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Hot Line Session Results: Heart Failure and innovative approaches
Two clinical trials exploring remote monitoring in HF patients fitted with cardiac implantable electronic devices reported in yesterday’s Hot Line session failed to detect improved clinical outcomes over conventional care - although one study did show reductions in office visits and costs.
Despite advances, HF patients remain at high risk of death and hospitalisation. There has thus been much interest in whether the remote transmission of ICD data prompts improved clinical outcomes.
The REM-HF trial randomised 1650 patients from nine English hospitals to usual care and weekly remote monitoring or to usual care alone. The study, which was published simultaneously in JAMA, is the largest trial ever of remote monitoring.
Results at a median follow-up of 2.8 years showed that the primary endpoint of all-cause mortality or CV hospitalisation was neutral. Furthermore, no significant differences were found between the two groups in any of the secondary endpoints, and none of the baseline characteristics (age, gender, NYHA Class, type of device, history of coronary artery disease or history of atrial fibrillation) identified any group in which remote monitoring was more effective than usual care alone.
‘In the modern era of digital health we could find no evidence of additional benefit from weekly remote monitoring of these devices,’ said presenting investigator Martin Cowie from Imperial College London.
‘Our conclusion is, do not rush to recommend additional work or a change in the way we deal with data unless you are convinced that you will actually have better outcomes.’ Where HF programmes do not exist or there is poor quality treatment, he added, remote monitoring might make a difference. ‘But in the context of a randomised trial where patients are well treated, it seems there is not enough scope to improve outcome by forcing people to look at more data.’
In the MORE-CARE study, published yesterday in the European Journal of Heart Failure, 917 HF patients implanted with a CRT-D device with wireless transmission capabilities were randomised to remote device checks alternating with in-office visits (n=462) or to a standard arm with all checks in office (n=455). Results at a median follow-up of 24 months showed the rate of mortality and hospitalisations for cardiovascular or device-related reasons was 29.7% in the remote arm and 28.7% in the standard arm (HR 1.02 ; 95% CI 0.80-1.30). However, the study showed reductions in emergency department admissions for any reason, and outpatient visits for those having remote checks. Health care savings were calculated to be €2,899 per 100 patients at two years, and additionally there was a travel cost saving of €145 per patient over two years.
‘Our study shows that remote-monitoring avoids patients having to come to hospital, which they really appreciate,’ said study presenter Giuseppe Boriani from the University of Modena, Italy.
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ESC Congress is the world’s largest gathering of cardiovascular professionals contributing to global awareness of the latest clinical trials and breakthrough discoveries. ESC Congress 2016 takes place 27 to 31 August at the Fiera di Roma in Rome, Italy. The full scientific programme is here.
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