Heart device keeps pace with technology

Friday, July 1, 2005 | 7:51 a.m.

WEEKEND EDITION

July 2-3, 2005

For details about the Medtronic CareLink Network at Nevada Heart and Vascular Center call (702) 240-6482. Additional information can be found at medtronic.com/carelink.

Local teacher's aide Dinora DeMeo has for several years suffered from cardiomyopathy, commonly known as an enlarged heart, which has forced her to make numerous visits to doctors.

Now, thanks to a new remote heart-monitoring device that provides her doctor with information relayed over the Internet, she has a new lease on life and fewer doctor appointments.

The device, called an ICD (short for implantable cardioverter-defibrillator) and implanted in her chest, sends her doctor key data over a phone line to what the device's manufacturer says is a secure Web site.

"I feel great," 56-year-old DeMeo said, adding that instead of building her schedule around doctor visits, she "can go hiking at Mount Charleston and Red Rock and continue what for me has been an active life."

The ICD market is a $5 billion-a-year industry, according to the Dow Jones newswire. Experts see it growing even larger as the monitoring of patients with the devices speeds onto the Superinformation Highway.

"The Internet is absolutely where patient care is going in the next two decades," said Dr. Dwight Reynolds, president-elect of the Washington, D.C.-based Heart Rhythm Society and chief of cardiology at the University of Oklahoma.

"One of the tremendous expenses of health care today is hospitalization of patients. Being able to monitor patients from long distances give us the capability to better treat them and save them from the hassles and expense of travel to doctors. Remote monitoring has a tremendous upside."

One Internet monitoring system recently introduced to Southern Nevada is the Medtronic's CareLink Network, which is used in conjunction with ICDs manufactured by the large Minneapolis-based medical technology company that provides products for people with chronic diseases.

Dr. Robert Berkley of the Nevada Heart and Vascular Center, which uses Medtronic's system, says the potential for Internet monitoring is boundless, although the product currently is capable of transmitting just information as to whether the implanted device is operating properly.

"Now it gives us just the nuts and bolts information," said Berkley, who is board-certified in cardiology and has no investment in Medtronic or its products.

"But five years down the road it should give us (clinical) information (to help) manage patients' medications as well as make recommendations for activity, diet and follow-ups. It's like an Internet house call."

Dr. Reynolds, who is an investor in -- and consultant for -- Medtronic, echoes that sentiment.

"Eventually, the technology will evolve to allow a doctor to adjust (over the Internet) a patient's pacemaker from, let's say, 60 beats per minute to 70," he said.

To send data via the CareLink system, a patient places an antenna wand over the pager-sized implanted device, dials a number through a standard phone hooked up to a portable modem and sends pages of data to a clinician -- all from the comfort of his home or from anywhere in the continental United States.

Because the ICD has a defibrillator it delivers a shock when it detects an abnormal, dangerously fast heart rhythm. Berkley said patients who experience two or more such shocks in a short period of time should send their data over the Internet so a clinician can determine if the device is working properly.

Among other things, the clinician checks the connectors and the battery level. If the device is working right, patients may be told to go to the doctor's office or to an emergency room depending on the severity of their condition.

Medtronic warns that, while the monitoring system is a good early warning system, it is best for patients in serious distress to instead dial emergency 911 for an ambulance rather than use the phone to transmit data.

"When we submitted CareLink for FDA approval, we said it was to replace routine doctor visits -- not an emergency device," said Reggie Groves, vice president of patient management for Medtronic. "In an emergency situation, 911 is a patient's only choice to call."

Currently, 37,000 U.S. patients with Medtronic devices are hooked up to the CareLink Network, Groves said, noting that about 170,000 U.S. patients have Medtronic ICDs that are capable of using the Internet remote monitoring device.

In Las Vegas, 50 Nevada Heart and Vascular Clinic's patients are on Medtronic's CareLink system, Berkley said.

The ICD market has seen recalls of older model units that could malfunction.

In April 2004, Medtronic voluntarily recalled two mid- to late-1990s models of ICDs that are not compatible with the current CareLink technology. The devices were thought to have a defective high voltage capacitor that could take longer than normal to charge near the end of the battery service life. About 1,800 were implanted in patients at the time of the recall.

DeMeo was told when she underwent surgery last year to install a Medtronic InSync II Marquis ICD that by the time the batteries begin to die in about five to six years her implant will be surgically replaced because the technology of the current device will be obsolete by then.

Last week, Guidant Corp., the world's No. 2 ICD player behind Medtronic, began recalling some older model ICDs and offered replacement models at no charge to an estimated 39,000 patients.

The U.S. Food and Drug Administration said it issued a nationwide notification of a recall for some of Guidant's models, saying those defibrillators could short-circuit and fail to deliver a potentially life-saving shock.

Guidant does not yet offer an Internet monitoring system for its ICD patients.

Reynolds said it is difficult to gauge how future problems with ICDs will affect the Internet component of monitoring patients.

"The important thing is that the companies and the FDA, as well as physicians, are very carefully monitoring ICDs," he said. "The interplay with the Internet will have to be tracked as well.

"We'd love to have perfection in the technology. But the reality is we will never have perfection. Technology changes. Pacemakers of the 1970s that ran on nuclear batteries are still in a few patients today. But those models are no longer manufactured because newer technology has replaced them."

Medtronic's CareLink received FDA approval in January 2002 and went on the market four months later. Since then, Groves said, 75,000 transmissions have been made to CareLink with no product malfunctions.

Just three medical companies worldwide offer Internet monitoring for ICDs. St. Jude Medical and Biotronik are the other two. While all three companies offer a similar product, each has its own special bells and whistles.

Biotronik's "Home Monitoring" system, for instance, automatically transmits data if a patient has a cardiac event, said Biotronik spokesman Mark Johnson. The St. Jude Medical Housecall Plus Remote Patient Monitoring System, according to its Web site, offers patients "live interaction" with the clinician.

Regardless of the brand, the Internet monitoring technology, proponents say, will save the health care system money in the long run.

"The monitoring systems save patients four doctor visits a year (to check if the ICDs are operating properly)," Johnson said. "That could translate to about 600,000 fewer visits to the doctor each year in the United States.

"The (Internet-based) system gives the patient confidence because he knows he is being monitored on a regular basis without having to go to a doctor."

Biotronik has 5,000 U.S. patients on its Home Monitoring system.

None of the three company's monitoring systems are compatible with one another.

For DeMeo, a teacher's assistant for six years at Gene Ward Elementary School, the technology has been a godsend.

"I've always been on the go. Now I can continue with peace of mind," she said.

She didn't always have that peace of mind, however. People with her condition are at risk to develop arrhythmia and can die suddenly because their hearts can suddenly beat rapidly, then stop.

DeMeo was the first local test patient of Medtronic CareLink system that costs about $40,000, installed. She is as equally confident with her ICD as she is with the portable Internet monitoring unit.

"Since I have had the implant, I have had no shortness of breath, nor have I received a (life-saving) shock from it," DeMeo said. "And I have not had to take unnecessary time off from work. I'm always available for my students."

Berkley said use of the Internet monitoring network sure beats the old system where checking pacemakers required patients to come into the doctor's office quarterly to have the same thing done by a clinician that patients do at home with their CareLink monitors.

Berkley said that, to date, each device prescribed for Nevada Heart and Vascular Center patients has been approved by insurance companies.

Groves said her company's technology, under development since 1999, also complies with recent federal regulations designed to protect patients' privacy.

"Our server has enormous amounts of security," Groves said, referring to fire walls built into the part of the Web site that contains patient data.

Security concerns, she says, have stopped her company from immediately offering access to the CareLink Network via a cell phone connection.

"A cell phone is not as secure as a land line," Groves said. "We opted to start with a system that offers the greatest level of security before venturing into areas that are not as secure. We will add it (cell phone accessibility) when we feel we can do it securely."

The Internet technology, Groves said, also may one day be used to monitor patients with diabetes or those with neurological ailments including Parkinson's disease.

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