Second Artificial Heart Implant to Happen, Despite Death of First Pt

French artificial heart developer Carmat has its fate in the hands of four patients, one of whom has already died and three of whom are yet to be implanted. While that sounds like a perilous position to be in, these patients are already very sick and if they survive a month the study will be considered a success.

Two weeks ago we reported the news that the recipient of the first Carmat artificial heart to be implanted had died after 76 days. Now the company says it is expecting to try again to implant its experimental artificial heart in another patient “in several weeks”.

Background

The Carmat device, a self-contained unit implanted in a patient’s chest, is a mix of synthetic materials and animal tissue, and seeks to mimic the form and function of an actual human heart. In that sense, it varies greatly from other artificial hearts currently being used, which are cruder, mostly synthetic pumps.

At face value it might sound slightly cavalier to be implanting a second device so soon after the first recipient died, especially when the reason for death has not yet been established. Add to that the French Company Carmat’s claim that its device is designed to offer longer term support than other so-called artificial hearts and the ironic circle is seemingly complete.

Having said all of which, the first implants of this device are being performed on extremely sick patients for whom there is little alternative. You’ve got to believe the cause of death could be umpteen things other than the implanted device that aimed to keep them alive a bit longer, although time will tell on that front.

Add to this the success criteria laid down before the first study patient was even implanted. If he, or the other patients in the first cohort, last a month, it’s considered to have been successful enough to move on to implanting it in patients with less severe heart failure. They really are playing at the edge of life with this study and indeed this device, and when they say they want to pay tribute to the courage and the pioneering role of this patient and his family, as well as the medical team’s dedication, they’re not kidding.

Company comments

Philippe Pouletty, Carmat co-founder, reportedly told Europe 1 radio that a second experiment would depend on finding a suitable patient, adding that the company still had to wait for the results of an in-depth analysis of the first trial on a 76-year-old man.

“Currently we don’t know what the patient’s cause of death is, we are doing in-depth analyses before going on to the next implant,” Pouletty said, appearing to refute a theory that a short circuit caused the device to stop working.

Source: Agence Francais-Presse, NDTV

published: March 18, 2014 in: Cardio, Clinical Studies/Trials

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