REPLYING TO STAR. "TESTING THE PATIENT"

I read with great interest and concern, your featured article entitled “ Testing the patient” in Sunday STAR 29^th May 2011. It is written from a purely business angle, with no attempt to understand the medical way to formulate a diagnosis, and also the human body and disease processes. It is so much easier, to know what should have been done when the diagnosis is finally elucidated. But when you are faced with a clinical problem, say fever, you can never know whether it is going to turn out as dengue fever, or malignant fever due to a occult cancerous process. This problem of fever may have to undergo rigorous testing before the diagnosis is made. Once the diagnosis is made, the disease process eradicated, everything is so obvious. In our fraternity, we say that hind sight is always 20 /20.

It is true that as medicine becomes more complex with many new modes of treatment, sometimes clinical test are done, not just for diagnosis but also to stage diseases, so that diseases can be better treated. Different stage of a disease may require a different approach. It is never a one size fits all.

We in the medical fraternity is also very concern about the great number of test that is sometimes done. It is true that to be comprehensive, and to exclude all medical possibilities, sometimes, test to exclude certain conditions that may present unusually, is done. For example, what appears at first as a common headache is rarely due to a brain tumour. But you and I know that brain tumours does cause headache. So brain scans are sometimes done. You may call this approach a defensive approach, or you may call this thoroughness, depending on who you wish to crucify.

What we are more concern about is test instituted routinely by private medical centers, contracturely upon doctors. Meaning that by a doctor’s contract, when he admits a patient, certain test has to be done. So even if the doctors does not order the test ( not necessary ), the staff will do it. Your spokesman from the Private Hospital group should know that, because for many years, he was party to and enforcer for that kind of contract. We are also very concern about routine test for “ Executive screening profile”. It is virtually a licence to charge whatever you wish. We have 25 year old female being subjected to a stress ECG, which to many of us has such a high incidence of false positives that it should never be done routinely.

We are very concern about insurance agents who tell their clients, that they must be admitted to hospital if they wish to claim for certain test, that usually does not require admission, say a stress ECG or a brain scan. This is adding to cost.

We are very much against insurance companies who question a medical judgement to do a test, when they are not qualified to do so. Years ago, insurance companies were staff with staff nurses to vet claims. So we have staff nurses querying doctors as to why they do certain test for certain conditions. One even had the audacity to ask why the neuro-surgeon did the cranial removal of a brain tumour through two separate incisions. Our reply was to get your medical consultant to talk to me, or reject the claim and have the patient sue the insurance. One insurance staff asked me why I did a stress test for a 52 year old lady with a grossly ischemic ECG. That is the standard of many medical insurance companies at the moment.

All these reasons never appear in your article, which seem to imply that doctors are testing patients unnecessarily, adding to cost and discomfort. It is important to note that, 1. Doctors have little to gain when more test are done in private hospital. The hospital does. For example, the doctors fee for stress ECG reporting is RM 100 when the cost of stress ECG is RM 400. Doctor’s professional fees including reporting fees for test are mandated by law. There is nothing to gain for the doctors except for a quicker and better diagnosis, to help the patient get well faster and more completely, with less sequalae. 2. For everything that a doctor does, he is accountable. Doctors have a “face” with the patient. He has to answer all queries and charges. Hospital on the other hand, has “no face”. All complaints are pass on from one station to the next, until the complainant is too fed-up to pursue. Yes, patients can complaint, and a response is forthcoming, but when, and in what form. We call that bureaucratic redtape. 3. Some test are done without the medical consultant’s knowledge, by hospital staff.

What then is the solution? Hospitals must be more accountable. “Routine test” by non-medics ( hospital staff )must stop, by law if necessary. Insurance companies must improve on their insurance models and implementation. More medical professionals must be employed to act as medical consultants to insurance companies, so that when they talk to medics, it makes sense. Doctors of course must be more judicious in their choice and need to do investigations. In an emergency ( life and death situation ), where time is of the essence to save life, he may decide quickly to go ahead, and explain the test to patient / relative later. When lives are not at stake, the doctor must explain all tests to the patient / relatives, especially if test involves cost and risk of procedure. This we are all taught to do. Patients must learn to ask about the purpose and need for a certain test, especially if a test involves cost, pain of procedure and risks. Unless, the patient is satisfy, he / she does not need to agree to the test. Of course, if patient is unhappy, that no satisfactory explanation have been given, he / she always have the recourse of complaining to the medical center ( there is a grievance mechanism in all hospitals ), the ministry of Health or the Malaysian Medical Council. We are quite well regulated. Just like all of you, we do not condone unnecessary testing., but we always know that the word unnecessary is only known when the diagnosis is known and the patient well.Doctors are not perfect, but we do try our best.

It is well for all to remember, no two patients with the same complain are the same. And remember, hind sight 20 / 20, is always better than foresight.

THE ISSUE OF THE POLYPILL. HARM OR HELP?

The medical fraternity as well as the government have realised that diseases are better prevented than cured. This is especially true for chronic lifestyle diseases, like hypertension, diabetes, heart disease and strokes. In particular, cardiac and cardiovascular risk, can be reduced if coronary risk factors can be brought under control, either through aggressive lifestyle modifications ( and few can stomach that ), or through pills. If is very difficult and it would take a very discipline subject ( he is not even a patient, as he is well and not sick ), to work hard to reduce his cardiovascular risk profile. I suppose, if he has seen 1 or 2 of his siblings or relatives fall dead, or undergo CABG or PCI, he may be motivated. The average Johnny around the corner, is unlikely to. They may not mind taking a pill, to reduce their risks. Recently, we are seeing more, and more companies, manufacturing one pill with different drug ingredients, on the basic assumption that should the individual drug prevent CAD, the composite will do better. So now will have the 3 in 1 pill ( aspirin, ACE-I, statin), the 4 in 1 pill ( aspirin, ACE-I, diuretic, and statin ), and I am sure many other combinations, as soon as the patency of the targeted component drug expires. soon we should see combo pills with ARBs, and also atorvastatin.
To emphasize the point, there is an article published in PLoS one, may 25, 2011 online edition, entitled, "An international randomised placebo-controlled trial of a four-component combination pill ("polypill'') in people with raised cardiovascular risk", by the PILL collaborative group. Their 4 in 1 pill includes aspirin ( 75mg), Lisinopril (10mg), hydrochlorthiazide (12.5mg), and simvastatin (20mg). These are people in the moderately high risk group ( about 7.5% CV risk in 5 years by Framingham score ). After 12 weeks of therapy, there was a 10mmHg drop in BP and a 0.8mg/L drop in LDL-C. This may translate to a 60% reduction in CAD and strokes, over 5 years, if the sunjects stay on the drug. However, this came at a cost of almost 50% adverse effects in the treated group.
There comes the question, shall we give assymptomatic subjects a pill, which may contain components that the subject does not need, potentially have a 50% side effect rate, to prevent 6 out of 10 events over 5 years?
This is certainly not how medicine was taught to me. I was taught ( in the good old days ), to identify disease conditions and to treat them with specific therapy, accepting a certain incidence of potential side effects, in the belief that I am able to help him live better and longer. I was not taught to give drugs, where the subjects do not need, because it is in the 4 in 1 pill. Also, how can one size fit all. Some patients may need more than 10 mg of lisinopril or more than 20 mg of simvastatin. aspirin 75 mg is not without its problems in individuals with a history of ulcer disease.
The proponents would argue that by so doing, the polypill will save lives and cutdown healthcare cost in the long term, of course at the risk of some adverse reactions.
What do you think? Would you take a polypill?
There are more and more of these combo pills coming.

MORE GOOD NEWS FOR POST-MENOPAUSAL FEMALE FISH EATERS

We have always known that fish is good for the heart, that fish oils, may reduce triglycerides, and thin the blood and may have anti-inflammatory properties. There is also some evidence to suggest that it may reduce sudden cardiac death.
There is a paper out in the on-line edition of Circulation-Heart Failure led by Dr Rashad J Belin of North Western University, Chicago, entitled "Fish intake and the risk of incident heart failure: The Women's Health Initiative ". This is an observational called the Women Health Initiative - Observational Study ( WHI-OS). They followed up for 10 years, 84,500 post menopausal females aged 50-79 ( mean age 63 years ), with regular Food Frequency Questionaires, and their medical history. Patients with AMIs were excluded.
After 10 years of follow-up, they found that there was a 30% reduction in heart failures in those females who ate broiled or baked fish, more then 5 times a week. The darker the fish, the better. So Mackerel is better then cod. They also found that those who had 1 or more servings of fried fish a week, had a 50% increase in incidence of heart failure. They have adjusted for all the know heart failure con-founders..
I suppose the bottom line is, broiled and baked fish 5 times a week is good to prevent heart failure, and fried fish should only be occasionally taken. I suppose some of you would reason that I will consume fish oil capsules, 1-2 gms a day. Well, the authors noted that broiled and baked fish is not quite the same as fish oil capsules, and they do not think that the results can be translated.
I suppose for us, the message would be take fried fish sparingly, and prefer broiled or baked fish, the deeper the sea and the darker the fish, the better. Of course, I am transposing American results to South East Asians. It would be nice, if we can organise a similar studies here in SE Asia too.

UPDATE ON CCTA ( Coronary Computerised Tomography Angiogram )

This issue of CT angio for screening people for coronary artery disease has been debated for many, many years now. I remember when Dr Beh ( Bangsar Heart Scan ) first bought the EBCT scan ( the earliest single electronic beam scan ) it raised a hue and cry from the cardiac community. Actually, Dr Beh got the idea in the 90's from a visit that the Ministry of Health did to Australia, at that time,. I was told in confidence that the DG of Health then, was very impressed that one can visualise your coronary artery ( virtual angiogram ), without invading the body. When Dr Beh heard the idea, he negotiated with a company called Imatron then, to secure a sole rights to 5 machines, hoping to put up machines all over the country and make plenty of money. Well when his machine came up, the President of the National Heart Association Malaysia at that time, this was in the 90's, wrote a letter to the papers saying that there is no basis for such scans. From then on ( ask Dr Beh over tea, if you care ), the controversy raged on. Later on the 16 slice MSCT ( multi-slice CT scan ) came, and then the 64 slice MSCT. As God would have it, the same president, who wrote to tell the public that there was no good medical evidence for the CCTA, now invest in a 64 slice MSCT machine in town.
And the controversy rages on.
In the May 23rd issue of Arch of Int Medicine, there is an article by Dr John McEvoy of John Hopkins, Baltimore, studying the usefulness of CCTA in assymptomatic, low risk individuals.
The paper is entitled, "Impact of coronary computed tomographic angiography results on patient and physician behavior in a low risk population". They studied 2,000 assymptomatic subjects in the low and intermediate coronary risk group, and followed them up for 18 months. We cannot call them patients as they are not sick. They are like the people walking around the shopping complexes, and bus terminals. The kind, that may be tempted to do a CCTA just for the fun of it, because it is paid by insurance.
Well, what Dr McEvoy found out ( and the study was carried out in South Korea ), was that after 18 months, those with positive CCTA, only one had an event, and that non-fatal too. He concluded that "Weighing the totality of the evidence, we felt that, given the radiation dose, given the contrast, and given the increase in revascularizations and stress tests incurring extra costs, [CCTA screening] seems to be a strategy that is not optimal in patients without symptoms at low to intermediate risk for heart disease,"
In John Hopkins, USA, they use the CCTA in the Emergency department to exclude CAD, not to diagnose it.
Anyway, I am told that there are now 500 slice CCTA scans ( Toshiba ) available. This will be able to scan the whole heart in one heart beat, thereby limiting radiation and the need to beta-block the heart. It is also better for patients with atrial Fibrillation, who need to be scanned. This scan is not yet available in Malaysia. In Malaysia, we have various kinds of scans that uses the helical slice principle and some ( to increase their scan rate ) uses the dual source principle, saying that they are 64 slice with 32 anodes. It is not quite the same.
Anyway, the long and short is, if you are well, and wishes a cardiac check-up, good old cheap stress ECG, may still be the best, all things considered. Know your risk profile. Nice enticing, seductive pictures, does not mean that what you see if what you have.
I am sure that more will be known in the future. After twenty years, we are where we were before.

EUROPEAN CARDIOLOGIST CALLS FOR MORE SAY AND TOUGHER REGULATIONS FOR DEVICE APPROVALS

There is a strong move in Europe, calling for tougher regulations in medical devices. The May 14th issue of the British Medical Journal carried a series of articles on medical device regulations and approvals. They had editorials and commentaries on how regulatory authorities carry our device checks and clinical evidence, and how the process of approval is carried out.
At the same time, the European Cardiac Society, has submitted a consensus report to the European Council of Ministers and the European Parliament, calling for more consultation and a more active role for clinicians in device approvals.
Suffice to say that the at the moment, the European standards lags far behind the American standards. In the field that I know well, the stents and interventional cardiac devices, CE marks are obtain so easily, based only on the fact that there are studies ( sometimes relative small studies ) show that the devices are safe ( not necessarily good, or proven good ). They left it to the individual practitioner to use his discretion, too use or not to use. Sometimes, even this discretion is taken away, when healthcare facility owners, stock certain devices that are CE mark approved, are cheap and ask the practitioners in that institution to use them. In the end, the patient suffers. We must base our approval of devices, in the case of stents, these are permanent implants, on good clinical trial evidence of safety and efficacy.
There is not enough doctor and patients interest in the devices, what they are for, and how they are approved. As long as along the way, the vendor brings some papers, saying that there is CE mark, it is cheap, hospitals and even physicians are tempted to use them, as a lower cost of device may translate to a better profit margin, maybe a cheaper price for procedure, thereby with heaving marketing, claim that they can offer treatment at lower cost. By the time the device fails, it may be months or years down the road, and they cannot be blamed anymore.
I know this well, in the issue of stents and even drug eluting stents ( DES ). Every so often, I get to see ( for a second opinion ), patients who had "generic", me too, DES implanted where the efficacy is unproven The studies on those copy cat stents, involve 80-90 patients, over short period of time ( maybe 12-18 months ), they get CE mark, and bingo, it is touted as, as good as the proven stents. Of course, these "me too" generic stents cost almost half that of proven stents. I tell my patients, it is too good to be true. Cheap things no good, good things no cheap.
What the Europeans, and ourselves as well, is very concerned also, is the "too close" working relationship between the investigating physicians and the industry making the devices. Big name physicians, and in our circle we know who they are, always get involved in talking about, and launching new stents that they have fathered through regulatory authorities, using their "big name". Of course they are handsomely paid. It is well known in our circles that at this meeting, Dr A will teach and tout this DES as the best, and 6 months later, at another interventional meeting, he will teach and tout that the rival is the best. Of course he gets very rich.
I suppose, at the end of the day, like everything else in medicine, doctors and patients must keep abreast with the latest technologies, and also get more involved with the regulatory approval process. Patients must also read more widely and keep abreast. With the internet ( the world is flat ), we have access to a whole wealth of information that 20 years ago, we do not have. As I always tell my patients, what ever I say and discussed with you, you can always double check with " google.com", and read for yourself. We must empower the patient more, so that they are not easily taken in by shylocks.
Back home, it is even worse. We have been hearing of a "Medical Devices Act" for the last 10 years. We are still waiting. At the moment, registration of medical devices are voluntary. At the last count, there are more then 20 DES being used in the country. In USA, there are only 4 FDA approved DES. There are some DES being used whose manufacturing companies, I do not even know. The only thing is, they are cheap, and some physicians use them, so that they are "more affordable". But the total hospital discharge bills is the same as the FDA approved DES. Even if we have a medical devices act, I doubt that we can give our patients the best, based on medical evidence. We will probably end up like where European standards are at the moment. I suppose, it is still a small step forward. Even the FDA standards are not the best, but it is the best that we have. The FDA approval panels are also not beyond reproach.
Anyway, we all hope one day that our patients and our physicians will be better informed on medical devices and take a greater interest in what is being implanted into their body. The devices must be proven safe and effective, with good short term and long term medical evidence.

A BIT MORE NEWS FROM EUROPCR. DOES POLYMER MATTER?

Even as EuroPCR draws to a close, one of the Friday papers merits comments, as it is part of everyday decision making. Dr Stephen Windecker ( University hospital, Berne, Switzerland ), and group, did a meta-analysis of three large DES trials to compare the MACE rates and stent thrombosis rates of stents with bio-erodable polymers and permanent polymers. The trials involved ( all Europeans trials ) were ISAR-Test 3, ISAR-Test 4, and LEADERS. ISAR-Test 3,4 compared their Yukon Choice PC stent with bio-erodable polymer, and the LEADERS of course was using the Biomatrix Flex stent with biolimus A9 and abluminal surface, bio-eorable polymer. There were a total of 2358 patients followed for 3 years at least. They were all compared with the then standard Cypher, which had a permanent polymer with a topcoat ( old technology ). After 3 years, they found that the MACE rates were 18.2% for the bio-erodable group, and 20.1% for the Cypher group. The stent thrombosis rates were 1.2% for the bio-erodable group and 2.1% for the Cypher group, showing that the fact that the polymer erodes away, does lower stent thrombosis and also MACE rates. It is however important to note that the differences are small, 1.2 Vs 2.1 and 18.2 Vs 20.1, so that you would need to treat thousands and millions to see the real difference.
However, one must note that they are actually comparing a first generation DES ( Cypher ), with a second generation DES. You can also call this progress for the better.
I learn 2 points. The observation by the Berne-Rotterdam interventionist in 2006, Barcelona, that there is a problem of late stent thrombosis with the first generation DES is correct, but not as dramatic as they put it out to be. This has somewhat been addressed by inductry with second generation DES which have bio-erodable polymers. However, I also note that the big four stent companies are still bring out stents that have permanent polymers. This puzzles me. I would have thought that all DES now would have bio-erodable polymers, even as we move towards bio-degradable stent?
Incidentally ( not in EuroPCR ), I have just seen a paper on Biotronik's BIO DISOLVE DES. It is only a 6 months result. Looks promising. Obviously more work needs to be done. At least, if results are sustained, it will provide an alternative to the ABSORB DES from Abbott Vascular.

LOWERING CHOLESTEROL WITHOUT REGRESSING PLAQUE - A PROBLEM WITH EZETIMIDE

EuroPCR is still ongoing in Paris. I was looking very hard to see if there are any landmark information coming out of Paris at this time. Looks like the answer is now. Angioplasty and stents have reached a plateau and we are seeing refinements, and a shift to other forms of intervention like Renal Denervation and TAVI. Maybe I should mention two small piece of information out of Paris. Firstly, looking on at Resolute all comers, the diabetic subset did rather well. In fact a statement was made at the presentation that Endeavor resolute may be the stent of choice in Diabetic coronary artery disease. The TLR was in the range of 3-4%. That is very good. The second piece of information, is the launch of the 10,000patient strong Global Leaders, to test the Biomatrix Biolimus A9, abluminal biodegradable polymer coated stent, against another -limus ( unnamed ), which I guess must be Xience V. Lets see what happens in 3-5 years. I fear that after 5 years, the comparision is meaningless ( besides one up manship ), as the clinical issues and target may have moved. Anyway, Biosensors have decided to embark on it, so it is up to them

Anyway, today, I picked up a review of a paper by the group from University of Virginia Health System led by Dr Amy West. They studied a group of about 67 patients with peripheral vascular disease, involving the superficial femoral artery. 16 of the group ( those already on simvastatin and their LDL-C was controlled ) were on simvastatin, another 16 were on Vytorin ( simvastatin + ezetimide, and their LDL-C was also in the controlled range ) and the third group whose LDL-C was not controlled by simvastatin alone, had ezetimide added to bring the LDL-C down. All three groups achieved the target LDL-C of 80mg/L. All these patients had baseline, 1yr, 2 yr MRI scan of their superficial femoral artery, plaque volume. After 2 years of followup, group 1 ( simvastatin group ), had plaque regression, group 2 ( Vytorin group ), had no change in plaque volume, but in group 3 the plaque volume increased ( by almost 4% % in two years). Now this is worrying, as this same findings were also noted in the earlier ENHANCE, and ARBITER 6 study.
This raises two big issues. 1. Does ezetimide reduces LDL-C but progresses plaque? and what are the consequences of this, is it hard plaques or soft plaques? 2. How do we understand lower LDL-C with increase plaque volume as a concept? So cholesterol is not the only component of plaque build-up, and more importantly maybe smooth muscle cell proliferation or other cellular reactions. We can lower LDL-C and yet promote plaques. This has consequences.
So ezetimide is not so straight forward. Looking at LDL-C alone to see benefit in CAD treatment, may not be sufficient. It is true that this study is a small study and that MRI of superficial femoral artery is not a standard way of estimating plaque volume. Be that as it may, these findings are in line with two other bigger study, making it three studies over a period of time, over three different cohorts. Now that must mean something.
I suppose we should watch this scene carefully.
For the moment, I would only use ezetimide in statin intolerant patients, who have established CAD, and who cannot achieve their LDL-C target of 100 mg/L. Yes, I am rather conservative. By the way, ezetimide is not cheap either.

SPOTLIGHT FOR RENAL DENERVATION AT EURO PCR

When I first read of Renal denervation, or what I then called the Ardian Procedure ( after the company who developed the device ), I was quite impressed and decided that the GPs should hear about it as it was hot off the press from AHA, in the fall of 2010. I listed the topic in my program for the "Weekend seminar in Cardiology for GPs 2011". I asked one of our senior cardiologist to speak about it, of course, just a brief undertanding, under the section on "Hot Topics in Cardiology". The Cardiologist decline stating that he had no knowledge of this topic, so I had to teach on it myself, just from researching the topic and understanding it.
Well, EuroPCR, currently on in Paris, just gave the Melbourne boys ( pioneers in the technique ), center stage, by allowing them to show a live demo from Germany, on Renal denervation, and also a presentation of the evidence to date.
Of course, we are all viewing this revolutionary procedure for the management of hypertension from different angles.
I suppose the Melbourne and German boys are trying to see how to perfect the technique for routine use, so that good longterm results can be obtained. They are also trying to conduct more, large scale trails ( SYMPLICITY HTN-3) is scheduled to be launched in USA soon, so that they can begin to work towards FDA approval.
We are all looking to see, if the early results will hold up, and even more importantly, what role it will play in the whole scheme of management of hypertension. Not to forget that this is a multi-million dollar drug industry item, and the renal / hypertension physicians are not going to let this area go to interventionist without a fight ( I hope not literally ).
We interventionist seeing that this technique is rather simple and safe, wonder whether it can be more widely applied, like in pre-hypertension and patients who wish their hypertension "cured".
I am sure that we can all agree, that more studies needed to be done, and we simply need more studies, from multi-center, and well as across countries and continents. Hypertension is a very common problem, and there is a great potential that renal denervation, may be mis-used.
For our country, I have gently and strongly hinted to the company owning Ardian ( in this case Medtronic International ), to quickly identify a young and eager interventionist ( we are too old now ), to go study this procedure in Melbourne, and become an expert, to initiate a program here, as we are seeing a growing number of hypertensives and strokes, and many of our patients are not compliant on drugs, and so suffer numerous complications of strokes and renal failure. I certainly hope that they will do for renal denervation in Malaysia, what we did coronary angioplasty and stenting in Malaysia. All this while waiting for the long term results of SIMPLICITY HTN 1, 2 to come. We need improvement in hard end points in hypertension treatment ( when compared to medical therapy ), before we can finally say that Renal denervation is ready for prime time. For the moment, renal denervation should remain as a treatment modality for chronic resistant hypertension.

LATEST GENERATION OF BARE METAL STENT

The EuroPCR is currently on at Paris. One of the first papers presented was from Finland. The study is called BASE - ACS, basically, the use of this new generation bare metal stents in patients with the acute coronary syndrome. Dr Pasi Karjalainen and coleagues from the Satakunta Hospital Heart Center, Pori, Finland, studied 827 patients with ACS. To half they inplanted the new Titan 2 stent, and the other half received the Xience V ( DES ). At the end of 12 months, they found that the Titan 2 stent was non-inferior to the Xience V stent. The MACE rates were the same. I think they were attempting to say that the Titan 2 stent is as good as the Xience V.
The Titan 2 stent is basically a stainless steel stent, like the BX velocity, coated with Titanium Nitric Oxide. There is no polymer and no drug. Nitric Oxide, in animal experiments, has been shown to inhibit platelet aggregation, and also promotes healing.
I think that this new Titan 2 stent looks better then even the best cobalt chromium bare metal stent like the latest Medtronic integrity stent. I believe that the nitric oxide coating does confer some advantages. But, I must say that it is premature to say that Titan 2 is non-inferior to Xience V. maybe at 12 months in ACS patient that may be true. But we all know that DES are advantages because it lessens repeat target lesion revascularisation ( basically re-stenosis ) in the long term, like 3-5 years, and Titan 2 has not reach that place yet.
As the commentators discuss at the meeting, we are certainly pleased with the initial results of Titan 2, but certainly more work needs to be done. I do not think that this will spell the end of DES.
Of course, we are also keen to know the cost of this Titanium Nitric Oxide coated stent.
I am sure that we will hear more of Titan 2, in the future, be it good news or not so good news.

THE EVOLUTION OF CAD PATIENTS AND CABG - US STATS

There is an interesting paper presented at this years Annual Scientific meeting of the American Society of Thoracic Surgery ( STS ), at Philadelphia. Dr Andrew Bardissi researched into the STS data base and came out with an analysis of 1,475,545 CABGs done between 1999 till 2009, to see the changing trends and patients. 1.5 million CABGs is alot of CABGs and will certainly reflect the CABG scene in USA.
He found that over the 10 years ( 1999-2009 ), the patients smoke significantly less. That is about the only good thing in terms of changing patient characteristics. Otherwise, over the 10 years, the trend is that the patients are getting more obesed, have higher incidence of dyslipidemias, are younger and there are more males. There are also more hypertensives.
On the CABG side, everything is better. The mortality has fallen from 2.6% to 1.9%. More internal mammary grafts are implanted ( from 72% to 90% ), and the stroke rates are also down from 1.6% to 0.9%.
In the face of the severe Interventional cardiology challenge, the cardiac surgeons are getting more skillful. What Dr Andrew did not address ( which may not be in the data base, is that there are now, more cardiac centers doing fewer cases. It is no longer like the CABG factories of before. However, we noticed that despite falling numbers of CABGs done, and lesser numbers per centers, their decision making and supervision is much better, giving rise to more consistencies, and better outcomes.
This is to be lauded. They did not cave in, under pressure from the interventionist. They got better. That is what competition should do. Make us all better, so that the patient have good choices.
I have often wondered what our local numbers would be like. What are our true mortality numbers? our stroke risks?, our use of the internal mammary grafts? our graft attrition rates? Are we keeping up with the US numbers?.
Well, only time will tell, as we get our act together.

CARDIAC DANGERS OF NSAIDs. MORE INFORMATION

NSAIDs are non steriodal anti-inflammatory drugs, that we can often buy over the counter. They are pain killers. Of course, steroids are powerful pain killers too. So these are non steroid pain killers. Amongst the NSAIDs, we have the COX1 and the COX2 agents. COX 1 agents, like ibuprofen, naproxen, and voltaren, are cheaper, older generation painkillers, which also can cause gastic upsets. COX 2 painkillers are agents like Vioxx, Celebrex, which are newer, second generation painkillers which are more expensive with minimal gastric side effects. Of course we all remember Vioxx, which was withdrawn 5-6 years ago, because of fears of increase heart attack risks. After all that hooha with Vioxx, we are now looking carefully at painkillers to see if they have increase CVS risk. Looks like they all have this risk. For a long time, I thought that the CVS risk with NSAIDs were from long term use, like months and years, that using NSAID occasionally for a few days, or a week or two was safe.
It would appear that that is not so.
Circulation May 9th issue, carried an article by the Danish group led by Dr Anne-Marie Schjerning Olsen, entitled "Duration of treatment with nonsteroidal anti-inflammatory drugs and impact on risk of death and recurrent myocardial infarction in patients with prior myocardial infarction: A nationwide cohort study". They studied 83,675 patients from the Danish National Patient Registry, who had their first AMI and had also taken at least 1 NSAID after their AMI. The period under study was from 1997-2006. There were 63% males and their mean age was 68 yrs. The most common NSAID taken was ibupprofen 23% and diclofenac 13.4%, Vioxx 4.7% and celebrex 4.8%. Over the years of followup, there were 35,257 deaths or re-AMI, giving an event rate of 42.1%. All the NSAIDs were associated with an increase incidence of death or re-MI, when taken for 1 week or more following the MI. The agent with the highest risk was diclofenac ( Voltaren or Cataflam ). The safest was naproxen.
What then shall we do if we have pain, having suffered a heart attack previously? Well, I suppose one option is to take the NSAID with a dose of low dose aspirin, or Plavix ( standard dose ). Best is to avoid NSAIDs if possible. If you realy have to take the NSAID, take the least amount required for the shortest duration, and use an anti-platelet agent together.
Over the counter pain killers are not so innocent afterall. They should be taken only when absolutely necessary, and the least the better, especially if you have a history of previous heart attacks.

A CASE FOR AED ( Automatic External Defibrillator ) IN PUBLIC PLACES

A recent paper presented at the just concluded Annual Scientific session of the Heart Rhythm Society 2011, at San Francisco, brings up an important need in our country.
Dr Richard Page's paper is entitled "Sudden cardiac arrest at exercise facilities: survival and implication for AED placement". He is now in University of Wisconsin, but the study is a 12 year study ( 1996-2008), on survivors following sudden cardiac arrest at dance halls and fitness centers. This study was carried out in Seattle ( a city famous for her ability to perform CPR by laypersons. It is often quoted that in Seattle and Miami, 1:4 laypersons in the street can perform CPR. The study was carried out in Kings and Seattle county. The numbers are interesting. There were 960 episodes of reported sudden cardiac arrest during 1996-2008, making about 80 episodes a year, or 6-7 cases a month ( on the average ). The dance and fitness centers were divided into traditional facilities ( I gather that these are the ones where we do Tai-Chi, and Qi Kong etc, and the licensed exercise facilities like the dance halls and gymnasiums. The study found that in the registered facilities, the survival rate was 50%, while in the traditional facilities, the survival rate was 36% ( not bad. Even in our hospitals, the immediate survival rate is about 10-20% and the survival rate upon discharge is only about 1-2% ).
What is also interesting is that, of the sudden cardiac arrest, 16% occurred in the basketball courts, 9% during ballroom dancing, 5% at tennis, 4% at bowling, and 4% at swimming. Interesting. I always thought that bowling and dancing requires little physical exertion.
Anyway. looks like in Seattle, all the exercise facilities have AEDs and the people there know the basics of CPR and use of the AEDs.
This is what our government needs to consider. An AED in Malaysia, cost about RM15K. They are many companies selling them. I have one in my clinic. We ( the Federation of Private Medical Practitioners of Malaysia ) has been carrying out CPR course across the country teaching laypeople who would turn up. This is carried out with the help of the St John's Ambulance. The government should consider carrying out such a campaign, and also bring about legislation that would require public facilities to have AEDs in working condition available. Of course, with AEDs comes the responsibility of how to use them, and also a " Good Samaritans Act" to protect people who try to help, so that they will not end up being sued for trying, should the resuscitation fail ( as is likely ).

I suppose this is what a developed country is all about. For 1:4 of our population, to be able to carry out CPR, and to have 50% of our sudden cardiac collapses resuscitated, to reach a medical facility alive.
I wonder if this will appear in any of our Ministry of Health KPIs?

THE ISSUE ABOUT SALT AND HYPERTENSION. A small controversy.

There is an interesting and controversial paper out in the Journal of the American Medical association on urinary excretion amongst normal individuals, and their blood pressure and their 8 year outcome. An interesting paper that some have chosen to call as a afornt to the theory of reducing salt intake to lessen hypertension and strokes. I did not see it as such. The paper by Dr Katarzyna Stolarz-Skrzypek from the University of Leuven, Belgium, is entitled "Fatal and nonfatal outcomes, incidence of hypertension, and BP changes in relation to urinary sodium excretion".
The experts have chosen to label this paper in their editorial as " New salt paper raises controversies", claiming that the paper does not support the conventional wisdom that too much salt is bad for health.
Dr Skrzypek et al, studied 3681 subjects who were without heart disease. Followed them up for a mean of 7.0 years. reviewed them and assess their 24hrs urinary sodium excretion and blood pressure. After 7.9 years of follow-up, they found that those with lowest urinary sodium excretion in 24 hrs, had an 50% increase incidence of cardiovascular events, including fatal MIs. There were 50deaths in the lowest excretion tertile, 25 deaths in the intermediate group and 10 deaths in the highest urinary sodium excretion group. They also showed that this group, after 7.9 years of follow-up, had their BP mildly elevated.
These conclusions obviously raised much hue and cry, as it is commonly perceived that 24 hr urinary sodium excretion, is one way of assessing salt intake. The experts ( including my friend Dr Graham MacGregor ) concluded that the paper showed that people who ingested less sodium in their diet ( 24hr urinary sodium excretion ), had an increase CVS fatalities, while recording a marginal increase in blood pressure. These conclusions will certainly raise some eyebrows.
I did not see it the same way after going through the paper. I thought that the paper simply said that in their European population, low 24 hr urinary sodium excretion, was associated with increase CVS fatalities. There could be many reasons for a low 24 hr urinary sodium count, not excluding poor compliance, low 24 hr urine volume ( giving false positives ), or simply "not collecting properly". I think that all the fuss over this paper, is much ado about nothing.
It is undoubtedly true, that increase salt intake in our diet, is associated with an increase rise in BP ( logically, by pure physics, and also supported by a large body of evidence and epidermiological data ). An increase in blood pressure, will see an increase in strokes and CVS events.
It is good, in an academic community, to have some controversies and debates. That always allows us to re-examine of first principles and recheck our understanding, less we take them for granted. Controversies and debates are healthy and should be encourage. I suppose, in an academic discussion, there is unlikely to be violence. Innovations and a high income economy must also come with its fair share or controversies and debates, so that we can get new ideas, from which innovations comes. Sterile boring mono types, only breed complacency and the " continue with the same" mentality., otherwise called " lack of ideas". How then to have innovations??

RED WINE ELUTING STENTS. WHAT A NOVEL IDEA?

I came across this rather interesting paper by Dr Jim Kleinedler of the Louisiana State University Health Science Center, presented at the just concluded American Heart Association Arteriosclerosis, Thrombosis and Vascular Biology 2011 Annual Scientific Meeting at Chicago.
The paper is entitled " Red wine polyphenol-eluting stent reduces neointimal hyperplasia and promotes re-endothelialization in a rat model of stenting angioplasty". They studied rat carotid models with polyphenol eluting stents implanted. They showed that in these rat models, the polyphenol eluting stents did reduce restenosis, and also accelerated re-endothelialisation. This is ideal.
At the moment, our drug eluting stents are coated with drugs that either kill cells that cause restenosis, the process of neo-intimal hyperplasia, or actively inhibit them. By so doing, they reuce intimal hyperplasia, and so re-stenosis, but also leave the stent with delayed healing, thereby making it prone to stent thrombosis. We need the endothelial cells to protect the stent against thrombosis, but we do not need too much intimal hyperplasia to promote restenosis. Therefore, if an agent could come by, that can inhibit intimal hyperplasia, and yet promote re-endothelialisation, that would be ideal.
The active polyphenols in red wine are the " resveratrol and quercetin. The resveratrol part will reduce neointimal hyperplasia, reduce inflammation and promote re-endothelialisation, and the quercetin part will reduce platelet activation, reduce smooth muscle proliferation and also act as an anti-oxidant.
When they implanted the polyphenol stents in the rat carotids, they compared 4 groupd. The group with a low dose polyphenols, the group with high dose polyphenols, the group with bare metal stents and the group without any stents. The results show that both the polyphenol groups did better than the other two groups, in terms of restenosis and stent thrombosis.
What a novel idea. I suppose we should watch this page, for more developments. Sometimes what works in rats may not do well with humans.
It is also interesting to extend the hypothesis, to include drinking red wine to see if it affects restenosis of DES? Can we reduce the need of 1 year of dual anti-platelet therapy ( 1 year of chlopidogrel can be costly ), in those who consume red wine in moderation? Interesting. Some of us drink a bit of red wine and this could be a nice benefit. We all know that red wine helps the heart. This may also give a boost to the growing wine market.
I will surely watch this page to see how the work develops. For the moment, it will still be limus-eluting stents, and a glass of red wine. At worse, it does no harm. Cheers