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Experts debate benefits of heart implant in US



1 August, 2005: Medical experts has been increasingly debating the costs and benefits of the implantable defibrillator devices. Defibrillators are currently under spot light following the detection of defects by one of its producers: the Guidant Corporation. Defibrillallator, a device that sends out an electrical jolt to interrupt a chaotic heart rhythm, which is often fatal.

Sure, some patients need it. But several others who are being implanted by the units, may not need them because they are either too well or too sick, some medical experts say.

Over the years, the use of this one of the most costly medical devices has soared. Last year, an estimated 135,000 devices were implanted in patients in the United States alone, a near tripling of the number in 2000. And the three major device producers, Guidant, Medtronic, St. Jude Medical, have reaped a financial bonanza as domestic sales rose during that same period to $3.5 billion, from $1.3 billion, according to an investment firm.

Defibrillators pose unique issues because they are increasingly being used as a standard piece of safety equipment, like an air bag in an automobile, in an ever-growing number of heart patients whose individual need for the device is not clear. Defibrillator prices are also like those found on a new car, ranging from about $20,000 to $35,000 each.

In the 1980s, defibrillators were first used only in patients who had survived an episode of sudden cardiac arrest. But since then, studies largely funded by the industry have resulted in a steady expansion of the device's use to ever-broader pools of heart patients with varying degrees of risk of cardiac arrest, experts say.

The problem, however, is that medical researchers have not figured out how to tell which patients in these broader groups are at high risk and which ones are at low risk. As a result, they all qualify for a unit.

Health policy experts believe that manufacturers have used a variety of strategies to increase profits by keeping device prices high. For example, rather than offering a low-cost unit that does the basic job of stopping a bad heart rhythm, defibrillator makers are engaged in a sort of medical arms race in which producers turn over models by adding new features like different ways to measure heart rhythms.

Many physicians acknowledge that they do not consider product prices when deciding which model of defibrillator is best for their patient. And patients have little reason to care about cost because insurers like Medicare cover the cost of an implant procedure, which includes the device, regardless of its cost.

As in other areas of medicine, there have been claims that device makers retain the loyalty of physicians by providing them with consulting arrangements and other financial incentives. The companies insist that they have done nothing wrong and that their prices are fair. They also say they are responding to doctors' suggestions by producing the devices they want.

In January, both the financial and public policy stakes involving defibrillators were heightened when Medicare dramatically expanded the types of heart patients who qualify to receive a unit. The agency's ruling means that hundreds of thousands of heart patients each year will likely get a unit, compared with 135,000 last year.

The Medicare decision followed a clinical trial, sponsored by Medtronic and a division of the National Institutes of Health, which showed that patients with heart failure who got both a defibrillator and heart drugs had a 7 per cent higher survival rate than patients who were treated with just drugs. Heart failure is a progressive weakening of the heart caused by coronary disease or other factors.

However, that study also raised the troubling possibility that the sickest heart patients might not be helped by a defibrillator and might even be harmed if a device, as happens, misreads a rhythm and emits an unneeded shock. That possibility is currently just a theory, experts say

A defibrillator is implanted under the skin near the collarbone in a procedure that takes about an hour. The device, which is about the size of a pager, sends out an electrical charge when it senses a chaotic heart rhythm known as a ventricular fibrillation. That rhythm can cause sudden cardiac arrest by effectively shutting off blood flow from the heart.

Most defibrillators can also treat an abnormally fast heart rhythm, known as ventricular tachycardia, which can deteriorate into ventricular fibrillation. No one is suggesting that anyone be denied a device without better ways of selecting which patients face little risk. And there are many heart patients who could benefit from a defibrillator who have not got one.

But the steady broadening of the device's use - from high-risk groups like patients who survived a cardiac arrest to those at relatively lower risk like heart attack patients or patients with heart failure - has also led to a situation where more patients are receiving devices to find the one who will benefit.

In just two years, defibrillator-related costs to both Medicare and private insurers are expected to reach $10 billion, with Medicare covering about a half of that expense, according to an estimate by an investment firm. That would make defibrillators one of Medicare's biggest surgery-related costs.

With costs soaring, there is an increased urgency to find a way of both discriminating between high-risk patients and low-risk ones and hold down, or even reduce, the price of a device.


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