or at least getting them the power to work.

"That's exactly right, the battery," Chakka said. "That's what everyone is waiting on. Right now, the devices could only be made so small with the size of the battery." The key would be an improvement in battery technology. "Once the batteries got smaller, the devices could get smaller and do more," Chakka added.

And it isn't like the devices can be charged with an extension cord.

"It is an outpatient procedure," Chakka said. "We go in, take [the battery] out and put a new one in. It doesn't take very long, but they do have to be replaced."

The other component to any new technology is making sure that the technicians are up to date on how the equipment works.

Chakka said the learning curve isn't that steep.

"We have smart people who work here," he said. "We send them to training, but the techs, the nurses, they are smart and they learn how to make everything work. We don't have any problems."



February 2007

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