Review of Current Ventricular Assist Devices

Currently, Abbott’s HeartMate 3 LVAD is the only FDA approved blood contact VAD for longer-term usage. Heartmate 3 has had numerous recalls by the FDA and, on March 11, 2024, its communication system was recalled due to a risk that the system could unexpectedly cause the heart pump to stop or start.

Two other blood contact VADs: HeartAssist 5 and EvaHeart, are under clinical trials in the USA.

Medtronic’s LVAD, called the HVAD, was discontinued in June of 2021 because of excessive complications and mortality.

The Johnson & Johnson/Abiomed Impella Left Sided Blood Pumps are used for short term support during high-risk catheter-based procedures called percutaneous coronary interventions (PCI). They also are used when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack (acute myocardial infarction), open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy. Impella therapy aims to reduce the work of the heart's ventricles and provide support for the circulatory system so the heart has time to recover.

As a result of an FDA alert on March 21, 2024, Abiomed is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. During operations, the Impella device could cut through the wall of the left ventricle. The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, liver and kidney failure, and death. There have been 129 reported serious injuries, including 49 reports of death.

Implanting a VAD is expensive, even more expensive than a heart transplant, cost for the device itself approaching $100,000, with implantation and hospital costs being as or more expensive; insurance and Medicare have strict guidelines for coverage and many patients will not be eligible.

Once implanted, mobility is restricted by the device itself as it is cumbersome. The device is dependent upon a continuous supply of electricity. With a battery pack, 17 hours can be spent away from a source of electricity, and batteries require 4 hours to charge.

The patient cannot live alone; a designated care giver is required to be with the patient essentially at all times. Showering or bathing is difficult because of the wiring that is external to the body.

Many complications including infections, bleeding, device clotting, strokes, kidney failure, multi-organ failure have been seen with all VADs.