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Posts Tagged ‘courage study’

In one of my  meetings , I told a small gathering  , that regular exercise can shrink atherosclerotic plaques and regress CAD. I also quoted , a recent  large  study which  has proven this fact convincingly !

I concluded, simple  exercise  and other life style changes,risk factor correction  may convert a 90% lesion to 70 or even 50 % . I stressed the importance of this study and asked my colleagues to avoid misuse of  Angioplasties .

When many  seemed to agree with me , one  angry  Interventional cardiologist questioned me, and  asked  the name of the  study, and in which journal  it came , What was quality of the paper ?

evidence based medicine ebm experince

I told him , It is an Imaginary study done  in my back yard . It never got published in print. You may call it as E-journal* , not exactly though.It is not available in any websites , but located in the  biological servers, and  neuronal circuits as digital imprints in learned brains !

*Journal of experience

You may call it , a scientific  forgery , to quote a non-existent study,

But this study  benefits whole lot of my  patients”.

He was amused , and became agitated !

He told over the mike , “You are making  foolish statement. . . don’t corrupt young minds” !

May be , he is true !

I asked him to be calm and  requested  to listen to another study which I was about  to quote  . . .

He couldn’t sit any more  and rushed  out of the hall !

Final message

We  are ready to believe all those  rubbish stories about a fourth  generation   self disappearing BVS that is  able to scaffold a coronary artery and maintain a MLD by 2.5mm  and TVR by 20 % and prevent near MAZE  at 30 days  by 9 % and improve long term survival  by 6 months at  the cost of 100, 000 Rs  per month  .Only to realise, it may be a farce  . . .  5 years down the lane !

How to cleanse the darkened face of science ?

When falsehoods come with evidence and harm people , Good deeds can  be preached without evidence to save our fellow human beings !

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Coronary  atherosclerosis is the number one killer of mankind. Many would consider it as an  essential  process of aging .Modern  life styles and habits make this appear  very early in life . There is currently an endemic (or even  a pandemic ) of   CAD due to premature  atherosclerosis. We need to recognise CAD is not a  primary heart disease  .It is an irony, heart is an  innocent bystander  to the  biological derangement  of coronary  vascular system  when  it is infested with atherosclerotic plaques .

So , when we  are confronted  with  serious atherosclerotic lesions in a coronary artery   what shall we do ?

We have three options

  1. Take on the enemy in a direct confrontation (Like war on terror ) : This is  some times called as Interventional cardiology .Caution is required as the battle  is within the human coronary artery ,  cross fires and collateral  damage  are unavoidable.

2 .Next  method  is to  find the basic cause  of  terrorism , identify  the perpetuates, facilitators    and try to correct the   root cause of it (CAD ) .This approach  also refered to as medical management  in cardiology community*  . It  aims  at regression of plaque  by statins, and life style modification and preventive cardiology. This modality is most ridiculed and  insulted by the main stream cardiologists.

*Comparable to  bilateral peace talks for a political solution to terror

3. And third option is a  real  surprise !   This  neither  confronts   the lesion   nor does it  address the initiating factors . It   just ignores  the lesion and by pass it with a LIMA /SVG  fly over ,  as if  nothing has happened in this vital high way leaving the culprit scot-free  .This option is  executed by surgeons as  CABG surgery . . . and  for mysterious reasons  this is a  well accepted one .

CABG :Here the atherosclerotic  burden is untouched by surgery . The graft can get diseased  sooner or later , native vessel disease  shall  progress some times encroaching  the ostia of distal graft site . Incidence of acute coronary syndrome following CABG is not greatly reduced for the simple reason we are not doing anything primarily to the inflamed plaques .These issues  are left ,  to be  taken care by the  medical  management .

* This article  does not want to defame these great development in cardiology(PCI/CABG) . They have a  specific role to play. CABG AND PCI remain the only option for critical  lesions with limiting angina .But please remember without  proper  medical management  ( ie Targeting  the perpetuates of  crime )  both  PCI and CABG will be a big sham !

Final  message

Avoiding   the  lesion  or  attacking the lesion  is a  primitive  method to tackle CAD  . Passifying   the lesions  in a slow and gentle manner,   preventing  further progression  or regression  of lesions is the only  “sane” method for combating CAD   . PCI and by pass surgeries  can be termed  as  21st century’s   medical  adventure sports  which  has  limited role ,  in the overall control  of CAD  for the human kind .

And  now  answer this question . . .

Cardiologists attack the lesion and  surgeon avoids the lesion ?  Who is the winner in our fight against CAD  ?

Both of them are  clear losers .The winners are  all those  humble physicians and parmedical workers (or even the responsible lay public ) who  help recognise  the early forms  of  CAD  and  counsel properly to prevent it .

This is  what  Dean Ornish   in 1991  documented in  Lancet  which was never considered scientific   for the simple reason it has no commercial value !

Reference:

http://www.thelancet.it/journals/lancet/article/PII0140-6736(90)92230-F/fulltext

http://en.wikipedia.org/wiki/Dean_Ornish

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Manuals are not only for doctors . There are few heart  maintenance manuals for patients as well.

This one from Philadelphia ,  is worth reading and of-course  following  thereafter  !

 

Some books can be as effective as CABG or PCI .

This  one is definitely in that league  . . .

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Cleveland clinic is a leading centre for cardiac care .Major technological breakthrough occurs from this institute than any other place. Thousands of articles come out every year. Some articles , get global attention and make  a huge impact. These are usually related to a new hi- tech modality like CRT devices or percutaneous aortic valve deployment etc ,etc.

                                                Some articles , which are very important  may not get the due  attention . Journal editorial boards often  have a scorecard called impact factor .That is ,   how  a  journal  is  impacting the practice habits of  medical professionals . Ideally we need to have to grade individual   articles with impact factor .Many articles may not have any significant  impact  however good the impact factor of the journal.

Here is an article,  which excellently depicts the principles of management of ACS.  It was published in 2003 JACC,  by Steven Nissen  from Cleveland,  Ohio .It deserves more attention . Every cardiologist , involved in ACS management should read this, especially the interventionist.

Link to article placed her with courtesey of JACC

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MASS 2  study , the 10 year follow-up results are just out in circulation   september 2010 .

It is a rare study , where “one  to one vs  one” was compared  ie  the effect of  medical,  CABG , and  PCI    in chronic CAD .This was done in a single centre in Brazil,  between 1995 -2000 . It was  followed  up till 2010. Interestingly ,  such a study  may not be possible in the future ,   as  many of us  have  prematurely  glorified  the PCI and CABG over medical therapy . Recruiting  patients   for medical therapy alone is becoming a  difficult  job even in  developing countries.  Even if we recruit , huge cross over is likely  to PCI, CABG for all fancy reasons.

So , in MASS 2 we have a rare treasure on hand . . . Let us give three cheers to those  Brazilians  who did this study ,  and  shall carefully analyse and  interpret the results.

Highlights ( According to my  interpretation)

  • A total of about  600 patients with 200 in each group.
  • The overall death at 10 years  is not greatly different . (Around 25 % )
  • But ,cardiac deaths were distinctly higher by few percentages in pure medical  arm
  • Need for crossover  from medical to surgery and PCI to surgery was significant.

CABG tended  to prevent future MI in this study . This  could be  most significant observation from  this study ,( A revelation in fact ! ).It is against the popular  belief  created by CASS  legacy.

What are  the observed difference  between MASS 2 –  5 year results , which was published in 2004 ,  and  the 10 year follow-up , as  on  2010 ?

At the end of 5 years in 2004 , the differences  among the three groups were not obvious.The benefits of CABG mainly appeared after the 5th year and at 10 years it was significant.

Shortcoming of MASS 2

  • It is a single centre study .Numbers were less (600) .
  • It need to be emphasised    CABG was done  with  pump in all patients  . So the currently prevalent off  pump CABG  may not be really  comparable with reference to outcome.
  • Only   bare metal stents were used in PCI .(If only DES was used  . . . Considering the host of issues for and against DES , it will  be a  wild guess to judge it’s implication .  It could  have  tilted , either in favor or against  the  PCI  limb .)
  • In medical  limb ,  statins were not used in all.  Further , the dose of statins were not aggressive.This makes medical therapy appear less effective.

Intriguing  thoughts

When we say medical   therapy is  being  compared with PCI and surgery , we are actually comparing ,

Medical therapy  alone

Medical  therapy+ PCI

Medical  therapy + CABG .

Every patient  in all three  groups  receive  statin , antiplatelet and beta blocking drugs and so on.  Even though  statistics  would  vouch for  additional  benefit ,  over and above medical therapy  , in a given CABG  individual ,  how much  of the  the  accrued benefit  is contributed by co- administering   medical therapy  .It  is beyond   reasoning even  with all  gimmicks of statistics.

To exactly quantify  the individual benefits and efficiency  of  PCI ,  CABG  and medical therapy  two more  study limbs are necessary .

  • PCI without drugs.
  • CABG without drugs.

Such a study is possible only in a virtual world ! .  Decision  making  in favor of CABG ,  especially   in chronic stable angina ,  will continue , to be  difficult in the absence of refractory angina .This is due to  the modest benefit of CABG ,   that is  expected,  at an additional risk , cost and  expertise.

Please remember, a person can survive  , only  with medical  therapy for > 10 years  but no one can ever live with PCI or CABG  for that period of time without  adjunct drugs  . Guess  which modality   is  going to win the race  against CAD  in the long run  ?

Final message

If  any one  asks  for  conclusion of MASS 2  study ,  don’t ever say  “CABG is superior to  medical therapy” . Please emphasize , “CABG + medical therapy could   be , marginally superior to medical  therapy alone in some of the patients with chronic stable angina. (Each word  in the above statement is  important !) .

So . . . MASS 2 : Is it a  shot in the arm or shot  in the head for CABG ,  we do not know !

http://circ.ahajournals.org/cgi/content/abstract/122/10/949

http://circ.ahajournals.org/cgi/content/full/122/10/949 .This study was done by Zerbini foundation Brazil

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It is a well known fact  ,   CABG and PCI  provides immediate relief  for patients with angina ,  which is refractory to medical therapy. Of course , this happens only if a critical occlusion of  at least one epicardial coronary artery is  opened . It need to be realised ,  angina  due to  microvascular  disease can not be cured by maintaining  epicardial  patency .

While angina  relief is prompt ,  dyspnea is not ! . If we  believe,  opening  up a  coronary artery  in a patient with LV dysfunction will  restore the LV function  ,  it  is grossly mistaken !

Why is it so ?

Angina  relief requires  simple  restoration  of  oxygen supply and correction of local ischemia .  This happens without any issue as the blood  seeps in to the ischemic cells and soothes the ischemic nerve fibres that trigger the pain signals   . While  ,  for LV function to improve , the blood flow has to be converted to mechanical activity in the form of myocyte actin/myosin interaction. For this,   there need to be an intact  cellular contractile mechanism . The myocyte architecture should be appropriate .In post MI ventricles we know there is  zig zag  orientation of myofibrils due to myocyte slippage that interfere with mechanical recruitment . Further , integrity of  extracellular matrix  namely the collagen frame work is also vital . Note ,  angina relief  is not concerned with any of the above .

And now ,  we also realise  dyspnea  in failing ventricles  is vitally  dependent on diastolic function ,  which is also very much  impaired in ischemic DCM .There is little proof for  PCI/CABG  to correct the  molecular   mysteries in  diastolic dysfunction !

Dysfunctional LV means what ? (read the link )

It is a collection of  variety of myocardial tissues . Viz : Fully  necrosed , partially necrosed ,  ischemic viable, non ischemic viable, ischemic non viable, non ischemic non viable , Apart from this patchy necrosis, patchy ischemic, areas are common. Finally , necrosed segments   may  also be perfused normally by  spontaneous reopening of an IRA.

One can imagine the complexity  of events in these segments  once we do the  PCI /CABG . The response  is highly variable and unpredictable. The major concept we  , the physicians  believe or ( to be precise made to believe !) is  the  sanctity  devoted to  the viable myocardium .For  many us ,  it is considered a  holy  exercise  to identify viable myocardium in patients following MI and then revascularise them if  found to have significant viable myocardium (Atleast 20% of infarcted area )

A full 2 decades were lost or (shall  we   say wasted on this futile exercise !) as   we have since  realised most of the cardiologists do not follow this rule .

Now , even a scarred myocardium is revascularised in the hope of recovery .As such , we have reached a stage where  there is no contradiction for not doing a PCI /CABG   with reference to LV dysfunction.

Now every  patient  with post MI  LV dysfunction  is considered to  have  some amount of viable myocardium that is  fit   enough  for revascularization

Are we justified in doing  this ?

Many clinical  trials  have revealed  , the  recovery of LV function  in these segments  has not been consistent at all .

The most surprising discovery is  a viable myocardium need not  be ischemic   .It might get adequate blood supply either  from invisible collaterals or trickle of antegrade flow .  Hence an adequately  perfused myocardial segment can  still be   non contractile . This shatters the myth  that  revascularisation must have a dramatic effect on the recovery of contractility in all viable segments.

The other major finding is  ,  even ischemic   viable   myocardium ( documented by metabolic activities PET etc)  need not regain it’s original contractility  after the ischemia is fully corrected .

*reference for  both the above statements are available from variety of sources including real life experiences .(Type C evidence )

Final message

  • Do a PCI/CABG promptly for patients with refractory angina.
  • Never  advocate PCI/CABG  for  a primary relief of dyspnea .  (Never is a harsh word,  let it be  “use it  with caution ” ! and  the  patient  should be  revealed  the whole facts  about  what we know and what we do not know regarding the complex  hemodyanmic events  in  revascularisation   )

Counter point

If  the above statements are really true ,   How does PCI/CABG   help  relieving  dyspnea  and functional class  what is your answer for thousands of patients  with CAD and ischemic DCM who have greatly benefited from CABG ?

The answer could  be  simple , The revascularization  piggybacks  over the   medical management (which , these patients pursue vigorously)     like  ACEI,  statins, salt restriction, betablockers  , optimal diuretics and tend to hijack the credits from the poor  drugs !

Read a related blog

Revascularisation for ischemic DCM

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Medical profession has  evolved over centuries with humble discoveries by genuine researchers in the past . As we  pursued  science vigorously  , we  looked  for innovations , when innovation  work ( or many times shown to work !) we jump to sky , even as  some of these  innovations fail and crash down  to earth , many times  we continue to be in the clouds . This is the fundamental problem of modern medical science . When  our expectations reached  unrealistic proportions ,   we tend to lose the common sense . Prolonging life and reducing human suffering may be the ultimate aim of the medical  profession , but  If we try to fight the death with science and money without application of mind , our current  life may become  miserable ! Thats what is happening for the majority of the population of this planet . After all ,  death is an essential and final  component of life !

Coming to the issue of CAD ,  in our country , a  rich gets a 4th generation drug eluting stent for a insignificant  asymptomatic PDA lesion , and poor fellow with left main dies without any intervention .This is  fairly acceptable   to this uneven world  , where a rich westerner  dies due to obesity related disease and a  poor African dies to malnutrition .

This article is in   response to  my  recent  experience  when  . . . I advised

Simple life style modification &   few drugs   for a patient with chronic multivessel   CAD  , I was  made to look   ordinary , inferior  and funny   by  many of the current generation cardiologists .

Further , the term optimal medical therapy(OMT)  for chronic stable angina has evoked laughter in one of the interventional cardiology  conferences  I  attended !

It is a sorry state of affairs  for the whole cardiology community , a  genuine scientific  fact , proven by  real life experience  as well,   is  being  ridiculed.

Richard  Conti tells in this excellent editorial in his journal   Clinical cardiology about the issue of medical management of CAD

“Respect in clinical trials”

Chronic stable angina pci vs cabg vs medical courage trial oat trial ethics in cardiology

Click here to reach the article  http://www3.interscience.wiley.com/cgi-bin/fulltext/122512853/PDFSTART

A similar study which  suggested  exercise  could be  better than PCI in the recent 2009 ESC is suffering the same fate !

What if regular exercise were as good as a stent for stable angina?

http://www.theheart.org/article/1000047.do

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