The rate of hospitalisation for heart failure is reduced by 39% in patients who have had a wireless monitoring device implanted, research has shown. The authors of the CHAMPION study, published Online First today in The Lancet, say that the devices were safe and reliable and their use could lead to significant reductions in the cost of care of people with heart failure.
Researchers in Ohio enrolled 550 people from 64 centres across the US, all of whom had moderately serious heart failure and a previous hospital admission for heart failure. They randomised participants to either standard care alone (control group – 280 patients), or to standard care plus implantation of the CardioMEMS wireless device to measure pulmonary artery pressure (treatment group – 270 patients). Standard care comprised monitoring patient-reported changes in symptoms and daily weights.
During the first 6 months’ follow-up, people in the treatment group had a 30% reduction in hospital admissions for heart failure compared with those in the control group. Over the whole follow-up period, which was a mean of 15 months, there were 153 heart failure hospitalisations in the treatment group compared with 253 in the control group, a reduction of 39%.
The devices were also safe – none failed, and none of the three cases of device- or system-related complications had serious consequences. The researchers said: “The CHAMPION trial represents the first positive, randomised, adequately powered clinical trial of implantable haemodynamic monitoring in patients with moderately symptomatic heart failure. The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved heart-failure management and leads to a reduction in heart-failure-related hospitalisations.”
The author of an accompanying Comment was a little more cautious: “In terms of insertion of this device becoming a widespread or routine procedure, we are still some way off.
But he added: “Nevertheless, the risk versus benefit profile of the CardioMEMS device, as reported in CHAMPION, suggests that strong consideration should be given to its implantation in appropriate patients, even in the absence of a standard indication for right-heart catheterisation. With increasing clinical use of these devices will come further technological advances. We are only at the beginning of this revolution in patient monitoring.”
Amy Thompson, senior cardiac nurse at the British Heart Foundation, said: “While this research finds the wireless device reduces hospitals admissions for some people with moderate heart failure, it requires an invasive procedure and the researchers did not measure its impact on long term survival rates. We’d need to see much more research and larger trials before we could be confident this is a practical next step for monitoring heart failure patients.”