Outcomes With Ventricular Assist Device Versus Extracorporeal Membrane Oxygenation as a Bridge to Pediatric Heart Transplantation

Extracorporeal membrane oxygenation (ECMO) has long been the sole means of mechanical support for pediatric patients with end‐stage cardiac failure, but has a high waitlist mortality and a reported survival to hospital discharge of less than 50%. The purpose of this study was to compare waitlist mortality and survival for ECMO versus ventricular assist device (VAD) support. A review was conducted of all patients listed for heart transplantation (HTx) since 2002 and requiring mechanical support. VAD support has been available from 2004 (Berlin Heart Excor Pediatrics). Competing risks analysis was used to model survival to one of four outcomes (HTx, death on waitlist, delisting, improvement). Thirty‐six patients were on mechanical support while awaiting HTx (21 ECMO, 12 VAD, three both). Median age at listing was 1.2 years (birth–16.6 years) for ECMO and 11.3 years (0.3–14.6 years) for VAD. Diagnosis was cardiomyopathy in 33% for ECMO and 93% for VAD. Median time to HTx was 37 days (1–930) overall, 20 days (1–85) for ECMO, and 39 days (5–108) for VAD. Mechanical support was associated with increased odds of HTx (hazard ratio [HR] 2.4 [1.7–3.3], P < 0.0001) but also delisting or death waiting (HR 3.0 [1.1–7.8], P = 0.03). Waitlist mortality of 38% on ECMO was reduced to 13% with VAD use. Survival post‐HTx to hospital discharge was better in the group on VAD support (92 vs. 80%). Pediatric patients requiring mechanical support as a bridge to HTx have short wait times but high waitlist mortality. Those patients who survived to be put on the Berlin Heart Excor Pediatric device based on individualized clinical decision making then had a lower waitlist mortality, a longer duration of support, and a higher survival to transplantation and hospital discharge.     

Incidence of healthcare-associated infections in a pediatric population with an extracorporeal ventricular assist device

During the last decade, ventricular assist devices (VADs) have become a precious tool to support children with end-stage heart failure. However, thromboembolic events, bleeding, and infections may have a considerable impact on outcome. We retrospectively analyzed the incidence of healthcare-associated infections (HAIs) in nine patients supported by EXCOR Pediatric (Berlin Heart [BH]) VAD in a pediatric cardiosurgical intensive care unit between January 1, 2009 and March 31, 2011 (27 months). Median age was 8 months (interquartile range [IQR] 6-11), median weight 7.5 kg (IQR 4.5-8.5). Seven patients were supported with a left VAD, two with a biventricular VAD (BiVAD). Six patients with a left VAD underwent heart transplant after 89 days (median, IQR 41-143) of support. One patient is still on the waiting list. All patients with BiVAD died after 12 days of assistance due to VAD malfunction. Sixteen HAIs were reported in five out of nine patients (56%). All infected patients were supported by a left VAD. When compared with noninfected patients, they had a longer mechanical support period (median 131 days, IQR 75-164, vs. 25 days, IQR 11-61, P = 0.03), a longer intensive care unit stay (median 159 days, IQR 85-188, vs. 48 days, IQR 17-87, P = 0.06) and a longer length of hospital stay (median 186 days, IQR 105-222, vs. 64 days, IQR 34-113, P = 0.06). Overall, nine mechanical devices were replaced for thromboembolic issues, most of them (67%) in patients with VAD-related infections. Overall, infection rate was 17.6 per 1000 patients days, 1.3 BH endocarditis per 1000 BH days, 4.0 surgical sites infections per 1000 BH days, 12.5 central line-associated blood stream infections per 1000 central venous catheter days, 5 catheter-associated urinary tract infections per 1000 urinary catheter days, and 13.5 ventilator-associated pneumonia cases per 1000 mechanical ventilation days. Overall, VAD-related infections were 5.4 per 1000 BH days. Of the 17 isolated pathogens, 53% were Gram-negative rods, with a prevalence of Pseudomonas aeruginosa (35.3%). Four bacteria were multidrug resistant (25%), three were carbapenem-resistant P. aeruginosa (50% of all isolated pseudomonads), and one was a methicillin-resistant S. aureus. VADs used as a bridge to cardiac transplantation are associated with a large number of HAIs. Patients with infected VADs were admitted for longer time in intensive care and in hospital with increased healthcare costs but with no impact on survival.     

Pneumatic pulsatile ventricular assist device as a bridge to heart transplantation in pediatric patients

Despite the remarkable advances with the use of ventricular assist devices (VAD) in adults, pneumatic pulsatile support in children is still limited. We report on our experience in the pediatric population. A retrospective review of 17 consecutive children offered mechanical support with Berlin Heart as a bridge to heart transplant from February 2002 to April 2010 was conducted. The median patient age was 3.9 years (75 days to 13.3 years). The median patient weight was 14.1 kg (2.9–43 kg). Before VAD implantation, all children were managed by multiple intravenous inotropes and mechanical ventilation (14) or extracorporeal membrane oxygenation (3). All patients had right ventricular dysfunction. Nine patients required biventricular mechanical support (BVAD), but in all other cases a single left ventricular assist device proved sufficient (47%). The median duration of VAD support was 47 days (1–168 days). The median pre‐VAD pulmonary vascular resistance index (Rpi) was 5.7 WU/m² (3.5 to 14.4 WU/m²). Eleven patients (65%) were successfully bridged to heart transplantation after a median duration of mechanical support of 68 days (6–168 days). Six deaths occurred (35%), three for neurological complications, one for sepsis, and two others for device malfunctioning. Since 2007, the survival rate of our patients has increased from 43% to 80%, and the need for BVAD has decreased from 86% to 30%. In two patients with Rpi >10 WU/m², unresponsive to pulmonary vasodilatator therapy, Rpi dropped to 2.2 and 2 WU/m² after 40 and 23 days of BVAD support, respectively. Seven patients (41%) required at least one pump change. Of 11 patients undergoing heart transplant, four developed an extremely elevated (>60%) panel reactive antibody by enzyme‐linked immunosorbent assay, confirmed by Luminex. All of them experienced at least one acute episode of rejection in the first month after heart transplant, needing plasmapheresis. The survival rate after heart transplantation was 100% with a median follow‐up of 25.4 months (6 days to 7.7 years). Mechanical support in children with end‐stage heart failure is an effective strategy as a bridge to heart transplantation with a reasonable morbidity and mortality. BVAD support may offer an additional means to reverse extremely elevated pulmonary vascular resistance.     

The Berlin Heart EXCOR Pediatrics—The SickKids Experience 2004–2008

The ventricular assist device (VAD) Berlin Heart EXCOR Pediatrics was utilized at our institution since 2004 for bridging pediatric patients to cardiac transplantation or myocardial recovery. The present study reviewed our results following VAD implantation. We retrospectively reviewed patients that underwent implantation of a VAD between October 2004 and October 2008. Data collected included age at implantation, gender, weight, underlying disease, pre‐ and postdevice clinical status, complications, and outcome. Fifteen patients were identified (9 female and 6 male, average age: 8.8 years, range 0.3–14.8; average weight 31.1 kg, range 5.2–86.4). Indications for VAD support were dilated cardiomyopathy in 14 patients and progressing heart failure with a single ventricle physiology (bidirectional Glenn shunt) in one patient. Three patients (20%) were bridged from extracorporeal membrane oxygenation to VAD. Average support was 29 (1–108) days. Fourteen patients were on a bi‐VAD, one patient (single ventricle) had single VAD support. Three patients developed mediastinal/pericardial fluid collections, requiring surgical exploration in two, and drain insertion in one. Three patients presented with neurological symptoms. In two patients, a total of three blood pumps were exchanged due to thrombus formation. No patient was weaned off the VAD; two patients (13%) died on the VAD. All surviving patients are neurologically intact at follow‐up. In our experience, VAD support provides an effective means of bridging children with advanced dilated cardiomyopathy or heart failure to transplantation with a relatively small number of complications and deaths given the complexity of the patient population.     

Ventricular Assist Device in Single‐Ventricle Heart Disease and a Superior Cavopulmonary Anastomosis

Our objective is to describe the use of a ventricular assist device (VAD) in single‐ventricle patients with circulatory failure following superior cavopulmonary anastomosis (SCPA). We performed a retrospective chart review of all single‐ventricle patients supported with a VAD following SCPA. Implantation techniques, physiologic parameters while supported, medical and surgical interventions postimplant, and outcomes were reviewed. Four patients were supported with an EXCOR Pediatric (Berlin Heart Inc., The Woodlands, TX, USA) following SCPA for a median duration of 10.5 days (range 9–312 days). Selective excision of trabeculae and chords facilitated apical cannulation in all patients without inflow obstruction. There were two pump exchanges in the one patient supported for 312 days. Two patients were evaluated by cardiac catheterization while supported. Three of four patients were successfully bridged to transplantation. One patient died while supported. All patients had significant bleeding at the time of transplantation, and one required posttransplant extracorporeal membrane oxygenation with subsequent full recovery. VAD support can provide a successful bridge to transplantation in patients with single‐ventricle circulation following SCPA. A thorough understanding of the challenges encountered during this support is necessary for successful outcomes.     

Pulsatile mechanical cardiac assistance in pediatric patients with the Berlin heart ventricular assist device

Mechanical cardiac assistance for neonates, infants, children and adolescents may be accomplished with pulsatile ventricular assist devices (VAD) instead of extracorporeal membrane oxygenation or centrifugal pumps. The Berlin Heart VAD consists of extracorporeal, pneumatically driven blood pumps for pulsatile univentricular or biventricular assistance for patients of all age groups. The blood pumps are heparin-coated. The stationary driving unit (IKUS) has the required enhanced compressor performance for pediatric pump sizes. The Berlin Heart VAD was used in a total number of 424 patients from 1987 to November 2001 at our institution. In 45 pediatric patients aged 2 days-17 years the Berlin Heart VAD was applied for long-term support (1-111 days, mean 20 days). There were three patient groups: Group I: "Bridge to transplantation" with various forms of cardiomyopathy (N = 21) or chronic stages of congenital heart disease (N = 9); Group II: "Rescue" in intractable heart failure after corrective surgery for congenital disease (N = 7) or in early graft failure after heart transplantation (N = 1); and Group III: "Acute myocarditis" (N = 7) as either bridge to transplantation or bridge to recovery. Seventeen patients were transplanted after support periods of between 4 and 111 days with 12 long-term survivors, having now survived for up to 10 years. Five patients (Groups I and III) were weaned from the system with four long-term survivors. In Group II only one patient survived after successful transplantation. Prolonged circulatory support with the Berlin Heart VAD is an effective method for bridging until cardiac recovery or transplantation in the pediatric age group. Extubation, mobilization, and enteral nutrition are possible. For long-term use, the Berlin Heart VAD offers advantages over centrifugal pumps and ECMO in respect to patient mobility and safety.     

The combined use of extracorporeal life support and the Berlin Heart pulsatile pediatric ventricular assist device as a bridge to transplant in a toddler

There is a very limited published material about experience with long-term pediatric mechanical circulatory support as a bridge to heart transplant. We report on a 2-year-old, 12 kg boy admitted with 2-week history of low-grade fever, ear pain, pulmonary edema, and congestive heart failure. Trans-thoracic echocardiography confirmed severe myocardial dysfunction with a left ventricular ejection fraction of 0.20 and percentage shortening of 13. After 2 days of ventilatory and inotropic support, the patient continued to deteriorate and subsequently required femoro-femoral extracorporeal life support (ECLS). This was later complicated by a progressive coagulopathy and massive bleeding. On day 17, a pulsatile pediatric paracorporeal biventricular assist device (VAD) (Berlin Heart) was implanted. The patient's condition improved significantly with all coagulopathies corrected, and the patient was extubated 21 days later. After 109 days of bi-VAD support, the patient was successfully transplanted and discharged home 45 days post transplant. Our early experience with initial ECLS bridge to VAD and subsequently to transplant was encouraging. It allowed for additional time to select the ideal organ donor and optimize the recipient's comorbid condition and multiorgan failure. VAD provides an additional armamentarium of circulatory support in pediatric patients with severe heart failure.     

Results of the European Clinical Trial of Arrow CorAide Left Ventricular Assist System

The aim of this study was to evaluate the safety and performance of the Arrow CorAide left ventricular assist system (LVAS) (Arrow International, Reading, PA, USA), a continuous‐flow left ventricular assist device, as bridge to transplantation or recovery as well as destination therapy in patients with New York Heart Association (NYHA) class IV heart failure. Twenty‐one patients were implanted with the CorAide LVAS between February 2005 and February 2006 in a prospective, multicenter, nonrandomized trial. Seventeen patients (81%) survived to >180 days or to transplantation. The cumulative time on device was 16.58 patient years (range 23–796 days, median 192 days). No intraoperative technical issues were observed at the time of implantation. Of the 21 implants, nine patients died on device, two were converted to other devices, and 10 were transplanted. Three patient deaths were attributed to pump polymer coating delamination. Postmortem device inspection determined delamination of the polymer coating on the pump's internal surface to be the cause of the late hemolysis and sudden fatal pump stops. No embolic or driveline infection event was recorded. The automatic flow control algorithm functioned reliably throughout the trial. Primary performance trial endpoint was achieved with 81% survival to 180 days or transplantation. Delamination of the polymer coating on the internal surface of the pump with resultant hemolysis and pump stops was the sole major device event in this trial. Elimination of the polymer coating and replacement with an amorphous carbon coating has resolved this in preclinical testing, prior to initiation of further clinical testing of this device.     

European experience of DuraHeart™ magnetically levitated centrifugal left ventricular assist system

Objective: The DuraHeart (Terumo Heart, Inc., Ann Arbor, Michigan, USA) is the world's first approved magnetically levitated centrifugal left ventricular assist system designed for long-term circulatory support. We report the clinical outcomes of 68 patients implanted with the DuraHeart as a bridge to cardiac transplantation in Europe. Methods: Sixty-eight patients with advanced heart failure (six females), who were eligible for cardiac transplantation were implanted with the DuraHeart between January 2004 and July 2008. Median age was 58 (range: 29–74) years with 31% over 65 years. Thirty-three of these patients received the device as a part of the European multi-center clinical trial. Survival analyses were conducted for 68 patients and other safety and performance data were analyzed based on 33 trial patients. Results: Mean support duration was 242 ± 243 days (range: 19–1148, median: 161) with a cumulative duration of 45 years. Thirty-five patients (51%) remain ongoing, 18 transplanted, 1 explanted, and 14 died during support with a median time to death of 62 days. The Kaplan–Meier survival rate during support was 81% at 6 months and 77% at 1 year. Of the 13 patients (21%) supported for >1 year, 4 supported for >2 years, 1 supported >3 years, 2 transplanted, 2 died, and 9 ongoing with a mean duration of 744 ± 216 days (range: 537–1148, median: 651). Major adverse events included driveline/pocket infection, stroke, bleeding, and right heart failure. There was no incidence of pump mechanical failure, pump thrombosis, or hemolysis. Conclusions: The DuraHeart was able to provide safe and reliable long-term circulatory support with an improved survival and an acceptable adverse event rate in advanced heart failure patients who were eligible for transplantation.     

Neurological Complications During Pulsatile Ventricular Assistance With the Berlin Heart EXCOR in Children: Incidence and Risk Factors

The aim of this study is to describe the incidence of brain injury (BI) in children with end‐stage cardiac failure who were supported with the Berlin Heart EXCOR ventricular assist device (VAD) as a bridge to heart transplantation. Between January 2002 and January 2012, all patients <18 years of age who underwent the implantation of the Berlin Heart EXCOR at Bambino Gesú Children's Hospital were included. A total of 25 patients were included in this study. Median age and weight at implantation were 22.4 months (range 3.6–154.2) and 10 kg (range 4.5–36), respectively. Diagnosis included cardiomyopathy (n = 20) and congenital heart disease (n = 5). Eleven patients received atrial cannulation. Nine patients underwent biventricular assist device support. Seven patients underwent extracorporeal membrane oxygenation before the implantation of the EXCOR VAD. Median duration of VAD support was 51 days (range 2–167). Nine patients had evidence of acute BI including intracranial hemorrhage (n = 5) and cerebral ischemia (n = 4). Freedom from BI at 30, 60, and 90 days from VAD implantation was 80.7, 69.9, and 43.3%, respectively. Weight <10 kg at implantation was significantly associated with BI. BI is a frequent complication among children supported with EXCOR VAD and is associated with lower weight at implantation. However, our data do not support the association between size and BI. Future prospective multicenter studies are warranted to further help understand the etiology and the impact of BI and to improve functional outcomes for children undergoing EXCOR VAD mechanical support.     

The Use of Ventricular Assist Device Support in Children: The State of the Art

Improved survival, recognition, and management of patients with congenital heart disease have increased the number of pediatric patients with ventricular dysfunction. Many of these patients require mechanical support to bridge to transplant or recovery. Development of pediatric ventricular assist devices has lagged behind adult devices. Until recently, adult devices were used in pediatric patients, with suboptimal results in the smaller patient population. Extracorporeal membrane oxygenation can be life saving, but is a poor choice for long‐term support. The Berlin Heart EXCOR (Berlin Heart AG, Berlin, Germany) is a paracorporeal device with a variety of pumps for patients of all sizes. The PumpKIN Trial will compare this device to the Infant Jarvik 2000 (Jarvik Heart, New York, NY, USA) in a prospective, randomized study. The single ventricle population presents unique challenges to placement and proper functioning of assist devices. Data are anecdotal and mortality is high. A registry has been developed to assist in caring for this challenging population.     

Waitlist Outcomes of Liver Transplant Candidates Who Were Reprioritized Under Share 35

Under Share 35, deceased donor (DD) livers are offered regionally to candidates with Model for End‐Stage Liver Disease (MELD) scores ≥35 before being offered locally to candidates with MELD scores <35. Using Scientific Registry of Transplant Recipients data from June 2013 to June 2015, we identified 1768 DD livers exported to regional candidates with MELD scores ≥35 who were transplanted at a median MELD score of 39 (interquartile range [IQR] 37–40) with 30‐day posttransplant survival of 96%. In total, 1764 (99.8%) exports had an ABO‐compatible candidate in the recovering organ procurement organization (OPO), representing 1219 unique reprioritized candidates who would have had priority over the regional candidate under pre–Share 35 allocation. Reprioritized candidates had a median waitlist MELD score of 31 (IQR 27–34) when the liver was exported. Overall, 291 (24%) reprioritized candidates had a comparable MELD score (within 3 points of the regional recipient), and 209 (72%) were eventually transplanted in 11 days (IQR 3–38 days) using a local (50%), regional (50%) or national (<1%) liver; 60 (21%) died, 13 (4.5%) remained on the waitlist and nine (3.1%) were removed for other reasons. Of those eventually transplanted, MELD score did not increase in 57%; it increased by 1–3 points in 37% and by ≥4 points in 5.7% after the export. In three cases, OPOs exchanged regional exports within a 24‐h window. The majority of comparable reprioritized candidates were not disadvantaged; however, 21% died after an export.     

Comparison of Continuous‐Flow and Pulsatile‐Flow Blood Pumps on Reducing Pulmonary Artery Pressure in Patients With Fixed Pulmonary Hypertension

Pulmonary hypertension (PH) is considered as a risk factor for morbidity and mortality in patients undergoing heart transplantation. Recently, left ventricular assist device (LVAD) implantation has been increasingly used in reducing pulmonary artery pressure (PAP) in patients with PH unresponsive to medical therapy. Herein, we aimed to compare the efficacy of continuous‐flow and pulsatile‐flow blood pumps on the improvement of PH in mechanical circulatory support patients. Twenty‐seven patients with end‐stage heart failure who underwent LVAD implantation surgery were enrolled. Fifteen of them (55.6%) had continuous‐flow pump (HeartWare Ventricular Assist System, HeartWare, Inc., Miramar, FL, USA), and 12 of them (44.4%) had pulsatile pump (Berlin Heart EXCOR ventricular assist device, Berlin Heart AG, Berlin, Germany). The efficacy of LVADs on the improvement of PH was compared between continuous‐flow and pulsatile pumps by the evaluation of systolic PAP, tricuspid annular plane systolic excursion (TAPSE), right ventricular systolic motion (RVSM), right ventricular ejection fraction (RVEF), and grade of tricuspid insufficiency (TI) for each of the study participants. All of the 15 patients who underwent continuous‐flow blood pump implantation surgery (Group 1) were male with a mean age of 46.9 ± 11.7 years, and in pulsatile‐flow blood pump implanted participants (Group 2), the mean age was 40.6 ± 16.8 years, all of whom were also male (P = 0.259). Mean follow‐up was 313.7 ± 241.3 days in Group 1 and 448.7 ± 120.7 days in Group 2 (P = 0.139). In Group 1, mean preoperative and postoperative systolic PAP were measured as 51.7 ± 12.2 mm Hg and 22.2 ± 3.4 mm Hg, respectively, while those in Group 2 were 54.5 ± 7.5 mm Hg and 33.9 ± 6.4 mm Hg, respectively. A significantly greater decrease in systolic PAP was noticed in patients with continuous‐flow blood pumps (P = 0.023); however, no statistically significant difference was found when we considered the change in TAPSE between study groups (P = 0.112). A statistical significance in the alteration of RVEF, RVSM, and the grade of TI during study visits was not found between the study groups (P = 0.472, P = 0.887, and P = 0.237, respectively). Although the two studied types of LVADs were found to be effective in reducing PAP in heart transplantation candidates with PH, lesser postoperative systolic PAP values were achieved in patients who underwent continuous‐flow pump implantation surgery.     

Evaluation of anticoagulation and nonsurgical major bleeding in recipients of continuous‐flow left ventricular assist devices

Continuous‐flow left ventricular assist device (LVAD) placement has become a standard of care in advanced heart failure treatment. Bleeding is the most frequently reported adverse event after LVAD implantation and may be increased by antithrombotic agents used for prevention of pump thrombosis. This retrospective cohort included 85 adult patients implanted with a Heartmate II LVAD. Major bleeding was defined as occurring >7 days after implant and included intracranial hemorrhage, events requiring 2 units of packed red blood cells within a 24‐h period, and death from bleeding. Primary outcome was intensity of anticoagulation between patients with or without at least one incidence of nonsurgical major bleeding. Major bleeding occurred in 35 (41%) patients with 0.48 events per patient year and a median (IQR) time to first bleed of 134.5 (39.3, 368.5) days. The median (IQR) INR at time of bleed was 1.7 (1.4, 2.5). Median INR during follow‐up did not differ between groups and patients with major bleeding were not more likely to have a supra‐therapeutic INR. Patients who bled were more likely to have received LVAD for destination therapy, to have lower weight, worse renal function, and lower hemoglobin at baseline. Duration of LVAD support and survival were similar between groups with no difference in occurrence of thrombosis. Incidence of nonsurgical major bleeding was not significantly associated with degree of anticoagulation. Certain baseline characteristics may be more important than anticoagulation intensity to identify patients at risk for bleeding after LVAD implant. Modification of anticoagulation alone is not a sufficient management strategy and early intervention may be required to mitigate bleeding impact.     

Complication Profile of the Berlin Heart EXCOR Biventricular Support in Children

In chronic cardiomyopathy, mechanical circulatory support (MCS) plays an increasingly important role for children as the shortage of suitable donor hearts increases waiting time on the transplant list. We report our experience with the paracorporal Berlin Heart EXCOR System (Berlin Heart AG, Berlin, Germany) used as a biventricuclar assist device (BVAD). Nine patients with a BVAD EXCOR system were treated between 2006 and 2012; out of these patients, four were less than 18 years old (6, 14, 14, and 17 years old). Their diagnoses were postcardotomy failure (n = 1), dilatative cardiomyopathy (n = 2), and terminal heart failure (n = 1). Overall survival, waiting time for heart transplantation (HTx) and complication profile for the BVAD were analyzed retrospectively. Thirty days' mortality was 25% (n = 1). One child died after 84 days on support due to cerebral bleeding. Mean support time was 218.75 days (4, 84, 262, and 525 days). Pump chamber exchange was necessary three times due to pump chamber thrombosis (n = 2) and partial pump chamber membrane rupture (n = 1). Complications included: sepsis (n = 1), drive line infection requiring intravenous antibiotics (n = 2), and recurrent epistaxis (n = 3). Two children were successfully transplanted after 262/525 days on BVAD; they are currently at home (follow‐up: 1.9 and 2.3 years). The EXCOR is a life‐saving MCS system suitable for long‐term paracorporeal biventricular assistance.     

Transplanting hepatitis C virus–infected hearts into uninfected recipients: A single‐arm trial

The advent of direct‐acting antiviral therapy for hepatitis C virus (HCV) has generated tremendous interest in transplanting organs from HCV‐infected donors. We conducted a single‐arm trial of orthotopic heart transplantation (OHT) from HCV‐infected donors into uninfected recipients, followed by elbasvir/grazoprevir treatment after recipient HCV was first detected (NCT03146741; sponsor: Merck). We enrolled OHT candidates aged 40‐65 years; left ventricular assist device (LVAD) support and liver disease were exclusions. We accepted hearts from HCV‐genotype 1 donors. From May 16, 2017 to May 10, 2018, 20 patients consented for screening and enrolled, and 10 (median age 52.5 years; 80% male) underwent OHT. The median wait from UNOS opt‐in for HCV nucleic‐acid‐test (NAT)+ donor offers to OHT was 39 days (interquartile range [IQR] 17‐57). The median donor age was 34 years (IQR 31‐37). Initial recipient HCV RNA levels ranged from 25 IU/mL to 40 million IU/mL, but all 10 patients had rapid decline in HCV NAT after elbasvir/grazoprevir treatment. Nine recipients achieved sustained virologic response at 12 weeks (SVR‐12). The 10th recipient had a positive cross‐match, experienced antibody‐mediated rejection and multi‐organ failure, and died on day 79. No serious adverse events occurred from HCV transmission or treatment. These short‐term results suggest that HCV‐negative candidates transplanted with HCV‐infected hearts have acceptable outcomes.     

Ventricular assist device support in children and adolescents with heart failure: the Children's Medical Center of Dallas experience

Children with heart failure unresponsive to medical therapy are left with few options for survival. Ventricular assist devices (VADs) are life-saving options for such patients, allowing for bridge to transplantation or cardiac recovery. Retrospective review of cases from May 2006 to October 2010 was undertaken. Fourteen patients underwent implantation of VADs for refractory heart failure. Mean age was 9 years (range 1-17 years), and weight was 41 kg (range 9.7-71 kg). Indications for support: end-stage cardiomyopathy (n = 8), myocarditis (n = 3), univentricular failure (n = 2), and congenital heart disease/postcardiotomy (n = 1). Level of limitation at time of implant included critical cardiogenic shock in six (43%) and progressive decline in eight (57%). Extracorporeal membrane oxygenation was used as a bridge to VAD in five (36%) patients. Preimplant variables: 86% of patients requiring mechanical ventilation (mean 10.3 days), hyperbilirubinemia in 75%, and acute renal insufficiency in 79%. Device selection was systemic VAD in 11 (79%) and biventricular assist device in three (21%). Berlin Heart EXCOR was used in eight patients, while six patients received a Thoratec implantable VAD or paracorporeal VAD. Mean duration of support was 68 days (range 8-363 days). Overall survival was 79%. Ten patients (71%) were successfully bridged to transplantation, three (21%) died while on a device, one remains on support, and no patients were weaned from VAD. Children supported for single ventricle heart failure had a 50% survival with none currently bridged to transplantation. Complications included bleeding requiring reoperation in 21% (n = 3), stroke in 29% (n = 4), and driveline infections in 7% (n = 1). In two patients, a total of six pump exchanges were performed for thrombus formation. Survival for pediatric patients of all ages is excellent using current device technology with a majority of patients being successfully bridged to transplantation. Morbidity is acceptably low considering the severity of illness. Significant challenges exist with long-term extracorporeal support due to lack of donor availability and the high incidence of preformed alloantibodies especially in the failing single ventricle.     

Pneumatic pulsatile ventricular assist devices in children under 1 year of age.

OBJECTIVE: Although considerable progress has been made on ventricular assist devices (VAD) for adults, pneumatic pulsatile circulatory support in young infants is still limited. There is a need for long-term ventricular assist devices to bridge the failing myocardium of young children until recovery or transplantation. Miniaturized devices and innovative modalities need to be optimized. We report on our experience. METHODS: From 1/1992 to 6/2004, 18 infants (6 male/12 female) under 1 year of age were treated with the Berlin Heart Excor VAD. The infants were divided into two groups, depending on the year of treatment. Group A consists of eight infants resuscitated and supported with a pulsatile pneumatic ventricular assist device between 1992 and 1998 and group B consists of 10 infants treated between 1999 and 6/2004. With the pediatric-sized Berlin Heart we used miniaturized extracorporeal pneumatically driven blood pumps, the lowest stroke volume being 10 ml. RESULTS: In 18 children, age 3-345 (median 147) days, artificial replacement of heart function was applied for long-term support (1-64, median 10 days) as a life-saving measure in our hospital. Nine had LVAD and nine BVAD support. All were in cardiogenic shock with multiorgan failure; three had fulminant myocarditis, four cardiomyopathy, and one chronic stage of congenital heart disease. Five children were weaned from the system, three reached heart transplantation, and 10 died on the VAD. There were no differences between groups A and B regarding age, body weight or diagnosis, but the duration of mechanical support differed: Group A, median 2, range 1-16 days; group B, median 12, range 1-100 days. Since 1999 (group B), the survival rate of our small infants has increased to 70% whereas none of the infants in group A survived to be discharged. CONCLUSIONS: The outcome of VAD support in small infants is no longer inferior to that of adult support, now optimized cannulas, modified anticoagulation and optimized surgical and intensive care management have been established.     

Successful bridge to transplant using the Berlin Heart left ventricular assist device in a 3-month-old infant

The EXCOR Berlin Heart (Berlin Heart, Berlin, Germany) was successfully used as a pediatric left ventricular assist device as a bridge to cardiac transplantation. The pneumatically driven paracorporeal device successfully supported a 7 kg patient for 53 days until a suitable heart was obtained for transplantation.     

Anesthesia for noncardiac procedures for children with a Berlin Heart EXCOR® Pediatric Ventricular Assist Device: a case series

Objectives: To report our experience of providing anesthesia for noncardiac procedures in children with in situ Berlin Heart EXCOR Pediatric^® ventricular assist devices and to suggest principles of anesthetic management. Background: With the initiation of the first North American training and support center for Berlin Heart at our institution in 2006, we have been asked to provide anesthesia for noncardiac procedures to these children. No current anesthetic approach to these children has been reported. Methods/Materials: Anesthetic records for all noncardiac procedures for children with Berlin Heart between August 2006 and February 2009 in a tertiary care pediatric hospital were retrospectively reviewed. Charts were reviewed for demographic and clinical data, perioperative management, and occurrence of hypotension. Results: Twenty‐nine procedures were performed on 11 patients. Hypotension was a common occurrence with all anesthetic induction and maintenance agents even at low doses. Ketamine induction, however, was less likely to produce hypotension, odds ratio for hypotension 0.1333 (95% confidence range 0.021–0.856). Hypotension was responsive to fluid bolus (60%) and alpha‐receptor agonists (100%). Preoperative stability and presence of biventricular ventricular assist device (BiVAD) did not predict intraoperative hemodynamic course. Conclusions: Unlike patients with other ventricular assist devices, these children do not tolerate reductions in systemic vascular resistance (SVR) because of the relatively fixed cardiac output of this device. Agents that reduce SVR should be avoided where possible. Preoperative stability is not predictive. Fluids and alpha‐agonists should be first‐line response to hypotension in this population. Further study of this unusual population is warranted to further delineate best anesthetic practice.