CARMAT today confirms the announcement by the National Research Center for Cardiac Surgery on the successful transplant of a donor heart in the first international patient implanted with the CARMAT heart in October 2017
The surgery, consisting in the explant of the CARMAT bioprosthesis followed by the transplant of a heart graft, was successfully performed by the team headed by Dr. Yuriy Pya, CEO of the National Research Center for Cardiac Surgery, following 8 months of excellent support provided by the CARMAT total artificial heart (TAH).
The end-stage heart failure patient was initially not eligible for a heart transplant as he suffered from pulmonary hypertension. The implant of the CARMAT device was performed in October 2017 as a bridge to transplant within the framework of the PIVOTAL study.
The patient’s health condition improved considerably during the 8-month period due to the CARMAT device allowing the patient to efficiently recover from pulmonary hypertension, become eligible for transplantation, and ultimately successfully receive a donor heart in June.
The primary objective of the PIVOTAL study was largely met for this patient, as the study protocol calls for a 180-day (i.e. 6 months) post-implant survival or a successful heart transplantation replacing the device, within the 180-day timeframe.
Dr. Yuriy Pya, CEO of the National Research Center for Cardiac Surgery, comments: “This patient, who was not initially eligible for a heart transplant due to pre-existing pulmonary hypertension, was supported by the CARMAT TAH for 8 months. During this time, our team was able to monitor the improvement of the pulmonary hypertension assisted by the hemodynamic data which are continuously provided by the CARMAT TAH. The patient was in excellent condition before the transplant procedure and was only on light anticoagulant medication. The explant of the device left a natural space for the donor heart, which was then implanted according to our standard procedure. The patient is going well and we look forward to further contributing to the success of the clinical study of this exciting new therapeutic option for patients suffering from end-stage heart failure.”
Stéphane Piat, CEO of CARMAT, adds: “We congratulate the team at the National Research Center for Cardiac Surgery on this first donor transplantation in a patient who was supported by the CARMAT TAH. The outstanding follow up provided by Dr. Pya’s team to this patient underline the CARMAT strategy to work with centers of excellence for our international PIVOTAL study, which provides for the inclusion of both patients eligible and not eligible to a heart transplant. The excellent functioning of the prosthesis during 8 months together with the considerable improvement of the patient’s health condition reinforces our confidence in the potential of the CARMAT heart to efficiently treat end-stage heart failure.”