Thursday, October 14, 2010

TRANSMYOCARDIAL LASER REVASCULARISATION. TMR / TMLR : IS THIS THE END?

Transmyocardial laser revascularisation is a technique of using laser catheters to punch micro-holes in the myocardium of the left ventricule, in an attempt to improve the blood supply, directly to the heart muscle. This technique was invented to try and help those patients who could not be revascularised either percutaneously ( PCI ) or surgically ( CABG ). This technique was extensively studied in the mid 90s, with many clinical trials done, some showing that it helped, and others showing that it was essentially a placebo effect and that it did not help.
Well ( re-hashing old news that I just discovered), NICE has just stopped re-imbursement for TMR / TMLR in UK, saying that the cost does not justify the benefit, and quoting severe lack of data to suport its continual use. As we all know, NICE stands for the National Institute for Health and Clinical Excellence.
Just to recap, TMR / TMLR was quite popular in the late 90s and early part of the 21st century. In fact, some US centers are still using it. I see some advert promoting it in the Cleveland clinic website.
The concept is really quite attractive. There are sophisticated equipment invented to map out ( in 3-D ) the ischemic regions of the myocardium. These are patients who had 3-VD, had undergone CABG previously and also PCI, until it is no longer possible to PCI and no more vessels to graft, or maybe CABG is too risky for too little gain. With the 3-D mapping ti guide, a laser catheter is introduced percutaneously, and manipulated to the ischemic region and burst of laser ( usually CO2 laser ), is applied, to create micro-holes. Some patients feel better, and their grade 3-4 angina got better ( maybe to grade 2-3 ). This clinical improvement was thought to be due to improvement in direct blood flow to the myocardium ( something like the Vineberg techniqe ). There was also a theory that making small holes in the myocardium, may stimulate angiogenesis, so that new blood vessels are formed and so myocardial blood supply is improved. Remember that these are class 3-4 angina patients who have no other choice. Of course, the effect is only temporary and repeated courses are necessary. At the height, in 1999, many centers were buying the machines and the technique was shown at live demo courses.
Well, further research revealed that the micro-holes barely lasted 2 weeks before they close off
And also, no consistent pattern of angiogenesis was noted. Patients symptoms invariable recurred and the process had to be repeated with less and less effects. So NICE put a stop to it.
I think Malaysia also need some kind of NICE or NICE equivalent. Of course, UK has a social health system to deliver healthcare. Through taxes ( rather high ) UK citizens are looked after by the NHS ( National Health System ). NICE is a very respected body who look into treatment and treatment modalities. They study clinical trial materials and drugs and see if certain drugs or procedures help more then harm. Those that harm, does not help enough ( cost effectiveness ) will not be recommended for re-imbursement by NHS. Which means that that drug or technique will lose its main payer, which usually means that it will slowly fade away. The payer controls the use.
I suppose with rising cost of healthcare, we do need this type of body, to adjudicate, what should and should not be used. All specialist have their favourate hobby horses, some of which do not add significantly to quality or quantity of life. We need a " NICE-like " body to say, enough is enough.
I suppose, in away, it does ask the question, how much is life worth? Especially when society have to pay for it. Would you spend RM 50K per course for 3 courses to prolong life for 9 months in a patient with incurable cancer. Such a difficult question to answer, when emotions get in the way. Is this money better spend helping more patients with hypertension better treated. That is where NICE play their part.
As for TMR / TMLR, NICE has decided in May 2009, enough is enough. And I think it is fair.

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