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Background Chronic thyroiditis (CT) is a common cause of thyroid dysfunction and could therefore adversely affect outcomes in patients undergoing heart transplant (HT). The incidence of post-HT CT and whether amiodarone, a commonly used anti-arrhythmic drug in patients with heart failure during pre-HT period, is associated with the development of post-HT CT are unknown. Methods A retrospective review of HT recipients from February 2, 2010 to October 16, 2018 was performed. Patients who lacked relevant pre-/post-HT records, underwent thyroidectomy, had pre-HT thyroid dysfunction or thyroiditis within 15 days post-HT, and those on amiodarone during the post-HT period were excluded, yielding a final cohort of 75 patients. Results Patients had a mean age of 63.3 ± 1.4 years and were predominantly male (90.7%) and white (80%). The incidence of post-HT CT was 32% with the majority (83.3%) manifesting as hypothyroidism. Median time to diagnosis of CT after transplant was 10.2 months (interquartile range, 4-27.4). Additionally, the CT group had higher pre-HT use of amiodarone (non-CT vs CT: 21.6% vs 50%, P = .01), higher prevalence of atrial fibrillation (non-CT vs CT: 23.5% vs 45.8%; P = .05), and more stage IV/V chronic kidney disease (non-CT vs CT: 2% vs 16.7%, P = .02). On multivariate analysis, pre-HT amiodarone use was associated with the development of post-HT CT after adjustment for age, sex, and chronic kidney disease (odds ratio, 3.65; 95% CI, 1.17-11.44; P = .03). Conclusion The incidence of post-HT CT is high and is strongly associated with pre-HT amiodarone use underpinning the importance of closely following the post-HT thyroid profile in these patients.

Tacrolimus is a core component of immunosuppressive regimens. This study compared active pharmaceutical ingredient (API) and dissolution kinetics of branded tacrolimus and formulations from three generic manufacturers (Mylan, Dr. Reddy’s, Intas) including samples from patients who suffered acute cardiac allograft rejection. Generic samples showed similar API content compared to branded samples with no major impurities. Capsules that underwent uniformity testing had consistent capsule-to-capsule API. Dissolution testing showed similar profiles between branded tacrolimus and Mylan, but notable differences with Dr. Reddy’s and Intas. The approximate maximal inhibitory concentration (IC(50)) was highest in branded tacrolimus (29 minutes), followed by Mylan (26 minutes), Dr. Reddy’s (19 minutes), and Intas (14 minutes) (Student-Newman-Keuls Multiple Comparisons Test; overall ANOVA: p = 0.0199, F = 6.469). This study suggests that the bioavailability of certain generic tacrolimus formulations peak significantly earlier than branded tacrolimus. Further study is needed to determine whether these differences are clinically relevant.

Heparin-induced thrombocytopenia (HIT) is a prothrombotic complication following heparin exposure. Data is limited on the incidence of HIT and validity of 4Ts score in the solid organ transplant population. This retrospective observational cohort included patients who underwent lung transplant between August 2015 and June 2018 and had a clinical suspicion of HIT with heparin-PF4 testing. The 4Ts score was correlated with the heparin-PF4 antibody and serotonin release assay (SRA) results, with positive SRA considered confirmed HIT. Of 146 patients evaluated, the overall incidence of HIT was low (2(1%)). Fifty-one patients had heparin-PF4 testing and were included in the cohort; 5 (10%) had positive heparin-PF4 and 1 (2%) had confirmed HIT. The median 4Ts score was 3 (3-4). Thirty (59%), 17 (33%), and 4 (8%) patients had low, intermediate, and high risk, respectively. The intermediate/high risk group compared to the low risk group had a higher use of alternative non-heparin anticoagulation [13 (62%) vs 7 (23%); p = 0.0086)] and a higher incidence of thrombosis [13 (62%) vs 1 (3%); p 0.0001]. No patient with a low 4Ts score had confirmed HIT, supporting the utility of low 4Ts score to exclude HIT diagnosis in lung transplant recipients.

Continuous-flow left ventricular assist device (LVAD) placement has become a standard of care in advanced heart failure treatment. Bleeding is the most frequently reported adverse event after LVAD implantation and may be increased by antithrombotic agents used for prevention of pump thrombosis. This retrospective cohort included 85 adult patients implanted with a Heartmate II LVAD. Major bleeding was defined as occurring >7 days after implant and included intracranial hemorrhage, events requiring 2 units of packed red blood cells within a 24-h period, and death from bleeding. Primary outcome was intensity of anticoagulation between patients with or without at least one incidence of nonsurgical major bleeding. Major bleeding occurred in 35 (41%) patients with 0.48 events per patient year and a median (IQR) time to first bleed of 134.5 (39.3, 368.5) days. The median (IQR) INR at time of bleed was 1.7 (1.4, 2.5). Median INR during follow-up did not differ between groups and patients with major bleeding were not more likely to have a supra-therapeutic INR. Patients who bled were more likely to have received LVAD for destination therapy, to have lower weight, worse renal function, and lower hemoglobin at baseline. Duration of LVAD support and survival were similar between groups with no difference in occurrence of thrombosis. Incidence of nonsurgical major bleeding was not significantly associated with degree of anticoagulation. Certain baseline characteristics may be more important than anticoagulation intensity to identify patients at risk for bleeding after LVAD implant. Modification of anticoagulation alone is not a sufficient management strategy and early intervention may be required to mitigate bleeding impact.

Purpose Guidelines suggest optional use of Cytomegalovirus (CMV) T Cell immunity monitoring (TCell) to guide primary prophylaxis duration or need for secondary prophylaxis after infection. This may help balance the negative implications of CMV (rejection, coronary artery vasculopathy) against those of valganciclovir (expense, leukopenia/neutropenia). We present one year of experience to evaluate the potential utility of this test. Methods CMV TCell was implemented at our center to assess immunity at end of primary prophylaxis (R+ serostatus) and need for secondary prophylaxis after treatment of CMV. Heart transplant recipients with CMV TCell September 2019 to 2020 were retrospectively reviewed. Primary prophylaxis tests were excluded if R- serostatus or within 6 months of rATG. Tests at time of CMV detection prior to treatment were also excluded. Results Table 1 describes requirements for implementation. 24 patients had CMV TCell during study period; 1 never processed. Patients were excluded for: R- serostatus (6), rATG (1), and at time of CMV detection (2). 14 patients were included for analysis; 5 CMV R+ to guide primary prophylaxis discontinuation, 8 for secondary prophylaxis after infection treatment, 1 early for neutropenia. The early test for neutropenia was inconclusive after G-CSF administration. Immunity was noted at first test in 2/5 (40%) of the primary prophylaxis and 4/8 (50%) of the secondary group. Of non-immune in primary prophylaxis group, 2 had inconclusive tests concurrent to non-CMV infection and other in setting of neutropenia. After repeat tests, 9/14 (64%) patients were noted to have immunity. Of those with immunity, 5/9 (55%) had recurrence of low level viremia; 2 treated at detection, 3 self-cleared without treatment. Conclusion Early review of our data suggests CMV TCell may serve a role to identify patients who would benefit from secondary prophylaxis after treatment of CMV infection. Additional data over future years will help better define optimal utilization of this test.

Background This study evaluated the impact of body mass index (BMI) and patient functional status on the risk for surgical complications after kidney transplant. Methods This retrospective cohort study of adult kidney transplant recipients grouped patients by baseline Karnofsky status (low function ≤ 70%) and further stratified by morbid obesity (BMI ≥ 35 kg/m2) to assess surgical complication risk. Results 736 patients were included with surgical complications occurring in 25%. Logistic regression analysis with interaction terms demonstrated that morbid obesity and low functional status conditionally impact risk with an OR of 2.8 [95% CI (1.1–7.3)]. Within the functional status cohort, BMI ≥35 kg/m2 was associated with increased risk of surgical complication, superficial wound infection, and DGF. Independent predictors for surgical complications included diabetes and morbid obesity with low functional status. There was no significant difference in graft loss or death across the cohorts. Conclusions While neither morbid obesity nor poor functional status alone predicts increased complications, the combined presence is associated with significant increase in risk for surgical complications after renal transplantation.

Pump thrombosis (PT) is a severe complication of left ventricular assist device (LVAD) support. This study evaluated PT and bleeding after LVAD placement in patients responsive to a standard aspirin dose of 81 mg using platelet inhibition monitoring compared with initial nonresponders who were then titrated upward to achieve therapeutic response. Patients ≥ 18 years of age with initial placement of HeartMate II LVAD at our institution and at least one VerifyNow Aspirin test performed during initial hospitalization were included. The primary endpoints were bleeding and PT compared between initial aspirin responders and nonresponders. Of 85 patients, 19 (22%) were nonresponsive to initial aspirin therapy. Responders and nonresponders showed similar survival (p = 0.082), freedom from suspected/confirmed PT (p = 0.941), confirmed PT (p = 0.273), bleeding (p = 0.401), and incidence rates in PT and bleeding. Among the initial responders (