February 9th, 2011
Trial Finds Benefit in Wireless Pulmonary Artery Monitoring in HF
Larry Husten, PHD
Results of a new trial suggest that an implanted device that provides continuous wireless sensing of pulmonary artery pressures can reduce hospitalizations in patients with heart failure (HF). In a report published online in the Lancet, William Abraham and members of the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) Trial Study Group randomized 550 patients with NYHA class III HF to receive either the CardioMEMS heart sensor or conventional therapy.
After six months, there were 83 HF-related hospitalizations in the treatment group versus 120 in the control group — a 30% reduction. At 15 months, the reduction in HF-related hospitalizations reached 39%. There were no pressure-sensor failures and 8 patients had a complication related to the device.
The authors concluded that the “trial represents the first positive, randomized, adequately powered clinical trial of implantable hemodynamic monitoring in patients with moderately symptomatic HF. The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved HF management and leads to a reduction in HF-related hospitalizations.”
In an accompanying comment, Henry Krum wrote that “the CardioMEMS device seems to be a simple but ingenious piece of bioengineering. Its simplicity lies in its smallness and ability to derive and transmit clinically useful data (continuous pulmonary artery pressures), via an implantation procedure that seems to add very little in terms of time or risk to that of standard right-heart catheterization.” Nevertheless, he questioned whether there should be “rapid uptake” of the device and said that “we are still some way off” from “widespread or routine” use of the device.
Even though the reported incidence of device related complications was low I believe the trial should have included a true control group with patients randomized not to have it implanted. With the data we have one cannot tell how many admissions were in fact a result of having the CardioMEMS monitor in place.