McGowan Institute for Regenerative Medicine faculty member Michael P. Siegenthaler, M.D. (pictured), associate professor of surgery, division of cardiac surgery, University of Pittsburgh Medical Center (UPMC) Heart Lung and Esophageal Surgery Institute, is the co-investigator of the trial of a miniature heart pump under evaluation at UPMC. The trial aims to determine whether or not the heart pump could eliminate the need for emergency open heart surgery in patients undergoing high-risk coronary catheter procedures. The research study will determine its safety and efficacy in high-risk patients.
UPMC is the third leading enroller in the research study among U.S. heart centers participating in the PROTECT II pivotal trial with Abiomed’s Impella 2.5 System -- the world’s smallest heart pump only slightly larger in diameter than a drinking straw. Researchers hope to enroll 150 patients overall during the 2-year multi-center clinical feasibility trial, which is being funded by Abiomed.
“One of the potential main advantages of the Impella is that it may eliminate the need for major surgery with an open chest incision and placement of the patient on heart/lung bypass. This miniature pump is placed percutaneously with a small incision at the groin and inserted much the same way as a balloon tip or cardiac stent, which means less recovery time, fewer complications, and shorter hospital length-of-stay,” said Dr. Siegenthaler.
The Impella 2.5 System is an investigational device that has not yet been approved by the U.S. Food and Drug Administration. The heart pump is inserted much the same as a balloon angioplasty and stent, inside the cardiac catheterization lab. Once the heart pump is secured, the regular balloon angioplasty and/or stent procedure is completed. This pump is being tested to determine if the patient’s heart can rest and recover by reducing the heart’s workload and oxygen intake and to improve heart function even after the procedure. Patients will be supported on the device during the cardiac catheterization procedure. However, if the cardiologist decides that the patient’s heart should be supported for a longer time, the Impella can be left in place for up to 5 days.
According the National Heart Lung and Blood Registry for Percutaneous Coronary Intervention, more than 1 million cardiac catheterization procedures are performed in the United States each year. Due to the rise in multiple-vessel disease in patients with poor cardiac function, which is caused by coronary vessel blocks in three or more vessels of the heart, the researchers hope to demonstrate that the Impella 2.5 provides a new treatment option that aims to improve patient outcomes.
Illustration: McGowan Institute for Regenerative Medicine.
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Video of the Impella 2.5 Procedure at the UPMC Catheterization Lab
Abiomed’s Graphic Animation Video of How the Impella 2.5 Heart Pump Works