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Preoperative variables can predict short term left ventricular assist device (LVAD) survival, but predictors of extended survival remain insufficiently characterized.Patients undergoing LVAD implant (2012-2018) in the Intermacs registry were grouped according to time on support: short-term (1 year, n = 7,483), mid-term (MT, 1-3 years, n = 5,976) and long-term (LT, ≥3 years, n = 3,015). Landmarked hazard analyses (adjusted hazard ratio, HR) were performed to identify correlates of survival after 1 and 3 years of support.After surviving 1 year of support, additional LVAD survival was less likely in older (HR 1.15 per decade), Caucasian (HR 1.22) and unmarried (HR 1.16) patients (p0.05). After 3 years of support, only 3 preoperative characteristics (age, race, and history of bypass surgery, p0.05) correlated with extended survival. Postoperative events most negatively influenced achieving LT survival. In those alive at 1 year or 3 years, the occurrence of postoperative renal (creatinine HR MT = 1.09; LT HR = 1.10 per mg/dl) and hepatic dysfunction (AST HR MT = 1.29; LT HR = 1.34 per 100 IU), stroke (MT HR = 1.24; LT HR = 1.42), infection (MT HR = 1.13; LT HR = 1.10), and/or device malfunction (MT HR = 1.22; LT HR = 1.46) reduced extended survival (all p ≤ 0.03).Success with LVAD therapy hinges on achieving long term survival in more recipients. After 1 year, extended survival is heavily constrained by the occurrence of adverse events and postoperative end-organ dysfunction. The growth of destination therapy intent mandates that future LVAD studies be designed with follow up sufficient for capturing outcomes beyond 24 months.

Aims Optimal blood pressure (BP) control is imperative to reduce complications, especially strokes, in continuous flow ventricular assist device (VAD) patients. Doppler BP has been shown to be an accurate and reliable non‐invasive BP measurement method in HeartMate II and HVAD patients. We examined whether Doppler BP is also accurate in patients with the HeartMate 3 VAD. Methods and results In a prospective, longitudinal cohort of HeartMate 3 patients, arterial line BP and simultaneously measured Doppler opening pressure were obtained. Correlation and agreement between Doppler opening pressure and arterial line mean arterial pressure (MAP) versus systolic blood pressure (SBP) were analysed, as well as the effect of pulse pressure on the accuracy of Doppler opening pressure. A total of 589 pairs of simultaneous Doppler opening pressure and arterial line pressure readings were obtained in 43 patients. Doppler opening pressure had good correlation with intra‐arterial MAP (r = 0.754) and more closely approximated MAP than SBP (mean error 2.0 vs. −8.6 mmHg). Pulse pressure did not have a clinically significant impact on the accuracy of the Doppler BP method. These results in HeartMate 3 patients are very similar to previous results in HeartMate II and HVAD patients. Conclusions Doppler BP method should be the default non‐invasive BP measurement method in continuous flow VAD patients including patients implanted with the HeartMate 3.

Introduction: The Seattle Proportional Risk Model (SPRM) is a validated model developed in systolic heart failure patients without implantable cardioverter-defibrillators (ICDs) to estimate the proportion of all-cause mortality (ACM) due to sudden death. This study aims to ascertain if SPRM has utility in risk stratification for secondary prevention ICD. Methods: The AVID (Antiarrhythmics Versus Implantable Defibrillators) trial was a multicenter, randomized clinical trial in which 1,016 patients presenting with ventricular fibrillation or sustained, symptomatic ventricular tachycardia were randomized to ICD or antiarrhythmic (AA) drug therapy. Using routine clinical variables, we applied the SPRM to patient-level data (n=995 with complete data) and assessed if the ICD benefit for ACM varied with SPRM-predicted probability of sudden death. Results: SPRM was predictive of sudden death vs. non-sudden death in patients without an ICD (logistic regression p=0.005). The ICD hazard ratio for ACM was 0.59. ICD survival benefit varied with SPRM for ACM (p=0.013) with benefit (ICD HR≤0.80) seen in patients with SPRM>40%. ICD benefit trended higher in patients with a history of heart failure (HF) vs no HF (HR=0.52 vs. 0.81, interaction p=0.13) (Figure 1). In comparison to the AA group, patients with either HF or SPRM>51% (median) had a meaningful ICD benefit (HR=0.60, p=0.017), and patients with both HF and SPRM>51% had the greatest ICD benefit (HR=0.38, p Conclusions: In a population of patients with VF or sustained VT, secondary prevention ICDs decreased ACM by 41%. ICD survival benefit varied with SPRM-predicted proportion of sudden death, and trended higher in patients with HF. SPRM may therefore provide a useful tool for risk stratifying patients for secondary prevention ICD. Figure 1: Survival benefit for ICD therapy varies with SPRM-estimated proportion of sudden death, and HF versus no HF.

BACKGROUND Heart transplant programs and regulatory entities require highly accurate performance metrics to support internal quality improvement activities and national oversight of transplant programs, respectively. We assessed the accuracy of publicly reported performance measures. METHODS We used the United Network for Organ Sharing registry to study patients who underwent heart transplantation between January 1, 2016 and June 30, 2018. We used tests of calibration to compare the observed rate of 1-year graft failure to the expected risk of 1-year graft failure, which was calculated for each recipient using the July 2019 method published by the Scientific Registry of Transplant Recipients (SRTR). The primary study outcome was the joint test of calibration, which accounts for both the total number of events predicted (calibration-in-the-large) and dispersion of risk predictions (calibration slope). RESULTS 6,528 heart transplants were analyzed. The primary test of calibration failed (p

Heart failure (HF) manifests as a severe functional limitation and myriad physiological derangements. Divining signals from this milieu is the domain of the HF specialist among whom there is an indelible belief that more effective HF care intrinsically arises from more communication, more measurement and, increasingly, more complex methods of acquiring and processing patient-generated data. Mobile technologies and electronically integrated systems of care eem to facillitate perfectly the steps of data generation, transmission, synthesis, interpretation, action and, ultimately, benefit to the patient. Unfortunately, realising improved outcomes among persons with HF enabled by outpatient monitoring has been elusive. In this issue of Heart , Rahimi et al 1 present results of a randomised trial designed to test whether centralised decision support optimised medical therapies and improved quality of life among patients compared with monitoring without centralised decision support. This hypothesis is of paramount importance. The authors’ study employs state-of-the-art blinding, randomisation, endpoint measurement and analysis to maximise the validity of their study. Nonetheless, the study ultimately could not conclude that expert support and alerts improved the primary outcome of medication use and dosing and quality of life compared with monitoring alone. The weighted change in medication optimisation demonstrated an improvement of 3% in the control group and 8% in the intervention group (p=0.20) …

Highly specialized left ventricular assist device care is not readily available in many areas, potentially limiting access to therapy. This retrospective analysis examines the relationship of outcomes by patient distance from implanting left ventricular assist device center within the Mechanical Circulatory Support Research Network. Zip codes were used to calculate patient distance, with the primary outcome of interest being 3-year survival by distance from the surgical center. Secondary outcomes included 90-day survival and incident event rates for the following: gastrointestinal bleeding, infection, cerebral event, and pump thrombosis. Across the four centers, there were 1184 patients supported for a median of 486 days. Overall survival was 91 ± 0.8% at 90 days and 61 ± 1.9% at 3 years, with worse 3-year survival in those living >90 vs. ≤90 miles from the ventricular assist device implant center (55 ± 3.0% vs. 64 ± 2.5, p = 0.019). Patients living >90 miles from an implant center were older, more likely to be implanted for destination therapy support, had a prior sternotomy, and had worse renal function than those living closer (p

Mechanical circulatory support (MCS) has markedly improved the likelihood of transplant among patients with advanced heart failure. Transplant survival following MCS is similar for supported and unsupported recipients. Transplant survival is only reduced following left ventricle assist device (LVAD) support complicated by infection, total artificial heart support, and extracorporeal life support. Despite allosensitization and a higher incidence of vasoplegia syndrome, posttransplant survival for durable LVADs is similar to patients with inotropes alone at the time of transplant. MCS as a bridge to transplant offers significant benefits over waiting without support.

The purpose of this project was to build and formatively evaluate a near-real time heart failure (HF) data mart. Heart Failure (HF) is a leading cause of hospital readmissions. Increased efforts to use data meaningfully may enable healthcare organizations to better evaluate effectiveness of care pathways and quality improvements, and to prospectively identify risk among HF patients.We followed a modified version of the Systems Development Life Cycle: 1) Conceptualization, 2) Requirements Analysis, 3) Iterative Development, and 4) Application Release. This foundational work reflects the first of a two-phase project. Phase two (in process) involves the implementation and evaluation of predictive analytics for clinical decision support.We engaged stakeholders to build working definitions and established automated processes for creating an HF data mart containing actionable information for diverse audiences. As of December 2017, the data mart contains information from over 175,000 distinct patients and100 variables from each of their nearly 300,000 visits.The HF data mart will be used to enhance care, assist in clinical decision-making, and improve overall quality of care. This model holds the potential to be scaled and generalized beyond the initial focus and setting.

Objectives This study sought to assess the impact of implantable cardioverter-defibrillators (ICDs) on waitlist mortality in patients listed for heart transplantation (HT). Background The impact of ICDs on preventing sudden cardiac death in patients awaiting HT has not been studied in large multicenter cohorts. Furthermore, whether ICDs benefit patients with a left ventricular assist device (LVAD) is unknown. Methods Adults (age ≥18 years) listed for first-time HT in the United States between January 1, 1999, and September 30, 2014, were retrospectively identified from the United Network for Organ Sharing registry. The primary predictor variable was the presence of an ICD at the time of listing. Primary outcome variable was all-cause waitlist mortality. Results Data on 32,599 patients (mean age 53 ± 12 years, 77% male, 70% Caucasian) were analyzed. During median follow-up of 154 days, 3,638 patients (11%) died on the waitlist (9% in ICD group vs. 15% in no-ICD group; p Conclusions ICD use was associated with improved survival on the HT waitlist in patients with or without LVADs. These findings strengthen the current guideline recommendations of using ICDs in nonhospitalized patients awaiting HT and provide new insight into the effectiveness of ICDs on survival in LVAD-supported patients.

Introduction Survival is nearly 50% after 5 years of LVAD support. While preop variables can predict short-term (ST) survival, correlates of long term (LT) survival remain poorly characterized. Hypothesis We hypothesize that preop risk stratification will be limited to predicting ST survival and not LT success. Method Patients (n=16474) undergoing LVAD implant (2012-18) in Intermacs-STS were grouped according to time on support: ST ( Results Of those alive on LVAD support at 1 Y, the 3, 5, and 6 Y survivals were 75%, 53%, and 45%, respectively. Patients who were alive on LVAD support at 3 Ys had survivals of 60% at 6 Ys. The table shows adjusted associations between clinical variables and mortality for the MT and LT survival groups starting at 1 and 3 Ys, respectively. For the MT group, older, obese and Caucasian patients and those with preop RV dysfunction, active smoking, unmarried status or comorbidities had higher mortality after 1 Y of support. The occurrence of postop malnutrition, renal, and hepatic dysfunction also increased mortality. Finally, each episode of stroke, device infection or device malfunction increased mortality by 13-42%. For the LT group, postop organ dysfunction and malnutrition impacted extended LVAD survival and mortality increased by 10-46% per adverse event. The only preop correlates of survival beyond 3 Ys were older age, Caucasian race, and history of CABG. Conclusion The success of LVAD support hinges on achieving LT survival. In operative survivors, LT LVAD survival is heavily constrained by the occurrence of events after LVAD placement. Preop, this also limits our ability to provide individualized, LT survival estimates.

Purpose The heart allocation system allocates hearts based on geographic distance between donor and transplant centers, blood type and severity of illness. The Donor Service Area (DSA) designation and fixed distance radii may be abolished if a continuous allocation is implemented. This study sought to assess whether donor heart allocation within the DSA is associated with a survival benefit. Methods Heart transplant recipients between 2010 and 2018 were identified in the Organ Procurement and Transplant Network (OPTN). Following adjustment for the expected post-transplant graft survival, a Bayesian logistic regression model was used to assess the effect of DSA versus extra-DSA allocation of donor hearts. The primary outcome was one-year graft survival adjusted for risk of graft failure using the Scientific Registry of Transplant Recipient's (SRTR) January 2019 adjustment model. Results Locally allocated donor hearts were more likely younger and gender matched and had lower prevalence of donor diabetes and smoking when compared to those imported from another DSA (Table 1). The proportion of locally shared organs between regions varied significantly (p Conclusion Following adjustment for recipient and donor factors, we found that allocation of organs within the DSA did not reduce one-year graft failure rates.

We describe how patient characteristics influence hospital bypass, interhospital transfer, and in-hospital mortality in patients with heart failure in Washington. Rural patients with heart failure may bypass their nearest hospital or be transferred for appropriate therapies. The frequency, determinants, and outcomes of these practices remain uncharacterized.Mean excess travel times based on hospital and patient residence ZIP codes were calculated using published methods. Hospitals and servicing areas were coded based on bed size and ZIP code, respectively. Transfer patterns were analyzed using bootstrap inference for clusters. Analysis of mortality and transfer-associated factors was performed using logistic regression with generalized estimating equations. There were 48,163 patients, representing 1106 instances of transfer, studied. The mean excess travel time increased 7.14 minutes per decrease in population density (metropolitan, micropolitan, small town, rural; P.0001). The rural mean excess travel time was greatest at 28.56 minutes. Transfer likelihood increased with younger age, male gender, admitting hospital rurality, higher Charlson Comorbidity Index, and stroke. Transfer was less likely among women (odds ratio [OR], 0.82; 95% confidence interval [CI], 0.72-0.94) and patients over 70 years old (OR, 0.15-0.46; 95% CI, 0.10-0.65). Adjusting for comorbidities and transfer propensity, transfer exhibited a stronger association with mortality than any other measured patient risk factor (OR, 2.15; 95% CI, 1.69-2.73), excluding stroke (OR, 7.09; 95% CI, 4.99-10.06).Rural hospital bypass is prevalent among patients with heart failure, although its clinical significance is unclear. Female and older patients were found to have a lesser likelihood of transfer adjusted for other factors. Interhospital transfer is associated with increased mortality when adjusted for comorbidities.

BACKGROUND: Patients with heart failure having a low expected probability of arrhythmic death may not benefit from implantable cardioverter defibrillators (ICDs). OBJECTIVE: The objective was to validate models to identify cardiac resynchronization therapy (CRT) candidates who may not require CRT devices with ICD functionality. METHODS: Heart failure (HF) patients with CRT-Ds and non-CRT ICDs from the National Cardiovascular Data Registry and others with no device from 3 separate registries and 3 heart failure trials were analyzed using multivariable Cox proportional hazards regression for survival with the Seattle Heart Failure Model (SHFM; estimates overall mortality) and the Seattle Proportional Risk Model (SPRM; estimates proportional risk of arrhythmic death). RESULTS: Among 60,185 patients (age 68.6±11.3 years, 31.9% female) meeting CRT-D criteria, 38,348 had CRT-Ds, 11,389 had non-CRT ICDs, and 10,448 had no device. CRT-D patients had a prominent adjusted survival benefit (HR 0.52, 95% CI 0.50–0.55, pmedian had substantially more ICD-attributable benefit (absolute risk reduction of 2.6%/year combined; p

Heart transplant patients are followed with periodic right heart catheterizations (RHCs) to identify post-transplant complications and guide treatment. Post-transplant positive outcomes are associated with a steady reduction of right ventricular and pulmonary arterial pressures, toward normal levels of right-side pressure (about 20mmHg) measured by RHC. This study shows more information about patient progression is obtained by combining standard RHC measures with mechanistic computational cardiovascular systems models. This study shows: to understand how cardiovascular system models can be used to represent a patient's cardiovascular state, and to use these models to track post-transplant recovery and outcome. To obtain reliable parameter estimates comparable within and across datasets, we use sensitivity analysis, parameter subset selection, and optimization to determine patient specific mechanistic parameter that can be reliably extracted from the RHC data. Patient-specific models are identified for ten patients from their first post-transplant RHC and longitudinal analysis is done for five patients. Results of sensitivity analysis and subset selection show we can reliably estimate seven non-measurable quantities including ventricular diastolic relaxation, systemic resistance, pulmonary venous elastance, pulmonary resistance, pulmonary arterial elastance, pulmonary valve resistance and systemic arterial elastance. Changes in parameters and predicted cardiovascular function post-transplant are used to evaluate cardiovascular state during recovery in five patients. Of these five patients, only one patient showed inconsistent trends during recovery in ventricular pressure-volume relationships and power output. At a four-year recovery time point this patient exhibited biventricular failure along with graft dysfunction while the remaining four exhibited no cardiovascular complications., Comment: 53 Pages (including supplement), 9 figures in manuscript, 9 figures in supplement

Left ventricular assist device (LVAD) use has continued to grow. Despite recent advances in technology, LVAD patients continue to suffer from devastating complications, including stroke and device thrombosis. Among several variables affecting thrombogenicity, we hypothesize that insertion depth of the inflow cannula into the left ventricle (LV) influences hemodynamics and thrombosis risk. Blood flow patterns were studied in a patient-derived computational model of the LV, mitral valve (MV), and LVAD inflow cannula using unsteady computational fluid dynamics (CFD). Hundreds of thousands of platelets were tracked individually, for two inflow cannula insertion depth configurations (12 mm-reduced and 27 mm-conventional) using platelet-level (Lagrangian) metrics to quantify thrombogenicity. Particularly in patients with small LV dimensions, the deeper inflow cannula insertion resulted in much higher platelet shear stress histories (SH), consistent with markedly abnormal intraventricular hemodynamics. A larger proportion of platelets in this deeper insertion configuration was found to linger in the domain for long residence times (RT) and also accumulated much higher SH. The reduced inflow depth configuration promoted LV washout and reduced platelet SH. The increase of both SH and RT in the LV demonstrates the impact of inflow cannula depth on platelet activation and increased stroke risk in these patients. Inflow cannula depth of insertion should be considered as an opportunity to optimize surgical planning of LVAD therapy.

Background The number of adult congenital heart disease (CHD) patients undergoing heart transplantation is increasing rapidly. CHD patients have higher surgical risk at transplantation. High-volume adult CHD transplant centers may have better transplant outcomes. Objectives This study aimed to evaluate the effect of center CHD transplant volume and expertise on transplant outcomes in CHD patients. Methods The authors studied heart transplantations in CHD patients age ≥18 years using the United Network of Organ Sharing (UNOS) database for the primary outcomes of waitlist mortality and post-transplant outcomes at 30 days and 1 year. Transplant centers were assessed by status as the highest CHD transplant volume center in a UNOS region versus all others, presence of Adult Congenital Heart Association accreditation, and adult versus pediatric hospital designation. Results Between January of 2000 and June of 2018, 1,746 adult CHD patients were listed for transplant; 1,006 (57.6%) of these underwent heart transplantation. After adjusting for age, sex, listing status, and inotrope requirement, waitlist mortality risk was lower at Adult Congenital Heart Association accredited centers (hazard ratio: 0.730; p = 0.020). Post-transplant 30-day mortality was lower at the highest volume CHD transplant center in each UNOS region (hazard ratio: 0.706; p = 0.014). Conclusions Designated expertise in CHD care is associated with improved waitlist outcomes for CHD patients listed for transplantation. Post-transplant survival was improved at the highest volume regional center. These findings suggest a possible advantage of regionalization of CHD transplantation.

Aims Heart failure (HF) is associated with an increased risk of sudden cardiac death (SCD). This study sought to demonstrate the incidence of SCD within a multicentre Japanese registry of HF patients hospitalized for acute decompensation, and externally validate the Seattle Proportional Risk Model (SPRM). Methods and results We consecutively registered 2240 acute HF patients from academic institutions in Tokyo, Japan. The discrimination and calibration of the SPRM were assessed by the c-statistic, Hosmer–Lemeshow statistic, and visual plotting among non-survivors. Patient-level SPRM predictions and implantable cardioverter-defibrillator (ICD) benefit [ICD estimated hazard ratio (HR), derived from the Cox proportional hazards model in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)] was calculated. During the 2-year follow-up, 356 deaths (15.9%) occurred, which included 76 adjudicated SCDs (3.4%) and 280 non-SCDs (12.5%). The SPRM showed acceptable discrimination [c-index = 0.63; 95% confidence interval (CI) 0.56–0.70], similar to that of original SPRM-derivation cohort. The calibration plot showed reasonable conformance. Among HF patients with reduced ejection fraction (EF; < 40%), SPRM showed improved discrimination compared with the ICD eligibility criteria (e.g. New York Heart Association functional Class II–III with EF ≤ 35%): c-index = 0.53 (95% CI 0.42–0.63) vs. 0.65 (95% CI 0.55–0.75) for SPRM. Finally, in the subgroup of 246 patients with both EF ≤ 35% and SPRM-predicted risk of ≥ 42.0% (SCD-HeFT defined ICD benefit threshold), mean ICD estimated HR was 0.70 (30% reduction of all-cause mortality by ICD). Conclusion The cumulative incidence of SCD was 3.4% in Japanese HF registry. The SPRM performed reasonably well in Japanese patients and may aid in improving SCD prediction.

Adult Congenital Heart Disease (ACHD) heart transplant recipients may have lower than average post-transplant survival as a result of higher peri-operative mortality than non-ACHD patients, but they also have a decreased incremental late mortality risk. However, long-term survival between groups has

The prevalence of ventricular assist device (VAD) therapy has continued to increase due to a stagnant donor supply and growing advanced heart failure (HF) population. We hypothesize that left ventricular (LV) size strongly influences biocompatibility and risk of thrombosis. Unsteady computational fluid dynamics (CFD) was used in conjunction with patient-derived computational modeling and virtual surgery with a standard, apically implanted inflow cannula. A dual-focus approach of evaluating thrombogenicity was employed: platelet-based metrics to characterize the platelet environment and flow-based metrics to investigate hemodynamics. Left ventricular end-diastolic dimensions (LVEDds) ranging from 4.5 to 6.5 cm were studied and ranked according to relative thrombogenic potential. Over 150,000 platelets were individually tracked in each LV model over 15 cardiac cycles. As LV size decreased, platelets experienced markedly increased shear stress histories (SHs), whereas platelet residence time (RT) in the LV increased with size. The complex interplay between increased SH and longer RT has profound implications on thrombogenicity, with a significantly higher proportion of platelets in small LVs having long RT times and being subjected to high SH, contributing to thrombus formation. Our data suggest that small LV size, rather than decreased VAD speed, is the primary pathologic mechanism responsible for the increased incidence of thrombosis observed in VAD patients with small LVs.

The authors previously developed the Seattle Proportional Risk Model (SPRM) in systolic heart failure patients without implantable cardioverter-defibrillators (ICDs)to predict the proportion of deaths that were sudden. They subsequently validated the SPRM in 2 observational ICD data sets. The objectives in the present study were to determine whether this validated model could improve identification of clinically important variations in the expected magnitude of ICD survival benefit by using a pivotal randomized trial of primary prevention ICD therapy.Recent data show that 50% of nominally eligible subjects receive guideline- recommended primary prevention ICDs.In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), a placebo-controlled ICD trial in 2,521 patients with an ejection fraction ≤35% and symptomatic heart failure, we tested the use of patient-level SPRM-predicted probability of sudden death (relative to that of non-sudden death) as a summary measurement of the potential for ICD benefit. A Cox proportional hazards model was used to estimate variations in the relationship between patient-level SPRM predictions and ICD benefit.Relative to use of mortality predictions with the Seattle Heart Failure Model, the SPRM was much better at partitioning treatment benefit from ICD therapy (effect size was 2- to 3.6-fold larger for the ICD×SPRM interaction). ICD benefit varied significantly across SPRM-predicted risk quartiles: for all-cause mortality, a +10% increase with ICD therapy in the first quartile (highest risk of death, lowest proportion of sudden death) to a decrease of 66% in the fourth quartile (lowest risk of death, highest proportion of sudden death; p = 0.0013); for sudden death mortality, a 19% reduction in SPRM quartile 1 to 95% reduction in SPRM quartile 4 (p 0.0001).In symptomatic systolic heart failure patients with a Class I recommendation for primary prevention ICD therapy, the SPRM offers a useful patient-centric tool for guiding shared decision making.

Objectives This study sought to assess the association of multiple listing with waitlist outcomes and post–heart transplant (HT) survival. Background HT candidates in the United States may register at multiple centers. Not all candidates have the resources and mobility needed for multiple listing; thus this policy may advantage wealthier and less sick patients. Methods We identified 33,928 adult candidates for a first single-organ HT between January 1, 2000 and December 31, 2013 in the Organ Procurement and Transplantation Network database. Results We identified 679 multiple-listed (ML) candidates (2.0%) who were younger (median age, 53 years [interquartile range (IQR): 43 to 60 years] vs. 55 years [IQR: 45 to 61 years]; p Conclusions Multiple listing is a rational response to organ shortage but may advantage patients with the means to participate rather than the most medically needy. The multiple-listing policy should be overturned.

Multivariable risk scores and exercise measures are well-validated risk prediction methods. Combining information from a functional evaluation and a risk model may improve accuracy of risk predictions. We analyzed whether adding exercise measures to the Seattle Heart Failure Model (SHFM) improves risk prediction accuracy in systolic heart failure.We used a sample of patients from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) study (http://www.clinicaltrials.gov; unique identifier: NCT00047437) to examine the addition of peak oxygen consumption, expired volume per unit time/volume of carbon dioxide slope, 6-minute walk distance, or cardiopulmonary exercise duration to the SHFM. Multivariable Cox proportional hazards models were used to test the association between the combined end point (death, left ventricular assist device, or cardiac transplantation) and the addition of exercise variables to the SHFM.The sample included 2,152 patients. The SHFM and all exercise measures were associated with events (all p0.0001) in proportional hazards models. There was statistically significant improvement in risk estimation when exercise measures were added to the SHFM. However, the improvement in the C index for the addition of peak volume of oxygen consumption (+0.01), expired volume per unit time/volume of carbon dioxide slope (+0.02), 6-minute walk distance (-0.001), and cardiopulmonary exercise duration (+0.001) to the SHFM was small or slightly worse than the SHFM alone. Changes in risk assignment with the addition of exercise variables were minimal for patients above or below a 15% 1-year mortality.Exercise performance measures and the SHFM are independently useful for predicting risk in systolic heart failure. Adding cardiopulmonary exercise testing measures and 6MWD to the SHFM offers only minimal improvement in risk reassignment at clinically meaningful cut points.

Precise risk stratification in heart failure (HF) patients enables clinicians to tailor the intensity of their management. The Seattle Heart Failure Model (SHFM), which uses conventional clinical variables for its prediction, is widely used. We aimed to externally validate SHFM in Japanese HF patients with a recent episode of acute decompensation requiring hospital admission.SHFM was applied to 2470 HF patients registered in the West Tokyo Heart Failure and National Cerebral And Cardiovascular Center Acute Decompensated Heart Failure databases from 2006 to 2016. Discrimination and calibration were assessed with the use of the c-statistic and calibration plots, respectively, in HF patients with reduced ejection fraction (HFrEF;40%) and preserved ejection fraction (HFpEF; ≥40%). In a perfectly calibrated model, the slope and intercept would be 1.0 and 0.0, respectively. The method of intercept recalibration was used to update the model. The registered patients (mean age 74 ± 13 y) were predominantly men (62%). Overall, 572 patients (23.2%) died during a mean follow-up of 2.1 years. Among HFrEF patients, SHFM showed good discrimination (c-statistic = 0.75) but miscalibration, tending to overestimate 1-year survival (slope = 0.78; intercept = -0.22). Among HFpEF patients, SHFM showed modest discrimination (c-statistic = 0.69) and calibration, tending to underestimate 1-year survival (slope = 1.18; intercept = 0.16). Intercept recalibration (replacing the baseline survival function) successfully updated the model for HFrEF (slope = 1.03; intercept = -0.04) but not for HFpEF patients.In Japanese acute HF patients, SHFM showed adequate performance after recalibration among HFrEF patients. Using prediction models to tailor the care for HF patients may improve the allocation of medical resources.

Background The timing of transplant listing after implantation of a left ventricular assist device (LVAD) remains uncertain, given high device complication rates and apparent stability of some LVAD-supported patients. This investigation quantifies the effect of delayed transplant listing and transplantation rates on medium-term survival and LVAD complications. Methods and Results A Markov model was used to simulate the effects of delaying initial transplant listing after LVAD implantation. Modeled parameters were derived from the Standard Transplant Analysis and Research file. When transplant listing was delayed and 5-year results were examined, fewer persons underwent transplantation (53% in base model vs 51% in 180-day-delay model) and the fraction of deaths while waiting increased (17% in base model vs 21% in 180-day delay model). Life expectancy changed minimally from the base model (3.50 y) when initial listing was delayed by 180 days (3.51 y). Conclusions Delaying initial transplant listing increased the likelihood of death while waiting for a transplant and decreased the likelihood of transplantation. In aggregate, life expectancy was unchanged by delays in listing. This study suggests that delaying transplant listing with the expectation of providing additional life expectancy is not likely with current LVAD technology.

Background: As heart failure prevalence continues to increase in the setting of a static donor supply, left ventricular assist device (LVAD) therapy for end-stage heart failure continues to grow. Anecdotal evidence suggests that malalignment of the LVAD inflow cannula may increase thrombosis risk, but this effect has not been explored mechanistically or quantified statistically. Our objective is to elucidate the impact of surgical angulation of the inflow cannula on thrombogenicity. Methods and Results: Unsteady computational fluid dynamics is used in conjunction with computational modeling and virtual surgery to model flow through the left ventricle for 5 different inflow cannula angulations. We use a holistic approach to evaluate thrombogenicity: platelet-based (Lagrangian) metrics to evaluate the platelet mechanical environment, combined with flow-based (Eulerian) metrics to investigate intraventricular hemodynamics. The thrombogenic potential of each LVAD inflow cannula angulation is quantitatively evaluated based on platelet shear stress history and residence time. Intraventricular hemodynamics are strongly influenced by LVAD inflow cannula angulation. Platelet behavior indicates elevated thrombogenic potential for certain inflow cannula angles, potentially leading to platelet activation. Our analysis demonstrates that the optimal range of inflow angulation is within 0±7° of the left ventricular apical axis. Conclusions: Angulation of the inflow cannula >7° from the apical axis (axis connecting mitral valve and ventricular apex) leads to markedly unfavorable hemodynamics as determined by computational fluid dynamics. Computational hemodynamic simulations incorporating Lagrangian and Eulerian metrics are a powerful tool for studying optimization of LVAD implantation strategies, with the long-term potential of improving outcomes.

Objectives In this study, the authors developed the Seattle Proportional Risk Model (SPRM) to estimate the proportion of total mortality due to sudden death. We prospectively validated the model in HF-ACTION (Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) and tested whether the implantable cardioverter-defibrillator (ICD) benefit varied with the SPRM. Background Prediction of which heart failure patients are most likely to die of sudden death versus nonsudden death is an important factor in determining who will benefit the most from an ICD. Methods Among 2,331 patients enrolled, 1,947 patients were retained for analysis over a median follow-up of 2.5 years. The SPRM was calculated using age, gender, diabetes, body mass index, systolic blood pressure, ejection fraction, New York Heart Association functional class, sodium, creatinine, and digoxin use. Results An ICD (ICD or CRT-D) was in use before death in 1,204 patients (62%). SPRM was predictive of sudden death versus nonsudden death in those without an ICD (p = 0.002). The hazard ratio representing ICD versus no ICD was 0.63 for all-cause mortality (p = 0.0002). The ICD benefit varied with the SPRM for all-cause mortality (p = 0.001), with a greater benefit in those with a higher conditional probability of sudden death. Conclusions In population of ambulatory patients with a New York Heart Association functional class II-IV HF and ejection fraction of ≤35%, the SPRM was predictive of the proportional risk of sudden versus nonsudden death. ICDs were associated with a decreased risk of all-cause mortality by 37% and the ICD benefit varied with the SPRM. The SPRM may be useful in risk stratifying patients for a primary prevention ICD. (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure; NCT00047437 )

This study examined patient outcomes after left ventricular assist device (LVAD) implantation across a range of center surgical volumes.In order for a center to qualify for reimbursement, Centers for Medicare and Medicaid Services (CMS) requires it to implant ≥10 LVADs or total artificial hearts over a 3-year period. The impact of center LVAD surgical volumes on patient outcomes has not been thoroughly scrutinized.Center volumes were provided for 7,416 patients undergoing LVAD implantation who were enrolled in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). Center LVAD volume was categorized as either very low (≤10 implants/year, n = 617), low (11 to 30 implants/year, n = 2,561), medium (31 to 50 implants/year, n = 2,458), or high (50 implants/year, n = 1,750). The main outcome of interest was patient survival based on center volume derived from Kaplan-Meier and multivariate Cox regression.Overall survival was associated with center volume (p = 0.003), as follows: 71 ± 1.8% (very low volume), 81 ± 0.8% (low volume), 83 ± 0.8% (medium volume), and 79 ± 1.0% (high volume) at 1 year. Compared with medium volume centers, the 90-day mortality was higher in very low volume (odds ratio [OR]: 1.35; p = 0.04) and high volume (OR: 1.28; p = 0.018) VAD centers. The adjusted hazard ratios (HRs) for mortality were 1.32 (95% confidence interval [CI]: 1.11 to 1.56), 1.07 (95% CI: 0.95 to 1.21), and 1.17 (95% CI: 1.03 to 1.30) for very low, low, and high volume centers, respectively. Center volume did not predict mortality (p = 0.25; n = 3,688) in INTERMACS profile 1 patients (patients who had sustained cardiogenic shock) and profile 2 patients (patients with progressive hemodynamic decline despite inotropes).Center volume correlates with post-VAD survival, with worse survival noted at very-low volume centers. These findings suggest that current U.S. VAD center standards warrant reconsideration.

Introduction Endomyocardial biopsies (EMB) and gene expression profiling (AlloMap) are performed after heart transplant (HT) to evaluate for asymptomatic rejection though acute rejection is rare after year 2. The cost-effectiveness of routine surveillance studies is unknown. Hypothesis Routine surveillance for acute rejection is not cost-effective in patients greater than 2 years from HT. Methods A Markov model was constructed to compare 3 surveillance strategies: (1) Stopping routine surveillance studies 24 months after HT (baseline), (2) routine EMB every 6 months from 24-60 months, and (3) routine AlloMap every 6 months from 24-60 months. In all strategies, patients underwent an EMB for signs/symptoms of rejection. The model cycle length was 30 days. Hospitalization costs for rejection were based on the Healthcare Cost and Utilization Project and costs for tests and procedures from the Medicare & Medicaid Services Physician fee schedule. Patients were assumed to be treated as an inpatient for symptomatic acute cellular rejection (ACR) and all antibody-mediated rejection (AMR) and as an outpatient for asymptomatic ACR detected on routine surveillance. Probabilities used in the analysis were derived from patients transplanted at the University of Michigan from 2007 until January 2016 and who survived at least 2 years. Utilities for this analysis were based on literature review, when available. The analysis was performed with TreeAge Pro software. Results Probabilities were derived from 159 patients undergoing routine surveillance for rejection (4,645 cycles). After a routine EMB, AMR occurred with a probability of 0.005 and ACR never occurred. Probability of EMB after a routine AlloMap was 0.06 with a subsequent probability of ACR of 0.04 and no AMR. Compared to a baseline strategy of no surveillance, surveillance EMB was dominated and AlloMap had an incremental cost effectiveness ratio (ICER) $1.57 million/Quality-adjusted life year (QALY) (Table). Sensitivity analyses supported these findings; AlloMap remained cost prohibitive at a threshold of $100,000/QALY, and EMB was dominated up to a 25% risk of death for ACR and 15% risk for AMR. Conclusions Acute rejection is rare after post-HT year 2 and routine surveillance for rejection is not cost-effective.

Purpose The resistance compliance (RC) time describes the relationship between the pulmonary vascular resistance (PVR) and the pulmonary artery compliance (PAC) reflecting right ventricular (RV) afterload. Increased left atrial pressure shifts this relationship, lowering PAC for any given PVR leading to ventricular-arterial uncoupling and increased RV afterload. We hypothesize that decreased RC time is associated with increased in-hospital mortality due to poor right heart compensation in acute shock. Methods Admission right heart catheterization (RHC) data were analyzed in consecutive patients from 2014 to 2016 with cardiogenic shock as defined by a cardiac index Results We studied 235 patients with 265 unique encounters, where 15.3% died during the hospitalization. The mean RC time in our study sample was 0.33 (SD ±0.21). The hazard ratio (HR) for in-hospital mortality risk with the RC time was 0.161 (p-value = 0.07). Compared to the highest tertile, the lowest tertile of RC time was associated with increased mortality (HR 0.323, p-value = 0.045). The mortality risk persisted when adjusted for the RAP (HR 0.344, p-value = 0.056). The mean PAPi was 3.08 (SD ±3.79). The HR of in-hospital mortality with the PAPi was 0.806 (p-value = 0.166). Compared to the highest tertile, the lowest tertile of PAPi was associated with an increased mortality (HR 0.382, p-value = 0.045). This association was non-significant when adjusted for the RAP (HR 0.461, p-value = 0.202). Conclusion We demonstrate that a low RC time and increased RV afterload is associated with increased mortality in patients admitted with cardiogenic shock. In contrast to the PAPi, this association is independent of right atrial pressure, suggesting that the RC time may be a better marker of outcomes independent of central venous pressure. Further studies are needed to evaluate the role of these markers in cardiogenic shock.

There are rare reports in the literature of bortezomib induced cardiotoxicity. We report a presentation of fulminant myocarditis due to bortezomib. A 53 year old male with recent diagnosis of multiple myeloma, on lenalidomide, bortezomib, and dexamethasone, presents to the ER with chest pain. ECG

The digitalis glycosides (digoxin) have been ensconced by history, efficacy, therapeutic necessity, and lack of definitive evidence as treatments for both heart failure (HF) and atrial fibrillation (AF). There is a reluctance to abandon digoxin because of its perceived ability to additively improve

Background Heart transplant volumes are not matching growing demand, and donor heart use may be decreasing. Objectives This study sought to investigate the benefit of heart transplantation compared with waiting while accounting for the estimated risk of a given donor-recipient match. Methods This study identified 28,548 heart transplant candidates in the Organ Procurement and Transplant Network between July 2006 and December 2015. Donor-recipient match quality was estimated from the donor risk index. A time-dependent covariate Cox model was used to determine the effect of donor-recipient match quality on the likelihood of a composite outcome while waiting for a transplant or after transplantation. The composite outcome was death or delisting as too ill. Results Donor and recipient risk estimates were inversely related to the candidate urgency. Net benefit from heart transplantation was evident across all estimates of donor-recipient status 1A and 1B candidates: status 1A (lowest-risk quartile hazard ratio [HR]: 0.37; 95% confidence interval [CI]: 0.31 to 0.43; highest-risk quartile HR: 0.52; 95% CI: 0.44 to 0.61) and status 1B candidates (lowest-risk quartile HR: 0.41; 95% CI: 0.36 to 0.47; highest-risk quartile HR: 0.66; 95% CI: 0.58 to 0.74). Status 2 candidates showed a benefit from heart transplantation; however, survival benefit was delayed. For the highest-risk donor-recipient matches, a net benefit of transplantation occurred immediately for status 1A candidates, after 12 months for status 1B candidates, and after 3 years for status 2 candidates. Conclusions This study demonstrated a survival benefit of heart transplantation across all ranges of estimated donor-recipient match risk for status 1A and status 1B candidates. Donor heart acceptance should be the favored strategy for these candidates. The benefit of transplantation for status 2 candidates was less apparent and dependent on estimated donor-recipient match risk, suggesting that a measure of donor-recipient match quality may be useful when considering the immediate benefit of heart transplantation for status 2 candidates in stable condition.

The development of new aortic insufficiency after a period of support with a left ventricular assist device can result in progressive heart failure symptoms. Transcatheter aortic valve repair can be an effective treatment in selected patients, but the lack of aortic valve calcification can result in unstable prostheses or paravalvular leak. We describe a technique of deploying a self-expanding CoreValve (Medtronic, Minneapolis, MN, USA) into the aortic annulus, followed by a balloon-expandable SAPIEN-3 (Edwards, Irvine, CA, USA).

Background The HeartMate II Left Ventricular Assist Device (LVAD) receives power via a percutaneous lead connected to an external controller and batteries. At times, this lead can be damaged during normal wear, as well as by traumatic fracture, which may jeopardize the functionality of the LVAD. If there is significant internal damage, surgical replacement of the LVAD is required. However it is possible to repair externally damaged leads by replacing the distal portion of the lead to avoid pump replacement. We report the overall experience and outcomes in patients with external lead repairs. Methods A procedure for full external lead replacement has been developed and is approved for implementation by the FDA. Pre-procedural steps include examination of high resolution x-rays of the driveline and analysis of pump log files. Efficacy and outcomes of all attempted external lead repairs were evaluated between initiation of repairs in 2008 through 2014. Results A total of 321 repairs were attempted in 297 patients with suspected isolated external lead damage after a median of 2.0 yr [range: 7d to 8.7 yr] of support. Of 297 patients, 37 (12.5%) had attempts at external repair that were unsuccessful due to concomitant internal lead damage. 31 patients (10.4%) had additional serious malfunctions after lead repair resulting in 17 with repeat repairs and 14 who continued on ungrounded cables, and ultimately 14 of these 31 patients required pump exchanges. 27 of the 297 patients (9.1%) with lead repairs had only minor additional problems, including cuts or abrasion in the insulation which was fixed with tape or external reinforcement. There was one catastrophic failure during attempted lead repair requiring emergent pump exchange, and there were three deaths within 14 days of attempted repair related to continued percutaneous lead damage. One of these patients refused pump exchange, and two were not candidates for other clinical reasons. 202 of the 297 patients (68%) have had no recurrence of lead problems after a median follow-up of 189 days [n=11 over 2 years, longest 5.8 yr]. Conclusions HeartMate II dysfunction due to percutaneous lead damage is uncommon but is of serious concern due to potential abrupt pump stoppage. Lead repair by replacement of the external distal percutaneous lead can be performed by trained personnel in a standardized fashion and may provide a durable solution in select patients with isolated external lead damage, thus avoiding the need for surgical pump exchange. We provide an algorithm for evaluating potential lead damage.

Background Allocation of donor hearts in the United States is accomplished by an algorithm based on status, time waited, and geographic boundaries. Although not designed to always transplant the highest acuity candidates, the ability of current United Network for Organ Sharing policies to prioritize highest acuity candidates is unknown. Methods We analyzed 32,866 adult match runs generated from 2007 to 2014. Each candidate's sequence number within a match run was compared with the candidate's risk of mortality using Kendall's tau-b—a measure of rank correlation. Two primary methods of evaluating risk of mortality were used: status designation–based risk (i.e., status 1A risk > status 1B > status 2) and status justification–based risk (e.g., status 1A justified by presence of a complication). Results Median sequence number for transplanted candidates was 3 (interquartile range [IQR]: 1, 9). Median correlation among match runs for status-based risk was 0.57 (IQR: 0.47, 0.66) and for justification-based risk was 0.51 (IQR: 0.39, 0.60). Sensitivity to status 2 candidates was evident when status 2 candidates were removed from the sample (status-based tau-b = 0.31, justification-based tau-b = 0.1) and with restriction of the data set to only the first 20 candidates (status-based tau-b = 0.35, justification-based tau-b = 0.15). Conclusions There is only mild correlation between status and priority under the current allocation algorithm and poor concordance when more detailed risks are considered. The geographic allocation rule is responsible for most of the measured discordance.

Transplantation studies in mice and rats have shown that human embryonic-stem-cell-derived cardiomyocytes (hESC-CMs) can improve the function of infarcted hearts, but two critical issues related to their electrophysiological behaviour in vivo remain unresolved. First, the risk of arrhythmias following hESC-CM transplantation in injured hearts has not been determined. Second, the electromechanical integration of hESC-CMs in injured hearts has not been demonstrated, so it is unclear whether these cells improve contractile function directly through addition of new force-generating units. Here we use a guinea-pig model to show that hESC-CM grafts in injured hearts protect against arrhythmias and can contract synchronously with host muscle. Injured hearts with hESC-CM grafts show improved mechanical function and a significantly reduced incidence of both spontaneous and induced ventricular tachycardia. To assess the activity of hESC-CM grafts in vivo, we transplanted hESC-CMs expressing the genetically encoded calcium sensor, GCaMP3 (refs 4, 5). By correlating the GCaMP3 fluorescent signal with the host ECG, we found that grafts in uninjured hearts have consistent 1:1 host–graft coupling. Grafts in injured hearts are more heterogeneous and typically include both coupled and uncoupled regions. Thus, human myocardial grafts meet physiological criteria for true heart regeneration, providing support for the continued development of hESC-based cardiac therapies for both mechanical and electrical repair.

The Seattle Heart Failure Model (SHFM) is a multivariable model with proven prognostic value. Cardiopulmonary exercise testing (CPX) and neurohormonal markers (eg, B-type natriuretic peptide [BNP]) are also well accepted assessment techniques in the HF population and have both demonstrated robust prognostic value. The purpose of this investigation was to assess the combined prognostic value of the SHFM and CPX.This study included all 453 patients enrolled in the Multicenter In-Sync Randomized Clinical Evaluation (MIRACLE) trial. Baseline SHFM and CPX were used. Both peak oxygen consumption (VO(2)) and ventilatory efficiency (VE/VCO(2)) were determined. In a univariate Cox proportional model analysis, SHFM and log-transformed peak VE/VCO(2) were stronger predictors of 6-month mortality (both P .001) than log-transformed BNP (P = .013) or peak VO(2) (P = .066). In a multivariable Cox proportional hazards model, neither peak VO(2) nor BNP were independent predictors when added to the SHFM (P .1). Conversely, peak VE/VCO(2) was a strong independent predictor when added to the SHFM, with an increase in the Cox proportional hazards model Wald χ(2) from 22.7 for SHFM alone to 33.8 with inclusion of log-transformed peak VE/VCO(2) (P .0001) and significant changes in the net reclassification improvement and integrated discrimination index (both P .002).These results indicate that the SHFM and peak VE/VCO(2) work synergistically to improve prognostic resolution. Further investigation is needed to continue to optimize multivariable prognostic models in patients with HF, a chronic disease population that continues to suffer from a high adverse event rate despite advances in medical care.

In this study we investigated whether the addition of peak oxygen consumption (VO(2)) improves the predictive accuracy of the Seattle Heart Failure Model (SHFM). The SHFM is a validated multivariate risk model that uses NYHA classification to assess functional capacity rather than peak oxygen consumption (VO(2)).Outpatients (n = 1,240) evaluated for transplant at three centers had their SHFM score calculated and peak VO(2) measured. The outcomes assessed were death/LVAD/urgent transplant with censoring at the time of elective transplant.Over the course of 4.0 (mean) years of observation, there were 571 events. Both the SHFM score (χ(2) = 227) and peak VO(2) (χ(2) = 88, both p0.0001) were highly predictive of outcomes. The SHFM and peak VO(2) were modestly correlated (r = 0.39, p0.0001). In a multivariate Cox model, peak VO(2) added to the SHFM with a hazard ratio of 0.949 (p0.0001) for each 1-ml/kg/min increase. Peak VO(2) improved both the net reclassification improvement and integrated discrimination index (both p ≤ 0.0002). Peak VO(2) provided additive prognostic information within each SHFM score (p0.05). The 1-year areas under the receiver-operating characteristic curve were obtained for peak VO(2) (0.645, 95% CI 0.606 to 0.684), SHFM (0.758, 95% CI 0.721 to 0.795) and SHFM with peak VO(2) (0.766, 95% CI 0.731 to 0.802). The SHFM-predicted vs actual survival free of LVAD/UNOS Status 1 transplant at 1 year (86% vs 83%) and 4 years (63% vs 63%) were similar.The multivariate SHFM is a powerful predictor of death/LVAD/urgent transplant. Peak VO(2) adds prognostic information across the spectrum of the SHFM, but changes in decision regarding transplant listing occur mainly in moderate-risk patients.

Despite positive associations with rejection, the clinical value of B-type natriuretic peptide (BNP) monitoring in heart transplant recipients has not been established. We sought to determine the predictive value of changes in serial BNP level for identifying patients with acute allograft rejection.BNP, hemodynamics and biopsies were obtained for 205 transplant recipients who underwent a total of 4,007 endomyocardial biopsy procedures. Samples analyzed were collected ≥ 180 days post-transplant, without evidence of rejection on the immediately preceding biopsy. Using a repeated-measures multivariate model, we assessed the association of change in BNP with Grade ≥ 3A (2R) rejection. We also determined predictive values of various cut-off thresholds of change in serial BNP levels to predict Grade ≥ 3A rejection.There were 47 episodes of Grade ≥ 3A rejection among the 1,350 samples analyzed. Median change in serial BNP (ΔBNP) for those with Grade ≥ 3A rejection was 20 pg/ml (IQR -26 to 169 pg/ml) and among those with Grade3A rejection was -4 pg/ml (IQR -34 to 22 pg/ml, p = 0.003). On multivariate analysis, ΔBNP remained the most potent independent predictor of Grade ≥ 3A rejection (p = 0.001). ΔBNP100 pg/ml predicted increased risk of Grade ≥ 3A rejection (OR = 5.3, p0.001) with high specificity (93.3%) and positive predictive value (13.0%) and excellent negative predictive value (97.3%).Change in serial BNP level is an independent predictor of cardiac allograft rejection. With wide availability, rapid turnaround, low cost, favorable positive predictive value and excellent negative predictive value, serial BNP monitoring has several advantages for non-invasive monitoring of heart transplant recipients for acute cardiac allograft rejection.

ObjectivesThe goal of this research was to identify disparities in risk within heart transplant urgency designations.BackgroundPatients with left ventricular assist devices (LVADs) are given 30 days of elective status 1A time. This allowance may create competition for organs between stable LVAD-supported registrants and less stable registrants listed status 1A or 1B.MethodsThe Scientific Registry of Transplant Recipients database was analyzed for all status 1A and 1B listings between 2005 and 2010. Cox models were used to estimate the relative and absolute risk of adverse events (death or delisting as too ill) during status 1A or 1B listing.ResultsStatus 1A registrants supported with dual inotropes and right heart monitoring had a higher risk of adverse events compared to those supported with implanted LVADs using elective 1A time (hazard ratio: 3.2; 95% confidence interval: 1.8 to 5.7). The 30-day risk of events was 1% (95% confidence interval: 0.1% to 3%) for implanted LVADs using elective 1A time and 6% (95% confidence interval: 4% to 8%) for dual inotrope support. Registrants listed with paracorporeal ventricular assist devices had a higher risk of adverse events (hazard ratio: 9.1; p < 0.0001) compared with registrants with implanted LVADs using elective 1A time. The odds of transplant were higher for implanted LVADs (odds ratio: 1.5; p < 0.0001) compared with dual-inotrope and intra-aortic balloon pump support.ConclusionsThe historic allowance for 30 days of elective status 1A time for implanted LVADs creates disparities in risk among status 1A registrants. The allowance of 30 days of elective status 1A time should not be allocated to stable registrants with implanted LVADs. Registrants supported with paracorporeal ventricular assist devices should be listed status 1A indefinitely.