FDA Approves Tiny Heart Pump that Promises "Seismic Shift" in Heart Attack Survival Rates

April 21, 2016


DETROIT – The doctor who pioneered angioplasty to stop a heart attack 32 years ago says a straw-sized heart pump just approved by the FDA could have a similar, dramatic effect on heart attack survival rates.

“It’s going to truly be life-saving for thousands and thousands of people in the United States and around the world,” says world-renowned Henry Ford cardiologist William O’Neill. He was the lead investigator for the study that led to the U.S. Food & Drug Administration’s April 7 approval of the Impella pump for the treatment of cardiogenic shock.

Dr. O’Neill says the approval will start a seismic shift in the treatment of patients in cardiogenic shock. The condition most commonly occurs when a massive heart attack damages the heart, preventing it from pumping blood to the body’s extremities and sending the patient into shock. Untreated, 90% of patients die.

“I think we’re going to totally change the paradigm of the treatment of cardiogenic shock, one of the most lethal conditions in medicine,” he said. But the most recent studies with the Impella pump suggest 70 percent of people can survive cardiogenic shock if the Impella catheter is placed quickly. The Impella pump, inserted through a catheter in the leg and into the heart, takes over the heart’s pumping action to keep blood flowing to the rest of the body until the heart heals.

Dr. O’Neill, director of the Henry Ford Center for Structural Heart Disease, first used angioplasty – opening blocked blood vessels of the heart using a balloon inserted through a catheter – to increase blood flow and stop a heart attack in 1984. The breakthrough treatment increased patients’ survival rate from 10% to about 50% and is now a standard in the treatment of heart attacks.

One of the measurements of a successful angioplasty program is “door-to-balloon time,” the time between when a patient arrives at the hospital door and when the cardiologist opens the balloon in the patient’s blocked artery. He said the use of Impella pump to “unload” blood from being pumped by the heart may change hospitals’ gold standard.

“Now it’s not going to be ‘door-to-balloon,’ but it’s going to be ‘door-to-unload,’ says Dr. O’Neill, one of about three dozen Master Fellows in the world of the Society for Cardiovascular Angiography and Interventions (SCAI), the professional medical society for invasive and interventional cardiologists. “The sooner we can get the patients treated, the sooner we can get the blood pressure up, the sooner that we can get circulation to the body, the more likely the survival.”

The technology is yet another offering by the Edith and Benson Ford Heart & Vascular Institute to help patients with heart disease survive and thrive. The center is one of few in Michigan offering highly specialized evaluation and treatment all in one program. The cardiac and vascular surgeons, electrophysiology and vascular medicine experts, and cardiologists work together to develop personalized treatment plans, coordinating with to specialist teams such as the Multidisciplinary Aorta Program, the Center for Structural Heart Disease, and the Henry Ford Transplant Institute, celebrating 30 years of performing heart transplants in 2014. The Henry Ford rhythm team offers cutting-edge treatments for various arrhythmias and heart failure using catheter ablation and cardiac devices, along with expertise in complex lead extractions.

Henry Ford cardiologists were the first in the United States to perform an aortic valve replacement through a catheter and the highly specialized transcaval procedure to improve access to the heart. Henry Ford cardiologists also are pioneering the treatment of valve issues and the use of heart pumps in those with advanced heart disease. The institute is also home to the only cardiologist in the Midwest with highly successful expertise blasting through coronary blockages, allowing patients to avoid bypass surgery.

For more information or an appointment, call the Henry Ford Center for Structural Heart Disease at (313) 916-1878 or visit Structural Heart.

Media Contact:
Tammy Battaglia
(248) 881-0809