Last I looked maybe 3 years ago, there were no head to head trials, and abiomed played alot of statistical games. Basically wasn't better than a balloon pump, possibly even more complications. ABMD would do single arm comparisons to historical controls that weren't well matched. - ThreadSky

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pbafuma.bsky.social • 161 days ago

Last I looked maybe 3 years ago, there were no head to head trials, and abiomed played alot of statistical games. Basically wasn't better than a balloon pump, possibly even more complications.

ABMD would do single arm comparisons to historical controls that weren't well matched.

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pbafuma.bsky.social•161 days ago

Though danger was positive, thats counter to at least 3 negative trials before it. Idk. Impella may do something (and I've def pushed for them before)..., but low threshold to encourage removal if any complications from the device arise.

load-dependent.bsky.social•161 days ago

Registry trials suggested harm compared to IABP (which does not work in acute STEMI shock), but they’re obviously confounded. DANGER Shock is the best evidence we have, pointing to benefit (but also demonstrating the harms if used in those that would have survived anyway).

redneeraj.bsky.social•161 days ago

10 years to enrol 360 patients 🫤. This is either a barely adequate trial or hardly required intervention.

load-dependent.bsky.social•161 days ago

Thankfully, it’s an increasingly rarely needed intervention with the decline in STEMI incidence.
Additionally, inclusion in perimortem RCTs is extremely difficult.

redneeraj.bsky.social•161 days ago

So, both?

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