The company Carmat, which produces and sells prostheses among which also the prosthetic heart or artificial heart, said he had sold one of his artificial hearts for the first time since its foundation in 2008, for implantation in an Italian patient awaiting transplant. The company obtained the European CE marking in December 2020 for the sale of the Aeson prosthetic heart as “bridge for transplantation “.
Prosthetic heart: some details on the study
The operation “It was performed by the team led by heart surgeon Dr. Ciro Maiello in the hospital Colli Hospital of Naples, one of the centers with the greatest experience in the field of artificial hearts in Italy,The company explained in a statement.
All this was made possible by the results of a study known by the name PIVAL, undertaken in 2016 and still ongoing today. In November 2019, the results of the first 11 patients involved in the study showed that 73% survived for six months with the prosthesis or managed to undergo a successful transplant during the same period.
Carmat said the first commercial sale of his artificial prosthetic heart marked “an important milestone that opens a new chapter in the development of the company “, adding that he hopes to find more customers in France is Germany before the end of the year. A spokesperson told theAFP which was the first time one of the hearts was used outside of a clinical trial.
The costs for the operation – more than 150,000 euros ($ 177,000) – were borne by the regional health system, as the Italian national system will not cover treatment until it has been in use for several years On July 15, Carmat announced the first implantation of an Aeson prosthetic heart in a patient in the United States, in a clinical trial at Duke University Hospital of Durham, North Carolina. Now the company is looking for 10 eligible patients to participate in a study approved by the US Food and Drug Administration.
Aeson prosthetic heart: this is how it was born
An experimental artificial heart includes a self-regulating control mechanism, or Auto-Mode, which can adapt to the changing needs of patients treated for end-stage heart failure. The outcomes of the first series of patients managed with the new cardiac replacement pump in Auto-Mode are presented on the ASAIO Journal, official journal of the American Society for Artificial Internal Organs.
The study reports the answer to “self-regulation of blood flow based on pressure sensors”In ten patients up to two years after implantation of the Carmat Total Artificial Heart (CTAH). “Automatic C TAH mode with integrated pressure sensors effectively produces appropriate physiological responses that reflect changing needs daily of patients and therefore provides almost physiological cardiac replacement therapy “, was pioneered in the new research. The lead author is Ivan Netuka, MD, of the Institute of Clinical and Experimental Medicine, Prague.
Heart replacement pumps can restore cardiac output in patients with end-stage biventricular heart failure (affecting both sides of the heart) whose only other option is a heart transplant. However, to allow patients to return home from the hospital and return to their normal activities, the pump should emulate normal heart function, with minimal need for adjustment.
To achieve this, the TAH C incorporates a automatic mode that automatically adapts the pumping action of the right and left ventricles in response to the pressure sensors located inside the device, based on the parameters set by the physician. The goal is to mimic normal physiological responses to changing needs, especially physical activity.
The Dr. Netuka and colleagues studied the performance of Auto-Mode in the first 10 patients who underwent C TAH implantation in the first European clinical experiences. The patients were all men, mean age 60 years. The C TAH was used as a bridge for heart transplantation in six patients and as a permanently implanted device in four.
In all patients, the artificial heart was successfully switched from manual control to automatic mode in the operating room. The automatic mode led to “an immediate response of appropriate cardiac output ”To the targeted settings. Hemodynamic data recorded by the C TAH showed expected changes in the pumping output of the left and right ventricles, in response to changes in pressure and heart rate. Heart rate averaged 78 to 128 beats per minute; blood pressure was also normal.
In nearly five years of aggregate follow-up, medical teams only made changes to the automatic mode settings 20 times. Most adjustments were made during the first 30 days after device placement. Only four were done after the patient returned home from the hospital – a rate of about 1 change every 11 months.
“The reduced need for device management changes can contribute to greater autonomy for patients outside the hospital setting and to improving their quality of life“, Write dr. Netuka and the co-authors. They recognize that their practice is an initial experience in a relatively small number of patients.
“However“, They add,”represents a significant leap into the next phase of replacement therapy cardiac more physiological. The overall experience of over four years of device performance represents a positive and promising result for patients, while requiring only minimal intervention by the clinician “. Researchers plan further refinements based on preliminary results; future studies will provide data on exercise response and hospital readmission rates. A clinical trial of the C TAH is expected to begin shortly in the United States.
Here’s how a prosthetic heart was implanted in Naples
Carmat’s first prosthetic or bioartificial heart was transplanted to a 56-year-old patient who is not eligible for a heart transplant, declared the Azienda Ospedaliera dei Colli.
“The device, unlike the Syncardia device, which is totally mechanical, has biological valves and works with small electric motors that pump blood into the aorta or pulmonary artery, and is also designed to self-regulate the range of blood flow thanks to in the presence of sensors and software “, it is emphasized. “
“The device – explains Marisa De Feo, director of the UOC of General Cardiac Surgery e Director of the Department of Cardiac Surgery and Transplantation – was implanted in a patient who, due to his clinical condition, was not eligible for heart transplant. Thanks to this intervention it will be possible to restore the lung function necessary to start the process for inclusion in the list transplants “.
“The optimal management of this procedure was possible thanks to multidisciplinary work and the cooperation between those who, in our department, for years, have been selecting patients with appropriate indication for total artificial heart implantation and the Carmat specialists who have followed us both in training phase, which took place at the laboratory of the Georges Pompidou hospital in Paris, which during the delicate operating and perioperative phase“. “This new technology – adds – it is much quieter and easier to manage in the post-operative phase, and ensures patients a better quality of life “.
“The Azienda Ospedaliera dei Colli is proud to have been the first center in Europe selected, after the experimentation phase, by Carmat for the implantation of this innovative device.” He says Maurizio di Mauro, general manager of the Colli Hospital. “With this additional tool available – concludes – we are setting another step to offer patients suffering from advanced heart failure the best possible care ”.
The treatment of the bioartificial prosthetic heart was performed by the team headed by Ciro Maiello, in charge of the UOSD Cardiac Transplant Surgery and made up of cardiac surgeons Cristiano Amarelli is Viviana Galgano, by anesthesiologists Antonio Pisano is Daniela Giordano, by the nursing staff Carlo Bianco, Viviana Di Lorenzo is Rossella Cardenio, by perfusion technicians Ivana Almerazzo ed Emanuele Petrazzuolo and by the cardiologist Vittorio Palmieri who followed the patient along the path that led to the surgery. In support of the Monaldi team ready to assist with Carmat’s multidisciplinary team composed of professor Christian Latremouille, doctor Claude Girard and technicians Pauline Devaux is Josef Nowak.
The patient is currently hospitalized in intensive cardiac surgery, directed by Nicola Galdieri, and is constantly monitored. The conditions are stable and he breathes spontaneously but, considering the complexity of the intervention, the prognosis is reserved.