FDA Grants Expanded Indication to CardioMEMS PA Pressure Monitor

The US Food and Drug Administration has extended the indications for the CardioMEMS pulmonary artery pressure monitor (Abbott) to include patients with NYHA class II heart failure (HF) who have either been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides.

That extension is supported by the results of the GUIDE-HF trial, which were actually neutral for the primary endpoint: reduction in HF events and mortality with pressure-guided care. The lack of benefit, however, is believed to have stemmed from COVID-19 pandemic lockdowns and hospital avoidance.

For the trial as a whole, no significant differences were seen for patients with NYHA II-IV heart failure randomized to hemodynamic monitoring as compared with guideline-directed medical care alone. In an analysis restricted to the period prior to COVID-19 lockdowns, however, investigators saw a statistically significant drop in the number of patients dying or requiring hospitalization if their management could incorporate data provided by the CardioMEMS sensors.

The device was originally approved in 2014 for use in NYHA class III heart failure patients with a prior HF hospitalization within the last year. According to a press release issued by Abbott, the expanded indication will extend eligibility to an additional 1.2 million US patients. Whether those patients actually receive the device will likely hinge on a parallel extension of a national coverage determination by the US Centers for Medicare & Medicaid Services.

The CardioMEMS device is a wireless, battery-less sensor implanted via a right heart catheterization into the pulmonary artery to remotely transmit pulmonary artery pressures that would warrant a change in management. Prior research has established that increases in pressures typically precede hospitalizations by days or weeks, potentially allowing for up-titration of medications like diuretics that might stave off an urgent hospitalization.

Principal investigator JoAnn Lindenfeld, MD (Vanderbilt University, Nashville, TN), presented GUIDE-HF in the opening Hot Line session of the virtual European Society of Cardiology Congress 2021; the results were published simultaneously in the Lancet.