New tools for helping heart patients

On a recent Monday, Helen Elzo got
a call from her doctor’s office. A device implanted in her heart was not
functioning. She needed to go to the hospital and have it replaced.

She was aghast – her heart is
damaged and, at any time, can start quivering instead of beating. If the
device, a defibrillator, was unable to shock her heart back to normal, her life
was in danger.

In the old days, Elzo, 73, who
lives outside Tulsa, Oklahoma, could have gone for months before the problem
was discovered at a routine office visit.

But she has a new defibrillator
that communicates directly with her doctor, sending signals about its functions
and setting off alarms if things go wrong.

On the horizon is an even smarter
heart device, one that detects deterioration in various heart functions and
tells the patient how to adjust medications.

They are part of a new wave of
smart implantable devices that is transforming the care of people with heart
disease and creating a bonanza for researchers. The hope is that the devices,
now being tested in clinical trials, will save lives, reduce medical expenses
and nudge heart patients toward managing their symptoms much the way people
with diabetes manage theirs. Patients, who often are frail or live far from
their doctors, can be spared frequent office visits. Doctors can learn
immediately if devices are malfunctioning or if patients’ hearts are starting
to fail.

The big leap forward came a few
years ago when device companies figured out how to make transmitters that send
data over a broader range, six or nine meters. That meant that, with her
device, Elzo did not have to wait till her doctor could put a receiver directly
on her chest. Instead, she simply went near a small box, which is attached to a
phone jack near her bed. Once a week, she also measures her weight and blood
pressure – key indicators of heart failure – and that information is
automatically transmitted to her doctor. If there are problems, the machine
alerts her doctor.

“Now, every single day the device
is being queried,” said her doctor, James Coman of the Heart Rhythm Institute
in Tulsa. “It’s just a phenomenal tool.”

There is a downside, though:
“Information overload is a very serious problem” for the doctors, said Dr.
Lynne Warner Stevenson, director of the Heart Failure Program at Brigham and
Women’s Hospital in Boston and a professor at Harvard Medical School, who
counts herself as a proponent of smart devices. More information, she warned,
is not always beneficial.

Stevenson likened such information
to the game of “Jeopardy!” – Doctors are given answers in search of a question.
It’s a challenge even for the nation’s 1,000 heart failure specialists. But it
can be even harder for primary care doctors, who have less expertise in heart
failure yet care for most of the 6 million patients in the country with the

For researchers the information
deluge leads to a different problem: how to analyse the data. A large clinical
trial of a cardiac device used to involve 1,000, maybe 2,000 patients. Now,
Boston Scientific, a maker of one of the smart heart devices, is following
400,000 patients.

Boston Scientific gets data from
patients’ defibrillators. It also gets information on deaths from Medicare.

The data are stripped of patient
identifiers and analysed, a task requiring the company to become more like a
Google or a Microsoft, handling enormous amounts of information. There are, for
example, more than four million recordings of weights and blood pressures and
over 60,000 instances when the defibrillators went off, shocking a patient’s

So far, Saxon’s group has reported
on the first 90,000 patients. Half of them had not been enrolled for remote
monitoring and served as a control group.

Patients whose doctors looked at
the data survived 5 percent to 15 percent longer than patients in earlier
clinical trials of the devices, Saxon reported. And, in a paper under review,
the group reports that their three-year survival was significantly greater than
that of patients in the study whose doctors did not see the data.

“The plausible reason, we think, is
that we got to these people much sooner in the course of their illness,”
Crossley said. “We think we did not let the people in the remote sensing group
get into heart failure.”