Study Links Impella Heart Pump to Severe Bleeding, Limb Damage and Other Serious Complications

Amid recent concerns about Impella pump heart perforation risks, which have resulted in some recalls and a number of reported adverse events, the findings of a new study suggest that the devices may significantly increase the risk of bleeding, limb ischemia, hemolysis, device failure, and worsening aortic regurgitation.

The Abiomed Impella pump is a cardiac support device designed to assist patients with severe heart conditions. The minimally invasive system involves inserting a pencil-sized pump into the heart’s left ventricle via the femoral artery.

Once in place, the Impella pump aids in circulating oxygen-rich blood throughout the body by drawing blood from the left ventricle and expelling it into the ascending aorta. It is primarily used during complex cardiac procedures and in treating conditions like cardiogenic shock, where the heart fails to pump sufficient amounts of blood.

Impella Heart Pump Recalls and Warnings

While Abiomed’s Impella pumps have been widely adopted by cardiologists and hospitals for treatment of patients with severe heart conditions since 2008, the devices have been linked to over 100 injuries and fatalities that have prompted FDA recalls and warnings, raising concerns over whether Impella heart pump side effects were fully disclosed.

The Impella Heart pumps have been linked to a wide range of problems in recent years, including decreased survival rates in real-world settings compared to clinical trials, leakage of purge fluid leading to device failures, motor damage particularly in post-TAVR procedures, inadequate instructions on managing blood clot risks, and severe complications from catheters piercing the heart’s left ventricle.

Last month the FDA issued a Class I recall for the Impella Left Sided Blood Pump, after it was found that the pump catheters could pierce the wall of the left ventricle, potentially causing serious and life-threatening effects. The manufacturer has identified at least 129 serious injuries and 49 deaths linked to these heart perforations.

Impella Heart Pumps Linked to Bleeding Events and Limb Damage

In the findings of a study published in The New England Journal of Medicine on April 7, Dr. Jacob Eifer Møller, a professor at the Department of Cardiology at Odense University Hospital and a consultant at the Cardiac Intensive Care Unit at Copenhagen University Hospital Rigshospitalet in Denmark, found that while the Impella device resulted in a 13% reduction in fatalities among a select class of patients receiving the device to treat cardiogenic shock, the Impella heart pump was associated with a wide array of problems.

Møller and his team looked at data on 355 patients who received both an Impella heart pump and standard-care (179) and compared the outcomes to patients who received only the standard-care (176), and found that 24% of patients using the Impella pump experienced;

• Severe bleeding: Excessive blood loss which can lead to shock or organ failure.
• Limb ischemia: Reduced blood flow to limbs, causing pain and potential tissue damage.
• Hemolysis: Breakdown of red blood cells, potentially causing anemia and kidney damage.
• Device failure: Malfunction of the pump, risking inadequate circulatory support.
• Worsening aortic regurgitation: Increased backward blood flow through a leaky aortic valve, worsening heart strain.

In contrast, only 6.2% of patients in the study that received standard care experienced these serious adverse outcomes. The study also noted that 41.9% of the Impella group requiring renal replacement compared to 26.7% for the standard care group.

Abiomed Impella Heart Pump Lawsuits

Given the growing number of undisclosed Impella side effects resulting in serious injuries and fatalities, and new evidence that suggests Abiomed may have known about such risks since January 2018, lawyers are now investigating Impella heart pump lawsuits.

Lawsuits are being investigated due to the manufacturer’s potential failure to disclose known adverse events, which could have prevented patients and doctors from making fully informed decisions about the safety of the pumps, potentially leading to additional injuries and deaths.

Financial compensation may be available through an Impella heart pump lawsuit for individuals who suffered any of the following complications after receiving the heart pump:

• Heart tear/perforation
• Stroke
• Organ failure
• Wrongful death
• Anemia
• Blood clots
• Hypertension
• Bleeding events
• Prolapsed valve
• Vascular damage
• Reduced blood flow
• Hemolysis (Red blood cell destruction)
• Other serious injury