Feeds:
Posts
Comments

Posts Tagged ‘primary PCI vs thrombolysis’

“We have a 24/7 cath lab with an open door policy. Our cardiologist arrives at 15 minutes’ notice. Door to balloon time is less than 60-90 minutes”, 

“Great, so, you can always offer a successful treatment for STEMI”

“No, that we can never guarantee.” 

 “Oh, It Is not the answer, I  expected”

“I agree, it sounds disappointing, but. truths are less pleasing. What I am trying to say is, there are a number of factors other than the availability of a grand cath lab and agile and effortless hands, that try to reperfuse the myocardium in distress.  I agree, we do save lives occasionally in a dramatic fashion. Recently we resuscitated an almost dead man with CPR and ECMO-guided PCI. But, most times it turns out to be just a customary ritual that takes us to the legal and therapeutic  endpoint* of STEMI management”

*Both salvage & non-salvage

“I didn’t get you, Can you explain further?

See this curve and try to understand it yourself. (I would say, this is the ultimate curve to understand in the entire field of coronary care)

Can you guess what will be the outcome for C to B, or B to A ?  In the real world, a substantial number of interventions take place at an Invisible point E beyond A  Source: Gersh BJ, Stone GW, White HD, Holmes DR Jr. Pharmacological facilitation of primary percutaneous coronary intervention for acute myocardial infarction: is the slope of the curve the shape of the future? JAMA. 2005;293:979–86

Slippery slopes and edgy Interventions

At what point the patient lands up in the curve & at what point the interventional cardiologist intervenes (or does not intervene) matters the most. 

The gaps between benefit and harm can change in a few strokes of time. The reperfusion tamasha can get more curious if we realize both the slope of the curve & its absolute position are dynamic. It can shift to the right or left with reference to the patient’s Initial medications, MVo2 confounders, the quantum of collateral circulation, myocardial hypoxia threshold,  previous ischemic episodes, conditioning, etc. So, basically, we are reacting to events and trying to rush up things. Don’t worry about all this. Cardiologists have every expertise and equipment to tackle untoward events.

STEMI is not always myocardium under fire

Finally, and most importantly STEMI, though a cardiac emergency. all should not be equated with the house(myocardium) on fire analogy. It can also be a spontaneously aborting, settling, or evolving, self-extinguished controlled fire, and the myocardium may take it easy. All that it requires is some deep ischemic slumber. Don’t try to poke it with all our violent hardware at one go in the name of salvaging. What is required is proper CCU care to take care of potential arrhythmia, angina, or failure. One may create more damage if trying to dowse non-existing flames furiously, which expresses in the form of reperfusion Injury and no-reflow to the myocardium. (Which might have reperfused at leisure without experiencing the injury.)

It is worth pondering over this question.

Why does even an apparently well-timed primary PCI of IRA leave behind a significant LV dysfunction or even a  scar? This is a clear case of “successful PCI failed reperfusion syndrome”. It is better cardiology community defines successful primary PCI with reference to predischarge  LV function, not on the IRA patency and mystery endpoint called TIMI 3 flow.

Final message

Cath lab doors that are open 24/7,  with experienced cardiologists may matter little if we are double-blinded against multiple scientific and non-scientific factors that are visible as well as invisible. 

Counterpoint

How good is late PCI? Are you not aware benefits of the open artery hypothesis?

You need to learn a lot man, before posting such posts.

Read Full Post »

Background STEMI knowledge check : Evidence-based Ignorance

I think , It is unfortunate, In the management of STEMI , the two popular strategies of myocardial reperfusion is made to fight with each other as if they are perennial enemies for over two decades. Suddenly, someone with a rare coronary insight thought, why fight each other , they can have a friendly hug and work together. That brought the concept of pharmco -Invasive approach or strategy(PIA) backed up by STREAM, FAST-MI, and TRANSFER AMI studies.Yes, it appears to work well and devoid of all the early adverse events of pPCI. (Much to the dismay of ardent fans of Primary PCI )

*May I add one more shocker of a fact . Deep subset data mining from the above trials did show very early lysis may even act as a perfect stand-alone therapy negating the need for acutely one pharmaco Invasive PCI altogether.(Which was never published) Don’t get alarmed the concept is nothing but , the good old lysis , followed by leisure & elective Ischemia guided PCI in all uncomplicated STEMI.

Now coming to the FAQ in Cardiology Boards: Why is the time window for PIA is 3 to 24 hrs ?

The simple answer for an uncomplicated fellow is “published studies have shown benefit only in this time window. If you do PCI early (,<3h) after lysis paradoxically both bleeding and pro-thrombotic complication over the stented lesions are more common. The upper limit is 24 hrs , since by that time we lose all the potential for myocardial salvage”

End-

Larger version of the answer

(Advanced readers who are willing to get confused, may read further)

1. Lysis and immediate PCI doesn’t go well at least in trial world. (FINESSE study, by Ellis et all NEJM 2008) Though cardiologists tend to blame lysis (effect of) to Interfere with their hand skills, it can very well be the opposite. The PCI undo the true benefit of lysis. For cardiologists to accrue maximum benefit in the early time window, they need to be too fast, in the process, they accelerate and fuse adverse events of both modalities.

2. The time window 3 to 24h could simply be evidence-based empiricism. In the major STREAM trial, invasive limb happened between 6 and 16 hours only. We stretched both in the top and bottom in the time clock and made it 3 to 24 hours with other trial data.

3. One realistic reason could be this. It requires a minimum of three hours for a patient to reach a place of coronary Invasion after lysis. So one may argue its time allowance for transport .It comes in handy at times.

4 .If the patient reaches earlier, we need to delay the PCI intentionally to please the evidence based medicine. Mind you, every minute delay increases the chance of no reflow as the microvasculature goes for edematous and porous death.

5. Please note, the time window for pharmaco Invasive strategy will go for a tail spin if the initial lysis is failed. Here, we have to rush I guess. Mind you, In this situation, the evidence based blaming that early PCI increases the adverse events immediately following lysis goes topsy turvy . This is where , we should recall old studies of routine rescue PCI (without clinical criteria) rarely succeeded to correct failed thrombolysis (SWIFT trial)

6.Now, why not PCI after 24hrs? The game can be played reversed if you document ongoing Ischemia in IRA or Non IRA, one may do it . The problem arises when the flawed thought process of a cardiologist could legally justify all PCI beyond 24 h /class 3 Indication after STEMI.The argument goes like this. I think this patient has residual silent Ischemia in- spite of severe LV dysfunction (Suspicion is the justification, to which ,unfortunately no one can dispute) It only suggests open artery hypothesis is still trying to raise from the graveyard more than a decade after its near burial.

Final message

To all those energetic, evidence-based cardiac physicians, we all know coronary care is all about time. In fact, we need to be blessed much more than a sense of time. There is something called medically( or spontaneously )stabilized ACS.  Please realise , “timely and safe intervention” for your patients could simply mean either playing the time button slow/ fast / slow or fast forward / pause or simply shutdown the cath lab, reach home early and enjoy some music or movie in your favorite streaming player.

Reference

1.Ellis SG, Tendera M, De Belder MA, FINESSE Investigators Facilitated PCI in patients with ST-elevation myocardial infarction. N Engl J Med. 2008;358(21):2205–2217. [PubMed]

2. Armstrong PW, Gershlick AH, Goldstein STREAM Investigative Team Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013;368(15):1379–1387. [PubMed]

3. Danchin N, Puymirat E, Steg PG, T, on behalf of the FAST-MI 2005 investigators Five-year survival in patients with ST-segment-elevation myocardial infarction according to modalities of reperfusion therapy: the French Registry on Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) 2005 Circulation. 2014;129(16):1629–1636. [PubMed]

4. Cantor WJ, Fitchett D, Borgundvaag B, TRANSFER-AMI Trial Investigators Routine early angioplasty after fibrinolysis for acute myocardial infarction. N Engl J Med. 2009;360(26):2705–2718.. [PubMed]
5.. Bonnefoy E, Steg PG, Boutitie F, , CAPTIM Investigators Comparison of primary angioplasty and pre-hospital fibrinolysis in acute myocardial infarction (CAPTIM) trial: a 5-year follow-up. Eur Heart J. 2009;30(13):1598–1606. . [PubMed]

Read Full Post »

Primary PCI (pPCI) is a  glorious revascularization strategy for STEMI practiced for over 2 decades  but still has not proved its perceived mettle convincingly as a large population based strategy. In the mean time, the utility value  of  thrombolysis  was systematically  (Intentionally too! )  downgraded in the minds of both academic and public mind.
Truth can’t be buried for long. Series of revelations are coming up restoring the superiority of early thrombolysis over pPCI even in PCI capable centers.
In 2013, the high Impact STREAM trial argued  for pharmacoinvasive approach within 3 hrs as it was at equipoise with a pPCI. Now, EARLY -MYO  from China vouch  for pharmaco- Invasive approach  till 6 hours. (Just published in Circulation September 2017 )
 
 I think we need to wait for some more time , for another prevailing  falsehood that need to be busted ,(Looking  out for some straight thinking new generation cardiologist to do it !)
What is that ?
Many of us have misunderstood(rather made to !)  that pharmaco Invasive has a defined therapeutic endpoint ie taming  & stenting the IRA . This is absolute ignorance  happening even in state of the art centres ,ironically this beleaguered concept is  backed by peer-reviewed papers from premier journals. The fact of the matter is , If thrombolysis is stunningly successful (Which at the least happens in 50 % ) one can stop with that , it’s also a therapeutic endpoint at least for time being .
Is coronary angiogram a baseline test like ECG ?
That’s what current cardiologists with cutting edge knowledge  seem to believe !  Do you agree ! I am sure I’m not !
 Patients with STEMI who had successful thrombolysis who had an  apparently uncomplicated course (Assessed by strict clinical ECG, ECHO criteria) need not go for coronary angiogram in the immediate future.In fact some good guidelines strongly argue for it and call it as Ischemia driven PCI ! but very few seem to respect that concept.)This will not only contain the cost and ensure the vast majority of Inappropriate (  scientific quackery) coronary plumping activity in human race.
Searching for an elusive data ! Can some one help ?
I have been searching for data , from all those major pharmaco invasive studies (Which is not being reported /shared or analysed )
How many  patients in the “success cohort” after thrombolysis  who subsequently land up with urgent PCI related complications when trying to stent an already reperfused IRA or while tackling  coexisting Innocent or non-innocent non IRA lesions ?
* Complications and adverse events  may be acceptable in patients who had failed thrombolysis or who are  unstable  but even minor adverse events are forbidden in patient with a truly successful and asymptomatic patient.
Final message
So called scientific facts have very short half life !  for the simple reason they are let loose in human domain prematurely !
Reference 

Read Full Post »


Professional competence is defined as doing things, always in the Interest of patients. It’s generally believed small hospitals are not competent enough to treat cardiac emergencies . . .Do you agree with that ? No, Its largely a myth . Do you know there is a absolute lack of proficiency threatening to plague our country’s coronary care system. ? It’s the professional Incompetence by the space age, star hospitals (mis)managed by masters of the noble business. None (am I right ?) of this hospitals either monitor or publish the outcome of their treatment.

Backed by pseudo scientific data , amplified by unrealistic expectations of ill Informed patients , some hospitals are avoiding Initial emergency treatment of acute MI , instead they waste time ( load DAPT ofcourse !) in securing the finance for the costly Invasive procedures or refer them out of their premises if they can’t afford for it.In the ensuing emotional and financial melee many of the ill-fated patients lose vital time window of thrombolysis as well ! and carry risk of fatality or damaged myocardium.

Every stake holder in the current coronary care system simply assume the enforced modality must be far superior because they administer the most modern and costly treatment suggested by few high intensity cared clinical trials originating from west. The wisemen who run the corporate hospitals never realise medical competence and outcome is not entirely defined by science. Their primitive cognition wouldn’t allow to think beyond business equations either.

Please believe me, time and again, I have witnessed patients reaching Government hospitals after being shunned away by big (Some times even medium sized ) hospitals who boast themself only as PCI enabled care. Even if they want to lyse they stock only the Tenekteplace .

I think tragedy is a lesser word to describe the scenario , where a distressed family is trying to arrange for a Rs30,000 shot of Tenekteplace when thirty times cheaper still equally efficacious (Rs 1000 Streptokinase) is concealed from their visibility .The Govt should urgently look into instances of large private hospitals avoiding Govt insurance scheme patients even in cardiac emergencies ! To label our poor patients as unaffordable ones is a outright misnomer, rather its the rich hospitals that are “not affordable” to lose profit and treat our countrymen , in a cost effective manner is the reality !

Who is Poor ? You decide.

Two forbidden things in coronary care

1.Cajoling and manoeuvring a distressed family for a primary PCI as a routine treatment hyping its beneficial effect and underplaying the true advantages of thrombolysis in largely technical jargons is the current norm in most coronary care units.

2.Another issue is , after confused confabulations with the duty medical officer, if a rare patient family choose the option of thrombolysis , comes the next googly*. Many noble minded hospitals do not stock the low-cost and equally efficacious thrombolytic agent and offering only the costly option to the anxious families when the myocardium is on fire.

Hospitals that practice these two coronary protocols need to be shamed and labeled as “Coronary Incompetent ” In spite of having 24/7 cath labs. (Realise , they are just like any remote rural hospitals , at least the later can’t be faulted as they don’t withhold a reperfusion strategy !)

Final message

I think , mindless proliferation of cath lab based cardiac care , which follow this theme , ie “Thrombolysis incapable but PCI capable “ are biggest threat to coronary care in our country ! For the best coronary care for any country ,what we need is efficient prehospital thrombolysis team .We have conveniently forgotten the great study of CAPTIM wherein the ambulance drivers replicated the same effect of primary PCI performed by highly trained cardiologists in modern labs.

In India, primary health centers which is within few km reach of entire population can be designated as static ambulance equivalents with basic resuscitation facility . If a multipurpose health worker can be trained to lyse, with remote supervision that will accomplish 90 % of what the cathlab guys can achieve ! Selective shifting is suffice.

Postamble : Ofcourse, not doing pPCI for high risk or complicated STEMI is unscientific and we need to have proper consenting and referring frame-work for such patients.

Counter point : One of my colleagues asked me ? Why do I enjoy attacking the established scientific practices ? May be I have a problem , yes, but I think in a true medical democracy we have right to debate anything , absolute truth is a ongoing journey !

*Googly: An unplayable ball delivered to a batsman in the game of cricket.

Read Full Post »

Time is muscle. This quote  became  sort of ” cardiology sermon”  in the last  few decades .Cardiologist think  they stand  on a 100 meters sprint track once a patient with STEMI arrives .This is indeed true ,  if we  agree  time is  muscle and  our urge is to reduce the door to balloon time .Please  remember ,  this rush matters  much ,  only if the patient comes through very early  when the muscle is really getting damaged . (No issues  . . . even if the fire engine comes in  slow motion if the  house is burnt fully !)

Time is muscle agreed  . . .  but  muscles are  kept alive by  factors other than time  !  So muscles can  defy time if God  is willing !

Time is one of the important components of management of STEMI.  Other things matter too !  Age , baseline co-morbidity ,  underlying extent of CAD, collateral support of IRA territory , and finally  individual variation in hypoxic damage in myocyte is (Rarely  been studied in detail.)

Door  to balloon time for a patient  who lands up within  1 hour window need  to be  much  different from a patient who comes at 10 th hour .The issue is important  because  we use a procedure which requires delicate decision-making ,(IRA-Non IRA issues etc)  the results can be  sub optimal ,  and even be hazardous in low risk STEMI . So , door to balloon time  may be a less  important  component of  time window in a patient who comes after 6 hours .This is the reason  overall outcomes are not changing in a large cohort  of rapidly performed PCI.

The presumed  absolute  relationship  between  “Time  and  muscle”  concept is  always been a suspect . This  is proven by a flawless study from  NEJM .

nejm stemi most important article

http://www.nejm.org/doi/full/10.1056/NEJMoa1208200

This study should infuse more sense to  us ,  time and again, we are  hijacked and sedated by high dose of  pseudo scientific concoction .In fact ,  indiscriminate rapid PCI may not be in  the good interest of  all  patients with STEMI ,  if it is not properly done  .Without realising this fact many developing countries are indulging in extravagance of  costly STEMI programs wasting  the exchequer.

This landmark NEJM  paper convincingly underscores a fact  that  achieving  rapid door to balloon time  is not  going to be the game changer in  conquering  the Global   STEMI  championship  . We have to take the coronary care into the streets  or to their homes as well .This is where the pre-hospital thrombolysis will  emerge in a big way in the future .

A slow and steady thrombolysis beats a fast and furious primary PCI on any given day in all uncomplicated STEMI .This we have proven for over three decades in  one of the India’s largest coronary care unit .( Where is the data man ?  Genuine experience is data . Why  we require , the act of publication to convert an experience into evidence . Often times ,  I  would feel , data is the most unscientific word in medicine . Many Truths  lack evidence , false hoods come with plenty !  For all those  scientific  homo sapiens  , please recall  70 % of ACC/AHA class 1 recommendations are backed by level C evidence ie simple opinion from  perceived experts! )

Final message

A fast and furious primary PCI may not be  the answer in all STEMI population

Thrombolysis  can be  done  with near  zero time delay , it does not require special expertise where an ambulance driver can reperfuse   a myocardium without much fuss and glamor ! He does not have to  split his hair to identify which is the IRA in a complex multivessel STEMI as well ! The streptokinase and TPA will home in  to the target site  smoothly and swiftly .

If indeed ,  time is the major factor in STEMI , we have many other ways to tame  the time . If muscle is more important than time ,  pPCI is  rarely  the answer !

Some India specific  thoughts

Is it not a shame  , we talk about primary PCI  for all  our patients  who do not even get timely Aspirin* after a STEMI! .It is something akin to what we witness every day ,  as our country folks  wield touch screen  Androids  . . . conversing  in open air toilets !

* While the importance of  Aspirin is undermined , It is different story altogether , these patients  get sorbitarate promptly whenever they get chest pain  (mis-placed and  dangerous priority ! )  prescribed by the  roaring  GPs ,  who suffer from discontinuous medical education ,  propelled  by the deeply penetrated 1000 crore oral Nitrate market .

And STEMI workshops are conducted by self-proclaimed experts  every few months in posh  7 star hotels all over India .

Read Full Post »