Solid Organ Transplant Programs Research Articles

Medication Education Pilot Program for Heart Transplant Patients

Purpose As a high volume solid organ transplant center, we implemented a medication education didactic (MED) pilot program as a quality improvement initiative to enhance patient knowledge, increase patient and provider engagement, reduce medication errors, and identify target patient populations for more intense education interventions. Methods After reviewing our current practice of medication education, we initiated a MED program incorporating auditory, visual and kinesthetic teaching materials and enrolled 31 patients. Pharmacist-led educational interventions included a sample discharge medication list, medication flashcards, and a pre and post teaching assessment. Provider interventions included implementation of virtual rounding, coordinated discharge medication handoff between multidisciplinary staff, and creation of patient education videos. Results Our primary outcome analyzed patients’ pre and post education assessment scores, with a mean pretest score of 55.11 + 15.523 and a mean posttest score of 90.46 + 10.167. Post test scores comparing English versus non-native English speakers were 93.32% and 75.94%, respectively. To assess patient and provider engagement, we administered surveys to staff and a cohort of patients. After MED program, 93.33% of patients reported feeling moderately to extremely knowledgeable about their medications. 70% of staff observed a positive change in provider engagement and 90% reported that new virtual rounding has been at least moderately beneficial. Chart reviews for each patient demonstrated no recorded medication errors in their first 30-days post discharge. Conclusion Our study suggests intensive teaching from a dedicated pharmacist greatly increases patient medication knowledge. We identified non-native English-speakers would benefit from more intensive education sessions prior to discharge and are developing additional translated written materials and videos. Our initial data also suggests the MED program to be a highly effective method for improving patient outcomes and quality of care. Further research is ongoing to fully characterize the benefits of MED program implementation. Due to the overwhelming success of this pilot study, MED program initiatives have expanded across our institution's solid organ transplant programs.

Machine learning-based prediction of health outcomes in pediatric organ transplantation recipients.

Prediction of post-transplant health outcomes and identification of key factors remain important issues for pediatric transplant teams and researchers. Outcomes research has generally relied on general linear modeling or similar techniques offering limited predictive validity. Thus far, data-driven modeling and machine learning (ML) approaches have had limited application and success in pediatric transplant outcomes research. The purpose of the current study was to examine ML models predicting post-transplant hospitalization in a sample of pediatric kidney, liver, and heart transplant recipients from a large solid organ transplant program. Various logistic regression, naive Bayes, support vector machine, and deep learning (DL) methods were used to predict 1-, 3-, and 5-year post-transplant hospitalization using patient and administrative data from a large pediatric organ transplant center. DL models generally outperformed traditional ML models across organtypes and prediction windows with area under the receiver operating characteristic curve values ranging from 0.750 to 0.851. Shapley additive explanations (SHAP) were used to increase the interpretability of DL model results. Various medical, patient, and social variables were identified as salient predictors across organ types. Results demonstrate the utility of DL modeling for health outcome prediction with pediatric patients, and its use represents an important development in the prediction of post-transplant outcomes in pediatric transplantation compared to prior research. Results point to DL models as potentially useful tools in decision-support systems assisting physicians and transplant teams in identifying patients at a greater risk for poor post-transplant outcomes.

Implications for body weight extremes in solid organ transplantation.

The pharmacokinetic profiles of medications are altered in overweight and underweight patients, but few studies have described these differences in patients with body mass index extremes. As solid organ transplant programs expand their candidate selection criteria to accommodate a growing population of patients with weight extremes, it has become imperative to understand and evaluate the impact weight extremes have on the pharmacokinetics of life-sustaining immunosuppression in this population. This review will describe pharmacokinetic and dosing considerations for weight extremes in solid organ transplant recipients, including changes following bariatric surgeries, non-pharmacologic and pharmacologic management strategies for weight loss and gain, and potential drug-drug interactions with popular weight management products.

Measles outbreak risk assessment for transplant candidates and recipients.

Solid organ transplant (SOT) candidates and recipients are at risk of significant morbidity and mortality from infection, including those circulating in the community from unexpected outbreaks. In late 2018-summer of 2019, a measles outbreak occurred in the New York City area, with a total of 649 cases reported. We developed a systematic 3-part approach to address measles risk in our adult SOT program through: (a) identification of nonimmune adults living in outbreak ZIP codes, (b) education focused on risk reduction for patients from outbreak ZIP codes, and (c) risk reduction for nonimmune patients. All waitlisted or previously transplanted patients residing in outbreak areas received a measles patient education handout. The electronic medical record of patients born in or after 1957 was reviewed for serologic evidence of measles immunity. Measles immunity testing was performed in patients without documentation of immunity. Patients who tested nonimmune were offered MMR vaccination or intravenous immunoglobulin depending on their transplant phase and risk profile. Thus, we demonstrate successful implementation of a systematic risk assessment during a large measles outbreak to identify and protect at-risk SOT patients. As vaccine hesitancy persists, our strategies may be increasingly relevant to transplant centers and those caring for immunocompromised patients.

Alternative pneumocystis prophylaxis in solid organ transplant recipients at two large transplant centers.

Trimethoprim-sulfamethoxazole (TMP-SMX) is the drug of choice for Pneumocystis jirovecii pneumonia (PJP) prophylaxis and has activity against other opportunistic infections (OIs) after solid organ transplant (SOT). We aimed to describe the incidence, reasons for and outcomes of use of alternative prophylactic agents (APAs) across SOT programs in our high volume centers. Solid organ transplant recipients (SOTRs) at our centers from 1/2015-12/2016 were identified. Pharmacy records identified APA (pentamidine, atovaquone, or dapsone) use within 1year. Records were reviewed for allergies, laboratory values at APA initiation, diagnostic tests for TMP-SMX-preventable OIs, and APA side effects. An APA was initiated in 105/1173 (8.9%) SOTRs. Of these, 51 (48.6%) were because of sulfonamide allergy recorded pre-SOT, mostly rash/hives (58.8%). The remaining 54 (51.4%) had TMP-SMX discontinued post-SOT, mostly for neutropenia (48%) and renal effects (34%). Differences occurred across programs, with kidney transplant never stopping TMP-SMX for renal issues. Of those changed to APAs post-transplant, 19 (35%) were later successfully re-challenged with TMP-SMX. With thresholds in mind, 67 (64%) received an APA unnecessarily, accounting for up to $100000/y excess cost. Potential TMP-SMX-preventable OIs occurred in 7 (5 Nocardia; 2 PJP). APA side effects occurred in 14/105 (13.3%). Use of APAs for PJP prophylaxis after SOT is less than previously reported but often unwarranted. Such decisions require scrutiny to avoid TMP-SMX-preventable OIs, cost and important APA side effects. Use of reasonable thresholds for cessation of TMP-SMX and data-driven approaches to re-challenge would substantially reduce APA use.

Clinical pharmacy programmatic perspectives on use of direct-acting antivirals for acquired hepatitis C infection in solid organ transplant recipients.

An institutional workflow developed by clinical pharmacists for initiation of directing-acting antiviral (DAA) therapy for patients who receive solid organ transplants from hepatitis C (HCV)-positive donors is described; programmatic challenges in providing pharmaceutical care to these patients are reviewed. In recent years the introduction of new oral DAAs, coupled with faster screening of donor organs for HCV infection through use of a nucleic acid test (NAT), has facilitated transplants of organs from HCV-seropositive donors to HCV-seronegative recipients. The solid organ transplant program of a North Carolina health system began performing such transplants in December 2017. In the pharmacist-developed workflow, patients are initiated on DAA therapy in the outpatient clinic setting, and clinic pharmacists are consulted regarding drug selection. Prescriptions for DAA therapy are sent to an on-site specialty pharmacy, where pharmacists and pharmacy technicians work to obtain prior authorization and, if necessary, payment assistance through manufacturer-sponsored programs. The medical team is notified at the time of patient approval to begin treatment. Pharmacists provide counseling at the time of DAA therapy initiation and follow up with patients every 2 weeks to confirm adherence. As of June 2019, about 100 transplants of HCV NAT-positive organs had been performed (approximately 50% were kidney transplants; 15%, lung transplants; 20%, heart transplants; and 15%, liver transplants). Many challenges are encountered in the process of providing pharmaceutical care to this patient population, including challenges in patient selection and counseling, overcoming financial barriers and insurance restrictions, and coordinating with an internal specialty pharmacy to ensure timely delivery of medication to patients. Within a solid organ transplantation program, clinical pharmacists and other pharmacy personnel can play vital roles in ensuring safe and effective DAA therapy for recipients of transplanted HCV NAT-positive organs.

Comment on Gross and MacDougall “Roles of the clinical pharmacist during the COVID‐19 pandemic”

The editorial by Gross and McDougall highlights the innovative roles that pharmacists have taken on during the COVID-19 pandemic.1 We aim to share our unique experience of multidisciplinary collaboration and adaptation of pharmacy practice within one of the nation's largest solid organ transplant (SOT) programs during the COVID-19 era. Recognizing the need to mitigate virus transmission, many team members, including our pharmacist, transitioned to working remotely. Following this change, our team swiftly initiated virtual rounding twice daily to improve communication between team members working onsite and remotely; multidisciplinary patient care discussions and team unity were preserved while maintaining social distance. During these virtual rounds, our pharmacist effectively made medication recommendations in order to ensure timely updates to patient care needs that required urgent intervention. This allowed our pharmacist and transplant coordinators to more efficiently work with the nurses and support staff onsite to schedule virtual patient education sessions. The COVID19 pandemic also required innovative means of continuing communication with our patients. SOT patients require thorough education on posttransplant medications and lifestyle choices. Our team transitioned these educational sessions to telemedicine education sessions. Meetings were arranged for the patients through institution owned iPads and caregivers could join the videoconference remotely. Before leaving the hospital, each of our patients received several hours of education with our pharmacist to assist their learning of medications, during which multiple teaching methods and tools were utilized. This communication method was also utilized for pretransplant patients when evaluating prior-to-admission medications and for readmitted patients to reinforce education. Several patients whose primary language was not English were also able to participate through multiprovider visits with simultaneous video interpretation. Other key members of our team including nurse practitioners transplant coordinators, and dieticians were able to learn from our pioneering experience and use this technology to safely and effectively communicate with our patients. SOT is a medical discipline that relies heavily on the collaboration of the interdisciplinary team. To maintain safety of our patients and team during the COVID-19 pandemic, we demonstrated ability to work together effectively in adapted roles. Through our innovative communication strategies, we have maintained exemplary patient care and outcomes. We will carry the lessons we learned through these challenges beyond the pandemic and continue to use them to ensure safe delivery of care. The authors declare no conflicts of interest.

Mortality trends around the one-year survival mark after heart, liver, and lung transplantation in the United States.

One-year post-transplant survival is a significant quality measure for solid organ transplant programs in the United States. It is not known whether the use of this metric is associated with changes in life-sustaining clinical practices that would delay mortality for solid organ recipients until just beyond the one-year time point. We compared trends in mortality in the time period immediately preceding the one-year post-transplant mark compared to the period immediately after using second-order Cox proportional hazard regression models. Among recipients of heart, liver, and lung transplantation, mortality did not decrease significantly in the period immediately before day 365 or increase in the 14days thereafter. There was an increased adjusted hazard of mortality in the 30days following day 365 among lung transplant recipients (HR 1.33, 95% CI 1.03-1.72, P=.03) with a 0.76% absolute mortality rate (94 deaths) in month 12 following lung transplantation and a 1.14% absolute mortality rate in month 13 (113 deaths). Although we did not find evidence that life-sustaining treatment is routinely continued until just beyond the one-year mark in heart and liver transplantation recipients, there was an unexpected increased risk of mortality in the 30days following day 365 among lung transplant recipients.

Solid organ transplantation programs facing lack of empiric evidence in the COVID-19 pandemic: A By-proxy Society Recommendation Consensus approach.

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) pandemic has a drastic impact on national health care systems. Given the overwhelming demand on facility capacity, the impact on all health care sectors has to be addressed. Solid organ transplantation represents a field with a high demand on staff, intensive care units, and follow‐up facilities. The great therapeutic value of organ transplantation has to be weighed against mandatory constraints of health care capacities. In addition, the management of immunosuppressed recipients has to be reassessed during the ongoing coronavirus disease 2019 (COVID‐19) pandemic. In addressing these crucial questions, transplant physicians are facing a total lack of scientific evidence. Therefore, the aim of this study was to offer an approach of consensus‐based guidance, derived from individual information of 22 transplant societies. Key recommendations were extracted and the degree of consensus among different organizations was calculated. A high degree of consensus was found for temporarily suspending nonurgent transplant procedures and living donation programs. Systematic polymerase chain reaction‐based testing of donors and recipients was broadly recommended. Additionally, more specific aspects (eg, screening of surgical explant teams and restricted use of marginal donor organs) were included in our analysis. This study offers a novel approach to informed guidance for health care management when a priori no scientific evidence is available.

Detection of novel and confirmation of very rare and rare HLA alleles by next generation sequencing in Croatia.

Routine HLA typing in clinical practice encompassing solid organ and hematopoietic stem cells transplantation programs, disease association typing, volunteer marrow donor typing and population studies, provided a large dataset for studying HLA allele polymorphism in the Croatian population which led to the identification of new, very rare and rare HLA alleles. Over the last 4 years we have identified six new HLA alleles (HLA-A*01:200, A*02:836, A*11:01:01:44, B*08:251, B*18:169 and C*05:46:01:02) and a number of very rare (HLA-B*08:78, DRB1*12:39, DRB1*13:23:02 and DQB1*06:09:04) or rare (HLA-A*24:41, B*39:40:01N, B*51:78:01, DRB1*01:31 and DRB1*14:111) alleles using sequence-based typing methods. The reported data enhance the knowledge about HLA polymorphisms in the Croatian population and provide a foundation for further studies in population genetics.

1638. Measles Outbreak Risk Assessment for Transplant Candidates and Recipients

BackgroundA measles outbreak began in 2018 with ongoing transmission in the New York City (NYC) area, affecting children and vulnerable adults. We developed a systematic 3-part approach to address measles risk in our solid-organ transplant program’s adult population by 1) identification of non-immune adults living in at-risk ZIP codes 2) education focused on risk reduction for all at-risk patients and families and 3) vaccination of non-immune waitlisted patients and consideration of prophylactic immunoglobulin G (IgG) for post-transplant non-immune patients at high risk for measles exposure.MethodsAll waitlisted and transplanted patients residing in any of 11 ZIP codes with recent measles cases in the NYC area as of April 4, 2019, were included. We also focused on the 4 ZIP codes in the NYC Health Commissioner’s vaccination order from April 9, 2019. We reviewed electronic medical records (EMR) of patients born after 1956 for measles immunity by serology or vaccine documentation. A 1-page measles patient education handout was created, reviewed for health literacy appropriateness and utilized in English and non-English language versions.Results118 waitlisted or previously transplanted patients resided in at-risk ZIP codes. Among the 118 patients, 56 (47.5%) were presumed immune based on birth year before 1957. Among 62 patients born in 1957 or later, 5 (8.1%) had preexisting positive measles IgG in the EMR and 1 patient had documentation of measles vaccination without measles IgG testing. Fifty-seven patients without EMR evidence of measles immunity were called to undergo measles IgG testing. 29 patients agreed to testing and an additional 19 patients had the test added to routine laboratories. Of these 48 patients, 1 was non-immune and 1 had equivocal immunity. Among transplanted patients identified as non-immune or with equivocal immune status, a recommendation for prophylactic IgG was made. All 118 patients received a measles informational handout by mail. Furthermore, we identified 21 patients born after 1956 living in the 4 zip codes targeted by the NYC health Commissioner’s order, and among those tested all were found to be immune.ConclusionA systematic risk assessment during a large measles outbreak identified at-risk transplant patients and provided timely education and screening for measles immunity.Disclosures All authors: No reported disclosures.

Comprehensive Assessment of Vascularized Composite Allotransplantation Patient-Oriented Online Resources.

Online resources have become a major source of medical information for the general public. To date, there has not been an assessment of patient-oriented online resources for face and upper extremity transplantation candidates and patients. The goal of this study is to perform a comprehensive assessment of these resources. Our analysis relied on 2 dimensions: comprehensiveness and readability. Comprehensiveness was evaluated using 14 predetermined variables. Readability was evaluated using 8 different readability scales through the Readability Studio Professional Edition Software (Oleander Software, Ltd, Vandalia, Ohio). Data were also collected from solid organ transplantation (SOT), specifically kidney and liver, programs for comparison. Face and upper extremity transplantation programs were significantly more likely to list exclusion criteria (73.9% vs 41.2%; P = 0.02), the need for life-long immunosuppression (87.0% vs 58.8%; P = 0.02), and benefits of transplantation (91.3% vs 61.8%; P = 0.01) compared with SOT programs. The average readability level of online resources by all face and upper extremity transplantation programs exceeded the sixth grade reading level recommended by the National Institutes of Health and the American Medical Association. The average reading grade level of online resources by these programs was also significantly higher than those of SOT with both exceeding the recommended reading level (13.95 ± 1.55 vs 12.60 ± 1.65; P = 0.003). Future efforts in face and upper extremity transplantation should be directed toward developing standardized, comprehensive, and intelligible resources with high-quality content and simple language.

Early experiences of independent advocates for potential HIV+ recipients of HIV+ donor organ transplants.

HIV+ to HIV+ solid organ transplants in the United States are now legally permitted. Currently, these transplants must adhere to the HIV Organ Policy Equity (HOPE) Act Safeguards and Research Criteria that require the provision of an independent recipient advocate, a novel requirement for solid organ transplant programs. The objective of this study was to understand the experiences of the first advocates serving in this role. We conducted semi-structured interviews with 15 HOPE independent recipient advocates (HIRAs) from 12 institutions. All HIRAs had a professional degree and experience in transplantation or infectious diseases. HIRAs' encounters with potential recipients varied in length, modality, and timing. The newness of the role and the lack of guidance were associated with unease among some HIRAs. Some questioned whether their role was redundant to others involved in transplantation and research since some potential recipients experienced informational fatigue. HOPE independent recipient advocates are ensuring the voluntariness of potential participants' decision to accept an HIV-infected organ. Many suggested additional guidance would be helpful and alleviate unease. Concerns about potential role redundancy raise the question of whether the HIRA requirement may be inadvertently increasing burden for potential recipients. Future work that captures the experiences of potential recipients is warranted.

Predicting for Cardiac Events Following Allogeneic Hematopoietic Stem Cell Transplantation in Adults

Introduction Cardiovascular (CV) complications occur after hematopoietic stem cell transplantation (HCT). Risk factors for events are unclear making it difficult to determine optimal pre-transplant screening. Solid organ transplants programs calculate pre-transplant risk to determine indication for further cardiac testing. Based on this, we investigated whether several commonly used CV risk calculators predicted for CV events after HCT. Methods This was a prospective case control study at a single academic institution. CV risk was estimated using the Framingham General CVD Risk Score (2008), ACC/AHA Pooled Cohort Hard CVD Risk (ASCVD; 2013) calculator, and JBS3 QRISK Lifetime calculator. Results Forty-eight patients transplanted between 2012 and 2016 were analyzed. 27 (56%) were female. Ages ranged from 53-74 with a median of 64. Diseases transplanted were: AML (38%), MDS (31%), Non-Hodgkin's lymphoma (15%), and others 47% had high risk for CVD (score>2) by Framingham score. 67% had high risk by ASCVD calculator (10 year risk >7.5%). 70% had high risk by QRISK Lifetime calculator. 9%were low risk by Framingham score, but high risk by QRISK Lifetime calculator. Cardiac events evaluated included atherosclerotic events (myocardial infarction and stroke), atrial fibrillation (a-fib), and others (other arrhythmia, CHF, drop in LVEF, and cardiac arrest). 40% had any cardiac event. 15% had an atherosclerotic event (MI or CVA). 21% had a-fib. Framingham Risk, ASCVD and QRISK calculators did not predict for either atherosclerotic events or any cardiac events after HCT [Table 1]. Risk factors for a-fib specifically, were also evaluated: history of MI, diastolic or systolic dysfunction, CHF, valvular disease, tobacco use, diabetes, and hypertension. Only CHF was a predictor for a-fib (p=0.08). Conclusion CVD risk calculators commonly used in the general population and by solid organ transplant programs did not predict for CV events post-HCT here. However, this analysis was limited by small study size. Study in a larger population is being planned to allow incorporation of transplant related variables to develop a HCT-specific multivariate risk calculator to accurately predict post-HCT CV events.

Acceptance of Vascularized Composite Allotransplantation (Face and Hand Transplant) in Singapore

Recent advancements and innovations in the burgeoning field of vascularized composite allotransplantation has enabled face and hand transplant to become a reality in the Western world. Plastic surgeons from the United States, France, and Spain have since performed vascularized composite allotransplantation as a novel therapeutic option in patients suffering from severe facial disfigurement and limb loss. Results have demonstrated remarkable functional and esthetic outcomes with improvements in the immense psychological, social, and emotional burdens that can arise in these patients. Despite the success of existing national solid organ transplant programs, face and hand transplant has yet to be established in this region. The specific aims of this study were to assess the attitudes and amount of risk Singaporeans are willing to accept towards receiving or donating face and hand transplants; and hence ultimately evaluate the feasibility of establishing such a program in Singapore.

P113 Developing an assay to detect and quantify donor-derived dna in the blood and urine of solid organ transplant patients

Aim Detection of circulating donor-derived cell-free DNA (cfDNA) as a non-invasive biomarker of graft injury shows tremendous potential for transplant monitoring. Increases in the amount of cfDNA in blood or urine indicate injury to the transplanted organ, including rejection. Also known as a liquid biopsy, this method is less invasive and more sensitive than an actual biopsy to detect early rejection. We proposed to develop a clinical test based on the detection and quantification of donor single-nucleotide polymorphisms (SNPs) using cfDNA extracted from plasma and urine of solid organ transplant patients. Methods Using genomic DNA, informative SNP markers from donor and recipient (ThermoFisher) will be identified using real-time PCR (Roche). cfDNA from transplant recipients will be extracted from plasma and urine (Qiagen), and informative SNPs will be quantified using digital-droplet PCR (ddPCR), (Bio-Rad). For development of the assay blood and urine samples were collected from 25 healthy individuals, genomic and cfDNA were extracted, and analytical parameters determined including limits of detection (LOD) and limits of quantification (LOQ) using ddPCR. Results cfDNA extraction was successfully performed from blood and urine. The average cfDNA concentration was 1.36 ± 0.54 ng/ul from plasma, and 1.15 ± 2.1 ng/ul from urine. Determined from genomic DNA, an average of 4.9 informative markers was present between any two of the 25 individuals, although one pairing had no informative markers present, indicating the need for a larger panel using more than 36 SNPs. LOD studies determined the false positivity rate to be less than 0.0025%. Preliminary LOQ testing indicates that 0.5–0.75% donor-derived DNA can be detected. Conclusions We have established a laboratory developed test to detect donor-derived cfDNA from multiple sample types such as blood and urine at a sensitivity that appears acceptable for clinical testing. In collaboration with the local solid organ transplant program, the clinical utility of this assay will be evaluated in kidney transplant recipients.

P004 Retrospective analysis of deceased donor samples for ZIKA virus infection in high-risk population, a three-year study

Aim The recent epidemic of Zika Virus in the United States has necessitated screening for the presence of this agent in high-risk transplant solid organ donors to avoid the transmission to potential recipients. In this study, we performed a retrospective analysis of Cadaver Donors from Auxilio Mutuo Hospital (HAM) in Puerto Rico. Methods One hundred fifty-six (156) serum samples from Deceased Donors were obtained from Puerto Rico. Aliquots of serum, were maintained at −20 °C since collection. There were 38 samples from 2014, 62 from 2015, and 56 from 2016. These samples were tested with the RealStar® Zika Virus RT-PCR Kit U.S.® kit (Altona Diagnostics), and Anti-Zika Virus ELISA IgG and IgM kits (EUROIMMUN). These assays were validated with a separate group of freshly obtained Zika-positive samples from an ambulatory clinic at HAM. Results Of the 156 total deceased donor specimens retrospectively tested, none were positive for PCR, 2 were positive for IgM, and 22 were positive or borderline for IgG. The breakdown over the 3-year period indicated an increase in long-term exposure, as indicated by the increase in IgG positive samples. In 2014, only 5.2% were positive. However, by 2015 19.4% of the samples were positive. This indicates that almost 20% of the Deceased Donors tested had some contact with the Zika Virus (or a related Flavivirus , such as Dengue or West Nile). Of the positive IgG samples, only 2 were positive for IgM, indicating the exposure was likely more than 3 months prior. The results of the PCR study were not surprising, as we have seen in our laboratory, the long-term storage of serum for later RNA-based PCR testing has been unsuccessful. Conclusions Zika testing utilizing PCR-based assays in conjunction with serological assays in areas of known infection is essential, especially when servicing solid organ transplant programs. The use of donors potentially infected with Zika virus could have a significant impact in transplant success as there are some indications that immunocompromised individuals may develop more severe symptoms or illnesses. The correct storage of serum samples is crucial to obtain reliable results of this test.

A national survey of screening and management of hypogammaglobulinemia in Canadian transplantation centers

Infection remains one of the most common transplant-related causes of death in patients undergoing transplantation. Secondary hypogammaglobulinemia (HGG) as a component of immune suppression and deficiency is associated with both solid organ transplantation (SOT) and hematopoietic cell transplantation (HCT). Available data and clinical experience for the supplementation of immunoglobulin (Ig) in these patients is conflicting, and differing clinical opinion accounts for non-uniform practice in the use of Ig treatment. We aimed to survey lead transplant practitioners for current practice around polyvalent Ig use in post-transplant recipients across Canada. We performed a survey study using short questionnaires to estimate rate of screening of HGG, use of polyvalent Ig, and physician's opinion on Ig treatment and infection prevention. Directors of 24 SOT and 23 HCT centers across Canada were invited to participate in the survey via an electronic mail. Overall response rate was 63.8%. Twenty percent of SOT programs routinely measured Ig levels pre-transplant compared to 33% of allogeneic (allo-) and 21% of autologous (auto-) HCT programs. Post-transplant Ig levels were measured in 13%, 75%, and 29% in SOT, allo-HCT, and auto-HCT, respectively. The SOT and auto-HCT groups indicated that they do not prescribe Ig therapy (100% and 86%), contrary to the allo-HCT group (42%). Of the respondents in the SOT, allo-HCT, and auto-HCT groups, 60%, 67%, and 36%, respectively, thought infections could be prevented with intravenous immunoglobulins (IVIg). A majority of respondents indicated they would be interested in participating in a randomized controlled trial evaluating the use of IVIg in the SOT and in both HCT groups (100%, 83%, and 57%, respectively). Our study shows significant variation in practice between SOT and HCT centers with respect to screening and management of HGG. There is willingness to participate in a randomized controlled trial to address whether Ig treatment reduces infection in post-transplant recipients.

Use of a Sulfa Desensitization Protocol in Solid Organ Transplant Recipients

BackgroundTrimethoprim–sulfamethoxazole (TMP-SMX) is first-line for pneumocystis prophylaxis in solid organ transplant (SOT) recipients. TMP-SMX also offers the advantage of urinary tract infection (UTI) prophylaxis (for kidney recipients) and activity against other opportunistic infections. Alternatives for sulfa allergic patients are inferior from the standpoint of pneumocystis protection, activity against other opportunistic infections and cost.MethodsIn 2013, our SOT program adopted a system-wide protocol for TMP-SMX desensitization during the index transplant hospitalization. Patients with a historical non-anaphylactic allergy were exposed to increasing doses of TMP-SMX and monitored for allergic reaction. If tolerated, they received standard prophylaxis with TMP-SMX. We completed a retrospective chart review of all patients identified for desensitization. We performed a cost analysis to estimate cost savings associated with the protocol.ResultsForty-three patients were identified and consented for the desensitization protocol. Thirty-eight (88%) were kidney recipients and the remainder were liver or heart recipients. See Figure 1 for pre-desensitization historical allergies. Thirty-six (84%) did not have an allergic reaction during desensitization; 33 ultimately completed 3 months of TMP-SMX prophylaxis; 7 had non-serious allergic or other reactions either during desensitization or before completing 3 months of prophylaxis (Figure 2). See Table 1 for details of reactions. Based off approximate average wholesale prices for 3 months of standard prophylaxis dosing of TMP-SMX ($65), pentamidine ($600) and nitrofurantoin ($220), we estimated a savings of $755 per kidney recipient, comparing TMP-SMX to an alternative of pentamidine and nitrofurantoin (for UTI prophylaxis for kidney recipients).ConclusionSystematic, protocol-driven TMP-SMX desensitization during index transplant hospitalization is safe and effective in SOT recipients, with resultant cost savings and broader spectrum coverage than second line agents.Table 1Allergic responses n = 7Occurred during protocol resulting in discontinuation4Occurred during index hospital stay6Resulted in higher acuity of care or prolonged admission0Hives2Other reaction5Disclosures L. Strasfeld, Merck: Independent Contractor, Salary

Potential Implications of Recent and Proposed Changes in the Regulatory Oversight of Solid Organ Transplantation in the United States.

Every 6 months, the Scientific Registry of Transplant Recipients (SRTR) publishes evaluations of every solid organ transplant program in the United States, including evaluations of 1-year patient and graft survival. The Centers for Medicare & Medicaid Services (CMS) and the Organ Procurement and Transplantation Network (OPTN) Membership and Professional Standards Committee (MPSC) use SRTR's 1-year evaluations for regulatory review of transplant programs. Concern has been growing that the regulatory scrutiny of transplant programs with lower-than-expected outcomes is harmful, causing programs to undertake fewer high-risk transplants and leading to unnecessary organ discards. As a result, CMS raised its threshold for a "Condition-Level Deficiency" designation of observed relative to expected 1-year graft or patient survival from 1.50 to 1.85. Exceeding this threshold in the current SRTR outcomes report and in one of the four previous reports leads to scrutiny that may result in loss of Medicare funding. For its part, OPTN is reviewing a proposal from the MPSC to also change its performance criteria thresholds for program review, to review programs with "substantive clinical differences." We review the details and implications of these changes in transplant program oversight.