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Heart valve replacements; New study reveals patients not told about risks


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1/16/2015
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Many patients are saying that hospitals have not been properly informing them about all of the consequences of having valve replacement surgeries. 

Reuters reports on the new speculation. Research shows that U.S. hospitals are telling their patients about all of the benefits involved with valve replacement but none of the risks.

Apparently the consequences are actually very severe. Heart valve surgeries have a doubled risk of the patient getting a stroke. Patients are usually unaware of this serious factor.

“Transcatheter aortic valve replacement (TAVR) was recently introduced as a less invasive method than open surgery for opening a narrowed aorta, the main artery carrying blood from the heart to the rest of the body. When the aortic valve narrows, which can be congenital or more often caused by calcium deposits that develop with age, the heart must work harder to pump blood to the rest of the body. This may cause chest pains or blood backing up into the lungs,” according to Reuters.

Around two percent of people over age 65 develop this narrowed valve. It is called aortic stenosis. Experts say that this issue may not necessarily require invasive treatment, however if it does, the valve can be replaced with open aortic valve surgery.

How does this happen?

It is done through a large incision in the chest. The Centers for Medicare and Medicaid Services approved coverage of TAVR in 2012, which achieves the same thing by putting in the new valve through a catheter.

Dr. Neuman of the anesthesiology and critical care department at the Perelman School of Medicine of the University of Pennsylvania in Philadelphia authored the new study.

How was it conducted?

Neuman and his coauthors scrutinized the websites of all 317 hospitals in an official TAVR registry; out of this 262 had their own web pages describing the procedure.

What were the results?

“Of those, 260 listed at least one benefit of TAVR relative to open aortic valve replacement, most often that it is less invasive, recovery is quicker, it does not require the use of a heart-lung machine during surgery and quality of life is improved. Only 69 websites, roughly one quarter of the hospitals, listed any risks of TAVR. Patients who have the transcatheter procedure have twice the risk of stroke compared to patients who have open surgery, the study authors note, but only 48 websites mentioned stroke at all, and even fewer quantified the risk,” according to Reuters.

The researchers were surprised to find that only a small number of sites mentioned the potential for kidney injury or need for a new pacemaker. They also did not list more repeat hospitalizations and more frequent need for additional procedures, all of which are associated with TAVR. The authors write about their research in JAMA Internal Medicine.

The experts say patients should have access to clear and balanced information about procedural risks and advantages, as well as comprehensive outcomes information, but it is difficult to find reliable, balanced data.

Dr. Neuman told Reuters,

“We feel that the websites and the information that’s on the websites have the potential to influence decision making in a meaningful way, and by providing better information on what the downsides could be they could portray a more balanced picture.”

 



Category: Surgical Mistakes

Gerry Oginski
NY Medical Malpractice & Personal Injury Trial Lawyer

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