ACC.17: Detroit cardiologists increase cardiogenic shock survival rate to 84% using Abiomed heart pump

A coalition of medical centers in southeast Michigan have found a way to increase the survival rate of cardiogenic shock patients to 84 percent by using a heart pump manufactured by Danvers, Massachusetts-based Abiomed.

The study was presented at the American College of Cardiology’s 66th Scientific Session on March 19 in Washington, D.C.

The encouraging findings were part of a larger study conducted by Abiomed to test the efficacy of its Impella heart devices. Data was derived from their Impella Quality Assurance Program database, which holds information on 50,000 U.S. patients and includes more than 15,000 acute myocardial infarction cardiogenic shock cases. Results showed a survival improvement rate of 14 percent from the previous year, yielding an overall survival rate of 58 percent.

However, the coalition, branded the Detroit Cardiogenic Shock Initiative, provided the most notable results in the study, improving survival rates by 65 percent. The initiative included five major health systems in the region, which all agreed to manage cardiogenic shock patients in the same manner. It was led by veteran cardiologist William W. O’Neill, MD, who is currently the medical director of the Center for Structural Heart Disease at Henry Ford Hospital.

Other institutions included were Beaumont Hospital, Detroit Medical Center, Ascension’s St. John and Providence hospitals and Saint Joseph Mercy Health System.

O’Neill has been working on methods to decrease mortality rates for cardiogenic shock patients for more than 30 years, he said in an interview.

Before balloon angioplasties were used, the mortality rate for people who suffered cardiogenic shock was 90 percent. Once physicians began routinely using the balloon method, mortality dropped to 50 percent, but progress has been slow since the early '90s.

“We’ve been at a frustrating level where we’ve gotten balloon pumps to improve outcomes to a 50-percent mortality rate, but we haven’t been able to move the needle at all,” O’Neill said. “But the approval of the Impella has given us the breakthrough that has dramatically improved the chances of people surviving a massive heart attack and cardiogenic shock.”

The Impella CP pump, which was approved by the U.S. Food and Drug Administration (FDA) in 2009, was the model used in the trial. It is designed to assume the role of the heart by pumping blood out to the body and giving the muscle a break to rest and recover.

In the study, the five health systems treated 37 patients with cardiogenic shock as they worked to develop best practices that would result in a patient’s survival. Thirty one of the 37 patient survived, yielding a survival rate of 84 percent.

“Prior to this, we would have expected 19 patients to die in this group, so there’s a very substantial improvement in survival for our institutions,” O’Neill said. “But getting it up to an 84-percent survival rate, I was pleasantly surprised.”

The method included unloading the left ventricle of the heart with Impella before percutaneous coronary intervention, reducing the escalation of inotrope therapy and utilizing hemodynamic monitoring for escalation and weaning during support. Additionally, the program calls for only experienced physicians to implant the heart pumps and for patients to be treated within four hours of shock onset.

Abiomed hopes the results will encourage more physicians to begin using their products, according to company representatives. In 2016, there were 89,000 cardiogenic shock cases nationwide, but only 5,000 of them, or about 6 percent, were treated with Impella heart pumps. The majority of physicians use intra-aortic balloon pumps and blood pressure medication to treat shock patients, but the chances of survival are reduced.

Looking ahead, O’Neill said he wants to expand the approach beyond the Detroit area and enroll 50 centers nationwide to use the procedures his team developed.

“We’re going to get them to apply the same treatment algorithm and protocol to treat people systematically,” O’Neill said. “We think that’s going to move the bar nationally in terms of survival for shock.”