What a time to be alive. CARMAT, a French company specializing in developing artificial hearts, has announced that it has successfully, for the first time ever, managed to implant an artificial heart in a new clinical trial. The success of this clinical study, named the PIVOTAL trial, will hopefully lead to European regulatory approval.
The artificial heart is similarly sized to the real thing and is powered by an external source. It is designed to closely mimic the natural biomechanics of a human heart, and with the help of the external power source it may be able to sustain patients continuously for years if the trial and subsequent observations prove successful.
This revolutionary creation was a creative collaboration between doctors and engineers. The project was engineered by team consisting of Dr Alain Carpentier, the developer of mitral valve repair, and mechanics and engineers from Airbus. Yep, it is the same Airbus that manufactures civil aircrafts and large jets.
This collaboration was necessary because while the mechanism of heart might be understood for years, but to continuously supply power, and to move fluids around without creating stress and turbulence to such an intricate organ for years, is a major engineering feat.
With this latest discovery CARMAT aims to design and deliver the most advanced fully functional artificial heart transplant to patients suffering from end-stage biventricular heart failure. The first implantation of its bioprosthetic artificial heart was carried in accordance with the authorization received from ANSM (French national agency for the safety of medicines and health products) and CPP (Patient Protection Committee).
By pursuing the development of its totally artificial heart, CARMAT intends to overcome the well-known shortfall in heart transplants for the tens of thousands of people suffering from irreversible end stage heart failure, the most seriously affected of the 20 million patients with this progressive disease in Europe and the United States.
Indeed, according to the Centers for Disease Control and Prevention (CDC), heart attack remains the number one killer in the US. With this discovery, CARMAT will potentially benefit the lives of thousands of patients a year with no risk of rejection and with a good quality of life.
CARMAT has managed to develop a first of its kind artificial heart that provides proper hemocompatibility. The issue of hemocompatibility is a highly important one and can lead to destruction of red blood cells (hemolysis) or activate the coagulation chain (thrombosis), which can result in the formation of a clot that blocks a blood vessel, leading to pulmonary embolism or a cerebral vascular accident.
What CARMAT has managed to do is nothing short of a miracle: optimized design for ventricular cavities. The scientist managed to include a physiological ejection movement by the membrane, mimicking ventricular contraction and ensuring the ventricles empty at each cycle.
The scientists incorporated microporous biological and synthetic biomaterials which enable continuous protein-like coverage, which allows all surfaces of the artificial heart to come in direct contact with the blood. The scientists have managed to create the only device using biological valves proven to have low long-term thrombogenicity.
Why Heart Failure Is Such A Big Problem?
The term heart failure is used when the heart no longer carries out its essential function of pumping blood and supplying it to all of the other organs in the body. The main causes are coronary artery diseases and hypertension. The commonest complications are dysrhythmias, thromboembolic events (clot formation) and kidney failure. It is a severe progressive and often fatal disease. Almost half of patients die within a year after their first hospitalization.
The treatment of heart failure is mostly palliative, meaning it often revolves around reducing the pain instead of treating the actual condition. The treatment usually involves drugs, cardiovascular rehabilitation, multi-site pacing, conventional surgical revascularization, mitral annuloplasty and mechanical circulatory assistance techniques.
The only treatment for patients with advanced bi-ventricular heart failure who do not respond to any of these treatment options is cardiac transplantation. However, fewer than 4,000 donor hearts are available each year throughout the world compared to over 100,000 patients waiting in line.
The first in-man implantation was performed on December 18, 2013, and was funded by the European Commission. CARMAT has been granted the largest subsidy ever given to a small and medium sized enterprise by Bpifrance, a French investment bank, a total of €33 million. CARMAT was awarded the right to conduct these trials in 2013. At the same time, CARMAT had begun legal procedures to obtain approval to implant its artificial heart in other European countries.
There have been many remarkable innovations in the world of cardiac medicine. Experts from Stanford University School of Medicine have found that the heart muscle cells made from human induced pluripotent stem cells (hiPSCs) under lab conditions resemble gene expression of the donor heart tissues. The study found that genetic expression of particular cardiac proteins involved in metabolic and stress pathways lead the variation of drug response amongst various individuals.
This discovery will take us to new beginnings in cardiac treatment and corresponding precision cardiovascular medicine that explains how some drugs lead to heart damage for few people and not for the other, suffering from a similar ailment. This breakthrough cardiac research was recently published in the journal, Cell Stem Cell.