A 76-year-old man with end-stage heart failure who was the first person implanted with the world’s first permanent, biosynthetic artificial heart has died 75 days after receiving the device. The patient died March 2, 2014, physicians at European Hospital Georges-Pompidou (EHGP) in Paris announced Monday night.
Assistance Publique — Hôpitaux de Paris (APHP) released a statement saying that the cause of death is being investigated but will not be known until a thorough analysis of medical and technical data is conducted.
“The doctors directly involved in postoperative care wish to emphasize the importance of the first lessons they have learned from this first clinical trial regarding patient selection, postoperative care, treatment, and prevention of complications,” says APHP.
The device manufacturer, Carmat, said it is “of course premature to draw conclusions from a single patient, either before or, in this case, beyond the 30-day postimplantation survival period.”
The patient was the first in a feasibility study aiming to enroll four patients suffering from irreversible end-stage, biventricular heart failure (LVEF <30%) who were not eligible for transplantation. The study is examining patient survival at 30 days, prosthesis function, and patient quality of life.
“We are currently recruiting the other three patients,” explained Prof Christian Latrémouille (EHGP) at a French cardiology society meeting in January. “The total artificial heart bioprosthesis, Carmat, is now [officially] in clinical trials.”
Carmat is not expected to communicate the results of the study until implantation and 30-day follow-up is completed in all four subjects.
The patient, whose name has not been made public, was implanted with the device in mid-December; in February, an update from the hospital indicated that the patient had been taken off anticoagulants on January 10; and as of February 18, it reported he was able to walk without respiratory assistance. French newspaper Le Parisien reported today that no signs of thrombosis were seen on the device after postmortem explantation.
By way of comparison, the first patient to receive a heart transplant in 1967, Louis Washkansky, aged 55, survived the operation and lived for just 18 days before succumbing to massive bilateral pneumonia induced by the immunosuppressive regimen.
Fully Implanted Artificial Heart Mimics Cardiac Physiology
Carmat total artificial heart.
The brainchild of renowned cardiologist Prof Alain Cribier, the Carmat pump was designed with a morphology similar to that of the human heart, with two separate ventricles and four bioprosthetic valves. Unlike left ventricular assist devices (LVADs) approved for use in end-stage heart-disease patients, either as destination therapy or as bridges to transplantation, the Carmat, weighing 900 g, is designed to fully reproduce heart function, using biomaterials, including bovine valves.
The device consists of two ventricular cavities with two volume spaces separated by a flexible biomembrane: one for blood and one for the “actioning fluid,” the company website explains. A flexible, external bag contains this actioning fluid and beats at the same rate as a native heart, displacing the biomembrane and mimicking the movement of the native ventricle wall during heart contraction: that motion admits and ejects the blood. A sensor monitors and regulates prosthesis operation according to patient’s needs.
At present, the investigational device is powered either by a hospital-based console or by an external battery with a battery life of four to six hours. An internal backup battery operates the artificial heart for 20 minutes. The company is currently developing a fuel cell that would increase device autonomy to 16 hours.