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Archive for the ‘innovations in cardiology’ Category

BMS, the original stent technology with meticulous metallurgy and design has been silently replaced by the drug eluting stent (DES) for over a decade. DES was introduced to bail out BMS from perceived high rates of  restenosis . It was a fundamental flaw, we failed to give due  weightage to the multiple variables like  operator expertise, lesion morphology, patient factors that determined the restenosis  rate .

There was never a single study done in large scale that compared a well deployed BMS with a poorly deployed BMS/ DES in terms of restenosis rate.This would have clearly quantified the technical component in the  restenosis rate that brought  pseduo -bad name for BMS in early days.

Without applying mind, wrong questions were asked and tested. No body could refute a “novel concept” , when some big names in industry  suggested  we must involve an anti cancer drug to prevent cell growth and neo-vascularisation  and hence restenosis. But , in reality  the technology of DES essentially complicated the metal behavior by adding a drug and drug adhesive agent(Polymer)  to the otherwise inert metal. Further , the , metallurgy  engineers had to restart / reduplicate from the scratch since we had  already well developed stent technology for BMS . The manipulation was  to add a drug to the metal.

The  irony of DES lies in the fact it Intentionally allowed to interfere /damage the endothelial healing and make the extended anti-platelet mandatory.  Still , DES was able to rule the world backed up by hyped data  with   bloated  reduction in restenosis rate. (Now we realise  the true benefits of DES  are nil  or at best marginal or even harmful in certain subsets of ACS .Read NORSTENT Trial linked below  )

Yes DES has a concern , but its not the drug you know !, 

Off late , since the polymer was  assumed as  culprit, variety of new generation stents with disposable /Non durable /Zero poylmer were developed. Still, polymer could not be proven as true culprit , some have started blaming  the drug again. Recently, It led to one famed DES based on Paclitaxel (which has a pride of place in the Land mark SYNTAX  study ) exited the human domain  with disgrace . (I wonder can  we conclude then SYNTAX study is also become invalid !)

This study done with over 9000 patients  concluded  like this  . . .

The DES industry was (is) so powerful it could easily shrug  the challenge of truth that came out briefly  in early 2000s when DES got hit with increased  acute complications.

Now, in 2016 NORSTENT study again showed us BMS is as good as DES in all walks of CAD.  Let us see what happens , still  its very unlikely mature cardiologists do not trust BMS.

*I have a belief  (Paranoid or not time will tell !) one of the reasons  DES are strongly promoted  is to sustain DAPT market alive and kicking for a long haul !

Scenerio  in India is frightening.

While the developed countries have DES usage rate around 65 % , India leads the world with DES constituting 95% (NIC registry 2017) of all deployed stents.What a way for a poor country  to  tackle CAD , which doesn’t even have prompt prehospital Aspirin for  bulk of their ACS patients, ready to waste  its resources in DES.

India , a country Infested with an unregulated health industry  became the perfect battle  ground for abusing the stents. With direct collusion with the large hospital managements the issue got exploded recently  .The Govt was compelled to come out with urgent restrictions and price control  in the use of stents.

Funny world this. World’s richest economies  are worried about the cost and want to phase out inappropriate therapy whenever possible, its absolute arrogance most of us feel shamed to keep BMS in their cathlab.

Final message

A  good metal based flexible ,trackable , thin struted  BMS should be the default choice for coronary stenting .( We used have one , now it vanished !)It avoids unnecessary prolonged DAPT .Most importantly one BMS costs 25 % of the cost of DES   . . . think of 4 critical proximal LAD lesions of a poor man can be fixed at the cost of one DES , that’s  definite way forward. Govt of India can pass another regulation in this regard. If you think  NORSTENT is NONSENSE  let us atleaset  insist for a large scale Indian  study for BMS /DES and  Cardiological society of India has much work to do !

Future for BMS  . . . looks bright !

While the  superiority  of DES is being increasingly questioned , the concept of surface modified BMS is being tested .This I believe is a face saving way to bring back the BMS in lieu of DES. There is a distinct  possibility of many of the new generation  DES going the BVS way in the near future.

Reference 

1.Hassan AK1, Bergheanu SC, Stijnen T, van der Hoeven .J Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis.Eur Heart 2010 May;31(10):1172-80. 

2.Zhang K1, Liu T, Li JA, Chen JY, Wang J,   Surface modification of implanted cardiovascular metal stents: from antithrombosis and antirestenosis to endothelialization.J Biomed Mater Res A. 2014 Feb;102(2):588-609.

3. https://www.pcronline.com/eurointervention/114th_issue/volume-12/number-17/350/ultra-hydrophilic-stent-platforms-promote-early-vascular-healing-and-minimise-late-tissue-response-a-potential-alternative-to-second-generation-drug-eluting-stents.

4.Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease NORSTENT Investigators N Engl J Med 2016; 375:1242-1252

Post-ample : Only For non believers  ( who think this article is near rubbish ) 

I am  very much  convinced DES should be superior  for the simple reason it elutes a drug and the whole world believes it works !

Do you know, what these drugs do, and what they are expected to do ! In this elegant study  by Hassan AKEur Heart J. 2010 May;31(10):1172-80.  Its proven with IVUS , DES is many fold likely to cause late stent apposition than BMS.( Thus carrying the risk long term )  Reason is simple , patchy and incomplete endothelisation on the luminal side and pathological metal vessel wall interface  in abluminal promoting late mal-apposition.

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PCI and coronary stents are revolutionary concepts , still , they may not be  great life saving devices  . . . though the collective cardiology wisdom may seem to suggest so !

stents-india

The ideal way to describe a stent could be “Its a metal coil , if inserted properly in certain population of severely obstructive forms coronary artery disease may save some lives in acute situations  or give relief to pain in non acute situations”

*While the true benefits for the patient population is unsure . . . it’s absolutely certain stents  confer highest  quality of life to the  manufacturers and their chain of associates including the Noble professionals !

sir-william-osler

I wonder , what would be his comment about ubiquitous stents that rule the current era !

Learnt cardiologist’s  will know the true life saving potential of these stents (In the way its been currently used ) Their conscience will also tell how Inappropriate and Indiscriminate usage of stents has possibly injured or consumed  more human lives , that may even beat the number of lives saved .(Oh, Its a wild, rude statement  friend!)

I sincerely believe the move by Government of India to control the stent price ( to enable all our countrymen to get it)  . . . as if  “stents are the only staple diet” for heart patients is ill-founded and dangerous .

What the Government may not be aware of  is  . . .This 45000 crore omnipresent stent  industry is playing havoc in the life of patients not only financially  but also biologically to harm their blood vessels.

It is near foolish to tackle the scourge of human beings -Atherosclerosis,   a diffuse medical disease with a lesion specific intervention .This is especially true when we want to tackle it in population based approach . Yes, some super rich and elite  get sophisticated stents thinking that they are privileged .Please understand  rich tend to suffer more  with technology. Often  times non affordability is also a bliss for the poor .(You can’t write any rubbish man !)

Who will tell this to our  policy makers ?

Never ape the private sector health care , states must have different priorities.There are Infinite number of studies that  very clearly reveal medical management and life style modification is the sure and successful way to tackle CAD.(I think I need not dwell into this as evidence is explicit .)

Meanwhile, let me give one example of  the futility of innovation and perils of premature release of half baked science .While one section of Industry is coming out with stents made up of exotic new metals , simultaneously other group is innovating and experimenting the exactly opposite , how to get rid of the metal ie bioreabsorable stents. Mind you, one of the latest generation stents was severely reprimanded in a Landmark trial ABSORB 2 and 3. Its a comical irony some of the hospitals and cardiologists  feel bad  to miss this red flagged stent that are taken out of their cath lab because of price cap. ( A pat for the Govt for this !)

Its a multi billion dollar Industry (Note : there is no pardon for Indian companies to exploit either !) trying to disseminate a commercially motivated concept intelligently including the stake holder Government in their loop. The move to liberalise stent usage is  most unfortunate thing  as the Govt has  inadvertently increased the risk of abuse .Let the new age Indian not be proud  about “Stent for all ” movement since the  Govt will ultimately  have to shell  out for this imperfect therapeutics through public insurance .

Final message 

Though capping the price of the stent by Government  do carry  some sense  . . . ultimately      I feel its a trap . It’s akin to let loose a dubious  modality in public domain within easy reach . Already the companies want to increase per capita metal consumption. That process will only get accelerated now.In a country where bulk of the ACS patients not even get prehospital Aspirin, we talk about primary PCI for all.It is a shocking medical economic hijack played in day light by a  new generation thrombolytic called TNK -TPA is able to jack up the cost of coronary care with  marginal benefits based on dubious off shore  studies. I guess , very shortly the thrombolytic  warrior Streptokinase is likely to be declared as  endangered  species and perilious  for STEMI patients.If Govt really wants  to tackle population based  emergency cardiac care they should first upgrade country wide taluk or municipal level  hospital with 24 h coronary care facility with trained doctors who can save more lives than the combined efforts of socially concerned  corporate care takers.

Some one should tell the Govt, cath labs would never come into the scheme of things for mangaing ACS in bulk of our country men.The Law makers and the corridors of power should be  “forced  to realise”  there is an urgent &  broader issue to be addressed.Its not only in cardiology but in all walks of health delivery system. How to prevent “contamination of  medical science by pseudo cost effective scientific interventions fueled by corporate greed ? They should start  sensitizing the young medical professionals in medical schools that will help the Noble profession remain Noble !

Postample

Its heartening to note Govt of India  is Indeed taking some harsh steps to make drugs and devices affordable in a fair manner .The new authority National pharmaceutical pricing authority (http://nppaindia.nic.in/ ) has clear targets and are in hot pursuit towards righteousness in health care. Still, they have to be very watchful and work in tandem with medical council of India  since  commerce masquerades as science ,  price control alone is not a solution and there needs to be body regulating the true Indications as well .

Visit the site for more Info

http://nppaindia.nic.in/

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Artificial pacemaker is one of the major discoveries in cardiology that has given new lease of life to patients suffering from serious bradycardia and heart blocks . Now, the technology has grown beyond pacing , for delivering shock ,defibrillate , resynchronise failing heart etc. For accomplishing  all these tasks we need electrical power . . . non stop on board !

Though , the energy required for sustaining an electric pacemaker is miniscule (About 40 micro watts) still, the lithium ion battery can last only around  10 years with the available technology.Various alternate sources for power* are being  explored. One great innovation is on the horizon .A new “scientific spark”  came from a totally unexpected  quarter.

 If Automatic Swiss watch can run without a battery  life long ?  Why not a cardiac  pacemaker  ?

 How about harvesting mechanical energy from the heart itself  ? (The ultimate biological bundle of energy ! ) .

The concept was  originally suggested by University of Berne Switzerland , researchers from Stanford has successfully used the cardiac  muscle activity as a dynamo to generate and store minute amount of electricity that can sustain heartbeats in an electro  mechanical coil loop model.

heart-powered-pacemaker

A person’s heartbeat  moves a magnet and generate electricity for a pacemaker

enerharvpromo-1

Trials done on pig’s heart are promising .(Reference 1)

Final message 

The idea may look dramatic , but it works.Hope  it becomes reality in our patients in near future.

Further reading

* Creating gene modified  biological pacemaker cell is .

Sharing this  article from  Via: New Scientist

By Lisa Zyga
Science Blogger
InventorSpot.com

  At first glance, this idea seems somewhat impossible, like using the movement of an engine’s pistons to power a car. However, researchers David Tran and his colleagues from Stanford University explain in a recent patent that the idea is very plausible. For one thing, a heart-powered pacemaker can generate and store more electricity than required to operate, and use the stored energy when needed. Also, a battery could be included in the pacemaker, and power from the heart would extend the life of the battery.

Overall, the researchers hope that the invention could at least double the lifetime of today’s pacemakers. Currently, the batteries in pacemakers can last up to ten years, although they typically last only four to five years. (Originally, batteries lasted for as little as a year.)

The invention also has the potential to reduce the size of the pacemaker by one-half or more. For example, a typical commercial pacemaker with a volume of 16 milliliters may be reduced in overall size to as small as 1-8 milliliters.

An embedded generator could continuously produce power in several ways, such as through electromagnetic induction or the piezoelectric effect (electric energy generated via mechanical stress).

In the Stanford team’s design, the generator is implanted near the heart wall, such as attached to the myocardium or pericardium, which would subject the generator to regular pulsating movements produced by the beating heart.

The generator itself consists of a magnet, a conductor (both micro- or even nano-sized), and electrical leads hooked up to the medical device. Contraction of the heart muscle causes relative motion between the magnet and the conductor (such as a coil of wire). This relative motion between the magnetic and coil induces an electric current in the wire, which is transmitted through the leads to the implanted pacemaker.

Movements produced by the beating heart would have a frequency of between about 0.5 Hz and 2 Hz, which could generate between 40 microwatts and 200 microwatts of power. The pacemaker would only require about 40 microwatts, so the excess power could be stored and used for later use, such as when the heart stops beating.

Besides using the movement generated by the muscular contractions of the heart, other versions of the pacemaker could generate power from heat differentials, physiological pressures, and flows and movements, such as blood flow. And in addition to pacemakers, the researchers suggest that similar systems could be used to power defibrillators, ventricular assist devices, muscle , neurological stimulators, cochlear implants, monitoring devices, and drug pumps.

Reference

http://powerelectronics.com/energy-harvesting/energy-harvesting-poised-eliminate-pacemaker-battery

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