F.D.A. Approves Assist Device For Permanent Use
HeartMate II offers option to thousands of heart failure patients
More than 100,000 people with advanced heart failure who do not qualify for a heart transplant may now have a long-term option thanks to a recent approval by the U.S. Food and Drug Administration. Now a heart assist device called the HeartMate II can be used as destination therapy, or long-term therapy. While widely available, the heart assist device was previously only approved for short term use as a bridge to transplantation.
“This is significant because previously patients who were not transplant candidates had few options once medications failed,” said Edwin McGee Jr., MD, cardiac surgeon and the surgical director of heart transplantation and mechanical assistance at the Bluhm Cardiovascular Institute. “It’s important for heart failure patients and physicians to know that this option exists, and that there is hope even when faced with a difficult diagnosis.”
Experts at Northwestern Memorial’s Bluhm Cardiovascular Institute offer the HeartMate II as both a bridge to transplant and as long term destination therapy. Northwestern is a ventricular assist device center of excellence, and its Medicare Destination Therapy Ventricular Assist Device program was honored with a Certificate of Distinction from the Joint Commission as a result of the volume, level of expertise of clinicians and excellent outcomes.
HeartMate II works by taking over the pumping action of a diseased heart and helps circulate blood to the body. The lightweight pump is implanted into a pocket in the abdominal wall and an electric cord passes through the patient's skin to an external battery and controller device. The small size of the pump offers an additional benefit as it allows physicians to use it in patients of smaller stature.
“Patients suffering from advanced heart failure often experience symptoms such as swelling, fatigue, shortness of breath and are not able to exert themselves,” said McGee. “Assist devices can dramatically improve length and quality of life in the patient with advanced heart failure. Assist devices allow patients to regain their independence.”
Jerry Allen is a Northwestern Memorial patient who was implanted with a HeartMate II in July 2009. Allen, who previously experienced severe dizziness and shortness of breath, says his symptoms have dramatically improved since receiving the device. “In short, without this technology I probably wouldn’t be here,” said Allen. Allen is currently listed for a heart transplant.
McGee says it’s rewarding to see patients like Allen go from being bedridden to resuming normal activities such as dining out with friends and enjoying their hobbies.
Clinicians at the Bluhm Cardiovascular Institute will be participating in a trial for another assist device called HeartWare as destination therapy. The HeartWare device promises to offer even fewer side effects and complications when compared to HeartMate II, as it sits adjacent to the heart, is smaller and requires less surgery to implant.
For more information about the Bluhm Cardiovascular Institute’s heart failure program and heart assist devices, visit www.heart.nmh.org.