Preliminary National Cardiogenic Shock Initiative Study Results Confirm 50% Jump in Survival

September 21, 2018
Basir at TCT

SAN DIEGO – Preliminary results from a large, national study confirm the effectiveness of a protocol established in Detroit to treat heart attack patients in cardiogenic shock, Henry Ford Health System doctors announced today.

The study found 80 or 77% of the 104 patients who have been treated to date with the National Cardiogenic Shock Initiative (National CSI) protocol at sites across the United States survived their heart attack.Typical survival rate for patients in cardiogenic shock had been about 50% before pioneering cardiologist Dr. William W. O’Neill and his colleagues developed the protocol in Detroit.

Henry Ford cardiologist Dr. Mir “Babar” Basir announced the results today, accompanied by Dr. O’Neill, director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit. They and National CSI coordinator Michael Hacala presented data from “One Year Outcomes from the Detroit Cardiogenic Shock Initiative Pilot Study," at Transcatheter Cardiovascular Therapeutics (TCT), one of the world’s largest educational meetings specializing in interventional cardiovascular medicine.  

“This proves the National CSI protocol can save lives anywhere,” said Dr. O’Neill, who also helped establish stenting to treat patients during a heart attack. “We’re thrilled for the sites across the country that we were able to increase survival rates for their patients so drastically.”

Now, the protocol is being voluntarily replicated by 56 hospital sites across the United States. An additional 30 sites are preparing to join the Initiative, and the study is ongoing.

The devastating heart attack complication cardiogenic shock affects approximately 5% to 8% of heart attack patients in the United States annually. In these patients, the pump function of the heart is severely depressed, causing low blood pressure and vital organs to be deprived of sufficient blood supply. Despite contemporary treatments, an average of about 50% of patients experiencing the condition historically died. But heart attack survival rates increased dramatically in cardiogenic shock patients who were provided rapid hemodynamic support before treating the cause of a heart attack.

Doctors following the protocol insert an Impella, a straw-sized pump approved by the FDA in 2008 and specifically for treatment of cardiogenic shock in 2016. The pump is inserted through a catheter in the groin and into the heart to keep blood pumping throughout the body.

The basis for the protocol used retrospective data collected by the pump’s manufacturer, Massachusetts-based Abiomed, in 15,529 patients – 72% men and an average age of 63 – treated between 2009 and 2017. The investigators noticed that survival rates in patients treated with the Impella pump fluctuated wildly by hospital. A third of hospitals experienced a 25% survival rate; a third, 50% survival; and a third, 75%.

“There was a huge variation in outcomes between the centers, between the lowest performing and highest performing centers,” Dr. O’Neill said. “It looked as though putting the Impella in soon, before you do anything else, is connected to survival.”

Inserting the pump first ensures the patient’s other vital organs are supported, buying time for cardiologists to open the blocked arteries to restore natural blood flow. The hospitals with high survival rates also used less inotropes and catheters to monitor heart pressure, O’Neill added.

To test the best practices, O’Neill organized five hospital systems in southeast Michigan to follow a specific protocol in acute myocardial infarction patients who showed signs of cardiogenic shock between July 2016 and April 2017. Of the 41 patients supported with the Detroit Cardiogenic Shock Initiative protocol, 31 or 76% survived – replicated by the preliminary study results announced today.

Key to the protocol is medical personnel recognizing cardiogenic shock in patients as soon as possible, said Dr. Basir.

“If they think the patient needs medication to raise the blood pressure, that’s when they should be thinking, ‘Get them someplace where they can get a pump implanted,’” Dr. Basir said.

For more information on the initiative or protocol, visit HenryFord.com/cardiogenicshock

MEDIA CONTACT:
Tammy Battaglia
Henry Ford Health System
Tbattag1@hfhs.org
248-881-0809