No longer let you "heartbreak": permanent full artificial heart is about to "service"

Release date: 2017-01-18

Syncardia Systems' "Full Artificial Heart" (TAH) implant renderings.

Carmat artificial heart implant renderings.

BiVACOR's artificial heart prototype.

The human heart is an engineering miracle. In the chest of an ordinary adult, the heart beats about 100,000 times a day. The blood of the human body can go up to the brain and down to the fingers and toes. The "behind the scenes" is the heart of the pump and the elastic arteries. The heart has four chambers, one on each side and one in the ventricle, used to pump blood throughout the body.

The design of nature is so enviable for engineers. Since the 1950s, countless scientists have been trying to develop artificial hearts, but the results are always unsatisfactory. According to a recent report by IEEE Spectrum, four companies around the world claim that they have found the right technology. In 2017, clinical trials and animal testing may eventually prove that a permanent artificial heart is expected to enter the patient's chest for life.

Simulated natural heart

At present, about 5.7 million people in the United States are diagnosed with heart failure, and many patients can only wait in line for heart transplants, but donors are embarrassed. It is reported that there are only 2,000 to 2,500 heart donors in the United States each year. Thousands of seriously ill patients have to undergo heart transplant surgery. It takes several months or even years to wait for many people to die.

The "Man-made Heart (TAH)" developed by SynCardia Systems, Inc., based in Arizona, USA, has been reviewed by US regulators. Although the SynCardia TAH function is very good, it can only be used as a “transitional therapy before heart transplantation”, and the air compressor needs to be replaced every 3 months.

Now, the company is recruiting patients to conduct clinical trials of the device as a permanent heart substitute. The company's CEO, Michael Garryp, said the trial only recruited 28 patients because more than 1,600 implants have proven the artificial heart to be safe.

According to Gary, the device is designed to be simple and durable, "there is almost no electronic product in the patient's body." SynCardia's heart uses two plastic ventricles to simulate the heart's functioning ventricle; each plastic ventricle is divided into two lobes by a diaphragm, which is filled with air and loaded with blood. Patients with SynCardia TAH will carry an air compressor of approximately 6 kilograms, connecting the tubes through the abdomen to deliver air to the two ventricles, pushing the diaphragm to drive blood circulation on the other side. The air compressor has a large hammering frequency with a frequency of 120 times per minute.

A French company called Carmat wants to do better. The company's chief medical officer, Pete Janssen, said: "Our equipment is quiet." Like SynCardia's equipment, Carmat's heart also has two artificial ventricles with aponeurosis, pressed outwards to pump blood circulation, but its use It is not compressed air, but a hydraulic fluid driven by an implanted pump. Although Carmat's artificial heart is bigger, heavier and more complex than SynCardia's equipment, the company's designers are proud of the sensors they provide and the microprocessors that calculate heart rate changes.

The first feasibility study of the Carmat artificial heart seems to be unfavorable: two of the four patients died within three months, but industrial analyst Andrew Thompson said the patients themselves were very ill, "not so much equipment The failure is not as good as the patient's body itself has been exhausted."

The company hopes to implant the device into 20 patients by the end of 2017; it will be certified as a permanent implant in Europe in 2018.

Eliminate mechanical wear

Two other companies that have not yet entered the clinical testing phase will take a different approach and adopt a completely different technology. Some experts believe that this technology is more promising. “Man-made mechanical devices are unlikely to stabilize the heart for 35 million beats per year without wear because they do not have the heart's self-healing function.”

As a result, the two companies did not use a beating diaphragm, but instead used a centrifugal pump with a rapidly rotating fan-shaped blade to push the “continuous blood flow” through the artery. In 2015, an experiment conducted by Cleveland Hearts Inc. (based on technology developed by the Cleveland Clinic in the United States' top comprehensive medical facility) allowed two calves to live healthy for 90 days. Another company, BiVACOR, is currently working with the Texas Heart Institute to conduct a 90-day study with calves.

BiVACOR's product design is simple: a rotor with two blades rotates in a small titanium chamber, a small blade compresses blood into the right ventricle and reaches the lungs; larger blades allow blood to flow out of the left ventricle into the circulatory system. All over the body. The rotor is suspended in the magnetic field, and the loss is further reduced by the elimination of friction. The magnetic levitation technique controls the rotation of the blade to match the amount of activity of the user.

This device eliminates mechanical wear and failure from the source, and only Carmat heart 1/3 size, high energy efficiency, large output, suitable for a variety of body types. But the potential drawback is that the blood produces a small amount of foam that can cause internal bleeding, stroke or other complications.

At present, the two companies are still adjusting their designs and hope to conduct human trials as soon as possible.

Cardiac surgeon Gianluca Torre Grossa has repeatedly implanted SynCardia devices into patients, and he is very optimistic about the two companies.

Let time judge

All of the above four companies need to conduct clinical trials in a very harsh environment to prove that their technology is feasible. A number of clinical trials in 2017 may show us an engineering miracle created by people rather than biology.

William Cohen, director of the Center for Technology and Innovation at the Texas Heart Institute, said: "Perhaps BiVACOR will prove to be a huge failure; perhaps Carmat's subsequent human trials will be a huge success, and only time will reveal the answer." One of the technologies works, and it is possible to get the patient out of a long and painful wait.

What is the ultimate goal of permanent TAH? Can it replace a heart transplant? These questions are only given to the time to "judgment."

Source: Technology Daily

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