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Hot Line Session Results: Heart Failure and innovative approaches
Use of implantable cardioverter-defibrillators in patients with non-ischaemic systolic heart failure did not improve overall survival over usual care, according to results presented a Hot Line study yesterday.
The DANISH trial, published simultaneously in the New England Journal of Medicine, did, however, show that the risk of sudden cardiac death in these subjects was halved. There were also findings related to age, with those under 68 showing a lower mortality rate.
The study, which was said to be the first to consider ICDs within the context of ‘modern therapy’, raised questions about the role and recommendation of ICDs in non-ischaemic HF. Prophylactic ICD implantation currently has a class 1A recommendation in US guidelines and a class IB in Europe for patients with HF and reduced left ventricular systolic function.
‘So far, there has only been limited data on ICDs in this population,’ said study presenter Lars Kober from Rigshospitalet, University of Copenhagen. ‘Our trial fills that gap by now suggesting that ICDs should not be routinely implanted in all patients with systolic heart failure.’
The DANISH trial itself was designed to investigate the usefulness of ICDs in patients with HF not caused by ischaemic heart disease. Guideline indications for primary prophylactic ICD in patients with HF but without CAD have been based on small to medium trials and subgroup analyses, with no large definitive trials showing a benefit for ICDs in these patients. Furthermore, said Kober, medical therapy has improved considerably since the early ICD trials.
In this study 1116 patient with non-ischaemic systolic HF were randomised to receive ICD and usual care (n=556) or to a control group (n=560) of usual care. Notably, all patients were treated well, with around 58% in each group receiving a CRT, 90% ACE inhibitors/ARBSs, and 90% beta blockers.
After a median follow-up of 67.6 months, death occurred in 21.6% of the ICD group and 23.4% of the control group, a non-significant difference (HR 0.87; 95% CI 0.68-1.12). Results also found no difference in rates of cardiovascular mortality.
There was, however, a significant difference in the secondary outcome of SCD, which occurred in 4.3% of ICD patients and 8.2% of controls (HR 0.50; 95% CI 0.31-0.82; P=0.01).
The subgroup analysis showed that ICD patients under 68 had a significantly lower mortality rate than controls (HR 0.64, 95% CI 0.46-0.91), a result not found in those over 68.
Commenting on the results, former AHA President Mariell Jessup, an author on both the US and recent European guidelines, said: ‘The study showed ICDs work and are especially effective in people who are not going to die from comorbidities. No countries are putting in enough ICDs to prevent sudden death in patients who can expect to live more than a year.’
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