During a gymnastics class in 1998, Bob Baker began to notice persistent abdominal pain, prompting a visit to his doctor. As a children's gymnastics teacher, Bob Baker demonstrated handstands, cartwheels, and the splits--pretty amazing moves for a man in his 70s. The visit to the doctor, however, led to a follow-up electrocardiogram that revealed Bob's "abdominal pain" was actually a heart attack.

"I had none of the traditional symptoms of a heart attack," Baker recalled. Additional tests revealed an immediate need to undergo angioplasty to open a blocked coronary artery. After the procedure that evening, a night nurse noted that Bob began to experience a very serious, irregular heart rhythm. "Once again, I didn't really feel anything, so I was extremely lucky to be in the hospital and on a heart monitor when it happened."

Bob's doctor presented the gymnastics coach with his options, one of which included an implantable cardioverter defibrillator (ICD). For Bob, the decision was a no-brainer.

"The decision to get the device wasn't difficult at all," Bob now says. "If I had elected not to get it, I could have died anytime. Also, the medication I'm on is no guarantee that I couldn't end up in a dangerous fast heart rhythm again. My doctor recommended a combination pacemaker and defibrillator."

While the defibrillator has never gone off, Bob regards the device as his internal guardian angel, a vigilant guard against potentially lethal heart rhythms. The pacemaker portion works when needed, monitors his heart, and then delivers pacing pulses if his heart rate becomes abnormal.

"Little did I know how dangerous my condition was," Bob says. "This came as a complete surprise. Now that I have a device. I feel like I've come to respect life more. I've been given another chance, and I can enjoy things more fully because of it. It really helps you to learn to live each day and make the most of it. You take inventory of your blessings."

One of those blessings is the ICD. And thanks to diligent monitoring of his heart, he's still able to do the work he loves. Like other ICD patients, including our own Vice President Dick Cheney, Bob Baker is now living a full life.

As previously reported in the Post (July/August 2002), the results of the landmark MADIT II trial provide hope for many patients with prior myocardial infarction (MI) who would otherwise become victims of sudden cardiac death (SCD), a condition that claims the lives of more than 300,000 Americans each year--with about 80 to 90 percent of those deaths caused by ventricular fibrillation. MADIT II demonstrated that ICDs provide the most effective method to date for preventing sudden cardiac death in high-risk coronary patients.

"We think the impact of this device in the treatment of patients who have mild to moderate heart failure will have a major impact in the practice of medicine and cardiology," Dr. Arthur Moss, principal investigator of the MADIT II trial, told the Post. "There are three million people in the United States alone who qualify for the ICD."

As a result of these landmark findings from MADIT and other studies, the American College of Cardiology, the North American Society of Pacing and Electrophysiology, and the American Heart Association issued joint guidelines calling for expanded use of ICDs for the primary prevention of sudden cardiac death. The groups concurred that ICDs not only enhanced the quality of life in individuals suffering from heart failure, but also helped reduce the incidence of SCD in patients suffering from heart rhythm disturbances and in heart attack survivors, among others. The organizations drafted guidelines indicating that the eligible population for the ICD include patients with a depressed ejection fraction of less than 30 percent, Class III heart failure, or those with a broad QRS complex duration, as well as patients with electrical conduction disturbances, among other conditions.

Last summer, however, the Centers for Medicare and Medicaid Services (CMS)--the group that regulates reimbursement issues--announced only modest expansion of Medicare coverage for ICDs, a measure that drew sharp criticism from physicians and other groups around the country.

To learn more about the controversy and implications of the ruling, the Post spoke with Dr. Douglas P. Zipes, world-renowned electrophysiologist, past president of the American College of Cardiology, and distinguished professor at Indiana University School of Medicine who was consulted when Vice President Cheney received his ICD in 2001.

Post: Could you briefly outline the CMS ruling on the eligible population for the implantation of ICDs, and how it differs from the previously suggested eligible population determined by the MADIT II trial?

Zipes: The MADIT II criteria took patients who were greater than one month post-myocardial infarction with ejection fractions of 30 percent or less and randomized them to ICD versus either conventional therapy or the anti-arrhythmic drug amiodarone and found a significant improvement in mortality in those patients receiving an ICD. There was a nine percent absolute reduction in mortality and relative reduction of 31 percent.

CMS looked at those data and also looked at the fact that patients with QRS prolongation--greater than 120 milliseconds--demonstrated a trend in the data of receiving the biggest impact from the ICD, though it wasn't statistically significant. Nevertheless, CMS said that it would approve ICD implantation in this population, with the added criterion that it would be for patients with QRS duration exceeding 120 milliseconds

QRS is an electrocardiographic criterion that measures how long it takes the heart to contract. QRS duration has now been identified as a risk for total and sudden death mortality.

Post: Were the MADIT trials focusing on the prophylactic use of ICDs?

Zipes: MADIT I was the first prophylactic ICD trial in which they took a group of patients, post-myocardial infarction, who had ejection fractions equal to or less than 35 percent and were subjected to an electrophysiology study with VT (ventricular tachycardia) induction that was not then suppressed by an anti-arrhythmic agent. They then were randomized to device or drugs.

MADIT II took an even lower EF of 30 percent and eliminated the electrophysiology study.

Post: Three major groups--ACC, NASPE, and AHA--all supported ICD implantation based on the MADIT II trial criteria. What was the reaction in the community when CMS limited coverage to a smaller group?

Zipes: Everyone has objected to CMS right after the ruling.

First of all, CMS is playing doctor, which is totally inappropriate. Second, CMS did a retrospective analysis of the data, which from a scientific standpoint is totally inappropriate. Third, CMS is placing physicians in a very difficult situation. If I now have a patient who meets MADIT II criteria and doesn't meet the QRS duration prolongation, then I can't implant an ICD in that patient and expect to be reimbursed. If that patient then does not get an ICD and goes home and has sudden death, that physician might face lawsuits because he did not follow the indications from MADIT II, which are now accepted by the majority of cardiology societies as an indication for ICD implant.

Post: With the CMS ruling, what percentage of the original population estimated to be eligible for the ICD under MADIT criteria now receives the implant?

Zipes: That is not entirely clear and depends on how you look at the data. According to data that I have seen, about one-half of the patients who fit MADIT II criteria may have private insurers who reimburse regardless of the CMS decision. Another quarter of patients fit the CMS criteria, so you may be down to 25 percent of patients who might not get an ICD because of the CMS ruling.

Post: Could you discuss the Sudden Cardiac Death Heart Failure Trial (SCD-HeFT) that was just completed, and how it may impact the CMS ruling?

Zipes: We are all waiting to hear what SCD-HeFT shows, because CMS has said that they may review their decision based on data from SCD-HeFT. Data will be presented at the American College of Cardiology meeting in March 2004.

Post: You presented a major presentation on the economics of the ICD at the 2003 Scientific Sessions meeting of the American Heart Association. Could you provide an overview of your conclusions?

Zipes: Based on published studies on cost-effectiveness of ICD therapy, the additional cost per life year saved ranges between $30,000 and $185,000. In the U.S., we consider $20,000 to $40,000 cost per life year saved as very reasonable therapy, and that is well within accepted therapies such as dialysis, hypertension treatment, and so on.

The cost per life year saved is calculated as follows: the cost of treatment A minus the cost of treatment B, divided by the additional life provided by treatment A minus that by treatment B. Let's say treatment A costs $100 and treatment B is $50, so 50 is your numerator. Let's say you live one year with treatment A, but only 0.5 years with treatment B. Your denominator is 0.5. You divide 0.5 into 5 and get 10, so there would be $10 per additional life year saved. If one looks at multiple ICD studies, the cost differential between an ICD and drug therapy is in the range of $14,000 to 8$6,000. However, the additional life provided by an ICD varies with the particular study. It ranges from maybe as short as 0.2 years up to 0.8 years. Obviously, the bigger the denominator, the smaller the quotient or cost per life year saved.

The greater the impact on years added provided by the ICD, the smaller the cost will be per life year saved.

If you have a population at great risk for sudden death, the impact of the ICD is much greater. Those studies that are very expensive in terms of life years saved--$185,000--did not have terribly sick patients, while those that had $30,000 per life year saved had very sick patients. The upshot of all this is that we need to better select that population who would benefit most by the ICD. In so doing, we will increase that denominator--the extension of their lives--and therefore reduce the cost per life year saved. Can we afford it? Absolutely.

Post: Dick Cheney has almost become the poster man for ICDs. Did he match the MADIT II trial criteria?

Zipes: He fit MADIT I criteria.

Post: Are physicians then being put into a position of deciding who gets that second chance or better quality of life? Isn't that awkward?

Zipes: To some degree, yes. I also published another study several years ago that was supported by Medtronic. We reviewed the discharge diagnoses of 4½ million Americans at hospital discharge and searched for discharge diagnoses that would fit ICD criteria for implantation. Basically, we found that only one-third of Americans who fit existing ICD indications prior to MADIT II were actually receiving an ICD. We are underusing ICDs, never mind the argument about MADIT II.

Post: In 2001, we spoke to you about your meeting with President Bush on the Patient's Bill of Rights. September 11 came along and changed focus. Should we revive the Patient's Bill of Rights so that all people can take advantage of the technology that can help improve their lives?

Zipes: That would certainly be a very reasonable thing to do. We need to bring this issue to the people, because if you look at the impact of ICDs on the overall healthcare budget, total expenditures for ICDs are something like $2.3 billion, which represents 0.16 percent of the healthcare budget. If you consider ballpark figures of $100 billion cost for waste, fraud, abuse, inappropriate antibiotic use, etc., $2.3 billion is a tiny amount.

We are talking about a very small amount of money spent on known therapies that save lives. It would be very helpful for people to write to their congressmen.

Post: What message do you want to bring to the public?

Zipes: The main message is that almost one of every two Americans dies of heart disease--and almost half of those die of a heart rhythm problem. Knowing that the vast majority of heart rhythm problems can be saved by an ICD, that pretty well puts the issue into perspective.