EXCOR membrane motion analyzer (EMMA) to quantify and assess hemodynamic performance of the EXCOR pediatric heart assist device.

BACKGROUND: Pediatric heart failure is associated with high mortality rates and is a current clinical burden. There is only one FDA approved pediatric VAD, Berlin Heart EXCOR, for treatment. Thrombo-embolic complications are a significant clinical challenge, which can lead to devastating complications such as stroke and impair efficient EXCOR function. Currently, clinicians perform largely qualitative periodic assessment of EXCOR operation by observing the motion of a rapidly moving membrane, which can be prone to human error and can lead to missing out on crucial information. METHODS: In this study, we design and implement a quantitative early warning system for accurate and quantitative assessment of the EXCOR membrane, named EXCOR Membrane Motion Analyzer (EMMA). Using a combination of image analysis, computer vision and custom designed algorithm, we perform rigorous frame by frame analysis of EXCOR membrane video data. We developed specialized metrics to identify relative smoothness between successive peaks, time between peaks and overall smoothness indicators to quantify and compare between multiple cases. RESULTS: Our results demonstrate that EMMA can successfully identify the motion and wrinkles on each video frame and quantify the smoothness and identify the phases of each cardiac cycle. Moreover, EMMA can obtain the smoothness of each frame and the temporal evolution of membrane smoothness across all image frames for the video sequence. CONCLUSIONS: EMMA allows for a fast, accurate, quantitative assessment to be completed and reduces user error. This enables EMMA to be used effectively as an early warning system to rapidly identify device abnormalities.

Safety issues with an inter-hospital transport of a patient with a Berlin Heart Excor biventircular assist device.

BACKGROUND: Interhospital transfers of pediatric patients on the Berlin Heart Excor have been published on an occasional basis. METHODS: Nowadays medicine evolves away from just feasibility towards quality and safety issues. Management tools like risk analysis have found their way into clinical practice. RESULTS: Exemplary, we present a case of a 20 months old boy on a Berlin Heart BiVAD Excor who underwent a 224 km ground transport. After a systematic review of the published literature, we describe our safety management with the aim was to provide highest quality of care for the transport. CONCLUSION: Besides a risk analysis, we also describe our training and simulation protocol.

Investigating the hemodynamics of Berlin Heart EXCOR support in Norwood patients across diverse clinical scenarios with computational modeling.

BACKGROUND: Infants with single-ventricle (SV) physiology undergo the 3-stage Fontan surgery. Norwood patients, who have completed the first stage, face the highest interstage mortality. The Berlin Heart EXCOR (BH), a pediatric pulsatile ventricular assist device, has shown promise in supporting these patients. However, clinical questions regarding device configurations prevent optimal support. METHODS: We developed a combined idealized mechanics-lumped parameter model of a Norwood patient and simulated two additional patient-specific cases: pulmonary hypertension (PH) and post-operative treatment with milrinone. We quantified the effects of BH support across different device volumes, rates, and inflow connections on patient hemodynamics and BH performance. RESULTS: Increasing device volume and rate increased cardiac output, but with unsubstantial changes in specific arterial oxygen content. We identified distinct SV-BH interactions that may impact patient myocardial health and contribute to poor clinical outcomes. Our results suggested BH settings for patients with PH and for patients treated post-operatively with milrinone. CONCLUSIONS: We present a computational model to characterize and quantify patient hemodynamics and BH support for infants with Norwood physiology. Our results emphasized that oxygen delivery does not increase with BH rate or volume, which may not meet patient needs and contribute to suboptimal clinical outcomes. Our findings demonstrated that an atrial BH may provide optimal cardiac loading for patients with diastolic dysfunction. Meanwhile, a ventricular BH decreased active stress in the myocardium and countered the effects of milrinone. Patients with PH showed greater sensitivity to device volume. In this work, we demonstrate the adaptability of our model to analyze BH support across varied clinical situations.

Pediatric patient with restrictive cardiomyopathy on staged biventricular assist device support with Berlin Heart EXCOR® underwent heart transplantation successfully: the first case in Japan.

Pure restrictive cardiomyopathy is a strong risk factor for poor outcomes in children with cardiomyopathy on ventricular assist devices. Owing to concomitant right heart failure, children with end-staged restrictive cardiomyopathy who are supported with a ventricular assist device often require a biventricular assist device, which is another risk factor for waitlist mortality in heart transplantation candidates. Herein, we report the case of a 3-year-old boy with pure restrictive cardiomyopathy who successfully underwent heart transplantation after 12 months of support with staged biventricular assist devices. Owing to the progression of diastolic dysfunction, the left ventricular assist device could not provide adequate circulation support. Despite the provision of biventricular assist device support, the patient required a complex management strategy that involved balancing the left and right ventricular assist device supports. We were able to stabilize the patient by careful synchronization of the supports and proceeded to heart transplantation. TRIAL REGISTRATION: Clinical Registration No.: Institutional Review Board of Osaka University Hospital, approval no. 16105.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Long term CentriMag biventricular support using hybrid cannulation as a bridge to transplant in a pediatric patient.

Paracorporeal continuous-flow ventricular assist devices designed for short-term support can also potentially provide long-term circulatory support as bridges to transplantation in children. We describe the long-term use of the CentriMag biventricular assist device with multiple pump changes in a 9-year-old boy with idiopathic-dilated cardiomyopathy. The initially implanted Berlin Heart EXCOR pumps were replaced by CentriMag due to thromboembolic complications. The CentriMag pumps were exchanged 15 times due to clot and fibrin formation or when the pumps reached their expiration dates. Connecting CentriMag to Berlin Heart EXCOR cannulae effectively served as an alternative long-term hybrid bridge to transplantation for 235 days. The patient successfully underwent a transplant after 284 days. Judicious pump monitoring and timely pump exchanges can potentially overcome device-related complications and extend the duration on support.

Impact of Long-Term Support with Berlin Heart EXCOR® in Pediatric Patients with Severe Heart Failure.

Berlin Heart EXCOR® (BHE) ventricular assist device (VAD) (Berlin Heart, Berlin Heart AG, Berlin, Germany) implantation is prevalent in patients with severe heart failure. However, clinical outcomes of pediatric patients on long-term BHE support remain mainly unknown. This study aimed to report our clinical experience with long-term support of pediatric patients with severe heart failure supported by BHE VAD. Clinical outcomes of 11 patients (median age 8.4 months; two male), who underwent LVAD implantation of the Berlin Heart EXCO® (BHE) VAD (Berlin Heart, Berlin Heart AG, Berlin, Germany) between 2013 and 2017 at our institution were reviewed. The median support period was 312 (range 45-661) days and five patients were supported for more than 1 year. The longest support duration was 661 days. No mortality occurred, and six patients were successfully bridged to heart transplantation, while three patients were successfully weaned off the device. Two patients are currently on BHE support while they await heart transplantation. Four patients had cerebral bleeding or infarction, but only one case of persistent neurological deficit occurred. No fatal device-related infection occurred during LVAD support. BHE VAD can provide long-term support for pediatric patients with severe heart failure with acceptable mortality and morbidity rates with long-term support.

Infections in patients after Berlin Heart® EXCOR assist device implantation.

OBJECTIVES: Berlin Heart® EXCOR devices (BHED) are ventricular assist devices (VAD) used mainly as a bridge to heart transplantation (HT) in pediatric population. The aim of our study is to report the infections diagnosed in adult patients undergoing a BHED implantation. METHODS: Adult patients receiving a BHED between Jul 2009 and Oct 2017 at our institution were included. Infections were classified according to the International Society of Heart and Lung Transplantation definitions in VAD-Specific (VAD-S), VAD-Related (VAD-R) and non-VAD (N-VAD). RESULTS: Fifteen patients underwent BHED implantation, which was maintained for a mean of 92 (19-195) days. Infection occurred in 13 patients who developed 36 infectious episodes: 5 VAD-S (5 cannula infections); 8 VAD-R (5 bloodstream infections and 3 mediastinitis) and 24 N-VAD (7 urinary tract infections, 6 Cytomegalovirus diseases and others). Overall, 27 (75%) were bacterial, 7 (19.4%) were viral and there was one (2.7%) fungal infection. Eleven patients underwent HT and all of them developed at least one infection after it. In 3 cases, all VAD-R or VAD-S infections were caused by the same etiology as before HT. Their median time of appearance was on day +6 (3-11) after BHED removal and HT. Overall mortality was 6/15 (40%). None of the deaths were related to VAD Infection. CONCLUSIONS: Infection complicated BHED implantation in 86.7% of the patients. Overall, 13.9% were specific of BHED and 22.2% were related. However, infections did not preclude HT in any case and carried no attributable mortality.

Characteristics of deposits and pump exchange in the Berlin Heart EXCOR ventricular assist device: Experience with 67 cases.

Pump exchanges are frequently required in the Berlin Heart EXCOR VAD. We intended to describe the characteristics of pump deposits in a larger patient series and evaluate if changes in our exchange procedure over time have led to increased complications. We reviewed all EXCOR pump exchanges in our institution from July 2004 to October 2014. We gathered data on size and location of pump deposits and exchange procedures. EXCOR devices were implanted in 38 children. Support was LVAD only in 22, BiVAD in 13, and SVAD in 3 cases. Sixty-seven pumps were exchanged. The incidence of pump exchanges per month was higher for smaller pumps and for RVADs vs LVADs. Indications were visible pump deposit in 55, stroke without visible deposit in 5, incorporation of membrane oxygenator in 3, pump size change in 2, and sepsis in 1 case, respectively. Deposits were located in the outflow valve in 73%, inflow valve in 22%, pump body in 3%, and outflow cannula in 3%. EXCOR pumps are predominantly exchanged for deposits, which are most frequently located in the outflow valves. The procedure is now carried out without sedation at the bedside. No major complications were observed during exchanges.

A New 2D Echocardiographic Approach to Evaluate the Membrane and Valve Movement of the Berlin Heart EXCOR VAD Chamber in Pediatric VAD Patients.

The use of Berlin Heart EXCOR VAD (BH) is a validated therapy to bridge pediatric patients to heart transplant. Serial echocardiographic (ECHO) assessment of VAD patients is necessary to support patients' management. This work aims at developing an innovative strategy to evaluate the BH device functioning by ECHO and its interaction with the native heart in a pediatric population. ECHO evaluation of BH membrane movement, and inflow and outflow valves was performed in 2D, 2D-color Doppler, M-mode, and M-mode color Doppler to assess the functioning of the device by direct positioning of the ECHO probe on the BH cannulas and membranes. Forty Berlin Heart EXCOR VAD were analyzed in 18 patients. Seven BH were placed as RVAD and 33 as LVAD. Results evidenced that 14 (21) inflow (outflow) valves presented a mild regurgitation, while 5 inflow (3 outflow) valves presented a moderate regurgitation. In three cases, we observed severe valve regurgitation with back flow in the left ventricle/right atrium. In both cases, the BH chambers were substituted, but we observed that in one case the regurgitation was due to cannulas compression, while in the other case it was due to valve malfunctioning. The M-mode and the ECHO of the membranes and valves permitted to appreciate the beat phenomenon to assess if the native heart and the BH are working in opposite or in the same phase. The membrane ECHO permits evaluation of minimal changes in membrane movement to assure the completely empty-completely fully work modality. Systematic ECHO assessment of BH chamber might support the BH programming and the detection of anomalous VAD-heart interaction.

Evolution of Biventricular Loading Condition in Pediatric LVAD Patient: A Prospective and Observational Study.

The aim of this study was to describe the echocardiographic trend of left ventricular (LV) and right ventricular (RV) function after implantation of a pulsatile flow left ventricular assist device (LVAD) in children. From 2013 to 2016, we prospectively evaluated 13 consecutive pediatric Berlin Heart EXCOR LVAD patients. Clinical and echocardiographic data were collected at baseline, within 24 h after implantation and monthly until LVAD explant. Median age and weight at the implantation was 8 (4-23) months and 5 (4.6-8.3) kg at the time of implantation, respectively. All were affected by dilated cardiomyopathy. Average LVAD support time was 226.2 ± 121.2 days. Nine (70%) were transplanted, 4 (30%) died. LV end-systolic and end-diastolic volumes were reduced until the follow up of two months (P = 0.019 and P = 0.001). A progressive increase in RV dimensions was observed. After 4 months of follow up, RV fractional area change worsening was statistically related with the deterioration of LV unloading (P = 0.0036). Four patients needed prolonged inotropic support for RV failure. Pulsatile LVAD in pediatrics is followed by an early and mid-term LV unloading, as expressed by a decrease in LV volumes and diameters at echocardiogram. The effects of unloading do not remain stable at long term follow up. RV function improved in the acute phase, but a progressive dilatation of RV was noted over time. In some patients, RV failure might lead to the need of an increase of inotropic support at long term follow up.

Outcomes of Berlin Heart EXCOR® pediatric ventricular assist device support in patients with restrictive and hypertrophic cardiomyopathy.

The outcomes of pediatric ventricular assist device support in patients with diastolic heart failure have not been well described. This study reviews the North American experience with Berlin Heart EXCOR® ventricular assist device implants in children with such physiology. The Berlin Heart clinical database was reviewed. Patients with primary diastolic dysfunction are included in this study. Twenty pediatric patients with restrictive cardiomyopathy (n = 13), hypertrophic cardiomyopathy (n = 3), or congenital heart disease with restrictive physiology (n = 4) who were supported with EXCOR® were identified. Of these, nine (45%) were successfully bridged to transplant, one (5%) weaned from support, and 10 (50%) died after support was withdrawn. Of patients under age 3 years (n = 13), 38.5% survived, whereas those aged 3 or older (n = 7) had 71.4% survival (P = .35). Biventricular assist device (BiVAD) patients experienced a 27.3% survival, vs 77.8% for patients with left ventricular assist device only (P = .07). Primary causes of death included stroke, infection, acidosis, multisystem organ failure, and bleeding. Pediatric patients with diastolic heart failure comprise a high-risk population for mechanical circulatory support. However, half of patients with this physiology have been successfully supported to explant with EXCOR® . The trends toward higher mortality for younger patients and those receiving BiVAD support warrant consideration.

Central Extracorporeal Life Support With Left Ventricular Decompression to Berlin Heart Excor: A Reliable "Bridge to Bridge" Strategy in Crash and Burn Patients.

The aim of this study was to compare patients with severe biventricular heart failure who underwent Berlin Heart Excor implantation with (cardiogenic shock [CS] status) or without the need for preoperative extracorporeal life support (ECLS) as a bridge to long-term device. A total of 40 consecutive patients with severe biventricular heart failure underwent Berlin Heart Excor implantation with (CS status, n = 20, 50%) or without (control, n = 20, 50%) the need for preoperative ECLS as a bridge to long-term device from March 2007 to May 2015 at our institution. Demographics and preoperative baseline characteristics as well as early and long-term outcomes including mortality and complication rates were retrospectively compared between the two groups. There were no statistically significant differences in terms of demographics and most preoperative clinical characteristics. The mean age in the ECLS (CS group) and control group was 43.5 ± 19.4 and 41.3 ± 16.4 (P = 0.705), whereas 20 and 25% of patients were females (P = 1.000). However, patients from the ECLS group had preoperatively higher lactate (P = 0.037), aspartate aminotransferase (P < 0.001), and alanine aminotransferase (P < 0.001) levels, all of them significantly decreased after surgery (P  = 0.004, P = 0.017, and P = 0.001, respectively) and did not show any statistical differences to the corresponding values from the control group (P = 0.597, P = 0.491, and P = 0.339, respectively). Postoperatively, patients from the control and ECLS groups had statistically similar incidences of liver failure (30 vs. 35%, P = 0.736), renal failure (45 vs. 70%, P = 0.110), need for reopening (35 vs. 60%, P = 0.113), major cerebrovascular events (35 vs. 30%, P = 0.736), sepsis (10 vs. 25%, P = 0.407), wound infection (20 vs. 30%, P = 0.716), abdominal ischemia requiring surgery (28.6 vs. 36.8%, P = 0.719), and acute respiratory distress syndrome (25 vs. 35.3%, P = 1.000). The proportion of patients who were bridged to transplantation was statistically similar between the ECLS and the control groups (40 vs. 52.6%, P = 0.429). Furthermore, there were no statistically significant differences in terms of early (Breslow [generalized Wilcoxon] P = 0.907) and long-term (log-rank [Mantel-Cox] P = 0.787) overall cumulative survival accounting for 30-day survival of 75 versus 75%, 6-month survival of 60 versus 55%, 1-year survival of 54 versus 40%, and 7-year survial of 47 versus 40% in the control and ECLS groups, respectively. ECLS in critical CS as a bridge to implantation of the Berlin Heart Excor ventricular assist device is safe and is associated with improvement in end-organ function leading to similar excellent early and long-term survival and incidences of major complications as in patients without the need for preoperative ECLS support.

Case Report: Sustained ventricular arrhythmia in a child supported by a Berlin heart EXCOR ventricular assist device.

Mechanical circulatory support is an established therapy to support failing hearts as a bridge to transplantation. Although tolerated overall, arrhythmias may occur after ventricular assist device implantation and can complicate patient management. We report on an infant with dilated cardiomyopathy who developed ventricular tachycardia followed by recalcitrant ventricular fibrillation, refractory to comprehensive medical therapy post Berlin Heart EXCOR® (BHE) implant.

Cardiomyocyte deoxyribonucleic acid damage and cardiac recovery in paediatric dilated cardiomyopathy.

OBJECTIVES: The goal of this study was to identify the clinical significance of the deoxyribonucleic acid (DNA) damage response marker, phosphorylated H2A histone variant X, on the bridge to recovery in low-weight paediatric patients with dilated cardiomyopathy (DCM) after having a Berlin Heart EXCOR implanted. METHODS: Consecutive paediatric patients with DCM who had an EXCOR implanted for DCM at our hospital between 2013 and 2021 were reviewed. Patients were classified into 2 groups according to the degree of DNA damage in the left ventricular cardiomyocytes-the low DNA damage group and the high DNA damage group-using the median value as the threshold. We examined and compared the preoperative factors and histologic findings associated with cardiac functional recovery following the explant procedure in the 2 groups. RESULTS: Competing outcome analysis of 18 patients (median body weight, 6.1 kg) showed that the incidence of an EXCOR explant was 40% at 1 year after the implant procedure. Serial echocardiography revealed significant left ventricular functional recovery in the low DNA damage group 3 months after the implant. The univariable Cox proportional hazards model revealed that the percentage of phosphorylated H2A histone variant X-positive cardiomyocytes was the significant factor associated with cardiac recovery and the EXCOR explant (hazard ratio, 0.16; 95% confidence interval, 0.027-0.51; P = 0.0096). CONCLUSIONS: The degree of DNA damage response to the EXCOR implant may aid in predicting the bridge to recovery with EXCOR among low-weight paediatric patients with DCM.

Successful bridge to transplantation with long-term support using Berlin heart EXCOR in a child with failing Fontan.

A 2-year-old girl underwent the Fontan operation for aortic valve stenosis, mitral valve stenosis, a hypo-plastic left ventricle, and a non-compacted right ventricle. The patient's cardiac function reduced gradually thereafter, mainly due to systemic ventricular dysfunction. A Berlin Heart EXCOR (BHE) ventricular assist device with a 10-mL pump was implanted at 4 years of age. After 465 days, BHE support without major complications, the patient underwent heart transplantation. A safe and long-term BHE support was achieved with proper case selection and repeated examinations.

Long-term paracorporeal pulsatile mechanical circulatory support in adolescent and adult patients.

OBJECTIVES: Our goal was to analyse adverse events in adolescent and adult patients with the Berlin Heart EXCOR and to assess the outcome of a subsequent heart transplant (HTX). METHODS: From 2006 to 2020, a total of 58 patients (12-64 years old) received a biventricular assist device (BIVAD) at our institution and were included in this study. RESULTS: The causes of biventricular heart failure were nonischaemic cardiomyopathy (62.1%), ischaemic cardiomyopathy (22.4%) and myocarditis (15.5%). The median INTERMACS score was I (I-III). The median age was 49 years (interquartile range, 34-55 years), and 82.8% were male. Causes of death were multiorgan failure (25.0%), septic shock (17.9%), cerebral haemorrhage (14.3%), bleeding (14.3%) and embolic events (14.3%). Major bleeding was more frequent in the patients who died while on BIVADs (60.7 vs 6.7%, P < 0.001). Wound infections were more prevalent in HTX recipients (n = 21, 70.0%). After BIVAD thrombosis, 104 chamber exchanges were performed in 28 patients (48.3%). HTXs were performed in 52.6% of the patients after a BIVAD support time of 316 ± 240 days. The mean time to follow-up of 30 HTX recipients was 1722 ± 1368 days. One-, 6- and 12-month survival after an HTX were 96.7%, 90.0% and 76.7%, respectively. Long-term survival after 5 and 10 years was 69.7%. CONCLUSIONS: Pump thrombosis, infections and bleeding after receiving a BIVAD did not preclude a successful HTX. Although only 50% of patients with BIVADs were successfully given a transplant, long-term survival after an HTX in patients with BIVAD was noninferior compared to that of other recipients.

A Mechanistic Lumped Parameter Model of the Berlin Heart EXCOR to Analyze Device Performance and Physiologic Interactions.

PURPOSE: The Berlin Heart EXCOR (BH) is the only FDA-approved, extracorporeal pulsatile ventricular assist device (VAD) for infants and children with heart failure. Clinicians control four settings on the device-systolic and diastolic drive pressures, device pump rate, and systolic time as a percentage of the pump cycle. However, interactions between BH pneumatics and the native circulation remain poorly understood. Thus, establishing appropriate device size and settings can be challenging on a patient-to-patient basis. METHODS: In this study we develop a novel lumped parameter network based on simplified device mechanics. We perform parametric studies to characterize device behavior, study interactions between the left ventricle (LV) and BH across different device settings, and develop patient-specific simulations. We then simulate the impact of changing device parameters for each of three patients. RESULTS: Increasing systolic pressure and systolic time increased device output. We identified previously unobserved cycle-to-cycle variations in LV-BH interactions that may impact patient health. Patient-specific simulations demonstrated the model's ability to replicate BH performance, captured trends in LV behavior after device implantation, and emphasized the importance of device rate and volume in optimizing BH efficiency. CONCLUSION: We present a novel, mechanistic model that can be readily adjusted to study a wide range of device settings and clinical scenarios. Physiologic interactions between the BH and the native LV produced large variability in cardiac loading. Our findings showed that operating the BH at a device rate greater than the patient's native heart decreases variability in physiological interactions between the BH and LV, increasing cardiac offloading while maintaining cardiac output. Device rates that are close to the resting heart rate may result in unfavorable cardiac loading conditions. Our work demonstrates the utility of our model to investigate BH performance for patient-specific physiologies.

Outcomes in small children on Berlin Heart EXCOR support: age and body surface area as clinical predictive factors.

OBJECTIVES: The Berlin Heart EXCOR (BHE) offers circulatory support across all paediatric ages. Clinically, the necessary care and the outcomes differ in various age groups. The EUROMACS database was used to study age- and size-related outcomes for this specific device. METHODS: All patients <19 years of age from the EUROMACS database supported with a BHE between 2000 and November 2021 were included. Maximally selected rank statistics were used to determine body surface area (BSA) cut-off values. Multivariable Cox proportional hazard regression using ridge penalization was performed to identify factors associated with outcomes. RESULTS: In total, 303 patients were included [mean age: 2.0 years (interquartile range: 0.6-8.0, males: 48.5%)]. Age and BSA were not significantly associated with mortality (n = 74, P = 0.684, P = 0.679). Factors associated with a transplant (n = 175) were age (hazard ratio 1.07, P = 0.006) and aetiology other than congenital heart disease (hazard ratio 1.46, P = 0.020). Recovery rates (n = 42) were highest in patients with a BSA of <0.53 m2 (21.8% vs 4.3-7.6% at 1 year, P = 0.00534). Patients with a BSA of ≥0.73 m2 had a lower risk of early pump thrombosis but a higher risk of early bleeding compared to children with a BSA of <0.73 m2. CONCLUSIONS: Mortality rates in Berlin Heart-supported patients cannot be predicted by age or BSA. Recovery rates are remarkably high in the smallest patient category (BSA <0.53 m2). This underscores that the BHE is a viable therapeutic option, even for the smallest and youngest patients.

Wound Infections in Adult Patients after Berlin Heart® EXCOR Biventricular Assist Device Implantation.

The Berlin Heart® EXCOR is a paracorporeal, pulsatile ventricular assist device used in patients of all age groups. However, adolescent and adult patients on EXCOR support are scarcely explored. Herein, we present a detailed description of infectious complications in this patient cohort. From 2006 to 2020, 58 patients received a biventricular assist device (BiVAD) at our institution and were included in this study. Postoperative infections were assessed after BiVAD implantation and subsequent heart transplantation (HTx). A Berlin Heart® EXCOR BiVAD was implanted as a bridge to transplantation in 58 patients (12-64 years). Most patients were INTERMACS I, and their median age was 49 years. Wound infections (WI) specific to the ventricular assist device (VAD) occurred in 31 (53.4%) patients with a mean time of 113 ± 155 days after BiVAD implantation. HTx was performed in 30 (51.7%) patients and thereof 10 (33.3%) patients developed at least one WI post-HTx. The mean time of WI after HTx was 17 ± 14 days. In four cases, WIs were caused by the same pathogen as before HTx. According to our institutional BiVAD wound classification, the mean wound score was 3. The VAD-specific wound infections were manageable and did not increase mortality nor precluded HTx in Berlin Heart® EXCOR patients. No specific risk factors for VAD-specific wound infections could be identified.