Heart transplants are needed by patients who suffer from birth defects of the heart, dilated cardiomyopathy and those who suffer from severe coronary artery disease with scarred heart tissue formed after a heart attack.

However, transplant lists are getting longer and longer.

Research has been done on bioengineering tissues to grow organs such as the heart and kidneys in the lab, however blessed with advanced technology, human health can also be enhanced by artificial augmentation and implantation such as pacemakers, hearing aids, prosthetic limbs and hip replacements - just to name a few.

French company Carmat has taken it one step further in the world of transhumanist medicine, by creating an artificial, robotic heart that can be controlled by a power supply and monitoring system.

Their aim is to completely permanently replace the human heart for patients with end stage heart disease who have less than two weeks without surgery to eliminate the need to wait for a transplant.

The company started the project 15 years ago and recently announced their second trials, which commences in 2017 for European approval for their device.

However, how feasible is this?

Exceeding expectations despite patient deaths


When Carmat started out this project, their first trial endpoint was a survival period of 30 days. They had four subjects, all of which have passed away from complications related to the device.

The first transplant patient passed away in March 2014, two-and-a-half months after the installation of the heart due to a device failure. The second, in May 2015, nine months after the operation. Both deaths were caused by a "micro-leakage of the blood area to the operating liquid of the prosthesis", which led to a "disturbance electronic engine control" of the artificial heart, according to the analysis of Carmat.

The third also passed away after nine months, however the patient was suffering from a combination of severe diseases, particularly chronic kidney disease, which was diagnosed prior to the implantation of the prosthesis and required regular hospital visits. The cause of death was reported as the patient having suffered from "respiratory arrest during chronic renal failure" and when the medical team turned off the prosthetic device upon confirmation of the death, the heart still continued to beat.

Not much information regarding the fourth patient was released. It was just stated that the patient died from medical complications associated with his pre- and post-operative conditions.

One thing to bear in mind is that the endpoint of the survival period was 30 days. That is, 30 days more for the patients who were facing no other alternatives and were nearing their death. However, the heart enabled some of them to live for up to nine more months, and that should exceed expectations and prove the feasibility of the robotic heart, at least in dying patients.

The company will enrol 25 patients for their second trial and push their endpoint to a survival period of three more months. Consequently, after the trials, the company aims to commercialise the robotic heart at the beginning of 2018 in selected Central European countries according to Carmat CEO Marcello Conviti.

Prepare to have a heavy heart


Literally - the device is three times heavier than an average human heart, which is not surprising, as it is made up of biomaterials such as tissue obtained from a cow's heart and a five-year lithium battery to operate it.

Carmat is not the first to develop an artificial heart. Past attempts have been made and the pacemaker is one good example. The difference is that Carmat aims to make their version self-regulating, to mimic the real human heart, through an array of complex sensors.

The valves and membrane sac in the robotic heart are developed from cow heart tissue and has sensors installed to regulate the pressure within the device. The information from the sensors allow an internal control system to adjust the flow rate in response to the patient's body demands.

During the post-operative period however, the heart is connected to an external power supply and a monitoring system to allow doctors to control the heart. Subsequently, a portable power supply is used for outpatient visits. A communication system is also supplied for the patient to communicate with his/her doctor should any problem arise.

Is there a future for the artificial heart?


Like any controversial scientific product or invention, people against it are uncomfortable with the idea - despite it being potentially better than the original biological version. For example, 30 years ago when prosthetics were seen as a medical innovation, most people were not comfortable.

Generally, the majority are just not ready to step into the world of cyborgs unless they need to. But what if the artificial heart will perform better than the biological heart? Will people queue up when it becomes available? Probably - if they can afford it - the Carmat heart costs USD$200,000.

Looking at a broader perspective, the future of artificial hearts may be bright. They could replace the need to visit a doctor as the device will be able to monitor the health and blood of the patient - if the alcohol content is too high or if an infection has occurred, to name a few.

They can also have computer chips and Wi-Fi features built into them, allowing the heart to be controlled remotely or even via smartphones.

Assassination made easy


Recently, pacemakers made by medical device company St. Jude were claimed to be hackable by MedSec, a cybersecurity research company and Muddy Waters, an investment company.

Scientists from the University of Michigan have been asked to investigate into the issue. A mixed response was collected as there was a lack of clinical data available and no substantial evidence to prove that the pacemakers could be hacked. St. Jude has since filed a lawsuit against MedSec and Muddy Waters.

This nonetheless did not help in dispelling the fear of thousands of people depending on pacemakers. Even back in 2014, the former vice president of the United States Dick Cheney who relies on a pacemaker, had the wireless functionality of his heart implant disabled due to fears of an assassination attempt. Which begs the question, is it possible to breach the security?

It is not entirely impossible as other research has revealed that medical devices such as insulin pumps are also vulnerable to security breaches. This may be the biggest disadvantage of artificial hearts. These artificial hearts are the lifeline of future patients and if hackers or an authoritarian government targets a well-known person with an artificial heart, viruses could be transmitted into the heart's software or passwords controlling the heart on your smartphone could be misused.

This does place many robotic and especially biomechanical devices in a tight spot despite their possible capabilities in the medical world. Not to mention, a whole array of ethical issues that have to be taken into account. MIMS

Sources: 
http://spectrum.ieee.org/the-human-os/biomedical/devices/were-pacemakers-from-st-jude-medical-really-hacked
http://d.muddywatersresearch.com/wp-content/uploads/2016/08/MW_STJ_08252016_2.pdf
http://www.theregister.co.uk/2016/09/07/st_jude_sues_over_hacking_claim/
http://motherboard.vice.com/read/era-artificial-heart-permanent-transplants
http://readwrite.com/2016/09/07/how-close-are-we-to-the-robotic-human-heart-dt4/

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