With HVAD Out, Is Mechanical Circulatory Support Entering a Dark Age?

Heart failure specialists said it was the right move to pull the HeartWare heart pump but debated whether its departure leaves the field of mechanical circulatory support (MCS) in a stagnant state lacking innovation and excitement.

Medtronic halted global distribution of the HeartWare Ventricular Assist Device (HVAD) in June, attributing this to the excess neurological events and mortality with the device. As a result, Abbott’s HeartMate 3 became the only durable left ventricular assist device (LVAD) available that is approved by the FDA.

“Competition breeds innovation. When competition is absent or minimal, there is little incentive for corporations to innovate,” said Jennifer Cowger, MD, MS, of Henry Ford Hospital in Detroit, during the Heart Failure Society of America (HFSA) meeting, held both virtually and in Denver.

“While I believe the removal of the HVAD from the market was the ethical thing to do, unless we as a field start embracing MCS technology and change our messaging to the general cardiology community, our field is going to be viewed as niche to referring cardiologists and we’re going to face irrelevance and we’re going to have bad times ahead,” she added.

But having one vendor dominate the market now doesn’t necessarily mean there’s an absence of a competitive environment in MCS, argued Nancy Sweitzer MD, PhD, of the University of Arizona in Tucson, during the debate.

Sweitzer noted that there are at least nine companies worldwide developing heart pumps for this estimated $3-4 billion market. Several devices under investigation — implantable ones with no external component — will probably proceed to first-in-man trials in the next year, she said. “There’s a lot of money if you do this well,” she added

Internal competition alone may be enough to advance the field, Sweitzer argued, given the historic evolution of the old HeartMate XVE to the HeartMate II within the same company, Thoratec.

“They put their own device up against their own device. So I would argue that corporate competition isn’t necessary when the stakeholders realize that we need to get better at this. I think the companies in this space realize there’s a huge unmet need here if we develop a really good MCS that was truly portable, gave people excellent quality of life, and had lower complications,” she said.

Yet with the pace of LVAD research, “in the next decade, we have case for concern in the MCS field,” Cowger countered.

Both debaters suggested that MCS technology shouldn’t stop at HeartMate 3, even with its relatively impressive performance in MOMENTUM 3.

“Outcomes on HeartMate 3 are not the outcomes we really want for these patients. There are still innumerable complications. Hospitalization rates are extraordinarily high in these patients post-implant even if they’re successful implants. They bleed, they get infected, they get strokes. That still happens,” noted Sweitzer.

Innovation issues aside, Cowger pointed out that HeartMate 3 is also much larger than the HVAD. The departure of the smaller device took away a treatment option for smaller children and adults — usually women and racial minorities.

HeartWare was approved in 2012 as a bridge to heart transplantation and as destination therapy in advanced heart failure patients not eligible for transplant in 2017. HeartMate 3 got the nod for bridging and destination therapy in 2017 and 2018, respectively.

Cowger bemoaned the recent “sense of apathy and loss of enthusiasm for MCS,” which was not helped by HVAD’s departure and the ensuing media messages of how HeartWare recipients had been failed by the FDA.

“Physicians don’t want to use technology that will harm or be perceived to harm patients,” she said, noting that sentiment has shifted from “VADs are sexy, cool” to “we would not choose LVADs over [heart] transplant.”

This is evident in the recent changes to the national donor heart allocation system, in which transplant candidates on LVAD support have less priority than they did in the old system. “We want transplants, that’s why we did an extra training year of advanced heart failure. So how do we get to transplant? Right now it’s not with MCS. It’s with temporary support,” Cowger said.

“There are thousands of LVAD candidates out there and limited [donor] hearts. The message that we send to the medical community about LVAD therapy is critical for the sustainability of our field,” she added.

Last Updated September 14, 2021