Digitized Heart

Prospects of personal cardiomedicine

Mikhail Petrov, "The Attic"

Digital technologies are increasingly coming to the modern clinic: now, according to genome data, they can choose the optimal treatment, and the composition of bacteria in your stomach will help you decide on a suitable diet. Digital cardiology also has its own achievements: Igor Efimov, professor at George Washington University (USA) and the Moscow Institute of Physics and Technology (MIPT), told the correspondent of "Attic" about implantable sensors that monitor the state of the heart, dissolving pacemakers and other breakthroughs in cardiomedicine.

– Is there a demand for "digital" cardiology in society?

– Five or six years ago I was in St. Petersburg at a conference meeting with the Russian scientific diaspora, and before that I was talking on the radio about how my company is developing an implantable defibrillator for the treatment of atrial fibrillation. The very next day, a whole delegation came to me: it turns out that there is an association of patients with atrial fibrillation in St. Petersburg – they could not find treatment in any way and asked me when it would be possible to buy our device. So I think the demand in society is very serious: cardiovascular diseases are one of the leaders in the world statistics of mortality and lost man-hours.

– And how is atrial fibrillation treated now?

– Many arrhythmias occur due to malfunctions in a very small area of the myocardium, and if it is cauterized by electric current, then the arrhythmia goes away. This is called the ablation method, and it is the only method of treating atrial fibrillation that currently exists. The patient is placed on the operating table, an incision is made in the groin area, a catheter is inserted into the heart through a vein, tracking the entire process on an X-ray machine, and then an intense electric current with a frequency of about a megahertz is applied to the desired area. The heart tissue in the area of contact with the electrode heats up to 60 degrees Celsius, and you literally destroy the diseased myocardial cells, which are eventually replaced by a scar, but do not touch the rest of the healthy heart. True, it is often necessary to burn not just one point, but whole lines, which inevitably reduces the volume of the remaining healthy myocardium, but for many patients with atrial fibrillation this is more than justified: atrial fibrillation is sometimes deadly and so worsens the quality of life that you have to choose. But, unfortunately, ablation is available to very few patients, because hospitals simply lack the necessary equipment, good diagnostics and doctors who are able to perform such operations.

– How is your approach different?

– Our implantable defibrillator for the treatment of atrial fibrillation acts more pointwise and corrects the work of errant areas of the myocardium as problems arise. It is similar to a defibrillator for the treatment of sudden cardiac death, but it works with less energy, and therefore, hopefully, it is less painful for patients.

This was our main task – to reduce the intensity of the current and minimize the proportion of false positives, because people with atrial fibrillation are always conscious, and they do not want to receive unnecessary or too painful electric shocks at all.

Now the private company Cardialen is engaged in this device, and it seems to me that we are close to success: the device is at the stage of clinical trials.

– In your speech at the Open Innovations conference, you mentioned the second company.

– The second company that my colleagues and I have just created is called Cardiaform, and it is engaged in the creation of both invasive and non–invasive flexible electronic devices for the diagnosis or treatment of the heart, including using the ablation method. Our devices will not be soldered in iron, but will repeat the shape of the heart. Maybe we will even do them individually for each patient, if necessary. The flexible plastic frame of the device will echo the heartbeats – expand and contract, which will greatly improve the sensitivity and accuracy of diagnostics. In addition, we will make wearable electronics devices – for example, a disposable sensor that attaches to the skin and tells you when you have spent too much time in the sun and it's time to hide in the shade.

– Here you will have many competitors: Apple Watch, Fitbit, many other companies.

– Yes, but they have drawbacks: no mass manufacturer of fitness bracelets has yet learned how to take an ECG, and medical devices for recording ECG do not yet know how to work automatically, online. For example, iRhytm makes good portable sensors for ECG recording, but it takes two weeks to decrypt their data. The patient walks with the device, then his records are sent to the office, where they are first analyzed automatically using various algorithms, and then real people finish all the work with pens. Otherwise, it is impossible to reliably find all the anomalies and negative events in the heart rhythm now. As a result, I have heard of at least one case where a patient died while his recording was being decrypted.

A three-dimensional flexible device for multifunctional diagnostics of the rabbit's heart condition. Blue light is provided by a built-in LED, the radiation parameters of which depend on the transmembrane potential of the heart. Image: Nature

– So, soon we should expect breakthroughs in this area related to neural networks or other advanced information processing algorithms? Are they supposed to help set up the process?

– Now everything in this area rests on sensors, not on information processing algorithms – this is a bottleneck. Data from modern sensors is too raw to be processed efficiently and quickly on a computer. That is why we are so hopeful about our approach with conformal, heart-shaped electronic devices.

– What materials do you use for this?

– We use various "smart" polymers that can change their structure and properties under the influence of external excitations, and choose those materials that have already received permission for clinical use. For example, they could have been used as insulating materials on electrodes for many years and during this time show only minimal side effects. In addition, we make completely new materials for our devices – electrically conductive polymers (they both remove the signal from the heart and are simultaneously used for electrical stimulation) and biodegradable polymers.

– Why do you need biodegradable materials?

– Sometimes you need to make some kind of implantable sensor that monitors the heart, or a diagnostic therapeutic machine that will work only for a certain time. For example, some heart procedures may cause a temporary block of impulses between the atrium and ventricle, which lasts two to three weeks. At this time, a person is put on a pacemaker. Then the block is removed, the need for a stimulator disappears and the patient is put back on the operating table to remove the device. With biodegradable materials, everything will be easier: they will work out the same two or three weeks, and then you will send a signal and the device will dissolve in the body without any consequences.

– Due to what such a heart implant will work all this time? Does he have built-in batteries, which can also decompose in the body without consequences?

– There are no batteries in our device – we transmit energy inductively from a coil outside the body: first, a temporary implant is implanted in the patient, then it is pumped with energy for the required period of time, and then it simply dissolves on a signal from the outside. With a continuous supply of energy from the outside or work on your own resources in this area is still difficult. The first approach is too expensive and inconvenient – a patient with an implanted stimulator, it turns out, should always be near an energy source, and for the second there are no batteries suitable in capacity, size and compatibility yet.

– And what is the situation with information? Can it be transmitted constantly?

– Not yet, the information is transmitted only during synchronization sessions in the same way as with our competitors. For example, there is an interesting Medtronic Reveal Lynq device – they implant a small cylinder under the skin that can continuously record an ECG, but it only sends data to a special receiver, and only when you are no further than two meters away from it. Such a receiver can be installed at home, in the country, in the car, and it is not necessary to go to the hospital – he will send all the data to the doctor himself, but no one can continuously record the activity of the heart and transmit it, for example, to a mobile phone yet.

– Are you not afraid of hackers who can interfere with the operation of implantable devices for diagnosis or therapy of the heart?

– There are such fears and this is a big problem, because the same defibrillators or pacemakers can kill a person if someone sets this goal, but so far I have not heard of such cases. Therefore, many companies do not want to disclose their protocols for collecting and transmitting information, which also creates difficulties for personal cardiomedicine: data from different companies turn out to be incompatible with each other, and it is not yet possible to create a large common base for training algorithms or for constant monitoring of patient health.

– How to solve this problem? Without a single base and unity of approaches, digital cardiology will not become a real medicine

– There are independent hospitals in the USA with tens of thousands of employees, millions of patients a year and huge databases. They have enough power to force all manufacturers of implantable equipment to develop compatible formats – in the medical world, no one can afford to lose such large markets. Similar things are currently being done at the Mayo Clinic and the Cleveland Clinic: they are making an add-on that can read raw data from 20 different devices from different companies and translate this data into the clinic format. At the same time, if manufacturing companies are closed organizations and their data is protected by trade secrets, then the blades themselves are already open organizations and their generalized data should become available to all people. It seems to me that there is no other way to solve the issue of a single format of medical data - at least in America. There, the state has neither the right specialists nor the levers of pressure to use laws to force medical firms to come to uniform formats and make uniform electronic medical records for all patients; such a top-down approach can be effective only in Slovenia, Finland or other relatively small countries where the main player in the medical market is services – the state itself.

– And then who should bring mass digital medicine to Russia – private companies or the state?

– Russia may just have problems. On the one hand, this is not a very large market for private companies and hospitals and, as a result, they do not have sufficient strength in Russia. On the other hand, Russia is not such a small country to introduce digital medicine from above, but history shows that all innovations in healthcare are always gradually spreading around the world. Therefore, sooner or later digital medical records will be available in Russia.

– A recent study by the Higher School of Economics showed that only 30% of Russians are ready to use implantable health sensors, and for many people such technologies even look unethical and dangerous.

It was the same with pacemakers: when they first appeared in the USA and Western Europe, most patients did not want to use them, and one or two generations of people changed until they adopted these devices. The same will happen with digital cardiology: the same Reveal Lynq devices – they are, of course, for diagnostics, not for therapy, like pacemakers, but people were still wary of implanting them into their bodies at first; now Reveal Lynq has a huge market of $ 500 million a year. Over time, people will realize how much they benefit from implantable devices, and everyone will forget about the rejection of such technologies.

Portal "Eternal youth" http://vechnayamolodost.ru 11.11.2016