Acute myocardial infarction complicated by cardiogenic shock has dismal outcomes. Pharmacologic therapy, intra-aortic balloon pumps, ventricular assist devices, et cetera, all have limitations. So, why not extracorporeal life support (ECLS)? Well, for one, it’s resource-intensive, expensive, and little high-quality evidence supports its use. But, on the other hand, it’s fancy and magical and reputed to beget miracles.
Published as a brief research report, this small article describes an open-label pilot of 42 patients suffering cardiogenic shock, randomized to ECLS or no mechanical circulatory support. The primary outcome was left-ventricular ejection fraction at 30 days, with multiple secondary outcomes crammed into their short bit.
The short answer: zero difference – median 50% vs. 50.8%, and no reason to tell you which is which because they’re the same. Mortality favored ECLS at 19% vs. 33%, but these outcomes and their survival curves are so entwined there is no reliable difference to be made from this small sample – and moreso even because the control group had greater illness burden at baseline. Process outcomes, such as intensive care unit length-of-stay and duration of mechanical ventilation favored the control cohort, as expected, given the relative resource intensity of ECLS.
The new sexy thing is always alluring and presumed to be better, but as these authors conclude: “This raises an urgent call for randomized controlled trials assessing survival as primary endpoint.”
“Extracorporeal Life Support in Cardiogenic Shock Complicating
Acute Myocardial Infarction”
https://www.ncbi.nlm.nih.gov/pubmed/31072581
Do you really think it’s ethical either to publish or comment on pilot studies? This adds nothing to our knowledge, and never would have. But now many will learn from Twitter that ECMO has been shown to be worthless, the authors of this “study” will get lines on their CVs, and you will get clicks. I agree that rigorous research on ECMO in this setting should be done (although the barriers to this are nearly insurmountable) but this paper is worse than useless.
I’m not sure “ethical” is the right way to put it – unless you’re going to somehow call into question every step of the research and publication pathway. This is a small, prospective RCT. Data were peer-reviewed and published in a prominent journal. I can’t fathom how ethics would play into whether I commented upon it. Even if I grossly misinterpreted the results, that wouldn’t be unethical – unless I were specifically spinning it to misrepresent the findings with the aim of misleading folks.
These data are what they are: of very little weight in a Bayesian evaluation of the treatment effect. However, ECLS is one of those things gaining popularity absent rigorous prospective evaluation – and I agree with their main conclusion.
Perhaps disingenuous would be a better term. And yes, I think the process of research and publication at present is deeply flawed on many levels, and has many incentives for people to publish garbage. You read the literature very carefully and critically, but you may underestimate how many people draw conclusions from abstracts or even headlines. I really think those in FOAMed with large audiences ought to be careful about what they draw attention to. I’ve run into many residents who think POP UP showed a lack of benefit for stress ulcer prophylaxis.
I totally agree – there is both responsibility on authors to be good stewards of knowledge translation, and also on students and residents to learn the skills to process and critically appraise the primary literature as well as FOAMed sources.
I’m not familiar with POP-UP, but I agree it doesn’t show much of anything. It is a “negative” trial, to be sure, but folks need to understand summarizing a trial as “negative” might discard a great deal of relevant information about whether a trial was adequately powered, the distribution of likely effect sizes, etc.
And, anyway, why are they still citing POP-UP instead of SUP-ICU?