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PubMed2004

[Bio-artificial organs: cardiac applications].

The most important bio-prosthetic organs in cardiovascular medicine are artificial heart valve prostheses and blood pumps. Cardiac valve prostheses can be divided in 'mechanical' and 'biological' valves. Mechanical prostheses are entirely made of artificial materials and require a meticulous anticoagulation therapy. The biological heart valves or heterografts (the allo- and autografts are not considered in this issue) are made of fixed or crosslinked biological tissue and therefore anticoagulation of the patient is not necessary. Actual mechanical heart valves consist of a titanium ring in which one or more leaflets made of pyrolite carbon assure the opening and closing mechanism. Biological heart valves are made of fixed porcine aortic valves or of fixed bovine pericardium. Both tissues can be mounted on a metal frame (so-called 'stented valves') or they can lack this structure ('stentless valves'). The problem with these biological valves is the durability: during the years they start degenerating or calcifying. To prevent this, recent biological heart valves are treated with an anti-mineralisation procedure. Since recent years intense research is ongoing to develop a living heart valve by 'tissue engineering'. When the entire heart fails, and pharmacological treatment remains inadequate or a heart transplantation is not immediately possible, artificial blood pumps are implanted. In general, two categories of blood pumps can be distinguished: displacement and rotary blood pumps. Displacement pumps move a certain amount of blood by the movement of a flexible membrane. This movement is pneumatically or electrically driven and requires an extensive installation: artificial ventricles, tubing, motors, pneumatic systems and driving consoles. Examples in clinical use are: Novacor, Heart Mate, Thoratec, Medos/HIA. Recent developments focus on miniaturisation and endovascular implantation. The rotary blood pumps are well suited for these purposes. They can be either axial, diagonal or radial pumps. A promising new develoment is the Impella pump: this is an axial flow pump having a diameter of 4 mm, which is implanted, inclusive the electrical motor, in the failing heart and delivers an output of 2 to 10 liter/minute. Clinical testing of this device is ongoing.

Animals↗
PubMed1983

Impact of regulations on artificial organs research.

From a research perspective, some of the primary problems created by the FDA regulations include: the amount of time necessary to comply with the regulations and to obtain FDA and IRB review of the studies. The cost of such delays may be great in terms of statistical death. Lack of understanding of the regulations on the part of investigators. Escalated costs and extra restrictions on the use of animals. Benefits of the regulations appear to be: better preclinical testing performed prior to initiating clinical trials, and improved testing protocols, both of which may result in lower risks to patients.

Artificial Organs↗