Lancet: The first clinical application of a bioprosthetic artificial heart

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Release date: 2015-08-03

For patients with end-stage heart disease, the development of artificial heart has been a major problem for thromboembolism or bleeding. Because heart valves are associated with a low incidence of these complications, the researchers decided to use bioprosthetic materials in the production of a new artificial heart ( C-TAH ). The researchers report here the characteristics of the device and the first clinical application in two end-stage dilated cardiomyopathy patients. The aim of this study was to evaluate the feasibility and safety of CARMAT TAH in patients with life- threatening biventricular heart failure and unsuitable transplant patients.

The C-TAH is an implantable electro-hydraulic pulsed dual ventricular pulsation pump. Except for the battery, all components are placed in a single device after the original ventricular resection. The researchers selected admission patients who were at risk of death but did not meet the requirements for cardiac transplantation. These patients with irreversible biventricular failure were from three cardiac surgery centers in France.

C-TAH was transplanted into two male patients. Patient 1, age 76 years, C-TAH implantation at December 18, 2013; 2 patients, aged 68 years old, 5 August 2014 implanted C-TAH. The cardiopulmonary bypass times of patients 1 and 2 were 170 min and 157 min , respectively . Two patients were extubated within the first 12 hours after surgery , and they quickly recovered their breathing and circulatory function as well as their normal mental state.

Patient 1 required reintervention because of tamponade at 23 days. Postoperative bleeding disorders suggest discontinuation of anticoagulant therapy. C-TAH works well with a cardiac output of 4.8-5.8 L / min. At 74 days, the patient died due to equipment failure. Despite a 50- day period of no anticoagulation, the autopsy did not have any associated thrombosis in biopsy and in different organs. Patient 2 experienced renal failure and pericardial effusion requiring drainage, but postoperatively calm. He was discharged 150 days after surgery with a wearable system that did not require technical assistance. After 4 months at home , the patient suffered from low cardiac output. The researchers tried to make a change in C-TAH , but the patient died of multiple organ failure.

This initial experience can make an important contribution to the development of a fully artificial heart using bioprosthetic materials.

Source: MedSci

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