Data Requirement for Animal-Derived Wound Care Devices: Limitations of the 510(k) Regulatory Pathway.

BACKGROUND: Device classification and preclinical data requirements for animal-derived wound care products were recently reviewed by the FDA. Given the possible performance differences for these products, we evaluated the FDA data requirements as well as the published literature for all animal-derived wound care products ever cleared through the FDA. STUDY DESIGN: The publicly available online database was queried for all animal-derived wound products; premarket data requirements for each product were recorded. A PubMed search was conducted to determine the number of published clinical studies for each product, and manufacturer websites were accessed to obtain the price for each product. RESULTS: A total of 132 animal-derived wound products have been cleared by the FDA since the Center for Devices and Radiological Health was established in 1976. Of these, 114 had a publicly available clearance statement online. Preclinical biocompatibility testing was performed in 85 products (74.6%) and referenced in 10 (8.8%). Preclinical animal wound healing testing took place in 17 (14.9%). Only 9 products (7.9%) had clinical safety testing, and no products had clinical effectiveness data. We found no published peer-reviewed clinical data for 97 products (73%). Cost was infrequently available but ranged from $4.79 to $2,178 per unit. CONCLUSIONS: Although the current pathway is appropriate for efficiently clearing new wound care products, clinical effectiveness is not included in the regulatory review process. Wound care products are primarily evaluated by the FDA for safety and biocompatibility. Thus, any claims of clinical effectiveness require independent validation, which is often lacking.

Evaluation of the Risk of Hypertrophic Scarring and Keloid Following Eyelid Procedures: A Systematic Review.

BACKGROUND: Eyelid surgeries are common operations performed for both cosmetic and functional purposes. Because the periorbital region is highly visible, it is important to avoid poor scar formation in this cosmetically sensitive region. No study to date has investigated the possible existence of keloid formation following eyelid procedures. OBJECTIVES: This study systematically reviewed the literature to identify cases of hypertrophic scar and keloid formation following cosmetic or functional (nonburn) eyelid procedures to aid surgeons when counseling patients. METHODS: A PubMed/MEDLINE search was conducted on May 17, 2022, using appropriate search terms: "blepharoplasty," "tarsorrhaphy," "canthotomy," "ptosis repair," "epicanthoplasty," "keloid," "hypertrophic scar," and related lay terms. All eligible articles in English with no lower date limit were included for analysis. Descriptive statistics, exclusion criteria, and summarized results are reported. RESULTS: The PubMed search yielded 107 abstracts/articles. Full-text review resulted in 34 articles included for analysis. Twenty manuscripts reported no occurrences of hypertrophic scars. Only 13 manuscripts reported patients with hypertrophic scarring, which equated to 36 patients out of 3650. One individual was identified in a series of 77 patients who developed a keloid after a tarsorrhaphy. No articles reported a keloid as an outcome of strictly cosmetic procedures. CONCLUSIONS: This study concludes that there are no reported instances of keloid formation following cosmetic (nonburn) eyelid procedures in the existing literature. Hypertrophic scar formation is minimally reported. The absence of keloid scar formation on the eyelid is critical knowledge for surgeons when educating patients about maladaptive scarring risks following eyelid procedures.

Urban Telemedicine: The Applicability of Teleburns in the Rehabilitative Phase.

Telemedicine has been successfully used in many areas of medicine, including triage and evaluation of the acute burn patient. The utility of telemedicine during the rehabilitative phase of burn care has yet to be evaluated; therefore, we expanded our telemedicine program to link our burn center with a rehabilitation facility. The goal of this project was to demonstrate cost-effective improvements in the transition and quality of care. A retrospective review was performed on all patients enrolled in our telemedicine/rehabilitation program between March 2013 and March 2014. Data collected included total number of encounters, visits, type of visit, physician time, and readmissions. Transportation costs were based on local ambulance rates between the two facilities. The impact of telemedicine was evaluated with respect to the time saved for the physician, burn center, and burn clinic, as well as rehabilitative days saved. A patient satisfaction survey was also administered. A total of 29 patients participated in 73 virtual visits through the telemedicine project. Virtual visits included new consults, preoperative evaluations, and postoperative follow-ups. A total of 146 ambulance transports were averted during the study period, totaling $101,110. Virtual visits saved 6.8 outpatient burn clinic days, or 73 clinic appointments of 30-min duration. The ability to perform more outpatient surgery resulted in 80 inpatient bed days saved at the burn hospital. The rehabilitation hospital saved an average of 2 to 3 patient days secondary to unnecessary travel. Satisfaction surveys demonstrated patient satisfaction with the encounters, primarily related to time saved. The decrease in travel time for the patient from the rehabilitation hospital to outpatient burn clinic improved adherence to the rehabilitation care plan and resulted in increased throughput at the rehabilitation facility. Videoconferencing between a burn center and rehabilitation hospital streamlined patient care and reduced health care costs, while maintaining quality of care and patient satisfaction. This program has improved inpatient burn rehabilitation by maximizing time spent in therapy and avoiding unnecessary patient travel to offsite appointments.

The National Institute on Disability, Independent Living, and Rehabilitation Research Burn Model System: Twenty Years of Contributions to Clinical Service and Research.

The National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) established the Burn Model System (BMS) in 1993 to improve the lives of burn survivors. The BMS program includes 1) a multicenter longitudinal database describing the functional and psychosocial recovery of burn survivors; 2) site-specific burn-related research; and 3) a knowledge dissemination component directed toward patients and providers. Output from each BMS component was analyzed. Database structure, content, and access procedures are described. Publications using the database were identified and categorized to illustrate the content area of the work. Unused areas of the database were identified for future study. Publications related to site-specific projects were cataloged. The most frequently cited articles are summarized to illustrate the scope of these projects. The effectiveness of dissemination activities was measured by quantifying website hits and information downloads. There were 25 NIDILRR-supported publications that utilized the database. These articles covered topics related to psychological outcomes, functional outcomes, community reintegration, and burn demographics. There were 172 site-specific publications; highly cited articles demonstrate a wide scope of study. For information dissemination, visits to the BMS website quadrupled between 2013 and 2014, with 124,063 downloads of educational material in 2014. The NIDILRR BMS program has played a major role in defining the course of burn recovery, and making that information accessible to the general public. The accumulating information in the database serves as a rich resource to the burn community for future study. The BMS is a model for collaborative research that is multidisciplinary and outcome focused.

Digital mobile technology facilitates HIPAA-sensitive perioperative messaging, improves physician-patient communication, and streamlines patient care.

BACKGROUND: Mobile device technology has revolutionized interpersonal communication, but the application of this technology to the physician-patient relationship remains limited due to concerns over patient confidentiality and the security of digital information. Nevertheless, there is a continued focus on improving communication between doctors and patients in all fields of medicine as a means of improving patient care. In this study, we implement a novel communications platform to demonstrate that instantaneously sharing perioperative information with surgical patients and members of their support networks can improve patient care and strengthen the physician-patient relationship. METHODS: 423 consecutive patients scheduled to undergo elective surgical procedures were offered complimentary registration to a secure, web-based service designed to distribute perioperative updates to a group of recipients designated by each patient via Short Message Service (SMS) and/or email. Messages were created by attending surgeons and delivered instantaneously through the web-based platform. In the postoperative period, patients and their designated message recipients, as well as participating healthcare providers, were asked to complete a survey designed to assess their experience with the messaging system. Survey results were statistically analyzed to determine satisfaction rates. RESULTS: Of the qualifying 423 patients, 313 opted to enroll in the study. On average, patients selected a total of 3.5 recipients to receive perioperative updates. A total of 1,195 electronic messages were generated for distribution to designated recipients during the study period and delivered to recipients located around the world. There were no documented errors or failures in message delivery. Satisfaction surveys were completed by 190 users of the service (73 %). Respondents identified themselves as either patients (n = 48, 25.5 %), family/friends (n = 120, 63.8 %), or healthcare providers (n = 15, 12 %). Satisfaction with the service was high: 94.2 % of users "enjoyed this software" and and 94.2 % of family/friends "felt more connected to their loved ones during surgery." 92.5 % would "recommend their loved ones sign up for this service". Ninety percent of patients who completed the survey reported "an improved hospital experience". CONCLUSION: Digital communications platforms can facilitate the immediate transfer of HIPAA-compliant data to patients and their designees. Such systems can greatly improve the level of communication between physicians, patients, and patients' families and caregivers. All types of users, including healthcare professionals, patients, and their loved ones, recorded high levels of satisfaction. Based on these observations, we conclude that mobile digital communications platforms represent a way to harness the power of social media to enhance patient care.

The use of negative pressure wound therapy in severe open lower extremity fractures: identifying the association between length of therapy and surgical outcomes.

BACKGROUND: Negative pressure wound therapy (NPWT) is a widely accepted method of temporary coverage for complex lower extremity wounds before definitive reconstruction. However, the precise role of NPWT in the perioperative management of patients with complicated lower extremity injuries remains unclear. In this study, we examine the effect of NPWT on flap complications and overall outcomes based on timing of soft-tissue reconstruction relative to initial injury and implementation of NPWT. METHODS: We retrospectively reviewed the medical records of 32 consecutive patients presenting to a single institution receiving lower extremity reconstruction after Gustilo class IIIB or IIIC open tibial fractures over a 5-y period. Length of hospitalization, number of surgical procedures, flap failure, infection, and nonunion were parameters of interest in this study. RESULTS: The incidence of complications in patients treated with NPWT was lower compared with patients who underwent wet-to-dry dressing changes, regardless of when surgery was performed. The highest rate of complications was observed in patients operated on >6 wk after injury and who received wet-to-dry dressing changes wound care. By comparison, those who underwent surgery within 1 wk of injury and who were bridged with NPWT had the lowest rate of complications. CONCLUSIONS: The use of NPWT therapy in the perioperative management of patients with open lower extremity fractures reduces complication rates associated with limb salvage surgery. Our results suggest that NPWT can be used as a temporizing measure to optimize patients before flap surgery, effectively lengthening the window of opportunity for definitive reconstruction.

Social media use and impact on plastic surgery practice.

BACKGROUND: Social media platforms have revolutionized the way human beings communicate, yet there is little evidence describing how the plastic surgery community has adopted social media. In this article, the authors evaluate current trends in social media use by practicing plastic surgeons. METHODS: An anonymous survey on the use of social media was distributed to members of the American Society of Plastic Surgeons. Prevalent patterns of social media implementation were elucidated. RESULTS: One-half of respondents were regular social media users. Reasons for using social media included the beliefs that incorporation of social media into medical practice is inevitable (56.7 percent), that they are an effective marketing tool (52.1 percent), and that they provide a forum for patient education (49 percent). Surgeons with a primarily aesthetic surgery practice were more likely to use social media. Most respondents (64.6 percent) stated that social media had no effect on their practice, whereas 33.8 percent reported a positive impact and 1.5 percent reported a negative impact. CONCLUSIONS: This study depicts current patterns of social media use by plastic surgeons, including motivations driving its implementation and impressions on its impact. Many feel that social media are an effective marketing tool that generates increased exposure and referrals. A small number of surgeons have experienced negative repercussions from social media involvement. Our study reveals the presence of a void. There is a definite interest among those surveyed in developing best practice standards and oversight to ensure ethical use of social media platforms throughout the plastic surgery community. Continuing discussion regarding these matters should be ongoing as our experience with social media in plastic surgery evolves.

Comparison of immediate implant placement versus the staged tissue expander technique in breast reconstruction.

BACKGROUND: Tissue expansion is currently the most common method used in prosthetic breast reconstruction. Skin-sparing mastectomy techniques have facilitated immediate placement of a permanent implant. Proposed benefits to immediate implants include less time and fewer operations to complete reconstruction. Whether it leads to poorer outcomes remains unknown. The authors compared immediate implant-based and staged tissue expander breast reconstruction. METHODS: Thirty-five consecutive immediate implant-based breast reconstruction patients (62 breasts) and a matched group of 50 tissue expander immediate reconstruction patients (89 breasts) were identified. Normative data, complication rates, revision rates, number of office visits, total reconstructive time, and aesthetic outcomes were compared. RESULTS: Demographic variables and surgical risk factors were similar in both groups. At a mean follow-up of 14 months, the overall complication rates were similar (p = 0.97), and the need for revision surgery was also similar (p = 0.94). Mean final implant volume did not differ between the two groups (397 ± 93 cc for implants and 386 ± 128 cc for expansion; p = 0.57). Mean number of office visits/time to nipple reconstruction was significantly different at 5.0 ± 4 versus 9.2 ± 3 visits (p < 0.001) and 22 ± 19 versus 43 ± 24 weeks (p < 0.001) in the implant versus tissue expander group, respectively. Aesthetic evaluation revealed no significant differences. CONCLUSIONS: Immediate implant-based breast reconstruction has similar complication rates, need for revision, and aesthetic outcomes but fewer office visits and less reconstructive time when compared with tissue expander immediate breast reconstruction. In the appropriately selected patient, it is a safe option that provides similar outcomes in less time compared with staged expander-based reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Comparison of implant-based immediate breast reconstruction with and without acellular dermal matrix.

BACKGROUND: Acellular dermal matrix is frequently used in implant-based breast reconstruction to cover the inferior aspect of the breast pocket. Its performance profile remains equivocal. The authors studied whether adding it in implant-based immediate breast reconstruction improved outcomes when compared with non-acellular dermal matrix reconstruction. METHODS: Patients undergoing implant-based immediate breast reconstruction at a single academic medical center were evaluated. Aesthetic outcomes and postoperative complications were assessed and direct comparisons were made between acellular dermal matrix and non-acellular dermal matrix cohorts. RESULTS: A total of 203 patients underwent 337 immediate expander-based breast reconstructions [with acellular dermal matrix, n=208 (61.7 percent); without, n=129 (38.3 percent)]. Patient characteristics, including age at time of reconstruction (mean, 49±11 versus 47±10 years) and body mass index (mean, 23±5 versus 23±3 kg/m) were similar between groups (p>0.05). Complications occurred in one-third of patients (33.5 percent). In univariate analyses, acellular dermal matrix use had fewer overall complications (odds ratio, 0.61; 95 percent CI, 0.38 to 0.97). The incidences of seroma/hematoma (p=0.59), infection (p=0.31), and wound complications (p=0.26) did not differ. Aesthetic outcomes were higher in the acellular dermal matrix group. In multivariate logistic regression, acellular dermal matrix use was associated with less capsular contracture (odds ratio, 0.18; 95 percent CI, 0.08 to 0.43) and mechanical shift (odds ratio, 0.23; 95 percent CI, 0.06 to 0.78). CONCLUSIONS: Optimizing the inframammary fold with acellular dermal matrix creates a superior aesthetic result. Its use appears safe and is associated with less capsular contracture and mechanical shift and improvement in the inframammary fold appearance, without increasing postoperative complications. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Arterial allograft allows in-line reconstruction of prosthetic graft infection with low recurrence rate and mortality.

Surgical management of infected prosthetic vascular grafts is associated with a significant risk of recurrent infection, limb loss, and mortality. Treatment options include graft excision with extra-anatomic bypass and in-line repair with prosthetic graft, vein, or artery. We hypothesized that in-line reconstruction using cryopreserved arterial allografts would be associated with a lower recurrent infection rate, limb loss, and mortality than other alternatives. We reviewed all cases where adults underwent surgical management of infected prosthetic aortic, iliac, or femoral bypass grafts with cryopreserved arterial allograft at our medical center from 2001 to 2008. Cryopreserved arterial allografts were used in 21 patients. There were nearly equal number of men (n = 11, 52%) and women (n = 10, 48%). The median age was 63 years and median time since cryoartery repair was 4 years. There have been no deaths in the follow-up period. Complications (19%) included colon perforation (n = 1), lower extremity compartment syndrome (n = 1), limb ischemia (n = 1), and reinfection with pseudoaneurysm and subsequent limb amputation (n = 1). These positive findings of low morbidity and absence of mortality in high risk patients have resulted in a shift at our institution to the preferential use of cryopreserved arterial allograft with in-line reconstruction for infected prosthetic grafts.

Molecular mediators of liver ischemia and reperfusion injury: a brief review.

Ischemia and reperfusion injury is a dynamic process that involves multiple organ systems in various clinical states including transplantation, trauma, and surgery. Research into this field has identified key molecular and signaling players that mediate, modulate, or augment cellular, tissue, and organ injury during this disease process. Further elucidation of the molecular mechanisms should provide the rationale to identify much-needed novel therapeutic options to prevent or ameliorate organ damage due to ischemia and reperfusion in clinics.

Type I, but not type II, interferon is critical in liver injury induced after ischemia and reperfusion.

We have documented the key role of toll-like receptor 4 (TLR4) activation and its signaling pathway mediated by interferon (IFN) regulatory factor 3, in the induction of inflammation leading to the hepatocellular damage during liver ischemia/reperfusion injury (IRI). Because type I IFN is the major downstream activation product of that pathway, we studied its role in comparison with IFN-gamma. Groups of type I (IFNAR), type II (IFNGR) IFN receptor-deficient mice, along with wild-type (WT) controls were subjected to partial liver warm ischemia (90 minutes) followed by reperfusion (1-6 hours). Interestingly, IFNAR knockout (KO) but not IFNGR KO mice were protected from IR-induced liver damage, as evidenced by decreased serum alanine aminotransferase and preservation of tissue architecture. IR-triggered intrahepatic pro-inflammatory response, assessed by tumor necrosis factor (TNF-alpha), interleukin 6 (IL-6), and chemokine (C-X-C motif) ligand 10 (CXCL-10) expression, was diminished selectively in IFNAR KO mice. Consistent with these findings, our in vitro cell culture studies have shown that: (1) although hepatocytes alone failed to respond to lipopolysaccharide (LPS), when co-cultured with macrophages they did respond to LPS via macrophage-derived IFN-beta; (2) macrophages required type I IFN to sustain CXCL10 production in response to LPS. This study documents that type I, but not type II, IFN pathway is required for IR-triggered liver inflammation/damage. Type I IFN mediates potential synergy between nonparenchyma and parenchyma cells in response to TLR4 activation.

Light-assisted stab phlebectomy: early postoperative experience.

Light-assisted stab phlebectomy (LASP) is a technique that we have developed for treatment of lower extremity varicose veins. It combines powered and stab phlebectomy with minimally invasive surgical instruments to optimize intraoperative visualization of varicose veins and to remove branch veins with minimal bruising, hematoma, or pain. The early experience with this technique has not been reported. We conducted a retrospective review of all patients who underwent LASP to characterize the associated perioperative experience and to identify postoperative factors that indicated a successful outcome. From 2004 to 2006, LASP was performed on 268 limbs to remove lower extremity branch veins. The majority of patients were women (75%), and the mean age was 52 years. A group of 184 patients underwent LASP in combination with another procedure, and 49 patients underwent LASP alone. Nearly all patients had conscious sedation for anesthesia (99%); operating room time averaged 44 minutes, and blood loss averaged 88 cc. Immediate postoperative complications were infrequent, occurring in 10 per cent of patients, and included unresected or missed veins, hematoma, and cellulitis. LASP provides improved visualization of branch veins and allows varicose veins to be removed with a short operating room time and minor postoperative complications.

Light-assisted stab phlebectomy: report of a technique for removal of lower extremity varicose veins.

We report a new technique to remove varicose veins and reduce recurrence from missed veins. A rigid cannula with a light source injects tumescent solution and transilluminates under veins. Varicose veins are removed with stab phlebectomy using a modified crochet hook and mosquito clamp. Additional tumescent solution flushes hematomas and compresses empty vein channels, resulting in less pain, bleeding, and pigmentation. More than 200 patients have undergone light-assisted stab phlebectomy at the Gonda Vascular Center, with high patient and surgeon satisfaction. This sutureless technique allows complete and rapid varicose branch vein removal with few missed varicose veins, little bruising, and an excellent cosmetic result.

Liver transplantation criteria for hepatocellular carcinoma should be expanded: a 22-year experience with 467 patients at UCLA.

OBJECTIVE: To assess the efficacy of orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC) and the impact of current staging criteria on long term survival. SUMMARY BACKGROUND DATA: HCC is becoming an increasingly common indication for OLT. Medicare approves OLT only for HCCs meeting the Milan criteria, thus limiting OLT for an expanding pool of potential liver recipients. We analyzed our experience with OLT for HCC to determine if expansion of criteria for OLT for HCC is warranted. METHODS: : All patients undergoing OLT for HCC from 1984 to 2006 were evaluated. Outcomes were compared for patients who met Milan criteria (single tumor < opr =5 cm, maximum of 3 total tumors with none >3 cm), University of California, San Francisco (UCSF) criteria (single tumor <6.5 cm, maximum of 3 total tumors with none >4.5 cm, and cumulative tumor size <8 cm), or exceeded UCSF criteria. RESULTS: A total of 467 transplants were performed for HCC. At mean follow up of 6.6 +/- 0.9 years, recurrence rate was 21.2%, and overall 1, 3, and 5-year survival was 82%, 65%, and 52%, respectively. Patients meeting Milan criteria had similar 5-year post-transplant survival to patients meeting UCSF criteria by preoperative imaging (79% vs. 64%; P = 0.061) and explant pathology (86% vs. 71%; P = 0.057). Survival for patients with tumors beyond UCSF criteria was significantly lower and was below 50% at 5 years. Multivariate analysis showed that tumor number (P < 0.001), lymphovascular invasion (P < 0.001), and poor differentiation (P = 0.002) independently predicted poor survival. CONCLUSIONS: This largest single institution experience with OLT for HCC demonstrates prolonged survival after liver transplantation for tumors beyond Milan criteria but within UCSF criteria, both when classified by preoperative imaging and by explant pathology. Measured expansion of OLT criteria is justified for tumors not exceeding the UCSF criteria.

Incidentally discovered tumors of the endocrine glands.

Clinically inapparent masses, or 'incidentalomas' of the endocrine glands are increasingly common owing to continued advancements in medical imaging. Incidentalomas of the adrenal glands have received substantial attention in the literature, whereas lesions of the thyroid and endocrine pancreas, though frequently encountered in the clinic, have received relatively little attention. We review the detection and subsequent management of incidentalomas of the thyroid, adrenal and pancreas, with specific attention paid to the mode of detection and risk stratification of lesions.

Incisional hernia after liver transplantation.

BACKGROUND: Incisional hernia is a potential complication of orthotopic liver transplantation (OLT), with various options for repair. STUDY DESIGN: We conducted a retrospective review of a series of adult patients with incisional hernias after OLT to identify risk factors and to compare methods of repair. RESULTS: Incisional hernia repair was performed in 44 of 959 patients (4.6%) who underwent OLT from 1999 to 2005. Mean age at time of OLT was 53 years, and 73% were men. One or more complications of OLT occurred in 33 patients (75%) and included reoperation for bile leak or hemoperitoneum (34%), pulmonary problems (27%), early acute rejection (7%), and severe ascites and retransplantation (5% each). Incisional hernia was diagnosed at 419 days (range 62 to 1,524 days) and repaired at 471 days (range 109 to 1,581 days) after OLT. Presentation included pain or discomfort (78%) and incarceration or strangulation (5%); 17% were asymptomatic. Herniorrhaphy techniques included fascial repair with onlay polypropylene mesh reinforcement (n=25, 57%); fascial repair only (n=15, 34%); or inlay mesh sewn to fascial edges (n=4, 9%). Complications of repair included recurrence in seven patients (16%) and wound infection and seroma in one patient each. Recurrence occurred in five patients with primary repair and two with mesh techniques (33% versus 6%, p=0.04). CONCLUSIONS: Incisional hernia is a late complication of OLT for which male gender and early post-OLT complications are risk factors. Repair is safe when undertaken after acute problems have resolved and is best accomplished using mesh reinforcement of autologous tissue.

Management of hepatitis C-infected liver transplant recipients at large North American centres: changes in recent years.

Large (>or=45 transplants per year) North American liver transplant centres were surveyed regarding management of hepatitis C virus (HCV). A total of 25/41 (59%) and 28/48 (58%) of centres responded to the surveys in 1998 and 2003, respectively, with 17 centres participating in both surveys. HCV was the most common indication for transplantation. Use of protocol liver biopsies was higher in 2003 and 60% used them to monitor HCV disease. Fewer centres reported modifying primary immunosuppression (IMS) for HCV-positive (vs. non-HCV) patients in 2003 (26%) vs. 1998 (56%). IMS was most frequently tacrolimus-based, but mycophenolate mofetil use increased in 2003 (52% vs. 23% in 1998). In both years, approximately 40% treated allograft rejection differently in HCV-positive recipients, with less use of OKT3 in 2003. Combination anti-HCV therapy for 12 months or more was the treatment of choice and growth factor use was common (68%). HCV-positive recipients were considered candidates for retransplantation but HCV-specific criteria were used in decision-making. Practice of centres changed over time with an increase in HCV transplantation and use of protocol liver biopsies, and a trend towards lesser modification of IMS in HCV-positive recipients. We conclude that there is considerable variability in the management of HCV among transplant programs and over time.