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Vagus Nerve Implant Fails to Fix Heart Failure

Boston Scientific's stimulator showed no benefit in big European trial, but Cyberonics' smaller, earlier-stage trial succeeded

2 min read
Vagus Nerve Implant Fails to Fix Heart Failure
Implanted devices that stimulate the vagus nerve in the neck help with epilepsy and depression but not, it seems, heart failure.
Illustration: Getty Images

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Attempts to use electronic implants to treat heart failure by stimulating one of a pair of nerves in the neck led to mixed results according to research presented this week at the 2014 European Society of Cardiology (ESC) Congress, in Barcelona. Boston Scientific's large, randomized trial failed to meet its key goals. But Cyberonics, which pioneered the use of such stimulators to combat epilepsy and depression, ran a smaller trial without controls that succeeded, according to Reuters.

Both trials used implanted electric stimulators that attached to one of a pair of key nerves in the neck, the vagus nerve. The nerve connects the brain to the heart, stomach, and other organs. It's a key target for medical device developers because it allows convenient access to the brain to treat disorders of that organ, such as epilepsy and depression, as well as to gut organs to treat other problems, such as obesity.

Heart failure, the inability of the heart to pump enough blood to satisfy the body's needs, has also been on the list of targets. The failure of Boston Scientific's trial was a big surprise to its leaders. "There is robust pre-clinical data showing the benefit of [vagus nerve stimulation], but the NECTAR-HF trial failed to demonstrate a successful clinical translation of this protocol," Faiez Zannad an investigator in the trial at l'Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu, in Vandoeuvre-lès-Nancy, France, said in a press release.

Boston Scientific was hoping to see a key marker of improvement—a decrease in the size of the left ventricle when it's fully contracted. They were also looking for other heart dimension measurements,  as well as improvements in exercise capacity and in levels of the hormone tied to heart failure.

The results were especially disappointing because of the care used in designing the study. 96 heart failure patients were recruited from across Europe, and all received implants for their right vagus nerve. Two-thirds had the stimulator turned on, while one third acted as controls with the stimulator off. All received the best standard treatment for heart failure during the following six months. After that point the controls, too, had the stimulator switched on.

Zannad suggested that the failure to see results may have been because the treatment group was already pretty well managed using standard medical therapies or because six months is too short a time period. The amount of current delivered might also have been too low.

The Cyberonics trial also followed patients for six months, but it was less convincing because it lacked a control group that received implants but no stimulation. Together, the 60 patients averaged a 4.5 percent improvement in left ventricular ejection fraction—a measure of how much blood makes it out of the left ventricle when it contracts.

"I think, at six months, that [4.5 percent improvement] is a very impressive achievement," study leader Inder Anand from the University of Minnesota told reporters.

Clearly, more clinical trials will be needed to see if this therapy can make a difference. But, following the failure of Boston Scientific's trial, whether or not to pay for that research will likely be a more difficult question.

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Restoring Hearing With Beams of Light

Gene therapy and optoelectronics could radically upgrade hearing for millions of people

13 min read
A computer graphic shows a gray structure that’s curled like a snail’s shell. A big purple line runs through it. Many clusters of smaller red lines are scattered throughout the curled structure.

Human hearing depends on the cochlea, a snail-shaped structure in the inner ear. A new kind of cochlear implant for people with disabling hearing loss would use beams of light to stimulate the cochlear nerve.

Lakshay Khurana and Daniel Keppeler

There’s a popular misconception that cochlear implants restore natural hearing. In fact, these marvels of engineering give people a new kind of “electric hearing” that they must learn how to use.

Natural hearing results from vibrations hitting tiny structures called hair cells within the cochlea in the inner ear. A cochlear implant bypasses the damaged or dysfunctional parts of the ear and uses electrodes to directly stimulate the cochlear nerve, which sends signals to the brain. When my hearing-impaired patients have their cochlear implants turned on for the first time, they often report that voices sound flat and robotic and that background noises blur together and drown out voices. Although users can have many sessions with technicians to “tune” and adjust their implants’ settings to make sounds more pleasant and helpful, there’s a limit to what can be achieved with today’s technology.

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