on June 4, 2010 |
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Topics: Service Lines, Outcomes, Quality, Performance Improvement, Technology Assessment, Methodologies, Technology Assessment, Planning, Strategy
Results from a randomized multi-center trial indicate that implantation of pulmonary-artery (PA) pressure sensor in advanced heart failure patients can help optimize medication management and reduce heart failure hospital admissions. The sensor, developed by CardioMEMS, is 15mm in length and 3.5 mm wide, and is positioned within the pulmonary artery at right-heart catheterization.
The randomized trial called CardioMEMS Heart Sensor Allows Monitoring of Pressure To Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) included 63 sites. All 550 patients enrolled in the trial were implanted with the device and randomized to either standard medical management or to PA-pressure-guided medical therapy in addition to standard management. All patients checked their PA daily, but physicians treating patients assigned to the control group were blinded to the results. Physicians with access to the PA pressure readings adjusted medications to meet pre-defined PA targets. The results showed that six-month heart failure hospitalization rate for patients in the PA-pressure guided group experienced a 6-month hospitalization rate of 31% compared to 44% in the control group. Furthermore, annualized hospitalization rates were significantly lower in the PA-pressure guided therapy group.
These finding provide hope for more effective strategies for treating patients iwth advanced heart failure and for reducing hospital readmissions. That said, the device still needs to be FDA approved, which may be challenging as the agency is often cautious about approving diagnostic implantable devices. The Roundtable will continue to follow progress on this device. (theheart.org, 06/01/10)
