Studies Try to Find More Eligible Users Amid Falling Sales
CHICAGO -- With sales of implanted cardiac defibrillators in a slump, manufacturers are working to win approval to market the devices to larger groups of patients.
At a seminar on the sidelines at the American College of Cardiology conference Monday, some cardiologists expressed pessimism about defibrillators' prospects for wider use, saying that no good way exists to identify patients who can most benefit from them.
Also Monday, analyst Larry Biegelsen at Wachovia Corp. said the number of defibrillator, or ICD, implantations in February had fallen 1% to 2% from the year-earlier month, based on a survey of 16 hospitals by the bank. The Wachovia report also projected a 5% year-over-year decline in U.S. ICD sales for the just-ended first quarter and a 2% drop for all of 2008.
ICD sales fell to $3.9 billion last year from $4 billion in 2006. In October, sales leader Medtronic Inc. recalled wires that connect ICDs to the heart.
Sales grew about 28% a year from 2001 through 2005 as manufacturers and the government published several medical studies showing that the devices could avert the most common cause of death -- a stopped heart -- among increasingly broad groups of patients.
When an ICD detects that a heart has stopped, it delivers an electrical jolt to restart it. The devices cost an average of about $25,000. Medtronic has half of the market, followed by Boston Scientific Corp. and St. Jude Medical Inc. Manufacturers are funding new scientific studies to try to broaden the group of patients eligible for an ICD, including newer cardiac resynchronization therapy defibrillators, which try to heal failing hearts by making their muscles beat more efficiently. Such a device costs about $30,000.
Medtronic plans to announce the results from one of those studies Tuesday morning. The company is attempting to show that resynchronizing defibrillators, also called CRT-Ds, can help patients with mild heart failure achieve higher scores on a physical exam and questionnaire.
In two other studies, Boston Scientific and Medtronic are trying to show that a CRT-D can reduce deaths among patients with mild heart failure -- a group thought to include 900,000 Americans. About 400,000 Americans have a more severe grade of heart failure, according to some estimates.
By some industry estimates, only 30% of patients eligible for a defibrillator have had one implanted. The decline in implantations has frustrated electrophysiologists who believe patients are being deprived of a life-saving treatment.
"It's pure skepticism," Eric Prystowsky, an Indianapolis electrophysiologist, said at a Medtronic-sponsored seminar Monday. "We spent all our lives trying to figure out how to stop sudden death, and when we finally find the therapy, people don't do it."
Several doctors who spoke out at the symposium were pessimistic about tests that try to separate patients who benefit from ICDs from those who don't. "None of the tests are any good," said Robert Califf, a Duke University cardiologist, describing the current diagnostic situation as "chaos."
Part of that skepticism comes from the number of defibrillators necessarily to save one life. In studies of lower-risk patients, most defibrillators never fire a jolt -- meaning one life is saved for every 10 or 20 people who have a defibrillator implanted.
Defibrillators have also come under scrutiny for reducing patients' quality of life. A jolt is excruciatingly painful -- worth it to save a life, but not when an ICD makes a mistake, which happens sometimes. A 2003 study funded by Boston Scientific's Guidant unit was hailed as a triumph for demonstrating that ICDs could reduce deaths by 38% among patients with a previous heart attack and heart failure. But in a little-noticed 2007 analysis, those benefits were negated after factoring in the diminished quality of life of patients with an ICD.
By Keith J. Winstein
Wall Street Journal; April 1, 2008
