This article is more than 5 years old. Information may no longer be current.
Hemodynamic support system improves survival in acute MI, cardiogenic shock
Click Here to Manage Email Alerts
WASHINGTON — Use of a percutaneous heart pump for hemodynamic support before PCI in patients with acute MI and cardiogenic shock appears to improve survival, according to a presentation at the American College of Cardiology Scientific Session.
William W. O’Neill, MD, FACC, FSCAI, medical director of the Center for Structural Heart Disease at Henry Ford Hospital, Detroit, and a member of the Cardiology Today’s Intervention Editorial Board, said in a presentation that mortality rates for acute MI and cardiogenic shock have not changed in many years.
ardiogenic shock is increasing.”
The hemodynamic support system (Impella family of products, Abiomed) can be used to unload the left ventricle before PCI in this patient population and was approved for that indication by the FDA in April 2016. It was initially approved in 2009 as a percutaneous LV assist device for patients undergoing high-risk PCI.
O’Neill presented data from 15,259 patients with acute MI and cardiogenic shock from the Impella Quality Assurance Program (IQ Database; mean age, 64 years; 73% men), which represents U.S. commercial use since the 2009 approval, and 1,090 with acute MI and cardiogenic shock from the cVAD Registry (mean age, 66 years; 76% men) of 65 high-volume institutions.
Best practices created based on data from the databases include using the hemodynamic support system implanted by an experienced operator to unload the LV before PCI and avoiding escalation of inotrope therapy, but in 2016, only 6% of all procedures for patients with acute MI and cardiogenic shock used Impella for support, compared with 42% for support with intra-aortic balloon pumps, “despite the fact that multiple randomized trials have demonstrated that there is no improvement in survival with balloon pumps, no decrease in infarct size and marginal improvement in cardiac power,” O’Neill said.
Outcomes varied across sites, with the top 20% having a mean survival rate of 76%, but the bottom 20% having a mean survival rate of 30%, he said.
Compared with use of intra-aortic balloon pumps and inotropes for support, use of Impella for support before PCI was associated with improved survival in the IQ Database cohort (59% vs. 52%; P < .001) and in the cVAD Registry (67% vs. 62%; P < .001), according to O’Neill.
Those who had hemodynamic monitoring had improved survival compared with those who did not (IQ Database: 63% vs. 49%; P < .0001; cVAD Registry; 76% vs. 68%; P = .002), he said.
However, increased inotrope or pressor use was associated with mortality in the cVAD Registry (none, 32%; one, 54%; two, 65%; three, 65%; four or more, 74%), according to the researchers.
O’Neill also presented data from the Detroit Cardiogenic Shock Initiative, a collaboration between five hospitals in the Detroit area using best practices created based on data from the databases.
In that cohort of 37 patients (mean age, 63 years; 62% supported with Impella before PCI; 80% with decreased inotrope or vasopressor use), survival to explant was 89% compared with 51% in Detroit-area hospitals from the IQ Database between January 2015 and July 2016, O’Neill said. Survival to discharge was 84%. There was a 58% increase in cardiac power output after Impella support (P < .001) and all patients who survived had full native heart recovery, he said.
“Despite [FDA] approval, Impella is used in just a small minority of patients with acute MI and cardiogenic shock in the United States,” O’Neill said. “When it is used, there is wide institutional variation in outcomes with this device. This suggests that the systematic best practices have to be systematically employed. These best practices include increased institutional experience with Impella. The Impella has to be placed quickly and has to be placed prior to the angioplasty. With this, you can dramatically reduce exposure to high doses of inotropes. ... We’ve now applied this in a systematic prospective way in the Detroit Cardiogenic Shock Initiative. We have shown that this institutional quality program can dramatically improve outcomes. I believe this will set the new standard of care for the management of acute MI and cardiogenic shock.” – by Erik Swain
Reference:
O’Neill W, et al. Featured Clinical Research III. Presented at: American College of Cardiology Scientific Session; March 17-19, 2017; Washington, D.C.
Disclosure: The IQ Database and cVAD Registry were funded by Abiomed. O’Neill reports receiving consultant fees/honoraria from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic, and holding equity in Neovasc.
Perspective
Back to Top
Srihari S. Naidu, MD, FSCAI, FACC, FAHA
I would like to applaud the researchers for putting together a consortium to tackle the issue of cardiogenic shock in a system-wide approach, which is unusual. They put the following approach together to see if it would move the needle on cardiogenic shock: rapid transfer with Impella support, done pre-PCI, followed by PCI and invasive hemodynamic monitoring to determine escalation and weaning of therapies, with reduced use of inotropes when possible. This observational study shows that that approach is feasible. A group of hospitals can get together, at least with a small number of patients, and do all of these things with a high survival rate. What the results don’t tell us is what the survival rate would have been if any of the steps didn’t happen. It’s not a proof of concept that these steps improve survival, but that they are safe and feasible to do; they did not seem to cause harm. The overall survival of more than 80% is markedly higher than we would expect in an acute MI/cardiogenic shock population needing assist devices, but it cannot be ultimately proven in this trial.
It is reasonable to try to standardize this approach in a larger registry series compared with other types of patients who come in with similar risk factors to see if these patients are actually improving in survival. Factors such as how fast the patient came in, whether support was used before or after PCI and the number of inotropes used can be controlled for. Perhaps a case-control study between the different approaches in patients at similar risk would be warranted. It’s very hard to do that with 37 patients, so a larger number of patients would be needed to determine an actual improvement in survival.
Ideally, we’d like to see a randomized trial, but it has always been very difficult to do randomized controlled trials for shock. Some have been done, but with relatively small numbers of patients. It’s hard to compare this approach to “standard care” when there would probably be significant portions of patients stabilized with devices ahead of time, with some but not all of the features of the Detroit initiative’s approach.
These findings are impressive, especially because they were produced by collaboration among competing hospitals. It was encouraging to see survival was high with this approach. The findings are further confounded by the fact that these are highly skilled operators who are quite good at taking care of patients with cardiogenic shock. Whether this can be generalized throughout the country therefore also becomes an issue.
Click Here to Manage Email Alerts