Medtronic HVAD Stroke Risk May Be Higher Than HeartMate3: Study

Recalled Medtronic HeartWare Ventricular Assist Devices (HVAD) appear to be linked to a higher rate of strokes and other neurological problems than its competitor, Abbott’s HeartMate3, according to the findings of a recent study.

Last week, the FDA declared when the Medtronic HVAD was removed the market on June 3, the action constituted a Class I medical device recall, which is the most serious recall designation, and suggests that use of the product poses a risk of severe injury or death.

The Medtronic HVDA recall was issued after recent investigations could not pinpoint the root cause of problems involving HVAD pump restart failure, which may impact approximately 4,630 devices. Healthcare professionals have been urged to stop using the devices.

In a recently published study, researchers with Johns Hopkins University appeared to confirm there are serious problems with the recalled HVAD systems, after comparing outcomes to patients who received a HeartMate 3, a centrifugal-flow left ventricular assist device (CF-LVAD), manufactured by Abbott. Their findings, published in the medical journal Circulation, found the Heartware systems had more than double, and almost triple, the risk of neurological health effects on its recipients.

The HeartWare Ventricular Assist Device (HVAD) by Medtronic first received premarket approval from the FDA in November 2012, with a design intended to help pump blood from the heart to the rest of the body among patients who are awaiting a heart-transplant and at risk of death from end-stage left ventricular heart failure.

The system includes a pump implanted in the space around the heart, with a controller that regulates the speed and function of the pump. Benefits of the devices included the ability to be used in either a hospital setting or during patient transport. However, over the last decade, Medtronic has issued at least 13 recalls involving component defects and malfunctions, ranging from startup failure to the company needing to update instructions for use and patient manuals.

In this latest study, researchers used data from the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) on 6,205 adult patients who received either the HeartMate3 or HeartWare system. According to the findings, 16.4% of Heartware patients suffered major neurological adverse events (NAEs), compared to just 6.4% for those implanted with the Heartmate 3 system.

Those risks appeared after the early hazard phase, in which both systems were about on par, and occurred primarily during the constant hazard phase, according to the researchers’ findings.

“HM3 is associated with lower hazard of major NAEs than is HVAD beyond the early post-implantation period and during the constant hazard phase,” the researchers concluded. “Defining the explanation for this observation will inform device selection for individual patients.”

Both Systems Plagued By Problems, Recalls

The HeartMate series of implants have also been linked to a number of problems in recent years, however.

In May 2018, the FDA announced a Class I HeartMate 3 recall, impacting more than 5,000 devices, due to the potential for the outflow graft assembly to experience a malfunction causing the graft to twist and occlude, or close up, over time. Officials warned occlusion of the outflow graft may reduce or stop the pump flow which could lead to serious side effects, such as bloods clots, or even death.

In 2017, Abbott recalled 29,000 HeartMate II LVAS Pocket System Controllers following 26 reports of patient deaths due to the devices malfunctioning after patients tried to change the controller improperly or too slowly. The devices were not withdrawn from the market, rather, Abbott provided patients with a fully upgraded system with new yellow alignment markings and new drivelines.

However, the Heartware systems are no longer an option for healthcare professionals. The decision to remove the implants from the market came after the latest recall in March, when Medtronic issued a Heartware pump failure recall following 100 complaints involving a delay or failure to restart the HVAD internal pump, which has caused a total of 14 deaths and 13 emergency pump removal surgeries.

In May 2020, Medtronic issued another HeartWare HVAD Class I recall following nearly 100 reports of problems where the strain relief screw broke and outflow graft tore while preparing the device for implant. The recall warned the design defect placed patients at risk of suffering serious injuries, including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, and the need for additional medical procedures or death.

In June 2018, Medtronic issued a HeartWare HVAD recall impacting more than 16,000 units that had been implanted in patients as of May 22, 2020. The recall was initiated after Medtronic discovered the electrical connection between the system’s power source, such as the battery, AC adapter, or DC adapter, and the HVAD controller could be interrupted, potentially causing the pump to stop working, resulting in an exacerbation of heart failure symptoms, including weakness, dizziness, anxiety, nausea, loss of consciousness or death.

Earlier this month, the independent newsroom ProPublica published an investigative journalism report into the heart pump problems, indicating that both Medtronic and the FDA have known of the device issues for nearly a decade, yet have done little to dissuade the widespread use of the HeartWare implants.

According to the report, the FDA had received more than 3,000 reports of patient deaths by the end of 2020, all linked to HeartWare implant problems.