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There has been an increase in the use of extracorporeal membrane oxygenation (ECMO) to bridge critically ill patients to lung transplant (LTX). This study evaluates how ambulatory status on ECMO affected waitlist and post-LTX outcomes. The United Network of Organ Sharing (UNOS) database was queried for patients aged of greater than or equal to 18 years and between 2016 and 2021 to identify pre-LTX patients supported by ECMO. The patients were classified in venous-arterial (VA) ECMO and veno-venous (VV) ECMO cohorts and further classified as ambulatory (AMB) and non-AMB (nAMB). Each cohort was controlled against the non-ECMO patients. Univariate statistical tests, as well as Kaplan–Meier survival curves, were used for analysis. The 90 day waitlist survival was the highest among the non-ECMO group (96%), but both AMB VV and VA groups had superior survival compared to the nAMB group (85% vs.75%, 78% vs.65%, p< 0.01). After adjusting for the median lung allocation score (LAS) (88) in the VV ECMO group, the waitlist survival was superior in the AMB VV ECMO compared to those not on ECMO (86% vs.78%, p> 0.01). The 1 year post-LTX survival between non-ECMO and AMB VV ECMO was comparable (88% vs.88%, p= 0.66). Ambulating patients or use of physical therapy while on ECMO can help improve lung transplant outcomes.

Clinical predictors of posttransplant graft loss since the United Network for Organ Sharing (UNOS) heart allocation system change have not been well characterized. Single organ adult heart transplants from the UNOS database were identified (n = 10,252) and divided into a test cohort (n = 6,869, 67%) and validation cohort (n = 3,383, 33%). A Cox regression analysis was performed on the test cohort to identify recipient and donor risk factors for posttransplant graft loss. Based on the risk factors, a score (max 16) was developed to classify patients in the validation cohort into risk groups of low (≤1), mid (2–3), high (≥4) risk. Recipient factors of advanced age, Black race, recipient blood group O, diabetes, etiology of heart failure, renal dysfunction, elevated bilirubin, redo-transplantation, elevated pulmonary artery pressure, transplant with a durable ventricular assist device, or transplant on extracorporeal membrane oxygenation (ECMO) or ventilator were associated with more posttransplant graft loss. Donor factors of ischemic time and donor age were also associated with outcomes. One year graft survival for the low-, mid-, high-risk groups was 94%, 91%, and 85%, respectively. In conclusion, easily obtainable clinical characteristics at time of heart transplant can predict posttransplant outcomes in the current era.

RT Cardiac Systems (RTCS, Raleigh, NC) is developing an intravascular percutaneous mechanical circulatory support (pMCS) device drive system for use during high-risk percutaneous coronary intervention and emergent cardiogenic shock. The proprietary pMCS device (US patent 10,780,206) consists of a miniaturized axial flow pump with an integrated motor connected via a short flexible drive system. This novel flexible drive system creates a flexible pump that is advantageous for percutaneous placement and conforming to anatomy. This design also has the benefit of not requiring a continuous external lubrication source. In this article, we present engineering development and feasibility testing of the prototype pMCS system. Computational fluid dynamics (CFD) modeling was performed to evaluate candidate blade set designs (impeller leading and trailing edges, diffuser) and predict hydrodynamic performance and hemolysis risk. Bench testing of candidate lip seal designs (radial interference, durometer, and seal angle) was evaluated for leak rate. Two 16Fr prototype devices were then fabricated and tested in a static mock flow loop. Experimental testing demonstrated 3 L/min flow against 110 mmHg and 4 L/min flow against 80 mmHg, which matched the CFD-predicted hydrodynamic performance. These results demonstrate feasibility of the engineering design and performance of the prototype devices.

This retrospective study included children aged ≤18 years who had durable ventricular assist devices (VADs) as a bridge to transplantation from the United Network Organ Sharing (UNOS) database between 2011 and 2020. We evaluated 90 day waitlist mortality and 1 year posttransplant mortality after VAD implantation in children stratified by race/ethnicity: Black, White, and Others. The VAD was used in a higher proportion of Black children listed for heart transplantation (HT) (26%) versus Other (25%) versus White (22%); p< 0.01. Black children had Medicaid health insurance coverage (67%) predominantly at the time of listing for HT. There was no significant overall difference in waitlist survival among the three groups supported with VAD at the time of listing (log-rank p= 0.4). On the other hand, the 90 day waitlist mortality after the VAD implantation at listing and while listed was the lowest among Black (6%) compared with White (13%) and Other (14%) (p< 0.01). The multivariate regression analysis showed that Other race (hazard ratio [HR], 2.29; p< 0.01), Black race (HR, 2.13; p< 0.01), use of mechanical ventilation (HR, 1.72; p= 0.01), and Medicaid insurance (HR, 1.54; p= 0.04) were independently associated with increased 1 year posttransplant mortality. In conclusion, Black children had more access to durable VAD support than White children. The 90 day waitlist mortality was significantly lower in Black children compared with White and Other after VAD implantation. However, Black and Other racial/ethnic children with VAD at transplant had higher 1 year posttransplant mortality than White children. Future studies to elucidate the reasons for these disparities are needed.

Many patients with end-stage heart disease die because of the scarcity of donor hearts. A total artificial heart (TAH), an implantable machine that replaces the heart, has so far been successfully used in over 1,700 patients as a temporary life-saving technology for bridging to heart transplantation. However, after more than six decades of research on TAHs, a TAH that is suitable for destination therapy is not yet available. High complication rates, bulky devices, poor durability, poor biocompatibility and low patient quality of life are some of the major drawbacks of current TAH devices that must be addressed before TAHs can be used as a destination therapy. Quickly emerging innovations in battery technology, wireless energy transmission, biocompatible materials and soft robotics are providing a promising opportunity for TAH development and might help to solve the drawbacks of current TAHs. In this Review, we describe the milestones in the history of TAH research and reflect on lessons learned during TAH development. We summarize the differences in the working mechanisms of these devices, discuss the next generation of TAHs and highlight emerging technologies that will promote TAH development in the coming decade. Finally, we present current challenges and future perspectives for the field.

The new United Network for Organ Sharing (UNOS) policy has resulted in a significantly higher number of temporary mechanical circulatory support device usage such as extracorporeal membrane oxygenation, Impella, and intra-aortic balloon pump due to provision of higher priority with their use while on the waiting list. We aimed to identify Impella use in patients awaiting heart transplantation and temporal changes in its usage. The UNOS database was queried between years 2015 and 2019 for patients aged greater than or equal to 18 years, listed to undergo heart transplantation. A total of 378 patients had Impella support while listed for heart transplantation. Impella use skyrocketed from 2015 (1%) to 2019 (4%, p< 0.01). The most substantial increase in Impella use occurred after the UNOS policy change. The patients listed on Impella support after the policy change had significantly lower waiting time (median 12 days vs.45 days, p< 0.01). More patients with Impella were directly transplanted (80% vs.56%, p< 0.01) after the policy change, had significantly lower waitlist mortality (25% vs.13%, p< 0.01) and fewer converted to a durable support (13% vs.3%). The translatability (likelihood for receiving organs faster) was significantly improved after the policy change. A multivariable Cox regression model showed that post-transplant survival of Impella patients was not adversely affected after the policy change (hazard ratio = 0.9; p= 0.8). This increase in Impella use represents a substantial change in practice patterns of listing and managing patients on the heart transplant waiting list.

Supplemental Digital Content is available in the text.The study aim was to examine the impact time in therapeutic range (TTR, International Normalized Ratio [INR] 2.0–3.0) has on survival and adverse events in patients receiving the HeartWare HVAD System in the ENDURANCE and ENDURANCE Supplemental Trials. Evaluable subjects (n = 495) had >1 INR value recorded 1–24 months postimplant and were categorized as: low TTR (10–39%), moderate TTR (40–69%), and high TTR (≥70%). Baseline characteristics, adverse events, and survival were analyzed. Low TTR patients experienced higher rates of major bleeding (1.69 vs. 0.54 events per patient year [EPPY]; p< 0.001), GI bleeding (1.22 vs.0.38 EPPY; p< 0.001), stroke (0.47 vs.0.17 EPPY; p< 0.001), thrombus requiring exchange (0.05 vs.0.01 EPPY; p= 0.02), infection (1.44 vs.0.69 EPPY; p< 0.001), and renal dysfunction (0.23 vs.0.05 EPPY; p< 0.001) compared with high TTR. Moderate TTR had higher rates of major bleeding (0.75 vs. 0.54 EPPY; p< 0.001), thrombus requiring exchange (0.05 vs.0.01 EPPY; p= 0.007), cardiac arrhythmia (0.32 vs.0.24 EPPY; p= 0.04), and infection (0.90 vs.0.69 EPPY; p= 0.001) compared with high TTR. Two year survival was greater among moderate and high versus low cohorts (Log-rank p= 0.001). The significant reduction in morbidity and mortality in destination therapy (DT) HVAD patients with well-controlled TTR (≥70%) emphasizes the importance of vigilant anticoagulation management.

Patients with left ventricular assist devices currently require long-term anticoagulation with warfarin. Warfarin requires frequent blood tests and is associated with adverse events when not in the therapeutic range. Apixaban is a possible alternative that is potentially better for compliance and requires no additional testing. The purpose of this study was to compare adverse events in patients with a HeartMate 3 LVAD receiving apixaban versuswarfarin. Thirty-five patients underwent HM3 implantation between January 01, 2016 to January 31, 2021. The groups compared were apixaban (n = 15, 43%) and warfarin (n = 20, 57%). All patients received 325 mg aspirin daily. Stroke, bleeding, and death were identified as primary outcomes after LVAD implant. Univariate nonparametric statistical analysis was performed. The median duration of treatment with apixaban was 148 days (37–606 days). The groups were comparable in terms of age (56 vs. 54 years), gender (male, 85% vs. 75%), and renal function (Cr 1.5 vs. 1.4). The apixaban group had significantly higher mean pulmonary artery pressure (41 vs. 34, p= 0.03) and there were more (p< 0.05) ischemic cardiomyopathy and INTERMACS profile >3 in the warfarin group. At 6 months, thrombotic complications and death were not different between the groups. The two deaths in the apixaban group were from right heart failure. The apixaban group had clinically lower rates of bleeding complications (5% vs. 30%). The adverse events of bleeding, stroke, and death were similar in HM3 patients receiving warfarin or apixaban. Apixaban may be a safe alternative anticoagulant therapy in HM 3 LVAD patients.

Supplemental Digital Content is available in the text.The objective of the study is to compare the clinical characteristics, risk factors, and overall survival (waitlist and posttransplant) outcomes in children with congenital heart disease (CHD) bridged to transplantation with either a ventricular assist device (VAD) versusextracorporeal membrane oxygenation (ECMO) versusno mechanical circulatory support (MCS) in the recent era. The study included 2,899 primary heart transplantations in patients <18 years with CHD between 2010 and 2019 from the United Network Organ Sharing database. Patients who had ECMO or VAD at listing or while listed were included, and their waitlist and posttransplant outcomes were compared with CHD patients who did not require MCS. Of all, 464 (16%) had ECMO and 200 (7%) VAD at the time of or during the listing. The VAD utilization increased over the last decade (4% in 2010 to 10% in 2019, p< 0.01). The 90 days post-MCS survival was better with VAD than ECMO (67 vs.49%, p< 0.01). The transplantability rate at 90 days was decreased with younger age (odds ratio [OR], 0.91; 95% CI, 0.86–0.95), lower body mass index (BMI) (OR, 0.93; 95% CI, 0.89–0.98) and lower albumin <3g/dl (OR, 0.6; 95% CI, 0.53–0.7). The multivariate model predicted that lower BMI (OR, 1.12; 95% CI, 1.06–1.18), pretransplant ECMO (OR, 2.19; 95% CI, 1.39–3.45), and higher bilirubin (OR, 1.15; 95% CI, 0.97–1.36) decreased 1-year posttransplant survival. Patients transplanted with VAD had better 1-year survival than ECMO (88 vs.70%, p= 0.01). Waiting list survival of children with CHD supported by VAD is better compared to ECMO. The 1-year posttransplantation outcome of CHD patients supported by VAD is similar to the no MCS patients and better than ECMO-supported patients. There is no significant difference in post-HT survival between patients transitioned from ECMO to VAD while listed and those with VAD-first.

Limited data exist regarding complication rates of implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy devices (CRT-D) in patients with left ventricular assist devices (LVAD).

Left ventricular assist devices (LVADs) improve quality of life (QoL) and functional capacity (FC) for patients with advanced heart failure. The association between adverse events (AEs) and changes in QoL and FC are unknown. Patients treated with the HeartWare ventricular assist device (HVAD) with paired 6-minute walk distance (6MWD, n = 263) and Kansas City Cardiomyopathy Questionnaires (KCCQ, n = 272) at baseline and 24 months in the ENDURANCE and ENDURANCE Supplemental Trial databases were included. Patients were stratified based upon occurrence of clinically significant AEs during the first 24 months of support and analyzed for the mean change in 6MWD and KCCQ. The impact of AE frequency on change in 6MWD and KCCQ from baseline to 24 months was evaluated. Of the AEs examined, only sepsis was associated with an improvement in 6MWD (109 m vs.16 m, p= 0.002). Patients without improvement in 6MWD test from baseline to 24 months had significantly more AEs than those with FC improvement (p= 0.0002). Adverse events did not affect the KCCQ overall summary score. In this analysis, patients with fewer AEs had greater improvement in FC during the 24-month follow up. The frequency of AEs did not have a significant impact on QoL after LVAD implantation.

Supplemental Digital Content is available in the text.Pediatric heart failure (HF) patients have been a historically underserved population for mechanical circulatory support (MCS) therapy. To address this clinical need, we are developing a low cost, universal magnetically levitated extracorporeal system with interchangeable pump heads for pediatric support. Two impeller and pump designs (pump V1 and V2) for the pediatric pump were developed using dimensional analysis techniques and classic pump theory based on defined performance criteria (generated flow, pressure, and impeller diameter). The designs were virtually constructed using computer-aided design (CAD) software and 3D flow and pressure features were analyzed using computational fluid dynamics (CFD) analysis. Simulated pump designs (V1, V2) were operated at higher rotational speeds (~5,000 revolutions per minute [RPM]) than initially estimated (4,255 RPM) to achieve the desired operational point (3.5 L/min flow at 150 mm Hg). Pump V2 outperformed V1 by generating approximately 30% higher pressures at all simulated rotational speeds and at 5% lower priming volume. Simulated hydrodynamic performance (achieved flow and pressure, hydraulic efficiency) of our pediatric pump design, featuring reduced impeller size and priming volume, compares favorably to current commercially available MCS devices.

Logfiles from the HeartWare HVAD System provide operational pump trend data to aid in patient management. Pump thrombosis is commonly associated with increases in the logfile power that may precede the clinical presentation. A Power Tracking algorithm was developed to detect significant deviations in pump power that may be associated with pump thrombus (PT). The Power Tracking algorithm was applied retrospectively to logfiles captured in the ENDURANCE, ENDURANCE Supplemental, and LATERAL clinical trials. From a combined dataset of 896 patients, available logfiles with suspected PT (n = 70 events in 60 patients) and available logfiles from patients without adverse events (AEs) (n = 106 patients, consisting of 27.4 patient-years of monitoring) were organized into two cohorts. The Power Tracking algorithm detected PT cases on or before the recorded AE date with a sensitivity of 85.7%, with detection occurring an average of 3.9 days before clinical presentation. The algorithm averaged one false alarm for every 6.85 patient-years of monitoring from logfiles without AEs. The favorable performance of the Power Tracking algorithm may enable earlier detection of pump thrombosis and allow early medical management versussurgical intervention.

Supplemental Digital Content is available in the text.

Supplemental Digital Content is available in the text.There is limited data on the cost-effectiveness of continuous-flow left ventricular assist devices (LVAD) in the United States particularly for the bridge-to-transplant indication. Our objective is to study the cost-effectiveness of a small intrapericardial centrifugal LVAD compared with medical management (MM) and subsequent heart transplantation using the respective clinical trial data. We developed a Markov economic framework. Clinical inputs for the LVAD arm were based on prospective trials employing the HeartWare centrifugal-flow ventricular assist device system. To better assess survival in the MM arm, and in the absence of contemporary trials randomizing patients to LVAD and MM, estimates from the Seattle Heart Failure Model were used. Costs inputs were calculated based on Medicare claim analyses and when appropriate prior published literature. Time horizon was lifetime. Costs and benefits were appropriately discounted at 3% per year. The deterministic cost-effectiveness analyses resulted in $69,768 per Quality Adjusted Life Year and $56,538 per Life Year for the bridge-to-transplant indication and $102,587 per Quality Adjusted Life Year and $87,327 per Life Year for destination therapy. These outcomes signify a substantial improvement compared with prior studies and re-open the discussion around the cost-effectiveness of LVADs.

Supplemental Digital Content is available in the text.This study reports the first analysis regarding cost-effectiveness of left ventricular assist device (LVAD) implantation viathoracotomy. Cost-effectiveness of LVADs implanted viathe traditional surgical approach of sternotomy has been improved through the years because of technological advances, along with understanding the importance of patient selection and postimplant management have on positively affecting outcomes. Given the positive clinical outcomes of the thoracotomy approach, we seek to study the cost-effectiveness of a centrifugal LVAD viathis less invasive approach. We developed a Markov model. Survival and quality of life inputs (QALY) for the LVAD arm were based on data from the LATERAL clinical trial. For the Medical Management arm, survival was derived from the Seattle Heart Failure Model. The heart transplant probability was derived from INTERMACS. Survival after heart transplantation used International Society for Heart and Lung Transplantation data. Cost inputs were calculated based on Medicare data and past literature. The incremental cost-effectiveness ratio was found to be $64,632 per quality adjusted life year and $57,891 per life year in the bridge to transplant indication. These results demonstrate further improvement in the overall cost-effectiveness of LVAD therapy and confirm implantation of LVADs viaa less invasive approach as being cost-effective.

The effect of blood group on heart transplant list mortality in the era of continuous flow left ventricular assist devices (VADs) is unknown. We sought to examine mortality from the United Network for Organ Sharing (UNOS) database, with focus on mortality among VAD versusnon-VAD recipients according to blood group. The UNOS database from 2007 to 2015 was evaluated to compare the rates of waitlist mortality or delisting for clinical worsening at 1-year postlisting among various blood types based on the presence or absence of durable continuous VAD. Patients with pulsatile VAD, temporary VAD, or with incomplete data were excluded. A total of 16,803 patients met the inclusion criteria. Of these, 2,663 had a HeartMate II or HeartWare VAD implanted before listing or by 365th day of listing. The rate of adverse events on the waitlist, irrespective of VAD, was highest among group O patients (odds ratio [OR] 1.54, p< 0.001). The use of VAD was associated with significant relative risk reduction (OR 0.43, p< 0.001) in waitlist adverse events among all patients, with relative risk reduction that overall did not vary by blood group. Among VAD recipients, waitlist adverse events were similar across all blood types. Among listed patients, there is a significantly higher adverse event rate in group O patients compared with others, irrespective of VAD use. With implantation of continuous flow HeartMate II or HeartWare VAD, all blood groups experience similar relative benefit and similar rates of adverse events. All patients, but particularly those with blood group O, eligible for VAD as a bridge to transplant should be considered for VAD placement.

The severe acute respiratory syndrome (SARS)-CoV-2 is an emerging viral pathogen responsible for the global coronavirus disease 2019 (COVID)-19 pandemic resulting in significant human morbidity and mortality. Based on preliminary clinical reports, hypoxic respiratory failure complicated by acute respiratory distress syndrome is the leading cause of death. Further, septic shock, late-onset cardiac dysfunction, and multiorgan system failure are also described as contributors to overall mortality. Although extracorporeal membrane oxygenation and other modalities of mechanical cardiopulmonary support are increasingly being utilized in the treatment of respiratory and circulatory failure refractory to conventional management, their role and efficacy as support modalities in the present pandemic are unclear. We review the rapidly changing epidemiology, pathophysiology, emerging therapy, and clinical outcomes of COVID-19; and based on these data and previous experience with artificial cardiopulmonary support strategies, particularly in the setting of infectious diseases, provide consensus recommendations from ASAIO. Of note, this is a “living document,” which will be updated periodically, as additional information and understanding emerges.

Strokes remain a leading cause of morbidity and mortality in patients with ventricular assist devices (VADs). Varying study populations, event definitions, and reporting methods make direct comparison of neurologic event risk across clinical trials and registries challenging. We aim to highlight important differences among major VAD studies and standardize rates of neurologic events to facilitate a comprehensive and objective comparison. We systematically identified and analyzed key clinical trials and registries evaluating the HeartMate II (HMII), HeartMate 3 (HM3), and HVAD devices. Reported neurologic events were nonexclusively categorized into ischemic stroke, hemorrhagic stroke, disabling stroke, fatal stroke, and other neurologic events per the studies’ definitions. Event rates were standardized to events per patient-year (EPPY) and freedom from event formats. Seven key clinical trials and registries were included in our analysis. There is significant variation and overlap in neurologic event rates for the three VAD platforms across clinical trials (all neurologic events [EPPY]: HM3 0.17–0.21; HMII 0.19–0.26; HVAD 0.16–0.28). None performs consistently better for all types of neurologic events. Furthermore, stroke rates among VAD trials correlated with baseline stroke risk factors including ischemic etiology, history of atrial fibrillation, and history of prior stroke.

Hemorrhagic or thrombotic events are common complications in heart failure patients with continuous-flow left ventricular assist device (CF-LVAD) support. Aim of this study is to investigate the effect of change in antiplatelet therapy after thrombotic or hemorrhagic events in patients with CF-LVAD support. A total of 231 CF-LVAD patients were included in this study. Patients with CF-LVAD were categorized into three groups: (1) high antiplatelet regimen as control group (aspirin [ASA] 325 mg; n = 115), (2) low antiplatelet regimen (ASA 81 mg; n = 82), started after hemorrhagic complications, and (3) double antiplatelet therapy (ASA/clopidogrel; n = 34) started after thrombotic complications. In our analysis, indications for low antiplatelet therapy were gastrointestinal (GI) bleeding (36%), hemorrhagic stroke (8%), and epistaxis (9%). Freedom from major bleeding events after changing therapy was comparable at 1 year for all three groups respectively 96%, 97%, and 91% (log rank = 0.421). Major indications for double antiplatelet therapy were pump thrombosis (15%) and coronary artery stent placement (2.5%). Freedom from thrombotic events after changing therapy was comparable at 1 year for groups 1, 2, and 3, respectively, 97%, 98%, and 91% (log rank = 0.317). Logistic regression shows that Heartmate II patients required more antiplatelet therapy changes compared with HeartWare (odds ratio [OR]: 3.611, 95% confidence interval [CI]: 1.8–6.9; p= 0.0001). HeartMate II required more adjustment of antiplatelet therapy during follow-up. Reducing or increasing antithrombotic therapies in response to major thrombotic hemorrhagic events in CF-LVAD patients is a safe strategy to avoid recurrences.

Left ventricular assist devices (LVADs) are an increasingly used strategy for the management of patients with advanced heart failure with reduced ejection fraction. Although these devices effectively improve survival, atrial and ventricular arrhythmias are common, predispose these patients to additional risk, and complicate patient management. However, there is no consensus on best practices for the medical management of these arrhythmias or on the optimal timing for procedural interventions in patients with refractory arrhythmias. Although the vast majority of these patients have preexisting cardiovascular implantable electronic devices or cardiac resynchronization therapy, given the natural history of heart failure, it is common practice to maintain cardiovascular implantable electronic device detection and therapies after LVAD implantation. Available data, however, are conflicting on the efficacy of and optimal device programming after LVAD implantation. Therefore, the primary objective of this scientific statement is to review the available evidence and to provide guidance on the management of atrial and ventricular arrhythmias in this unique patient population, as well as procedural interventions and cardiovascular implantable electronic device and cardiac resynchronization therapy programming strategies, on the basis of a comprehensive literature review by electrophysiologists, heart failure cardiologists, cardiac surgeons, and cardiovascular nurse specialists with expertise in managing these patients. The structure and design of commercially available LVADs are briefly reviewed, as well as clinical indications for device implantation. The relevant physiological effects of long-term exposure to continuous-flow circulatory support are highlighted, as well as the mechanisms and clinical significance of arrhythmias in the setting of LVAD support.

The objective of the study is to evaluate the impact of the Affordable Care Act (ACA) on accessibility to solid organ transplant and outcomes. Data source registry: United Network of Organ Sharing database. Patients aged =18 years listed for kidney, liver, heart, and lung transplant between years 2010 and 2016 were classified by insurance and status of Medicaid adoption under ACA to evaluate insurance distribution. Between 2010 and 2016, states that adopted Medicaid had 2 to 4 per cent point increase in the proportion of patients listed with Medicaid across all organs. One-year waiting list survival of Medicaid patients was better in the ACA era. States that expanded Medicaid under the ACA had a significant increase in the proportion of patients listed with Medicaid and better one-year waiting list survival.

The structural integrity of platelet receptors is essential for platelets to play the normal hemostatic function. The high non-physiologic shear stress (NPSS) commonly exists in blood-contacting medical devices and has been shown to cause platelet receptor shedding. The loss of platelet receptors may impair the normal hemostatic function of platelets. The aim of this study was to quantify NPSS-induced shedding of three key receptors on the platelet surface. Human blood was subjected to the matrix of well-defined shear stresses and exposure times, generated by using a custom-designed blood-shearing device. The expression of three key platelet receptors, glycoprotein (GP) Ibα, GPVI, and GPIIb/IIIa, in sheared blood was quantified using flow cytometry. The quantitative relationship between the loss of each of the three receptors on the platelet surface and shear condition (shear stress level and exposure time) was explored. It was found that these relationships followed well the power law functional form. The coefficients of the power law models for the shear-induced shedding of these platelet receptors were derived with coefficients of determination (R2) of 0.77, 0.73, and 0.78, respectively. The power law models with these coefficients may be potentially used to predict the shear-induced platelet receptor shedding of human blood.

Left ventricular assist device (LVAD) thrombosis is a devastating complication that occurs in about 10% of patients despite anticoagulation and antiplatelet treatment. How the thrombus initiates and propagates is unknown. We pathologically and immunohistochemically examined 28 thrombi removed from 17 HeartMate II LVADs. Two groups of thrombi were found: those formed in the inlet/outlet and those on the rotor. The four thrombi found at the inlet (three inlet conduit and one inlet tube) and outlet (three at outlet elbow and one outlet graft) appeared similar and were composed of a loose meshwork of fibrin(ogen), von Willebrand factor, leukocytes, and aggregated platelets. The majority of the thrombi (20/28), however, were located on the rotor: nine at the inlet bearing, five on the rotor vanes, and six at the outlet bearing. Laminated thrombi formed around the inlet bearing in rings, an area of blood recirculation. The inner rings of the thrombus had fibrin and von Willebrand factor. Aggregated platelets were found in the outer thrombi rings, but limited evidence of platelets within the laminated thrombi was noted. The presence of distinct rings suggests development of the clot over time. The increased platelets in the outer rings of the inlet bearing thrombi would support further investigation into their role in thrombus growth. Initiating events require further investigation, but the fibrin-rich structure of HeartMate II thrombi suggests that alternative anticoagulation strategies are needed to prevent thrombosis in our LVAD patients.

The aim of this study was to prospectively evaluate the impact of blood pressure management on stroke rates in patients receiving the HeartWare HVAD System.

Nonsurgical bleeding (NSB) in heart failure (HF) patients with continuous-flow left ventricular assist device (CF-LVAD) support is the most common clinical complication. The aim of this study was to investigate the association between oxidative stress and platelet glycoproteins GPIbα and GPVI shedding on the incidence of NSB in CF-LVAD patients. Fifty-one HF patients undergoing CF-LVAD implantation and 11 healthy volunteers were recruited. Fourteen patients developed NSB (bleeder group) during 1 month follow-up duration, while others were considered nonbleeder group (n = 37). Several biomarkers of oxidative stress were quantified at baseline and weekly intervals in all patients. Surface expression and plasma elements of platelet receptor glycoproteins GPIbα and GPVI were measured. Oxidative stress biomarkers and platelet GPIbα and GPVI receptor-shedding (decreased surface expression and higher plasma levels) were found to be preexisting conditions in baseline samples of both groups of HF patients when compared with healthy volunteers. Significantly elevated oxidative stress biomarkers and platelet glycoprotein receptor shedding were observed in postimplant bleeder group temporarily when compared with nonbleeder group. Strong significant associations between biomarkers of oxidative stress and platelet glycoprotein receptor shedding were observed, suggesting a possible role of oxidative stress in platelet integrin shedding leading to NSB in CF-LVAD patients. Receiver operating characteristic analyses of GPIbα and GPVI indicated that the likelihood of NSB had a predictive power of bleeding complication in CF-LVAD patients. In conclusion, elevated oxidative stress may play a role in GPIbα and GPVI shedding in the event of NSB. Thus, oxidative stress and GPIbα and GPVI shedding may be used as potential biomarkers for bleeding risk stratification in those patients.

The effects of pulmonary hypertension (PAH) on survival after heart transplantation are debated, especially for patients with left ventricular assist devices (LVAD). The United Network of Organ Sharing database was retrospectively queried from January 2005 to June 2015 to identify adult patients who underwent heart transplantation. Four groups were defined: patients without PAH, persistent PAH, resolved PAH, and developed PAH between listing and transplant. A total of 15,914 patients underwent heart transplant of which 4,662 (29%) were implanted with an LVAD. Of the total population, 10,872 (68%) had PAH at time of listing and 9,661 (61%) had PAH at time of transplant. Long-term survival was significantly worse for patients with an LVAD than for those without who had PAH at time of transplant (p= 0.010). Kaplan–Meier analysis showed a trend of worse long-term survival for patients with an LVAD who developed PAH by the time of transplant but improved survival for patients with resolved PAH while on LVAD therapy (p= 0.052). PAH at time of transplant results in worse long-term survival for patients with an LVAD. Furthermore, the development of PAH while on LVAD therapy may negatively impact long-term post-transplant survival, while resolution of PAH improves long-term survival.

Recent reports have shown an increase in the number of organ donors from drug intoxication. The impact of donor drug use on survival after cardiac transplant remains unclear. The aim of our study was to illustrate changes in donor death mechanisms and assess the impact on posttransplant survival. We queried United Network of Organ Sharing thoracic transplant and deceased donor databases to identify patients undergoing heart transplantation between 2005 and 2015. We evaluated annual trends in donor death mechanisms. Recipients were propensity matched (drug‐intoxicated—non‐drug‐intoxicated = 1:2) and posttransplant survival was compared using Kaplan‐Meier curves. In total, 19 384 donor hearts were used for transplant during the period (donor age 31.6 ± 11.8 years, 72% male). Use of drug‐intoxicated donors increased from 2% (2005) to 13% (2015) and decreased from blunt injury (40%‐30%) and intracranial hemorrhage (29%‐25%). After propensity matching, posttransplant survival of drug‐intoxicated donor hearts was 90%, 82%, and 76% at 1, 3, and 5 years, which was similar to non‐drug‐intoxicated. Heart transplants using drug‐intoxicated donors have significantly increased; however, they have not adversely affected posttransplant survival. Hearts from drug‐intoxicated donors should be carefully evaluated and considered for transplant. This article evaluates changes in the demographics of heart donors, utilization of hearts from drug‐intoxicated donors for transplantation, and the impact of donor drug intoxication on posttransplant survival.

Recent reports have shown an increase in the number of organ donors from drug intoxication. The impact of donor drug use on survival after cardiac transplant remains unclear. The aim of our study was to illustrate changes in donor death mechanisms and assess the impact on posttransplant survival. We queried United Network of Organ Sharing thoracic transplant and deceased donor databases to identify patients undergoing heart transplantation between 2005 and 2015. We evaluated annual trends in donor death mechanisms. Recipients were propensity matched (drug-intoxicated—non-drug-intoxicated = 1:2) and posttransplant survival was compared using Kaplan-Meier curves. In total, 19 384 donor hearts were used for transplant during the period (donor age 31.6 ± 11.8 years, 72% male). Use of drug-intoxicated donors increased from 2% (2005) to 13% (2015) and decreased from blunt injury (40%-30%) and intracranial hemorrhage (29%-25%). After propensity matching, posttransplant survival of drug-intoxicated donor hearts was 90%, 82%, and 76% at 1, 3, and 5 years, which was similar to non-drug-intoxicated. Heart transplants using drug-intoxicated donors have significantly increased; however, they have not adversely affected posttransplant survival. Hearts from drug-intoxicated donors should be carefully evaluated and considered for transplant.