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“The study, called the Cabana trial, found that the procedure (catheter ablation) was no more effective than much cheaper medications at reducing mortality, cardiac arrest, major bleeding and stroke.”
I have a personal interest in the article linked and excerpted below. It is not easy to live day-in, day-out with chronic afib. But I choose to do this because I didn’t want to undergo the therapy calledcatheter ablation, the subject of the study below.
The issue with a late stage side effect like chronic afib is trying to figure out how much of a problem these side effects can be. In the case of chronic afib, my “ejection fraction” droped to 45%. This means that blood that stays in my heart too long and is not “ejected” and is more likely to clot.
Therefore I’ve got to figure out how to live with or fix my afib. Over the years I have wondered if my chronic afib can be healed, or surgically repaired or I’ve wondered if I should simply live with it?
According to the article linked below, the common “standard of care” therapy to fix chronic afib is cathater ablation. Cathater ablation can cost more than $20,000 and is meant to “cure” a person’s afib.
For now, I will continue living with my chronic afib, work to reduce my risk of stroke and live my life without havng catheter ablation.
“Atrial fibrillation, a condition affecting three million to six million Americans, is caused by irregular contractions of the heart and results in an increased risk of stroke and death. Over the past two decades, cardiologists have increasingly treated it with a procedure called catheter ablation, in which small plastic catheters are used to create scars in the damaged heart tissue to prevent the aberrant electrical signals from spreading. Many have touted catheter ablation, which can cost well above $20,000, as a “cure” for atrial fibrillation.
Yet a new randomized controlled trial, the gold standard of clinical research, has produced disappointing results. The study, called the Cabana trial, found that the procedure was no more effective than much cheaper medications at reducing mortality, cardiac arrest, major bleeding and stroke.
These results come on the back of another prominent trial published last year, which showed that stents used to relieve blockages in patients with stable chest pain provided no benefit over medications.
In the furor over the Cabana results, which have been presented at a scientific conference but not yet published, many have argued that the underlying data suggests that catheter ablation does help some people. But a different kind of study will be needed to confirm that. The fact is that years after catheter ablation hit the market, we shouldn’t have this many questions about it.
The bar for approval of medical devices is too low. There is no reason we shouldn’t require, as we almost always do for drugs, a randomized placebo-controlled trial showing improvements in “hard” outcomes like mortality before approving them…
After a device has reached the market, companies have little incentive to do a high-quality trial. Why risk a study showing that your device’s benefit doesn’t exceed its harms when cardiologists are already implanting it?
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