The development of the Field of modern arterial surgery has been greatly accelerated by the development ( 28) and improvement (1,3,4,9,11,13,21,24,28,30,32,36) of arterial prostheses for both replacement and bypass. Although the autologous arterial graft and the autologous venous graft would appear to be nearly ideal arterial graft materials (5,7,14,17,22) ( Fig. 1A), their use is grossly curtailed by the paucity of supply of dispensable vessels of the diameters and lengths required . The use of the human homograft artery has been curtailed not only by Problems of procurement , but also because healing is subject to frequent degenerative changes resembling atherosclerosis and/or aneurysm formation (8,12,15,18,19,20,26,29) Fig. 1 Recovered arterial grafts.A) Autograft in pig thoracic aorta after 5 months , B) freeze-dried homograft from pig thoracic aorta after 7 months, C) human homologous aortic bifuraction graft after 7 1/2 years implantation, (Fig. 1B, C). Heterograft artery has also been disappointing because of thrombosis or aneurysm formation (Fig. 1D). Modification of heterograft arteries would appear to improve their biologic fate to a remarkable degree (23), but they are applicable only to certain locations not including the use of bifurcations. Basic principlesThe concept of the porous arterial prosthesis as introduced by Voorhees (28) has been hailed as a significant advance. A number of materials and fabrications have been devised and tested, often directly in the human without prior animal experimentation. One of the early clinical graft mateshowing aneurysm formation with rupture ( courtesy Dr. John L. Madden ), D) freeze-dried canine heterograft from thoracic aorta of dog after 6 months in thoracic aorta of pig Downloaded by: Universite Laval. Copyrighted material.
The historical and surgical perspectives with respect to standards for vascular prostheses are summarized under three headings: (1) device legislation tracing the activities of the Food and Drug Administration (FDA), ASTM, and International Organization for Standardization (ISO) from 1964 culminating in the present Medical Device Legislation as signed in 1976; (2) scientific community involvement via the media of ASTM, American Society for Artificial Internal Organs (ASAIO), Association for the Advancement of Medical Instrumentation (AAMI), and ISO; and (3) research observations focusing upon the causes of failure of vascular prostheses. Failures fall into six classes containing multiple specific causes. The conclusion is that the time is ripe for the establishment of performance standards and specifications for vascular prostheses from the aspects of political and governmental climate, scientific community awareness, willingness and expertise, and technical knowledge for the development of methods of testing and evaluation to minimize the risk of failure of vascular prosthetic devices and of the patients bearing these same implants.
During 30 years of active participation in clinical vascular surgery and the screening and development of vascular prostheses, greater than 450 different fabrications have been evaluated. Vascular prosthesis retrieval and analysis during this period of time have been systematized, and greater than 40 different causes of failure of vascular prostheses have been classified into six classes: failure of diagnosis, error of implantation, patient contribution, complications of healing, fabrication failure, and infection. Such analyses allow for scientific evaluation, testing development, and the elaboration of performance standards so badly needed at present. Such a task is being organized by American Society for Testing and Materials (ASTM) Subcommittee F04.04 on Cardiovascular Materials and Devices and will require the active participation of all knowledgeable individuals.
Surgical research is in serious trouble. Economic reasoning favors clinical and quick-fix solutions over basic surgical investigation. Political ambitions, using animal welfare as a tool, turn the public opinion against experimental surgery.As a direct result, physicians receive their surgical training in the clinical operating theater; the surgical innovator is discouraged by the increasing barriers to investigative surgery, which include legal obstacles. This is the time to pause in the daily fight with the "wings of windmills," and to reflect on where we have come from and where we are going. The past 100 years of medicine have shown the greatest advances ever in medical care at an ever increasing rate of progress and success. Current hurdles in the pursuit of surgical research make us wonder whether we have sufficiently prepared the way for the scientists in our field of tomorrow. Are we stimulating the best of our graduates to enter medical research? Are we generating excitement for the career of scientist and teacher in medicine and surgery? Are we giving high enough priorities to a research-conducive, problem-solving environment in academia? Are we educating the public on our needs and motives? Are we supporting each other in our struggles to maintain honesty and high professional ethics in the development and dissemination of our research results?These reflections led a few concerned scientists to develop means to foster the art, science, and technology of surgical research through critical publication and decoration. The Academy of Surgical Research hosts annual scientific meetings for progress reports and publishes the Journal of Investigative Surgery for scholarly writing.An award was instituted to publically decorate and celebrate the great teachers and innovators in our field.The late Jacob Markowitz was selected as a symbol for the new scientific approach to surgery that marks this century. The award was named for him because he had great compassion for surgical science, his fellow man, and animals.
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