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Surgeons at Jewish Hospital First in Kentucky to Implant HeartMate 3™ After FDA Approval

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LOUISVILLE Cardiovascular surgeons at Jewish Hospital, part of KentuckyOne Health, were the first in Kentucky to implant the HeartMate 3 LVAD by Abbott, which was recently approved by the FDA for short-term use. Along with his team, Mark S. Slaughter, MD, professor, and chair of the Department of Cardiovascular and Thoracic Surgery at the University of Louisville and Jewish Hospital, played an important role in the clinical trial.

The HeartMate3 offers another option for physicians managing advanced heart failure patients who need short-term hemodynamic support, namely bridge-to-transplant or bridge to myocardial recovery. The system also provides patients living with their device new benefits that embody the evolution of left ventricular assist device (LVAD) therapy, such as improved blood flow in a pump that uses full magnetic levitation to reduce trauma to blood passing through the system.

More than 5.7 million people in the United States suffer from heart failure and approximately 915,000 new patients are diagnosed with the disease each year. For advanced heart failure patients who can no longer rely on earlier stage treatment options, an LVAD can help their weakened heart pump blood through the body and provide crucial support as patients await further treatment, including heart transplants.

“With each new generation of heart pumps, we continue to see improvements in reducing adverse events and better durability and reliability of the pump,” says Slaughter. “The HeartMate 3 is the first completely magnetically levitated continuous flow heart pump. It has no touching parts so there can be no wear and tear’ on the device, thus improving durability. Also, it is more compatible with blood causing less hemolysis or trauma to the blood.”

The HeartMate 3 system was designed to take LVAD therapy further and provide physicians new benefits for their patients by reducing the system’s size while reimagining how blood passes through an LVAD. The HeartMate 3 system deploys Full MagLev™ (fully magnetically-levitated) technology to reduce trauma to the blood passing through the pump while optimizing blood flow. Improved blood flow can help minimize complications – such as pump thrombosis – that can be associated with LVAD therapy, ultimately improving the patient’s quality of life.

Jewish Hospital is home to a number of firsts in heart care dating back to 1965, when Western Kentucky’s first adult open heart surgery was performed there. The hospital is the site of the region’s first dedicated heart and lung center. To date, Jewish Hospital is home to nearly 40 “firsts” in heart care, including:

Kentucky’s first transcatheter aortic-valve replacement (TAVR), a medical breakthrough giving hope to patients in need of a valve replacement who are not well enough to undergo open heart surgery
Nation’s first female patient implanted with the C-Pulse Heart Assist System
World’s first AbioCor totally implantable hearts
And the world’s first phase-one FDA-approved clinical trial using “c-kit-positive” adult cardiac stem cells to treat heart disease Surgeons still have the option of using the HeartMate II™, which is indicated for long-term or “destination therapy” for patients who are not candidates for heart transplants or who will live with their device long-term.

The HeartMate 3 system is the only commercially-approved continuous flow implantable left ventricular assist system to utilize Full MagLev™ Flow technology, which allows the device’s rotor to be “suspended” by magnetic forces—rather than bearings—with the goal of being able to more gently pass the blood cells through the pump. The magnets keep the rotor in place by calibrating tens of thousands of times per second to ensure it stays suspended and centered within the pump, no matter the speed settings used by a physician. This ensures the pump is performing effectively while continuing to deliver the best patient therapy possible.

The HeartMate 3 system also uses a wide pump pathway, designed so the blood cells are not damaged when passing through. The HeartMate 3 system includes the LVAD pump as well as the rest of the components that are crucial to making this technology work—an external, wearable controller, driveline and battery system that powers the pump. The HeartMate 3 System was CE Mark approved in Europe for both short-term and long-term support in October 2015.

U.S. approval of the HeartMate 3 system was supported by the MOMENTUM 3 clinical study. In that study, patients who received a HeartMate 3 system had a significant improvement in their heart failure status, an 83% increase in their walk distance and a 68% improvement in quality of life at six months. Patients receiving HeartMate 3 also had an 86% survival rate with freedom from disabling stroke and reoperation to replace the pump at six months.