The FDA has approved a new alternative surgical technique for the HeartMate 3 heart pump (Abbott) that will allow more advanced heart failure patients to avoid open heart surgery. The new, less invasive approach is designed to provide surgeons a choice in surgical method for patients receiving the HeartMate 3 left ventricular assist device (LVAD).
With approval for an alternative surgical technique, according to a press release, Abbott’s HeartMate 3 heart pump can now be implanted via lateral thoracotomy—a surgical approach in which an incision is made between a patient’s ribs to access the heart. The press release states that physicians believe that for many patients this technique has advantages over open heart surgery because it can result in less bleeding and a shorter recovery time for patients.
The approval is based on two studies—the ELEVATE study (a multicentre, voluntary, observational registry collecting post-marketing data) and the LAT Feasibility study (a single-arm, prospective, multicentre study). The press release adds that the results of the two trials found that bleeding (requiring surgery), infection and arrhythmias were lower in the group implanted via the less-invasive surgical approach than those who underwent open heart surgery.
Igor Gosev (University of Rochester Medical Center, Rochester, USA) comments: “This is a significant advancement for patients who can now receive a life-saving LVAD through an alternative procedure that can yield shorter hospital stays and a faster recovery. Heart failure is a crippling and costly disease so being able to offer patients the HeartMate 3 heart pump with this less-invasive approach gives them the opportunity to return to a better quality of life more quickly.”
Robert L Kormos, medical director for mechanical circulatory support at Abbott, states: “We continue to focus on advancing our heart failure devices and techniques to make life better for the patients we serve. The first approved LVAD—HeartMate I—was approved more than 25 years ago. Since that time, the technology has evolved immensely. Today’s HeartMate 3 device, including its design and size, allows physicians to successfully implant it without having to perform open heart surgery and offers survival rates, as demonstrated in the MOMENTUM 3 clinical trial, at two-years that are comparable to heart transplants.”