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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
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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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MAIN incl criteria:
LV EF <35%
Extensive CAD (defined by BCIS Jeopardy score)
Viability in at least 4 LV segments subtended by a diseased artery
MAIN excl criteria:
ACS within past 6 weeks
Severe angina
eGFR <25
Note, LMS disease not an exclusion criterion
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Viability could be assessed by DSE, CMR or SPECT, depending on local availability & expertise
70% had CMR, 26% DSE & 4% nuclear
For CMR, viability defined as <25% TEI of LGE, or if 26-50% at local centre's discretion depending on if low-dose DOB then given
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It took *40 centres* 7 years to recruit 700 patients across the UK
Mean age 70yrs
88% male
90% Caucasian
50% prior MI
~18% AF
70% NYHA I - II 2/3 had no angina, remaining 1/3 minimal or non-limiting angina
Mean LV EF 27%
Median follow-up 41 months (3.4 years)
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We are misisng full data regarding the viability testing but also regarding revasc
We know that median number of treated vesssels was 2, that 97% stents were DES, that LMS disease present in 14% & proximal LAD disease in just over 50%
3VD in ~40% and 2VD in ~50%
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We don't know what % stent deployments were guided by IVUS or OCT (or both), what % had FFR/iFR measured (will come back to that) & how coronary anatomy talied with viability tests
That data is all to come, apparently...
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Unplanned revasc was 2.9% in PCI group vs 10.5% in GDMT only group - exact details for why unplanned revasc performed not clear but, looking at this table, it could well have been for the spontaneous MIs?
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Primary EP - all-cause death or HF hospitalization - occurred in 40%
Death occurred in just under 1/3 patients
We should stop & read that again - with best GDMT in 2022, nearly 1 in 3 people with ischaemic CM were dead within 3.4yrs follow-up 😞
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I won't delve into all the 2ndry EPs, it's all there in the paper. And we've discussed unplanned revasc, the one with the most eye-catching KM curve
The study conclusion - that event rates in this population are high, and this is not improved by adding PCI to GDMT
1) I know it is so tempting to compare this trial to STICH but, please, stop it! STICH was so different:
1) CABG, not PCI 2) Yonks ago, pre-ARNI & pre-SGLT2i 3) Viability testing not mandated 4) No CMR in viability sub-study
etc etc
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I have seen that some are critising the authors for 'only' doing viability testing and not mandating ischaemia testing too
Well...that's not straight forward & I don't believe the data support that requirement either
We touched on this issue in our review back in 2013. The data on this are conflicting
Recall the original 'Smart Heart' hypothesis by the late great Shahbuddin Rahimtoola - that the heart tries to protect itself from ischaemia by downregulation & limiting cellular activities...
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So, should we really be surprised that we cannot induce ischaemia, in myocardium that (we believe) is trying to protect itself from ischaemic insults?
Also, if myocardium is dysfunctional at rest but not scar tissue / infarcted, *by definition* it is ischaemic
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This leads on to 'physiologic assessment' of lesion severity - should we expect FFR / iFR measurements in these patients in this setting?
I'm not an IC, but I don't see the role of those measurements here (in severe LVSD)
IMPORTANT CAVEATS
1) This does not apply to ACS patients 2) This does not apply to highly symptomatic patients 3) The results in the GDMT group may be less impressive in healthcare systems where ARNI / SGLT2i / MRA are less widely accessible 4) We don't know full revasc details
1) 'Routine' PCI in patients with ischaemic CM does not improve prognosis at short/mid term follow-up. 10yr follow-up will be good to see 2) Modern GDMT +/- ICD +/- CRT is good but morbidity & mortality are still v high
3) This trial has major implications not just for the HF & IC docs but also the imaging community
What *exactly* is the role of viability testing going forwards?
Here is a table comparing prior studies looking at hibernating myocardium...
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We still often get requests from surgeons for low-dose DSE to prove presence of contractile reserve in patients with poor LV function, pre-CABG or pre-valve surgery
Such long-standing ingrained practices take time to change. I don't think they will change overnight
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But we should think carefully whether these tests are needed and, if so, when?
STICHES showed CABG benefit at 10 years compared to GDMT alone, and that was in a trial that did not select patients based on viability (though most did have viability)
So, lots to think about, I think the result is as expected
Modern GDMT is good, but I would't get too excited with 40% having events and ~1/3 dead after just 3.4 years...that is not great
ANSWER - Prevention!!
Much better to stop people getting ischaemic CM in the 1st place!
Finally, don't miss the excellent write-up of this trial by @michaelTCTMD for @TCTMD here:
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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
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
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 🇬🇧