Round two MADIT II: the experts react

Susan Jeffrey

March 19, 2002

CLICK HERE TO SEE RELATED STORY: MADIT II: Mortality reduction with ICD implantation for patients with prior MI, LV dysfunction

Atlanta, GA - The Multicenter Autonomic Defibrillator Implantation Trial II (MADIT II) results were the focus of great interest at the ACC meeting here, given the potentially large expansion of patients eligible for ICD therapy. Doctors appeared to struggle with the idea of embracing the results outright, given the cost and sheer numbers of procedures - and EP manpower - this would require.

"What we've heard today unquestionably increases the indications for use of ICDs, and will then increase the pool of individuals who would qualify for implantation," said ACC president and electrophysiologist Dr Douglas P Zipes (Krannert Institute of Cardiology, Indianapolis, IN).

 

What we've heard today unquestionably increases the indications for use of ICDs, and will then increase the pool of individuals who would qualify for implantation.

 

However, Zipes adds, "The financial implications are profound, and I think that given an average cost at our institution of about $60000 total cost for ICD implantation, if you do the math, you're talking about hundreds of millions, if not billions of dollars."

Zipes reiterated an assertion he has made on other occasions, that device manufacturers should begin offering less sophisticated, and therefore cheaper, ICDs, "a Volkswagen rather than a Rolls Royce, a $10000 'shock box' I call it."

More data on which patients will benefit most from implantation will help in making use of the devices more cost-effective, Zipes added. In the meantime though, adopting the MADIT II results into practice will be an individual decision for clinicians, he told heartwire .

An impressive study, but current guidelines still hold sway

"Whether I'm ready to implant an ICD in every patient postinfarct with an EF of 30%, as Art's data would suggest - I'd like to see the results of SCD-HeFT," Zipes said, referring to a second ongoing study comparing ICDs and amiodarone to placebo in this population of patients. Wider indication or not, he pointed out that only about 50% of patients who already need ICDs presently get them. "I'd be happy if cardiologists paid attention to the existing approved ACC/AHA guidelines."

American Heart Association chief science officer Dr Sidney Smith (University of North Carolina, Chapel Hill, NC) told heartwire he will also probably wait for more information to adopt these new data into practice.

"I think it's a very impressive study, and it addresses a major problem that is sudden death," Smith said in an interview here. "If one were to accept the premise of the study, that all you need to do was an echo and enroll the patient and put in a defibrillator, it would certainly be a very simple approach," he said. "I would just be concerned that the number of patients who would end up being eligible for the procedure under that definition would be substantial, the cost would be significant, and we do need in some way to identify a subpopulation of patients within this group who would benefit."

Smith called the observation of a nonsignificant increase in heart failure admissions in the ICD group "interesting," and speculated, as the researchers did on the mechanism of the increase. "Certainly if more people are alive with failure, you're going to have more admissions for failure," he said. "It might be an effect, however, of recurrent defibrillation, or of pacing, which is known to affect myocardial performance. I think we need to know a bit more about how the admissions for failure could relate to the presence of an ICD."

Debating costs vs benefits

MADIT II principal investigator Dr Arthur J Moss was philosophical about the doubts expressed, pointing out that similar questions were raised about the costs of bypass surgery and pacemakers when they were first proven useful.

"We set out to do a good scientific study and came up with what we think is an outstanding result," he told heartwire . "Once you show the scientific need, the need will be met," Moss said.

"My feeling is that market forces will bring the prices down, appropriately so, and my prediction is 5 years from now, the price of pacemakers and defibrillators will be virtually the same," he said.

Dr James Young (Cleveland Clinic Foundation) pointed out that public health care funding should be looked at in context with other strategies undertaken to save lives. He pointed to a recent British study that showed the single most expensive technique was side-door airbags. "It's so far out, spending millions of pounds per lives saved and yet it's federally mandated," Young said. "I don't know where the economic analysis of lives saved here is going to fall out, but I bet it's around the 25 000-a-year mark, and perhaps less than that. We do have to put it in perspective with the other things we do."

Manpower issues?

Another issue that came up during the discussion of implications of the MADIT II results is that of the number of electrophysiologists that would be required to keep up with the expanded indications for ICD implantation.

Zipes noted that the complexity of the devices has been reduced significantly, and the ease of use of the ICD has improved dramatically. "There is also a creeping suggestion - and I'm not certain whether I'm pro or con - that nonelectrophysiologists might be implanting these devices in the future depending on what the volumes are," he said. Moss reiterated that this type of progress is analogous to other previously "new" and expensive procedures like bypass surgery. "It's one thing to advance the science, and the second thing is to apply it. We've only completed one stage, and one shouldn't be frightened of the application."

 

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