Credenciamento de Transplantes: um guia sobre os aspectos éticos, técnicos e legais em Goiás / Transplant accreditation: a guide on ethical, technical and legal aspects in Goiás

Guia básico sobre o processo documental relacionado às autorizações dos médicos e estabelecimentos de saúde que realizam ou possuam interesses em transplantes no território goiano e aborda as atividades do setor de Credenciamento da Central Estadual de Transplantes de Goiás, com o propósito de orientar os estabelecimentos e equipes profissionais sobre suas permissões junto ao Ministério da Saúde, na realização de transplantes no Estado

Basic guide on the documental process related to the authorizations of physicians and health establishments that perform or have an interest in transplants in the territory of Goiás and addresses the activities of the Accreditation sector of the State Transplant Center of Goiás, with the purpose of guiding establishments and teams professionals about their permissions with the Ministry of Health, in the performance of transplants in the State

Nota Técnica N. 3/2021 - GERTRAN/CCM - 19813 - fluxo regulatório da Central Estadual de Transplantes de Goiás / Technical Note N. 3/2021 - GERTRAN/CCM - 19813 - regulatory flow of the Goiás State Transplant Center

Em Goiás, desde a publicação do Decreto N.º 4.930/98, que criou o Programa Goiás Transplantes, as ações relacionadas aos transplantes, tem evoluído constantemente, atingindo um maior número de doadores, os órgãos e tecidos captados são enviados para outras unidades federativas. Diante disso, todo esse processo complexo é monitorado pelo Sistema Nacional de Transplantes ­ SNT do Ministério da Saúde ­ MS e para padronizar e organizar essas atividades a Portaria MS/SAS N.º 2600/2009, determina que a coordenação, promoção, controle e fiscalização das ações relacionadas aos transplantes, são incumbências das Centrais Estaduais de Transplantes ­ CETs. Tendo em vista que no âmbito dos receptores, as ações iniciam-se com a inclusão em lista de espera para o transplante, desse modo, é intrínseco que entre as responsabilidades da CET/GO há o compromisso com as atividades de regulação do acesso, para este fim. De modo a atender a demanda existente em Goiás, a CET/GO apresenta o fluxo regulatório para as solicitações do agendamento de consultas destinadas à avaliação especializada em transplantes em todas as modalidades disponibilizadas, via SUS no Estado

In Goiás, since the publication of Decree N.º 4.930/98, which created the Goiás Transplants Program, actions related to transplants have constantly evolved, reaching a greater number of donors, the organs and tissues collected are sent to other federative units. . Therefore, this entire complex process is monitored by the National Transplant System - SNT of the Ministry of Health - MS and to standardize and organize these activities, Ordinance MS/SAS N.º 2600/2009 determines that the coordination, promotion, control and supervision of actions related to transplants, are the responsibility of the State Transplant Centers ­ CETs. Considering that, in the scope of the recipients, the actions begin with the inclusion in the waiting list for the transplant, in this way, it is intrinsic that among the responsibilities of the CET/GO there is the commitment to the activities of access regulation, to this end. In order to meet the existing demand in Goiás, CET/GO presents the regulatory flow for requests for scheduling appointments for specialized evaluation in transplants in all available modalities, via SUS in the State

In ovo culturing of turkey (Meleagris gallopavo) ovarian tissue to assess graft viability and maturation of prefollicular germ cells and follicles.

Biobanking of turkey ovarian tissue appears to be the most cost-effective method for the long-term preservation of female genetics. However, to ensure the successful transplantation of biobanked ovarian tissue for breed or line revival, the transplantation and development of fresh ovarian tissue must be evaluated. To assess transplantability, ovaries from poults 1 to 15 days posthatch (dph) were cultured in ovo in chicken eggs for 6 d and compared with the equivalent fresh tissue. The viability of cultured ovarian tissue was evaluated visually, whereas the level of late-stage apoptosis was measured via the TUNEL assay. In addition, the diameter and density of prefollicular germ cells and follicles (primordial and primary) were measured to assess maturation. Results showed that all cultured grafts (74/74), on surviving chicken chorioallantoic membrane, were viable with low levels (0.8 ± 0.1%) of late-stage apoptosis. The diameter of prefollicular germ cells in cultured ovaries from poults at 5 and 7 dph were larger (P < 0.002) than that of their preculture counterparts but were not able to reach their in vivo size. No significant follicular growth was observed in ovaries cultured in ovo; however, prefollicular germ cell density was over 4-fold greater in ovaries cultured from 7 dph poults (81,030 ± 17,611/mm3) than in their in vivo counterpart (16,463 ± 6,805/mm3). Interestingly, cultured ovaries from all other ages displayed equal or lower (P ≤ 0.05) prefollicular germ cell densities than their in vivo counterparts. Cultured ovaries from poults at 5 and 7 dph also exhibited an increase (P ≤ 0.05) in follicle density compared with their preculture counterparts; whereas, cultured ovaries from 15 dph poults had decreased densities (P < 0.001) compared with their preculture counterparts. This study demonstrated that, although age of ovarian tissue cultured in ovo did not affect the overall viability, 7 dph ovaries appeared to have a better cellular morphology after culturing in ovo than other ages. In addition, we also demonstrated for the first time that avian follicles can form during tissue culturing in ovo.

[Clinical study on reconstruction of posterior cruciate ligament with platelet rich plasma combined with 3-strand peroneus longus tendons].

OBJECTIVE: To investigate the effectiveness of the reconstruction of posterior cruciate ligament (PCL) with platelet rich plasma (PRP) and 3-strand peroneal longus tendons under arthroscope. METHODS: Between June 2014 and December 2017, 58 patients with PCL rupture were randomly divided into two groups: the trial group (PRP assisted reconstruction of 3-strand peroneal longus tendons) and the control group (4-strand hamstring tendon reconstruction alone), 29 cases in each group. There was no significant difference in gender, age, injury side, Kellgren-Lawrence grade, time from injury to operation, and preoperative American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, International Knee Documentation Committee (IKDC) score, Lysholm score between the two groups ( P>0.05). Before operation, at 3 months and 12 months after operation, the IKDC score and Lysholm score of the two groups were recorded to evaluate the knee joint function, AOFAS ankle-hindfoot score was used to evaluate ankle function; KT-2000 examination (knee flexion of 90°, 30 lbs) was used to evaluate the difference of bilateral knee joint posterior relaxation at 12 months after operation, and MRI was used to evaluate ligament reconstruction; CT was used to evaluate the bone tunnel expansion of femur and tibia at 3 months and 12 months after operation. RESULTS: The operation was completed successfully in both groups, there was no complication in the donor tendon area. All the incisions healed by first intention. All the patients were followed up for more than 1 year. The follow-up time of the trial group was 13-17 months, with an average of 15.0 months; that of the control group was 15-20 months, with an average of 15.4 months. At 3 and 12 months after operation, there was no significant difference in AOFAS ankle-hindfoot score when compared with preoperative score and between the two groups ( P>0.05). At 3 and 12 months after operation, the IKDC score and Lysholm score of the two groups were significantly improved, and further improvement was found at 12 months when compared with at 3 months ( P<0.05); the scores in the trial group were significantly better than those of the control group ( P<0.05). At 12 months after operation, the difference of the posterior relaxation of the bilateral knees in the trial group was less than 5 mm in 27 cases, 6-10 mm in 2 cases; in the control group was less than 5 mm in 20 cases, 6-10 mm in 6 cases, and >10 mm in 3 cases; the difference between the two groups was not significant ( Z=0.606, P=0.544). At 12 months after operation, MRI of knee joint showed that all patients had good PCL graft. The MRI score of the trial group was better than that of the control group ( t=2.425, P=0.019). CT examination at 3 and 12 months after operation showed that the bone tunnel expansion of femur and tibia in the trial group were significantly better than those in the control group ( P<0.05). CONCLUSION: PRP combined with 3-stand peroneal longus tendons can significantly improve the function and stability of knee joint, effectively promote graft remodeling, and promote tendon bone healing, reduce the expansion of bone tunnel. The effectiveness is satisfactory.

Comparison of half-thickness tragal cartilage graft to temporalis fascia graft Tympanoplasty Type I: A randomized control trial.

OBJECTIVE: To compare half-thickness tragal cartilage graft with temporalis fascia graft in terms of graft take-up and acoustic outcomes in type-I tympanoplasty. METHODS: The randomised control trial was conducted at Lady Reading Hospital, Peshawar, Pakistan, from January to December 2017, and comprised patients aged 16-60 years undergoing tympanoplasty. The patients were divided into two equal groups using systemic random sampling method. In Group A, tympanoplasty type-I was done using half-thickness tragal cartilage graft, while in Group B, it was done using temporalis fascia graft. Data was analysed using SPSS20. RESULTS: Of the 40 patients, there were 20(50%) in each of the two groups. Overall, there were 24(50%) males and 16(40%) females. The mean age of Group A was 28.57±8.00 years, and in Group B it was 27.14±6.18 years. The graft success rate in Group A was 19(95%) and in Group B it was 18(90%) (p>0.05). CONCLUSION: The graft success rates for half-thickness tragal cartilage and temporalis fascia were statistically non-significant.

Deceased donor organ transplantation potential: A peep into an untapped gold mine.

Organ transplantation is the gold standard for treating end-stage organ diseases, many of whom are on waiting lists. The reasons for this include the nonavailability of suitable organs to be transplanted. In many nations, most of these challenges have been surmounted by the adoption of deceased donor program, which is not so in sub-Saharan countries such as Nigeria. This study is to audit the potentially transplantable organs available from potential deceased donors from a Nigerian tertiary hospital. This is a study of deaths in the intensive care unit (ICU) and the accident and emergency units of the University of Ilorin Teaching Hospital, Nigeria. Data included the biodata, social history, diagnosis or indications for admission, time of arrival and death, causes of death, associated comorbidities, potential organs available, social history, and availability of relations at the time of death. There were 104 deaths in the ICU and 10 patients in the accident and emergency unit. There were 66 males (57.9%) and 48 females (42.1%). Eighty patients were Muslims (70.2%) and 34 were Christians (19.8%). A total of 33 participants were unmarried (28.9%),whereas 81 (71.1%) were married. The tribes of the patients were Yoruba (105, 92.1%), Igbo (7, 6.1%), Hausa (1, 0.9%), and Nupe (1, 0.9%). The age range was 0.08-85 years. Twenty-two (19.3%) had primary and the remaining had at least secondary education. The causes of death were myriad, and there were relatives available at the times of all deaths. The Maastricht classification of the deaths were Class I - 1 (0.9%), Class II - 37 (32.2%), Class III - 9 (7.8%), Class IV - 20 (17.4%), and Class V - 47(40.9%). There were no transplantable organs in 42 (36.5%), one organ in eight (7%), two organs in two (7%), three organs in one (0.9%), four organs in 13 (11.3%), five organs in six (5.2%), six organs in 11 (9.6%), seven organs in 11 (9.6%), eight organs in five (13%), and nine organs in five (4.3%). Deceased donor sources of organs are worthy of being exploited to improve organ transplantation in Nigeria.

Hypothermic Machine Perfusion as an Alternative to Biopsy Assessment in Transplantation of Kidneys Donated After Cardiocirculatory Death: A Pilot Study.

BACKGROUND: Transplantation of kidneys from donation after cardiocirculatory death (DCD) donors is becoming an ever-increasing reality. So far, biopsy histologic assessment is the main parameter for evaluation of graft suitability, but it has several drawbacks and has poor reliability. The aim of this study is to verify if real-time renal resistance (RR) measurement during hypothermic machine perfusion (HMP) can be used as a reliable parameter to evaluate the quality of grafts from DCD and extracorporeal membrane oxygenation (ECMO) donors. METHODS: From January 2015 to September 2018, HMP has been systematically applied to all organs from DCD and ECMO donors. All grafts underwent preimplantation biopsy histologic assessment with Karpinski's score. Single kidney transplants (SKTs) or double kidney transplants (DKTs) were performed according to biopsy score results. Kidneys were considered suitable for transplant if RR reached ≤ 1.0 within 3 hours of perfusion. RR trend and postoperative outcome were analyzed considering biopsy score and donor type. RESULTS: A total of 30 kidneys (15 from DCD and 15 from ECMO donors) were used to perform 26 transplants (22 SKTs and 4 DKTs). Considering RR trend, all grafts were considered suitable for transplant within 1 hour of perfusion. Biopsy confirmed this result in all cases, and median score was 3 (range, 0-7). SKT score kidneys had lower starting RR than DKT ones (1.88 vs 2.88; P = .04) but identical final RR (0.58 vs 0.57; P = .76). DKT recipients had faster postoperative creatinine reduction than SKT recipients but similar postoperative day 30 value (1.42 vs 1.15 mg/dL; P = .20). No differences were found between DCD and ECMO grafts in terms of RR trend and postoperative outcome. CONCLUSIONS: HMP can be an alternative to histologic biopsy assessment for evaluation of transplant suitability of DCD and ECMO kidneys. If acceptability threshold is reached, SKT can be performed in all cases. ECMO donors should be considered like DCD donors.

Intestinal Preservation Injury: A Comparison Between Rat, Porcine and Human Intestines.

Advanced preservation injury (PI) after intestinal transplantation has deleterious short- and long-term effects and constitutes a major research topic. Logistics and costs favor rodent studies, whereas clinical translation mandates studies in larger animals or using human material. Despite diverging reports, no direct comparison between the development of intestinal PI in rats, pigs, and humans is available. We compared the development of PI in rat, porcine, and human intestines. Intestinal procurement and cold storage (CS) using histidine-tryptophan-ketoglutarate solution was performed in rats, pigs, and humans. Tissue samples were obtained after 8, 14, and 24 h of CS), and PI was assessed morphologically and at the molecular level (cleaved caspase-3, zonula occludens, claudin-3 and 4, tricellulin, occludin, cytokeratin-8) using immunohistochemistry and Western blot. Intestinal PI developed slower in pigs compared to rats and humans. Tissue injury and apoptosis were significantly higher in rats. Tight junction proteins showed quantitative and qualitative changes differing between species. Significant interspecies differences exist between rats, pigs, and humans regarding intestinal PI progression at tissue and molecular levels. These differences should be taken into account both with regards to study design and the interpretation of findings when relating them to the clinical setting.

Modifying the Organ Matrix Pre-engraftment: A New Transplant Paradigm?

The availability of solid organs for transplantation remains low and there is a substantial need for methods to preserve the viability of grafted tissues. Suppression of solid-organ transplant rejection has traditionally focused on highly effective T cell inhibitors that block host immune lymphocyte responses. However, persistent and destructive innate and acquired immune reactions remain difficult to treat, causing late graft loss. Pretreatment of grafts to reduce organ rejection provides an alternate strategy. Approaches using antithrombotics, stem cells, genetic modifications, modulation of infrastructural components (connective tissue, CT; glycocalyx) of donor organs, and engineering of new organs are under investigation. We discuss here new approaches to modify transplanted organs prior to engraftment as a method to reduce rejection, focusing on the CT matrix.

Patients' Expectations for Longevity of Kidney Transplant.

INTRODUCTION: Prior to transplantation, the transplant team is responsible for transplant education and posttransplant expectations. The majority of outcomes research focuses on 1- and 3-year graft survival, with a lack of literature focused upon whether patients have a realistic understanding of how many years deceased donor kidneys can be expected to function after transplant. OBJECTIVE: To determine whether potential kidney transplant patients' expectations for how long a deceased donor kidney will function after transplantation differs from transplant surgeons, using quantitative analysis. DESIGN: A cross-sectional survey was used with potential adult kidney transplant recipients and transplant surgeons. Patient surveys included demographics, quality-of-life questions, and questions of expectations of kidney function for deceased donor kidneys from the Kidney Donor Profile Index. The survey categorized donor organ risk as 0% to 20%, 21% to 85%, and 86% to 100%, and results were compared to responses from US Transplant Surgeons. Surgeons were contacted via e-mail using an online survey program. RESULTS: Responses included 154 transplant surgeons and 172 patients. Surgeon and patient responses were compared using Fisher exact test, showing a significant difference in each of the donor organ categories. We found that 47% of patient respondents did not correctly interpret the Kidney Donor Profile Index continuum. CONCLUSION: In every organ donor category, patients had a significantly different expectation for how long a transplanted kidney will last after transplant when compared to transplant surgeons. More study is required to determine why 47% of patients did not correctly interpret the Kidney Donor Profile continuum.

Redesigning Transplant Organ Labeling to Prevent Patient Harm and Organ Loss.

BACKGROUND: In 2012, the Health Resources and Services Administration and the United Network for Organ Sharing launched the "Electronic Tracking and Transportation" (ETT) project, in response to "labeling and packaging issues" being a frequently reported safety incident. This article describes an improvement project conducted as part of this United Network for Organ Sharing project. METHODS: An interdisciplinary team conducted a Process Failure Modes and Effects Analysis, laboratory simulations of organ labeling during procurement, and a heuristic evaluation of a label software application to inform the design of TransNet, a system that uses barcode technology at the point of organ recovery. A total of 42 clinicians and staff from 10 organ procurement organizations and 2 transplant centers in the United States participated. Processes Addressed: Key features of the redesigned labeling system include independent, double entry of label information into the software application, a machine-readable barcode on each organ's label, and a handheld printer for at "point of use" label printing. OUTCOMES: The new labeling system, TransNet, has become mandatory since June 2017. A survey conducted on early adopters (N = 11), after 1 year of use, indicates the process is safer and more efficient. IMPLICATIONS FOR PRACTICE: The findings from this study suggest that the application of quality planning methods, common in other industries, when redesigning a health-care process, are valuable and revelatory and should be adopted more extensively. Future evaluation of TransNet effectiveness to reduce safety incidents is critical.

Regulatory aspects of tissue donation, banking and transplantation in India.

Amendments to India's Transplantation of Human Organs Act, 1994, have established the legality of tissue donation and transplantation from deceased donors and the conditions under which they are permitted. The amended Act, now known as The Transplantation of Human Organs and Tissues Act, 1994, seeks to prevent the commercialization of tissue donation and to guarantee the safety of indigenous allografts. Registration of tissue banks, compliance with national standards and the appointment of transplant co-ordinators in hospitals registered under the Act are now mandatory. A national registry and Regional and State networks for donation and transplantation of tissues have been introduced. Despite the amendments a few anomalies of the principal Act persist as some of the differences between tissue and organ donation and transplantation have been overlooked. These include the possibility of skin donation in locations other than hospitals; the donation of medical and surgical tissue residues which does not pose any risk to the living donor; the non-requirement for compatibility between donor and recipient; the delayed time factor between tissue donation and transplantation which makes identification of a recipient at the time of donation impossible; and the easy availability of alternatives to tissues which make waiting lists redundant for many tissues. Rules for the implementation of the amended Act were framed in 2014 but like the Act must be adopted by the State health assemblies to become universally applicable in the country.

Unintended Consequences in Use of Increased Risk Donor Kidneys in the New Kidney Allocation Era.

BACKGROUND: The new kidney allocation system (KAS) intends to allocate the top 20% of kidneys to younger recipients with longer life expectancy. We hypothesized that the new KAS would lead to greater allocation of Public Health Service (PHS) increased-risk donor organs to younger recipients. METHODS: Analyses of the Organ Procurement and Transplantation Network data of patients who underwent primary deceased kidney transplantation were performed in pre- and post-KAS periods. RESULTS: The allocation of PHS increased-risk kidney allografts in various age groups changed significantly after implementation of the new KAS, with an increased proportion of younger individuals receiving increased-risk kidneys (7% vs 10% in age group 20-29 y and 13% vs 18% in age group 30-39 y before and after KAS, respectively; P < .0001). This trend was reversed in recipients 50-59 years old, with 31% in the pre-KAS period compared with 26% after KAS (P < .0001). CONCLUSIONS: The new KAS resulted in a substantial increase in allocation of PHS increased-risk kidneys to candidates in younger age groups. Because increased-risk kidneys are generally underutilized, future efforts to optimize the utilization of these organs should target younger recipients and their providers.

The UK DCD Risk Score: A new proposal to define futility in donation-after-circulatory-death liver transplantation.

BACKGROUND & AIMS: Primary non-function and ischaemic cholangiopathy are the most feared complications following donation-after-circulatory-death (DCD) liver transplantation. The aim of this study was to design a new score on risk assessment in liver-transplantation DCD based on donor-and-recipient parameters. METHODS: Using the UK national DCD database, a risk analysis was performed in adult recipients of DCD liver grafts in the UK between 2000 and 2015 (n = 1,153). A new risk score was calculated (UK DCD Risk Score) on the basis of a regression analysis. This is validated using the United Network for Organ Sharing database (n = 1,617) and our own DCD liver-transplant database (n = 315). Finally, the new score was compared with two other available prediction systems: the DCD risk scores from the University of California, Los Angeles and King's College Hospital, London. RESULTS: The following seven strongest predictors of DCD graft survival were identified: functional donor warm ischaemia, cold ischaemia, recipient model for end-stage liver disease, recipient age, donor age, previous orthotopic liver transplantation, and donor body mass index. A combination of these risk factors (UK DCD risk model) stratified the best recipients in terms of graft survival in the entire UK DCD database, as well as in the United Network for Organ Sharing and in our own DCD population. Importantly, the UK DCD Risk Score significantly predicted graft loss caused by primary non-function or ischaemic cholangiopathy in the futile group (>10 score points). The new prediction model demonstrated a better C statistic of 0.79 compared to the two other available systems (0.71 and 0.64, respectively). CONCLUSIONS: The UK DCD Risk Score is a reliable tool to detect high-risk and futile combinations of donor-and-recipient factors in DCD liver transplantation. It is simple to use and offers a great potential for making better decisions on which DCD graft should be rejected or may benefit from functional assessment and further optimization by machine perfusion. LAY SUMMARY: In this study, we provide a new prediction model for graft loss in donation-after-circulatory-death (DCD) liver transplantation. Based on UK national data, the new UK DCD Risk Score involves the following seven clinically relevant risk factors: donor age, donor body mass index, functional donor warm ischaemia, cold storage, recipient age, recipient laboratory model for end-stage liver disease, and retransplantation. Three risk classes were defined: low risk (0-5 points), high risk (6-10 points), and futile (>10 points). This new model stratified best in terms of graft survival compared to other available models. Futile combinations (>10 points) achieved an only very limited 1- and 5-year graft survival of 37% and less than 20%, respectively. In contrast, an excellent graft survival has been shown in low-risk combinations (≤5 points). The new model is easy to calculate at the time of liver acceptance. It may help to decide which risk combination will benefit from additional graft treatment, or which DCD liver should be declined for a certain recipient.

Advances of radiation sterilisation in tissue banking.

Under the auspices of the IAEA tissue banking programme on "Radiation Sterilisation of Tissue Graft" conducted from 1985 to 2004, many scientists and surgeons were involved in various regional research and development (R&D) projects mainly in dealing with radiation dose selection, radiation effects on human tissues and quality system in radiation sterilisation. New findings on radiation effects, tissue processing and preservation were shared during the regional and interregional meetings and workshops. Many tissue banks started to use radiation (25 kGy) to sterilize tissue grafts for tissue safety and efficacy and still continue to use it. The IAEA Code of Practice for Radiation Sterilization of Tissues Allografts developed in 2007 offered simpler methods to conduct radiation dose setting and dose validation experiments for tissue grafts. Advances in dose selection and dose mapping are continued under the quality management system when banks need to be certified to continue their operation. The combination of good tissue processing and preservation as well as good radiation practice will ensure the tissue products are properly sterilised thus safe and of high quality. Experience in meeting challenges in using radiation sterilisation and achievements reported by the tissue bankers are shared here.

Manual de rotinas e procedimentos operacionais padronizados da equipe de captação de orgãos de Goiás / Manual of standardized operational routines and procedures for the organ harvesting team in Goiás

A Central de Transplantes (CET) é um orgão executivo, subordinado Secretaria de Estado da Saúde e tem como responsabilidade planejar, coordenar, acompanhar e controlar todas as atividades de transplantes, ao nível estadual, em observância à legislação vigente referente ao processo de doação, captação, distribuição e transplantes de orgãos e tecidos no Brasil. Afim de organizar as atividades da CET-GO, criou-se este manual de rotina e procedimentos operacionais da Central de Transplantes de forma a oferecer qualidade e segurança nas tarefas executadas e resultados esperados

The Transplant Center (CET) is an executive body, subordinated to the State Health Department and is responsible for planning, coordinating, monitoring and controlling all transplant activities at the state level, in compliance with current legislation regarding the donation process, capture, distribution and transplantation of organs and tissues in Brazil. In order to organize the activities of CET-GO, this manual of routine and operational procedures of the Transplant Center was created in order to offer quality and safety in the tasks performed and expected results

Graft quality verification in coronary artery bypass graft surgery: how, when and why?

PURPOSE OF REVIEW: The coronary artery bypass graft (CABG) operation is one of the few remaining operations/interventions on diseased arteries that are not routinely verified during or immediately after the procedure. This review answers the 'how', 'when' and 'why' of intraoperative CABG assessment. RECENT FINDINGS: More recent than new literature on this topic, is the increased interest in quality assurance of CABG. This is most likely due to reports in the last 5 years suggesting CABG superiority to percutaneous coronary intervention (PCI) for improved mid-term and long-term outcomes; for example, for patients with diabetes mellitus (Freedom Trial by Farkouh in 2012), and for patients with SYNTAX score ≥ 33 (SYNTAX Trial by Mohr in 2013). Possibly CABG is re-emerging from the era-of-better-and-better-stents and is now deemed worthy of improvement. SUMMARY: In order to fully compliment PCI, the operative major adverse cardiac event rate of CABG must rival that of PCI. In order to reduce technical errors, it is best practice to perform intra-operative assessment of bypasses, especially since we have the tools.

Validation of microbiological testing in cardiovascular tissue banks: results of a quality round trial.

OBJECTIVES: Surgeons needing human cardiovascular tissue for implantation in their patients are confronted with cardiovascular tissue banks that use different methods to identify and decontaminate micro-organisms. To elucidate these differences, we compared the quality of processing methods in 20 tissue banks and 1 reference laboratory. We did this to validate the results for accepting or rejecting tissue. We included the decontamination methods used and the influence of antibiotic cocktails and residues with results and controls. The minor details of the processes were not included. METHODS: To compare the outcomes of microbiological testing and decontamination methods of heart valve allografts in cardiovascular tissue banks, an international quality round was organized. Twenty cardiovascular tissue banks participated in this quality round. The quality round method was validated first and consisted of sending purposely contaminated human heart valve tissue samples with known micro-organisms to the participants. The participants identified the micro-organisms using their local decontamination methods. RESULTS: Seventeen of the 20 participants correctly identified the micro-organisms; if these samples were heart valves to be released for implantation, 3 of the 20 participants would have decided to accept their result for release. Decontamination was shown not to be effective in 13 tissue banks because of growth of the organisms after decontamination. Articles in the literature revealed that antibiotics are effective at 36°C and not, or less so, at 2-8°C. The decontamination procedure, if it is validated, will ensure that the tissue contains no known micro-organisms. CONCLUSIONS: This study demonstrates that the quality round method of sending contaminated tissues and assessing the results of the microbiological cultures is an effective way of validating the processes of tissue banks. Only when harmonization, based on validated methods, has been achieved, will surgeons be able to fully rely on the methods used and have confidence in the consistent sterility of the tissue grafts. Tissue banks should validate their methods so that all stakeholders can trust the outcomes.

Histopathological evaluation of pretransplant donor biopsies in expanded criteria donors with high kidney donor profile index: a retrospective observational cohort study.

There is no consensus on the allocation of renal transplants from expanded criteria donors (ECD). The Kidney Donor Profile Index (KDPI) is used without the need for pretransplant donor biopsies (PTDB). We explored whether PTDB based on Remuzzi Score (RS) allows identification of those marginal kidneys in the highest calculated KDPI risk group (>91%) that appropriate for single transplantation. A retrospective study was conducted of 485 consecutive kidneys procured from a single center and transplanted if the RS was ≤4. We compared 5-year kidney and patients survival between KDPI groups and between RS <4 or =4 in the highest KDPI group. The median KDPI (interquartile range) was 71 (66-76) for KDPI <80% (n = 77), 86 (81-90) for KDPI 81-90% (n = 82), and 97 (94-100) for KDPI >91% (n = 205). Patient survival at 5 years was 85.7%, 85.3%, and 76.09% (P = 0.058) and death-censored graft survival was 84.4%, 86.5%, 73.6% (P = 0.015), respectively for each KDPI group. In >91% calculated KDPI group, there were no differences in graft survival depending on the RS (<4 vs. =4) (P = 0.714). The implementation of PTDB based on RS used for allocation of organs with the highest KDPI range could support to the acceptance of suitable organs for single transplantation with good patient and graft survival rate.