MORE EVIDENCE ON " OFF PUMP CABG " FROM BEIJING.

The 12th April 2010 online edition of Circulation, carried a publications by the Chinese ( we are seeing more and more of this now ), from Fu Wai Hospital, led by Prof Shengshou Hu. He compare 6665 CABGs done, 3266 done the " off pump way " and 3399 done the conventional on-pump way. He followed the patients for 4.5 years, and found ( like previous studies ), that the off pump technique tended to have significantly more incomplete re-vascularisation and more CV events following surgery. There were more repeat re-vascularisations, strokes and heart attacks following off-pumps. They did not study the CNS effects as was done by previous investigators like the "ROOBY" study, which showed no difference in CNS outcomes between on-pump and off-pump.
The other findings that is important ( we will see more and more ) is that the outcomes on CABG, both on and off pump, were comparable between the major Chinese centers and the major US or European centers. Looks like the Chinese are beginning to brand themselves with the international community ( in this case, it is the medical field ), as in all other fields. They hold one big advangtage in that their study size tend to be bigger then many other studies.
All in all, it does look like besides the cosmetic advantage, the off-pump CABG technique does not offer much else. Maybe that is why the whole world is still rather unconvinced about it. I suppose, I maybe a little biased on it.
Time will tell.

IS ROSIGLITAZONE SAFE? LOOKS LIKE THE END FOR THE "GLITAZONES ".

Since February, I have been reading all kinds of reports from the US senate, US FDA and many of my cardiology colleagues in USA on the dangers and lack of evidence of dangers of Rosiglitazones. Looks like the "noise" from ACCORD and RECORD just wont go away. The US senate is still investifating and the US FDA is not sure.
The question in point now has to do with the TIDE ( Thiazolidinedione Intervention with Vitamin D evaluation ), an ongoing trial comparing rosiglitazone against pioglitazone, to see which is better and safer, with Vitamin D in both arms by a factorial 2x2 design. Well, this trail had undergone enrollment, approved by FDA in 2009 and also by 227 safety monitoring committee in the many centers participating in the trials. Glaxo Smith Kline and Takeda had poured millions into the study. The question is, should it continue? Should the consent be re-obtained, in the light of concerns by Senate and FDA? or should it be allowed to continue, as it has a follow-up of 5.5yrs and in the Vit D arm, 10 yrs.
Indirectly, it also brings up the issue of whether the FDA and Senate, really think there is a concern. Some of us are not so convince, on the evidence that we have. It is a good drug. I do not use a ot of rosiglitazone, but I have not seen any increase incidence of angina or AMI in the few that I have used. My issue now is whether I should stop all my patients on Rosiglitazone and change them to something else. Fortunately, I do not have any patients on rosiglitazones and insulin ( the said troublesome combination ).
Whatever said and done, I think the days of the "glitazones" are number, not so much because it is a dangerous drug, but also because the unwanted publicity ( rightly or wrongly) have already make it a difficult drug to justify using. Should anything untoward happen ( even nothing related ), one would have great trouble trying to defend oneself, and in this difficult medical practice environment, these are stress that we do not need.
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UPDATES IN DRUG-ELUTING STENTS. THE BIOABSORBABLE DES IS ALMOST READY FOR PRIMETIME.

I have just seen a copy of the presentation given by Dr John Ormiston at the March 2010 ACC annual scientific meeting. He was updating us on his work in bioabsorbable stents, the latest generation.
I first met John, back in the late nineties when we were involved in a interventional conference. He was working in Greenlane Hospital, Auckland as an interventional cardiologist. However, their system in New Zealand is so good that he could also do a lot of research in the laboratory, with engineers and lab animals. He was one of the first to produce a model of what happens at the coronary artery bifurcation when we implant all our stents, the crushed stent model, the coulette stent model, the T stent model and the single stent model. It looks like after the 2006 Barcelona interventional cardiology fiasco when European researchers frigthtened us with the " stent thrombosis " hype, much research has gone into developing the bioabsorbable stent. Many felt that keeping stainless steel in the artery wall was not helpful in the long term and may even be harmful. I had seen some of the earlier work by the late Dr Tamai ( the Tamai bioabsorbable stent ) and also the Biotronik Magnesium bioabsirbable stent. The results were scary. The restenosis rates were worse then bare metal stents.
Therefore, when I saw the presentation of Dr Ormiston in ACC, March 2010, I was very impressed. He showed results, varified by OCT ( Optical Coherence Tomography ). OCT is a very sensitive ( also very costly ) way of studying the inside of the vessel wall. Supposedly better then intra-vascular ultrasound. Dr Ormiston showed his first generation bioabsorbable stent, on the Abbott multi-link platform with the everolimus drug, which at 6 months and two years, was as good as the Taxus and Endeavor stent ( the late loss, I mean ). Not satisfied with this result, he went on to work with a second generation multi-link stent which had closer struts and thinner. Also with the everolimus drug. At 6 months, there was no more stent and the late loss was better. I recond that in 3 years ( at the current pace of development ), we will see a bioabsorbable stent ( probably from Abbott ), CE mark approved for clinical use. This is certainly promising.
My only worry is that, I am not certain if late loss as measured by OCT is the best way to assess the bioabsorbable stent? The there also the question of stent thrombosis, especially late and very late stent thrombosis. Does a bioabsorbable stent solve that issue. I could not get that information from Dr Ormiston's presentation. I rather suspect that we do not know. In the first place, that was the 2006 september, Barcelona issue.
Be that as it may, we can look forward to a small revolution in PCI, the commercial use of the bioabsorbable stent. We can tell our patients that after 6 months, there will not be metal in the artery anymore. Only time will tell, if this is true. And as always, there is the issue of cost. Are we willing to pay two to three times the current DES cost, for a bioabsorbable stent, just to have no more metal in your artery wall, all else being equal.

THE IMPACT OF HEALTH INSURANCE OF HEART ATTACK TREATMENT

I have always felt that healthcare is a social responsibility, to be undertaken by the government. There are many hints lately that the government can no longer pay for comprehensive healthcare for the whole population and that the public must pay additional taxes ( direct or indirect, is yet to be decided ), for a healthcare insurance, almost like the UK-NHS system. I mus say that I am very concern about this move, planned under the 10th Malaysia Plan, healthcare transformation and re-structuring. And below is one of the reasons why.
In the April 14th on-line edition of the Journal of the American Medical Association, Dr Kim Smolderen of the Netherlands, published a study called the " Translational Research Investigating Underlying Disparities in AMI Patients Health Status ( TRUIMPH ) study. He studied 3,721 patients and divided them into 3 groups. Gp1 had full insurance coverage, Gp2 had partial ( inadequate ) insurance coverage and Gp3 had no insurance coverage. He found that in patients with chest pains and resulting heart attacks, there was asignificant delay in seeking treatment, between Gp1 and Gp2, and Gp3., meaning that those with adequate and full insurance coverage, not having to worry about the cost of treatment, will seek treatment earlier and on-time, compared to those with inadequate or no insurance coverage.
This is in fact stating the obvious as hospitalisation in the Netherlands is good but certainly not cheap.
I fear that this will also happen in Malaysia, when those who are in the lower income group will not dare to seek treatment, until it is way too late, if government hospitals no longer exist and all hospitals are run by third party payers, paid by health insurance, as proposed under the 10th Malaysia Plan Healthcare transformation and re-structuring.
At the moment, we have one of the better healthcare system in the world, when we are only spending 7% of our budget expenditure on healthcare ( RM1billion more then what we are alleged to have loss in the Port Klang Free Zone fiasco ). IF only the government will spend 14% of our budget on healthcare expenditure, we will be able to overcome all the current shortages in healthcare delivery, and potentially correct all the shortcomings, and still allo all citizens to get excellent healthcare with having to worry about insurance coverage.
I hope that we citizens will wake up and vote wisely, a government that will provide us with good healthcare, without new taxes.

CUTTING EDGE MEDICAL RESEARCH ; THERMO-TROPHIC ANTI-PLATELET THERAPY

The Arteriosclerosis, Thrombosis and Vascular Biology Society, just had their Annual Scientific Meeting at San Francisco, starting April 10th. 2010. Amongst the many papers presented was a very interesting paper, submitted as a poster presentation, by a group of researchers from Melbourne ( Australia ) and Emory ( Atlanta, Georgia ). This group was lead by Dr Karlheinz Peter of the Baker IDI Heart and Diabetic institute of Melbourne, Australia. Their work involved the use of an anti-platelet drug which was activated by cold and inactivated by heat. Cold meaning a temp of 22oC and heat meaning a temp >37oC. What that would mean is that when used, and the patient is cooled, the drug acts. Since it is an anti-platelet drug, it means that there is an anti-platelet effect preventing thrombus formation at distal sites. After surgery, once the body is heated up to body temperature, the drug is inactivated, and so controls post-op bleeding. What a smart idea.
Nowadays, it is possible to cool the body down, to slow down metabolism, to reduce organ ischemia. Much of this work is pioneered in the field of heart attacks, where cooling the body was a means of preventing heart muscle damage. The people at William Beaumont Hospital are experts in this and I have seen demonstration of this cooling jacket in use.
Also noted is that in open heart surgery, with the use of the heart lung machine, the body can easily be cooled to the desired temperature, at will. If this drug realy works, then I think that it is a significant breakthrough, both for the drug and also for the concept of temperature related drug therapy, or even broader, an intelligient drug therapy fitted to the body conditions.
It really opens up a whole new field.
Obviously much more work needs to be done. For those interested, the researchers are looking for funding, so they announced. Maybe a smart venture capitalist will pick them up, and make plenty of money.
I am only very intrigue that we could use an induced body state to activate and inactivate drugs. What an intelliegient thing to do. This surely is an intelligient drug, should it be proven safe and effective.

ENDOVASCULAR STENT : THE STATUS?

About a month ago, I refered a friend of mine for surgical resection of an aortic aneurysm. Since then I have been pondering whether I had done the right thing. Should he have gone for an endovascular stent.
I must say that my referal was somewhat biased by the fact that EVAR I ( EVAR stands for Endovascular Aneuysm Repair- a study led by Dr Juan Parodi, the inventor of the endovascular stent ), a trial whose results were released in 2009, showed no difference in longterm survival between an endovascular approach and open surgery ( aneurysm resection and grafting ), although there was higher operative risk. I was also aware that the endovascular stents ( first generation stents ) were not so good and there were significant post stenting complications, including geographical miss and migration of stents after implantation, etc. The training program for endovascular interventionist seemed to be somewhat less stringent then that of coronary interventionist. I can only imagine that the latest endovascular stents must be much improved by now. One day I had the opportunity of observing one of thelocal, senior endovascualr interventionist doing a stent graft. His case was just before mine. I could see him struggling and trying to force a stent graft in position. The whole abdomen seemed to shake as he tugged and pulled to position the stent. I told myself that it was all so crude. Vascular interventions was not suppose to be like this. Soon after that, I was sitting as a moderator in another live demo course and the senior Japanese vascular surgeon was trying to insert two stent into the thoracic aorta. It was also so crudely done with pulling and tugging. One always wonder what happens to all the branches coming off the aorta, during all these forceful movements.
I felt that a standard, simple aneurysm resection ( this friend was in the mid fifties with hypertension as the only co-morbidity ) should do very well with a surgical resection. The aneurysm measured 5 cm in diameter and was infra renal.
Lately, we have also seen the release of the EVAR II results, which also showed an increase vascular mortality in the non-intervention group, although the overall all cause mortality were the same as many died from cancers. The EVAR II was a trial to compare the use of the endovascular stent against non-intervention, in a group of patients with aortic aneurysms who were too sick for surgery.
I will have to keep a closer watch on the endovascular work. I do not do them myself as I believe that I am a cardiac interventionist and should not venture to intervene in all organs of the body, although I am quite sure that I can.

RE-VISITING CHOCOLATES AND THE HEART, THE TASTY NUTRICEUTICAL

Many have studied the health effects of food, in particular chocolates, on the heart. This has spun a new field called nutriceuticals. Much have been written about the good effects of chocolates and particularly the cocoa, and how the flavanoids can protect the heart. In fact my favourate saying used to be, "the darker the better, the more bitter the better ". We are eating, for good health.
The 31st March issue of the European Heart Journal carried an article by the German workers, led by Dr Brian Buijsse from the German Institute of Human Nutrition. He and his team analysed the data collected by the " European Prospective Investigation into Cancer ( EPIC )". They were actually looking into dietary patterns and cancer. In their protocol, they have enrolled 19,357 people, age between 35-65yrs, took their blood pressure and diet history, including chocolate consumption and followed them up two yearly, to see how they are. The study started in 1994-1998 with follow up two yearly, the last being 2008.
Looking into the data, Dr Buijsse et al, divided the chocolate eaters into quartiles, the hishest eaters are those consuming 7.5gms / day, and the lowest are those who concern less then 1.5gms/day. Just to put things in perspective, that one small square of chocolate, in your regular bar, is about 6gms. So we are not talking about eating alot of chocolate. Just one small square or slightly more. Lets call it medicinal doses of chocolate.
They found that those who consumed around 7.5gms/ day of chocolate, had a 39% reduction in the risk of strokes and AMI. on sub-analysis, it looked like there was more reduction in strokes then AMI, there also seemed to be a significant reduction in blood pressure. Very interesting. Eating dark chocolates lower BP and strokes and AMI. And it is all due to the flavanoids in the cocoa and chocolate. I think that we have heard all these before. This is just a re-visit, with more new evidence.
What I must also quickly emphasize is that the amount eaten, is not enough to make you gain weight. That is never a good thing. It is medicinal doses. Almost non of us who eat chocolate stop at one small square, I suppose unless it taste so bad. We usually eat the whole bar or more.
Well, for the good of your heart, eat just one small square a day. So the whole bar may last you 2-3 weeks, I suppose.
Certainly, much more research needs to be done. How much can we consume, without significant weight gain and yet with significant BP reduction, which should traslate to strokes and AMI reduction. Looks like this flavanoid stuff in our food is good stuff.
REMEMBER " the darker, the better, the more bitter the better, and now, also in small amounts ".

CIT Beijing 2010, 31st March-3rd April

I have just returned from Beijing after taking part in CIT Beijing 2010. What an exciting event. It was held at the new China National Convention Center ( next to the Olympic Water Cube Stadium ). There were about 4,000 attendees, and so many concurrent sessions that I could only concentrate at the main arena and the large Function Hall B. I learn a few things from the meeting

1. Interventional cardiology has taken off in a big way in China. There was live transmission from all over China, the names of some of the hospital, I have never heard before. Some were essentially military hospitals, but doing good interventional work with many high tech equipment. Last year, they performed about 200,000 interventional procedures from allover China. My colleague Prof Han AiLing, had performed over 2,000 CTOs ( chronic total occlusions, or chronic, totally blocked arteries ). Amazing numbers, but then China is a very big country.
2. That even the best ( the skilled and patient Japanese ), with all the hardware at their disposal ( all stents and guide-wires during this CIT, are bourne by the companies ), failed in all the 90% of the retrograde attempted, but finally finished the case in the good old antegrade fashion. There is still a role for the ante-grade technique, although the retrograde makes for a nice show.
3. I suppose the main theme throughout the congress is probably summed up by Dr Jean Marco ( Toulouse ), on the last day, when he was doing an ostial L Cx, that in all interventional procedure, plan your strategy well, and keep it simple. Simple is the best. If I maybe allowed to add, simple is also probably the cheapest. Each of us must give the best to our patients, but we must also think about the cost, and give cost effective treatment. If we plan our strategy properly, we can.
4. Of course Beijing have grown. New buildings, new flyovers, new highways. But I worry for them. Looks like the infra structure ( hardware ) is there, but the people ( software ) is still in the nineties. The water cube and birdnest stadium looked so nice when you see it from close, but the people are still spitting, still rush for things, still talk loudly on their mobile phones, etc. But I am sure that they will get there eventually.

All in all, it was a good 4 days experience in Beijing.