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Yes, Medicine is a funny science ( some don’t agree , Isn’t Art ?) Many of the noble professionals  are silently pursuing their job of saving lives and removing human suffering .Meanwhile, people like this author are needlessly bothered about some Imaginary Issues and write stuff like this one , . . that you are reading now !

Yes, there is an invisible  tectonic shift taking place in the name of  science.The way we practice  medicine currently, it fits in with any of the following descriptions . Divine, Godly,dramatic,miraculous , comical ,cruel or  even outright  brutal ! (I dare not quantify the weightage of each adjectives used above !)

The field of cardiology as I know personally for the past three decades is challenged by  uncontrolled growth (How about proposing 1000 dollar PCSK blocker Evolocumab for a meaningless reduction of few mg of LDL over and above Statin ) Further,the technology goes on to Implode at every corners of wall street ,(Mitra clip for mild MR of DCM ! TAVR for aged Aortic valve )  hijacking  commonsense and cost (where is the effectiveness ?) of every stake holder .

In the process ,the critical  healing power that resides within every biological system is ignored and ridiculed upon .(You become a fool if you say endothelial tissue plasminogen activator and lytic system will take care of a  bulk of the intravascular vascular thrombus if we wait, and  we shall permanently defer an Intervention! Current space aged physicians want to invade every existing (or non existing ) problem with multi pronged military strategy and guess what will happen to the humble  body which becomes the  battle ground.

Coming to the content proper

Sometimes I feel God throws some random truths at an unexpected  time through some extraordinary men ! Here is a most unusual study of its kind from the  Sanctum sanctorum of Medical science , namely  Harvard medical school and Massachusetts  General hospital .I think it was  presented  in ACC Scientific sessions 2018 , Orlando and published in Journal of American heart Association.

Cheers and congratulations to the lead author Dr.Anupam  B Jena* , Physician and professor , Department of health care policy , and Health economist

* A video profile of author is in the reference

There is no surprise a paper with such a title had a huge  media backlash. USA today reacts  . . .

My observations and final message 

The paper from MGH,  Boston  dwells a sensitive area ,of course it has come with a gross conclusion (However,  I feel it has hit the bull’s eye.) Still, for the critics, I want to tell one thing , who can deny the fact ?  the massive evidence base with 100s and thousands of research papers created by cardiology scientific Industry over the decades is largely a damn squib.

(The problem with acquiring this sort of  ready to synthesise knowledge stuff  is, It sits right inside our brain and bonds irreversibly , refuse to leave even if these dubious practices are proven dangerous ultimately !)

It might appear , the only option  to tackle fake science would be through some dramatic ,less than ideal or mediocre research papers (Or even another fake!) As long as final outcome is good for the public don’t bother about methodology  of such studies.(Does it sound in any way I am a supporter of Donald Trump ,! No I am not !)

Reference 

Now have a look at this (a long post ) which I wrote some time  back. Find out whether  these  scribblings of mine seem to have grown some scientific backing now .

A brief Info about  the author of this unusual paper that has put the field of Interventional cardiology into tail spin and fluttering in cross winds !

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One car company  recalls 100s of  thousands of cars for faulty equipment  issues in recent years . It goes on to add , beware , it’s potentially dangerous  . . . please fix it and bring your car at the earliest !

Toyota-Gra

Mean while , scientific medical literature is flooded with dangerous articles, papers and guidelines . . . and  pose serious threat to your patients !

Please search for the junk knowledge and then go on to expose, erase and  ,  . . . and throw it to dustbin ! After all , research is searching for truth , again and again !

Let us welcome a new era , where we shall get alerts about wrong knowledge  withdrawals and reversal ! Let it challenge  the self proclaimed sancto-scientific medical world  and a new medical literature cleansing movement (MLCM) begin in every sub specialty.

One such paper from Yale is linked below .

medical reversal

Finally  . . . the forbidden message !

venkat quotes 2

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Answer 

Though PTMC in the presence of LA clot is an option in low risk clots , my strategy would be the last one ,whenever feasible. Intensive, monitored Heparin /Oral anticoagulants ( Heparin 5000 units tds or qid  or Low molecular weight heparin Enoxaparin  40-60mg twice a day , Tablet Warfarin /Acitrom with an INR of 3 ) will dissolve  LA clot in  30-50% of times.(Our experience).

The percutaneous clot retrieval system is not available as on 2018.Aortic filters are FDA approved during TAVR. (Why not use the same in PTMC ?)  LA Catheter based regional lysis through PFO is can be an option if patient agrees to the risk.

How long to wait for clot dissolution with Heparin /OAC?

Most small clots or intermediate sized clots ((Up to 2 CM ?)  have been dissolved by 3  months. Even large clots gets dissolved at least in few Instances.Please note, this strategy is applicable only with valves that is fit for PTMC. All others are referred for surgery.

How does heparin lyse a clot  ?

Its a miracle to see it happen, though heparin / OAC are  never considered as thrombolytic agents .It happens because  both heparin and OAC tilts the local   endogenous fibrinolytic forces and thrombus melts , dissolves or disappear altogether. (I am waiting for the day , the scientific community to re-label heparin as a thrombolytic agent, Indirectly though !)

Is there a risk of dislodgement of LA clot during heparin /OAC therapy ?

This question shall be addressed to  God ! It all happens if bad luck strikes you and your patient.

Be wise  . . .  and call your surgeon Immediately when you encounter something like this !

Even if the valve is perfectly eligible for PTMC , high risk  mobile clots, history of  embolic episodes , probing and hyper-googling patients , its better to refer for surgery Immediately. Wait and watch game has a definite risk of stroke and it is especially bound to happen if your patient or their family is anxious !

Reference

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In the modern era of cardiology,  PCI has become the single therapeutic modality  that determines the survival of both cardiologists and possibly their patients! The procedure is all about launching  a metal coil inside the coronary artery of a live beating heart.

Post dilatation vs pre dilatation

Millions of diseased and (not much) diseased coronary arteries are serviced (either re/deconstructed ) world-wide on a day-to-day basis.The benefits of the modality is  directly related to the wisdom of treating cardiologist and patient’s luck than the original severity of the disease. However, with greatly improved coronary  metallurgy , well assisted by drug coating technology and antiplatelet Industry , cardiac physicians believe they have reached the zenith of this procedure.

But the truth is , PCI still has many lingering issues regarding safety , efficacy and cost effectiveness.Early hazard in the form of acute stent thrombosis and sudden death is  a  reality. Blaming it on patients and their lesions ( condition of blood , gene included) , metal behavior is easy , but, wrong selection (Ignoring the option of CABG) and technical inadequacy of the procedure in the setting of complex  vessel wall disease (Hard calcium , deep tunnels , fissures , dead spaces ) is a major cause for concern.

Some personal thoughts about Post dilatation 

Lesion preparation , pre/per-dilatation /POTS , etc by itself  a big topic (which is not discussed here) Post dilatation after direct stenting is much more vital concept that determines not only the immediate but also the , Intermediate and long-term outcome.

Is routine post dilatation harmful ? or beneficial ?

This is the most tough question to answer . The answer is both Yes and No !  While it was thought useful and mandatory by some , the oppositeis also being adviced few  (CCL 2003 POSTIT trial)

What balloon pressure one should post dilate ? At what compliance ?  What is the Inflation time ? 

It’s akin to asking a musician  how to play a piano with fingers or guitar with various strings !

The effect of balloon pressures in the long term outcome. note both low and high pressure dilatation ( blue and orange worms ) hike the risk of restenosis. Too gentle is as dangerous as too harsh making post dilatation a secret and unique art.

 

Physics of post-dilatation  . . . again more questions !

  • Is there a role for compliant balloons ?
  • Does the compliance of balloon gets altered with hard lesions?
  • Is regional compliance matters ?
  • Can balloon exert same radial pressure all 360 degrees ?

It’s very likely, the moment balloon encounters an area of resistance it tends to avoid that area and would love to drag on to the area of least resistance and this is often diagonally opposite  zone of hard lesions ( if that segment  is free from hardness).Then , it  will face more stress and likely to bear the brunt of the force risking endothelial disruption . In other words , concentric hard lesions are more amenable for dilatation than patchy hard segments. While the physical forces vary in a stented vs non stented segment , the principle of dynamic forces on static tissue masses  with Intervening metal is too complex. (Mind you , we are not discussing  entirely different  issue , ie  thrombus laded ACS lesion , where displacement and pinching of of inter-strut thrombus into distal circualtion would cause no reflow!)

Impact of newer hardware

*Ablation catheters either rotational or Orbital can help , but must be done prior to stenting .Unfortunately , the hardness of a lesion is often realised  only after stenting

Is selective high pressure inflations over a particular struts possible ?

As of now , it would be challenging ,( if not outright impossible) .

Let us realise with all our intellect, complex PCI as a whole is taking an uncalculated risk  and leave the rest to GOD and DAPT !

Reference article 

In an elegant study of more than 90000 PCIs from Sweden and  Holland (Ref : Fröbert O, PLoS ONE. 2013 ) found routine post-dilatation pushes the harm curve little more than benefit.  The was more with both low and very high pressures .

The outcome of post-dilatation  in 900,00 PCIs 

 

Estimated cumulative event rates of stent thrombosis (Panel A) Restenosis (Panel B ) Cumulative death (Panel C) in relation to post-dilatation .Note the height of coronary Irony, Post dilatation Increase stent thrombosis and restenosis but saves life too !

 

The stunning truth revealed in this study was , early deaths were more common if  post dilatation was not done ! (Panel C in above figure) 

Role of Imaging in the decision-making prior to  Post dilatation

IVUS, OCT has been extensively used in recent times to diagnose suboptimal deployment and to asses lesion morphology.Though they are expected to improve the quality of angioplasty and hence the  outcome , the real world scenario is not really confirming our expectations.

This is because , eagle-eyed HD  imaging throws  more questions than answers in many and it converts coronary artery into a confused Pandora’s box . In fact these Imaging modalities has created fresh confusions , definitions and guidelines for malapposition under and over expansion , strut fracture, plaque prolapse, internal elastic laminar stress.( Still , I am not able eo understand  whats malapposition  vs  under deployed stent from a practical , pateint point of view !)

Is the Self expanding  stent is the answer ?

The conundrum of post dilatation might be cracked if the built-in radial force of self expanding stents is optimally utilised .This could be useful in some  tricky lesions when the vessel goes for progressive Glagovian  remodeling post PCI. The self expanding stent because of the stored potential energy keep hugging the vessel wall as it expands centrifugally.

Final Message

Post dilatation is neither a mandatory nor a sacred  protocol in cath lab. However , it would seem bulk of PCI’s still will require it . Its done judiciously with reference to   clinical setting, (ACS vs CCS) , type and location of lesion , stent characteristics etc .Most Importantly , the experience of the cardiologists counts ,and he or she will decide when, where, how much of post dilatation is required (or not required) .

Please remember , PCI as a whole (more so the Pre/ Post dilatation !)  is an art by itself. It’s never learnt in text books or even  watching  live work shops. Every young Cardiologists are enouraged to master the art of PCI ,  with a huge caveat . Always ensure  patient’s  Interest are placed first in every step forward. If you are not clear in comphrehending  “What is meant by true  patient’s Interest ? never Indulge in the procedure or call your mentor , if you have one !

Reference

1.Brodie BR1, Cooper C, Jones MCatheter Cardiovasc Interv. 2003 Jun;59(2):184-92. Is adjunctive balloon postdilatation necessary after coronary stent deployment? Final results from the POSTIT trial. Postdilatation Clinical Compartative Study (POSTIT) Investigators.

2.Fröbert O, Sarno G, James SK, Saleh N, Lagerqvist B. Effect of Stent Inflation Pressure and Post-Dilatation on the Outcome of Coronary Artery Intervention. A Report of More than 90 000 Stent Implantations. Agostoni P, ed. PLoS ONE. 2013;8(2):e56348. doi:10.1371/journal.pone.005634

3.Zhang Z-J, Marroquin OC, Stone RA, et al. Differential effects of post-dilation after stent deployment in patients presenting with and without acute myocardial infarction. American heart journal. 2010;160(5):979-986.e1. doi:10.1016/j.ahj.2010.07.007.

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Cardiologists at confused cross roads !

Perils of  limited Intellect & Infinite greed  

When not so appropriately trained cardiologists  do Inappropriate things “use becomes misuse” . . . then, it won’t take much time for science to become total abuse. That’s what happened with the murky world of coronary stents .No surprise, it’s time to firefight the healers instead of the disease !

Now ,Comes the ORBITA study . Yes , it looks like a God sent path breaking trial that spits some harsh truths not only in cardiology, but also in behavioral ethics .Let us not work over time and hunt for any non-existing loop holes in ORBITA. Even if it has few, it can be condoned for sure as we have essentially lived out of flawed science  for too long  Injuring many Innocent hearts !

ORBITA pci vs medical mangement drsvenkatesan courage bari2d ethics in stenting auc criteria inappropriate coronary stenting placebo effect of stenting acc aha esc guidelines chronic st

Yes , its enforced premature funeral  times for a wonderful technology !

GIF Image courtesy http://www.tenor.com

Meanwhile, let us pray for a selective resurrection of  stenting in chronic coronary syndromes  and stop behaving like lesser professionals !

Postample

Extremely  sorry . . . to  all those discerning academic folks , who are looking for a true scientific review of ORBITA , please look elsewhere !

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hole in heart asd vsd hole in raod potholes

https://timesofindia.indiatimes.com/india/potholes-claimed-6-lives-a-day-in-india-in-2016/articleshow/61283355.cms

(more…)

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How often you assess the success of Primary PCI with degree of  ST segment regression or resolution ?

I posed this query to a  freshly hatched , Intelligent and energetic cardiologist in an upscale dedicated heart care center.

He said, “No, we don’t .We always go with TIMI flow in IRA .TIMI 3 flow with less than 30% narrowing of IRA is success, that’s it ! He continued ,very often ,we don’t even Insist to take serial ECGs after the procedure .  . . forget about analysing ST segment  !  His body language seemed to suggest,  he didn’t expect such a question (Silly !)  from me , talking about ECG  in this era of hyper Interventionism where we literally live within the coronary artery !

What a grave error in coronary cognition ?  . . . thats commited  day in day out of cath lab  all over the globe !

TIMI flows across IRA lesion tell  more about epicardial patency while the humble ECG  reveals the true myocardial reperfusion.

So ,which will you use for assessment for successful reperfusion ? Ideally both , right !

But , as of 2017 ST segment regression is not considered worthy to  define success of pPCI  by the all powerful world scientific cardiology community .This is unfortunate (Or Intentional ?) we have  ignored  this Inspite periodic research papers showing the importance of the same.  (Link to this land mark Brodie BR AJC 2005)

Do you know , none of the  trials that celebrated the superiority of primary PCI in the last two decades used  ST segment criteria. But then ,we realised much later even TIMI 3 flow can have near zero myocardial perfusion. So ,can we now say all these trials are invalid ?

We also never bothered to include no reflow as a liability during pPCI. We have enough data to say even restored No reflow during pPCI has worrying long-term outcome  as reocclusion and tissue level perfusion is dismal .(Can we call it a pPCI failure equivalent ?) This is because the Cocktail  of anti no-reflow drug  we administer often give us a momentary satisfaction with transient myocardial blushes ! (Only to occlude minutes later as the patient is wheeled out of cath lab .We will never ever know how often this happens  !) This is because , microvascular bed integrity is notoriously unpredictable and defies the conventional salvage time window . We have seen patients with ultrafast pPCI ending up with severe LV dysfunction.

to-succeed-in-life-you-need-two-things-ignorance-and-confidence-quote-1

Final message

If you apply the ST regression criteria by 90* minutes after  pPCI (as we do for lysis ) the true success rate of pPCI will emerge .My prediction would be , if you do that routinely  the hype of perceived superiority of pPCI might go down the drain (At Least in all low risk STEMI ! ) Let us do a large-scale trial comparing ST regression with TIMI flows, blushes ,frame counts etc and rediscover the true face of our beleaguered coronary microcirculatory sense !

*In fact ST regression should occur much early with pPCI than lysis (May be 10 minutes after restoring IRA patency ! )

Post-ample and a Quiz !

If coronary thrombus laden IRA  is the chief culprit in STEMI battle field , Why is that Immediate , routine aspiration of thrombus in the ground zero is counter productive ?

That’s what the sophisticated mega trials of coronary thrombus  TASTE, TOTAL revealed.  I’m looking for an answer !

Reference

 

Counter point (and adding more confusion !)

Surprisingly , a Danish(DANAMI)  study showed  ST regression may not be Important in pPCI .This appears curious , especially when it suggests , ST segment regression didn’t occur because of more complete revascularisation by PCI !

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