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

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More from @hmkyale

30 Aug
With much talk about wearables & devices picking up unappreciated atrial fibrillation, I was intrigued by this randomized trial of effect of an implantable loop recorder to detect afib on outcomes. These slides are from #ESCCongress presentation. Kudos Jesper Svendsen and team. Image
The team identified participants with a high risk of stroke and randomized them to an implantable loop recorder (Reveal LINQ by Medtronic), with a primary outcome of stroke or systemic embolism. Question: would better detection of afib improve outcomes? Image
They randomized 1:3 - so most people were in the control group. 1501 randomized to the implantable recorder (and 1420 received it, that will be important later) and 4503 in the control group (and none crossed over and received the recorder). They followed them for median 65 mos. Image
Read 18 tweets
27 Aug
Remarkable win streak for SGLT2i drugs continues…now specifically for heart failure with preserved ejection fraction (HFpEF), where effective therapies are scarce. Empagloflozin benefits one of every ~30 people treated over median of 26 mos. nejm.org/doi/full/10.10… #ESCCongress
What gives me confidence about the finding is it is consistent w/what we have seen in subgroups of other studies, but not yet in a dedicated trial. Kudos @JavedButler1 Stefan Anker and team. This is truly a landmark in heart failure care. #ESCCongress2021 #ESCcongress @escardio
@JavedButler1 @escardio Another notable about this EMPEROR-Preserved trial… empaglifozin won across a range of outcomes, across all the subgroups (incl people w/o diabetes), and w/o evidence of safety issues (more serious safety issues in the placebo group). Very welcome set of findings. #ESCcongress
Read 6 tweets
19 Aug
Illuminating the disparities… "During COVID-19, Black & AI/AN persons had highest excess all-cause mortality IRs among <25yrs & 25–64 years; among ≥65 yrs, largest excess mortality occurred among Black & Hispanic persons.” @CDCgov @jeremyfaust @YaleMed cdc.gov/mmwr/volumes/7… Image
@CDCgov @jeremyfaust @YaleMed We learned a lot in researching this study…using the metric we pioneered (I credit @YNHH CORE team and @jeremyfaust) we show: 'Black persons had highest excess mortality IR among <25 yrs with 14.1 excess deaths per 100,000 person-years in 2020, followed by AI/AN persons (6.5)."
@CDCgov @jeremyfaust @YaleMed @YNHH Also, "Among adults aged 25–64 years, the highest total excess mortality IR was among AI/AN persons (221.1), followed by Black (133.4), NH/PI (124.9), Hispanic (98.5), White (51.2) and Asian persons (30.2).” These differences are huge and demand our attention.
Read 7 tweets
8 Aug
For States and regions in the US that have low vaccination rates because people don’t want it, wouldn’t the federal gov’t be better off waiting until they ask for help rather than trying to push/force vaccinations on them, which just seems to increase resistance.
In this construct, the federal gov’t would say, we are ready and eager to help with vaccines, funding, people - let us know when you are ready. This, in place of being characterized as forcing people. De-politicize it… feds just wait to be invited to help.
The key is to make vaccines accessible and free to everyone; make trustworthy information about the vaccines abundant and clear. And let people make their choices. Be the sun and not the wind, and people will eventually take off their coats.
Read 6 tweets
17 Jun
“...first longitudinal imaging study in #COVID19 where patients initially scanned before contracted the disease.” An incredibly important @uk_biobank study… 'Brain imaging before and after COVID-19 in UK Biobank’ by an esteemed group. medrxiv.org/content/10.110… @medrxivpreprint
@uk_biobank @medrxivpreprint "significant, deleterious impact of COVID-19 on olfactory & gustatory cortical systems, w/more pronounced reduction of grey matter thickness & volume in L parahippocampal gyrus, L superior (dorsal) insula andL lateral orbitofrontal cortex in COVID patients.” #LongCovid
@uk_biobank @medrxivpreprint Here is the kicker… of the people w/COVID for whom there are records, very few had been hospitalized. These brain effects occurred largely in largely in people not sick enough to be hospitalized. Time to re-think how benign this is in people w/o severe symptoms. Time will tell.
Read 12 tweets
16 Jun
Another remarkable trial from the RECOVERY team. This time 'Casirivimab and imdevimab in patients admitted to hospital with COVID-19’ - and with an impressive finding. Kudos @PeterHorby @MartinLandray and all contributors. Now on @medrxivpreprint medrxiv.org/content/10.110… #COVID19 Image
@PeterHorby @MartinLandray @medrxivpreprint They studied @Regeneron monoclonal antibodies (casirivimab and imdevimab). They report: 'In patients hospitalised with COVID-19, the monoclonal antibody combination ... reduced 28-day mortality among patients who were seronegative at baseline.' Image
@PeterHorby @MartinLandray @medrxivpreprint @Regeneron An important finding in this trial is that the effect of the monoclonal antibodies was present in hospitalized patients with COVID-19 who were seronegative, but not those who were seropositive. A key insight into who benefits. Image
Read 5 tweets

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