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CARDIOVASCULAR
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Interview With Kevin Bourque, DVP, Research And Development

Kevin Bourque, currently DVP of Research & Development Mechanical Circulatory Systems, is also the co-developer of the HeartMate™ 3 LVAD, a life-changing1 technology for Heart Failure patients. The HeartMate 3 LVAD was launched in 2017 and is approved for both Destination Therapy (DT) and Bridge to Transplant (BTT) in the United States.

 

To kick things off can you give us a little background about yourself?

Absolutely. I’ve spent my whole career, 30 years, in medical devices and love being able to help patients and doctors. As DVP of R&D in the Mechanical Circulatory Systems group, my primary focus is, and has been, on LVAD. I mostly focus on blood pumps, primarily HeartMate II™ and 3, as well as CentriMag™ Acute Circulatory Support System. Our team was in-part the inventor of the Full MagLev™ Flow Technology, which is found in both the HeartMate 3 LVAD and CentriMag™ Pump. Lately, we’ve been working with other R&D groups within Abbott which has been exciting since it opens up new opportunities for product development.

 

As a founding member of the HeartMate 3 team, can you share some background about its development?

When I started at Abbott, the HeartMate XVE* was the only thing that existed at the time. In the first decade or so, we were so focused on pumping blood and solving that idea first. The HeartMate XVE was remarkable then, and now 20 years later it looks barbaric since it was gigantic and loud compared to what we have today. You couldn’t go to the symphony or movies with it. I revere it for its role because without the old technology we wouldn’t be where we are now with the HeartMate 3 LVAD.

In 1997, the idea of using magnetic levitation for the rotor to pump blood stemmed from thinking “geez, if we could avoid mechanical contact and expose the blood to lower shear forces, the reliability should be improved, and blood damage dramatically decreased.” This led to the initial idea of Full MagLev™ Flow Technology.

Our first attempt actually failed, which led to our fortuitous collaboration with our Swiss colleagues in what is now our Zurich office. Those are special engineers, remarkably innovative but rooted in practicality. The marriage of world class experts in magnetic levitation with our industry-leading expertise in blood pumps was perfect.

During HeartMate 3 LVAD development, the HeartMate II LVAD trial was gaining so much success2 that we had the enviable opportunity to pause and reevaluate our plan. We liked so many things about the HeartMate 3, except we wanted it to be smaller. So we made it smaller! This is a chance that we would not have had if it were not for the great success of HeartMate II LVAD.

We worked on optimizing Full MagLev Flow Technology for patients, with lots of feedback from our teams of engineers and clinicians. I will never forget the moment after I got to my hotel after our first HeartMate 3 LVAD implant after the culmination of 20 years of work. I had the realization of how far we had come and how meaningful it was for heart failure patients.

 

Was there a specific moment during the development of the HeartMate 3 LVAD that felt like a technological breakthrough?

The whole project felt like a breakthrough. The HeartMate 3 LVAD is really an example of just an idea that came to fruition. That doesn’t happen every day and sometimes ideas don’t work, but the ones that do work are huge. They’re revolutionary.

 

Has there been specific feedback provided by clinicians that has helped shape product development or prototypes?

There’s not too much on our device that doesn’t directly or indirectly stem from customer feedback. We find that dialogue critical to R&D. One recent example of feedback we implemented was the creation of a smaller diameter sewing cuff for the HeartMate 3 LVAD (compared to the original design), due to a number of European clinicians who asked for it.

 

How do you get feedback? Is there a specific process?

We hear feedback and are in discussion with lots of teams and groups throughout the development cycle and yes, there is a process. During development we actually have rigorous steps, “human factors,” they’re almost synonymous with usability engineering. This is what FDA and international standards look for.

We have to get customer feedback in a formal way at all stages of development, validation testing, and other things. After a product launches it’s a little different but there are design control aspects. All of the return products information is reviewed and sent forward to next generation technologies. Which means that part of the early phases of our design control is to establish patterns or lessons learned from previous generations of products.

 

What makes the HeartMate 3 LVAD, or any other product, a life-changing technology?

For me the idea of life-changing technology within heart failure means changing the notion of heart failure as an irreversibly progressive disease to one where remission is a possibility. There will be a therapy that has a chance to put you into cardiac remission for some meaningful period of time, perhaps 5 or 10 years at a time. Possibly you will relapse, but it will change how people think about heart failure.

More importantly, the blood pump is going to be an important player in that. We aim to have smarter pumps that will respond to physiological demands, and a strategy for getting the patient out of their acute illness, perhaps through some transition period. We don’t know how that will all work since it’s not a reality yet, but I think it can be in my lifetime. That is an exciting thing to be a part of.

 

What’s next for the HeartMate LVAD product line?

I just alluded to it. Now as we go through how we are pumping blood we have started thinking about what else the pump can do and how else we can improve quality of life for patients. There’s much more that can be done than just palliating symptoms while the disease continues to progress; even if it is at a slower rate with the pump. We are working with other divisions on where other technologies may provide value to the LVAD, like pressure sensors. I can’t comment too much more, but it is remarkable how far we’ve come in all the time I’ve been with Abbott, and how the acquisitions have opened up more possibilities for product innovation.


 

For more information about the HeartMate 3 LVAD including recent studies, clinical uses, and more, go to: cardiovascular.abbott.

*HeartMate XVE is no longer available.

 

References
  1. HeartMate II/3 : Mehra MR, Uriel N, Naka Y, et al. A Fully Magnetically Levitated Ventricular Assist Device-Final Report. N Engl J Med. 2019;380:1618-1627.
    HeartMate XVE: Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241-2251.
  2. Park SJ, Milano CA, Tatooles AJ, et al. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Failure. 2012;5(2),241-248.
INDICATIONS, SAFETY AND WARNINGS
INDICATIONS, SAFETY & WARNINGS

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Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Heartmate 3™ Indications

The HeartMate 3 Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.

Heartmate II™ Indications

The HeartMate II Left Ventricular Assist System is indicated for use as a “bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricle failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.

Heartmate 3 And Heartmate II Left Ventricular Assist System Contraindications

The HeartMate 3 and HeartMate II Left Ventricular Assist Systems are contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

Heartmate 3 And Heartmate II Left Ventricular Assist System Adverse Events

Adverse events that may be associated with the use of the HeartMate 3 or HeartMate II Left Ventricular Assist System are listed below: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS), thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) and possible pump thrombosis.

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