Gino Gerosa: “In two years the prototype of the tailor-made artificial heart"

The problem is well known, but no less deserving of a rapid, definitive and timely solution. On the contrary.
There are fewer and fewer hearts to transplant: they must in fact be perfect, without structural alterations, and this is not always the case in reality.
In Italy alone, around 750 patients are on the waiting list, 30 percent of whom risk dying before reaching the transplant.
The question is particularly close to the heart, it should be said, of a cardiac surgeon above all, a true luminary of the subject: Gino Gerosa, Full Professor of Cardiac Surgery atUniversity of Padua, Scientific Director of the Consortium for Health Research of the Veneto Region and, in November 2018, also elected President of the Italian Society of Cardiac Surgery.
Born in Rovereto in the province of Trento on 27 October 1957 and already a student of the Nunziatella military school in Naples, he graduated in Medicine and Surgery from the University of Verona, then specialized in Cardiac Surgery and worked in London for two years under the guidance of the British professor Donald Ross.
To counter the unfortunate situation of the shortage of cardiac organs, Gino Gerosa carried out, for the first time in Italy, the transplant of a heart that had been stopped for 20 minutes. In the case in question, the Paduan team directed by him had used a donor who was already in cardiovascular death and for whom it was not necessary to stop the heart but, on the contrary, to restart it. Once he returned to bat, the usual transplant procedure was followed.

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In 2007, the doctor from Trentino also performed the first total implantation of an artificial heart in Italy, referred to as Total Artificial Heart, in the acronym TAH.
The device, called “CardioWest 70cc”, consisted of two polyurethane chambers, each of which was divided in two by an elastic septum which, thanks to a pneumatic system, pumped blood into the arteries in place of the patient's malfunctioning native ventricles. Also due to the strong emotional impact, the intervention was covered by the press and national television with great and justified emphasis.
On 12 September 2011, Gino Gerosa's team removed the "Cardiowest" artificial heart, 1300 days after the application of the implant, to replace it with a real human heart, coming from a donor.
In 2015 in Padua, for the first time in the world, a microinvasive aortic valve bioprosthesis and repair of the mitral valve with a beating heart was also carried out. The surgical operation, performed by entering from the tip of the heart, allowed the patient's complete recovery and the total resolution of his cardiovascular problems.
In this context and on the basis of these extraordinary skills and experiences gained over the decades, the project to create a new Italian artificial heart began, again entrusted to the team of Gino Gerosa, who is interviewed by the editorial staff of Innovando.News together with the Italian one of Biomednews.it.

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Professor, can you confirm that the prototype of the first Italian artificial heart will be ready within two years?
“I confirm it, yes. The study will cost 50 million euros and will last five years, but in two we will have the prototype. To achieve it, the contribution of doctors, engineers, biologists and experts in biocompatible material will be necessary. We have found solid financial foundations to give substance to the project and we should be at a turning point. The first two years will be used to produce the prototype with which we will then proceed with bench tests and, if these are satisfactory, preclinical testing."

How does it differ from other artificial hearts already used?
“We tried to answer three questions: optimize the biocompatibility of the system to guarantee the best quality of life for the patient, reduce its dimensions to guarantee its use in all patients, regardless of gender and body size, and understand it no longer as a bridge to transplantation, but as a definitive replacement of the heart organ. Therefore as an alternative to a heart transplant, in such a way as to have a total artificial heart available. The patient who presents with a therapeutic need of that type will not have to wait for a potential donor, but the solution will be available immediately on the shelf in the operating room."

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Is it possible to estimate how many devices could be needed each year, once the heart is industrialized?
“In Italy, there are approximately 750-800 patients on the waiting list for a heart transplant and we respond to these in approximately 35 percent of cases. Once industrialized, the new artificial heart will be able to give a response of 60 percent. It must be taken into account, however, that to be put on the waiting list for the transplant you must not have contraindications which, most likely, would not apply to a total artificial heart".

Is this a personalized, "made-to-measure" device, or is standardization expected instead?
“It is personalized, in the sense that it is a device that should provide for the internal surface of the artificial ventricles to be repopulated by the endothelial cells of the potential recipient. In this case it would, in fact, be a customization. From the point of view, however, the mechanical-electrical sector is standardized".

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From a production point of view, where will it be made?
“These are subsequent steps that we will begin to take into consideration when the first devices are tested in the preclinical animal model and we will have clearer ideas on the industrial feasibility of the project itself”.

How many years have you been working on the project? What are the obstacles still to be overcome to make it happen?
“We have been thinking about the total artificial heart for at least ten years. Previously, the biggest handicap was the lack of stable financial resources. Now that we have these financial resources, and can develop the project, we have given ourselves a two-year timeline to produce the prototype. At the moment there are no obstacles, the result depends exclusively on our ability to know how to run to give substance to our ideas."

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Ten years to find stable financial resources leads us to a simple question: was all that time necessary?
With more timely responses, today we could already have the first artificial hearts implanted.

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