EXCOR Ventricular Assist Device Research Articles

(607) Successful Explantation of Children from the Berlin Heart Excor Ventricular Assist Device: A Systematic Review

(607) Successful Explantation of Children from the Berlin Heart Excor Ventricular Assist Device: A Systematic Review

Jumping and Pumping: Balancing Physical Activity and Anticoagulation in Ventricular Assist Devices

<h3>Introduction</h3> Pre-transplant rehabilitation, which includes physical activity, is critical for optimal outcomes in heart transplantation. Patients supported on ventricular assist devices (VAD) are on anticoagulation to limit adverse vascular events and ensure VAD function. However, anticoagulation is not without risk. We present the case of traumatic arthropathy related to physical activity in an anticoagulated VAD patient. <h3>Case Report</h3> A 27-month-old with left ventricular noncompaction, restrictive cardiomyopathy, developmental delay, and sensory processing disorder presented in heart failure. Despite inotropic support, he continued to decline and underwent placement of a 15-mL Berlin Heart EXCOR VAD as a bridge to transplant. He recovered well from the procedure and was maintained on bivalirudin and aspirin for anticoagulation. Direct thrombin inhibition (DTI) measurements were within goal (80-100 secs). He was able to participate in structured physical and occupational rehabilitation and continue physical activity outside of scheduled sessions. On VAD day 161 he developed irritability with resistance to flexion and increased pain at the right hip, shortly after jumping on a trampoline provided by the family. Ultrasonography demonstrated an effusion without soft tissue abscess or inflammation. An initial C-reactive protein was normal (0.9 mg/dl), increased to 17.7 mg/dl, but then normalized within 24 hours. He had a normal white blood cell (WBC) count and remained afebrile and hemodynamically stable. A right hip aspiration demonstrated an elevated WBC (152 K/microliter) with a neutrophil predominance (72%) and a red blood cell count of 14 K/microliter. Due to concern for septic arthritis he was started on broad spectrum antibiotics and had a right hip arthrotomy. As the gram stain and hip cultures remained negative for 72 hours, antibiotics were stopped. Following rest and pain control he was able bear weight and successfully underwent heart transplant. <h3>Summary</h3> Musculoskeletal symptoms in VAD patients require careful evaluation as they may represent a variety of pathologies. It is important for clinicians to balance anticoagulation strategies with structured and unstructured rehabilitative endeavors for patients on VAD support, recognizing that local trauma related to physical activity may be magnified by anticoagulation.

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.

Bleeding and thrombotic events occur early in children on durable ventricular assist devices

IntroductionDurable Ventricular Assist Devices (VADs) are increasingly used in children with end-stage heart failure. Major complications are bleeding and thromboembolism (TE). Our objective was to determine the timing, incidence and risk factors for bleeding and TE in children implanted with VADs. MethodsThis was a retrospective cohort of 8 years experience for children implanted with HeartWare HVAD and Berlin Heart EXCOR VADs at the Royal Children's Hospital, Melbourne. Results44 patients were implanted with Berlin Heart EXCOR or HeartWare HVAD devices. Major bleeding occurred in 17 patients (39%), 7 (16%) experienced thromboembolic strokes, 13 (30%) required device exchange for TE, and 4 (9%) experienced arterial thromboembolism. Twenty-seven patients (61%) were transplanted, three (7%) recovered, and six (14%) remain on device when censored. Eight patients (18%) died on VAD, with leading causes being thromboembolic stroke and intracranial bleeding. The majority of bleeding events and thromboembolic events occurred while patients were on unfractionated heparin (bleeding 66%, TE 40.5%) or transitioning between heparin and warfarin (bleeding 22%, TE 38%). Majority of patients were on more than one antiplatelet agent at the time of a major bleeding (87%) or thromboembolic (89%) event. ConclusionsThe majority of bleeding and TE events occurring in children supported with durable VADs occur when they are on unfractionated heparin or transitioning to warfarin. Modifications to anticoagulation and monitoring in the early post-operative periods should be a research focus.

In Vitro Hemocompatibility Evaluation of Ventricular Assist Devices in Pediatric Flow Conditions: A Benchmark Study.

Development of pediatric ventricular assist devices (VADs) has significantly lagged behind that of adult devices. This frustrating reality is reflected by the fact that the Berlin Heart EXCOR VAD is currently the only approved pediatric-specific device in the USA. An alternative option is an off-label use of adult continuous-flow VADs, such as HeartMate II (HMII), which inevitably causes patient-device size mismatch in small children. We sought to conduct in vitro hemocompatibility testing in a pediatric flow condition, with a specific aim to provide benchmark values for future pediatric device development. Given the aforementioned fact that both pulsatile and continuous-flow devices are being used in the pediatric population, we opted to test both types of devices in the present study. The EXCOR and HMII blood pumps were tested using bovine blood under constant hemodynamic conditions (flow rate, Q = 2.5 ± 0.25L/min; differential pressure across the pump, ΔP = 68 ± 5mm Hg). Hemolysis was measured by Harboe assay. There was a steady increase in plasma free hemoglobin during in vitro testing, with a statistically significant difference between 5 and 360 min for both EXCOR (P < 0.0001) and HMII (P < 0.001). However, the degree of an increase in plasma free hemoglobin was more significant with HMII (P < 0.001). Normalized index of hemolysis for EXCOR and HMII were 0.003 ± 0.0026g/100 L and 0.085 ± 0.0119g/100 L, respectively. There was also a steady increase in platelet activation detected by CAPP2A antibody using flow cytometry, with a statistically significant difference between 5 and 360 min for both devices (P < 0.05). The degree of an increase in platelet activation was similar between the two devices (P = 0.218). High molecular weight von Willebrand factor (HMW vWF) multimer degradation measured by immunoblotting was evident for both devices, however, it was more pronounced with the EXCOR. EXCOR blood samples from all three time points (120, 240, and 360 min) were significantly different from the baseline (5 min), whereas only 360 min samples had a significant difference from the baseline with the HMII. In conclusion, we have observed similarities and differences in hemocompatibility profiles between the EXCOR and HMII, both of which are commonly used in the pediatric population. We anticipate the benchmark values in the present study will facilitate future pediatric VAD development.

Utility and correlation of known anticoagulation parameters in the management of pediatric ventricular assist devices.

AIMTo assess utility and correlation of known anticoagulation parameters in the management of pediatric ventricular assist device (VAD).METHODSRetrospective study of pediatric patients supported with a Berlin EXCOR VAD at a single pediatric tertiary care center during a single year.RESULTSWe demonstrated associations between activated thromboplastin time (aPTT) and R-thromboelastography (R-TEG) values (rs = 0.65, P < 0.001) and between anti-Xa assay and R-TEG values (rs = 0.54, P < 0.001). The strongest correlation was seen between aPTT and anti-Xa assays (rs = 0.71, P < 0.001). There was also a statistically significant correlation between platelet counts and the maximum amplitude of TEG (rs = 0.71, P < 0.001). Importantly, there was no association between dose of unfractionated heparin and either measure of anticoagulation (aPTT, anti-Xa or R-TEG value).CONCLUSIONThis study suggests that while there is strong correlation between aPTT, anti-Xa assay and R-TEG values for patients requiring VAD support, there is a lack of relevant correlation between heparin dose and degree of effect. This raises concern as various guidelines continue to recommend using these parameters to titrate heparin therapy.

Pneumatic paracorporeal ventricular assist device as bridge to transplant in children ≤ 20 kg: Krakow experience

Pulsatile mechanical ventricular assist devices (VADs) of various designs and functional principles have been in use in adult patients for long-term support of the failing heart. Despite the remarkable advances with the use of VAD, its support in children is still limited. We report on our experience in the paediatric population. The aim is either recovery of the heart or, more often, to keep the patient alive until later transplantation. We retrospectively study of children ≤ 20 kg, who were mechanically bridged to heart transplantation using the Berlin Heart (BH) Excor VAD at our hospital. The period of review was from November 2009 to March 2017. A total eight patients were included in this analysis, with these patients weighing < 20 kg. The study included three boys and five girls, with a mean weight of 10.55 kg (5.30–20 kg) and mean age of 20.69 months (4.5 to 60 months). Eight patients were supported with the Berlin Excor VAD, and six patients were supported with a left-sided ventricular assist device (LVAD) and two patients were supported with biventricular assist device (BVAD). Three of eight patients (38%) have been successfully bridged to heart transplant. Insertion of pulsatile paracorporeal VADs in children with end-stage heart failure is an effective strategy as a bridge to heart transplantation. This study demonstrates VAD support had serious ceribrovascular complications, and implantation BVAD support results were not satisfactory.

Impact of a modified anti-thrombotic guideline on stroke in children supported with a pediatric ventricular assist device

Stroke is the most feared complication associated with the Berlin Heart EXCOR pediatric ventricular assist device (VAD), the most commonly used VAD in children, and affects 1 in 3 children. We sought to determine whether a modified anti-thrombotic guideline, involving more intense platelet inhibition and less reliance on platelet function testing, is associated with a lower incidence of stroke. All children supported with the EXCOR at Stanford from 2009 to 2014 were divided into 2 cohorts based on the primary anti-thrombotic guideline used to prevent pump thrombosis: (1) the Edmonton Anti-thrombotic Guideline (EG) cohort, which included children implanted before September 2012 when dual anti-platelet therapy was used with doses titrated to Thromboelastrography/PlateletMapping (TEG/PM); and (2) the Stanford Modified Anti-thrombotic Guideline (SG) cohort, which included children implanted on or after September 2012 when triple anti-platelet therapy was used routinely and where doses were uptitrated to high, weight-based dosing targets, with low-dose steroids administered as needed for inflammation. At baseline, the EG (N = 16) and SG (N = 11) cohorts were similar. The incidence rate of stroke in the SG cohort was 84% lower than in the EG cohort (0.8 vs 4.9 events per 1,000 days of support, p = 0.031), and 86% lower than in the previous Investigational Device Exemption trial (p = 0.006). The bleeding rate was also lower in the SG cohort (p = 0.015). Target doses of aspirin, clopidogrel and dipyridamole were higher (all p < 0.003), with less dosing variability in the SG cohort than in the EG cohort. There was no difference in adenosine diphosphate inhibition by TEG/PM, but arachidonic acid inhibition was higher in the SG cohort (median 75% vs 39%, p = 0.008). Stroke was significantly less common in pediatric patients supported with the Berlin Heart EXCOR VAD using a triple anti-platelet regimen uptitrated to high, weight-based dosing targets as compared with the dual anti-platelet regimen titrated to PM, and without a higher risk of bleeding. Larger studies are needed to confirm these findings.

Experience With a Long-term Pulsatile Ventricular Assist Device as a Bridge to Heart Transplant in Adults

Introduction and objectivesMost long-term ventricular assist devices (VADs) that are currently implanted are intracorporeal continuous-flow devices. Their main limitations include their high cost and inability to provide biventricular support. The aim of this study was to describe the results of using paracorporeal pulsatile-flow VADs as a bridge to transplant (BTT) in adult patients. MethodsRetrospective analysis of the characteristics, complications, and outcomes of a single-center case series of consecutive patients treated with the EXCOR VAD as BTT between 2009 and 2015. ResultsDuring the study period, 25 VADs were implanted, 6 of them biventricular. Ventricular assist devices were indicated directly as a BTT in 12 patients and as a bridge to decision in 13 due to the presence of potentially reversible contraindications or chance of heart function recovery. Twenty patients (80%) were successfully bridged to heart transplant after a median of 112 days (range, 8-239). The main complications included infectious (52% of patients), neurological events (32%, half of them fatal), bleeding (28%), and VAD malfunction requiring component replacement (28%). ConclusionsEighty percent of patients with the EXCOR VAD as BTT achieved the goal after an average of almost 4 months of support. The most frequent complications were infectious, and the most severe were neurological. In our enivonment, the use of these pulsatile-flow VAD as BTT is a feasible strategy that obtains similar outcomes to those of intracorporeal continuous-flow devices.

Neurologic, Neurocognitive, and Functional Outcomes in Children Under 6 Years Treated with the Berlin Heart Excor Ventricular Assist Device.

The objective of this study is to describe the neurologic, neurocognitive, and functional outcomes of children aged under 6 years supported on the Berlin Heart EXCOR ventricular assist device (VAD) followed in the Complex Pediatric Therapies Follow-up Program (CPTFP). Sixteen patients were prospectively followed through this longitudinal, developmental program. The patients were evaluated with neurologic physical examination. Intelligence quotients (IQ) and functional outcome scores (ABAS-II scores) were obtained. Neuroimaging reports from before, during, and after VAD implantation were retrospectively reviewed for reported brain injury (BI). Twelve patients (75%) had neuroimaging documented BI at some point in their life (i.e., before, during, or after VAD support). Five patients (31%) had neuroimaging evidence of acute BI incurred while on the VAD. The high overall number of patients with neuroimaging documented BI at any point in their life illustrates that the risk for BI also exists outside the window of VAD support. Patients with abnormal neurologic physical examination at follow-up had lower IQ and ABAS-II scores compared with patients with normal neurologic physical examination (mean full-scale IQ 66.9 vs. 95.0, p = 0.001; mean ABAS-II 66.3 vs. 94.2, p < 0.001).

Experiencia con una asistencia ventricular pulsátil de larga duración como puente al trasplante cardiaco en adultos

Introduction and objectivesMost long-term ventricular assist devices (VADs) that are currently implanted are intracorporeal continuous-flow devices. Their main limitations include their high cost and inability to provide biventricular support. The aim of this study was to describe the results of using paracorporeal pulsatile-flow VADs as a bridge to transplant (BTT) in adult patients. MethodsRetrospective analysis of the characteristics, complications, and outcomes of a single-center case series of consecutive patients treated with the EXCOR VAD as BTT between 2009 and 2015. ResultsDuring the study period, 25 VADs were implanted, 6 of them biventricular. Ventricular assist devices were indicated directly as a BTT in 12 patients and as a bridge to decision in 13 due to the presence of potentially reversible contraindications or chance of heart function recovery. Twenty patients (80%) were successfully bridged to heart transplant after a median of 112 days (range, 8-239). The main complications included infectious (52% of patients), neurological events (32%, half of them fatal), bleeding (28%), and VAD malfunction requiring component replacement (28%). ConclusionsEighty percent of patients with the EXCOR VAD as BTT achieved the goal after an average of almost 4 months of support. The most frequent complications were infectious, and the most severe were neurological. In our enivonment, the use of these pulsatile-flow VAD as BTT is a feasible strategy that obtains similar outcomes to those of intracorporeal continuous-flow devices.Full English text available from:www.revespcardiol.org/en

The Use of Berlin Heart EXCOR VAD in Children Less than 10 kg: A Single Center Experience.

Objective: Despite the improvement in ventricular assist device (VAD) therapy in adults and in adolescents, in infant population only Berlin Heart EXCOR (BHE) is licensed as long term VAD to bridge children to Heart Transplantation (HTx). Particularly demanding in terms of morbidity and mortality are smallest patients namely the ones implanted in the first year of life or with a lower body surface area. This work aims at retrospective reviewing a single center experience in using BHE in children with a body weight under 10 kg.Methods: Data of all pediatric patients under 10 kg undergoing BHE implantation in our institution from March 2002 to March 2016 were retrospectively reviewed.Results: Of the 30 patients enrolled in the study, 53% were male, 87% were affected by a dilated cardiomyopathy with an average weight and age at the implantation of 6.75 ± 2.16 Kg and 11.57 ± 10.12 months, respectively. Three patients (10%) required a BIVAD implantation. After the implantation, 7 patients (23%) required re-intervention for bleeding and 9 patients (30%) experienced BHE cannulas infection. A total of 56 BHE pump were changed for thrombus formation (1.86 BHE pump for patient). The average duration of VAD support was 132.8 ± 94.4 days. Twenty patients (67%) were successfully transplanted and 10 patients (33%) died: 7 for major neurological complication and 3 for sepsis.Conclusion: Mechanical support in smaller children with end stage heart failure is an effective strategy for bridging patients to HTx. The need for BIVAD was relegated, in the last years, only to restrictive cardiomiopathy. Further efforts are required in small infants to improve anticoagulation strategy to reduce neurological events and BHE pump changes.

Pediatric Acquired von Willebrand Disease With Berlin Heart Excor Ventricular Assist Device Support.

The balance of hemostasis and anticoagulation is a concern for patients dependent upon ventricular assist devices (VADs). Bleeding is a common complication with both short- and long-term use of these devices. A better understanding of the risk factors and etiologies of bleeding associated with these devices is needed and could improve the overall results. We sought to determine the relationship of mechanical circulatory assist device use with acquired von Willebrand disease (avWD) in children. Data were analyzed retrospectively via review of the medical record of 19 consecutive patients who were supported with the Berlin EXCOR VAD for greater than 24 hours. Laboratory testing for avWD was performed at the discretion of the clinical team, often in association with clinical bleeding. Of 19 pediatric patients, 10 (52.6%) had laboratory testing consistent with avWD. Median time to detection of avWD was 35 days postimplantation of device (range 0-310 days). Both minor mucosal bleeding and bleeding requiring intervention were highly prevalent in patients in whom avWD was identified (10/10 [100%] and 7/10 [70%]). The mean age of all patients was 3.3 years, but patients found to have avWD tended to be older (mean 5.3 years) and supported with larger volume VADs. This experience demonstrates a high prevalence of avWD following EXCOR implantation. Bleeding, older age, and larger VAD size may be associated with avWD. These results should stimulate critical evaluation of individualized anticoagulation regimens in pediatric VAD patients.

(103) - Measuring the Effect of Dipyridamole and Clopidogrel Using Thromboelastography/Platelet Mapping®: Is There Evidence of a Meaningful Dose-Response Relationship in Children Supported with the Berlin Heart EXCOR Ventricular Assist Device?

(103) - Measuring the Effect of Dipyridamole and Clopidogrel Using Thromboelastography/Platelet Mapping®: Is There Evidence of a Meaningful Dose-Response Relationship in Children Supported with the Berlin Heart EXCOR Ventricular Assist Device?

Clinical Durability of the CARMEDA BioActive Surface in EXCOR Ventricular Assist Device Pumps.

The durability of CBAS Heparin Surface on EXCOR pumps retrieved after clinical use for varying periods of time was studied by analyzing samples for surface heparin density and bioactivity. The mean time of clinical use of the investigated 14 EXCOR pumps was 178 days (range, 15-461 days). Mean heparin density was 3.1 ± 0.6 μg/cm² (range, 2.2-4.8 μg/cm²), and the measured mean heparin bioactivity was 14 ± 5 ρmol/cm² (range: 7-27 ρmol/cm²). There was no detectable degradation or loss of function of CBAS Heparin Surface over time. Samples from the housing and the membrane of the EXCOR pump showed no significant difference in heparin bioactivity or density. The CBAS Heparin Surface stays on the surface and remains bioactive on the EXCOR pump at least up until 1 year. This is an important demonstration of coating durability and supports the mid-term and long-term clinical use as bridge-to-heart transplantation or to myocardial recovery.

Pediatric ventricular assist devices.

The domain of pediatric ventricular assist device (VAD) has recently gained considerable attention. Despite the fact that, historically, the practice of pediatric mechanical circulatory support (MCS) has lagged behind that of adult patients, this gap between the two groups is narrowing. Currently, the Berlin EXCOR VAD is the only pediatric-specific durable VAD approved by the U.S Food and Drug Administration (FDA). The prospective Berlin Heart trial demonstrated a successful outcome, either bridge to transplantation (BTT), or in rare instances, bridge to recovery, in approximately 90% of children. Also noted during the trial was, however, a high incidence of adverse events such as embolic stroke, bleeding and infection. This has incentivized some pediatric centers to utilize adult implantable continuous-flow devices, for instance the HeartMate II and HeartWare HVAD, in children. As a result of this paradigm shift, the outlook of pediatric VAD support has dramatically changed: Treatment options previously unavailable to children, including outpatient management and even destination therapy, have now been becoming a reality. The sustained demand for continued device miniaturization and technological refinements is anticipated to extend the range of options available to children-HeartMate 3 and HeartWare MVAD are two examples of next generation VADs with potential pediatric application, both of which are presently undergoing clinical trials. A pediatric-specific continuous-flow device is also on the horizon: the redesigned Infant Jarvik VAD (Jarvik 2015) is undergoing pre-clinical testing, with a randomized clinical trial anticipated to follow thereafter. The era of pediatric VADs has begun. In this article, we discuss several important aspects of contemporary VAD therapy, with a particular focus on challenges unique to the pediatric population.

(190) - Thromboelastography/Platelet Mapping® and Aspirin: Is There Evidence of a Meaningful Dose-Response Relationship in Children Supported With the Berlin Heart EXCOR Ventricular Assist Device?

s S77 is poorer in the BTS patients as a whole. While more BTS patients are listed young, we could not discern a statistically significant difference between BTS and RVPA patients listed pre-stage II. Post-transplant outcomes were unaffected by shunt type.

Steroid Therapy Attenuates Acute Phase Reactant Response Among Children on Ventricular Assist Device Support

Hyperfibrinogenemia, which can create a procoagulant milieu, is frequently observed in patients supported with the Berlin EXCOR (Berlin Heart GmbH, Berlin, Germany) ventricular assist device (VAD). We began initiating corticosteroids in patients with systemic inflammatory response syndrome (SIRS) episodes to mitigate hyperfibrinogenemia. We set forth to describe the impact of corticosteroids on the hyperfibrinogenemic state in our institutional experience. Retrospective data was collected on 44 consecutive patients implanted with the Berlin EXCOR VAD from April 15, 2005 through May 6, 2013. Pertinent information was abstracted from the electronic medical record. The reduction of C-reactive protein (CRP) and fibrinogen levels among days from corticosteroid treatment were described. Infections and insulin use were reported based on whether patients received steroids and if steroids were given for SIRS. Over the initial 44 Berlin EXCOR VAD implantations, 14 patients were treated with 21 courses of corticosteroids for SIRS episodes as identified by clinical features and rise in CRP. Treatment with corticosteroids reduced fibrinogen levels by day 2 to a statistically significant degree (p= 0.008). No difference in hyperglycemia or infections occurred among patients receiving corticosteroids for SIRS. Treatment with corticosteroids can potentially mitigate the SIRS response among children supported on the Berlin EXCOR VAD. In patients who received corticosteroids to mitigate inflammation, there was no increase in infections or hyperglycemia requiring insulin administration compared with patients who did not receive steroids.

Ventricular assist devices in children

Ventricular assist devices (VADs) have revolutionized heart failure management in adults. Recently, VADs have similarly taken a prominent role in the management of end-stage heart failure in children. The purpose of this review is to describe the indications for VADs in children, types of devices available, current outcomes, and future directions of VAD therapy. There has been a dramatic increase in VAD utilization in children over the last decade. For small children, paracorporeal pneumatic pulsatile pumps (e.g., Berlin Heart EXCOR VAD, Berlin Heart GmbH, Berlin, Germany) are most commonly utilized for long-term support. In older children, intracorporeal continuous flow devices (e.g., HeartMate II Left Ventricular Assist System, Thoratec Corporation, Pleasanton, California, USA and HeartWare Ventricular Assist System, HeartWare Incorporated, Framingham, Massachusetts, USA) have been used and allow the possibility of destination therapy. Other devices, such as the total artificial heart, can be utilized for selected patients. Although overall outcomes of pediatric VADs are favorable, complication rates remain high. The utilization of VADs in complex circulations, such as single ventricle patients, remains infrequent and is associated with a high rate of adverse outcomes. VADs are well-established treatment for end-stage heart failure in children. Further investigation is needed to refine patient selection criteria, minimize complications, and develop additional pediatric-specific devices.

The use of the Berlin Heart EXCOR in patients with functional single ventricle

The frequency and successful use of pediatric ventricular assist devices (VADs) as a bridge to cardiac transplantation have been steadily increasing since 2003, but the experience in patients with complex congenital heart disease has not been well described. Using a large prospectively collected dataset of children supported with the Berlin Heart EXCOR VAD, we have reviewed the experience in children with single ventricular anatomy or physiology (SV), and compared the results with those supported with biventricular circulation (BV) over the same time period. The EXCOR Investigational Device Exemption study database was retrospectively reviewed. VAD implants under the primary cohort and compassionate use cohort between May 2007 and December 2011 were included in this review. Twenty-six of 281 patients supported with a VAD were SV. The most common diagnosis was hypoplastic left heart syndrome (15 of 26). Nine patients were supported after neonatal palliative surgery (Blalock-Taussig shunt or Sano), 12 after a superior cavopulmonary connection (SCPC), and 5 after total cavopulmonary connection (TCPC). Two patients received biventricular assist devices, 1 after stage I surgery and 1 after stage II. SV patients were supported for a median time of 10.5 days (range, 1-363 days) versus 39 days (range, 0-435 days) for BV (P = .01). The ability to be bridged to transplant or recovery in SV patients is lower than for BV patients (11 of 26 [42.3%] vs 185 of 255 [72.5%]; P = .001). Three of 5 patients with TCPC were successfully bridged to transplant and were supported with 1 VAD. Seven of 12 patients with SCPC were bridged to transplant, and only 1 of 9 patients supported after a stage I procedure survived. The EXCOR Pediatric VAD can provide a bridge to transplant for children with SV anatomy or physiology, albeit less successfully than in children with BV. In this small series, results are better in patients with SCPC and TCPC. VAD support for patients with shunted sources of pulmonary blood flow should be applied with caution.