Columbus, OH - Heart-failure patients managed with a wireless implantable hemodynamic monitoring system had a significant and large reduction in hospitalizations compared with standard management, according to the results of a randomized, multicenter clinical trial.
Investigators of the CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial, led by Dr William T Abraham (Ohio State University Medical Center, Columbus), showed that the pulmonary-artery (PA) pressure sensor implanted in NYHA class 3 heart-failure patients with a history of decompensation reduced hospitalizations 30% compared with standard care.
"The CHAMPION trial represents the first positive, randomized, adequately powered clinical trial of implantable hemodynamic monitoring in patients with moderately symptomatic heart failure," according to investigators. "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 hospitalizations."
The study, previously reported by heartwire when it was first presented at the Heart Failure Congress 2010 meeting of the Heart Failure Association of the European Society of Cardiology, was published online February 10, 2011 in the Lancet. As noted at the time, the device acts like an ambulatory, permanent Swan-Ganz catheter without the catheter and is designed to disclose early-stage elevations in PA pressure that can be managed with appropriate medical therapy before it worsens and potentially leads to congestion.
The Lancet results closely mirror the results from the European meeting, including the 30% reduction in heart-failure-related hospitalizations during the first six months and a 39% reduction in heart-failure-related hospitalizations during the entire randomized follow-up period, which was, on average, 15 months. Primary safety end points were also met, with 98.6% of patients free from a device-related or symptom-related adverse event and no reported cases of pressure-sensor failure. In addition, there were improvements in PA mean pressures, fewer patients admitted for heart failure, and better quality-of-life scores in the treatment arm.
The investigators also report that patients in the treatment group had a significantly greater number of changes in the drugs used in the treatment of heart failure. Although patients were taking similar baseline medications, the treatment group had an average of 9.1 changes over the six-month period compared with just 3.8 adjustments in the control arm. To heart wire , Abraham said that the changes in treatment were driven by the increases in PA pressure and involved titrating diuretic or vasodilator treatment, the two treatments typically adjusted, to reduce pulmonary-artery pressures.
"We had pressure targets, and the goal was to do whatever you could to bring the pressure down," said Abraham. He noted that the so-called dehydration effects, caused from overshooting the pressure targets, which can result in dizziness or postural hypotension, have been infrequent, less than 10%, in all the trials evaluating the device. He added that hospitalizations for non-heart-failure-related causes did not increase in the CHAMPION trial.
In an editorial accompanying the published study, Dr Henry Krum (Monash University, Melbourne, Australia) noted that a right-heart catheterization might be indicated in some patients with NYHA class 3 heart failure for routine diagnostic workups or for transplant assessment, but these patients are still in the minority. As a result, the use of the CardioMEMS device as a widespread or routine procedure is still some way off. That said, Krum noted that the use of devices to monitor these difficult-to-treat heart-failure patients represents a technological advance, with clinicians and patients entering an era of permanently implanted devices to "provide accurate long-term information about hemodynamic variables in patients in whom volume status could be an issue."
Krum adds: "[T]he risk-vs-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 catheterization."
| CardioMEMS sponsored the CHAMPION trial. Abraham, the study cochair, is a consultant to CardioMEMS. Disclosures for teh coauthors are listed in the paper.
Heartwire from Medscape © 2011
Cite this: CHAMPION published: Pressure-sensor implant guides HF treatment, cuts hospitalizations - Medscape - Feb 10, 2011.