Reshaping the Heart Is Not Help

An operation that once looked promising to treat heart failure has turned out not to help patients, doctors are reporting.
The operation, ventricular reconstruction, reshapes the heart’s main pumping chamber in the hopes of making it work better.
For about 20 years, surgeons have been performing it on some patients with heart failure who are already undergoing bypass surgery to treat blocked coronary arteries.
About five million Americans have heart failure, and it contributes to 287,000 deaths a year. Causes include damage from heart attacks, blocked coronary arteries, diseased heart valves, high blood pressure and diabetes.
As a result, the heart becomes enlarged, scarred, misshapen and too weak to pump enough blood. Patients can become short of breath and have trouble walking.
Doctors had hoped that reconstruction, by restoring the heart’s natural shape and size, would help people feel better and survive longer.
But it does not, according to a major study in which 1,000 people were randomly assigned to have either reconstruction as well as bypass surgery, or bypass alone.
Researchers then tracked the patients for a median of 48 months to see how many died or wound up in the hospital again.
They also looked at symptoms and ability to exercise.
There were no differences between the two groups.
Death and rehospitalization rates were the same, and symptoms improved equally in both groups. But the patients who had the reconstruction spent more time on the operating table and in the hospital.
Some surgeons say patients with severe scars on the heart, who were not studied, may benefit from the surgery.
But performing the operation routinely “cannot be justified,” wrote Dr. Howard J. Eisen, in an editorial published online Friday in The New England Journal of Medicine. Dr. Eisen, who did not take part in the study, is a cardiologist at the Drexel University medical school in Philadelphia.

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FDA Approves “Eyelash Fertilizer”

The Food and Drug Administration (FDA) has approved the cosmetic use of an eye disease drug, allowing it to be sold as an eyelash enhancer.
Currently called Lumigan, the drug is produced by Allergan, the same pharmaceutical company responsible for Botox.
Lumigan was originally developed to treat glaucoma; however, researchers at Allergan discovered that patients who used the drug grew thicker, longer and darker eyelashes as a result. Allergan plans to call the product “Latisse” when marketing it cosmetically and expects the repurposed drug to generate about a half a billion dollars annually, the Associated Press reports.
An Allergan-conducted review tested 278 patients over the course of 4 months, intending to confirm that the drug increased thickness, length and darkness of lashes. A review of the study by the FDA showed that participants using the drug saw significant cosmetic changes, as compared to patients who received a placebo.
Last Wednesday, the FDA posted a review of the active ingredient in Lumigan on its Web site, preceding an independent review of the drug by medical experts, who voted on Friday to approve the drug for cosmetic purposes.
The panel of eye and skin specialists voted unanimously that the drug’s benefits outweighed its risks, according to WPVI, ABC’s Philadelphia affiliate. However, the panel also voted 5–3 that Allergan should be required to continue studies on certain patient groups.
Allergan says it will sell Latisse under a “risk management plan” meant to encourage doctors to explain and monitor possible side effects. The drug can lower intraocular eye pressure (which is why it’s used as a glaucoma drug) and may cause skin darkening in some users.
However, some doctors believe these safeguards may be not be sufficient to prevent potential abuse of the drug. Dr. Marijean Miller, ophthalmologist with the Children’s National Medical Center in Washington said, “I’m worried about off-label, nonsupervised use of this medication, and I’m concerned teenagers might use it three or four times a day instead of once.”

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