According to a warning issued by federal regulators, problems with the Abiomed Impella RP Heart Pump System may increase the risk of death for certain patients.
The FDA sent a letter to healthcare professionals on May 21, warning about an increased rate of mortality among some patients using the Abiomed Impella RP Heart Pump System.
The Abiomed Impella RP Heart Pump System is used as an emergency implant to improve right ventricular function of the heart. It is often used for 14 days while patients are in the hospital for treatment.
The implant was approved in 2017, but the FDA required Abiomed to continue monitoring the device and conduct a post-approval study. Initial results of the post-approval study indicated low survival rates at 17%.
The letter indicates that if a patient would not have qualified for the clinical trials initially used to gain FDA approval, then they likely face an increased risk of death after being implanted with the heart pumps. This new information came from the results of the most recent post-approval study.
According to those findings, only 12 out of 42 patients enrolled in the study survived to the 30-day post device explant or hospital discharge mark. Roughly 28% of patients survived to the start of the next long-term therapy.
By comparison, patients who qualified for the premarket clinical studies had a 73% survival rate.
The main reason for the difference in survival rates was patient selection. Patients selected for the post-market study were not selected the same way as the first pre-market study. If they had been selected and qualified in the same way, the survival rate for the second study would have increased to 64% with 9 out of 14 patients surviving, according to the findings.
If the study had only been patients who would not have been selected for the premarket study, researchers estimate the survival rate would have dropped to 10%, or 3 out of 28 patients.
However, the FDA’s letter still indicates that, when used for the approved indication for the right patients, the benefits outweighed the risks and would benefit patients who needed it most.
FDA officials noted patients that would not have qualified for the premarket study were more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a pre-implant hypoxic or ischemic neurologic event before getting the system implanted.
In February, the FDA approved revised labeling for the system and issued an update letter to include more information about patient selection and survival rates, and which patients could benefit from treatment with the device.
The FDA also required Abiomed to make changes to the design of the study, adding subgroup analyses and establishing a minimum number of patients in each subgroup. The latest letter issued to healthcare providers is an update to the February 2019 letter.
The new update recommends healthcare providers follow the revised labeling, which includes a patient selection checklist to understand which patients will benefit from the treatment and which should not use the system or may face an increased risk.
Doctors should consider all the risks and benefits before recommending the system to a patient. The agency urges doctors and patients to report any side effects or adverse events to the FDA MedWatch Adverse Event Reporting program immediately.