Guidant Cardiac Defibrillator Recall and Lawsuit

Defibrillators can increase heart failure risk Jun 13 (Reuters Health) - Implanted cardioverter-defibrillators (ICDs) can improve the survival rates of carefully selected patients with chronic heart disease by 30 percent to 54 percent. However, investigators have found that ICDs also appear to increase the risk of heart failure.
ICDs are recommended for patients who have had a near-fatal episode of irregular heart rhythm, also referred to as an arrhythmia, and who have a high risk of another episode. The devices are designed to detect arrhythmias, where the heart beats too slowly or too rapidly, and to deliver a shock to restore normal rhythm.

Dr. Ilan Goldenberg, at the University of Rochester Medical Center in New York, and his associates reviewed the records of 1,197 patients who had an ICD. The investigators analyzed the factors associated with the progression to heart failure.

The patients had experienced a heart attack at least one month before receiving the ICD and had a weaken ability to pump blood from the heart, according to the report in the medical journal Circulation. Included were patients assigned to receive drug therapy only, a single chamber ICD or a dual chamber ICD.

The researchers found that the rate of hospitalization for heart failure was higher among those with single chamber ICDs (22.4 percent) and dual-chamber ICDs (24.9 percent) compared with patients in the conventional drug therapy group (17.4 percent).

Nevertheless, survival was increased by the ICDs, and was similar before and after a first heart failure event in patients who received the single-chamber ICD group. However, those who received the dual-chamber ICD had significantly worse survival rates after a heart failure event.

"The increased risk of heart failure among patients allocated to the ICD group was related to the life-prolonging effect of appropriate defibrillator shocks," Goldenberg's team suggests.

The investigators conclude that prevention of heart failure progression is vital after ICD implantation. One way to achieve this, they suggest, is through cardiac resynchronization therapy, along with drug therapy that includes a beta-blocker.

SOURCE: Circulation June 20, 2006.
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laura2
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PostPosted: Mon Jul 03, 2006 8:03 am Post subject: Reply with quote
Only one of the causes of CHF is a dysfunction between the synchronization of the ventricles. In an otherwise normal mechanical heart, the ventricles are synchronized and a bivent would have no benefit. Also, the study deals with ICDs inserted after AND because of a previous heart attack. The findings do not apply to electrical problems only without coronary artery disease.

Dale Briggs knew something was wrong, even though his heart valve surgery had gone all right. An avid reader, he couldn't concentrate on books, couldn't sleep, couldn't eat.

"I was having a lot of symptoms that I didn't even relate to depression," said Briggs, 60, of Clovis, Calif. But glancing at a list of symptoms in his doctor's office, he realized he had all of them except suicidal thoughts.

As many as half of all people hospitalized for surgery or other procedures to treat blocked heart arteries develop depression, according to a report in Wednesday's Journal of the American Medical Association.

Doctors believe the depression is brought on by the mental stress of facing serious illness, or perhaps by microscopic damage done to the brain by the surgery itself. For some patients, the depression is a new thing; for others, it may have been present beforehand.

It may have played a role in the apparent suicide of a Maryland publisher and former diplomat whose body was found earlier this month after he went out sailing on the Chesapeake Bay. The family of Philip Merrill said that he had undergone heart surgery more than a year ago and had become fatigued and unmotivated.

The good news for the more than 71 million Americans suffering from some type of cardiovascular disease is that not only is depression treatable. But more than half of patients respond to initial drug treatment, and 80 percent eventually respond to at least one antidepressant, research says.

Such drugs soon had Briggs back on his feet. He now helps run Mended Hearts, a support group that hopes to keep fewer heart patients from going through what he did.

Guidelines advise doctors to look for depression in heart patients, and simple questionnaires are available to help them do this, but specialists say that not enough doctors are checking for this problem.

"It's something that's very under-recognized," said Dr. Mary Whooley, an associate professor of medicine at the University of California, San Francisco, who wrote the JAMA report about depression in heart patients.

Depression is present in one of five people with coronary heart disease and in one of three with heart failure — far more than the 1 in 20 in the general population who have it, Whooley wrote.

Depression raises the risk of developing cardiac problems. But even people who were not depressed beforehand can develop "situational depression" when faced with a health crisis or major surgery. "The stress of the illness is a factor," Whooley said.

Also, studies have shown that after bypass surgery, microclots can travel to a patient's brain and cause problems that can include depression, said Dr. Cara East, medical director of the clinical cardiovascular research center at Baylor Heart and Vascular Hospital in Dallas.

Few illnesses are as dramatic or frightening as heart problems, said Wayne Sotile, a Winston-Salem, N.C., psychologist who has written a book on surviving heart disease. Women may be at higher risk of becoming depressed because they typically are nurturers and get less family support when they are in need of care, he said.

Sotile said hundreds of patients have told him they thought about suicide after developing heart problems.

Treating depression can have physical benefits as well, specialists say. Depressed people are less likely to exercise or regularly take their medication - things that can prevent heart problems from getting worse.

Most antidepressants help make the blood less likely to clot, which may help prevent a recurrence of cardiac problems, said Dr. Ranga Krishnan, head of psychiatry at Duke University Medical Center and a consultant for the Depression and Bipolar Support Alliance.

The first step is recognizing the need for treatment, East said.

"In our culture there's a big denial," East said. "People think that you can just control your mind, and you can't."

Why has Guidant recalled several of their heart defibrillators?

The recalls are linked to a potential flaw where some could short circuit and not work at all. The device can malfunction.
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laura2
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PostPosted: Mon Jul 03, 2006 8:23 am Post subject: Reply with quote
On the heels of another warning on pacemakers and defibrillators, Boston Scientific's chief executive said Monday that "deeper issues" at its Guidant division are likely to result in more alerts about its heart devices.
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PostPosted: Fri Jul 07, 2006 6:00 pm Post subject: defibrillator Reply with quote
A defibrillator is a medical device used in the defibrillation of the heart. It consists of a central unit and a set of two electrodes. The central unit provides a source of power and control. The two electrodes are placed directly on or in the patient. The device is designed to deliver an electric shock to the patient, in an effort to stop ventricular fibrillation.

* HeartStart simplicity makes use simple and easy
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The HeartStart™ AED is one of the best life saving devices we have seen. The HeartStart™ by Phillips is something no home, office, boat, gym or school should be without.

Like other pieces of essential safety equipment, The Philips HeartStart™ Home Defibrillator was designed to be safe, reliable and easy to use. The award-winning Philips HeartStart™ Home Defibrillator is designed with you in mind:
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PostPosted: Mon Jul 03, 2006 7:39 am Post subject: Reply with quote
Easy to Use

* 3 simple step voice-guidance
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*The Infant/Child pads cartridge is sold separately, and available by prescription only. Talk to your doctor.

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* You cannot use the HeartStart™ to treat yourself.
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laura2
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PostPosted: Mon Jul 03, 2006 7:40 am Post subject: Reply with quote
How do I use the Philips HeartStart™ Home Defibrillator?
HeartStart™ is specifically designed for use by virtually anyone to help save a life. If you suspect that someone is in sudden cardiac arrest--they are not breathing and you can't wake the person--call 911 first. Then follow this three-step process to restart a heart: Pull, Place & Press.

Step 1--Pull the cartridge handle--it's marked "PULL" in large letters. This initiates the clear calm voice that will guide you through the process.

Step 2--Place the pads on the patient's chest. The voice instructions tell you exactly what to do. HeartStart™ can even sense and adapt to your actions. If you are moving quickly, the voice prompts stay with you. If you are taking more time, HeartStart™ provides increasingly detailed instructions to help you place the pads correctly. Once HeartStart™ senses that the pads have been applied to the skin, it automatically begins analyzing the patient's heart rhythm. HeartStart™ decides whether a shock is needed--you don't have to.

Step 3-- Press the shock button. If HeartStart™ decides a shock is needed, it will instruct you to press the flashing orange button HeartStart™ is designed to only let you deliver a shock if it determines one is needed. HeartStart™ even provides CPR coaching.

Essentially, that's how it works. You can feel confident that the defibrillator is providing easy-to-follow, straightforward direction and coaching. All you need is the desire to save a life.

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Does the battery need recharging?
The long-life lithium battery does not need recharging. It contains power cells of the same kind safely used in many other consumer products, such as cameras.

The battery typically lasts approximately four years in "standby mode." "Standby mode" means HeartStart™ is standing at the ready to help save a life if needed. Every day, HeartStart™ runs self-tests to check its battery, pads freshness and internal circuitry. If it ever detects a problem, such as a low battery, it chirps like your smoke alarm to alert you.

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Can the Philips HeartStart™ Home Defibrillator treat an existing medical condition?
The Philips HeartStart™ Home Defibrillator is only intended for use in the treatment of the most common cause of sudden cardiac arrest, known as ventricular fibrillation (VF). VF occurs when the electrical system of the heart short circuits, causing the heart to quiver rather than pump in a normal rhythm.

If you have questions or concerns about your health, or an existing medical condition, please talk with your doctor. A defibrillator does not take the place of seeking medical care.

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Why is a prescription no longer needed?
The HeartStart™ Home Defibrillator is the first and only home defibrillator available without a prescription, which means that it is considered safe and easy to use by virtually anyone with the materials provided in the package.
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laura2
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PostPosted: Mon Jul 03, 2006 7:41 am Post subject: Reply with quote
Can HeartStart™ be used on a person with a pacemaker or ICD?
It is all right to use the HeartStart™ on a person with an implanted device such as a pacemaker or ICD, but do not place the pads directly over the implant. You can tell where an implant is located by a lump in the skin and a scar.

It is also all right to use HeartStart™ on someone wearing an oxygen mask.
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laura2
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PostPosted: Mon Jul 03, 2006 8:44 am Post subject: Reply with quote
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Jon



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PostPosted: Tue Jul 04, 2006 10:41 pm Post subject: Reply with quote
What is it? The HeartStart Home Defibrillator is a small, lightweight automatic external defibrillator (AED) specifically designed for home use without a prescription.

HeartStart is a battery-powered device that delivers an external electric shock through the patient’s chest to help restore a normal heart rhythm. It is intended to treat a person who experiences sudden cardiac arrest caused more frequently by ventricular fibrillation. During ventricular fibrillation, the electrical signals in the lower part of the heart are uncoordinated and ineffective. Very little blood is pumped from the heart to the body or the lungs. If ventricular fibrillation is not treated it will result in death.

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