Shocking news about the dangers of a new type of stent, which has been used for the past 12 to 18 months across the globe including in South Africa, is now being revealed bit by bit in medical journals.
There are signs that the new stent may hold unforeseen dangers and could lead to the death of more people than would normally be expected.
It appears these drug-eluting stents can turn anyone who receives one into a walking time bomb.
They may lead to a sudden massive heart attack or uncontrollable bleeding. The latest warning signs that the stents aren't as safe as was initially believed come from the Netherlands.
In the July issue of the Journal of the American College of Cardiology concerned Dutch cardiologists report that almost a third of their patients died within 32 months of receiving the new stent. Not one patient who received a metal stent died within this period.
This study was conducted on just 75 patients and the warnings are viewed as alarmist by some specialists. But the conclusions follow on the heels of seven articles in the March issue of the authoritative American medical journal The New England Journal of Medicine about the first shocking deaths resulting from side effects of the new stent.
American cardiologists are concerned about these developments. In America and the Netherlands investigations, further studies and thorough analysis of the data have now been requested to determine whether the stents or the doctors are at fault.
Do the stents initiate complications?
Did the cardiologists implant stents in people who shouldn't have received them?
Were the anaesthesiologists mindful of possible complications?
These questions now need to be answered.
According to the international reports the new drug-eluting stent could have safety implications for South Africans who've received one in the past 12 to 18 months.
While some South African specialists warn against the dangers of the new stent, even going so far as to say they would not allow it to be implanted in them until long-term studies have been conducted, others maintain it is safe.
Yet even these specialists advise against using it in anyone who has to undergo an operation within a year subsequent to the implant.
An investigation by YOU Pulse confirmed that at least three Cape Town patients who died in the past six months had been recipients of the new stent. One was a man who had a minor operation after receiving a stent a few months before.
To prevent too much bleeding during the operation he was advised to stop taking the mandatory strong anticoagulant. But after he'd been off the blood-thinning agent for only 12 hours a large blood clot formed in his heart and he had a massive heart attack. When doctors injected him with an anticoagulant to dissolve the blood clot in an attempt to save his life he started bleeding uncontrollably from the wound.
This is typical of the case studies being described one after the other by American specialists. The new brand of stent releases a type of anti-rejection drug, a South African cardiologist explains. The drug prevents tissue around the stent from growing inward and causing a new blockage.
Apparently, the simultaneous use of this drug and the strong anticoagulant causes a major upset in the blood coagulation process. It seems something is going wrong but exactly what and how is not yet clear, the cardiologist says. Some patients had a heart attack almost immediately after the planned discontinuation of their anticoagulant drugs.
The initial plan was that patients would stop taking the strong anticoagulants after a few weeks or months. But because of the unforeseen complications the period of drug use has been extended to almost two years.
The possibility exists that patients may have to take these strong drugs for the rest of their life. But this is like living with a time-bomb: if a person who has the new stent stops taking the anticoagulant he'll suffer a heart attack. If he continues using it he risks bleeding to death.
An anaesthesiologist told YOU Pulse that under current conditions he wouldn't allow a drug-releasing stent to be implanted in his heart.
Stents, cardiac artery bypass surgery and medication are the three most important treatment options for people with constricted coronary arteries. Each treatment option has its own merits. New techniques such as stem cell treatment have produced promising results but are still far from proven.
[This story originally appeared in the first edition of Pulse magazine. Buy the latest copy, on newsstand now, for more fascinating stories in the world of health and wellness.]
- (YOU Pulse: Spring edition, September 2007)