Cardiovascular diseases claim more lives than all cancers combined. Heart failure is the No. 1 killer in the world. Almost half of patients suffering from a heart failure die within a year. 100, 000 patients in the USA and Europe alone are on the transplant lists, but only 4, 000 donor hearts are available each year.
The first time an artificial heart was implanted into a person’s chest back in 1969 it served as a temporary replacement, a bridge, for a transplant. 13 different designs have been proposed and over 1, 400 artificial hearts intended as a bridge to donor heart transplant were implanted in patients with end-stage biventricular heart failure. 96% of all these implants were the SynCardia temporary Total Artificial Heart.
Although a brilliant temporary solution (P. Zorzetto lived almost four years on SynCardia’s heart before a heart transplant), it still requires a person to carry around a suitcase containing external components, limiting their productivity and the quality of their lives. There were many attempts to design a fully integrated artificial heart, which could serve as a permanent replacement for a failing human heart, but there were no land on the horizon.
After 30 years of research and development, ABIOMED Inc. developed the AbioCor total artificial heart, fully implantable within the body. After the clinical trial, which enrolled 14 patients, the FDA approved its use in 2006. Since then, only one such heart was implanted. Although everyone claims that no device malfunctions have been recorded, this fact alone confirms that there must be something that makes this solution unattractive. No additional information can be provided on the grounds of patient confidentiality issues. ABIOMED is currently developing an improved model of an implantable replacement heart, named AbioCor II, which will be much smaller, and which is expected to achieve better results than its predecessor.
A hope was awakened in 2013 when a team of surgeons at the Georges Pompidou Hospital in Paris performed their first successful artificial heart implant operation. The device manufactured by CARMAT SAS biomedical company is hailed as the most promising total artificial heart implant. It is fully autonomous, made from biomaterials that prevent blood from clotting, and equipped with sensors which regulate the blood flow according to the patient’s activity. It took CARMAT 15 years to develop this model.
A 76-year old recipient of this heart, diagnosed with a terminal heart failure, died 74 days after the operation. Nevertheless, it was a great success, since his organism didn’t reject the implant, nor there were any other problems which can arise from the use of synthetic materials. Having in mind that there is no viable option for this group of patients in the final stage of life, and that these kinds of surgeries are considered successful if a patient survives for more than 30 days after the operation, this pioneering step might be just the right answer for heart replacements.
In August 2014 the second patient underwent the same operation in Nantes University Hospital. After the recovery, in January this year, he has been released from the hospital and returned to normal life. CARMAT’s clinical trial, that aims to enroll four patients in the first stage of the trial, and, if all proves positive, twenty more in the next stage, aims to test the safety of their device, and prove that recipients can return to normal life after the treatment.
Weighing 2lbs, this artificial heart is of the size which can only fit in 86% of men and 20% women (three times the weight of an average human heart), although CARMAT is working on a new model that could fit in all adult patients.