Summary Background The development of artificial hearts in patients with end-stage heart disease have been confronted with the major issues of thromboembolism or haemorrhage. Since valvular ...bioprostheses are associated with a low incidence of these complications, we decided to use bioprosthetic materials in the construction of a novel artificial heart (C-TAH). We report here the device characteristics and its first clinical applications in two patients with end-stage dilated cardiomyopathy. The aim of the study was to evaluate safety and feasibility of the CARMAT TAH for patients at imminent risk of death from biventricular heart failure and not eligible for transplant. Methods The C-TAH is an implantable electro-hydraulically actuated pulsatile biventricular pump. All components, batteries excepted, are embodied in a single device positioned in the pericardial sac after excision of the native ventricles. We selected patients admitted to hospital who were at imminent risk of death, having irreversible biventricular failure, and not eligible for heart transplantation, from three cardiac surgery centres in France. Findings The C-TAH was implanted in two male patients. Patient 1, aged 76 years, had the C-TAH implantation on Dec 18, 2013; patient 2, aged 68 years, had the implantation on Aug 5, 2014. The cardiopulmonary bypass times for C-TAH implantation were 170 min for patient 1 and 157 min for patient 2. Both patients were extubated within the first 12 postoperative hours and had a rapid recovery of their respiratory and circulatory functions as well as a normal mental status. Patient 1 presented with a tamponade on day 23 requiring re-intervention. Postoperative bleeding disorders prompted anticoagulant discontinuation. The C-TAH functioned well with a cardiac output of 4·8–5·8 L/min. On day 74, the patient died due to a device failure. Autopsy did not detect any relevant thrombus formation within the bioprosthesis nor the different organs, despite a 50-day anticoagulant-free period. Patient 2 experienced a transient period of renal failure and a pericardial effusion requiring drainage, but otherwise uneventful postoperative course. He was discharged from the hospital on day 150 after surgery with a wearable system without technical assistance. After 4 months at home, the patient suffered low cardiac output. A change of C-TAH was attempted but the patient died of multiorgan failure. Interpretation This preliminary experience could represent an important contribution to the development of total artificial hearts using bioprosthetic materials. Funding CARMAT SA.
Induction of interleukin-1 production in patients undergoing cardiopulmonary bypass Haeffner-Cavaillon, N; Roussellier, N; Ponzio, O ...
Journal of thoracic and cardiovascular surgery/The Journal of thoracic and cardiovascular surgery/The journal of thoracic and cardiovascular surgery,
12/1989, Volume:
98, Issue:
6
Journal Article
Peer reviewed
Open access
Systemic reactions resembling inflammation occur in patients undergoing cardiopulmonary bypass. We now report that interleukin-1, an endogenous pyrogen and a key mediator of inflammation, is ...transiently and consistently generated in vivo by circulating monocytes within hours after cardiopulmonary bypass. Interleukin-1 production was assessed by measuring interleukin-1 functional activity and interleukin-1 beta antigen concentration in cell lysates from monocytes of patients during and after bypass. There was no increase in intracellular interleukin-1 activity during bypass and within the first hours after bypass, possibly because of a suppressive effect of hypothermia on interleukin-1 production, as documented in vitro. Maximal generation of interleukin-1 was observed 24 hours after extracorporeal circulation, concomitantly with the occurrence of a peak in body temperature. The amount of interleukin-1 generated at that time was linearly correlated with the increase in patients' body temperature. The peak in interleukin-1 production followed by 20 hours the peak in complement activation as assessed by determining C3a desArg and C5a desArg concentrations in patients' plasma. These results indicate that interleukin-1 may be involved in the pathogenesis of adverse systemic reactions associated with cardiopulmonary bypass.
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