麻豆果冻传媒影音

DALLAS -- No big surprises or concerns emerged from safety data collected on the CardioMEMS wireless pulmonary artery sensor from Abbott, researchers reported here.

In its first 3 years on the U.S. market (2014-2017), there were more than 5,500 total CardioMEMS HF System implants, the FDA Manufacturer and User Facility Device Experience (MAUDE) database showed. Of those, 2.8% of generated reports of adverse events.

"These postmarketing surveillance data provide an early look at the real-world safety profile of this device in less selected, higher-risk patients, demonstrating comparable estimated overall adverse event rates with the CHAMPION trial," according to Muthiah Vaduganathan, MD, MPH, of Brigham and Women's Hospital in Boston, and colleagues.

The findings were published and Vaduganathan presented them in person at the Heart Failure Society of America's scientific meeting here.

Of note were 28 reports of pulmonary artery injury or hemoptysis that were filed (0.5%); cases involving these injuries accumulated steadily after FDA premarket approval, plateauing off in 2016. Pulmonary artery injury was followed by six deaths, 14 ICU stays, and seven intubations, Vaduganathan noted.

Moreover, there were 46 cases of sensor failure, malfunction, or migration; 15 access site-related bleeds or infections; five cases of pulmonary embolism/device thrombosis; and 22 total deaths (0.4%).

"However, these data bring greater attention to infrequent but potentially consequential risks of pulmonary artery injury and need for reintervention or device recalibration," they continued, suggesting that the most serious observed complications may partly be blamed on the learning curve for CardioMEMS implantation.

The CHAMPION trial cited by Vaduganathan and colleagues was a randomized study of 550 patients reported in 2010, which ultimately supported FDA approval for the device. Trial participants tended to be younger, have a lower burden of medical comorbidities, and present with higher baseline pulmonary artery pressures compared with those getting CardioMEMS subsequently in regular use.

Median time to file reports on CardioMEMS in the MAUDE database was 6 weeks post-implant; about a quarter were filed within 1 week.

Vaduganathan's group acknowledged that their present analysis suffered from the MAUDE database's incomplete surveillance of U.S. implants.

Comment