CardioMEMS PA-Pressure Sensor Implant Performs in Clinical Practice as in Trials

Larry Hand

February 24, 2017

LA JOLLA, CA — Hemodynamic-guided heart-failure management with the implantable CardioMEMS HF System (St Jude Medical) device has been effective in US clinical practices and is associated with high rates of patient adherence to the daily remote-monitoring schedule for transmitting pulmonary-artery (PA) pressures, suggests a new study[1].

"This is a confirmation and validation of the CHAMPION trial. It showed that patients who had this implanted hemodynamic monitor had significant reductions in their pulmonary-artery pressures," first author Dr J Thomas Heywood (Scripps Clinic Torrey Pines, La Jolla, CA) told heartwire from Medscape.

"The pressures came down more in the 2000 patients we were able to evaluate in the real-world setting than even in the clinical trial. It was significantly better," he added. Heywood and colleagues conducted the analysis of the first 2000 patients implanted with the commercially available implantable PA-pressure monitor who had at least 6 months of follow-up.

According to previous research, monitoring of PA pressures can significantly reduce heart-failure hospitalizations. And the CHAMPION randomized trial[2] validated the use of the CardioMems system in reducing PA pressures within a clinical-trial setting. It has been unknown whether the system performed as well in general-practice patients, observes the group.

"What we sometimes will find in a randomized clinical trial may not necessarily reflect patient populations when we put them into real-world practices," Dr Michael Ong (University of California, Los Angeles), who was not involved with the study, told heartwire .

"It's good to see that they found similar types of information [as in the trial] in terms of pulmonary-artery pressures and saw a bigger drop for some of the patients who had very elevated pulmonary-artery pressures over time," he added. "From a physiological standpoint, that's information that we would want to be able to track for patients as we're managing their heart failure."

The 2000 consecutive patients in the current analysis were implanted at 416 sites throughout the US; their mean age was 70, 60% were male, and 34% had preserved ejection fraction (mean EF, 33.5%).

Mean PA pressure in the current clinical-practice cohort decreased from 34.9 mm Hg at baseline to 31.6 mm Hg after 6 months (P<0.001).

In area-under-the-curve (AUC) analysis, the AUC came out to be -32.8 mm Hg days after 1 month of management, -156.2 mm Hg days after 3 months, and -434.0 mmHg days after 6 months of hemodynamic-guided care and remote monitoring. That 6-month result compared with only -150.1 mm Hg days at 6 months (P<0.05) for the CHAMPION treatment arm and 42.0 mm Hg days at 6 months in the CHAMPION control group (P<0.0001).

However, according to the current analysis, AUC improvement in the CHAMPION treatment arm was more pronounced after 6 months in the subgroup with the highest baseline PA pressures of at least 35 mm Hg.

During the average follow-up time of 333 days, the participants activated 446,450 transmissions to the remote monitoring system. They initiated the transmissions a median of every 1.07 days after 1 month and 1.27 days after 6 months, "clearly demonstrating" continued close adherence to the remote monitoring schedule, according to the group.

"This is a good step forward," Ong observed. "It will be important to see how this information gets translated into reductions in terms of healthcare, hospitalizations, or readmissions."

St Jude Medical sponsored this research. Heywood reported consulting for St Jude; disclosures for the coauthors are listed in the article.

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