Use of an implanted device to remotely monitor the condition of patients with heart failure* could reduce the rate of hospitalisation due to the condition by 39%. The findings of the CHAMPION study, published Online First by The Lancet, also show a low device failure rate, suggesting that such devices can be safely used in heart failure patients and thus significantly reduce the costs of care. The Article is by Dr William T Abraham, Ohio State University, Columbus, OH, USA, and colleagues.
The implanted device works by measuring the pressures within the pulmonary arteries (those connecting the heart to the lungs). In the study, patients with moderately serious heart failure (New York Heart Association [NYHA] class III) and a previous hospital admission for heart failure were enrolled in 64 centres in the USA. Patients were assigned to either use of the wireless device, that measured pulmonary artery pressure daily in addition to standard care (treatment group); or to standard care only (monitoring of patient-reported changes in symptoms and daily weights) in the control group.
In 6 months, 83 heart-failure-related hospitalisations were reported in the treatment group (270 patients) compared with 120 in the control group (280 patients), giving a 30% reduction in hospitalisation in the treatment group. During the entire follow-up, the treatment group had a 39% reduction in heart-failure related hospitalisation compared with the control group (153 vs 253 events). Only three patients in each group had device-related or system-related complications, none of which led to serious consequences. No patients experienced pressure-sensor failures in their devices.
The authors conclude: "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."
In a linked Comment, Dr Henry Krum, Monash University and Alfred Hospital, Melbourne, VIC, Australia, says: "Going forward, a key issue is how rapid the uptake of this new device-based approach to heart-failure management might be. A right-heart catheter might be indicated in many patients with NYHA class III heart failure for routine diagnostic work-up, assessment for transplantation, or both, but overall these patients would be in the minority. Therefore, in terms of insertion of this device becoming a widespread or routine procedure, we are still some way off. 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."
For Dr William T Abraham, Ohio State University, Columbus, OH, USA, please contact Doug Flowers,Public Affairs and Media Relations. T) +1 (614) 293-3737 E) doug.flowers@osumc.edu / William.Abraham@osumc.edu
Dr Henry Krum, Monash University and ,Alfred Hospital, Melbourne, VIC, Australia T) +61417325834 E) henry.krum@med.monash.edu.au
For full Article and Comment, see: http://press.thelancet.com/wireless.pdf
FNOTE: THE ABOVE LINK IS FOR JOURNALISTS ONLY; IF YOU WISH TO PROVIDE A LINK TO THE FREE ABSTRACT OF THIS PAPER FOR YOUR READERS, PLEASE USE THE FOLLOWING, WHICH WILL GO LIVE AT THE TIME THE EMBARGO LIFTS: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60101-3/abstract
Note to editors: *heart failure is generally defined as the heart being unable to supply sufficient blood flow to meet the body's needs
Journal
The Lancet