clinical update publication

Preventing Sudden Cardiac Death

Sudden cardiac death (SCD) is the leading cause of mortality in the nation, claiming the lives of as many as 460,000 Americans annually. While tremendous awareness is generated for ailments like cancer and multiple sclerosis, unfortunately, there are no spokespersons promoting public awareness of SCD.

The good news… SCD is preventable. The key to surviving is to quickly terminate ventricular fibrillation by delivering an electrical shock to the heart, as each minute of delay before defibrillation reduces survival by about 10 percent.

Implantable cardioverter defibrillators (ICDs), designed for patients at high risk for SCD, can detect lethal arrhythmias and deliver an electrical shock to the heart to return it to a normal rhythm. Drug therapy can help prevent arrhythmias, but once an arrhythmia occurs, drugs cannot always convert the heart to a normal rhythm. Still, because some of the most effective drug therapies produce unwanted side affects, patient medication non-compliance remains an unresolved issue for physicians.

“Devices are the future,” stated Raffaele Corbisiero, MD, Director of the Section of Electrophysiology, “and I’ll tell you why. They are 100 percent compliant. If the device is in, then you have sudden cardiac death prevention – period,” explained Dr. Corbisiero. “It’s not like a beta-blocker that a patient may forget to take or stop taking because it makes them feel bad. The device is always there.”

Devices have become increasingly popular in recent years, not only because they have been streamlined from the larger, obtrusive contraptions of the past to the high-tech miniature devices used today, but also because they can radically improve a patients quality of life. According to Dr. Corbisiero, the fact that these devices also prevent sudden cardiac death is often a secondary benefit in the eyes of many patients, who simply do not believe they are in any real danger of SCD because it hasn’t happened…yet.

People at risk for SCD include those who have survived a heart attack, or a previous SCD episode, patients with a poor cardiac pump function, patients who have heart failure, or patients who have a family history of SCD. Amazingly, only 20 percent of this population actually has an implanted device. “We know what to do with these patients once we get them here,” said Dr. Corbisiero. “The question is, ‘How do we get them here?’”

SCD Research at a Glance: Device manufacturers, working with leading medical centers throughout the Nation, have sponsored numerous clinical studies over the years to prove that ICDs are a safe and effective treatment for SCD.

SCD-HeFT: The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) demonstrated that ICD therapy reduced overall mortality by 23 percent in patients with moderate heart failure. The SCD-HeFT trial was designed to determine whether implantable defibrillator therapy with conventional heart failure drug therapy improves overall survival when compared to conventional drug therapy and a placebo in patients with clinical symptoms of heart failure and an ejection fraction of less than 35 percent.

MADIT II: The Multicenter Automatic Defibrillator Implantation Trial (MADIT) II demonstrated that ICD therapy reduced overall mortality by 31 percent in patients who had experienced a previous heart attack and had an ejection fraction of less than 30 percent. MADIT II was designed to determine whether implantable defibrillator therapy with conventional medical therapy improves overall survival when compared to conventional therapy alone.

COMPANION: The landmark Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial demonstrated for the first time that cardiac resynchronization therapy reduces the risk of death or time to first hospitalization in patients with advanced heart failure. Additionally, COMPANION demonstrated that resynchronization therapy defibrillators reduced overall mortality by 36 percent in patients with moderate to severe heart failure. COMPANION included patients with moderate to severe heart failure (NYHA class III and IV) despite optimal medical therapy, who also had a wide QRS and an ejection fraction less than 35 percent.

DEFINITE: The DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial was the first major trial to exclusively focus on the potential mortality benefits of implantable defibrillators as primary prevention therapy in non-ischemic patients. DEFINITE included patients with mild to moderate heart failure with an ejection fraction of less than 35 percent and either an intermittent too-rapid heart beat or frequent abnormal or premature ventricular contractions. Although the trial design called for a 50 percent all-cause mortality reduction, the final results revealed a non-significant reduction of 35 percent. A pre-specified secondary analysis did reveal a significant 80 percent reduction in the risk of sudden cardiac death.

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