The fifth patient to receive an artificial heart produced by the Carmat Company died at the end of October. He underwent surgery in Nantes, approximately six weeks before his death, and was the first person to receive this artificial heart as part of a second series of tests involving twenty patients across Europe. The French National Agency for Medicines and Health Products Safety (ANSM) has instructed Carmat to suspend all implantations involving its cardiac prosthesis.
An ANSM spokesperson confirmed that, so far, it is unclear whether or not the transplanted heart was “responsible”. For its part, the Carmat Company confirmed in a press release that the prosthesis was not involved in the patient’s death. “We have asked Carmat to provide us with more information on the cause of death,” added the ANSM spokesperson.
Stéphane Piat, General Manager at Carmat announced that, “The prosthesis functioned normally during the first three implantations. Our motivation to provide an alternative for patients facing a therapeutic impasse is not diminished”.
At the end of last January, Carmat announced the death of a fourth patient and the end of its clinical feasibility trial to focus on a wider study.
Claire Macabiau, President of France Greffe Cœur and/or Lungs”has always urged caution, from the moment when the first implantation was announced”: “We were told that this person would be younger with less significant medical problems than the four previous patients. Therefore, it’s rather worrying”, she explained. She added that: “The Carmat Company doesn’t really communicate with us. We were informed more than one month after the death of the 5th patient”.
But the President of France Greffe Cœur et/ou Poumons, who herself underwent a heart transplant 19 years ago, remains positive: “We have to analyse all of the reasons behind the 5th death before implanting another device. We really should wait a little. The transplant works really well. We have patients who underwent transplant surgery more than 30 years ago. An average of 25 years is perfectly normal”.
Thierry Gesson, Vice-President of Fédération des Greffés Coeur-Poumon, explained that he was “a little bit disappointed”: “Perhaps I would have wanted to continue. Unfortunately, heart transplants with human grafts haven’t progressed a great deal over the last decade or so. We have to think about everyone who is waiting for a transplant today and all of those people with heart failure,” he explained. According to him, the Carmat artificial heart still “constitutes progress despite the deaths of five transplant patients to date”: “Like any element of progress, there are always failures at the beginning but you go on to achieve something in the years to come,” he explained. He had a heart transplant almost twelve years ago. He added: “There were results at scientific level, interesting results,” citing the example of one of the five patients who returned home, resumed sport and survived for nine months with the artificial heart.
As far as the Vice-President of the Fédération des Greffés Cœur-Poumon is concerned, the deaths can be partly explained by the state of health of the transplant patients, who presented with “extremely advanced heart failure,and who, in all honesty, were sadly going to die”.
The Carmat Society slumped when the Stock Exchange opened the day after the deaths were announced.
Franceinfo 01/12/2016
Le Monde 30/11/2016
Reuters 30/11/2016