Impact of Practice Based Management of PA Pressures in 2000 Patients Implanted with the CardioMEMS Sensor
Background—Elevated pulmonary artery (PA) pressures in patients with heart failure (HF) are associated with a high risk for hospitalization and mortality. Recent clinical trial evidence demonstrated a direct relationship between lowering remotely monitored PA pressures and HF hospitalization risk reduction using a novel implantable PA pressure monitoring system (CardioMEMS HF System, St Jude Medical). This study examines PA pressure changes in the first 2,000 US patients implanted in general practice use.
Methods—De-identified data from the remote monitoring Merlin.netTM (St. Jude Medical) database were used to examine PA pressure trends from the first consecutive 2,000 patients with at least 6 months of follow-up. Changes in PA pressures were evaluated using an area under the curve (AUC) methodology to estimate the total sum increase or decrease in pressures (mmHg-day) during the follow up period relative to the baseline pressure. As a reference, the PA pressure trends were compared with the historic CHAMPION Clinical trial. The AUC results are presented as mean ± 2SE and p-values comparing the AUC of general-use cohort with outcomes in the CHAMPION Trial were computed by t-test with equal variance.
Results—Patients averaged 70±12 years old, 60% male, 34% with preserved ejection fraction (EF) and were followed for an average of 333±125 days. At implant, the mean PA pressure for the general-use patients was 34.9±10.2 mmHg, compared with 31.3±10.9mmHg for CHAMPION treatment and 32.0±10.5mmHg for CHAMPION control groups. The general-use patients had an AUC of -32.8mmHg days at the 1 month time mark, -156.2mmHg days at the 3 month time mark and -434.0mmHg days after 6 months of hemodynamic guided care, which was significantly lower than the treatment group in the CHAMPION Trial. Patients consistently transmitted pressure information with a median of 1.27 days between transmissions after 6 months.
Conclusions—The first 2,000 general-use patients managed with hemodynamic guided HF care had higher PA pressures at baseline and experienced greater reduction in PA pressure over time compared to the pivotal CHAMPION Clinical Trial. These data demonstrate that general-use of implantable hemodynamic technology in a non-trial setting leads to significant lowering of pulmonary artery pressures.
- pulmonary artery pressure trend
- heart failure
- pulmonary artery
- Received October 28, 2016.
- Revision received January 27, 2017.
- Accepted February 6, 2017.