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European Society of Cardiology
Congress 2016
27–31 AUGUST 2016 • ROME, ITALY
One of the largest and most influential
cardiovascular meetings globally, this
year’s European Society of Cardiology
(ESC) Congress saw the release of
exciting clinical trial data, some of
which were contrary to current clinical
practice guidelines. The
PracticeUpdate
Editorial Team attended the Congress
and we bring you coverage of the key
clinical trials presented, including two
from Australian researchers: the SAVE
and NACIAM studies.
Implantable
cardioverter-
defibrillator 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, Den-
mark, 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, multi-
centre study to assess the efficacy of Implantable cardioverter
defibrillator in patients with nonischaemic Systolic Heart
failure on mortality.
Dr Kober said, “Prophylactic cardioverter-defibrillator im-
plantation 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, nonischae-
mic, 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 im-
plantable cardioverter-defibrillator (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 implantable
cardioverter-defibrillator in the implantable cardioverter-
defibrillator arm.
After a median of 67.6 months, the primary outcome of death
from all causes occurred in 21.6% of implantable cardioverter-
defibrillator patients and 23.4% of controls, a nonsignificant
difference.
Sudden death, a secondary outcome, occurred in 4.3% of
implantable cardioverter-defibrillator patients and was almost
doubled (8.2%) in the control group (hazard ratio 0.50; 95%
confidence interval 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 implantable cardioverter-defibrillator (hazard ratio 0.64;
95% confidence interval 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 implantable cardioverter-defibrillator 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 implantable cardioverter-
defibrillators, occurred in 5.9% of the implantable cardioverter-
defibrillator group.
American Heart Association guidelines include implantable
cardioverter defibrillator implantation as a class 1A recommen-
dation 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 specifi-
cally for patients with nonischaemic heart failure.
Dr Kober concluded, “Guidelines are based on multiple stud-
ies. 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.
CONFERENCE COVERAGE
PRACTICEUPDATE CARDIOLOGY
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