Heart implants known as left ventricular assist devices (LVADs) provide some patients with improved care, but may lead to an increased risk of death and other complications, according to the findings of new research.
In a study published this week in the Journal of the American Medical Association (JAMA), researchers indicate that individuals who had received heart stents and were also implanted with LVADs may face greater rates of death and major bleeding when compared to patients with intra-aortic balloon pumps (IABPs).
Researchers conducted a registry-based retrospective cohort study including 3,300 patients undergoing percutaneous coronary intervention for acute myocardial infarction from October 2015 to December 2017. They used data from hospitals participating in CathPCI and the Chest Pain-MI registries, both a part of the American College of Cardiology’s National Cardiovascular Data Registry.
Patients who suffered a heart attack and received percutaneous coronary intervention, also known as a heart stent, were treated with either with an intravascular microaxial LVAD or an intra-aortic balloon pump.
The data indicated LVADs were associated with a significantly higher risk of in-hospital death. Death rates for patients with LVADs were 45% compared to 34% for balloon pump patients.
Similarly, LVADs were linked to an increased risk of in-hospital major bleeding. Rates of major bleeding events occurred at 31% compared to 16% for IABP patients.
LVADs are implants near the heart which help deliver blood from the heart to the rest of the body. LVADs are often used in patients at risk of heart failure and awaiting heart transplants.
IABPs are essentially balloons placed within a patient’s artery to allow blood to flow through more freely. Patients who receive balloon pumps are often at risk of suffering a heart attack or have suffered one already and face increased risk of suffering another heart attack.
However, prior studies have shown LVADs are linked to increased side effects as well. In 2015 the FDA issued a safety warning indicating patients with LVADs experience high rates of bleeding, blood clot complications and strokes.
The maker of one type of LVAD issued a warning in 2019 indicating problems with the devices could lead patients to suffer fatal injuries. In a separate warning issued in 2017, a warning indicated LVAD devices could malfunction after patients attempt to charge the controller. The problem led to 26 deaths and 19 injuries.
“Among patients with AMI complicated by cardiogenic shock, use of intravascular microaxial LVAD was associated with significantly higher risks of patients experiencing in-hospital mortality and major bleeding compared with use of IABP,” the researchers determined. “These findings were consistent for patients regardless of the timing of device placement and transfer status.”
In general, LVADs have been shown to provide greater hemodynamic support, allowing more blood flow to the heart and to other organs in the body, compared balloon pumps. However, the risk of suffering severe and potentially fatal complications from LVADs is much greater, the researchers concluded.