Study: Abbott’s CardioMEMS monitor performs better in real world than pivotal trial

Real-world results from patients with Abbott‘s (NYSE:ABT) CardioMEMS implantable heart monitor, which it acquired along with St Jude Medical in Jan., show greater reduction in pulmonary artery pressure than seen in the pivotal Champion clinical trial of the device, according to a new study.

The study examined the 1st 2,000 patients implanted with the CardioMEMS device in general practice use, with results published in the Feb. 21 issue of the journal Circulation.

Researchers in the study analyzed de-identified data from St. Jude’s Merlin.net database to examine PA pressure trends of the 1st consecutive 2,000 patients with at least 6 months of follow ups.

Patient data indicated that at implant, PA pressure for general use patients was at 34.9±10.2 mmHg, higher than the average 31.3±10.9mmHg for those treated with CardioMEMS in the Champion trial.

General-use patients reported an AUC of -32.8mmHg days at 1 month, -156.2mmHg days at 3 months and -434mmHg days at 6 months, significantly lower than patients treated with the device in the pivotal Champion trial. The median time between patient transmission was 1.27 days, according to the study.

“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,” study authors concluded.

Data from a study of the CardioMEMS released last July indicated that use of the device can significantly reduces all-cause heart failure admissions, according to data from a new study released late last month.

The 21-patient retrospective review study aimed to evaluate the rate of heart failure hospitalizations in a postmarket community hospital population in patients equipped with the CardioMEMS device. Data from the study indicated a 13.7 reduction in average days spent in the emergency department after implantation, and an average reduction of 9.8 days for patients with chronic heart failure.

Study results also indicated an increase in significance of care post-implantation, with average phoe calls between physician and patient increasing from 1.2 to 2.6, and days between medication changes reducing from 11.7 to 6.2 days.

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