Ventricular assist device support for failing Glenn circulation: Impact of concomitant Fontan completion in select patients.

BACKGROUND: Ventricular assist device (VAD) support for failing Glenn circulation represents a unique challenge. METHODS: We conducted a retrospective review of clinical outcomes in patients with VAD support for failing Glenn circulation between 2010 and 2020 at a tertiary pediatric institution. RESULTS: Ten patients were included: INTERMACS profiles were 1 in 3 patients and 2 in 7 patients. The median age, weight, and body surface area were 3.2 years, 13.0 kg, and 0.5 m2, respectively. Seven patients (70%) were implanted with continuous-flow devices and 3 with para-corporeal devices. Nine patients (90%) received heart transplant, with a median support duration of 77 days. Four (67%) out of 6 patients supported with discharge-capable devices were managed as outpatients. Post-transplant survival was 100%, with a median (range) follow up duration of 3.5 (1.8-11.9) years. There were 3 neurologic complications in 3 patients (0.9 events per patient-year); 2 intraoperative events (fatal hypoxia and symptomatic embolic stroke) and 1 postoperative (asymptomatic subarachnoid hemorrhage). Pump thrombosis occurred in one patient (0.3 events per patient-year), requiring pump exchange at day 65. Five patients (50%) received concomitant Fontan completion (fenestrated in 1). The Fontan-upgraded patients (vs Glenn) tended to be larger (median (range): 15.9 (12.6-22.9) vs 9.1 (7.7-22.8) kg), older (4.7 (3.1-6.5) vs 1.1 (0.9-10.1) years) and had a higher PaO2/FiO2 ratio (192 (52-336) vs 76 (59-78) mm Hg) on postoperative day 1. CONCLUSION: Our experience suggests the feasibility of durable VAD support for failing Glenn circulation. Concomitant Fontan completion may be considered in select patients to improve oxygen delivery.

Trends in Body Mass Index and Association With Outcomes in Pediatric Patients on Continuous Flow Ventricular Assist Device Support.

Data are limited regarding body mass index (BMI) in pediatric patients supported by ventricular assist devices (VAD) and associated clinical outcomes and complications. We performed a retrospective single-center cohort study including patients aged ≤21 years on durable continuous-flow VAD support for ≥30 days from 2009 to 2020. Patients were classified based on BMI percentile at implant using the US Centers for Disease Control and Prevention criteria: underweight (<5th percentile), healthy weight (5th-<85th percentile, reference group), overweight (85th-<95th percentile), and obese (≥95th percentile). Primary outcomes were hospital mortality and length of stay (LOS) after implant. Secondary outcomes included infectious complications and pump thrombosis. Seventy-two patients (58 HeartWare, 13 HeartMateII, 1 HeartMate3) were included. At implant, the study cohort comprised 13% underweight, 53% healthy weight, 18% overweight, and 17% obese. BMI increased across all categories during support, with 29% gaining BMI categories. No patients with obesity reduced their BMI category. At explant, the study cohort comprised 1% underweight, 54% healthy weight, 22% overweight, and 22% obese. There was no significant difference in hospital mortality, postoperative LOS, or pump thrombosis. Patients who were overweight had more frequent non-VAD infections. Patients with obesity required longer duration on VAD support and were less likely to be transplanted. We concluded that pediatric patients on VAD support who are overweight or have obesity do not improve their BMI and instead have significant increase. Larger studies are needed to assess the impact of abnormal BMI on VAD complications in pediatric patients.

Pediatric Palliative Care in the Heart Failure, Ventricular Assist Device and Transplant Populations: Supporting Patients, Families and Their Clinical Teams.

Heart failure is a life-changing diagnosis for a child and their family. Pediatric patients with heart failure experience significant morbidity and frequent hospitalizations, and many require advanced therapies such as mechanical circulatory support and/or heart transplantation. Pediatric palliative care is an integral resource for the care of patients with heart failure along its continuum. This includes support during the grief of a new diagnosis in a child critically ill with decompensated heart failure, discussion of goals of care and the complexities of mechanical circulatory support, the pensive wait for heart transplantation, and symptom management and psychosocial support throughout the journey. In this article, we discuss the scope of pediatric palliative care in the realm of pediatric heart failure, ventricular assist device (VAD) support, and heart transplantation. We review the limited, albeit growing, literature in this field, with an added focus on difficult conversation and decision support surrounding re-transplantation, HF in young adults with congenital heart disease, the possibility of destination therapy VAD, and the grimmest decision of VAD de-activation.

"Compassionate" Cases of the Jarvik 2015 Ventricular Assist Device.

The Jarvik 2015 Ventricular Assist Device (VAD) (Jarvik Inc, New York, NY) is the first and currently only continuous-flow VAD specifically designed for small children, and it is being evaluated in the so-called Pump for Kids, Infants, and Neonates (PumpKIN) trial. Due to the strict inclusion criteria of the trial, there have been a group of patients who failed to meet the criteria and therefore received the Jarvik 2015 VAD under the designation of "compassionate use." This is the same phenomenon seen previously during the Berlin Heart EXCOR trial. While we await the results of the PumpKIN trial, which will report the device performance in a strictly selected population, the compassionate use cases represent actual "real world" experiences. We describe herein our experience of two compassionate use cases. In particular, this report has a special emphasis on the power consumption and hemolysis and inflammatory lab profile of the Jarvik 2015 VAD as hemocompatibility was the primary focus of the developmental and the preclinical phases.

Discharge and Readmissions After Ventricular Assist Device Placement in the US Pediatric Hospitals: A Collaboration in ACTION.

Discharging children on ventricular assist device (VAD) support offers advantages for quality of life. We sought to describe discharge and readmission frequency in children on VAD support. All VAD-implanted patients aged 10-21 years at Advanced Cardiac Therapies Improving Outcomes Network (ACTION) centers were identified from the Pediatric Health Information System database (2009-2018). Discharge frequency on VAD was calculated. Patients discharged on VAD were compared with those not discharged. Freedom from readmission was assessed using the Kaplan-Meier method. A total of 298 VAD-implanted patients from 25 centers were identified, of which 163 (54.7%) were discharged. Discharges increased over time (36.9% [2009-2012] vs. 59.7% [2013-2018], p = 0.001). Of 144 discharged patients with follow-up, 96 (66.7%) were readmitted for reasons other than transplantation. Heart failure was the most common reason for readmission (27.7%), followed by infection (25.8%) and hematologic concerns (16.8%). In-hospital mortality on readmission was uncommon (1.8%) and the median length of stay was 6 days (interquartile range 2-19 days). Discharge of children on VAD support has increased over time, although variability exists across centers. Readmissions are common with diverse indications; however, the risk of mortality is low. Further interventions, including collaboration in ACTION, are critical to increasing discharges and optimizing outpatient management.

Centrifugal-flow ventricular assist device support in children: A single-center experience.

BACKGROUND: Our institutional policy is to continue centrifugal-flow ventricular assist device support for 3 months or more without activation on the transplant wait-list for physical recovery and assessment of possible myocardial recovery. We evaluated our single-institutional outcomes with centrifugal-flow ventricular assist device support in children. METHODS: Prospectively collected outcomes data in consecutive patients aged 18 years or less with centrifugal-flow ventricular assist device support were reviewed. RESULTS: There were 40 implantations in 39 patients (28 with cardiomyopathy, 11 with congenital heart disease, including 3 with univentricular physiology). The median support was 8 months (range, 1-79), with 13 patients (33%) supported for 12 months or more and a cumulative duration of 41 patient-years. The median age and weight at implantation were 11 (4-18) years and 35 (14-98) kg, respectively. The median body surface area was 1.1 (0.7-2.2) m2, with 16 patients (40%) having a body surface area less than 1.0 m2. Thirty-four patients (85%) had Interagency Registry for Mechanically Assisted Circulatory Support 1 or 2. Children with congenital heart disease were significantly smaller (P < .01) and had more prior cardiac interventions (P < .01) than those with cardiomyopathy. There were 2 early mortalities (5%) in children with cardiomyopathy. Of the 38 patients with successful implantations, 36 (95%) were discharged home and managed as outpatients. Overall adverse event rates were 5.1 (bleeding), 0.8 (device malfunction), 6.1 (infection), 3.9 (neurologic dysfunction), and 1.0 (renal dysfunction) (per 100 patient-month). In the 21 patients with cardiomyopathy supported for 3 months or more, 5 (24%) experienced normalization of left ventricular function; 4 underwent successful explantation, and 1 remains on support. CONCLUSIONS: This study demonstrates favorable outcomes of centrifugal-flow ventricular assist device support in children, including those with congenital heart disease, with an increased incidence of cardiac recovery.

Improved 6 Minute Walk Distance and Brain-Type Natriuretic Peptide After Continuous-Flow Ventricular Assist Device Placement in Children.

Despite increasing continuous-flow ventricular assist device (CF-VAD) use in children, minimal data exist regarding the functional recovery and rehabilitation potential after device placement. We hypothesized that after CF-VAD implantation, children would demonstrate a time-limited improvement in 6 minute walk distance (6MWD) and brain-type natriuretic peptide (BNP). A retrospective cohort study of 27 patients was conducted, those <18 years of age at a tertiary-care center during the study period. Seventy-four percent were male; median age was 12.7 years. Six minute walk distance and BNP were evaluated within 365 days of implantation. Associations were examined before and after 90 days postimplantation because a plateau in both values was seen after 90 days. Data included 92 6MWD and 341 BNP values. In the first 90 days, 6MWD increased by 12 percent predicted (%P) per 30 days (P < 0.01); with no significant change thereafter, increasing 0.6 %P per 30 days (P = 0.482). In the first 90 days, BNP decreased by 59% per 30 days (P < 0.01); with no significant change thereafter, increasing 1.2% per 30 days (P = 0.561). Six minute walk distance and BNP improved after CF-VAD implantation, with a significant improvement only in the first 90 days. Routine use of 6MWD and BNP can help in assessment of functional recovery in children after CF-VAD placement.

Use of an Extracorporeal Centrifugal Pump with the Berlin Cannulas.

The Berlin EXCOR ventricular assist device has become a standard treatment in pediatric bridge to transplantation. Despite its increased use in pediatric heart failure, the patient population supported with this technology continues to suffer from hematologic issues such as postoperative hemorrhage and neurologic dysfunction secondary to thrombotic events. Finding a balance between hemorrhagic and thrombotic risks in the acute postoperative period poses a significant challenge. In this report, we describe our approach using a temporary centrifugal pump connected to cannulas designed for the Berlin EXCOR ventricular assist device. We believe that the interim use of an extracorporeal centrifugal pump allows time for hemodynamic stability, limits the hemorrhagic risks, and provides relevant hemodynamic information before conversion to the Berlin EXCOR.

Ventricular Assist Device Support: Single Pediatric Institution Experience Over Two Decades.

BACKGROUND: We reviewed our single institutional experience with pediatric ventricular assist device (VAD) support over the last 2 decades, with an aim to improve our current management and gain an insight into the future direction. METHODS: A retrospective review was conducted on all patients that had undergone VAD support between 1996 and 2017. Outcomes were analyzed based on the type of VADs, whether temporary or durable devices. Primary end points were positive outcomes, including bridge-to-transplantation, bridge-to-recovery, alive on device, and bridge-to-bridge to another VAD, or negative outcomes, including death during VAD support or in-hospital death after bridge-to-recovery. The Pediatric Interagency Registry for Mechanical Circulatory Support definition was used to classify adverse events. RESULTS: Overall, 201 VADs were implanted in 159 patients, with 82 (41%) and 119 (59%) being temporary and durable support, respectively. There has been a trend toward an increasing annual implant volume both with temporary and durable VADs. Positive outcomes were achieved in 80% (66 of 82) of those with temporary support, with bridge-to-recovery (53% [35 of 66]) and bridge-to-bridge to another VAD (38% [25 of 66]) being the predominant outcomes. Of those on durable support, 84% (100 of 119) achieved positive outcomes, with bridge-to-transplant (66% [78 of 119]) being the leading destination. The most notable change during the study period was the introduction of implantable continuous-flow VADs, resulting in outpatient management becoming a routine practice. No patients were discharged on VAD support before 2004, but 85% were discharged on VADs with discharge capability after 2013. CONCLUSIONS: The present study has demonstrated the evolutional changes of pediatric VAD support and their effect on clinical outcomes over the last 2 decades.

Titanium Plug Closure after HeartWare Ventricular Assist Device Explantation in a 15-Year-Old Girl: First U.S. Experience.

We describe the case of a teenage girl with anthracycline-induced cardiomyopathy who received a HeartWare ventricular assist device and underwent successful device explantation after cardiac recovery. During device support, the patient's cardiac function returned to normal. Twelve months after implantation, we explanted the device via repeat median sternotomy. To close the hole in the left ventricular apex and preserve the sewing ring in case future device support is needed, we used a German-manufactured titanium plug, developed specifically for this purpose. To our knowledge, this is the first use of this plug in the United States. The patient recovered uneventfully and was discharged from the hospital on postoperative day 11. Left ventricular biopsy specimens at explantation revealed the resolution of previous degenerative sarcomeric changes. Our patient did well clinically; however, recurrent late anthracycline cardiotoxicity might subsequently cause her cardiac function to deteriorate. In this event, our use of the titanium plug to preserve the left ventricular sewing ring would enable easier device replacement than would other explantation options.

Rectus-Sparing Technique for Driveline Insertion of Ventricular Assist Device.

We present a new technique for driveline insertion of the HeartWare ventricular assist device (HVAD) designed to preserve the integrity of the abdominal wall structure. Because of the size of the HVAD driveline connector (12 mm in diameter: triple the size of the driveline cable), the standard tunneling maneuver can result in tearing of the abdominal wall muscle layer, which is a primary mechanism to prevent ascending driveline infection. We find that our technique is particularly useful in children because their abdominal wall muscles are more fragile and thereby prone to accidental injury with blunt penetration when the standard technique is used.

A review of infections in patients with left ventricular assist devices: prevention, diagnosis and management.

Since the advent of ventricular assist devices with smaller configurations and continuous-flow technology, survival rates for patients with end-stage heart failure have dramatically improved. While the burden of infectious complications is decreased in patients on continuous-flow ventricular assist devices compared to bulkier pulsatile-flow devices, infection remains one of the most common causes of morbidity and mortality. The majority of infections occur at the driveline exit site, beginning with a disruption or trauma to the barrier between the skin and driveline and sometimes spreading deeper. Once infections develop, they can be difficult to eradicate. Depending on the degree of infection, treatment options may include local wound care, antibiotics, or surgical treatment. Preventive strategies and careful surveillance are crucial to improve patient outcomes.

Persistent blood stream infection in patients supported with a continuous-flow left ventricular assist device is associated with an increased risk of cerebrovascular accidents.

BACKGROUND: Common adverse events in patients supported with Continuous-flow left ventricular assist devices (CF-LVAD) include infections and cerebrovascular accidents (CVA). Some studies have suggested a possible association between blood stream infection (BSI) and CVA. METHODS AND RESULTS: Medical records of patients who received Heartmate II (HMII) CF-LVADs in 2008-2012 at a single center were reviewed. CVA was categorized as either hemorrhagic (HCVA) or ischemic (ICVA). BSI was divided into persistent (pBSI) and nonpersistent (non-pBSI). pBSI was defined as BSI with the same organism on repeated blood culture >72 hours from initial blood culture despite antibiotics. Univariate and multivariate analyses were performed to determine predictors. A total of 149 patients had HMII implanted; 76% were male, and the overall mean age was 55.4 ± 13 years. There were a total of 19 (13%) patients who had CVA (7 HCVA and 12 ICVA) at a median of 295 days (range 5-1,096 days) after implantation. There were a total of 28 (19%) patients with pBSI and 17 (11%) patients with non-pBSI. Patients with pBSI had a trend toward greater BMI (31 kg/m(2) vs 27 kg/m(2); P = .09), and longer duration of support (1,019 d vs 371 d; P < .001) compared with those with non-pBSI. Persistent BSI was associated with an increased risk of mortality and with all-cause CVA on multivariate analysis (odds ratio [OR] 5.97; P = .003) as well as persistent Pseudomonas aeruginosa infection (OR 4.54; P = .048). CONCLUSIONS: Persistent BSI is not uncommon in patients supported by CF-LVAD and is highly associated with all-cause CVA and increased all-cause mortality.

Echocardiographic Evaluation of Hemodynamics in Patients With Systolic Heart Failure Supported by a Continuous-Flow LVAD.

BACKGROUND: Hemodynamics assessment is important for detecting and treating post-implant residual heart failure, but its accuracy is unverified in patients with continuous-flow left ventricular assist devices (CF-LVADs). OBJECTIVES: We determined whether Doppler and 2-dimensional transthoracic echocardiography reliably assess hemodynamics in patients supported with CF-LVADs. METHODS: Simultaneous echocardiography and right heart catheterization were prospectively performed in 50 consecutive patients supported by using the HeartMate II CF-LVAD at baseline pump speeds. The first 40 patients were assessed to determine the accuracy of Doppler and 2-dimensional echocardiography parameters to estimate hemodynamics and to derive a diagnostic algorithm for discrimination between mean pulmonary capillary wedge pressure ≤15 versus >15 mm Hg. Ten patients served as a validation cohort. RESULTS: Doppler echocardiographic and invasive measures of mean right atrial pressure (RAP) (r = 0.863; p < 0.0001), systolic pulmonary artery pressure (sPAP) (r = 0.880; p < 0.0001), right ventricular outflow tract stroke volume (r = 0.660; p < 0.0001), and pulmonary vascular resistance (r = 0.643; p = 0.001) correlated significantly. Several parameters, including mitral ratio of the early to late ventricular filling velocities >2, RAP >10 mm Hg, sPAP >40 mm Hg, left atrial volume index >33 ml/m(2), ratio of mitral inflow early diastolic filling peak velocity to early diastolic mitral annular velocity >14, and pulmonary vascular resistance >2.5 Wood units, accurately identified patients with pulmonary capillary wedge pressure >15 mm Hg (area under the curve: 0.73 to 0.98). An algorithm integrating mitral inflow velocities, RAP, sPAP, and left atrial volume index was 90% accurate in distinguishing normal from elevated left ventricular filling pressures. CONCLUSIONS: Doppler echocardiography accurately estimated intracardiac hemodynamics in these patients supported with CF-LVAD. Our algorithm reliably distinguished normal from elevated left ventricular filling pressures.

A simplified echocardiographic technique for detecting continuous-flow left ventricular assist device malfunction due to pump thrombosis.

BACKGROUND: Malfunction of a continuous-flow left ventricular assist device (CF-LVAD) due to device thrombosis is a potentially life-threatening event that currently presents a diagnostic challenge. We aimed to propose a practical echocardiographic assessment to diagnose LVAD malfunction secondary to pump thrombosis. METHODS: Among 52 patients implanted with a CF-LVAD from a single center who underwent echocardiographic pump speed-change testing, 12 had suspected pump thrombosis as determined by clinical, laboratory, and/or device parameters. Comprehensive echocardiographic evaluation was performed at baseline pump speed and at each 1,000-rpm interval from the low setting of 8,000 rpm to the high setting of 11,000 rpm in 11 of these patients. RESULTS: Receiver operating characteristic curves and stepwise logistic regression analyses showed that the best diagnostic parameters included changes in the LV end-diastolic diameter (<0.6 cm), aortic valve opening time (<80 msec), and deceleration time of mitral inflow (<70 msec) from lowest to highest pump speed. One parameter was predictive of pump malfunction, with 100% sensitivity and 89% specificity, whereas 2 of 3 parameters increased the sensitivity to 100% and specificity to 95%. CONCLUSIONS: The 3 echocardiographic variables of measured changes in LV end-diastolic diameter, aortic valve opening time, and deceleration time of mitral inflow between the lowest (8,000 rpm) and highest pump speed settings (11,000 rpm) during echo-guided pump speed-change testing appear highly accurate in diagnosing device malfunction in the setting of pump thrombosis among patients supported with CF-LVAD. Further investigation is warranted to create and validate a prediction score.

Infección intrahospitalaria en pacientes con cáncer / Nosocomial infection in patients with cancer

Se efectuó una investigación descriptiva y transversal de todos los pacientes con cáncer que presentaron alguna infección intrahospitalaria en el Hospital Oncológico Provincial "Conrado Benítez" de Santiago de Cuba, desde enero hasta septiembre del 2009, a fin de caracterizarles clinicoepidemiológicamente. Del total de egresados, se infectaron 41 (1,5 por ciento), mientras que en la casuística predominaron el sexo masculino y el grupo etáreo de 40-59 años, así como los estadios clínicos III y IV, los cuales se hallaron entre los principales factores de riesgo, junto a la intervención quirúrgica y los problemas estructurales en el quirófano. Los microorganismos más frecuentes fueron: Pseudomonas aeruginosa en el cáncer de laringe y Escherichia coli en los tumores urológicos. De las infecciones, la mayoría se localizaron en heridas quirúrgicas; y de los pacientes infectados, gran parte presentaron leucocitosis y neutrofilia.

A descriptive and cross-sectional study was conducted in all cancer patients that had some nosocomial infection at "Conrado Benítez" Provincial Oncology Hospital of Santiago de Cuba, from January to September 2009, in order to characterize them clinically and epidemiologically. Of the discharged patients 41 were infected (1,5 percent), while male sex and age group of 40-59 years prevailed in the case material, as well as clinical stages III and IV, which were among the main risk factors together with surgical intervention and structural problems in the operating room. The most frequent microorganisms were Pseudomonas aeruginosa in larynx cancer and Escherichia coli in urologic tumors. Most of the infections were found in surgical wounds; and most of the infected patients had leukocytosis and neutrophilia.

Infección intrahospitalaria en pacientes con cáncer / Nosocomial infection in patients with cancer

Se efectuó una investigación descriptiva y transversal de todos los pacientes con cáncer que presentaron alguna infección intrahospitalaria en el Hospital Oncológico Provincial Conrado Benítez de Santiago de Cuba, desde enero hasta septiembre del 2009, a fin de caracterizarles clinicoepidemiológicamente. Del total de egresados, se infectaron 41 (1,5 por ciento), mientras que en la casuística predominaron el sexo masculino y el grupo etáreo de 40-59 años, así como los estadios clínicos III y IV, los cuales se hallaron entre los principales factores de riesgo, junto a la intervención quirúrgica y los problemas estructurales en el quirófano. Los microorganismos más frecuentes fueron: Pseudomonas aeruginosa en el cáncer de laringe y Escherichia coli en los tumores urológicos. De las infecciones, la mayoría se localizaron en heridas quirúrgicas; y de los pacientes infectados, gran parte presentaron leucocitosis y neutrofilia(AU)

A descriptive and cross-sectional study was conducted in all cancer patients that had some nosocomial infection at Conrado Benítez Provincial Oncology Hospital of Santiago de Cuba, from January to September 2009, in order to characterize them clinically and epidemiologically. Of the discharged patients 41 were infected (1,5 per cent), while male sex and age group of 40-59 years prevailed in the case material, as well as clinical stages III and IV, which were among the main risk factors together with surgical intervention and structural problems in the operating room. The most frequent microorganisms were Pseudomonas aeruginosa in larynx cancer and Escherichia coli in urologic tumors. Most of the infections were found in surgical wounds; and most of the infected patients had leukocytosis and neutrophilia(AU)