When Implanted Heart Devices Fail
The Odds -- and Consequences -- of Pacemaker, ICD Breakdowns
WebMD News Archive
ICD Replacement Risks continued...
"We were surprised by the high risk of infection and the number of
replacement procedures that required a second operation," Krahn says.
"We reported a 6% major complication rate. And 2% of patients with major
complications required a major surgical procedure. That is a compelling risk.
Our concern about the device has to cap that threshold for us to advocate
So what should you do if you've received an "advisory" warning that
your ICD might fail? This is a tough question, and the answer may be not to
have the device removed.
"The majority of advisories had a 1-in-10,000 to a 1-in-100 risk of
device failure," Krahn says. "And for some manufacturer advisories, you
can detect problems by monitoring the device. So the vast majority of the time,
you detect a problem before the patient feels anything. On the other hand, some
advisories warn of abrupt loss of function. Some patients suffer sudden
It's an unusual risk-vs.-benefit decision. Patients, Krahn says, should
first look at their own medical condition, then at the risk estimated for the
specific device they have implanted.
"Let's say a man had a first heart attackheart attack three years
ago, and the doctor advised him that his risk of sudden death is 2% to 5% per
year," Krahn says. "If that patient has device put in and finds out
there is a 1-in-1,000 chance the device will not be reliable, the patient may
say leave that alone. If, on the other hand, that patient received a shock
three months ago, and the doctor says, 'We checked the device, it saved your
life,' then the patient may want a new one, because his life clearly depends on
Wilkoff agrees that patients must carefully consider whether to replace an
ICD because of an advisory.
"It turns out that changing the device is not necessarily the lower-risk
answer," he says. "We shouldn't overreact to the realization these
remarkably effective devices aren't perfect. Maisel found a 1%-2% malfunction
rate, not death risk. But in the ICD population, there is a 7% to 15% annual
risk of death without a device. Is the ICD perfect? No. But we cannot have
people panicking about this when there are much bigger devils sitting outside