Median Duration Of Support Research Articles

Impact of Noninvasive Respiratory Support in Patients With COVID-19 Requiring V-V ECMO.

The impact of the duration of noninvasive respiratory support (RS) including high-flow nasal cannula and noninvasive ventilation before the initiation of extracorporeal membrane oxygenation (ECMO) is unknown. We reviewed data of patients with coronavirus disease 2019 (COVID-19) treated with V-V ECMO at two high-volume tertiary care centers. Survival analysis was used to compare the effect of duration of RS on liberation from ECMO. A total of 78 patients required ECMO and the median duration of RS and invasive mechanical ventilation (IMV) before ECMO was 2 days (interquartile range [IQR]: 0, 6) and 2.5 days (IQR: 1, 5), respectively. The median duration of ECMO support was 24 days (IQR: 11, 73) and 59.0% (N = 46) remained alive at the time of censure. Patients that received RS for ≥3 days were significantly less likely to be liberated from ECMO (HR: 0.46; 95% CI: 0.26–0.83), IMV (HR: 0.42; 95% CI: 0.20–0.89) or be discharged from the hospital (HR: 0.52; 95% CI: 0.27–0.99) compared to patients that received RS for <3 days. There was no difference in hospital mortality between the groups (HR: 1.12; 95% CI: 0.56–2.26). These relationships persisted after adjustment for age, gender, and duration of IMV. Prolonged duration of RS before ECMO may result in lung injury and worse subsequent outcomes.

Outcomes in Pediatric Post-Cardiotomy ECMO Support With Modification of Systematic Support Strategy.

Utilization of extracorporeal membrane oxygenation (ECMO) support in the post-cardiotomy setting is vital to successful perioperative outcomes following pediatric cardiac surgery. Specific analysis of protocolized management strategies and staff preparedness is imperative to optimizing institutional ECMO outcomes. All patients requiring post-cardiotomy ECMO support at a single institution from 2013 to 2019 were retrospectively reviewed. In 2015, several modifications were made to the ECMO support paradigm that addressed deficiencies in equipment, critical care protocols, and staff preparedness. Cases were stratified according to era of ECMO support; patients supported prior to paradigm change from 2013 to 2015 (Group EARLY, n = 20), and patients supported following the implementation of systematic modifications from 2016 to 2019 (Group LATE, n = 26). The primary outcomes of interest were survival to decannulation and hospital discharge. Median age at cannulation was 24.5 days (IQR 7-96) and median duration of support was 4 days (IQR 2-8). Overall survival to decannulation was 78.3% (65% EARLY vs. 88.5% LATE, P = .08) and overall survival to hospital discharge was 58.7% (35% EARLY vs. 76.9% LATE, P = .004). Systematic modifications to ECMO support strategy and staff preparation are associated with a significant increase in perioperative survival for pediatric patients requiring post-cardiotomy ECMO support.

Current applications and outcomes of venoarterial extracorporeal membrane oxygenation based on 6 years of experience: risk factors for in‑hospital mortality.

Data regarding venoarterial extracorporeal membrane oxygenation (VA ECMO) as a temporary circulatory support in cardiogenic shock (CS) for Central Europe are scarce. The aim of the study was to disclose indications, in-hospital, and long-term (1-year) mortality along with risk factors. The study is a retrospective investigation of patients who underwent VA ECMO for CS at a cardiosurgical tertiary center, from January 2013 to June 2018. A broad spectrum of pre- and postimplantation factors was tested using univariable analysis. A total of 198 patients met the inclusion criteria. The median (interquartile range) duration of support was 207 (91–339) hours, with no significant disparity among hospital survivors and nonsurvivors (P = 0.09). A total of 40.4% of patients died during ECMO support, while the joined in-hospital and 6-month mortality progressed to 65.2%, and 1-year mortality to 67.2%; 9% underwent a subsequent heart transplantation. Main adverse events were bleeding (76%), infection (56%), neurologic injury (15%), and limb ischemia (15%). Multiorgan failure was the most decisive risk factor of in-hospital mortality (odds ratio, 4.45; P <⁠0.001). Patients with postcardiotomy CS had a significantly lower out-of-hospital survival rate than the nonsurgical group (32.3% vs 45%; log-rank P = 0.037). The study showed survival benefit, despite frequent complications. The protocol focusing on proper candidate selection and timing can positively impact patient survival. Additional risk reduction can be achieved with a further increase of the team experience with ECMO.

Abstract 12471: Bleeding Challenges in Pediatric Ventricular Assist Devices- A Study From the ACTION Registry

Background: Ventricular assist devices (VAD) are increasingly used in children with end-stage heart failure. Bleeding is a major complication of VAD, but most reports have focused on central nervous system (CNS) bleeding. Our objective was to determine the incidence &amp; consequences of non-CNS bleeding in pediatric VADs. Methods: We examined adverse events (AE) &amp; outcomes of all patients implanted with a VAD at Advanced Cardiac Therapies Improving Outcomes Network (ACTION) centers between 9/2018-5/2021. Major bleeding event (MBE) was defined as an episode of suspected bleeding resulting in death, reoperation, hospitalization or blood transfusion (&gt;7days after implant). Variables were analyzed using chi square &amp; Mann Whitney test and outcomes were assessed by Kaplan Meier (KM) survival curves. Results: A total of 407 patients were prospectively enrolled in the ACTION registry, of which 82 (20.1%) had a MBE. The median duration of support was 72 days (range 6-1101). MBE was most common in paracorporeal continuous flow devices (42/82 devices, 51%). MBE was gastrointestinal in 30.3% &amp; thoracic in 38.5%. Patients with MBE were more likely to have congenital heart disease (CHD) or previous cardiac operation &amp; were less likely to have had VAD as a bridge to transplant (Table). Within 14 days post MBE, 31 subjects had another major AE (14 major infection, 13 another MBE, 2 stroke and 1 device malfunction). Unadjusted survival in patients with MBE was significantly worse than those without (p&lt;0.001) (Figure). Conclusion: MBE after VAD implant was seen in 20% of pediatric VAD patients, a higher proportion of whom had CHD. MBE was associated with other major AEs post-VAD and also with worse survival.

Current applications and outcomes of venoarterial extracorporeal membrane oxygenation based on six years of experience. Risk factors for in-hospital mortality

Abstract Introduction The data about use of venoarterial ECMO as a temporary circulatory support system in cardiogenic shock (CS) for Central Europe are scarce. Objectives The aim was to disclose the indications, in-hospital and long-term (1 year) mortality along with risk factors. Patients and methods The study is a retrospective investigation of patients who underwent VA ECMO support for the CS in the cardiac and cardiosurgical tertiary centre, from January 2013 to June 2018. We tested a broad spectrum of pre– and post-implantation factors along with their impact on mortality using univariate logistic regression analysis. Results 198 patients met the inclusion criteria. The median duration of support was 207 (IQR 91–339) hours, with no significant disparity in the length of support among hospital survivors and nonsurvivors (p=0.09). 40,4% of all patients deceased during ECMO support, while the joined in-hospital and six-month mortality progressed to 65,2% and one-year mortality to 67,2%. 9% underwent subsequent heart transplantation. The most frequent adverse events were bleeding (76%), infection (56%), neurologic injury (15%) and limb ischemia (15%). Multi-organ failure was identified as the most decisive risk factor of in-hospital mortality (OR 4,45, p&amp;lt;0,001). Patients with postcardiotomy cardiogenic shock had a significantly lower out-of-hospital survival rate than those with decompensated heart failure (32,3% vs 45%, log-rank p=0,037). The learning curve of our centre is noted with the lowest survival in the first two years of ECMO employment in comparison to the following 6-year period. Conclusion The outcomes of the study reinforce the clear survival benefit, despite frequent complications. The protocol focusing on proper candidate selection and timing can positively impact patients survival. The additional risk reduction can be achieved with the further increase of the team experience with ECMO. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): National Institute of Cardiology in Warsaw, Poland - research grant. Figure 1Figure 2

Ventricular assist devices in paediatric cardiomyopathy and congenital heart disease: An analysis of the German National Register for Congenital Heart Defects

BackgroundVentricular assist devices (VAD) are increasingly used in patients with end-stage heart failure due to acquired heart disease. Limited data exists on the use and outcome of this technology in children. MethodsAll children (<18 years of age) with VAD support included in the German National Register for Congenital Heart Defects were identified and data on demographics, underlying cardiac defect, previous surgery, associated conditions, type of procedure, complications and outcome were collected. ResultsOverall, 64 patients (median age 2.1 years; 45.3% female) receiving a VAD between 1999 and 2015 at 8 German centres were included in the analysis. The underlying diagnosis was congenital heart disease (CHD) in 25 and cardiomyopathy in 39 children. The number of reported VAD implantations increased from 13 in the time period 2000–2004 to 27 implantations in the time period 2010–2014. During a median duration of VAD support of 54 days, 28.1% of patients experienced bleeding complications (6.3% intracerebral bleeding), 14.1% thrombotic (10.9% VAD thrombosis) and 23.4% thromboembolic complications (including cerebral infarction in 18.8% of patients). Children with cardiomyopathy were more likely to receive a cardiac transplantation (79.5% vs. 28.0%) compared to CHD patients. Survival of cardiomyopathy patients was significantly better compared to the CHD cohort (p < 0.0001). Multivariate Cox-proportional analysis revealed a diagnosis of CHD (hazard ratio [HR] 4.04, p = 0.001), age at VAD implantation (HR 1.09/year, p = 0.04) and the need for pre-VAD extracorporeal membrane oxygenation (ECMO) support (HR 3.23, p = 0.03) as independent predictors of mortality. ConclusionsThe uptake of VAD therapy in children is increasing. Morbidity and mortality remain high, especially in patients with congenital heart disease and those requiring ECMO before VAD implantation.

LVAD decommissioning for myocardial recovery: Long-term ventricular remodeling and adverse events

Left ventricular assist devices (LVADs) mechanically unload the heart and coupled with neurohormonal therapy can promote reverse cardiac remodeling and myocardial recovery. Minimally invasive LVAD decommissioning with the device left in place has been reported to be safe over short-term follow-up. Whether device retention reduces long-term safety, or sustainability of recovery is unknown. This is a dual-center retrospective analysis of patients who had achieved responder status (left ventricular ejection fraction, LVEF ≥40% and left ventricular internal diastolic diameter, LVIDd ≤6.0 cm) and underwent elective LVAD decommissioning for myocardial recovery from May 2010 to January 2020. All patients had outflow graft closure and driveline resection with the LVAD left in place. Emergent LVAD decommissioning for an infection or device thrombosis was excluded. Patients were followed with serial echocardiography for up to 3-years. The primary clinical outcome was survival free of heart failure hospitalization, LVAD reimplantation, or transplant. During the study period 515 patients received an LVAD and 29 (5.6%) achieved myocardial recovery, 12 patients underwent total device explantation or urgent device decommissioning, 17 patients underwent elective LVAD decommissioning, and were included in the analysis. Median age of patients at LVAD implantation was 42 years (interquartile range, IQR: 25-54 years), all had a nonischemic cardiomyopathy, and 5 (29%) were female. At LVAD implantation, median LVEF was 10% (IQR: 5%-15%), and LVIDd 6.6 cm (IQR: 5.8-7.1 cm). There were 11 hydrodynamically levitated centrifugal-flow (65%), and 6 axial-flow LVADs (35%). The median duration of LVAD support before decommissioning was 28.7 months (range 13.5-36.2 months). As compared to the turndown study parameters, 1-month post-decommissioning, median LVEF decreased from 55% to 48% (p=0.03), and LVIDd increased from 4.8 cm to 5.2 cm (p=0.10). There was gradual remodeling until 6 months, after which there was no statistical difference on follow-up through 3-years (LVEF 42%, LVIDd 5.6 cm). Recurrent infections affected 41% of patients leading to 3 deaths and 1 complete device explant. Recurrent HF occurred in 1 patient who required a transplant. Probability of survival free of HF, LVAD, or transplant was 94% at 1-year, and 78% at 3-years. LVAD decommissioning for myocardial recovery was associated with excellent long-term survival free from recurrent heart failure and preservation of ventricular size and function up to 3-years. Reducing the risk of recurrent infections, remains an important therapeutic goal for this management strategy.

Therapeutic granulocyte infusion for patients with severe neutropaenia and neutrophilic dysfunction: New Zealand experience.

Studies have shown granulocyte transfusions (GTXs) may be beneficial in neutropaenic patients with severe systemic infections. New Zealand Blood Service has a policy for provision of granulocytes to New Zealand's District Health Boards. We set out to explore utilization of therapeutic granulocyte infusions in New Zealand. Patients who received GTXs in the 16-year period between 2000 and 2016 were identified by the New Zealand electronic blood management system, eProgesa. Information pertaining to recipient demographics, disease-related factors, methods of granulocyte collection and clinical outcomes was obtained by the review of electronic transfusion and clinical records. Forty-five septic patients received granulocyte support for a total of 263 days. The median age of the recipients was 16 (range 0-74) years. Seventy-nine percent of the recipients had an underlying haematological malignancy with 50% having acute leukaemia. The median neutrophil count on the last day of GTX was 0.02 × 109 /L (range 0-16.32). Sixty-three percent (27/43 patients with available data) had persisting severe neutropaenia when the GTXs were stopped. The median duration of support was 3 (range 1-32) days. Forty-six percent of granulocyte collections were performed via apheresis. Of the 44 patients, for whom survival outcome was available, 18 (41%) survived the acute illness. GTXs were infrequently used, most commonly in the setting of an underlying haematological malignancy. This may be explained by the current weak evidence base supporting this therapeutic modality. Procuring a sufficiently large dose of granulocytes for infusion remains an issue for adult recipients.

Early Outcomes of the First 200 US Patients Treated with Impella 5.5: A Novel Temporary Left Ventricular Assist Device.

To report the initial clinical experience with the Impella 5.5® with SmartAssist®, a temporary left ventricular assist device that provides up to 6.2 L/min forward flow, with recent FDA approval for up to 14 days. From October 2019 to March 2020, 200 patients at 42 US centers received the Impella 5.5 and entered into the IQ registry, a manufacturer-maintained quality database that captures limited baseline/procedural characteristics and outcomes through device explant. Post hoc subgroup analyses were conducted to assess the role of baseline and procedural characteristics on survival, defined as successful device weaning or bridge to durable therapy. Median patient age was 62 years (range, 13 to 83 years); 83.4% were male. The device was most commonly used for cardiomyopathy (45.0%), acute myocardial infarction complicated by cardiogenic shock (AMICS; 29.0%), and post cardiotomy cardiogenic shock (PCCS; 16.5%). Median duration of support was 10.0 days (range, 0.001 to 64.4 days). Through device explant, overall survival was 74.0%, with survival of 80.0%, 67.2%, 57.6%, and 94.7% in cardiomyopathy, AMICS, PCCS, and others (comprising high-risk revascularization, coronary artery bypass graft, electrophysiology/ablation, and myocarditis), respectively. Patients requiring extracorporeal membrane oxygenation and Impella support (35 patients, 17.5%) had significantly lower survival (51.4% vs 78.8%, P = 0.002). In the first 200 US patients treated with the Impella 5.5, we observed overall survival to explant of 74%. Survival outcomes were improved compared to historic rates observed with cardiogenic shock, particularly PCCS. Prospective studies assessing comparative performance of this device to conventional strategies are warranted in future.

Traumatic respiratory failure and veno-venous extracorporeal membrane oxygenation support.

Respiratory failure (RF) is a common cause of death and morbid complication in trauma patients. Extracorporeal membrane oxygenation (ECMO) is increasingly used in adults with RF refractory to invasive mechanical ventilation. However, use of ECMO remains limited for this patient population as they often have contraindications for anticoagulation. Medical records were retroactively searched for all adult patients who were admitted to the trauma service and received veno-venous ECMO (VV ECMO) support between June 2015 and August 2018. Survival to discharge and ECMO-related complications were collected and analyzed. Fifteen patients from a large Level I trauma center met the criteria. The median PaO2/FiO2 ratio was 53.0 (IQR, 27.0-76.0), median injury severity score was 34.0 (IQR, 27.0-43.0), and the median duration of ECMO support was 11 days (IQR, 7.5-20.0). For this cohort, the survival-to-discharge rate was 87% (13/15). The incidence of neurologic complications was 13%, and deep vein thrombosis was reported in two cases (13%). Survival rates of trauma patients in this study are equivalent to, or may exceed, those of non-trauma patients who receive ECMO support for other types of RF. With the employment of a multidisciplinary team assessment and proper patient selection, early cannulation, traumatic RF may be safely supported with VV ECMO in experienced centers.

Sensitization during short-term mechanical circulatory support. Determinants, therapeutic management, and outcomes after heart transplant

Introduction and objectivesThe development of human-leukocyte antigen antibodies is a well-known adverse effect of the use of long-term ventricular assist devices (VADs). The aim of this study was to determine the incidence of sensitization during short-term mechanical circulatory support with VAD (CentriMag), its determinants, and its impact on posttransplant outcomes. MethodsWe performed a retrospective review of patients who were bridged to transplant with short-term VAD from 2009 to 2019. Sensitization was defined as a calculated panel-reactive antibody> 10%. The endpoints included overall survival and rejection-free survival. ResultsA total of 89 patients (median age 56.0 [interquartile range, 50.0-59.9] years, 16.8% female) received a short-term VAD as a bridge to transplant. The median duration of support was 23.6 [interquartile range, 16.6-35.0] days. Eleven patients (12.4%) became sensitized during support. The only factor significantly associated with sensitization was female sex (OR, 8.67; 95%CI, 1.93–38.8; P=.005). Of the 89 patients, 21 patients died during support; 68 patients underwent heart transplant. After a mean follow-up of 49.6 ±31.2 months, 8 patients (11.8%) died and 20 (29.4%) had at least 1 rejection episode. On multivariate analysis, sensitization was an independent predictor of acute rejection (HR, 3.64; 95%CI, 1.42-9.33; P=.007), with a nonstatistically significant trend to higher mortality (HR, 4.07; 95%CI, 0.96-17.3; P=.057). ConclusionsSensitization with short-term VADs can occur and is significantly associated with female sex and with rejection. Sensitization also showed a nonstatistically significant trend to higher mortality.

Long-Term Outcomes of Adults with Congenital Heart Disease Supported by Durable Continuous-Flow Ventricular Assist Devices

<h3>Purpose</h3> End-stage heart failure is a leading cause of morbidity and mortality in adult congenital heart disease (ACHD) patients; however, advanced therapies such as ventricular assist devices (VADs) are rarely implemented in this population. The aim of this study was to examine the outcomes of ACHD patients supported by durable continuous-flow VADs. <h3>Methods</h3> We performed a retrospective review of patients with congenital heart disease >18 years of age at time of VAD implantation at Texas Children's Hospital and Baylor St. Luke's Medical Center from 2011-2020. <h3>Results</h3> In total, 13 patients (median age 34 years [IQR, 24-47]) received a VAD <b>(Table)</b>. All devices were implanted in the subaortic ventricle; 2 patients (15%) and 11 patients (85%) had moderate and great complexity congenital heart disease, respectively. Prior to implantation, 11 patients (85%) required inotropic support and 5 patients (38%) required temporary mechanical circulatory support. 12 patients (92%) survived to hospital discharge with a median postoperative LOS of 36 days (IQR, 27-50). Among those who survived to hospital discharge, all (100%) were NYHA class I or II at follow-up and the median duration of support was 816 days (IQR, 160-1629). Patients experienced device-related complications including neurologic events (n = 5; n = 2 disabling stroke), driveline infections (n = 3), presumed device infections requiring chronic antibiotic therapy (n = 4; n = 1 associated pump exchange), GI bleeds (n = 6), and presumed pump thromboses (n = 5; n = 2 associated pump exchanges). Overall survival (heart transplant censored) at 1, 3, and 5 years was 82%, 70%, and 32%, respectively. 2 patients (50%) were successfully bridged to transplant and 1 patient initially implanted as destination therapy eventually received a transplant. <h3>Conclusion</h3> Our data demonstrate that durable VADs can be used effectively in ACHD patients with end-stage heart failure and support efforts to more readily utilize these therapies in this population.

Contemporary Outcomes after Durable Left Ventricular Assist Device Explantation in Patients with Evidence of Cardiac Recovery

<h3>Purpose</h3> In patients with durable left ventricular assist devices, cardiac recovery allowing device explanation is a rare and poorly understood phenomenon. The aim of this study was to describe the clinical features and outcomes of patients with cardiac recovery who underwent LVAD explantation or decommission with no formal recovery protocol at two large academic medical centers. <h3>Methods</h3> We identified all patients with nonischemic cardiomyopathy (NICM) with a continuous flow durable LVAD implanted at two centers through 2017 who had evidence of cardiac recovery as determined by a multidisciplinary assessment of cardiac surgeons and heart failure specialists, and underwent either explant of the LVAD or its decommission (turned off but left in-situ). Clinical, laboratory, echocardiographic features, and outcomes were analyzed. <h3>Results</h3> Twenty individuals met entry criteria. Indications for LVAD explant/decommission included pump thrombosis (45%, N=9/20), driveline infection (30%, N=6/20), or cardiac recovery without concurrent LVAD complication (25%, N=5/20). The average age at LVAD explant/decommission was 41±13 years and the median duration of support was 656 (265-1,089) days. The average left ventricular ejection fraction (LVEF) was 13±4% at implant, 45±11% at explant/decommission, and 32±18% at last-follow-up. There were 4 deaths (3 within 369 days) and 5 LVAD reimplantations (4 within 16 days and 1 at 62 days) over 12,986 person-days of follow-up after explant/decommission. Only 15% of the total cohort (N=3/20) had sustained LVEF recovery (Figure). <h3>Conclusion</h3> A minority of patients with NICM who had evidence of cardiac recovery allowing LVAD explant/decommission maintained their improved function. In nearly one-half of patients, regression in cardiac function was catastrophic and resulted in death or required reimplantation of a durable LVAD. These observations highlight the need to better define predictors allowing safe withdrawal of durable LVAD support.

Ventricular Assist Device Outcomes in Children and Young Adults with Muscular Dystrophy: An ACTION Analysis

<h3>Purpose</h3> Cardiac disease results in significant morbidity and mortality in patients with muscular dystrophy (MD). Single centers have described their ventricular assist device (VAD) experience in this population, however broader applicability and outcomes remain unknown. <h3>Methods</h3> We examined outcomes of all patients with MD and dilated cardiomyopathy implanted with a VAD at Advanced Cardiac Therapies Improving Outcomes Network (ACTION) centers 9/2012-9/2020. <h3>Results</h3> A total of 19 VADs were implanted in 18 patients across 10 ACTION sites. The median duration of support was 252 days (range 11-1681 days). The majority of pts had dystrophinopathy (66%) and the median age at implant was 17.2 years (Table). Device strategy was bridge to transplant in 5 (27.8%), 4 of whom survived to transplant. The frequency of a positive outcome (transplanted or alive on device) at 6 months and 1 year were 89% and 84%, respectively (Figure). A single patient suffered a stroke (hemorrhagic), 2 patients developed sepsis, 1 patient developed respiratory failure requiring tracheostomy and 4 patients patient developed right heart failure (1 of whom required temporary right VAD). <h3>Conclusion</h3> In selected MD patients, VADs can serve as effective bridges to HT and chronic therapy. Right heart failure and infectious complications were relatively common, while stroke and respiratory failure were rare. Further research is needed to understand the patients who may benefit most from VAD therapy in terms of survival and quality of life and how to mitigate the risks the of the adverse events identified in the current report.

Atrial Cannulation in Pediatric Mechanical Circulatory Support

Purpose Several centers have considered the potential benefits of atrial inflow cannulation to provide mechanical circulatory support (MCS) among pediatric patients with small or restrictive ventricles particularly in those with potential for myocardial recovery. Limited pediatric data are available on contemporary outcomes of atrial cannulation. We sought to describe the characteristics, complications, and outcomes of children supported with atrial cannulation using the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) ventricular assist device (VAD) database. Methods Data were collected from the ACTION VAD database for all patients who underwent VAD implantation via atrial cannulation from 8/16/2012 to 9/8/2020. Patient characteristics, VAD types, complications, and outcomes were analyzed. Results Forty-one patients met the study criteria with 52 implants. Median age was 3.6 years (range 0.02 - 25.32), weight 13.6 kg (2.7-106), and BSA 0.6 (0.15 - 2.2). Diagnoses included dilated cardiomyopathy (42%), congenital heart disease (37%), transplant graft dysfunction (7%), restrictive and hypertrophic cardiomyopathies (5% each). VAD indications were bridge to decision (42%), bridge to transplant (42%), and bridge to recovery (17%). Eighty-four percent of patients were INTERMACS 1 or 2, 44% were on ECMO, and 63% were mechanically ventilated. Devices utilized included Berlin Heart Excor (40%), paracorporeal continuous flow devices (38%), Heartware (19%) and one Heartmate 3. Median support duration was 43.5 days (range 0-307). Overall mortality was 22%. Twenty patients (49%) were successfully transplanted, 7 (17%) recovered, and 5 (12%) are still alive on the device. Adverse events included major bleeding (24%), stroke (12%), sepsis (10%), right heart failure requiring RVAD (5%), and one instance of pump thrombosis. Conclusion Atrial cannulation in pediatric MCS can be performed across a variety of anatomic substrates and age ranges with outcomes and complication rates that are comparable to left ventricular cannulation strategies. This method may be advantageous in certain circumstances including patients with small or restrictive ventricles, potential for myocardial recovery, or multiple prior sternotomies to minimize surgical dissection. Further studies are needed to delineate the ideal patient population and benefits of varying atrial cannulation techniques.

Outcomes of Infants and Children with Stage 1 Single Ventricle Implanted with Ventricular Assist Devices: An Analysis of the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry

<h3>Purpose</h3> Ventricular assist device (VAD) use in patients with congenital heart disease is increasing. Data on VAD outcomes in infants/children with stage 1 single ventricle (SV) are limited. Our study aims to characterize the outcomes of this population using multi-center registry data. <h3>Methods</h3> We examined the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry for outcomes of stage 1 SV patients undergoing VAD implantation between March 2018 - June 2020. ACTION data are collected from 30 centers, and major adverse events undergo central adjudication using pre-specified event definitions. Clinical characteristics, major adverse events, and survival are reported. <h3>Results</h3> During the study period, 27 stage 1 SV patients underwent VAD implant with median age of 1 month (range 0.1-44), weight 3.7kg (2.4-17), and BSA 0.24 m² (0.18-0.65). Pre-implant comorbidities were frequent: ventilator support (85%), ECMO (37%), history of cerebral vascular accident (CVA, 30%), and pre-implant dialysis (18.5%). Device strategy included paracorporeal continuous-flow VAD in 11 patients, paracorporeal pulsatile VAD (12), and multiple devices (4). Concomitant surgical procedure was performed in 4 patients. Median support duration was 56 days (2-271). A positive clinical outcome, defined as transplant, weaned, or alive on device was obtained in 59%, with 12 patients transplanted while 11 died on device (Fig 1). Adverse events on VAD support included neurologic dysfunction (18.5%, with n=2 CVA), bleeding (22%), infection (48%), renal dysfunction (15%), and device malfunction (4%). <h3>Conclusion</h3> Stage 1 SV patients undergoing VAD support have frequent and severe pre-implant comorbidities, which likely contributed to the significant morbidity and mortality post-implant. A variety of device types and surgical strategies are employed by centers to support this challenging physiology.

HVAD Lavare Cycle Reduces Cerebrovascular Events and Improves Survival

<h3>Purpose</h3> The Lavare Cycle (LC) is a pre-programmed speed modulation algorithm in the HVAD device designed to automatically increase both ventricular and pump washing<b>.</b> The ReVOLVE trial suggested a reduction in adverse outcomes including stroke. We assessed the effect LC ON compared to LC OFF on HVAD implants. <h3>Methods</h3> We conducted a retrospective, single center study from 4/2017 to 6/2020 including all 46 patients who received a HVAD implant. The LC became available to our center on 06/2018. For the majority of patients LC was turned on at the time of implant admission. The primary endpoints were cerebrovascular events (CVE) by INTERMACS definition and survival between LC ON versus LC OFF. Secondary endpoints were GI bleeding and pump thrombosis rates. <h3>Results</h3> Fourty six patients (median age 57 years, 78% male, 58% non-ischemic cardiomyopathy) were implanted with HVAD device from 4/2017 to 6/2020. The median duration of HVAD support was 648 (245-902) days. The LC was activated in 33/46 patients. Median time to cycle activation in the LC ON group from implantation was, median (IQR): 4 (1-36) days. The LC ON group experienced less incidence of CVEs, with 6/33 (18%) in the ON vs. OFF 6/13 (46%), p=0.04 (Fig 1A). The median time of CVE from implant was for LC ON and OFF 223 and 104 days, respectively. Survival was significantly improved in the LC ON 31/33 (94%) vs OFF 7/13 (54%), p=0.003 (Fig 1B). There were however 7/33 GI bleeding events in the ON group while zero events in the OFF, p=0.08. Pump thrombosis events were equal rate in the ON 3/33 (9%) vs OFF 1/13 (8%), p=0.43. <h3>Conclusion</h3> LC ON was associated with a significant lower number of CVE (p =0.04) and better survival (p=0.003). The important impact of speed modulation on reducing neurologic events should be confirmed in a larger HVAD patient population.

Clinical Outcomes of Ventricular Assist Device for Failing Bidirectional Glenn Physiology

Purpose The number of patients with failing single ventricle physiology is increasing, and ventricular assist device (VAD) support in this population is challenging. The purpose of this study was to describe our clinical experience with VAD for failing Glenn physiology. Methods A retrospective review of clinical outcomes was conducted in patients that underwent durable VAD placement for failing Glenn circulation between 2010 and 2020 at Texas Children's Hospital. Results Ten patients met inclusion criteria; all had a morphologic right ventricle (RV): 6 hypoplastic left heart syndrome/variant and 4 with isomerism with RV dominant atrioventricular septal defect. INTERMACS profiles were 1 in 3 patients (1 with ECMO) and 2 in 7 patients. Four patients were intubated. Age, weight, and body surface area at VAD implantation were 3.2 (0.9-10.1) years, 13.0 (7.7-22.8) kg, and 0.50 (0.36-0.90) m2, respectively. The device-strategy included HVAD in 6, Jarvik 2015 in 1, and Berlin cannula (with Berlin and/or Rotaflow pumps) in 3. Concomitant Fontan completion was performed in 5 patients (1 with fenestration), while the other 5 remained with Glenn circulation. PaO2/FiO2 ratio (median, range) on postoperative day 1 was significantly higher with Fontan completion [192 (53-336)] than without [76 (59-78), p=0.05] except a patient with Glenn circulation on ECMO. The median duration of mechanical ventilation after VAD was 2 days (range, 1 - 14). There was 1 early mortality 8 days after HVAD placement with Fontan completion due to neurologic insult intraoperatively. The remaining 9 patients (90%) were bridged to transplant at a median support duration of 3.8 (0.1-16.6) months. Five of the 6 HVAD patients were able to be discharged home prior to transplant. One patient encountered a pump thrombus requiring pump exchange and 1 patient suffered a thromboembolic stroke due to a mobile intraventricular thrombus. One patient had a subdural and subarachnoid hemorrhage 27 days after VAD implantation, with complete neurologic recovery without deficits. Conclusion This single-institutional experience suggests long term VAD support is sustainable for failing Glenn physiology with accompanying Fontan completion in selected patients. Further studies are warranted to optimize long term VAD support in this challenging population.

Clinical course and outcome after treatment with ventricular assist devices in paediatric patients: A single-centre experience.

Heart failure is a rare condition in the paediatric population, associated with high morbidity and mortality. When medical therapy is no longer sufficient, mechanical circulatory support such as a ventricular assist device can be used to bridge these children to transplant or recovery. Coagulation-related complications such as thrombi, embolism and bleeding events represent the greatest challenge in paediatric patients on mechanical support. We aimed to describe the outcomes and coagulation-related complications in this patient population at our institution. A total of 20 patients with either Berlin Heart EXCOR® or HeartWare® implantation were reviewed in this retrospective study. Study endpoints were survival to heart transplant, weaning due to recovery or death. Thrombotic events were defined as thrombus formation in the device or in the patient, or cardioembolic strokes. Bleeding events were defined as events requiring interventional surgery or transfusion of red blood cells. The aetiology of heart failure included cardiomyopathy (n=12), end-stage congenital heart disease (n=6) and myocarditis (n=2). Of the 20 patients, 12 were bridged to transplant, 7 recovered and could be weaned and 1 died. The median duration of mechanical support was 84days (range: 20-524days). At least one major or minor bleeding event occurred in 45% of the patients. Thrombotic events occurred 21 times in 10 patients. Four of the patients (20%) had no bleeding or thromboembolic event. In all, 95% of the patients were successfully bridged to transplant or recovery. Bleeding events and thrombotic events were common.

Synchronized Nasal Intermittent Positive Pressure Ventilation versus Nasal Continuous Positive Airway Pressure for Prevention of Extubation Failure in Infants after Congenital Heart Surgery.

This study aimed to evaluate the application of synchronized nasal intermittent positive pressure ventilation (SNIPPV) in the respiratory weaning of infants after congenital heart surgery. We retrospectively analyzed the clinical data of 63 infants who were extubated from mechanical ventilation after congenital heart surgery between January 2020 and September 2020. The data, including demographics, anatomic diagnosis, radiology and laboratory test results, and perioperative variables were recorded. The extubation failure rate within 48 h after extubation was significantly lower in the SNIPPV group than in the nasal continuous positive airway pressure (NCPAP) group. The PaO2 level and PaO2/FiO2 ratio within 48 h after extubation were higher in the SNIPPV group than in the NCPAP group (P < .05). Meanwhile, the PaCO2 level within 48 h was significantly lower in the SNIPPV group (P < .05). Compared with the NCPAP group, the median duration of postoperative noninvasive support and the duration from extubation to hospital discharge were shorter in the SNIPPV group; the total hospital cost was lower in the SNIPPV group. No significant differences were observed between the two groups concerning VAP, pneumothorax, feeding intolerance, sepsis, mortality, and other complications (P > .05). SNIPPV was shown to be superior to NCPAP in avoiding reintubation after congenital heart surgery in infants and significantly improved oxygenation and reduced PaCO2 retention after extubation. Further studies are needed to confirm the efficacy and safety of SNIPPV as a routine weaning strategy.