EXCOR Pediatric Ventricular Assist Device Research Articles

(1036) Through the "Chimney": Berlin Heart Excor Pediatric Ventricular Assist Device Inflow Stenting via a Novel Direct Access to Inflow Tubing

(1036) Through the "Chimney": Berlin Heart Excor Pediatric Ventricular Assist Device Inflow Stenting via a Novel Direct Access to Inflow Tubing

Berlin Heart EXCOR Support in the First Year of Life: A Single Centre Experience

Berlin Heart EXCOR Pediatric Ventricular Assist Device (BHE) (Berlin Heart AG, Berlin, Germany, BHE) is used worldwide for mechanical circulatory support as a bridge to transplantation or recovery for children with end-stage heart failure. The study aim was to evaluate morbidity and mortality of children less than one year old supported with BHE to identify predictors of adverse outcomes. Data of all children aged less than one year supported with BHE between 2005 and 2018 at the Royal Children's Hospital, Melbourne were reviewed. Adverse events were defined using PediMACS criteria. Fourteen (14) children under 1 year of age were implanted with BHE at a median age and weight of 0.37 years (IQR 0.09-0.7) and 5.7 kg (IQR 3.5-7.95) respectively. Four (4) patients were neonates, and 10 were older infants. Twelve (12) patients had cardiomyopathy and two, myocarditis. Preoperative extracorporeal membrane oxygenation (ECMO) support was required in six patients for a mean of 9 days (IQR 6-13). Sepsis occurred in five patients (36%) and thromboembolic stroke in two patients (14%). Survival to bridge to transplantation (11) and recovery (1) was achieved in 12 patients (86%). Mortality was 14%. The median duration of BHE support was 110 days (IQR 40-161). Both patients who died were neonates with myocarditis and required surgical re-intervention during BHE support. BHE provides excellent support as a bridge to transplantation or recovery in infants, with a low incidence of neurological dysfunction. Neonates with myocarditis may be at greater risk for death after BHE implantation.

Marked Practice Variation in Antithrombotic Care with the Berlin Heart EXCOR Pediatric Ventricular Assist Device.

Management of antithrombotic therapy (ATT) for pediatric ventricular assist devices is challenging, and the Berlin EXCOR remains the only Food and Drug Administration (FDA)-approved option. Among those on the EXCOR, 28% have neurologic complications and major bleeding occurs in 50%. The Edmonton Protocol was developed to guide ATT, but the adverse event rate remains high, leading most centers to make modifications. The objective of this study is to characterize antithrombotic practice variation among North American pediatric ventricular assist device programs, in order to guide future research. In this descriptive cross-sectional study, a survey assessing antithrombotic (AT) practices was distributed by Berlin Heart Inc. to centers that implanted ≥1 EXCOR between January 2012 and January 2016. Practices were compared at high- versus low-volume centers. High volume was defined as ≥14 implants in this period. Seventeen of 38 centers (44.7%) participated; 4 were high volume. At half of all centers (9/17), ≤2 clinicians managed all AT decisions. Although 47.1% (8/17) followed the protocol "extremely/very closely," only 5.9% (1/17) felt it to be "very effective." Most centers (10/15; 66.7%) deviated in ≥2 protocol aspects. Over half modified either recommended antiplatelet agents (5/15) or anticoagulants (4/15). Adjunct medication use was highly variable. Most (11/17; 64.7%) deviated from protocol in either timing or type of AT lab monitoring. Despite widespread use of Thromboelastography (TEG)/Platelet Mapping (PM), concerns of inaccuracy were common. Most high-volume centers (3/4; 75%) abandoned TEG/PM as a primary tool. These practice variation analyses have identified areas in ATT that are amenable to care standardization and further research. Systematic study of optimal AT medication dosing and monitoring is needed.

Postapproval Outcomes: The Berlin Heart EXCOR Pediatric in North America.

The Berlin Heart EXCOR Pediatric Ventricular Assist Device (BH) was approved for use in the United States in December 2011, based on a prospective investigational device exemption (IDE) trial. Strict exclusion criteria for the trial selected a low-risk "ideal" cohort. We sought to determine whether postapproval usage of the BH in a "real world" cohort of recipients would result in similar outcomes. Preimplant diagnostic information was collected for all patients. Efficacy was evaluated by comparison of all children (efficacy group, n = 247) implanted between FDA approval and April 2015 to those in the IDE trial (IDE, n = 48), with regard to achievement of one of four end-states: transplanted, successful weaning, death/unsuccessful weaning, or still-on-device. Safety outcomes were compared between IDE patients and a subset of postapproval patients (safety group, n = 39) for whom adjudicated adverse events were tracked in a regulator-mandated dataset. Diagnostic categories were similar between groups: IDE (congenital 19%, dilated cardiomyopathy/myocarditis/other 81%) versus Efficacy Group (congenital 24%, dilated cardiomyopathy/myocarditis/other 75%). Patients in the IDE cohort were larger (median 14.8 kg, range 3.6-58.1 kg vs. 10.7 kg, 2.9-112.0 kg, p = 0.02). More IDE patients were successfully supported than in the efficacy group cohort (90% vs. 77%, p = 0.05). Proportions with bleeding and stroke were similar between the IDE and safety group cohorts (46% vs. 41%, p = 0.65; 29% vs. 33%, p = 0.68, respectively). With usage of the BH in a less-ideal population, rates of bridge to transplant and weaning have declined slightly, but remain encouragingly high. Bleeding and neurologic event rates have not increased.

Transplant Survival After Berlin Heart EXCOR Support.

The Berlin Heart EXCOR pediatric ventricular assist device (VAD) is approved by the Food and Drug Administration for bridge to cardiac transplantation (BTT) in children. As the clinical outcomes of the EXCOR continue to be evaluated in the United States, data on post-transplant survival are needed. The UNOS database was used to identify patients <18 years old undergoing orthotopic heart transplantation (OHT) from June 2004 to June 2014. Patients undergoing BTT with the EXCOR were identified. A matched cohort of (358) patients undergoing OHT without pretransplant mechanical circulatory support (no-MCS) was also identified as control subjects. The post-transplant survival between the two groups was compared. There were 2,885 pediatric OHT during the study period. Of these, 358 (50%) patients were BTT with the EXCOR. At time of listing, inotrope use was 51.7% vs. 53.4%, (p = 0.653) in the EXCOR cohort and the no-MCS cohort, respectively. At the time of transplantation, end-organ function was equivalent with same median creatinine levels (0.4, p = 0.203) and median total bilirubin (0.5, p = 0.682) for the EXCOR and the no-MCS cohorts. Kaplan-Meier post-transplantation survival did not differ between the two cohorts (30 day, 1 year, and 5 year post-transplant survival was 94%, 90%, and 72% [EXCOR cohort] vs. 98%, 91%, and 77% [no-MCS cohort]; p = 0.160). Short- and mid-term post-transplant survival using the EXCOR Pediatric VAD as a BTT in children is equivalent to patients who underwent OHT without pretransplant MCS.

Antithrombotic Therapy in a Prospective Trial of a Pediatric Ventricular Assist Device.

Efficacious ventricular assist device (VAD) support in pediatric patients depends on successful antithrombotic management. The experience with antithrombotic management for the EXCOR Pediatric VAD Investigational Device Exemption (IDE) study is described. All 68 children in North America enrolled in the IDE study from May 9, 2007 to December 10, 2010 are included. The Edmonton Anticoagulation and Platelet Inhibition Protocol was provided for management guidance. Monitoring parameters, drug dosing, targeted serious adverse events, and pump changes were reviewed. Major bleeding occurred in 43% of all subjects with most events occurring within 14 days of implantation. Bleeding events were probably/definitely related in 24% to antithrombotic management. Neurologic events occurred in 28% of subjects and were probably/definitely related in 9% to antithrombotic therapy intensity. Most neurologic events occurred between 4 and 30 days postimplantation and sporadically thereafter. Pump change occurred in 56% of subjects. Use of an antithrombotic protocol for enrolled subjects was possible in this multicenter study. Incidence of significant bleeding and thromboembolic events was acceptable when balanced against life-saving benefits of VADs. Further studies are needed to optimize the antithrombotic management of this patient population.

Single-Center Experience of Mechanical Circulatory Support with Berlin Heart EXCOR Pediatric Ventricular Assist Device in Children with Severe Myocarditis

Objective: Fulminant myocarditis with cardiogenic shock is a life-threatening disease with failure to aggressive medical treatment. In these cases, mechanical circulatory support represents a lifesaving measure to allow for myocardial recovery.

Abstract 19540: US Center Variability in the Incidence of Stroke for the Berlin Heart EXCOR Pediatric Ventricular Assist Device

Background: Ventricular assist device (VAD)-related stroke is an important performance benchmark for adult VAD programs. No benchmarks are available for pediatric VAD programs where the stroke rate is higher. We sought to describe center variability in the stroke rate for the Berlin Heart EXCOR® Pediatric VAD, the most commonly used durable VAD in US children, to support pediatric VAD quality improvement efforts. Methods: All children age &lt;18 years supported with a Berlin Heart EXCOR Pediatric VAD at a site participating in the EXCOR IDE or FDA Post-Approval Study were identified using the Sponsor’s database. The incidence of neurological dysfunction, defined by INTERMACS criteria, was estimated for patients at centers with at least 300 support days. Results: Between 2007 and March 2014, a total of 320 children underwent implantation of a Berlin Heart EXCOR Pediatric VAD at 42 centers, of which 271 patients at 25 centers met the study inclusion criteria. The baseline characteristics of the cohort have been reported previously. Overall, there were a total of 64 neurological dysfunction episodes in 53 unique patients over 20,875 days of support, yielding an overall stroke incidence of 0.31 events per 100 days of support and a prevalence of 19%. Centers varied considerably (ten-fold) in their incidence rate of stroke ranging from 0 events to 1.7 events per 100 days of support (Figure). Among 13 centers with at least 10 total implants (totaling 205 patients over 14,405 support days), the overall stroke prevalence was 20% (range 6 to 46%) (Incidence rate 0.33 events per 100 days of support). Centers with ≥10 implants did not have fewer strokes than lower volume centers (P=0.30). Conclusion: The incidence of stroke among pediatric VAD centers using the Berlin Heart EXCOR Pediatric VAD was 0.31 events per day of support and varied considerably across pediatric centers. These data may be useful for developing performance benchmarks for neurological dysfunction in pediatric VAD support.

(220) - Impact of a Modified Anti-Thrombotic Protocol on the Risk of Stroke and Thromboembolism in Children Supported With the Berlin Heart Excor Pediatric Ventricular Assist Device

(220) - Impact of a Modified Anti-Thrombotic Protocol on the Risk of Stroke and Thromboembolism in Children Supported With the Berlin Heart Excor Pediatric Ventricular Assist Device

(257) - Berlin Heart Post Approval Outcomes in North America

The Berlin Heart EXCOR Pediatric Ventricular Assist Device (BH) was approved for use in the U.S. in December 2011, based on a prospective Investigational Device Exemption (IDE) trial. The strict exclusion criteria for the IDE trial resulted in a relatively low-risk “ideal” cohort. We sought to determine whether post-approval usage of the BH in a “real world” cohort of recipients would result in similar outcomes.

Invited Commentary

The decision to use a biventricular assist device (BIVAD) versus a left ventricular assist device (LVAD) for a child awaiting transplantation remains difficult. This investigation by Zafar and colleagues [1Zafar F. Jefferies J.L. Tjossem C.J. et al.Biventricular Berlin Heart EXCOR pediatric use across the United States.Ann Thorac Surg. 2015; 99: 1328-1334Google Scholar] from the Berlin Heart EXCOR Pediatric EXCOR study reveals sobering conclusions regarding mechanical assistance in children. In essence, one-third of the patients in this study required BIVAD assistance. The demographic and clinical variables of white race, abnormal glomerular filtration rate, sites with fewer than five implants, and use of the 10-mL pump were identified as predictors of mortality in BIVAD patients. BIVAD support was not associated with improved survival in any identified subset of patients, and survival in BIVAD patients was 60% versus 80% in LVAD patients at 100 days. Although pediatric patients differ from adult patients, a similar inferior survival for BIVAD patients compared with LVAD patients exists for adults [2Cleveland Jr., J.C. Naftel D.C. Reece T.B. et al.Survival after biventricular assist device implantation: an analysis of the Interagency Registry for Mechanically Assisted Circulatory Support database.J Heart Lung Transplant. 2011; 30: 862-869Abstract Full Text Full Text PDF PubMed Scopus (123) Google Scholar]. Although one is tempted to conclude that perhaps BIVAD support should be avoided at all costs, this message is not the appropriate conclusion. As mechanical circulatory support evolves, we must continue to define which patients require BIVAD support and how we can then improve BIVAD outcomes. Clearly, the current study challenges us to question how the current pediatric BIVAD technology might change to improve BIVAD survival. Biventricular Berlin Heart EXCOR Pediatric Use Across the United StatesThe Annals of Thoracic SurgeryVol. 99Issue 4PreviewBiventricular assist device (BiVAD) support was a strong predictor of early mortality in the Berlin Heart EXCOR Pediatric investigational device exemption (IDE) study (Assess Safety and Probable Benefit of the EXCOR Pediatric Ventricular Assist Device [VAD]). In adults, it has been identified that 5% to 10% of the VAD population is benefited by BiVAD support over left ventricular assist device (LVAD) support. An analysis of the Berlin Heart study cohort was performed to characterize patients supported with BiVAD, examine risk factors of mortality in this group, and identify subsets of patients in whom BiVAD is associated with survival. Full-Text PDF

Biventricular Berlin Heart EXCOR Pediatric Use Across the United States

Biventricular assist device (BiVAD) support was a strong predictor of early mortality in the Berlin Heart EXCOR Pediatric investigational device exemption (IDE) study (Assess Safety and Probable Benefit of the EXCOR Pediatric Ventricular Assist Device [VAD]). In adults, it has been identified that 5% to 10% of the VAD population is benefited by BiVAD support over left ventricular assist device (LVAD) support. An analysis of the Berlin Heart study cohort was performed to characterize patients supported with BiVAD, examine risk factors of mortality in this group, and identify subsets of patients in whom BiVAD is associated with survival. All EXCOR Pediatric devices (Berlin Heart, Inc, The Woodlands, TX) placed in North America between May 2007 and December 2010 comprised the study cohort of 204 patients (128 [63%] LVADs and 76[37%] BiVADs). The following patient cohorts were analyzed to determine the effect of BiVAD use on survival: Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 patients, patients with abnormal bilirubin levels, patients who received previous extracorporeal membrane oxygenation (ECMO), and patients with a 10-mL pump size. There were more patients with BiVADs in INTERMACS profile 1 (63% compared with 46%; p=0.018). The incidence of major bleeding, neurologic and renal dysfunction, and infection was similar between BiVAD and LVAD groups. White race, abnormal glomerular filtration rate (GFR), sites with experience of less than 5 implantations, and use of 10-mL pumps were predictors of mortality in patients who received BiVADs. BiVADs were not associated with improved survival in any patient cohort; however, they were associated with increased mortality in patients who had undergone ECMO before receiving a VAD. BiVAD support was not associated with improved survival in any identified subset of patients. Although not randomized, these results (which were corrected for multiple possible risk factors) suggest that some children supported with BiVADs might have done better with LVADs alone. Further prospective studies will be needed to identify patient cohorts that will be better served with BIVAD support.

Delineating Survival Outcomes in Children

ObjectivesThe goal of this study was to delineate outcomes of children weighing <10 kg supported with the Berlin Heart EXCOR Pediatric Ventricular Assist Device (EXCOR Pediatric, Berlin Heart Inc., The Woodlands, Texas) and to identify factors that increased the risk of all-cause mortality in this population. BackgroundVentricular assist devices have been shown to be an effective bridge to transplant, with improved outcomes compared with use of extracorporeal membrane oxygenation. Smaller patients may be at greatest risk for poor outcomes, but it remains unclear if mortality is uniform across all smaller candidates. MethodsPatients included in the analysis were part of a multicenter prospective cohort study examining the use of the Berlin Heart EXCOR Pediatric Ventricular Assist Device as a bridge to transplant. All children who received the device between May 9, 2007 and December 31, 2010, and who were enrolled in the sponsor’s U.S. regulatory database, were identified and analyzed. Multivariable analysis was performed to determine risk factors associated with mortality. ResultsA total of 97 children weighing <10 kg were included (median age 6.2 months; median weight 6.2 kg; median duration of support 26 days). Successful outcomes were achieved in 56.7% of patients. Independent risk factors for mortality in smaller children included pre-existing congenital heart disease (odds ratio: 4.8 [95% confidence interval: 1.5 to 15.0]; p = 0.007) and an elevated bilirubin level (odds ratio: 5.3 [95% confidence interval: 2.0 to 14.3]; p = 0.001). ConclusionsOverall results for children weighing <10 kg were inferior to those of their larger counterparts. This outcome was primarily influenced by congenital heart disease and presence of elevated pre-implant bilirubin levels. These factors should be taken into consideration at decision making because reasonable outcomes can be achieved in a select population of children weighing <10 kg.

Letter by Singh Regarding Article, “Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children”

HomeCirculationVol. 128, No. 20Letter by Singh Regarding Article, “Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children” Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBLetter by Singh Regarding Article, “Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children” Tajinder P. Singh, MD, MSc Tajinder P. SinghTajinder P. Singh Department of Cardiology, Boston Children’s Hospital, Boston, MA Search for more papers by this author Originally published12 Nov 2013https://doi.org/10.1161/CIRCULATIONAHA.113.004612Circulation. 2013;128:e405To the Editor:The description of the overall Berlin heart EXCOR experience in US children by Almond et al1 is an important contribution to pediatric heart failure literature. After a careful evaluation of baseline factors and competing outcomes in EXCOR recipients, the authors found that reduced end-organ function—renal or hepatic—was independently associated with death after EXCOR implantation. Using the Schwartz equation to estimate glomerular filtration rate (GFR),2 children with a GFR value of 30% to 99% predicted for age were assigned the risk category of “moderate renal dysfunction”1 and were reported to be at higher risk of death after EXCOR compared with children with normal GFR. Although the key message of initiating EXCOR support in children in advanced heart failure before they are too sick is important, it is difficult to accept that either moderate renal dysfunction or the associated mortality risk begins at the GFR value of 99% predicted. Because the normal GFR at any pediatric age is a range of values3,4 and the normal range used in the study (or a reference for such values) was not provided, it is also unclear whether 100% predicted GFR values were the midpoint or the lower end of some range. These details are important for physicians trying to apply this knowledge in patient selection, in determining optimal timing for EXCOR, or in counseling parents regarding the risk benefit of EXCOR implantation in their child. They will also be important for investigators trying to replicate these results or assess risk factors in future cohorts. Determining optimal timing for initiating mechanical support in children with advanced heart failure will be an important area of research in the next decade. The article by Almond et al1 provides significant initial insights.Tajinder P. Singh, MD, MScDepartment of CardiologyBoston Children’s HospitalBoston, MADisclosuresNone.

Post-transplant Outcomes of Children Bridged to Transplant With the Berlin Heart EXCOR Pediatric Ventricular Assist Device

Recent data suggest that Berlin Heart EXCOR Pediatric (EXCOR) ventricular assist device improves waiting list survival for pediatric heart transplant candidates. Little is known about their post-transplant outcomes. The aim of this analysis was to determine whether there was a difference in early survival for children bridged to transplant with EXCOR versus status 1A pediatric heart transplant patients not transplanted with ventricular assist device support. Pediatric heart transplant patients (n=106) bridged to transplantation with EXCOR were compared with a similarly aged cohort (n=1021) within the Organ Procurement and Transplant Network (OPTN) database (both cohorts from May 2007 to December 2010). In the EXCOR group, 12-month post-transplant survival (88.7%) was similar to OPTN patients listed status 1A who were not on ventricular assist device support at transplant (89.3%; P=0.85) and significantly better than 12-month survival in OPTN patients on extracorporeal membrane oxygenation at transplant (60.3%; P<0.001). Rejection (50%) was a significantly (P=0.005) higher cause of 12-month post-transplant mortality in the EXCOR compared with the OPTN group. Death after transplant was also higher in EXCOR patients with congenital heart disease compared with those with cardiomyopathy (26.1% versus 7.2%; P=0.02). Post-transplant survival was similar in EXCOR patients with ≥1 serious adverse event during ventricular assist device support as those without an event during support. The 12-month post-transplant survival with EXCOR is comparable with overall pediatric heart transplant survival and superior to survival after extracorporeal membrane oxygenation. Neither adverse events during support nor factors associated with mortality during support influence post-transplant survival. Rejection was a significantly greater cause of post-transplant mortality in EXCOR than in OPTN patients.

The Berlin Heart EXCOR Pediatric ventricular assist device: history, North American experience, and future directions

Options for long-term mechanical circulatory support to sustain pediatric heart failure patients requiring cardiac transplantation while they wait for donor hearts have been unsatisfactory. The conventional approach has been to use extracorporeal membrane oxygenation (ECMO), but its lack of feasibility for long-term use and the major complications associated with the technology have limited its use, especially in light of lengthy waiting lists for donor hearts. With the advent of the Berlin Heart EXCOR® Pediatric ventricular assist device (VAD), pediatric heart failure specialists have gained an important tool for helping this patient population survive until a donor heart can be identified. The EXCOR Pediatric VAD is designed to support pediatric patients of all age groups, from newborns to teenagers, and can be used successfully for many months. This paper describes the early experience with the EXCOR Pediatric VAD and the challenging journey undertaken to gain U.S. FDA approval, including successful completion of the first worldwide prospective clinical study of VADs in a pediatric population.

Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children

Recent data suggest that the Berlin Heart EXCOR Pediatric ventricular assist device is superior to extracorporeal membrane oxygenation for bridge to heart transplantation. Published data are limited to 1 in 4 children who received the device as part of the US clinical trial. We analyzed outcomes for all US children who received the EXCOR to characterize device outcomes in an unselected cohort and to identify risk factors for mortality to facilitate patient selection. This multicenter, prospective cohort study involved all children implanted with the Berlin Heart EXCOR Pediatric ventricular assist device at 47 centers from May 2007 through December 2010. Multiphase nonproportional hazards modeling was used to identify risk factors for early (<2 months) and late mortality. Of 204 children supported with the EXCOR, the median duration of support was 40 days (range, 1-435 days). Survival at 12 months was 75%, including 64% who reached transplantation, 6% who recovered, and 5% who were alive on the device. Multivariable analysis identified lower weight, biventricular assist device support, and elevated bilirubin as risk factors for early mortality and bilirubin extremes and renal dysfunction as risk factors for late mortality. Neurological dysfunction occurred in 29% and was the leading cause of death. Use of the Berlin Heart EXCOR has risen dramatically over the past decade. The EXCOR has emerged as a new treatment standard in the United States for pediatric bridge to transplantation. Three-quarters of children survived to transplantation or recovery; an important fraction experienced neurological dysfunction. Smaller patient size, renal dysfunction, hepatic dysfunction, and biventricular assist device use were associated with mortality, whereas extracorporeal membrane oxygenation before implantation and congenital heart disease were not.

Management of Single‐Ventricle Patients With Berlin Heart EXCOR Ventricular Assist Device: Single‐Center Experience

There are minimal data regarding chronic management of single-ventricle ventricular assist device (VAD) patients. This study aims to describe our center's multidisciplinary team management of single-ventricle patients supported long term with the Berlin Heart EXCOR Pediatric VAD. Patient #1 was a 4-year-old with double-outlet right ventricle with aortic atresia, L-looped ventricles, and heart block who developed heart failure 1 year after Fontan. She initially required extracorporeal membrane oxygenation support and was transitioned to Berlin Heart systemic VAD. She was supported for 363 days (cardiac intensive care unit [CICU] 335 days, floor 28 days). The postoperative course was complicated by intermittent infection including methicillin-resistant Staphylococcus aureus, intermittent hepatic and renal insufficiencies, and transient antithrombin, protein C, and protein S deficiencies resulting in multiple thrombi. She had a total of five pump changes over 10 months. Long-term medical management included anticoagulation with enoxaparin, platelet inhibition with aspirin and dipyridamole, and antibiotic prophylaxis using trimethoprim/sulfamethoxazole. She developed sepsis of unknown etiology and subsequently died from multiorgan failure. Patient #2 was a 4-year-old with hypoplastic left heart syndrome who developed heart failure 2 years after bidirectional Glenn shunt. At systemic VAD implantation, he was intubated with renal insufficiency. Post-VAD implantation, his renal insufficiency resolved, and he was successfully extubated to daytime nasal cannula and biphasic positive airway pressure at night. He was supported for 270 days (CICU 143 days, floor 127 days). The pump was upsized to a 50-mL pump in May 2011 for increased central venous pressures (29 mm Hg). Long-term medical management included anticoagulation with warfarin and single-agent platelet inhibition using dipyridamole due to aspirin resistance. He developed increased work of breathing requiring intubation, significant anasarca, and bleeding from the endotracheal tube. The family elected to withdraw support. Although both patients died prior to heart transplantation, a consistent specialized multidisciplinary team approach to the medical care of our VAD patients, consisting of cardiothoracic surgeons, heart transplant team, hematologists, pharmacists, infectious disease physicians, psychiatrists, specialty trained bedside nursing, and nurse practitioners, allowed us to manage these patients long term while awaiting heart transplantation.

Outcomes of ventricular assist device support in young patients with small body surface area

Although the ventricular assist device (VAD) has been a well-established therapy for larger adolescents and adult patients with advanced heart failure, current experience with the use of VAD for mechanical circulatory support in infants and young children with small body surface area is still limited. Between January 1999 and December 2009, 56 small children with body surface area<1.2 m² were implanted with Berlin Heart EXCOR pediatric VAD in Germany Heart Institute Berlin. The etiology of end-stage myocardial failure included non-congenital (75%) and congenital heart disease (25%); the median age at implant was 1 year (12 days to 14 years), and the median support time was 55 days (1-432 days). Of the 56 pediatric patients, 24 were bridged to heart transplantation, 12 were explanted following myocardial recovery, two continued to receive support, and the other 18 died on support. The accurate rate of survival on VAD support was 81.1% ± 5.8% and 51.4% ± 9.3% at 30 days and 1 year after EXCOR implantation. Patients receiving biventricular support had a trend towards higher post-implantation mortality as compared with children implanted with left ventricular assist device (LVAD) (P = 0.09). Lower post-implantation survival was also observed in patients with congenital cardiac disease compared with children with a non-congenital etiology (P < 0.001). Berlin Heart EXCOR pediatric VAD could provide satisfactory and safe circulatory support for small children with end-stage heart disease.

Current Use of the EXCOR Pediatric Ventricular Assist Device

Since its initial application in the pediatric patient population, the Berlin Heart EXCOR ventricular assist device has become a widely accepted form of mechanical circulatory support in Europe and the USA. The versatility of the device makes it ideal for pediatric patients because it can be tailored to the size and needs of the patient. In this review, we will explore the broad range of clinical applications of this device including bridge to cardiac transplantation, bridge to recovery, and bridge to bridge implantation where the need for cardiac transplantation may be unclear but long-term mechanical support may be required.