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Cluster-Randomized Trial Comparing Ambulatory Decision Support Tools to Improve Heart Failure Care

Mukhopadhyay, Amrita; Reynolds, Harmony R; Phillips, Lawrence M; Nagler, Arielle R; King, William C; Szerencsy, Adam; Saxena, Archana; Aminian, Rod; Klapheke, Nathan; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:Mineralocorticoid receptor antagonists (MRA) are under-prescribed for patients with heart failure with reduced ejection fraction (HFrEF). OBJECTIVE:To compare effectiveness of two automated, electronic health record (EHR)-embedded tools vs. usual care on MRA prescribing in eligible patients with HFrEF. METHODS:BETTER CARE-HF (Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations for Heart Failure) was a three-arm, pragmatic, cluster-randomized trial comparing the effectiveness of an alert during individual patient encounters vs. a message about multiple patients between encounters vs. usual care on MRA prescribing. We included adult patients with HFrEF, no active MRA prescription, no contraindication to MRA, and an outpatient cardiologist in a large health system. Patients were cluster-randomized by cardiologist (60 per arm). RESULTS:The study included 2,211 patients (alert: 755, message: 812, usual care [control]: 644), with average age 72.2 years, average EF 33%, who were predominantly male (71.4%) and White (68.9%). New MRA prescribing occurred in 29.6% of patients in the alert arm, 15.6% in the message arm, and 11.7% in the control arm. The alert more than doubled MRA prescribing compared to control (RR: 2.53, 95% CI: 1.77-3.62, p<0.0001), and improved MRA prescribing compared to the message (RR: 1.67, 95% CI: 1.21-2.29, p=0.002). The number of patients with alert needed to result in an additional MRA prescription was 5.6. CONCLUSIONS:An automated, patient-specific, EHR-embedded alert increased MRA prescribing compared to both a message and usual care. Our findings highlight the potential for EHR-embedded tools to substantially increase prescription of life-saving therapies for HFrEF. (NCT05275920).
PMID: 36882134
ISSN: 1558-3597
CID: 5430312

Corrigendum to "Vascular endothelium as a target for perfluroalkyl substances (PFAs)" [Environ. Res. 212 (2022) 1-4/11339]

Wittkopp, Sharine; Wu, Fen; Windheim, Joseph; Robinson, Morgan; Kannan, Kurunthachalam; Katz, Stuart D; Chen, Yu; Newman, Jonathan D; [Levy, Natalie]
PMID: 36805490
ISSN: 1096-0953
CID: 5428782

Physician preferences for revascularization in patients with ischemic cardiomyopathy: Defining equipoise from web-based surveys

Mukhopadhyay, Amrita; Spertus, John; Bangalore, Sripal; Zhang, Yan; Tarpey, Thaddeus; Hochman, Judith; Katz, Stuart
BACKGROUND/UNASSIGNED:The optimal revascularization approach in patients with heart failure with reduced ejection fraction (HFrEF) and ischemic heart disease ("ischemic cardiomyopathy") is unknown. Physician preferences regarding clinical equipoise for mode of revascularization and their willingness to consider offering enrollment in a randomized trial to patients with ischemic cardiomyopathy have not been characterized. METHODS/UNASSIGNED:We conducted two anonymous online surveys: 1) a clinical case scenario-based survey to assess willingness to offer clinical trial enrollment for a patient with ischemic cardiomyopathy (overall response rate to email invitation 0.45 %), and 2) a Delphi consensus-building survey to identify specific areas of clinical equipoise (overall response rate to email invitation 37 %). RESULTS/UNASSIGNED:< 0.0001). In 17 scenarios (11.8 %), there was no difference in CABG or PCI appropriateness ratings, suggesting clinical equipoise in these settings. CONCLUSIONS/UNASSIGNED:Our findings demonstrate willingness to consider offering enrollment in a randomized clinical trial and areas of clinical equipoise, two factors that support the feasibility of a randomized trial to compare clinical outcomes after revascularization with CABG vs. PCI in selected patients with ischemic cardiomyopathy, suitable coronary anatomy and co-morbidity profile.
PMID: 36844107
ISSN: 2666-6022
CID: 5430302

Design and pilot implementation for the BETTER CARE-HF trial: A pragmatic cluster-randomized controlled trial comparing two targeted approaches to ambulatory clinical decision support for cardiologists

Mukhopadhyay, Amrita; Reynolds, Harmony R; Xia, Yuhe; Phillips, Lawrence M; Aminian, Rod; Diah, Ruth-Ann; Nagler, Arielle R; Szerencsy, Adam; Saxena, Archana; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:Beart failure with reduced ejection fraction (HFrEF) is a leading cause of morbidity and mortality. However, shortfalls in prescribing of proven therapies, particularly mineralocorticoid receptor antagonist (MRA) therapy, account for several thousand preventable deaths per year nationwide. Electronic clinical decision support (CDS) is a potential low-cost and scalable solution to improve prescribing of therapies. However, the optimal timing and format of CDS tools is unknown. METHODS AND RESULTS/RESULTS:We developed two targeted CDS tools to inform cardiologists of gaps in MRA therapy for patients with HFrEF and without contraindication to MRA therapy: (1) an alert that notifies cardiologists at the time of patient visit, and (2) an automated electronic message that allows for review between visits. We designed these tools using an established CDS framework and findings from semistructured interviews with cardiologists. We then pilot tested both CDS tools (n = 596 patients) and further enhanced them based on additional semistructured interviews (n = 11 cardiologists). The message was modified to reduce the number of patients listed, include future visits, and list date of next visit. The alert was modified to improve noticeability, reduce extraneous information on guidelines, and include key information on contraindications. CONCLUSIONS:The BETTER CARE-HF (Building Electronic Tools to Enhance and Reinforce CArdiovascular REcommendations for Heart Failure) trial aims to compare the effectiveness of the alert vs. the automated message vs. usual care on the primary outcome of MRA prescribing. To our knowledge, no study has directly compared the efficacy of these two different types of electronic CDS interventions. If effective, our findings can be rapidly disseminated to improve morbidity and mortality for patients with HFrEF, and can also inform the development of future CDS interventions for other disease states. (Trial registration: NCT05275920).
PMID: 36640860
ISSN: 1097-6744
CID: 5403312

An Evaluation of Alternative Technology-Supported Counseling Approaches to Promote Multiple Lifestyle Behavior Changes in Patients With Type 2 Diabetes and Chronic Kidney Disease

St-Jules, David E; Hu, Lu; Woolf, Kathleen; Wang, Chan; Goldfarb, David S; Katz, Stuart D; Popp, Collin; Williams, Stephen K; Li, Huilin; Jagannathan, Ram; Ogedegbe, Olugbenga; Kharmats, Anna Y; Sevick, Mary Ann
OBJECTIVES/OBJECTIVE:Although technology-supported interventions are effective for reducing chronic disease risk, little is known about the relative and combined efficacy of mobile health strategies aimed at multiple lifestyle factors. The purpose of this clinical trial is to evaluate the efficacy of technology-supported behavioral intervention strategies for managing multiple lifestyle-related health outcomes in overweight adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). DESIGN AND METHODS/METHODS:, age ≥40 years), T2D, and CKD stages 2-4 were randomized to an advice control group, or remotely delivered programs consisting of synchronous group-based education (all groups), plus (1) Social Cognitive Theory-based behavioral counseling and/or (2) mobile self-monitoring of diet and physical activity. All programs targeted weight loss, greater physical activity, and lower intakes of sodium and phosphorus-containing food additives. RESULTS:Of 256 randomized participants, 186 (73%) completed 6-month assessments. Compared to the ADVICE group, mHealth interventions did not result in significant changes in weight loss, or urinary sodium and phosphorus excretion. In aggregate analyses, groups receiving mobile self-monitoring had greater weight loss at 3 months (P = .02), but between 3 and 6 months, weight losses plateaued, and by 6 months, the differences were no longer statistically significant. CONCLUSIONS:When engaging patients with T2D and CKD in multiple behavior changes, self-monitoring diet and physical activity demonstrated significantly larger short-term weight losses. Theory-based behavioral counseling alone was no better than baseline advice and demonstrated no interaction effect with self-monitoring.
PMID: 35752400
ISSN: 1532-8503
CID: 5282392

Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design

Horwitz, Leora I; Thaweethai, Tanayott; Brosnahan, Shari B; Cicek, Mine S; Fitzgerald, Megan L; Goldman, Jason D; Hess, Rachel; Hodder, S L; Jacoby, Vanessa L; Jordan, Michael R; Krishnan, Jerry A; Laiyemo, Adeyinka O; Metz, Torri D; Nichols, Lauren; Patzer, Rachel E; Sekar, Anisha; Singer, Nora G; Stiles, Lauren E; Taylor, Barbara S; Ahmed, Shifa; Algren, Heather A; Anglin, Khamal; Aponte-Soto, Lisa; Ashktorab, Hassan; Bassett, Ingrid V; Bedi, Brahmchetna; Bhadelia, Nahid; Bime, Christian; Bind, Marie-Abele C; Black, Lora J; Blomkalns, Andra L; Brim, Hassan; Castro, Mario; Chan, James; Charney, Alexander W; Chen, Benjamin K; Chen, Li Qing; Chen, Peter; Chestek, David; Chibnik, Lori B; Chow, Dominic C; Chu, Helen Y; Clifton, Rebecca G; Collins, Shelby; Costantine, Maged M; Cribbs, Sushma K; Deeks, Steven G; Dickinson, John D; Donohue, Sarah E; Durstenfeld, Matthew S; Emery, Ivette F; Erlandson, Kristine M; Facelli, Julio C; Farah-Abraham, Rachael; Finn, Aloke V; Fischer, Melinda S; Flaherman, Valerie J; Fleurimont, Judes; Fonseca, Vivian; Gallagher, Emily J; Gander, Jennifer C; Gennaro, Maria Laura; Gibson, Kelly S; Go, Minjoung; Goodman, Steven N; Granger, Joey P; Greenway, Frank L; Hafner, John W; Han, Jenny E; Harkins, Michelle S; Hauser, Kristine S P; Heath, James R; Hernandez, Carla R; Ho, On; Hoffman, Matthew K; Hoover, Susan E; Horowitz, Carol R; Hsu, Harvey; Hsue, Priscilla Y; Hughes, Brenna L; Jagannathan, Prasanna; James, Judith A; John, Janice; Jolley, Sarah; Judd, S E; Juskowich, Joy J; Kanjilal, Diane G; Karlson, Elizabeth W; Katz, Stuart D; Kelly, J Daniel; Kelly, Sara W; Kim, Arthur Y; Kirwan, John P; Knox, Kenneth S; Kumar, Andre; Lamendola-Essel, Michelle F; Lanca, Margaret; Lee-Lannotti, Joyce K; Lefebvre, R Craig; Levy, Bruce D; Lin, Janet Y; Logarbo, Brian P; Logue, Jennifer K; Longo, Michele T; Luciano, Carlos A; Lutrick, Karen; Malakooti, Shahdi K; Mallett, Gail; Maranga, Gabrielle; Marathe, Jai G; Marconi, Vincent C; Marshall, Gailen D; Martin, Christopher F; Martin, Jeffrey N; May, Heidi T; McComsey, Grace A; McDonald, Dylan; Mendez-Figueroa, Hector; Miele, Lucio; Mittleman, Murray A; Mohandas, Sindhu; Mouchati, Christian; Mullington, Janet M; Nadkarni, Girish N; Nahin, Erica R; Neuman, Robert B; Newman, Lisa T; Nguyen, Amber; Nikolich, Janko Z; Ofotokun, Igho; Ogbogu, Princess U; Palatnik, Anna; Palomares, Kristy T S; Parimon, Tanyalak; Parry, Samuel; Parthasarathy, Sairam; Patterson, Thomas F; Pearman, Ann; Peluso, Michael J; Pemu, Priscilla; Pettker, Christian M; Plunkett, Beth A; Pogreba-Brown, Kristen; Poppas, Athena; Porterfield, J Zachary; Quigley, John G; Quinn, Davin K; Raissy, Hengameh; Rebello, Candida J; Reddy, Uma M; Reece, Rebecca; Reeder, Harrison T; Rischard, Franz P; Rosas, Johana M; Rosen, Clifford J; Rouphael, Nadine G; Rouse, Dwight J; Ruff, Adam M; Saint Jean, Christina; Sandoval, Grecio J; Santana, Jorge L; Schlater, Shannon M; Sciurba, Frank C; Selvaggi, Caitlin; Seshadri, Sudha; Sesso, Howard D; Shah, Dimpy P; Shemesh, Eyal; Sherif, Zaki A; Shinnick, Daniel J; Simhan, Hyagriv N; Singh, Upinder; Sowles, Amber; Subbian, Vignesh; Sun, Jun; Suthar, Mehul S; Teunis, Larissa J; Thorp, John M; Ticotsky, Amberly; Tita, Alan T N; Tragus, Robin; Tuttle, Katherine R; Urdaneta, Alfredo E; Utz, P J; VanWagoner, Timothy M; Vasey, Andrew; Vernon, Suzanne D; Vidal, Crystal; Walker, Tiffany; Ward, Honorine D; Warren, David E; Weeks, Ryan M; Weiner, Steven J; Weyer, Jordan C; Wheeler, Jennifer L; Whiteheart, Sidney W; Wiley, Zanthia; Williams, Natasha J; Wisnivesky, Juan P; Wood, John C; Yee, Lynn M; Young, Natalie M; Zisis, Sokratis N; Foulkes, Andrea S
IMPORTANCE/OBJECTIVE:SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis. METHODS:RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms. DISCUSSION/CONCLUSIONS:RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options. REGISTRATION/BACKGROUND:NCT05172024.
PMID: 37352211
ISSN: 1932-6203
CID: 5538502

Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design

Metz, Torri D; Clifton, Rebecca G; Gallagher, Richard; Gross, Rachel S; Horwitz, Leora I; Jacoby, Vanessa L; Martin-Herz, Susanne P; Peralta-Carcelen, Myriam; Reeder, Harrison T; Beamon, Carmen J; Chan, James; Chang, A Ann; Costantine, Maged M; Fitzgerald, Megan L; Foulkes, Andrea S; Gibson, Kelly S; Güthe, Nick; Habli, Mounira; Hackney, David N; Hoffman, Matthew K; Hoffman, M Camille; Hughes, Brenna L; Katz, Stuart D; Laleau, Victoria; Mallett, Gail; Mendez-Figueroa, Hector; Monzon, Vanessa; Palatnik, Anna; Palomares, Kristy T S; Parry, Samuel; Pettker, Christian M; Plunkett, Beth A; Poppas, Athena; Reddy, Uma M; Rouse, Dwight J; Saade, George R; Sandoval, Grecio J; Schlater, Shannon M; Sciurba, Frank C; Simhan, Hyagriv N; Skupski, Daniel W; Sowles, Amber; Thaweethai, Tanayott; Thomas, Gelise L; Thorp, John M; Tita, Alan T; Weiner, Steven J; Weigand, Samantha; Yee, Lynn M; Flaherman, Valerie J; ,
IMPORTANCE/OBJECTIVE:Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads. METHODS:RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators. DISCUSSION/CONCLUSIONS:RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero. CLINICAL TRIALS.GOV IDENTIFIER/BACKGROUND:Clinical Trial Registration: Unique identifier: NCT05172011.
PMID: 38128008
ISSN: 1932-6203
CID: 5612082

Long-term follow-up of acute and chronic rejection in heart transplant recipients from hepatitis C viremic (NAT+) donors

Stachel, Maxine W; Alimi, Marjan; Narula, Navneet; Flattery, Erin E; Xia, Yuhe; Ramachandran, Abhinay; Saraon, Tajinderpal; Smith, Deane; Reyentovich, Alex; Goldberg, Randal; Kadosh, Bernard S; Razzouk, Louai; Katz, Stuart; Moazami, Nader; Gidea, Claudia G
The long-term safety of heart transplants from hepatitis C viremic (NAT+) donors remains uncertain. We conducted a prospective study of all patients who underwent heart transplantation at our center from January 2018 through August 2020. Routine testing was performed to assess for donor-derived cell-free DNA, acute cellular rejection (ACR), antibody-mediated rejection (AMR), and cardiac allograft vasculopathy (CAV). Allograft dysfunction and mortality were also monitored. Seventy-five NAT- recipients and 32 NAT+ recipients were enrolled in the study. All NAT+ recipients developed viremia detected by PCR, were treated with glecaprevir/pibrentasvir at the time of viremia detection, and cleared the virus by 59 days post-transplant. Patients who underwent NAT testing starting on post-operative day 7 (NAT+ Group 1) had significantly higher viral loads and were viremic for a longer period compared with patients tested on post-operative day 1 (NAT+ Group 2). Through 3.5 years of follow-up, there were no statistically significant differences in timing, severity, or frequency of ACR in NAT+ recipients compared with the NAT- cohort, nor were there differences in noninvasive measures of graft injury, incidence or severity of CAV, graft dysfunction, or mortality. There were five episodes of AMR, all in the NAT- group. There were no statistically significant differences between Group 1 and Group 2 NAT+ cohorts. Overall, these findings underscore the safety of heart transplantation from NAT+ donors.
PMID: 36053676
ISSN: 1600-6143
CID: 5332222

Missed opportunities in medical therapy for patients with heart failure in an electronically-identified cohort

Mukhopadhyay, Amrita; Reynolds, Harmony R; Nagler, Arielle R; Phillips, Lawrence M; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:National registries reveal significant gaps in medical therapy for patients with heart failure and reduced ejection fraction (HFrEF), but may not accurately (or fully) characterize the population eligible for therapy. OBJECTIVE:We developed an automated, electronic health record-based algorithm to identify HFrEF patients eligible for evidence-based therapy, and extracted treatment data to assess gaps in therapy in a large, diverse health system. METHODS:In this cross-sectional study of all NYU Langone Health outpatients with EF ≤ 40% on echocardiogram and an outpatient visit from 3/1/2019 to 2/29/2020, we assessed prescription of the following therapies: beta-blocker (BB), angiotensin converting enzyme inhibitor (ACE-I)/angiotensin receptor blocker (ARB)/angiotensin receptor neprilysin inhibitor (ARNI), and mineralocorticoid receptor antagonist (MRA). Our algorithm accounted for contraindications such as medication allergy, bradycardia, hypotension, renal dysfunction, and hyperkalemia. RESULTS:We electronically identified 2732 patients meeting inclusion criteria. Among those eligible for each medication class, 84.8% and 79.7% were appropriately prescribed BB and ACE-I/ARB/ARNI, respectively, while only 23.9% and 22.7% were appropriately prescribed MRA and ARNI, respectively. In adjusted models, younger age, cardiology visit and lower EF were associated with increased prescribing of medications. Private insurance and Medicaid were associated with increased prescribing of ARNI (OR = 1.40, 95% CI = 1.02-2.00; and OR = 1.70, 95% CI = 1.07-2.67). CONCLUSIONS:We observed substantial shortfalls in prescribing of MRA and ARNI therapy to ambulatory HFrEF patients. Subspecialty care setting, and Medicaid insurance were associated with higher rates of ARNI prescribing. Further studies are warranted to prospectively evaluate provider- and policy-level interventions to improve prescribing of these evidence-based therapies.
PMID: 35927632
ISSN: 1471-2261
CID: 5285842

Pre-transplant immune cell function assay as a predictor of early cardiac allograft rejection

Maidman, Samuel D; Gidea, Claudia; Reyentovich, Alex; Rao, Shaline; Saraon, Tajinderpal; Kadosh, Bernard S; Narula, Navneet; Carillo, Julius; Smith, Deane; Moazami, Nader; Katz, Stuart; Goldberg, Randal I
INTRODUCTION/BACKGROUND:ImmuKnow, an immune cell function assay that quantifies overall immune system activity can assist in post-transplant immunosuppression adjustment. However, the utility of pre-transplant ImmuKnow results representing a patient's baseline immune system activity is unknown. This study sought to assess if pre-transplant ImmuKnow results are predictive of rejection at the time of first biopsy in our cardiac transplant population. METHODS:This is a single center, retrospective observational study of consecutive patients from January 1, 2018 to October 1, 2020 who underwent orthotopic cardiac transplantation at NYU Langone Health. Patients were excluded if a pre-transplant ImmuKnow assay was not performed. ImmuKnow results were categorized according to clinical interpretation ranges (low, moderate, and high activity), and patients were divided into two groups: a low activity group versus a combined moderate-high activity group. Pre-transplant clinical characteristics, induction immunosuppression use, early postoperative tacrolimus levels, and first endomyocardial biopsy results were collected for all patients. Rates of clinically significant early rejection (defined as rejection ≥ 1R/1B) were compared between pre-transplant ImmuKnow groups. RESULTS:Of 110 patients who underwent cardiac transplant, 81 had pre-transplant ImmuKnow results. The low ImmuKnow activity group was comprised of 15 patients, and 66 patients were in the combined moderate-high group. Baseline characteristics were similar between groups. Early rejection occurred in 0 (0%) patients with low pre-transplant ImmuKnow levels. Among the moderate- high pre-transplant ImmuKnow group, 16 (24.2%) patients experienced early rejection (P = .033). The mean ImmuKnow level in the non-rejection group was the 364.9 ng/ml of ATP compared to 499.3 ng/ml of ATP for those with rejection (P = .020). CONCLUSION/CONCLUSIONS:Patients with low pre-transplant ImmuKnow levels had lower risk of early rejection when compared with patients with moderate or high levels. Our study suggests a possible utility in performing pre-transplant ImmuKnow to identify patients at-risk for early rejection who may benefit from intensified upfront immunosuppression as well as to recognize those where slower calcineurin inhibitor initiation may be appropriate.
PMID: 35678734
ISSN: 1399-0012
CID: 5279542