The patient “implanted with a Carmat® prosthesis at the end of August 2016, died,” Carmat said in a statement without specifying the date of death. Medical sources consulted by AFP, he died “about a month and a half after the transplant”.
Carmat assured that “the analyzes carried out did not show involvement of the prosthesis in the death of the patient”. The National Agency for the Safety of Medicines and Health Products (ANSM) told the press that the biotechnology group had “suspended the clinical trial following the occurrence of the death”, and at its request.
Speaking before the publication of the Carmat communiqué, the agency said it was waiting for “the results of the investigations that are conducted to determine whether or not the heart is involved in the occurrence of this death” and before “possibly reauthorizing New settlements “.
First implantation on a patient eligible for a classical transplant
This fifth patient was the first to receive this artificial heart as part of the “pivotal phase” of the Carmat clinical trial, launched at the end of August – the final step towards obtaining the green light for marketing Of his artificial heart.
The first phase of the trial (the feasibility study) was staggered from late 2013 to early 2016. Four patients had successively received the total artificial heart developed by Carmat. All died, but the goal of survival at 30 days after implantation for at least half of them had been achieved, paving the way for the pivotal study.
The pivotal phase of the study should cover “20 to 25 patients followed up to 180 days” in ten centers in Europe. Unlike Phase 1 of the study, recruited patients are eligible for conventional transplants. They are, however, “at the end of the waiting list”, and therefore unlikely to actually benefit from a transplant.
The four previous grafts under the magnifying glass
The first patient transplanted in December 2013, with Carmat’s bio-prosthetic heart, died 74 days after the operation carried out in Paris at the age of 76 years. The second, aged 69, died in May 2015, nine months after being transplanted to Nantes in 2014 and four months after returning home.
These two deaths had been caused by a “micro-leakage of the blood zone towards the operating fluid of the prosthesis”, causing a “disturbance of the motor control electronics” of the artificial heart, according to analyzes of Carmat .
The third patient suddenly died of respiratory arrest on December 18, 2015. The prosthesis, “in perfect working condition”, was not involved in his death, linked to chronic renal insufficiency, according to Carmat. This 74-year-old man had returned to his home in late August, after having been transplanted from the artificial heart on 8 April 2015 in Strasbourg.
The fourth patient, aged 58, who was implanted at the Pitié Salpêtrière hospital in Paris on 22 December 2015, died of medical complications related to his pre- and post-operative critical condition, indicated in January 2016 Carmat, stating that The prosthesis was not involved in his death.
“With the prosthesis functioning normally during the last 3 implantations, our motivation to provide an alternative to these patients facing a total therapeutic stalemate continues to grow,” commented Stéphane Piat, CEO of Carmat, quoted in the group’s release Issued on 31 November 2016.
The “Carmat® core” is lined inside a coating made of bio-materials derived from bovine tissues, to avoid the formation of blood clots, which distinguishes it from other models of this type of prosthesis.