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ICD does not improve overall survival in
nonischaemic heart failure
Placement of an implantable
cardioverter-defibrillator in
patients with nonischaemic
systolic heart failure did
not improve overall survival
compared with usual clinical
care. Risk of sudden cardiac
death, however, was halved,
reports the DANISH trial.
L
ars Kober, MD, of Copenhagen
University Hospital, Denmark,
explained that the results suggest
a caveat to both European and American
Heart Association guidelines that recommend
implantable cardioverter-defibrillators for all
heart failure.
DANISH stands for DANish randomised,
controlled, multicentre study to assess
the efficacy of Implantable Cardioverter
Defibrillator (ICD) in patients with
nonischaemic Systolic Heart failure on
mortality.
Dr Kober said, “Prophylactic cardioverter-
defibrillator implantation is a class 1
recommendation in patients with heart failure
and reduced left ventricular systolic function
in both European and American guidelines.
The evidence is much weaker, however,
for patients with non-ischaemic aetiology.
Limited data supports the devices in this
population. The DANISH trial filled that gap
by suggesting the cardioverter-defibrillators
should not be routinely implanted in all
patients with systolic heart failure.”
A total of 1116 stable patients with chronic,
nonischaemic, symptomatic heart failure were
randomised to usual care including guideline-
recommended medications such as including
beta blockers, renin-
angiotensin inhibitors, and
mineralocorticoid-receptor
antagonists (n = 560); or an
ICD (n = 556).
An equal proportion of
patients (58%) in both
groups also needed cardiac
resynchronisation therapy,
which was delivered via
biventricular pacemaker
in the control arm, and a
device combining cardiac
resynchronisation therapy
and ICD in the ICD arm.
After a median of 67.6
months, the primary
outcome of death from all
causes occurred in 21.6%
of ICD patients and 23.4%
of controls, a nonsignificant
difference.
Sudden death, a secondary
outcome, occurred in 4.3%
of ICD patients and was
almost doubled (8.2%) in
the control group (hazard ratio 0.50; 95%
CI 0.31 to 0.82; P = 0.01). Results were
independent of whether or not a patient
received a cardiac resynchronisation device,
but an important interaction with age was
observed.
Dr Kober said, “Patients younger than 68
years of age had a significant reduction in
all-cause mortality if they received an ICD
(hazard ratio 0.64; 95% CI 0.45 to 0.90,
P = 0.01), suggesting that younger patients
may experience a survival benefit with
implantation of the device.”
Fifty-eight percent of controls had received
a biventricular pacemaker and device-related
infections occurred in both groups. Patients
not receiving cardiac resynchronisation
therapy in the ICD group, however, were at
excess risk of device infection (5.1% vs 0.8%
in controls; HR 6.35; 95% CI 1.38 to 58.87;
P = 0.006). Inappropriate shocks, another
risk associated with ICD, occurred in 5.9%
of the ICD group.
American Heart Association guidelines
include ICD implantation as a class 1A
recommendation for primary prevention of all-
cause mortality in patients with symptomatic
systolic heart failure, with no differentiation
between patients with ischaemic and
nonischaemic aetiology. European guidelines
carry a class IB recommendation specifically
for patients with nonischaemic heart failure.
Dr Kober concluded, “Guidelines are based
on multiple studies. Implantable cardioverter-
defibrillator treatment should still carry a
class 1A recommendation for prevention of
sudden cardiac death in nonischaemic heart
failure also. Patients at high risk of non-
sudden death, however, may not benefit,
and age should be an important factor in the
decision to implant the device, along with
comorbidities.”
Patients at high risk of
non-sudden death ...
may not benefit, and age
should be an important
factor in the decision to
implant the device, along
with comorbidities.
DECEMBER 2016
ESC 2016
19