The first implantation of Thoratec’s HeartMate 3 has been performed via mini-thoracotomy. The implant begins a European study to evaluate outcomes and complications using less invasive surgical placement through hemisternotomy and left thoracotomy techniques. The study will include ten cases performed at three European centres following one initial case to build experience at each centre, and will measure the outcomes specified in the HeartMate 3 CE mark trial after 30 days of follow-up.
HeartMate 3 is a centrifugal-flow chronic left ventricular assist system. The fully magnetically-levitated technology foundation of HeartMate 3 is designed to lower adverse event rates through improved haemocompatibility while enhancing ease of surgical placement through a compact size. “This achievement marks the latest step in our progress with HeartMate 3, and will help build important clinical experience as we validate the surgical versatility of this exciting new technology,” said D Keith Grossman, president and chief executive officer.
The first less invasive surgery with HeartMate 3 was performed at the Institute for Clinical and Experimental Medicine (IKEM) in Prague, Czech Republic, by associate professor Ivan Netuka, deputy head at IKEM and Jan Schmitto, director of the Mechanical Circulatory Support and Cardiac Transplantation Program at the Hannover Medical School in Hannover, Germany.
“The pump design ensured elegant placement in a petite 70-year-old female with body surface area of 1.65m2, and the patient has been discharged from the hospital in a normal post-operative manner. This demonstrates that HeartMate 3 can accommodate choice in surgical placement. We look forward to confirming an encouraging initial experience in this ongoing trial,” commented Netuka. “The ease of implant, combined with potential for improved clinical outcomes with HeartMate 3, provide for a very attractive next generation device capable of treating a wide range of patients,” added Schmitto.