Benoy Shah MD Profile picture
Dec 5 β€’ 23 tweets β€’ 6 min read
So...after time to read things through, a 🧡 on #IRONMAN

Better late then never! πŸ˜†

This was a useful exercise personally as iron deficiency (ID) in HF wasn't an area of great knowledge for me, but I've done my homework now!

Here's what I learnt

#cardiotwitter
Iron deficiency (ID) is common in HF. It isn't always associated with anaemia. Its aetiology is considered multifactorial:

⬇️ dietary iron intake
⬇️ dietary iron absorption
⬆️ GI tract iron loss
Impaired iron handling / redistribution
Previous studies of oral iron replacement were very small & did not find significant benefit

It is cheap & widely available but a very slow method of correcting ID, taking many months to produce noticeable changes
Previous RCTs have assessed role of IV iron replacement in HF

These include FAIR-HF, CONFIRM HF & AFFIRM HF

1 tweet per trial coming up
FAIR-HF

459pts with chronic HF, EF <40% & ID randomised to IV iron (ferric carboxymaltose - FCM) or placebo

PEP - Self-reported Patient Global Assessment & NYHA Class at 6m

PRO - signif improvement in PGA, NYHA Class & 6MWT distance

CON - small N, short F/U, no hard outcomes
CONFIRM-HF

304pts chronic HF, EF <45%, ID randomised to IV FCM or placebo for 1 year

PEP - 6MWT distance at 6m

PRO - Signif improvement in 6MWT, +18m vs -16m, p 0.002 & ⬇️ HF hospitalizations

CON - Small sample size
AFFIRM-HF

1110 pts, acute HF episode, EF <50% with ID, randomized to IV FCM or placebo

PEP: HF hospitalizations & CV death up to 1yr

Just failed to meet statistical significance - RR 0.79, p 0.059 - but strong trend towards benefit with IV iron
So...IRONMAN. Prospective open-label RCT at 70 NHS hospitals across πŸ‡¬πŸ‡§

Used ferric derisomaltose, not ferric carboxymaltose

Recruited Aug '16 - Oct '21, so was affected by COVID-19 pandemic (more on that later)

1869 pts screened, 1137 randomized: 569 IV iron, 568 usual care ImageImage
Incl / Excl Criteria

>18yrs age
New / known HF with EF <45% in past 2yrs
NYHA II - IV
Confirmed ID

PLUS either current HF hospitalization (or within past 6m) OR elevated biomarkers (NTproBNP > 250 or > 1000 for SR & AF, respectively

Hb <9g/dL or >14g/dL excluded
Mean age 73yrs
75% male
91% Caucasian
>50% ischaemic CM
58% NYHA II, 40% NYHA III
Mean EF 32-35%

44-50% AF
55% HTN
~50% T2DM
Mean eGFR ~50

2/3 recruited due to ⬆️⬆️ BNP
1/3 recruited after HF hospitalization

~90% on BBs
>85% on ACEi / ARB / ARNI
>50% on MRA
>80% loop diuretic ImageImageImage
Treatment

IV Iron Group

38% received 1 infusion
40% received 2 infusions
14% received 3 infusions
6% received 4 or more infusions
10 patients didn't receive IV iron

Usual Care Group

17% received IV iron!
12% had 1 infusion
4% had 2 infusions
1% had 3 or more infusions
Median F/U 2.7yrs

2% withdrew consent for F/U
1% lost to follow-up

These are extremely low percentages especially given the pandemic, so big credit to researchers for this πŸ‘πŸ½

COVID-19 & national lockdowns across πŸ‡¬πŸ‡§ affected trial, as many couldn't attend in person for IV iron
Endpoint

PEP - composite of CV death & all HF hospitalizations

Multiple secondary endpoints... Image
Authors explain that due to impact of the COVID-19 pandemic, they had an additional sensitivity analysis incorporated into the trial design, censoring patients 6 months after the 1st national lockdown in the UK (i.e. censored at 30/09/2020) Image
PEP occurred in 336 IV iron cohort vs 411 usual care cohort - 95% CI 0.66 - 1.02, p 0.07

Better QoL score at 4 months but no difference at 20 months - was this due to inadequate topping up of Fe levels due to pandemic??

EQ-5D scores & exercise capacity unchanged between groups
Conclusion

Authors conclude IV iron is good and should be used more widely in HF patients than presently done

Here's the AHA summary slide Image
My thoughts

Well run trial
Pragmatic design
Can't rule out placebo effect on that 4 month QoL score given open label design
⬇️ attendance for F/U visits over time may have been partly due to usual care group having less motivation to attend as know they're not getting treatment?
Financial CoIs

Present in 13/21 authors, combination of speaker fees, consulting fees, research grants & Board member

Fairly standard for modern RCTs, I would suggest
I suspect that a MA of IRONMAN, CONFIRM-HF & AFFIRM-HF may have enough power to show IV iron improves how people feel & may ⬇️ HF hospitalizations also

I really don't think it's a big deal if IV iron doesn't improve prognosis. If it makes you feel better, great!
I do think the paper's conclusion is a little strange, given strictly speaking the trial didn't meet its primary EP

If blaming COVID and thus wishing to emphasize the COVID-19 sensitivity analysis, why not state that unequivocally?
The 4 month QoL benefit was not apparent at 20 months
No improvement in exercise capacity
No improvement in EQ-5D score

Yet HF hospitalizations seem ⬇️. So maybe it helps your internal physiology without massive impact on symptoms? Though CONFIRM HF found symptom benefit ++?
There are on going trials in this field - it may require a meta analysis to prove definitively that routine screening of HF patients for ID with IV replacement is the right thing to do

I'm not a HF expert, so views / comments welcome! 😁
Finally, if you want to read a proper medical journalist write-up of IRONMAN, check this link out by @ShelleyWood2 for @TCTMD!

tctmd.com/news/ironman-m…

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More from @dr_benoy_n_shah

Aug 28
#ESCCongress

Let's get straight to the point about #INVICTUS

The only people not surprised by the results are imagers that do TOEs (TEEs) on these patients! No way VKA was going to lose to NOACs here!πŸ˜‚

A 🧡...

#medtwitter #cardiotwitter #echofirst #epeeps
#ESCCongress
Patients with rheumatic MV disease typically have very different atrial appearances on TOE. No matter how well anticoagulated, there is very often spontaneous echo contrast in the LA

These atria are just different...why?

Who is this?
The answer is Ludwig Aschoff (1866 - 1942), German physician & pathologist

He described what are now known as Aschoff bodies - inflammatory infiltrates in the atrial walls that eventually turn to fibrotic tissue, which contributes to the atrial myopathy we see in these patients
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Aug 27
#ESCCongress
A bit of a deep dive on #REVIVED - not ocean floor deep, but just a little more than below the surface!

A lot has already been discussed today, so I'll try not to be too repetitive
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This was NOT a trial of revasc in highly symptomatic patients or ACS patients. It was designed to answer the Q of whether PCI is beneficial in ischaemic myocardial dysfunction / ischaemic cardiomyopathy
#ESCCongress
These multi-centre RCTs are very hard work for steering committees and PIs, huge congrats to everyone that worked on delivering this trial - well done!
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Mar 12
*POSTERIORLY DIRECTED MITRAL REGURGITATION*

How many causes of posterior MR do you know?

Let's take a look in this mini 🧡

But...no cheating...vote first!

#echofirst #cardiotwitter #MedTwitter @ASE360 @BSEcho @TheBJCA @BJCA_Women_LTFT @global_wic @WessexSpRs
1. Anterior MV prolapse

Probably the first thing that occurs to most people

AMVL prolapse is less common than PMVL prolapse
Here you can see the highly eccentric, posteriorly directed jet of MR
Read 16 tweets
Jan 6
Electronic patient records (EPR) - I've seen some negative tweets recently about how cumbersome they can be...but EPR is here to stay so it's important to get them right

I'm fortunate to work somewhere with the most amazing EPR set-up...check it out!

A brief 🧡...
Our hospital's IT team have built 1 program from which we get all these options:

E-documents (clinic letters, memos etc)
Blood results
X-rays / scans
Drug chart
Request tests (bloods, imaging, micro, everything)
Link to primary care records
Observations (for in-patients)
There's so much more there too..."Outpatients" allows us to see what we have booked for upcoming clinics including procedural clinic lists like stress echo.

EDMS has the scanned records after hospital admissions

There's even a direct link to UpToDate!
Read 8 tweets
Dec 11, 2021
**VALVE CASE OF THE MONTH**
@BrHeartValveSoc

Last case of 2021!

If EVER you needed an example of why not to judge a 3-dimensional structure with 2-dimensional imaging...this it it!

I think you'll like this one...😁

#echofirst #cardiotwitter #MedTwitter
Male, late 60s, underwent biological MVR (29mm) 11 yrs previously for
Severe MR. Has permanent AF & VVIR pacemaker

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This is admission chest x-ray
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Dec 11, 2021
The #NHS and GMC expect doctors to speak up whenever they have concerns regarding patient safety...

Yet 'whistleblowers' (WB) continue to be treated abysmally, almost as if they're the problem - see latest example here

A brief 🧡...

bbc.co.uk/news/uk-englan…
Probably the most famous WB is Stephen Bolsin, the cardiac anaesthetist that was highly concerned by very high mortality rates in paediatric ❀ surgery in Bristol in late 1980s / early 1990s

He had to leave his job & could not find another job in πŸ‡¬πŸ‡§

en.wikipedia.org/wiki/Stephen_B…
So he emigrated to Australia. The entire concept of 'clinical governance' largely originated due to his work and the subsequent Kennedy report
Read 9 tweets

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