updated 5/14/2008 2:10:21 PM ET 2008-05-14T18:10:21

People with implanted heart devices need closer follow-up care, an international panel of heart specialists recommended Wednesday in the first guidelines for monitoring this rapidly growing group of patients.

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Nearly 2 million people worldwide have pacemakers, defibrillators or other machines to help their hearts beat faster, slower or more regularly.

For years, attention focused on who should get these gadgets and whether insurance should pay. Now doctors are facing the daunting task of making sure the devices keep working and that patients hear about safety issues such as the big recalls that have shaken the industry in recent years.

The guidelines spell out who should do what to ensure good care. They tackle ethical dilemmas, like when to turn off a device and let a patient die. This is aimed at preventing horror stories like those of dying cancer patients whose defibrillators continue to shock their failing hearts back to life.

The guidelines also endorse new wireless technology that lets doctors check devices remotely while a patient is at home — an emerging standard of care.

"To some people technology is scary and they would rather talk face to face,'' said the Cleveland Clinic's Dr. Bruce Wilkoff. But to others, home monitoring saves time and money, gives peace of mind, and avoids trips to the hospital, he said.

Wilkoff led the panel that wrote the guidelines. They were announced Wednesday in San Francisco at a meeting of the Heart Rhythm Society, doctors who treat heartbeat problems.

At the meeting, Cleveland Clinic researchers reported results of a five-year experiment with home monitoring. Remote checkups rose dramatically — from 94 people at the start of the study to more than 5,000 by its end — without a big burden to the clinic's staff.

Heart attacks"It's a whole new way of being able to treat patients,'' said Dr. Kenneth Ellenbogen, a heart device expert at Virginia Commonwealth University and a spokesman for the American Heart Association. "It is becoming standard with all new defibrillators and in the next couple years will become standard with all new pacemakers. It is going to provide us with data that we've never, ever had before.''

Robert Print, a 64-year-old heart attack survivor from suburban Cleveland, agreed to try it.

"It's quite amazing, a very nice convenience. All you have to do is dial the phone, put the monitor over your device, and it's being transmitted over the airwaves,'' he said.

Devices have not just grown more common, but they've increased in complexity and do not just run on "autopilot'' without regular maintenance, doctors said.

The new guidelines:

  • Assign the doctor who implants the device responsibility for follow-up care, unless another specialist takes over the job. This includes coordinating with the patient's primary doctor to keep track of patients as they move.
  • Recommend giving each patient an "ID card'' with details on the device to help resolve safety questions and guide emergency workers.
  • Urge checkups every three to 12 months — at least once a year in person.
  • Limit the role of manufacturer representatives to ensure that doctors and nurses are in charge of care, from the operating room where devices are implanted to homes where patients are monitored afterward.
  • Urge the government to call device problems "safety alerts'' instead of "recalls'' to avoid alarming patients who think a recall requires immediate surgery to remove a defective product. "You can't recall an implanted device the way you would a car,'' said Dr. Richard Page, cardiology chief at the University of Washington in Seattle and chairman of the conference.
  • Spell out when to grant requests to turn off heart devices artificially keeping terminal patients alive.

Pacemakers do their job with little notice by patients, but a defibrillator repeatedly and even painfully shocking a patient's heart can erode quality at the end of life and prolong suffering. Deactivating a defibrillator can be seen as similar to following "do not resuscitate'' orders in certain circumstances, the guidelines say.

"The most important thing is that the patient understands what's going on and it's their decision,'' Wilkoff said. "There are times where it's appropriate and times when it's not appropriate.''

On Thursday, a broad coalition of heart groups will update longstanding guidelines on who should get various heart devices and for what conditions.

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