Use Of Ventricular Assist Devices Research Articles

Waitlist and Post-Transplant Outcomes for Children with Myocarditis Listed for Heart Transplantation over Three Decades: A Multi-Institutional Analysis

<h3>Purpose</h3> Outcomes on children with myocarditis listed for heart transplantation (HT) is sparse and conflicting. Our study aims to determine if this population of listed patients have better outcomes pre- and post-HT in the current era given the advent of ventricular assist devices (VADs). <h3>Methods</h3> We queried the Pediatric Heart Transplant Society (PHTS) database from 1993-2019 to identify patients with myocarditis and dilated cardiomyopathy (DCM). Patients were divided into two eras: earlier (1993-2008) and current era (2009-2019). Clinical characteristics were compared. Kaplan-Meier method with log-rank test and adjusted using multiphase parametric hazard modeling to examine outcomes. <h3>Results</h3> During the study period, of the 9755 patients listed for HT, 323 (3%) had myocarditis and 3279 (34%) DCM. A higher proportion of myocarditis patients in the current era were status 1A (85% vs 58% earlier era), have lower AST (mean 195 vs. 560 U/L), ALT (mean 109 vs. 277 U/L) and higher eGFR (mean 96 vs. 75 ml/min/1.73m²) (p<0.05 for all) at listing. VAD use was higher in myocarditis patients in the current era at listing (28 vs. 8%; p<0.001) and at time of HT (38 vs. 12%; p<0.001). Waitlist and post-transplant survival has not improved for patients with myocarditis over time <b>(Figure a-b)</b>. In the current era, 5 year survival post-HT was higher in patients with DCM vs. myocarditis (88 vs. 79.5%, p=0.058). On multivariate analysis, myocarditis patients have increased post-HT mortality [HR 6.9, 95% CI 3.0-15.6; p<0.0001]. <h3>Conclusion</h3> Patients with myocarditis in the current era have better renal and hepatic function at listing and increased VAD use at listing and at HT. Overtime, however, there have been no improvements in waitlist or post-transplant outcomes for patients with myocarditis and post-transplant survival continues to be worse in patients with myocarditis compared to those with DCM.

Outcomes of Ventricular Assist Device Use for Bridge to Heart Transplant in Children with Single-Ventricle Heart Disease

<h3>Purpose</h3> As the use of pediatric ventricular assist devices (VAD) has increased, more children are being supported with VADs for single-ventricle heart disease (SVD). Little is known about outcomes for this rapidly growing population of advanced HF patients. We sought to examine trends in VAD use for SVD and to assess outcomes. <h3>Methods</h3> Organ Procurement and Transplant Network (OPTN) data were used to identify all children ≤21 years who underwent VAD placement between 2004 and 2020 for SVD. Cox proportional hazard modeling was used to identify risk factors for mortality defined as death or clinical deterioration. <h3>Results</h3> Of 1955 children with SVD, 315 were supported with an MCS device (145 SVADs and 170 ECMO only). Of the SVADs, 142 (97%) received an SVAD alone as the primary device, 2 (1%) received BIVADs and 1 (1%) a TAH. The most common VAD brands were the Berlin Heart EXCOR (N=44, 30%), the CentriMag/PediMag (N=40, 28%), Heartware HVAD (N=35, 24%), and the CentriMag/PediMag (ZZ%) and the Heartmate III (N=8, 6%). Since 2011 (when complete VAD survival data become available), overall survival to HT was 62% of whom 58% reached transplant; 38% died or deteriorated, and 2% recovered. Survival was significantly worse compared to pediatric VAD patients supported for DCM and comparable to patients supported for 2-ventricle CHD (P=0.79) (Find). Survival to transplant was highest for adult continuous flow devices (77%) and lower for the CentriMag/PediMag system (63%) and the Berlin Heart EXCOR (63%). <h3>Conclusion</h3> VAD outcomes for bridge to transplant for single-ventricle heart disease patients are similar to other forms of 2-ventricle CHD but inferior to DCM. The highest survival appears to be in patients receiving adult CF devices with room for improvement in smaller patients receiving non-dischargeable devices.

Exploring Preoperative Hypocalcemia as a Biomarker for Post Left Ventricular Assist Device Survival and Adverse Events

<h3>Purpose</h3> Abnormal calcium handling in cardiomyocytes plays a cardinal role in the initiation and progression of heart failure. However, the effect of serum calcium levels has not been studied in chronic heart failure patients undergoing left ventricular assist device (LVAD) placement. We investigate the impact of preoperative hypocalcemia on adverse events and all-cause mortality in this population over a 24-month period post durable LVAD implantation. <h3>Methods</h3> At a single center, 177 patients received LVAD therapy between June 2011 and October 2018. Patients were classified into either hypocalcemia [(serum calcium < 8.7 mg/dL) n=40] or normocalcemia [(8.7- 10.2 mg/dL) n=108] based on preoperative levels. 29 patients were excluded due to missing data. Unadjusted and adjusted cox models were used to examine for association between hypocalcemia and 2-year all-cause mortality. Survival was compared using Kaplan-Meir plot and log-rank statistics. <h3>Results</h3> The majority of patients in both groups were undergoing LVAD placement for destination therapy (77 vs. 73%, p=0.009) and had a similar history of chronic kidney disease across groups (21 vs. 28%, p=0.36). However, there was a significantly greater number of Caucasian patients in the hypocalcemia group (85 vs. 63%, =0.004). 24-month survival was equal across groups (Log-Rank p=0.13). Likewise on Cox-modelling, there was no difference in survival seen on either the unadjusted [HR= 1.42 (0.89 - 2.27) (p=0.14)] or adjusted survival [1.39 (0.86 - 2.24) (p=0.18)] when adjusted for age, gender, INTERMACS category, and eGFR. Perioperative renal failure and need for hemodialysis were similar between groups. However, the hypocalcemia group required prolonged intubation (46 vs 28%, p=0.03), tracheostomy (28 vs 11%, p=0.001) and increased right ventricular assist device use (23 vs 8%, p=0.02). <h3>Conclusion</h3> Despite no significant impact on survival at 24-months, hypocalcemia may be a poor prognostic marker for some adverse events.

Outcomes of Ventricular Assist Device Use in Children for Bridge to Heart Retransplantation

<h3>Purpose</h3> As the use of pediatric ventricular assist devices (VAD) has increased, more children are being supported with VADs for transplant graft failure as a bridge to heart re-transplant (HT). Little is known about VAD outcomes for graft failure where left ventricular (LV) function is preserved, and LV chamber dilation is uncommon. We sought to examine VAD outcomes as a bridge to HT for this important subset of HF patients. <h3>Methods</h3> Organ Procurement and Transplant Network (OPTN) data were used to identify all children ≤21 years who underwent VAD placement between 2004 and 2020 as a bridge to heart re-transplant. Cox proportional hazard modeling was used to identify risk factors for mortality. <h3>Results</h3> Of 723 children listed for heart re-transplant, 144 were supported with MCS (87 with a VAD and 57 with ECMO alone). Of 87 VAD recipients, 41 (68%) received an LVAD alone, 29 (33%) received BIVADs, 9 (10%) received an TAH, and 7 (8%) an isolated RVAD. The most common isolated LVAD used was the Berlin Heart (N=16, 39%), a percutaneous LVAD (Impella or Tandem, N=11, 26%), and Heartware HVAD (N=6, 15%). The most common BIVAD configuration was bilateral Berlin Hearts (N=15, 52%) and bilateral CentriMag (10%). Since 2011 (when complete VAD survival data become available), overall survival to HT was 72%, with 61% reaching transplant while 11% remained on the waitlist. Survival was significantly worse compared to pediatric VAD patients supported for DCM and comparable to children with CHD (P=0.31) (Figure). For children supported with the Berlin Heart, outcomes for LVAD and BIVAD patients were similar (P=0.69) in contrast to other diagnoses where BIVAD outcomes are typically inferior to LVAD outcomes. <h3>Conclusion</h3> VAD outcomes for bridge to re-transplant are significantly worse than DCM patients and comparable to outcomes for CHD. While BIVAD outcomes are typically worse than LVAD outcomes for most cardiac diagnoses, outcomes appear similar for children supported for graft failure.

Use of Percutaneous Continuous Flow Ventricular Assist Devices in Adults with Congenital Heart Disease

<h3>Purpose</h3> Adult congenital heart disease (ACHD) patients are disproportionally affected by heart failure and cardiogenic shock compared to the general population. Despite a growing and aging cohort, experience with percutaneous continuous flow ventricular assist device (pVAD) use in ACHD patients is rarely described in the literature. <h3>Methods</h3> Retrospective chart review at Texas Children's Hospital and Baylor St. Luke's Medical Center from 1/2016 to 8/2020 for patients with congenital heart disease who were adult age at time of pVAD placement. <h3>Results</h3> Six patients with ACHD received 7 pVAD devices with a median age at placement of 34 [IQR 23- 38] years (Table). Five (83%) patients were male and 5 (83%) had complex congenital heart disease. Three (50%) patients had Fontan circulation. Devices included: 4 (57%) Impella CP®, 1 (14%) Impella 5.0® and 2 (29%) Impella 5.5®. Four (57%) devices were placed in patients with INTERMACS profile score 1. Four (57%) devices were placed in patients with acute decompensated heart failure in the setting of chronic heart failure and 3 (43%) devices were placed due to peri-procedural hemodynamic compromise. Three devices (43%) were placed via hybrid-surgical method with axillary artery grafts and 4 (57%) Impella CP® devices were placed percutaneously in the femoral artery. Median duration of patient support was 20 [IQR 3-44] days. Major pVAD-related complications included severe hemolysis requiring replacement of Impella CP® with Impella 5.0 device® and aortic valve replacement at time of Impella® 5.0 removal and durable ventricular assist device implantation in a neo-aortic valve with pre-existing regurgitation. There were no significant limb injuries/ischemia, stroke or bleeding events. Two (33%) patients were bridged to a durable ventricular assist device; all 6 (100%) patients survived to hospital discharge. <h3>Conclusion</h3> Percutaneous continuous flow ventricular assist devices can be successfully used to hemodynamically support ACHD patients in cardiogenic shock.

Disparity in Use of Left Ventricular Assist Devices among African American Patients with Medicare

Purpose Heart failure (HF) disproportionally affects racial minorities and disparities in access to therapies exist. Recent work suggests greater use of left ventricular assist devices (LVAD) among African American (AA) patients compared to white patients that likely remains disparate due to a higher prevalence of HF in AA. We sought to understand disparities in LVAD use by race among a cohort of patients with similar HF severity and explore the impact of socioeconomic disadvantage. Methods We analyzed fee-for-service Medicare claims among 311,265 beneficiaries admitted with a principal diagnosis of systolic HF between 2008-2014. Inpatient and outpatient claims in prior 6 months used to estimate propensity for LVAD treatment using synthetic minority over-sampling, a machine learning method. Beneficiaries with ≥70% predicted probability of receiving an LVAD were included. These results were applied to model disparities using logistic regression with LVAD use and 1-year survival with and without LVAD among AA and white recipients as the dependent variables. Model covariates included race, clinical characteristics, distance from LVAD center, and year. After confirming a disparity, the Medicare low-income subsidy included to explore impact of socioeconomic disadvantage. Results The sample included 15,406 observations, of whom 45.2% (n=6,967) received an LVAD. AA were 23.6% (n=3,648) of the population and 21.8% (n=1,520) of LVAD recipients. One-year survival was 73% with LVAD and 62% without. Compared to white patients, AA patients matched for the propensity to receive an LVAD were 4.0% less likely to receive the therapy (95% CI -5.1 to -1.7; p Conclusion Disparities in the use of LVAD for AA Medicare beneficiaries with HF exist that are not entirely explained by socioeconomic disadvantage. These data suggest that other factors are impacting the application of LVAD therapy in AA patients. Potential explanations include racial biases or systemic racism that influence clinician decision-making or patient preferences.

Changes in Use of Left Ventricular Assist Devices as Bridge to Transplantation With New Heart Allocation Policy

ObjectivesThe goal of this study was to describe outcomes of patients with bridge to heart transplantation (BTT) after changes were made to the donor heart allocation system. BackgroundLeft ventricular assist devices (LVADs) have been used as a BTT. On October 18, 2018, the donor heart allocation system in the United States was updated. MethodsThis study identified adults in the United Network for Organ Sharing database with durable, continuous-flow LVAD at listing or implanted while listed between April 2017 and April 2020. Baseline recipient and donor characteristics, waitlist survival, and post-transplantation outcomes were compared pre- and post-allocation system change. ResultsA total of 1,794 patients met inclusion criteria: 983 in the pre-change period and 814 afterward. The number of patients listed with LVAD decreased nationally over time from 102 in April 2017 to 12 in April 2020 (p < 0.001). The proportion of patients with LVAD at time of transplant decreased from 47% to 14%. Before the change, the majority were Status 1A (75.8%) at transplantation; afterward, most were Status 2/3 (67.8%). Transplantation rates were not different (85.4% vs. 83.6%; p = 0.225), but waitlist time decreased in the post period (82 vs. 65 days; p = 0.004). Donors were more likely to be high risk (39.0% vs. 32.2%; p = 0.005), and both ischemic times and distance traveled increased (3.4 h vs. 3.1 h; p < 0.001; 199 miles vs. 82 miles; p < 0.001). Waitlist survival did not change, but post-transplantation survival was worse in patients with BTT post-change (p < 0.001). ConclusionsThe number of patients with BTT on the transplant list decreased steadily and dramatically after the allocation system change. Although time to transplant decreased, there was an increase in post-transplant mortality. These data suggest that the risks and benefits of LVAD implantation as a BTT have changed under the new allocation system and that the appropriate indication for this treatment strategy warrants a re-evaluation.

Heart transplant waiting list implications of increased ventricular assist device use as a bridge strategy: A national analysis.

The use of ventricular assist devices (VADs) as a bridge to heart transplant (HT) is increasing, while HT volume remains stagnant. This may portend longer waiting times and an otherwise more competitive environment for all patients on the HT waiting list. A retrospective analysis of patients who were listed for HT in the United Network for Organ Sharing (UNOS) database from 2000 to 2015 was conducted. Mean waiting time, proportion of HT reception (%HT), proportion of death (%death), and proportion of waiting list removal (%removal) were calculated across three eras: Era 1 (2000-2007), Era 2 (2008-2011), and Era 3 (2012-2015). During the study period, 29728 patients successfully underwent HT. 19127 (64.3%) were directly transplanted (direct HT); 4491 (15.1%) received VADs prior to listing as a bridge to decision (BTD); and 4593 (15.5%) received VADs after listing as a bridge to transplant (BTT). Across the three eras, the average number of registrants per year grew. Among all groups, waiting time increased across the eras. %HT generally decreased in the BTD and BTT groups but remained constant in the direct HT group. %removal increased, while %death decreased in all group across the eras. Waiting time for HT increased from 2000 to 2015. Patients with VADs as a bridge strategy experienced decreasing %HT and increasing %removal but stable survival. Improvements in VAD safety and durability will ensure their success as part of a bridge strategy to HT under the new UNOS allocation policy.

Hepatorenal dysfunction assessment with the Model for End-Stage Liver Disease Excluding INR score predicts worse survival after heart transplant in pediatric Fontan patients

BackgroundFontan physiology results in multiorgan dysfunction, most notably affecting the liver and kidney. We evaluated the utility of Model for End-Stage Liver Disease Excluding INR (MELD-XI) score, a score evaluating the function of both liver and kidney to identify Fontan patients at increased risk for morbidity and mortality post–heart transplant. MethodsThe Pediatric Heart Transplant Society database was queried to identify Fontan patients listed for heart transplant between January 2005 and December 2018. MELD-XI scores were calculated at listing and heart transplant. A multivariable analysis was conducted to identify risk factors for post–heart transplant mortality. Demographic, clinical characteristics, and survival differences were evaluated and compared between the high and low MELD-XI score cohorts. The impact of changing MELD-XI scores during the waitlist period on post–heart transplant outcomes was also evaluated. ResultsOf 565 Fontan patients who underwent transplantation, 524 (93%) had calculable MELD-XI scores at the time of heart transplant: 421 calculable at listing and 392 calculable at listing and at heart transplant. On multivariable analysis, only MELD-XI score (squared) (hazard ratio, 1.007), history of protein-losing enteropathy (hazard ratio, 2.1), and ventricular assist device use at transplant (hazard ratio, 3.4) were risk factors for early phase post–heart transplant mortality. Patients with high MELD-XI scores at heart transplant had inferior survival post–heart transplant (P = .02); those in the high MELD-XI score cohort at wait listing and heart transplant tend to have the worst post–heart transplant survival; however, this was not significant (P = .42). ConclusionsThe MELD-XI, an easily calculated score, serves as a valuable aid in identifying pediatric Fontan patients at increased risk for post–heart transplant mortality.

421: A Tertiary Cardiac Unit Experience in the Use of Ventricular Assist Devices in Infants

421: A Tertiary Cardiac Unit Experience in the Use of Ventricular Assist Devices in Infants

Abstract 16893: Thrombotic Events During Extended Microaxial Mechanical Circulatory Support for Cardiogenic Shock

Background: Percutaneous ventricular assist devices (VAD) are used in ~1/3 of patients (pts) with cardiogenic shock (CS). A percutaneous microaxial intracardiac VAD can offer hemodynamic support weighed against a risk of vascular complications. However, few studies have addressed the incidence of thrombotic complications, particularly in pts who require extended mechanical circulatory support (MCS). Methods: We conducted an observational cohort study to quantify the risk of thrombotic events during MCS in pts managed with a microaxial VAD for CS or mixed shock from 2015-2020 in a quaternary referral center. All consecutive pts were captured in a prospective registry of MCS and retrospectively reviewed for potentially device-related thrombotic events by 2 physician adjudicators. All pts received systemic anticoagulation with unfractionated heparin and/or bivalirudin. Results: The study included 106 pts (72% male, mean age 59.8). Peripheral artery disease, and a significant smoking history were present in 12% and 44% of cases respectively. The duration of microaxial VAD use was 5.3 days on average and &gt;7 days in 25%. A concurrent microaxial VAD and other MCS were used in 28% of cases. Thrombotic/ischemic events were observed in 24.5% and were subcategorized into limb ischemia with visualized thrombus (n=6), limb ischemia without visualized thrombus (n=6), systemic embolism (n=6), intraventricular thrombus (n=2), device thrombus (n=6), and device dysfunction (n=3). Three pts had more than one complication. Moderate to severe thrombocytopenia (&lt;100mcg/dL) was observed in 78% of pts. In-hospital mortality was 51% and was not higher in pts with thrombotic events (p=0.14). Conclusion: Thrombotic events are common with a microaxial intracardiac VAD with an observed rate that was higher than previously reported. Larger studies of all-comers with MCS for CS are needed to better define the rate of MCS-associated complications.

Survival After Heart Transplant Listing for Infants on Mechanical Circulatory Support

BackgroundInfants with heart failure remain at significant risk for wait list mortality, despite mechanical circulatory support (MCS). It is unclear if the outcomes are influenced by modality of support or underlying diagnosis. We sought to compare the outcomes of infants <10 kg, focusing on modality of support and underlying diagnosis.Methods and ResultsUsing the Pediatric Heart Transplant Society database, we evaluated survival following first MCS device in children <10 kg who were listed for heart transplant between 2010 and 2018. There were 2049 children <10 kg, with the predominant diagnosis being congenital heart disease (CHD) (59.8% [n=1226]) and 28.1% (n=577) requiring MCS. Extracorporeal membrane oxygenation (ECMO) was the most common form of MCS at listing, with ventricular assist device (VAD) more common after listing. There was no difference in the use of ECMO at or after listing for cardiomyopathy versus CHD (8.9% versus 7.2%; P=0.2; 5.4% versus 6.4%; P=0.4). However, there was a significant difference in the use of VAD both at listing (8% versus 2.4%; P<0.001) and after (22.8% versus 5.1%; P<0.001) between the 2 groups. When comparing these groups, patients with CHD were smaller and younger and had a higher proportion with previous cardiac surgery. Survival at 3 months demonstrated better survival for VAD therapy compared with ECMO (74.3% versus 48.6%; P<0.001). In patients <5 kg, survival did not differ between ECMO and VAD (P=0.01) for the CHD or the cardiomyopathy group (P=0.38), but patients with cardiomyopathy demonstrated better survival on both forms of support.ConclusionsSurvival for patients <10 kg on ECMO is inferior compared with VAD. Patients with cardiomyopathy <5 kg had better survival with both modes of MCS compared with those with CHD. These findings support the need for small, durable devices for neonates and infants, with particular focus in patients with CHD.

Pulsatile ventricular assist device as a bridge to transplant for the early high-risk single-ventricle physiology

BackgroundThe use of ventricular assist devices (VADs) as a bridge-to-transplant in patients with single-ventricle physiology post–stage one palliation has been associated with poor outcomes. We describe our center's successful experience in the use of paracorporeal pulsatile VADs in the palliation of high-risk single ventricle physiology before or after the first stage of palliation with an impetus on pre-palliation implant. MethodsThis is a single-center retrospective review of univentricular patients implanted with the Berlin Heart EXCOR VAD. Our center's approach includes early implantation of the Berlin Heart EXCOR with common atrial cannulation, a cardiac index between 3.5 and 5 L/min/m2, and a bivalirudin-based anticoagulation regimen. Patient-related data were collected postimplant at week 1 and months 1, 2, and 3. Post-transplant data, including neurological outcomes, were collected. ResultsNine patients were supported. Survival to discharge post-transplant was 83% (5/6) in patients bridged-to-transplant and 33% (1/3) in patients bridged-to-decision. Six patients had no previous palliation. Median hospital stay before implantation was 111 days for nonsurvivors versus 20 days for survivors. The need for extracorporeal membrane oxygenation and cardiopulmonary resuscitation in nonsurvivors versus survivors was 1 in 3 versus 1 in 6 and 2 in 3 versus 1 in 6, respectively. There were no major central nervous system complications except for 1 significant hemorrhagic event. The pediatric overall performance category score on follow-up was normal to mild disability in 83% of survivors. Limitations include hemolysis and intermittent periods of infection and/or inflammation. ConclusionsThe use of pulsatile paracorporeal VADs is a feasible option as a bridge-to-transplant in the peri–stage one high-risk single ventricle.

Waitlist and Post–Heart Transplant Outcomes for Children With Nondilated Cardiomyopathy

Although outcomes for pediatric cardiomyopathy (CMP) patients have improved, an understanding of outcomes by CMP phenotype is essential. This study assessed changes in waitlist and post-transplant survival in nondilated cardiomyopathy (DCM) patients over 2 decades, explored ventricular assist device (VAD) utilization in this cohort, and identified risk factors for waitlist and posttransplant mortality in the current era. Pediatric patients with a diagnosis of CMP listed for heart transplantation during three eras: Era 1: March 5, 1999 to December 31, 2004; Era 2: January 1, 2005 to December 15, 2011; and Era 3 (current era): December 16, 2011 to February 28, 2018 were included. Multivariable Cox proportional hazards regression was performed to assess waitlist and posttransplant survival. Compared with patients with DCM, those with hypertrophic and restrictive cardiomyopathy in the current era are less likely to be on VAD (23.4% vs 2.7% vs 4.5%); listed United Network for Organ Sharing Status 1A (75.6% vs 39.8% vs 34.8%), and more likely to have longer waitlist times (P < .01 for all). Only 3.3% hypertrophic and 2.4% restrictive cardiomyopathy patients had VAD implantation, although VAD use did not adversely impact waitlist survival in weighted non-DCM patients. Significant improvements have occurred in waitlist survival of hypertrophic and posttransplant survival of both types of non-DCM patients. Currently, waitlist and posttransplant survival is similar for all CMP phenotypes. VAD use is low in patients with non-DCM, although this did not increase waitlist mortality in adjusted analysis. Further studies in patients with non-DCM are needed to determine optimal timing and anatomic characteristics most likely to benefit from VAD implantation during the waitlist period.

Evolution of pediatric ventricular assist devices and their neurologic and renal complications-A 24-year single-center experience.

Utilization of ventricular assist devices (VADs) in adult populations with severe heart failure as a bridge to transplant has become the standard of care over the past two decades. Analogously, the use of VADs in pediatric populations has become more commonplace as pediatric heart transplantation has become more prevalent. We still have much to learn, however, about the complications after VAD placement in pediatric patients, their impact on transplantation and, in particular, how outcomes have changed over time. The objectives of this study were to (a) review the experience of a single pediatric VAD center, (b) identify risk factors that could lead to poor outcomes in patients on the transplant waitlist after VAD implantation and (c) demonstrate changes in outcomes over time. A retrospective cohort analysis was performed comparing death as a primary outcome and stroke and acute kidney injury (AKI) as secondary outcomes, across the study period divided into three timed eras. We analyzed 88 patients supported by a VAD over a 24-year timeframe. The duration, age at implant and indication for VAD support did not change significantly across the eras. We found that the incidence of stroke decreased over the study period and, while the rates of AKI did not change over the study period, those who developed AKI, while supported on VAD, had an increased risk of death.

Current status of pediatric mechanical circulatory support

The field of pediatric mechanical circulatory support has experienced exponential evolution in recent decades. With favorable complication profiles, implantable continuous-flow ventricular assist devices (VADs) have become a standard option in children, as has been seen in the adult counterpart. Nevertheless, there still exists room for further advances, not just for survival, but throughout the whole trajectory of treatment courses. With reviewing the current state of pediatric VAD support, including existing challenges, we aim to highlight the targets clinicians should focus on for further improvement of pediatric VAD support. The field of pediatric VAD has been steadily growing, as evidenced by an increasing number of total VAD implants, particularly with continuous-flow VAD. Currently, HeartWare HVAD (Medtronic Inc., Mounds View, MN) is the most widely used continuous-flow VAD in children with excellent performance. However, only half of the children with HVAD are discharged home, which is drastically different from adult patients, suggesting that the pediatric field is still in the process of maturation. Additionally, outcomes of VAD support for complex congenital heart defect, particularly single ventricle physiology, remain suboptimal, despite an increasing number of such patients. With the ongoing advancement, the field of pediatric VAD support is undergoing a rapid maturation process. This will eventually lead to further paradigm changes, including the use of VAD as permanent therapy.

Intraaortic Balloon Pump vs Peripheral Ventricular Assist Device Use in the United States

The objective of this study was to characterize practical use trends and outcomes for intraaortic balloon pump (IABP) and percutaneous left ventricular assist device (pVAD) use in cardiogenic shock at a national level. An analysis of all adult patients admitted nonelectively for cardiogenic shock from January 2008 through December 2017 was performed using the National Inpatient Sample. Trends of inpatient IABP and pVAD use were analyzed using survey-weighted estimates and the modified Cochran-Armitage test for significance. Multivariable regression models and inverse probability of treatment weights were used to perform risk-adjusted analyses of pVAD mortality, a composite of adverse events (AE), and resource use, with IABP as reference. Of an estimated 774,310 patients admitted with cardiogenic shock, 143,051 received a device: IABP, 127,792 (16.5%); or pVAD, 15,259 (2.0%). IABP use decreased (23.8% to 12.7%; P for trend <.001), whereas pVAD implantation increased significantly during the study period (0.2% to 4.5%; P for trend <.001). Inverse probability of treatment weights demonstrated significantly higher odds of mortality with pVAD (odds ratio, 1.9; 95% confidence interval, 1.7 to 2.2), but not AE (odds ratio, 1.1; 95% confidence interval, 0.96 to 1.27), compared with IABP. After risk adjustment, pVAD use was associated with an additional $15,202 (P < .001) in cost for survivors and $29,643 for nonsurvivors (P < .001). Over the study period, the rate of pVAD use for cardiogenic shock significantly increased. Compared with IABP, pVAD use was associated with increased mortality, higher costs, and several AEs. Multi-institutional clinical trials with rigorous inclusion criteria are warranted to evaluate the clinical utility of pVADs in the modern era.

Impella Placement in a Patient With d-Transposition of the Great Arteries After Mustard Procedure

Abstract Although durable ventricular assist devices (VAD) have previously been utilized for long-term ventricular support of the systemic ventricle in patients with a history of dextro-Transposition of the great arteries (d-TGA) after the Mustard procedure,1,2 the use of a temporary VAD has not been well-described as either bridge-to-decision or bridge-to-transplantation in these patients. Our case demonstrates the successful positioning and placement of an Impella® 5.0 device for refractory inotrope-dependent cardiogenic shock in this patient population, with simultaneous transesophageal echocardiographic (TEE) and fluoroscopic guidance, in a patient with significant barriers to heart transplantation. Unique considerations for placement of this device into the systemic ventricle post-Mustard include the crescent-shaped systemic ventricular geometry, proximity of the tricuspid valvular apparatus to device inlet placement, difficult visualization of the aortic valve due to its anterior position (analogous to the pulmonic valve in a non-congenital patient), and acoustic shadowing from the Impella® device itself. Here we demonstrate the critical role of multi-modality imaging in the visualization and positioning of this device in this patient with d-TGA post-Mustard anatomy.

The impact of uncorrected mild aortic insufficiency at the time of left ventricular assist device implantation

ObjectiveThe study objective was to investigate the progression of uncorrected mild aortic insufficiency and its impact on survival and functional status after left ventricular assist device implantation. MethodsWe retrospectively reviewed 694 consecutive patients who underwent implantation of a continuous-flow left ventricular assist device between January 2006 and March 2018. Pre–left ventricular assist device transthoracic echocardiography identified 111 patients with mild aortic insufficiency and 493 patients with trace or no aortic insufficiency. To adjust for differences in preoperative factors, propensity score matching was used, resulting in 101 matched patients in each of the mild aortic insufficiency and no aortic insufficiency groups. ResultsAlthough both groups showed similar survival (P = .58), the mild aortic insufficiency group experienced higher incidence of readmission caused by heart failure (hazard ratio, 2.62; 95% confidence interval, 1.42-4.69; P < .01). By using the mixed effect model, pre–left ventricular assist device mild aortic insufficiency was a significant risk factor for both moderate or greater aortic insufficiency and worsening New York Heart Association functional status (P < .01). ConclusionsPatients with uncorrected mild aortic insufficiency had a higher risk of progression to moderate or greater aortic insufficiency after left ventricular assist device implantation with worse functional status and higher incidence of readmission caused by heart failure compared with patients without aortic insufficiency. Further investigations into the safety and efficacy of concomitant aortic valve procedures for mild aortic insufficiency at the time of left ventricular assist device implant are warranted to improve patients' quality of life, considering the longer left ventricular assist device use as destination therapy and bridge to transplant with the new US heart allocation system.

US Trends in Pediatric VAD Utilization - Where are We Now?

Pediatric ventricular assist device (VAD) therapy is a rapidly changing field where devices and applications are rapidly evolving. We sought to describe some of the most recent trends in pediatric VAD use and contemporary outcomes since UNOS began collecting VAD data on all listed patients regardless of whether they survived. All children ≤21 years of age listed for isolated HT between Jan 2004 and 2019 and underwent VAD placement were identified using OPTN data. Descriptive statistics were used to characterize recent trends in VAD utilization. Waitlist survival in children with cardiomyopathy, CHD and single-ventricle heart disease were estimated using the Kaplan-Meier method. Overall, 2059 children met the study inclusion criteria of whom the median age was 11 (IQR 1, 17), median weight 38 (11,66) kg, 26% were black; 18.3 had congenital heart disease (CHD) including 5.1% with single-ventricle (SV) HD. Forty-nine percent were supported with a VAD at listing, 72% at transplant and 13% received a VAD but was not supported at listing or transplant. Overall, 64% received LVADs, 31% BIVADs, 2.5% RVADs 1.7% total artificial hearts (TAH). Implants of the Berlin Heart fell dipped sharply to 34 in 2015 after a peak of 63 but have rebounded since in the era of bivalirudin. As of 2018, the Heartware HVAD was the most commonly implanted VAD in children (N=61) followed by the Berlin Heart (N=48), CentriMag/PediMag (N=18) and Heartmate III (N=11). The fastest growing segment of VAD patients are single-ventricle patients (Figure). The total number of pediatric VADs continues to grow at a brisk pace. The most recent era has seen growth of the Heartmate III and resurgence of the Berlin Heart EXCOR, after a brief decline in 2015. Single-ventricle and Heartmate III patients represent the fastest growing segment of the VAD population.