Organ procurement and transplantation network. Final rule.

: HHS is issuing this final rule (herein referred to as ``this rule'') to add vascularized composite allografts (VCAs) as specified herein to the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network (OPTN) (herein referred to as the OPTN final rule). When it enacted the National Organ Transplant Act in 1984, Congress included a definition of the term organ and authorized the Secretary to expand this definition by regulation. The Secretary has previously exercised this authority and expanded the statutory definition of organ. Prior to this rule, the OPTN final rule defined covered organs as ``a human kidney, liver, heart, lung, or pancreas, or intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract). Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this part if the vessels are intended for use in organ transplantation and labeled `For use in organ transplantation only.' '' This rule also includes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended (NOTA).

A classification of clinical fat grafting: different problems, different solutions.

BACKGROUND: Fat grafting has reemerged from a highly variable procedure to a technique with vast reconstructive and cosmetic potential. Largely because of a more disciplined and scientific approach to fat grafting as a transplantation event, early adopters of fat transplantation have begun to approach fat grafting as a process, using sound surgical transplantation principles: recipient preparation, controlled donor harvest, time-efficient transplantation, and proper postoperative care. Despite these principles, different fat grafting techniques yield impressive clinical outcomes. METHODS: The essential variables of four types of fat grafting cases were identified and compared: harvesting, methods of cell processing, methods of transplantation, and management of the recipient site. RESULTS: Each case differed for most of the variables analyzed. The two clinical drivers that most impacted these differences were the volume demands of the recipient site and whether the recipient site was healthy tissue or pathologic tissue. After these two drivers, a matrix classification of small-volume versus large-volume and regenerative versus nonregenerative cases yields four distinct categories. CONCLUSIONS: Not all fat grafting is the same. Fat grafting, once thought to be a simple technique with variable results, is a much more complex procedure with at least four definable subtypes. By defining the essential differences in the recipient site, the key driver in fat transplantation, the proper selection of technique can be best chosen. In fat transplantation, different problems require different solutions.

[Composite Tissue Allotransplantation (CTA): organ or tissue transplantation?]. / Composite Tissue Allotransplantation (CTA): Organ- oder Gewebetransplantation?

Plastic surgery has a long tradition in transplantation issues. Skin transplantation has been introduced by plastic surgeons Padgett and Brown. The first kidney transplantation was performed by Dr. Murray, a plastic surgeon. Composite tissue allotransplantation (CTA) is an evolving new field with transplantation of hand, vascularised knees or partial faces. With the European Union (EU) directive 2004/23/EC come into effect with the German tissue law at August 1, 2007 one has question the classification of transplantation of the hands, arms or the face as tissue or organ transplantation. While solid organs are allocated based on the German Deutsche Stiftung Organspende (DSO) and EuroTransplant, this is not the case for tissues. While for example thoracic organ procurement is performed in heart-beating organ donors with established hemodynamics, this is not the case for tissues, either. Given the complexity of a hand or a face as a sample of bones, muscles, nerves, vessels, and skin this has to be taken into account for example in comparison to a cornea as a tissue graft. As such, Dr. Siemionow has proposed a face to be regarded as an organ when comparing it to a kidney. Currently, allocation procedures as well as procurement issues in CTA are much more similar to organ- rather than tissue transplantation. Thus, we believe that CTA of hands or partial faces has more similarities to organ than to mere tissue transplantation.

Composite tissue allotransplantation: a proposed classification system based on relative complexity.

Numerous achievements have been made encompassing a wide array of composite tissue allograft (CTA) subtypes. We sought to develop a simple, reproducible CTA classification system for the purpose of comparing clinical investigation. Each CTA subtype differs in relative complexity and can therefore be theoretically classified based on its unique combination of multiple factors. Eight complexity factors (CFs) are hypothesized: anatomic detail, psychological obstacles, rejection risk, required rehabilitation, relative antigenicity, functionality/cosmesis, skin ratio, and salvageability. A distribution of total complexity scores, ranging from 8 to 24, is classified into 3 ordered categories representing varying degrees of complexity. In conclusion, we have created a new classification system so that ongoing research and future data may be compared in a type-specific fashion.

A study of seven different types of grafts for jugular vein transplantation in the horse.

The aim of this study was to investigate the biological behaviour of vascular grafts replacing a section of the jugular vein in order to improve the results of the surgical treatment of complete thrombosis of the jugular vein in the horse. Seven graft types: fresh allograft, home frozen allograft, glutaraldehyde-fixed allograft, cryo-preserved allograft, PTFE-graft (Gore), small intestinal submucosa preparation (Cook) and fresh autograft, were randomly implanted in ponies. The grafts were removed after one month and examined histologically for: preservation of the graft structures, acceptance by the host, intima proliferation, presence of endothelium and patency. The glutaraldehyde- and cryopreserved grafts show reasonable results and the PTFE and autograft had the best results especially with respect to host acceptance, endothelium presence and patency. Further research is necessary to improve graft behaviour, especially to the aspect of endothelisation. Obstruction of the jugular vein in horses can be treated surgically.

Neurological devices; classification of human dura mater. Final rule.

The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Class II Special Controls Guidance Document: Human Dura Mater" that will serve as the special control for this device.