New Study Data Indicates Long-Term Defibrillator Benefits
May 14 2009 - 9:45AM
Dow Jones News
A landmark product trial that helped establish implantable
defibrillators as devices to help guard against sudden death from
heart failure also showed they have continued benefits out to eight
years, according to data released Thursday.
The original "Madit II" trial results were released early this
decade. The study helped fuel growth in a now $6 billion global
market for implantable cardioverter defibrillators, or ICDs, shared
by Medtronic Inc. (MDT), St. Jude Medical Inc. (STJ) and Boston
Scientific Corp. (BSX).
Boston Scientific sponsors the Madit II study by way of Guidant
Corp., which Boston Scientific purchased three years ago.
The new long-term results, unveiled at the Heart Rhythm
Society's annual scientific sessions, showed an expanded survival
benefit for patients with ICDs. Such data could help manufacturers
defend the market for the devices priced at roughly $25,000, which
are often used in Medicare-aged patients. It comes amid a search
for ways to wring savings from the U.S. health-care system.
The study looked at patients who had prior heart attacks that
did some damage and put them at risk of sudden-cardiac death based
on certain measurements of heart performance. ICDs are designed to
provide shocks when needed to jolt hearts back into proper
rhythms.
Among the 1,232 patients originally enrolled, the study showed a
31% relative reduction in risk of death at 20 months of follow-up
for patients who had an ICD plus medication compared with patients
on just drugs. Over an average follow-up period of about two years,
ICDs extended patient lives by about two months.
The eight-year results from Madit II showed a probability of
death by any cause of 45% among patients with an ICD, as compared
with a 61% probability for patients without one. The numbers
indicate that these are patients who face significant risks, and
many will die with or without protection from ICDs. Still, the
difference at eight years corresponds to an expanded 1.2 life-years
saved among ICD patients, according to a release from the Heart
Rhythm Society.
The results also indicate a 37% lower chance of death from any
cause at eight years among ICD patients.
Boston Scientific noted that at eight years in the study, one
life is saved for every six patients who received an ICD. That
compares with saving one life for every 17 patients with an ICD at
the two-year point.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com