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To assess the interaction of health literacy and a shared intervention concerning decision quality in patients considering the destination therapy of left ventricular assist device (DT LVAD) implantation.Evidence is limited for the use of decision aids by patients with low health literacy and with life-threatening illnesses.We performed a secondary analysis of the DECIDE-LVAD Trial, a randomized, stepped-wedge trial conducted from 2015-2017 in the United States. The intervention was the integration of a formal shared decision-making intervention. The main outcome was decision quality as measured by LVAD knowledge and values-treatment concordance. Two components of health literacy were measured by the Rapid Estimate of Adult Literacy in Medicine and Subjective Numeracy Scale instruments.Of the 228 patients studied, 44% (n = 101) received the formal shared decision-making intervention, and half had low health literacy. Knowledge of LVAD improved for patients with low literacy in the intervention group compared to the control group: the difference in increased knowledge score was 10.6%; P = 0.04. Values-treatment concordance improved significantly for patients with low literacy in the intervention group compared to the control group: the median improvement in values-treatment correlation coefficient was 0.43; P = 0.03. These benefits were not significant in those with adequate literacy (n = 171). Patients with low numeracy (n = 94) did not show significant improvements in either measure of decision quality, and patients with adequate numeracy (n = 134) showed improvement in LVAD knowledge but not in values-treatment concordance.Patients considering DT LVAD implantation with low literacy showed improvement in decision quality after the integration of a shared decision-making intervention.

Right ventricular (RV) failure is difficult to predict and is a major determinant of poor outcomes after left ventricular assist device (LVAD) implantation. We evaluated the associations of the following variables with severe RV failure in LVAD patients: tricuspid annular plane systolic excursion (TAPSE), pulmonary artery pulsatility index (PAPi), simplified RV contraction pressure index (sRVCPI), and HeartMate Risk Score (HMRS). We performed a retrospective case-control study on 216 patients who underwent continuous-flow LVAD implantation between 2008 and 2014. The primary analysis assessed the ability of HMRS, PAPi, sRVCPI, and TAPSE to predict severe RV failure. A secondary analysis evaluated the incremental benefit of combining predictive variables. Seventy-four patients developed severe RV failure (24%). Compared with the control group, the severe RV failure group had lower TAPSE (1.30 vs. 1.55; p < 0.001), lower PAPi (1.77 vs. 2.47; p = 0.001), lower sRVCPI (42.71 vs. 57.82; p < 0.001), and higher HMRS (2.12 vs. 1.65; p < 0.001). All four variables had similar receiver operating characteristic curves with modest area under the receiver operating characteristic curve (0.63-0.67, all p values < 0.001). In the evaluation of combined predictive variables, the combination of TAPSE with HMRS was found to be best for predicting severe RV failure. In summary, patients at risk for severe RV failure after LVAD implantation were successfully identified using TAPSE, PAPi, sRCPI, and HMRS. The combination of TAPSE and HMRS-incidentally, the least invasive and most readily available variables-proved to be superior to RV-centric metrics for predicting severe RV failure. The predictive and clinical use of these two variables should be tested prospectively.

IMPORTANCE: Orthotopic heart transplant (OHT) recipients are at increased risk for morbidity and mortality after SARS-CoV-2 infection. Although antibody response to COVID-19 vaccination is lower in solid organ transplant recipients, there has been no study assessing the safety and effectiveness of COVID-19 vaccination in OHT recipients. OBJECTIVE: To assess the safety and effectiveness of COVID-19 vaccination and associations with SARS-CoV-2 infection and clinical outcomes in a large population of adult OHT recipients. DESIGN, SETTING, AND PARTICIPANTS: This case-control study examined data from a US heart transplant program at a single center for all adult recipients of OHT who were followed up from January 15, 2021, through January 31, 2022. MAIN OUTCOMES AND MEASURES: The primary outcome was number of SARS-CoV-2 infections and related hospitalizations, intensive care unit (ICU) admissions, and deaths between vaccinated vs unvaccinated adult recipients of OHT. RESULTS: A total of 436 patients who received OHT were included in the study, of which 106 patients were infected with COVID-19. The mean (SD) age was 54 (17) years; 303 (69.5%) were men and 133 (30.5%) were women. There were 366 patients in the vaccinated cohort with 72 COVID-19 infections (19.7%), 15 hospitalizations (4.1%), 4 ICU admissions (1.1%), and 3 deaths (0.8%). There were 70 patients in the unvaccinated cohort with 34 COVID-19 infections (48.6%), 10 hospitalizations (14.3%), 3 ICU admissions (4.3%), and 3 deaths (4.3%). COVID-19 vaccination was associated with a lower risk of COVID-19 infection (risk ratio [RR], 0.41; 95% CI, 0.30-0.56), hospitalization (RR, 0.29; 95% CI, 0.14-0.61), and death (RR, 0.19; 95% CI, 0.05-0.82). Among the 366 vaccinated OHT recipients, there was no echocardiographic evidence of graft dysfunction, clinically significant rejection, or allosensitization at 6 months after they received the COVID-19 vaccine. CONCLUSIONS AND RELEVANCE: Patients with OHT who are infected with SARS-CoV-2 are at greater risk of severe infection and death compared with immunocompetent individuals. COVID-19 vaccination was associated with fewer COVID-19 infections, hospitalizations, and deaths, with no heart transplant–specific adverse events. COVID-19 vaccination for all OHT recipients is of paramount importance.

Primary graft dysfunction (PGD) is a potentially devastating complication of heart transplantation. Understanding the risk factors for PGD in the modern era of heart transplantation is of vital importance. This study investigated the relationship between post-left ventricular assist device (LVAD) right heart failure (RHF) and transplant outcomes. Patients with durable, continuous-flow LVADs who were transplanted between 2010 and 2016 at Barnes-Jewish Hospital were included in the study. Data collection was performed through retrospective chart review. The primary outcome was the incidence of PGD stratified by pretransplant incidence of RHF while on LVAD support. Among the 141 patients included in the study, 41 developed RHF. In the RHF cohort, 18 patients developed PGD as compared to 14 patients in the group without RHF (44% vs. 14%; p < 0.001). Mortality was significantly higher in the RHF group at 30 days (20% vs. 1%; p < 0.001) and 1 year (22% vs. 6%; p = 0.013). In a multivariable logistic regression model adjusted for confounding variables, RHF was associated with a nearly fourfold increased risk of PGD (odds ratio, 3.91; p = 0.003). The results of this study show that patients supported with LVADs who develop early severe RHF or late RHF are at increased risk of PGD and death following cardiac transplantation.

Tick-borne infections represent a significant health risk each year in the United States. Immunocompromised patients are typically at risk of more severe disease manifestations than their immunocompetent counterparts. Here we report a case of a newly emerging phlebovirus, Heartland virus, in a heart transplant recipient.

Objectives This study sought to determine whether severe right ventricular (RV) dysfunction in the pre-operative setting is associated with an increased risk of gastrointestinal bleeding (GIB) post-left ventricular assist device (LVAD). Background GIB is a significant complication in patients supported with continuous-flow LVADs. The impact of RV dysfunction on the risk of GIB has not been investigated. Methods We retrospectively identified 212 patients who survived index hospitalization after implantation of HeartMate II (Thoratec Corp., Pleasanton, California) or Heartware HVAD (HeartWare Corp., Framingham, Massachusetts) from June 2009 to April 2013. Patients with severe RV dysfunction on pre-LVAD echocardiogram (n = 37) were compared to patients without severe RV dysfunction (n = 175). The primary outcome was freedom from GIB. Results The majority of patients were male (79%) with a median INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile of 2 at LVAD implantation. There were no significant differences between cohorts with respect to demographics, comorbidities, device type, international normalization ratio, or aspirin strategy. During follow-up, 81 patients had GIB events: 23 of 37 (62%) in the severe RV dysfunction group versus 58 of 175 (33%) in the control group (p = 0.001). After adjustment for age and ischemic cardiomyopathy, severe RV dysfunction was associated with increased risk of GIB (hazard ratio: 1.799, 95% confidence interval: 1.089 to 2.973, p = 0.022). Conclusions In this single-center sample of patients supported with continuous-flow LVADs, severe RV dysfunction on pre-LVAD echocardiogram was associated with an increased risk of GIB. Further studies are needed to investigate possible mechanisms by which RV dysfunction increases the risk of GIB and to identify patient populations who may benefit from alterations in antithrombotic strategies.

Introduction: The DECIDE-LVAD Trial demonstrated the benefit of a decision support tool for patients considering destination-therapy left ventricular assist device (DT LVAD) implantation. We hypothesized that patients with low health literacy or numeracy may have benefited most from the intervention. Methods: We used the Rapid Estimate of Adult Literacy in Medicine (REALM-R) and the Subjective Numeracy Scale (SNS) to assess patients’ health literacy and numeracy, respectively. A REALM-R score of six or less out of eight identified patients at risk for poor literacy based on the original measure validation. An SNS score less than four out of six identified patients with poor subjective numeracy based on the mean score of the DECIDE-LVAD cohort. We assessed the effect of the decision support tool on LVAD knowledge and values-treatment concordance—concordance between patients’ stated values and their treatment outcome of LVAD or continued medical therapy—and their interaction with health literacy and numeracy. This interaction was assessed using linear mixed models for LVAD knowledge and the difference in Kendall’s tau correlation coefficient for values-treatment concordance. Results: Of the 248 DECIDE-LVAD patients, 228 with complete literacy and numeracy data were analyzed: 51% (116) had high literacy and numeracy; 18 (8%) had low literacy and high numeracy; 55 (25%) had high literacy and low numeracy; 39 (17%) had low scores for both measures. Average age was 63, 15% were female, 19% were racial/ethnic minorities. Patients with high scores for both measures were older, had more formal education, and higher total household income compared to the other 3 groups. Patients with low literacy and/or numeracy had significantly lower LVAD knowledge scores at baseline. In all groups, LVAD knowledge improved over time. The difference in LVAD knowledge between those with low literacy and high literacy decreased over time (baseline difference 9.4%, p=0.002; 6 month follow-up difference 1.4%, p=0.65). In those with high literacy, the decision support tool intervention increased the LVAD knowledge score by 4.2% relative to the control (p=0.15), while in those with low literacy, the intervention increased the score by 10.6% (p=0.04). For patients with low literacy, values-treatment concordance improved with use of the decision support tool (control vs. intervention tau: 0.234 vs 0.673, p=0.028). We did not observe differences in the effect of the intervention by participant numeracy score. Conclusion: All patient groups in the DECIDE-LVAD cohort of patients considering DT LVAD had improved LVAD knowledge with the use of the decision support tool. We did not observe a differential effect of the intervention by numeracy score. Compared to those with higher health literacy, patients with low health literacy improved their LVAD knowledge and values-treatment concordance after the intervention.

Introduction IL-6 is a pro-inflammatory cytokine that potentiates the effect of plasma cells, immunoglobulins, T-cells, and macrophages. IL-6 levels are associated with atherosclerotic plaque progression and graft fibrosis; IL-6 blockade may have a role in therapy for cardiac allograft vasculopathy (CAV). Preclinical data has also implicated IL-6 signaling in graft rejection. Tocilizumab, an IL-6 receptor antagonist, has successfully decreased donor-specific antibodies (DSAs) in renal transplant patients with antibody-mediated rejection (AMR). Herein, we report on the use of tocilizumab in a heart transplant recipient with treatment-refractory AMR and established CAV. Case Report A 65 year old male who underwent heart transplantation 13 years ago presented with dyspnea. His history was significant for AMR 5 years post-transplant and CAV 10 years post-transplant. On admission, studies revealed reduced LV ejection fraction (LVEF, 70% to 50%) and cardiac index (CI, 1.27 L/min/m2), severe 3-vessel CAV, and elevated pulmonary capillary wedge pressure (PCWP, 28 mmHg). He had new DSAs against HLA-A, -B, -DQ, and -DR antigens (MFI 5,792-24,748); biopsy grade was 1R/1A. He was treated with steroids, plasmapheresis, IVIg, and rituximab; maintenance immunosuppression was revised to tacrolimus, everolimus, mycophenolate, and prednisone. He was readmitted twice within the next month with acute decompensation requiring inotropes. He had a further decline in LVEF to 45%, CAV progression, and largely unchanged DSAs. He was again treated with steroids, plasmapheresis, and IVIg. Given progressive decline despite traditional AMR and CAV therapy, we initiated tocilizumab 800 mg monthly. He has received tocilizumab for one year without significant complications or hospitalizations; he reports NYHA class II symptoms. HLA screen showed resolution of HLA-A, -B, and -DR DSAs and MFI reduction of HLA-DQ DSA (24,748 to 14,994). Right heart catheterization was significantly improved (CI 2.06 L/min/m2 and PCWP 18 mmHg); LVEF remains unchanged and coronary angiography shows CAV progression. Summary To our knowledge, this represents the first report of using tocilizumab for refractory cardiac AMR and CAV. Additional studies are warranted to evaluate the safety and efficacy of tocilizumab in heart transplant recipients and to elucidate the mechanism of DSA clearance by tocilizumab.

Background Stroke is a significant complication in patients supported with continuous-flow left ventricular assist devices (CF-LVAD) and hypertension is a significant risk factor for stroke, but the association between blood pressure and stroke in LVAD patients is not well characterized. Methods We identified 275 consecutive patients who survived implant hospitalization between January 2005 and April 2013. Patients were grouped according to systolic blood pressure (SBP) as above a median and below a median of 100 mm Hg by their averaged systolic blood pressure during the 48 hours before discharge from implantation hospitalization. The groups were compared for the primary outcome of time to stroke. Results The above-median SBP group had mean SBP of 110 mm Hg and the below-median SBP group had mean SBP of 95 mm Hg. There were no significant between-group differences in body mass index, smoking, vascular disease, hypertension, atrial fibrillation, or prior stroke. During a mean follow-up of 16 months, stroke occurred in 16% of the above-median SBP group vs in 7% of the below-median SBP group (hazard ratio, 2.38; 95% confidence interval, 1.11–5.11), with a similar proportion of hemorrhagic and ischemic strokes in each group. In Cox proportional hazard models adjusting for age, diabetes, or prior stroke, the hazard ratio remained statistically significant. SBP as a continuous variable predictor of stroke had an area under the curve of 0.64 in a receiver operating characteristic curve analysis. Conclusions In this large, CF-LVAD cohort, elevated SBP was independently associated with a greater risk of subsequent stroke. These results identify management of hypertension as a potential modifiable risk factor for reducing the incidence of stroke in patients supported by CF-LVAD.

This study evaluated clinical outcomes associated with erythropoiesis stimulating agent (ESA) use in left ventricular assist devices (LVAD)-supported patients.Use of ESAs in patients with LVADs may minimize blood transfusions and decrease allosensitization. ESAs increase thrombotic events, which is concerning because LVADs are sensitive to pump thrombosis (PT).We retrospectively reviewed 221 patients at our center who received a HeartMate II (Thoratec Corp., Pleasanton, California) LVAD between January 1, 2009 and June 6, 2013. Patients were divided into those who received ESAs during index admission (n = 121) and those who did not (n = 100). Suspected PT was defined as evidence of thrombus in the LVAD or severe hemolysis (lactate dehydrogenase1,000 mg/dl or plasma-free hemoglobin40 mg/dl). Outcomes were compared between cohorts using inverse probability-weighted analyses.During a mean follow-up of 14.2 ± 11.9 months, suspected PT occurred in 37 patients (ESA 23%, no ESA 12%; p =0.03). The ESA cohort received ESAs 13.9 ± 60.9 days after LVAD implantation. At 180 days, event-free rates for suspected PT were ESA 78.6% versus no ESA 94.5% (p 0.001). ESA use had higher rates of suspected PT (hazard ratio [HR]: 2.35; 95% confidence interval [CI]: 1.38 to 4.00; p = 0.002). For every 100-unit increase in cumulative ESA dosage, the hazard of suspected PT increased by 10% (HR: 1.10; 95% CI: 1.04 to 1.16; p 0.001). After inverse probability weighting, ESA use was associated with a significantly higher rate of all-cause mortality (HR: 1.62; 95% CI: 1.12 to 2.33; p = 0.01).ESA use in LVAD patients is associated with higher rates of suspected PT.

Aims Although lesions deferred revascularization following fractional flow reserve (FFR) assessment have a low risk of adverse cardiac events, variability in risk for deferred lesion intervention (DLI) has not been previously evaluated. The aim of this study was to develop a prediction model to estimate 1-year risk of DLI for coronary lesions where revascularization was not performed following FFR assessment. Methods and results A prediction model for DLI was developed from a cohort of 721 patients with 882 coronary lesions where revascularization was deferred based on FFR between 10/2002 and 7/2010. Deferred lesion intervention was defined as any revascularization of a lesion previously deferred following FFR. The final DLI model was developed using stepwise Cox regression and validated using bootstrapping techniques. An algorithm was constructed to predict the 1-year risk of DLI. During a mean (±SD) follow-up period of 4.0 ± 2.3 years, 18% of lesions deferred after FFR underwent DLI; the 1-year incidence of DLI was 5.3%, while the predicted risk of DLI varied from 1 to 40%. The final Cox model included the FFR value, age, current or former smoking, history of coronary artery disease (CAD) or prior percutaneous coronary intervention, multi-vessel CAD, and serum creatinine. The c statistic for the DLI prediction model was 0.66 (95% confidence interval, CI: 0.61–0.70). Conclusion Patients deferred revascularization based on FFR have variation in their risk for DLI. A clinical prediction model consisting of five clinical variables and the FFR value can help predict the risk of DLI in the first year following FFR assessment.

Introduction The expectations and outcomes of elective inotrope use as adjunctive therapy during heart failure (HF) hospitalization are not known. This prospective study aims to describe the intent and results of inotropic therapy initiated electively during HF hospitalization in hemodynamically stable patients. Methods We used a prospective, multi-center design in 6 academic medical centers of the Heart Failure Apprentice Network to collect data on hemodynamically stable patients started electively on inotropes. Patients were excluded if deemed to need immediate inotropic therapy for progressive hemodynamic deterioration or other critical care for cardiogenic shock. We prospectively recorded data when intravenous inotropic therapy was initiated, including survey of the attending cardiologists regarding expectations for the clinical course. Patients were followed for events through hospital discharge, including documentation of advanced care planning. Baseline data from admission was collected retrospectively. Results A total of 93 patients were included and average age was 60 years and EF 24%±12%. At the time of inotrope initiation, attending cardiologists thought 50% of patients had a “high or very high” likelihood of becoming inotrope dependent and 58% had a “high” likelihood of death, transplant or durable ventricular assist device placement within the next 6 months. Despite these expectations, only 51% of patients had goals of care conversations prior to inotrope initiation. An additional 19% had it after inotrope initiation but before discharge. The average duration of inotrope therapy was 11±12 days. Ultimately, 29% were discharged on inotropes and 26% died or entered hospice by the time of discharge. Provider predictions about the long term need for inotropes or death/hospice was accurate 51% of the time. Conclusions Over half of patients electively started on inotropes with stable hemodynamics ultimately required home inotropes, died during admission or were discharged to hospice. Heart failure clinicians did not reliably identify those patients with inotropic dependence, death, or hospice by the time of discharge. In light of these poor outcomes and our limited ability to accurately predict them, goals of care discussions should be emphasized prior to inotrope initiation.

Introduction: CMT2A2 is associated with mutations in the mitofusin 2 gene, which encodes a protein involved in mitochondrial fusion. Ethambutol is an antimycobacterial agent associated with toxic optic neuropathies. Ethambutol-induced optic neuropathy occurs in patients with mutations in a related fusion gene, OPA1, which is responsible for autosomal dominant optic atrophy. Methods: We describe a patient with CMT2A2 (MFN2 mutation: T669G, F223L) who developed accelerated weakness, vocal cord paralysis, and optic atrophy after receiving ethambutol. Results: Deterioration began within months of initiating ethambutol therapy. After discontinuation of ethambutol, neurologic deterioration stabilized with subsequent improvement in visual fields. Conclusions: CMT2A2 is part of a group of genetic disorders which share an association with the process of mitochondrial fusion. This case shows that patients with CMT2A2, and possibly other mitochondrial fusion defects, may be uniquely susceptible to ethambutol-induced neurotoxicity. This has implications regarding the underlying pathophysiology of mitochondrial fusion defects. Muscle Nerve, 2013

Acute myocardial infarction (AMI) is an underrecognized phenomenon in patients with continuous-flow left ventricular assist devices (CF-LVAD). Previously, there has been an optimistic expectation of a benign clinical course; however, AMI in LVAD-supported patients can result in profound consequences and management remains controversial. We describe a case series of AMI in four CF-LVAD patients, each with a different presentation, clinical course, treatment, and outcome. The clinical variability and mixed outcomes of these patients highlights the unique challenges in diagnosis and management of AMI in this population, particularly the uncertain role of percutaneous intervention (PCI), and underscores the potentially poor prognosis of this entity. Several key points emerge from this review. First, LVAD-supported patients frequently have underlying abnormalities on the electrocardiogram (ECG) that obscure the diagnosis of AMI. Second, clinicians should have a high degree of suspicion for AMI in the presence of suggestive clinical features, elevated cardiac biomarkers, or new-onset ventricular arrhythmias. Third, the decision to proceed with PCI requires careful evaluation of the risk of hemorrhage, and strong consideration should be given to the use of bleeding avoidance strategies during and after PCI.

Background: Left Ventricular Assist Device (LVAD) pump thrombosis (PT) is a devastating complication of mechanical circulatory support. The diagnosis of LVAD thrombus is difficult in vivo, often only suggested by markers of hemolysis and echocardiographic features, which lack sensitivity. We sought to test a probe with high avidity anti-fibrin 99mTc to localize and quantify thrombus within the high shear environment of titanium axial-flow pumps. Methods: Monomeric bifunctional ligands with a fibrin-specific peptide, a short spacer, and technetium chelating amino acid sequence (F1A) were covalently inter-coupled via a 4-arm-PEG2000 tetramer to form F4A. Each was radiolabeled with 99mTc using the IsoLink procedure. We collected 20 explanted HeartMate II LVADs, of which 9 were explanted for suspected pump thrombosis and 11 were explanted during heart transplant or exchange for other complications. Ex-vivo imaging of explanted pumps was conducted in plasma using a mock circulatory loop running at 9400 RPM for 30 minutes as has previously been described. After imaging the devices were sent to the manufacturer for disassembly and thorough inspection for thrombus. Results: The majority of patients were male (85%) with a mean age of 54.1 6 9.8 and a median INTERMACS profile of 2. The median time of LVAD support prior to explant was 7.6 6 7.2 months. Of the 9 patients exchanged for suspected pump thrombosis all had undetectable haptoglobin levels and mean LDH levels of 3520 6 2596. All 9 had CT scans prior to LVAD exchange without any visualized thrombus or kinking of the inflow or outflow cannulas. Two of the pumps have been disassembled and inspected by the manufacturer. Both pumps were in patients with suspected pump thrombosis and both the pumps had thrombus found on SPECT imaging and on visual inspection (Figure 1A and 1B). Conclusions: A novel, fibrin-specific 99mTc small tetrameric probe offers the potential to detect, localize, and quantify intra-LVAD thrombus noninvasively. Once verified in a large cohort this agent offers the opportunity to diagnose LVAD pump thrombosis at an earlier stage. Definite and early diagnosis may confer therapeutic options to avoid pump failure and/or costly and morbid LVAD exchange.

Background— We evaluated thrombotic and bleeding outcomes in patients with continuous-flow left ventricular assist devices (CF-LVADs), stratified by anticoagulation intensity. Previous studies of outpatients with CF-LVADs have suggested that target international normalized ratio (INR) values Methods and Results— We retrospectively reviewed 249 outpatients at our center who received a CF-LVAD between January 2005 and August 2013. Using Poisson models, we analyzed their 10 927 INRs to determine INR-specific rates of thrombotic (ischemic stroke and suspected pump thrombosis) and hemorrhagic (gastrointestinal bleeding and hemorrhagic stroke) events occurring outside of the hospital. In multivariate analyses, we adjusted for age, sex, atrial fibrillation, coronary disease, and LVAD type as time-dependent Cox proportional hazard models. During a mean follow-up of 17.6±13.6 months, thrombotic events occurred in 46 outpatients. The highest event rate (0.40 thrombotic events per patient-year) was in the INR range of P =0.002). The optimal INR based on weighted mortality of thrombotic and bleeding events was 2.6. Conclusions— INR is inversely related to thrombotic events occurring outside of the hospital among patients supported with CF-LVADs. INR values

Introduction Primary graft dysfunction (PGD) is a devastating complication of heart transplantation that is associated with high rates of morbidity and mortality. Right heart failure (RHF) while on LVAD support may identify patients at higher risk for post-transplant complications. This study investigated the relationship between RHF while on LVAD support and post-transplant outcomes. Methods Patients with durable, continuous-flow LVADs who were transplantated between 2010 and 2016 at Barnes-Jewish Hospital were included. Data collection was performed through retrospective chart review. RHF was defined as the need for right ventricular assist device, the extended use of inotropes for more than 14 consecutive days post-LVAD implant, the need to reinitiate inotropes after 14 days but before 30 days after LVAD, or heart failure requiring medical intervention >30 days after discharge from LVAD implantation. The primary outcome was the incidence of PGD after transplant compared between patients with and without RHF. Secondary outcomes included 30-day and 1-year survival, incidence of vasoplegia, severity of PGD, and outcomes stratified by type of RHF. A multivariate logistic regression model was created and included baseline characteristics differing between groups using a p-value of Results Among the 141 patients included in the study, 41 developed RHF while supported with an LVAD. The cohort had a median age of 58, was mostly male (78.7%), and mostly white (74.5%). Most patients had a non-ischemic cardiomyopathy (57%) and were implanted with a HeartMate II LVAD (84.4%). The RHF group had a higher incidence of donor-recipient weight mismatch (3.0% vs. 14.6%, p=0.018) and lower donor EF (55% vs 60%, p=0.018), with no other significant differences in baseline characteristics. In the RHF cohort, 18 patients developed PGD as compared to 14 patients in the group without RHF (43.9% vs. 14.0%, p Conclusions The results of this study show that patients supported with LVADs who develop early severe or late RHF are at increased risk of PGD and death following cardiac transplantation. Donor factors may further increase the risk of these outcomes and should be carefully assessed in this high-risk group. Given the striking increase in PGD, increased vigilance for PGD and aggressive early hemodynamic support should be anticipated for these patients.

In patients who had left ventricular assist device (LVAD) prior to heart transplant, device infections are associated with worse survival at 1-year and 10-year after transplant. We hypothesize that LVAD-related infections are associated with higher risk of transplant rejection. We performed a

Background The safety of deferring revascularization based on fractional flow reserve ( FFR ) during acute coronary syndrome ( ACS ) is unclear. We evaluated the association of FFR and adverse cardiac events among patients with coronary lesions deferred revascularization based on FFR in the setting of ACS versus non‐ ACS . Methods and Results The study population (674 patients; 816 lesions) was divided into ACS (n=334) and non‐ ACS (n=340) groups based on the diagnosis when revascularization was deferred based on FFR values >0.80 between October 2002 and July 2010. The association and interaction between FFR and clinical outcomes was evaluated using Cox proportional hazards models within each group (mean follow‐up of 4.5±2.1 years). Subsequent revascularization of a deferred lesion was classified as a deferred lesion intervention ( DLI ), whereas the composite of DLI or myocardial infarction ( MI ) attributed to a deferred lesion was designated as deferred lesion failure ( DLF ). In the non‐ ACS group, lower FFR values were not associated with any increase in adverse cardiac events. In the ACS group, every 0.01 decrease in FFR was associated with a significantly higher rate of cardiovascular death, MI , or DLI (hazard ratio [ HR ], 1.08; 95% confidence interval [ CI ], 1.03 to 1.12), MI or DLI ( HR , 1.09; 95% CI : 1.04 to 1.14), DLF ( HR , 1.12; 95% CI , 1.06 to 1.18), MI ( HR , 1.07; 95% CI , 1.00 to 1.14), and DLI ( HR , 1.12; 95% CI , 1.06 to 1.18). Conclusion Lower FFR values among ACS patients with coronary lesions deferred revascularization based on FFR are associated with a significantly higher rate of adverse cardiac events. This association was not observed in non‐ ACS patients.

Current evidence supports deferral of revascularization for lesions with fractional flow reserve (FFR) values >0.80. The natural history after deferral of revascularization of lesions with borderline FFR values is unknown. This study evaluated the outcomes of patients after deferred revascularization of coronary stenoses based on a borderline FFR value. We retrospectively studied 720 patients with 881 intermediate-severity coronary stenoses who underwent FFR assessment from October 2002 to July 2010 and were deferred revascularization. Patients were divided into gray zone (0.75 to 0.80), borderline (0.81 to 0.85), and nonborderline (>0.85) FFR groups. Any subsequent percutaneous coronary intervention or coronary artery bypass grafting of a deferred stenosis during follow-up was classified as a deferred lesion intervention (DLI). Patient and/or lesion characteristics and clinical outcomes were compared between the FFR groups using univariate and propensity score–adjusted inverse probability of weighting Cox proportional hazards analyses. During a mean follow-up of 4.5 ± 2.1 years, 157 deferred lesions (18%) underwent DLI by percutaneous coronary intervention (n = 117) or coronary artery bypass grafting (n = 40). No statistically significant differences were observed in clinical outcomes between the gray zone and borderline FFR groups. Lesions with a borderline FFR were associated with a significantly higher risk of DLI compared with lesions with nonborderline FFR values (hazard ratio 1.63, 95% confidence interval 1.14 to 2.33, p = 0.007). Lesions deferred revascularization because of a borderline FFR (0.81 to 0.85) were associated with a higher risk of DLI compared with lesions with a nonborderline FFR (>0.85). Further study is needed to determine the optimal management of coronary stenoses with a borderline FFR value.

To assess whether video capsule endoscopy (VCE) affects the outcomes of left ventricular assist devices (LVADs) recipients with gastrointestinal bleeding.This is a retrospective study of LVAD recipients with obscure gastrointestinal bleeding (OGIB) who underwent VCE at a tertiary medical center between 2005 and 2013. All patients were admitted and monitored with telemetry and all VCE and subsequent endoscopic procedures were performed as inpatients. A VCE study was considered positive only when P2 lesions were found and was regarded as negative if P1 or P0 were identified. All patients were followed until heart transplant, death, or the end of the study.Between 2005 and 2013, 30 patients with LVAD underwent VCE. Completion rate of VCE was 93.3% and there was no capsule retention. No interference of VCE recording or the function of LVAD was found. VCE was positive in 40% of patients (n = 12). The most common finding was active small intestinal bleeding (50%) and small intestinal angiodysplasia (33.3%). There was no difference in the rate of recurrent bleeding between patients with positive and negative VCE study (50.0% vs 55.6%, P = 1.00) during an average of 11.6 ± 9.6 mo follow up. Among patients with positive VCE, the recurrent bleeding rate did not differ whether subsequent endoscopy was performed (50% vs 50%, P = 1.00).VCE can be safely performed in LVAD recipients with a diagnostic yield of 40%. VCE does not affect recurrent bleeding in LVAD patients regardless of findings.

Introduction: Poor health literacy is associated with worse outcomes in patients with heart failure; however, the role of health literacy in predicting outcomes in patients implanted with left ventricular assist devices (LVADs) has not yet been studied. We hypothesized that health literacy would independently influence clinical outcomes in patients implanted with continuous-flow LVADs (CF-LVADs). Hypothesis: Poor health literacy is associated with worse outcomes in patients with end-stage heart failure implanted with CF-LVADs. Methods: We performed a prospective, single center, cohort study of adult patients with implanted CFLVADs. We identified 118 patients implanted with a Heart Mate II (n5101) or an HVAD (n517) implanted between 8/2005 and 9/2013. Health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine (REALM), with adequate health literacy defined as a score $ 61 (REALM IV) and poor literacy defined as a score ! 61 (REALM I-III). The primary outcome was combined all-cause death, stroke, gastrointestinal bleeding (GIB), LVAD-related infection, or hemolysis/pump thrombosis; components of the combined primary outcome were analyzed separately as secondary outcomes. Results: The majority of patients were implanted with Heart Mate II LVADs and had an INTERMACS profile of 2. The poor health literacy group (n538) had significantly more patients with a history of smoking (76% vs. 49%, p 5 0.005), a destination therapy strategy (53% vs. 30%, p 5 0.05), and a history of GIB (58% vs. 26%, p 5 0.003). There were no significant differences between cohorts with respect to age, date of implant, BMI, race, sex, etiology of cardiomyopathy, or history of diabetes. During a follow-up period of 88.8 patient-years there were 89 events: 32 in the poor health literacy group and 57 in the adequate health literacy group (84% vs. 71%, HR 1.56, CI 1.01-2.42, p 5 0.0466), see figure. This was driven primarily by GIB events of which there were 22 in both groups (58% vs. 28%, HR 2.57, CI 1.56-5.81). There were no significant differences in individual secondary outcomes of all-cause death

Right ventricular (RV) dysfunction is a major determinant of poor outcomes after continuous flow left ventricular assist device (CF-LVAD) implantation but can be difficult to evaluate prior to surgery. The simplified Right Ventricular Contraction Pressure Index (sRVCPI=TAPSE × RV-Right atrial

reconstruction at time of transplant are considered even higher risk within this group. Hypothesis: We hypothesize that heterotaxy patients had inferior survival post heart transplantation compared to all patients undergoing heart transplantation. Methods: Heart transplant recipients were identified at our center between January 1992 and October 2010 (Group A: Complex venous reconstruction; Group B: All other recipients). Survival was censored at 12 y using the Kaplan-Meier method Multivariate Cox proportional hazard regression analysis was adjusted for age, sex, ischemic time, dialysis, life support, VAD use, wait time & HLA mismatch. Results: 1625 heart transplant recipients were identified during the study period: 18 (1.1%) in Group A and 1607 (98.9%) in Group B. Median age was: Group A: 9 years (IQR 6 15) and Group B: 53 y (IQR 36-61). Survival (1 month, 1y, 5y, 10y) was: Group A (89%, 83%, 52%, 52%) and Group B (96%, 87%, 73%, 56%). There was no significant survival difference (log rank, p50.36). Unadjusted HR for all-cause mortality was 1.47 (CI 0.66-3.30, p50.34). Adjusted multivariate analysis showed HR 1.16 (CI 0.36-3.75, p50.81). Conclusion: Heterotaxy patients requiring complex venous reconstruction at the time of heart transplantation have comparable outcomes to all other heart transplant recipients performed at our center.