Thread by @hmkyale

CardioMEMS. Expensive, invasive device. Initial trial contaminated. FDA approves & it sells. Definitive trial now completed yrs later. No sig benefit. However, authors, look only at pre-COVID results, claim benefit, conclude it's worthwhile. #ESCcongress thelancet.com/action/showPdf…

Authors write: 'In conclusion, haemodynamic-guided management
across spectrum of ejection fraction & symptom severity was safe but did not reduce a composite of mortality and total heart failure events.” This seems very straightforward. We should stop using it. #ESCCongress2021

Then they say… "in a pre-COVID-19 analysis, a benefit of haemodynamic-guided management on the primary outcome, driven by a decrease in heart failure hospitalisations, was shown… supporting benefits of haemodynamic-guided management in patients with chronic heart failure."

I am all for looking at pre-COVID analysis, but isn’t the onus on the Abbott to show that this strategy is effective… the pre-COVID might provide a rationale for more study. But given the history, this is just a mess.

For more background, Sanket Dhruva and I wrote about this in @JACCJournals … & laid out the case for needing evidence of benefit for CardioMEMS. Meanwhile they are a money maker for health systems. Hence the problem. jacc.org/doi/10.1016/j.… #ESCCongress2021 #ESCcongress @YaleMed

@JACCJournals @YaleMed On the original CardioMEMS study: '...FDA reviewed e-mails between sponsor & investigational sites (interaction that was completely unexpected) & concluded the communications included management suggestions… that may have biased the study'

@JACCJournals @YaleMed We concluded 'CardioMEMS was therefore approved with lingering uncertainty regarding the benefits’… and I believe that this is still true. @YaleMed @jsross119