Berlin Heart EXCOR Research Articles

Successful support of biventricular heart failure in an adult patient by the Berlin Heart EXCOR system as a bridge to transplant: literature review.

Right heart failure is ahuge challenge in left ventricular assist device therapy and its occurrence is associated with increased mortality and morbidity. Other options include the use od temporary right ventricular assist device, use of two continous flow biventricular assist devices, use of total artificial heart and the use of paracorporeal biventricular assist devices.In this report we described the successful use of the paracorporeal pulsatile Berlin Heart EXCOR system as abridge to transplant in a62 years old patient with end-stage biventricular heart failure (Tab. 1, Fig. 3, Ref. 22). Keywords: biventricular heart failure, mechanical circulatory support, biventricular assist device, Berlin Heart EXCOR system, heart transplantation.

Management of Cannula Wound Problems with Vacuum-Assisted Therapy for a Child Who Received Berlin Heart EXCOR Implantation.

A child being supported with an extracorporeal ventricular assist device, such as the Berlin Heart EXCOR (Berlin Heart GmbH, Berlin, Germany), must have at least 2 large cannulae for a long period. Management of cannula wounds is crucial since a cannula forms a track of prosthetic material passing the mediastinum to the heart. Deep wound complications, if they occur, can be troublesome and difficult to control with conventional methods. We applied vacuum-assisted closure to a patient who had Berlin-Heart EXCOR and a gap at the cannulation site. Herein, we describe the technical aspects of management in detail.

The little ones are catching up-mechanical circulatory support with a pulsatile pneumatic ventricular assist device.

It has been a little over 3 decades since the first child, 8 years old, was bridged to heart transplantation with an adult-sized Berlin Heart EXCOR ventricular assist device (VAD) (Berlin Heart AG, Berlin, Germany) with a ventricle of 50 ml of stroke volume. This 27-kg bodyweight boy suffered from terminal heart failure and life-threatening ventricular tachycardia, the sequelae of a congenital heart defect. With the EXCOR, cardiogenic shock could be reversed and after no more than an 8-day waiting period on the pump, orthotopic heart transplantation was successful [1]. During the following year, this pump underwent miniaturization with 25/30-ml pumps fitting children above 15 kg bodyweight. This was the kick-off for multiple support in children, first reported in those with fulminant myocarditis: in the mid-1990s, the outcome of fulminant myocarditis with cardiogenic shock was poor. With the artificial replacement of heart function in 4 previously healthy children suffering from myocarditis with low cardiac output and multiorgan failure, the temporary support with biventricular assist devices (BVAD) was lifesaving for all 4 [2]. We learned during those years that prolonged VAD support was an effective method not only in adults but also in children.

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

Interhospital transfers of pediatric patients on the Berlin Heart Excor have been published on an occasional basis. Nowadays medicine evolves away from just feasibility towards quality and safety issues. Management tools like risk analysis have found their way into clinical practice. 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. Besides a risk analysis, we also describe our training and simulation protocol.

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

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. 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. 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. 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.

First-in-man use of the EXCOR Venous Cannula for combined cavopulmonary and systemic ventricular support in Fontan circulation failure

The Berlin Heart EXCOR system has been developed for mechanical circulatory support (MCS) of pediatric patients with terminal heart failure. A recently introduced iteration of the system (EXCOR Venous Cannula, Berlin Heart GmbH, Berlin, Germany) is dedicated to support patients with univentricular physiologies by facilitating implantation of the EXCOR device into the Fontan pathway. We report the worldwide first successful implantation of the EXCOR Venous Cannula in a biventricular support concept for a 12-year-old boy (140 cm, 42.7 kg, body surface area 1.29 m2, Pedimacs Level 2) with severe systemic ventricle dysfunction and failing Fontan circulation. Surgery comprised of standard Berlin Heart EXCOR implantation to support the failing ventricle (12 mm apex / staged 12/9 mm arterial cannula / 50 ml ventricle). Cannulation for subpulmonary EXCOR support was achieved by performing a total cavopulmonary connection takedown with subsequent anastomosis of a staged 12/9 mm outflow cannula to the pulmonary artery and implantation of a 14/18 mm EXCOR Venous Cannula as subpulmonary inflow graft, which was connected to the superior vena cava and Fontan tunnel using GORE-TEX grafts. In the postoperative course, cardiac output and central venous pressures rapidly improved with hepatic and renal functions restoring to age- and condition-specific norm values. The Berlin Heart EXCOR Venous Cannula is the first system for standardized mechanical support of Fontan circulatory failure. In our patient, subpulmonary support restoring a biventricular circulation combined with systemic MCS normalized hemodynamics and reversed end-organ dysfunction.

Ventricular assist device support in children: better, but not perfect

Ventricular assist device (VAD) support of children as bridge to transplantation or recovery can be associated with major morbidity. In infants and small children, VAD support is especially challenging and restricted to para-corporeal devices. Additional anatomic, physiologic and access limitations, along with coagulation system immaturity, further increase VAD complications in these small children. In the current issue of the EJCTS, Rohde et al. reviewed the European Registry for Patients with Mechanical Circulatory Support database and identified 230 children who received the Berlin Heart EXCOR device between 2011 and 2021. They found that 46/230 (20%) had cerebrovascular accident (CVA) and that majority of these (71%) occurred within 90 days following VAD implantation. They also identified pump thrombosis and need for right VAD as risk factors for CVA [1]. In the original EXCOR study, reported CVA was 29% while transplantation was achieved in 88% of patients [2]. This was in a controlled trial setting with very strict selection criteria. When the follow-up extended study was published, 36% of children died and 55% reached transplantation [3]. Most importantly, CVA and multisystem organ failure were the most common reasons for death after VAD [4]. The clinical experience with the EXCOR device has since increased worldwide and the findings from Rohde are in line with other published reports in children [4, 5]. For example, a report from the Netherlands has shown that 50% of children had CVA, with 68% of those occurring in the first 30 days. Similarly, CVA was the most common cause of death [5]. While the study by Rohde examining a contemporary experience was unable to demonstrate an era impact on CVA occurrence, other reports seem to suggest a trend towards lower CVA rate in the recent era [1, 4, 6]. What can we attribute the improving trends to? Two factors seem to play a significant role: (i) the clinical status of the patient going into VAD implantation and (ii) potential improvements in early postoperative management.

Asistencia de larga duración en pacientes pediátricos: 15 años de experiencia

Background and aimThe aim is to analyse clinical and survival results after the implant of a long-term mechanical assist device in pediatric patients in the end stages of heart failure. MethodsBetween January 2006 and November 2021 34 Berlin Heart EXCOR® devices were implanted in pediatric patients. We analysed preoperative and intraoperative characteristics, together with complications after implant. Outcomes were also evaluated (transplant vs. death). Statistical analysis with STATAIC15. ResultsThe mean age was 51±53 months (1-180), mean weight 17±16kg (2.2-65). Underlying heart disease was myocardiopathy in 68% and congenital heart disease in 32%. The Berlin Heart EXCOR® device was univentricular in 64% of the patients. Surgical indication was bridge to transplant in 97%. Mean duration of mechanical support was 92±105 days (1-511). Postoperative complications were common: 62% infectious and 44% neurological (29% ischaemic and 15% haemorrhagic). Mortality of haemorrhagic strokes 80%, ischaemic 20%. Since 2019, when heparin was changed to bivalirudin, no mortal strokes were observed. 71% of the patients has been transplanted, 29% has died. ConclusionsAs a response to the increasing number of paediatric patients in end stages of congestive heart failure, the use of the Berlin Heart EXCOR® device has spread, especially if the intention is to use it as bridge to transplant. Neurological events, mostly haemorrhagic, are the most feared because of high mortality. Nevertheless, it is an encouraging alternative as a long-term mechanical assist device in children, allowing them to reach the transplant in 71% of the cases.

Cerebrovascular accidents in paediatric patients supported by the Berlin Heart EXCOR.

Ventricular assist device support as a bridge to transplant or recovery is a well-established therapy in children on the cardiac transplant waiting list. The goal of this study was to investigate the incidence of and the associated factors for cerebrovascular accidents in paediatric patients supported by a Berlin Heart EXCOR. All patients <19 years of age supported by a Berlin Heart EXCOR between January 2011 and January 2021 from the European Registry for Patients with Mechanical Circulatory Support were included. In total, 230 patients were included. A total of 140 (60.9%) patients had a diagnosis of dilated cardiomyopathy. 46 patients (20.0%) sustained 55 cerebrovascular accidents, with 70.9% of the episodes within 90 days after the ventricular assist device was implanted. The event rate of cerebrovascular accidents was highest in the first era (0.75). Pump thrombosis and secondary need for a right ventricular assist device were found to be associated with a cerebrovascular accident (hazard ratio 1.998, P = 0.040; hazard ratio 11.300, P = 0.037). At the 1-year follow-up, 44.4% of the patients had received a transplant, 13.1% were weaned after recovery and 24.5% had died. Event rates for mortality showed a significantly decreasing trend. Paediatric ventricular assist device support is associated with important adverse events, especially in the early phase after the device is implanted. Pump thrombosis and the need for a secondary right ventricular assist device are associated with cerebrovascular accidents. Furthermore, an encouragingly high rate of recovery in this patient population was shown, and death rates declined. More complete input of data into the registry, especially concerning anticoagulation protocols, would improve the data.

Neonatal ventricular assist device implantation for high-risk hypoplastic left heart syndrome: How we do it.

Neonatal ventricular assist device implantation for high-risk hypoplastic left heart syndrome: How we do it.

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

OBJECTIVESOur 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).METHODSFrom 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.RESULTSThe 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%.CONCLUSIONSPump 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.

Ventricular assist device support for children with chemotherapy-induced cardiomyopathy and advanced heart failure: Perspectives gained from a single-center experience.

Guidance and data on ventricular assist device (VAD) support for children with chemotherapy-induced cardiomyopathy, particularly within the first 2years after chemotherapy, are limited. We performed a single-center retrospective case series, reviewing medical records of children <18years of age with chemotherapy-induced cardiomyopathy and advanced heart failure (HF) who received durable VAD support. Six patients met inclusion criteria-5 HeartWare™ HVAD, 1 Berlin Heart EXCOR® . Median age at cancer diagnosis was 6years (IQR 4.5-10years). Median dose of anthracycline received was 540mg/m2 (IQR 450-630mg/m2 ). All patients developed HF within 1year after initiation of cancer treatment (median 8months, IQR 6-11.5months) and were initiated on durable VAD support at a median of 8months after completion of cancer treatment (IQR 3.3-43.5months). Four patients had significant right ventricular dysfunction needing oral pulmonary vasodilator therapy, one patient had a major bleeding complication, and two patients had thromboembolic strokes while on VAD support. Median duration of VAD support was 7.5months (IQR 3-11.3months). Two patients underwent VAD explant due to recovery of LV function, one died due to cancer progression, and three underwent heart transplantation. Durable VAD support should be considered as a therapeutic option for children who have advanced HF due to chemotherapy-induced cardiomyopathy, even within 2years of completing cancer treatment. A multi-disciplinary approach is essential for appropriate patient selection prior to implant and to ensure comprehensive care throughout the duration of VAD support.

Successful Explantation of Berlin Heart Excor in Two Young Children.

Berlin Heart EXCOR ventricular assist device (VAD) implantation in children is widely used as bridge-to-heart transplantation. Berlin left ventricular assist device (LVAD) support as a bridge to recovery is rare. There is a scarcity of literature describing systematic evaluation in pediatric VAD explantation. Patient 1. A 3 month old boy presented with acute heart failure secondary to myocarditis. An echocardiogram demonstrated severely depressed left ventricular function. He required ECMO cannulation and was decannulated 11 days later. He continued to be hemodynamically unstable and required Berlin LVAD implantation with the intent to bridge to transplantation. Patient 2. A 3 month old boy presented initially with a heart rate of 250 beats/min and an electrocardiogram showed multifocal atrial tachycardia. An echocardiogram showed severely decreased left ventricular function. He was placed on ECMO due to unstable hemodynamics. He did not tolerate ECMO decannulation due to persistent chaotic atrial rhythm and underwent Berlin LVAD implantation with the intent to bridge to transplantation. After both patients showed evidence of myocardial recovery, they underwent a weaning protocol that includes: screening, trial-off with echocardiography, and trial-off in the catheterization suite. Our patients met the criteria and underwent successful explantation. Explantation of VAD can be successfully performed even in young children with appropriate candidate selection and a multidisciplinary and systematic approach.

In Search for the Right Partner. First Multicenter Results of the Hybrid VAD Procedure cfLVAD and Durable Paracorporeal RVAD

<h3>Purpose</h3> Continuous-flow durable left ventricular assist devices (cfLVAD) has become routine treatment for severe heart failure nowadays. Fully implantable cfLVAD are safe, reduce mortality and allow for high patient comfort. However, right ventricular (RV) failure (early or late after cfLVAD) remains a crucial limitation and is associated with high morbidity and mortality. Temporary RVAD fails to reverse RV-Failure in 9-42%. RV-Failure prediction models exhibit heterogeneous derivation and validation methodologies with insufficient power of prognosis of RV-Failure. Results of cf-BIVAD are limited and application remains "off-label-use" while pulsatile paracorporeal RVAD treatment is approved with excellent data. Pulsatile RVAD flow is precise, physiological and prevents lung hyperperfusion. The purpose of this national multi-center trial was to evaluate the results of the durable Hybrid VAD strategy using 3rd generation continuous flow left ventricular assist devices (cf-LVAD) and a paracorporeal pulsatile right ventricular Assistent device (RVAD). <h3>Methods</h3> We retrospectively analyzed 10 consecutive patients (8 male, 80%; 43.1 ± 17.9 years) who underwent permanent cfLVAD and durable pulsatile RVAD implantation (Berlin Heart EXCOR) subsequently for end-stage heart failure and impaired right heart function. The durable RVAD implantation was performed on CPB and beating heart with a sternotomy approach. Bridge-to-transplantation (BTT) was intended in all cases. The procedure was performed one-staged in 50% of all cases. <h3>Results</h3> INTERMACS class on cfLVAD at time of pulsatile RVAD implantation was class I in 9 (90%) and class II in 1 case (10%) with temporary MCS in 9 cases (90%) using ECLS in 7 (77.8%) and temporary RVAD in 2 patients (22.2%). Upon follow up survival was 70% with 5 (50%) patients transplanted, 2 patients on ongoing hybrid support and 3 patients deceased. Time on hybrid-device was 140.3 ± 122.1 days. <h3>Conclusion</h3> Intention to treat heart failure with cfLVAD alone is comprehensive and sensible if applicable. There is a need for bail-out strategy for early/late RV-Failure beyond temporary RVAD. With our initial results we here provide the very first evidence of the Hybrid VAD support with promising results. Hybrid VAD procedure is associated with good survival (70%) allowing for sufficient preparation for heart transplant (BTT).

Outcome of Paediatric Cardiac Re-Transplantation in the Mechanical Support Era

<h3>Purpose</h3> To review the outcome of paediatric cardiac re-transplantation (reOHTx) in the mechanical cardiac support (MCS) era. <h3>Methods</h3> A retrospective study of patients less than 18 years of age who underwent reOHTx in our Institution. Data were obtained from departmental databases and hospital medical records. <h3>Results</h3> From 1987 to 2021, 21 patients underwent reOHTx. Diagnoses leading to first transplant were dilated cardiomyopathy in 12 (10 idiopathic, 1 post-chemotherapy, 1 related to viral myocarditis), restrictive cardiomyopathy in 1, hypertrophic cardiomyopathy in 1 and congenital heart disease in 7 patients. Mean age at first OHTx was 8 years. Prior to primary transplant, one patient was supported with Levitronix Centrimag LVAD, one with BIVAD, a child with VA-ECMO followed by Berlin Heart EXCOR LVAD and one child with VA-ECMO only. Mean time course between first and second OHTx was 82 months. Eleven patients were mechanically supported as a bridge to reOHTx: 8 with Levitronix Centrimag BIVAD (2 from VA-ECMO), 4 with VA-ECMO, 2 with Berlin Heart EXCOR BIVAD, 2 with Berlin Heart EXCOR LVAD and 1 with Heartware. Mean time on support was 54 days (1-275). There was only one early death after reOHTx. This patient received the second heart 8 days after the first transplant and died from 2 days post reOHTx due to brain hemorrhage. One patient required 2 VA-ECMO runs due to acute graft failure. Two patients required VA-ECMO post reOHTx. Eight patients required renal replacement therapy. Five suffered a cerebrovascular accident. Mean follow up is 112 months. There were 7 late deaths in this period of 34 years, 2 of them related to rejection due to poor compliance with immunosuppressive treatment. <h3>Conclusion</h3> Re-transplantation in children carries a very good outcome. With mechanical cardiac support we can bridge children to reOHTx more effectively. Furthermore, MCS can be also used in acute graft failure or for immunological manipulation in acute rejection.

VAD Support of High-Risk Infants with HLHS: Comparison of Rescue VAD After Prior Palliation versus Primary VAD Insertion

<h3>Purpose</h3> To evaluate outcomes in high-risk infants with hypoplastic left heart syndrome (HLHS) supported with the Berlin Heart Ventricular Assist Device (VAD), comparing those with rescue VAD after prior palliation vs those with primary VAD insertion. <h3>Methods</h3> We reviewed all 11 high-risk infants with HLHS who were supported with the Berlin Heart VAD at our institution. Patients are divided into two categories: bridged to decision (BTD) and bridged to transplant (BTT). Patients categorized as BTD were either status post prior palliation or had delayed referral for treatment and had cardiac failure and severe end-organ injury. Patients categorized as BTT were deemed too high risk for staged palliation and underwent primary VAD insertion along with placement of bilateral pulmonary artery bands and atrial septectomy if needed. The primary outcome was mortality. <h3>Results</h3> 11 patients were supported by the Berlin Heart EXCOR between 2012-2021. <b>BTT</b>: 64% (n=7) of the patients were categorized as BTT (median age = 20 days; median weight = 3.2 kilograms). Elevated panel reactive antibody was present. Median duration of VAD support was 101 days. 71% (n=5) in the BTT group survived to hospital discharge. All 5 (100%) were alive one year after orthotopic heart transplant. <b>BTD</b>: 36% (n=4) of the patients were categorized as BTD (median age = 121.5 days; median weight = 3.8 kilograms). Elevated panel reactive antibody was present in 50% (n = 2). Median duration of VAD support was 212 days. 50% (n=2) in the BTT group survived to hospital discharge. Zero (0%) were alive one year after orthotopic heart transplant. Additional patient data is summarized in Table 1. <h3>Conclusion</h3> Outcomes for VAD insertion in infants with HLHS and end-organ injury after failed prior palliation or delayed referral are suboptimal and not as good as outcomes after primary VAD insertion. Neonates with HLHS at high risk for staged palliation should be considered for primary VAD insertion to facilitate cardiac transplantation.

Ventricular Assist Device Implantation for Infant End-Stage Heart Failure - A Single-Center Experience

<h3>Purpose</h3> Ventricular assist device (VAD) application in children is increasing these days. But, there are many challenges to successful clinical outcomes as a bridge to pediatric heart transplantation in young infants. We present our VAD implantation experience in a single center for pediatric end-stage heart failure in the infant. <h3>Methods</h3> We retrospectively reviewed clinical records of pediatric patients (n=10) under one year old who underwent VAD implantation between January 2018 and August 2021. Primary endpoints were heart transplantation, ongoing VAD support, or death. <h3>Results</h3> The median patient age was 11 month-old (239days old) (range: 3-12 month-old). The median BSA was 0.35m² (range: 0.26-0.45). The leading cause of heart failure requiring VAD support was dilated cardiomyopathy (<i>n</i> = 5), restrictive cardiomyopathy (n=1), myocarditis (<i>n</i> = 1), congenital heart disease (<i>n</i> = 2). There were two cases of the majority with INTERMACS Level 1 and 2 at the time of implant. Six patients (66.6%) had Berlin Heart EXCOR® LVAD, whereas four patients underwent BVAD implantation. The median length of HVAD support was 116 days (range 6-186 days). Among the nine patients, survival during VAD therapy to date is 77.7% (7/9), with four (57.1%) bridged to heart transplantation, two (28.5%) continuing to receive support, one recovery of ejection fraction and weaning from VAD support (14.2%). Posttransplant survival has been 100%, with a median follow-up of 509 days (range 353-830). <h3>Conclusion</h3> An active application of VAD implantation can provide excellent pediatric heart failure management results for very young and small end-stage heart failure patients. Further large-scale multicenter registration and standardization of management could improve clinical outcomes for infant patients with VAD.

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.

Bridging patients in cardiogenic shock with a paracorporeal pulsatile biventricular assist device to heart transplantation-a single-centre experience.

We evaluated the outcome of patients in cardiogenic shock receiving a paracorporeal pulsatile biventricular assist device as a bridge to transplantation. We performed a retrospective single-centre analysis of all patients who received a Berlin Heart Excor® at our institution between 2004 and 2019. A total of 97 patients (90 adults, 7 paediatric) were analysed. Eighty-four patients were in Interagency Registry for Mechanically Assisted Circulatory Support level 1 (80 adults, 4 paediatric). Diagnoses were dilated cardiomyopathy (n = 41), ischaemic cardiomyopathy (n = 17) or myocardial infarction (n = 4), myocarditis (n = 15), restrictive cardiomyopathy (n = 2), graft failure after heart transplant (n = 7), postcardiotomy heart failure (n = 5), postpartum cardiomyopathy (n = 3), congenital heart disease (n = 1), valvular cardiomyopathy (n = 1) and toxic cardiomyopathy (n = 1). All patients were in biventricular heart failure and had secondary organ dysfunction. The mean duration of support was 63 days (0-487 days). There was a significant decrease in creatinine values after assist device implantation (from 1.83 ± 0.79 to 1.12 ± 0.67 mg/dl, P = 0.001) as well as a decrease in bilirubin values (from 3.94 ± 4.58 to 2.65 ± 3.61 mg/dl, P = 0.084). Cerebral stroke occurred in 16 patients, bleeding in 15 and infection in 13 patients. Forty-eight patients died on support, while 49 patients could be successfully bridged to transplantation. Thirty-day survival and 1-year survival were 70.1% and 41.2%, respectively. A pulsatile biventricular assist device is a reasonable therapeutic option in cardiogenic shock, when immediate high cardiac output is necessary to rescue the already impaired kidney and liver function of the patient.

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

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. 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. 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. 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.