Preserving the Rhythm of Life: Leading Heart Experts Call for Broader Use of Implantable Defibrillator Technology That Is Improving and Saving the Lives of Heart Attack Survivors
For the millions of Americans at risk for sudden cardiac death (SCD), new guidelines crafted by cardiology experts from three leading medical organizations may help save their lives. After impressive results of clinical trials reported on in the Post (July/Aug. `02, Sept./Oct. `02), implantable cardioverter defibrillators (ICDs) have moved into the mainstream, as the American College of Cardiology, the North American Society of Pacing and Electrophysiology, and the American Heart Association call for expanded use of ICDs for the primary prevention of sudden cardiac death. Landmark studies have demonstrated that implantable defibrillators not only enhance the quality of life in individuals suffering from heart failure, but also help reduce the incidence of SCD in patients suffering from heart rhythm disturbances and in heart attack survivors, among others.
To learn more about the guidelines and how they might affect you, the Post interviewed Mark Schoenfeld, M.D., president, North American Society of Pacing Electrophysiology (NASPE) and clinical professor of medicine, Yale University School of Medicine.
Post: Could you please tell our readers about the guidelines recently issued on the use of implantable cardioverter defibrillators?
Schoenfeld: The guide lines are presently the most important document governing the practice of arrhythmia management at this time and represents a joint approach that involves the North American Society of Pacing and Electrophysiology (NASPE), the American College of Cardiology (ACC), and the American Heart Association (AHA). Everyone looks to this document for guidance and medical insight on this issue.
There are, however, two other important pieces to the puzzle. One involves the FDA, whose job is to make sure that a technology is both safe and efficacious. Earlier this year after the MADIT II trial, the FDA agreed that the ICD is a safe and effective technology for patients who have an ejection fraction less than or equal to 30 percent in the setting of coronary disease.
However, while the FDA agrees that the device is safe and effective, that doesn't mean that you will be reimbursed for the ICD, which is where the third-party payers--in particular older folks--and the Centers for Medicare and Medicaid Services (CMS) come into play. CMS' final opinion on reimbursement will soon be available. A few private insurers have begun accepting and paying for ICDs for MADIT II-type patients, but it is not a widespread practice.
Post: Who is eligible for the ICD under the new guidelines that your organizations drafted?
Schoenfeld: Patients who have a depressed ejection fraction, typically have Class III heart failure, or have a broad QRS complex duration are eligible. Some patients have conduction disturbances, electrically speaking, that can aggravate the way the heart pumps. They may already have weakened heart muscle due to coronary disease or some noncoronary process. Add to that an electrical disturbance called left bundle branch block, which is very common and estimated to occur in anywhere from 15 to possibly 25 percent of patients who have heart failure. It is a very widespread illness, probably one of the most common hospital admitting diagnoses for patients--certainly heart patients. This major diagnosis entails many and prolonged hospitalizations. But just as the regulators are concerned about the impact in terms of cost for defibrillators, by the same token if we have a therapy that can have an impact on the number of heart therapy hospitalizations, you can significantly cut costs.
Post: What is the cost for an ICD?
Schoenfeld: ICD costs vary--somewhere around $20,000 to $30,000.
Post: Could you discuss the benefits of the devices for heart patients?
Schoenfeld: Cardiac resynchronization therapy, which is biventricular pacing, entails putting a special pacemaker lead into the coronary sinus that allows for pacing from the left ventricle in concert with the right ventricle. …