A system used to help heart function may actually increase the risk of death, according to a new warning issued by federal health regulators this week.
The FDA sent a letter to healthcare providers on February 4, alerting them to potential problems with the Abiomed Impella RP System, which has been linked to a high mortality rate.
The Abiomed Impella RP System was approved by the agency in September 2017, and is used as an emergency implant to help with right ventricular function. It is typically only used for about 14 days while patients stay in the hospital for treatment.
In the clinical trials relied on to approve the device, 44 out of 60 patients, or 73.3 percent, survived up to 30 days following use of the device. However, the agency required the manufacturer Abiomed to continue to monitor the device once it hit the market and conduct a post-approval study (PAS).
According to the interim post-approval study, only four out of 23 patients enrolled survived longer than 30 days; a rate of only 17.4 percent. The FDA suggests that the preclinical trial may not have done a good enough job of analyzing the mortality rate in a real-world setting.
“The FDA required additional analyses from Abiomed, and data submitted by the firm in January 2019 suggest that the high mortality rate observed in the PAS may be primarily related to differences in pre-implant characteristics of the PAS patients compared to the patients in the premarket clinical studies. Sixteen (16) of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies,” the letter states. “Specifically, before getting the Impella RP system implanted, patients in the PAS were more likely than the premarket clinical study patients to have been in cardiogenic shock for longer than 48 hours, experienced an in-hospital cardiac arrest, been treated with an intra-aortic balloon pump, or suffered a pre-implant hypoxic or ischemic neurologic event.”
The FDA is recommending doctors be aware that the device was approved based on patients who had been in cardiogenic shock for less than 48 hours, and that none of those patients had experienced an in-hospital cardiac arrest, were treated with an intra-aortic balloon pump, or had suffered a hypoxic or ischemic event before the Impella was implanted. The agency also urges doctors to carefully consider the interim survival results from the post-marketing study.
Currently, there are no other device interventions approved for those types of patients by the FDA, which the agency also noted doctors should be aware of when making decisions for patients.
The FDA called for doctors or patients to report any adverse events related to the use of the Impella RP to the FDA’s MedWatch adverse event reporting system.