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 Ensuring
proper standard cardiac stents in the market
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He cites a recent case in Mumbai, India, where the Health authorities have warned a hospital where sub-standard stents had been used on some patients.
He says if this has happened in India, the same things entering the market here is not a remote possibility. He writes:
Cardiac stenting the heart patients
Basically cardiac stents are implanted in heart patients whose arteries are clogged. Recent technological improvements have now led to the use of drug eluting stents that are coated with medicine that allow for better healing once the stent is implanted.
In Sri Lanka
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The two primary internationally accepted approvals for medical devices are the US FDA approval or the European CE marking. While these are recognized in Sri Lanka, we also allow the registration of products that in use in the country of manufacture.
This loophole could allow sub-standard products also to be registered in the country. The critical nature of these products warrants the utmost care in approving products that should be used to treat such heart patients.
In Mumbai
The recent scare in India regarding cardiac stents highlighted the lax nature of approvals given for such critical products. Recent media reports about the use of unapproved cardiac stents on heart patients in a Mumbai hospital have brought to light the state of regulatory control on medical devices in the country.
Maharashtra State FDA which detected the case has found that these imported drug eluting stents were being used by the hospital on patients without any regulatory approvals.
FDA officials have found that 10 companies in Mumbai were importing these stents from various countries and selling to different hospitals in the city.
Companies importing cardiac stents must be asked to furnish the relevant international approvals and meet all the safety conditions expected of such critical medical devices.
Background - Stents
Stents are delivered into the coronary artery on a catheter during a PCI procedure. They are then 'deployed' in the artery by either expansion by a balloon or by a unique 'self expanding' delivery design.
They serve as a scaffold to prop the inside of the artery (the lumen) open which increases blood flow to the heart muscle. They are permanently deployed devices that stay in the artery. They are not removed. They ultimately become covered with cells and in essence become part of the artery over time.
Stents are proven to reduce the incidence of 'Restenosis'. Restenosis generally occurs within 4-6 months following a PCI procedure.
Before stents, the incidence of restenosis was about 35-45%. Restenosis is a re-narrowing of the treated coronary artery which is largely related to the development of neo-intimal hyperplasia that occurs within an artery after it has been treated with a balloon or atherectomy device.
Stents are the only widely available PCI device that has been proven to reduce the incidence of restenosis. Stents reduce restenosis by approximately one-third. While they do not offer a 'cure' for coronary artery disease, they do have a major impact on decreasing the need for a repeat procedure.
Sometimes referred to as a 'coated' or 'medicated' stent, a drug-eluting stent is a normal metal stent that has been coated with a pharmacologic agent (drug) that is known to interfere with the process of restenosis (reblocking).
Restenosis has a number of causes, it is a very complex process and the solution to its prevention is equally complex.
However, in the data gathered so far, the drug-eluting stent has been extremely successful in reducing restenosis from the 20-30% range to single digits.
There are three major components to a drug-eluting stent:
Type of stent that carries the drug coating
Method by which the drug is delivered (eluted) by the coating to the arterial wall (polymeric or other)
The drug itself - how does it act in the body to prevent restenosis?
Dr. D. P. Atukorale writes on:
Brady Cardia and heart blocks
IN A normal person the heart speed (which is the same as pulse rate) is about 70 to 80 per minute. The term brady cardia (slow heart rate) is used when the heart speed is less than 60 per minute. When your heart speed is very slow (say 30 to 50) the term heart block is used.
Low blood pressure could be fatal
When the heart rate is very slow as in heart blocks and in a condition called (sick sinus syndrome), the amount of oxygen-rich blood reaching the brain is insufficient and this leads to low blood pressure and you may feel faintish and sometimes you may lose consciousness, and may even get fits. If the slow heart rate (brady cardia) persists this can even be fatal if left untreated.
Electrical impulses
Electrical impulses tell the chambers of the heart when to pump. But the signals may be slowed or blocked as in heart block or sick sinus syndrome, as these signals travel on the heart's electrical pathways.
Causes of heart block
Heart block can be caused by aging, scarred heart tissue or damage from heart disease as in acute myocardial infarction (heart attack) or as in myocarditis (Inflammation of the heart muscle) usually due to virus infections.
'When the heart speed is very slow, not enough blood is pumped to the brain and to the rest of the body and the patient may faint.
Other causes
Other causes of heart block are drugs such as digoxin, verapamil, diltiazem, beta-blockers (e.g. propramoll and atenold) and amiodarone.
There is a type of heart block called congenital heart block which may be associated with congenital heart diseases such as ventricular septal defect (VSD).
Management of heart block depends on the aetiology of heart block. If heart block (or sick sinus syndrome) is due to drugs, the drug should be omitted and the patient should be hospitalised and if the symptoms are severe, a temporary pace-maker should be inserted by a cardiologist (or a cardiologist registrar).
Heart block following 'Kaneru' (yellow oleander) poisoning which is a fairly common type of attempted suicide among young Sri Lankans, the patient should be immediately transferred to an intensive care unit (ICU) where a temporary pace maker can be inserted.
Similarly in case of heart block secondary to acute myocardial infarction, the patient should be managed in an ICU with facilities for temporary pacing.
All cases of chronic heart block should be subjected to Holter-monitoring and majority of these patients have to be subjected to permanent pacemaker insertion which prolongs their lifespans.
Climbed peak
One of my patients with chronic heart block climbed Adams Peak two months after permanent pace maker insertion.
Permanent pacing in Colombo and Kandy National Hospitals
Permanent pacing is routinely performed in the Cardiology Units of National Hospital, Colombo (NHSL) and General Hospital, Kandy and in a few private nursing homes in Colombo.
It costs about Rs. 150,000 to the Health Ministry for each pace maker insertion and about 200 to 300 such operations are done per year under local anaesthesia in the cardiology unit, Colombo with 100 per cent success.
(Dr. Atukorale has sent this article in reply to a question on 'heart blocks' by HealthWatch reader A. B. Jayatilleke of Udaperadeniya, Peradeniya on 29.9.2005).
Check the expiry date of LP Gas cylinders - SLMA
THE Sri Lanka medical Association informs the public that there is an expiry date for L.P. gas cylinders and the public should check that date when purchasing them for domestic use.
The SLMA in a notice carried in its notice board says "Most of you may not have known that there is an expiry date (physical life) for LPG cylinders.
Date expired cylinders are not safe for use, as they may cause accidents. In this regard please be cautious at the time of purchase of your L.P. gas cylinders from the vendor.
Here's how you can check it
On one of three side stems of the cylinder the expiry date is coded alpha numerically as follows.
A or B or C or D with some two digit number. for example - D06
The alphabet stands for quarters
A for March (First Qtr)
B for June (Second Qtr)
C for Sept. (Third Qtr)
D for Dec. (fourth Qtr)
The digit stands for the year till it is valid. Hence for example :- D06 would mean December quarter of 2006
SLMA says:- Share this message with everyone you know and thus help create awareness of this among the public.
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