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Showing papers by "David L.S. Morales published in 2013"


Journal ArticleDOI
TL;DR: Smaller patient size, renal dysfunction, hepatic dysfunction, and biventricular assist device use were associated with mortality, whereas extracorporeal membrane oxygenation before implantation and congenital heart disease were not.
Abstract: Background—Recent data suggest that the Berlin Heart EXCOR Pediatric ventricular assist device is superior to extracorporeal membrane oxygenation for bridge to heart transplantation. Published data...

392 citations


Journal ArticleDOI
TL;DR: Pediatric outcomes with a HMII LVAD are comparable to that of young adults, and as technology progress and second- and third-generation devices are introduced, the number of children who will benefit from mechanical support will continue to grow.
Abstract: Objective The HeartMate II (HMII; Thoratec, Pleasanton, CA) continuous-flow left ventricular assist device (LVAD) is an established treatment modality for advanced heart failure in adults. The objective of this study was to evaluate outcomes of pediatric patients supported by the HMII LVAD. Methods This was a retrospective review of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) of patients supported with a HMII from April 2008 to September 2011. The primary cohort comprised pediatric patients aged 11 to 18 years. Outcomes were compared with a group of young adults aged 19 to 39 years who underwent HMII implant during the same period. Ischemic etiologies for heart failure were excluded. Results There were 28 pediatric patients, of whom 19 (68%) were males, 14 (46%) were African American, and 7 (25%) underwent device placement in a pediatric hospital. Competing outcomes analysis showed that at 6 months of follow-up, the composite of survival to transplantation, ongoing support, or recovery was 96% for the pediatric group, which was not significantly different from the young adult group (96%, p = 0.330). The 2 groups had similar INTERMACS profiles but differed in diagnosis, weight, and morbidities. Bleeding complications requiring surgical intervention were more common in the pediatric group. Conclusions Pediatric outcomes with a HMII LVAD are comparable to that of young adults. As we continue to monitor this growing group, more sophisticated characterization and comparisons will be possible. Also, as technology progress and second- and third-generation devices are introduced, the number of children who will benefit from mechanical support will continue to grow.

102 citations


Journal ArticleDOI
TL;DR: It is found that HF-related hospitalizations were common in ACHD and associated with an increased risk of death compared to non-HF admissions, and the risk of mortality is increased with the diagnoses of VSDs and the presence of specific comorbidities such as respiratory failure and sepsis.
Abstract: Background Heart failure (HF) accounts for >3 million hospital admissions annually in adults with acquired cardiovascular disease, but there are limited data on HF admissions in adults with congenital heart disease (ACHD). The purpose of this study was to test the hypotheses that HF admissions are common in ACHD and associated with significant morbidity and mortality. Methods The 2007 Nationwide Inpatient Sample was used to assess national prevalence, morbidities, and risk factors for mortality during hospitalizations among ACHD with HF. Results Of the 84 308 (95% CI 71 345–97 272) ACHD admissions in the United States in 2007, 17 193 (95% CI 14 157–20 229) had a diagnosis of HF (20%). ACHD with HF was associated with an increased risk of death compared to ACHD without HF (OR 3.3, 95% CI 2.6–4.1). On multivariable analysis independent risk factors for mortality included nonoperative intubation (OR 6.1, 95% CI 3.3–11.4), sepsis (OR 4.3, 95% CI 2.4–7.4), and acute myocardial infarction (OR 3.2, 95% CI 1.8–5.7). Cardiac defects associated with an increased risk of mortality included ventricular septal defects (VSDs) (OR 1.8, 95% CI 1.0–3.4). Conclusions In this large population-based study, HF-related hospitalizations were common in ACHD and associated with an increased risk of death compared to non-HF admissions. The risk of mortality is increased with the diagnoses of VSDs and the presence of specific comorbidities such as respiratory failure and sepsis.

74 citations


Journal ArticleDOI
TL;DR: Single-ventricle patients demonstrated increased mortality after cardiopulmonary resuscitation, while recent cardiac surgery was associated with a reduced odds of death after cardiac arrest in this high-risk population.
Abstract: Objective: Hospitalized children with cardiovascular disease may be at increased risk of cardiac arrest; however, little data exist regarding prevalence, risk factors, or outcomes of cardiopulmonary resuscitation in these patients. We sought to characterize national estimates of cardiopulmonary resuscitation and death after cardiopulmonary resuscitation for hospitalized children with cardiovascular disease. Setting: A total of 3,739 hospitals in 38 states participating in Kids’ Inpatient Database. Design: Retrospective analysis of the 2000, 2003, and 2006 Healthcare Cost and Utilization Project Kids’ Inpatient Database was performed. Sample weighting was employed to produce national estimates. Measurements and Main Results: Cardiovascular disease was identified in 2.2% of the estimated 22,175,468 (95% confidence interval 21,391,343–22,959,592) hospitalizations. Cardiopulmonary resuscitation occurred in 0.74% (3,698; 95% confidence interval 3,205–4,191) of hospitalizations of children with cardiovascular disease, compared with 0.05% (11,726; 95% confidence interval 10,647–12,805) without cardiovascular disease (odds ratio 13.8, 95% confidence interval 12.8–15.0). The highest frequency of cardiopulmonary resuscitation occurred with myocarditis (3.0% of admissions), heart failure (2.0%), and coronary pathology (2.0%). Compared with other forms of cardiovascular disease identified in this study, single-ventricle patients were the only subgroup who exhibited a higher mortality after cardiopulmonary resuscitation (mortality 65% vs. 55%; odds ratio 1.7 [95% confidence interval 1.2–2.6]), while those who had undergone cardiac surgery exhibited a lower mortality rate (mortality 48% vs. 57%; odds ratio 0.6 [95% confidence interval 0.5–0.8]). Conclusions: Cardiopulmonary resuscitation occurs in approximately 7 per 1,000 hospitalizations of children with cardiovascular disease, a rate greater than ten-fold that observed in hospitalizations of children without cardiovascular disease. Single-ventricle patients demonstrated increased mortality after cardiopulmonary resuscitation, while recent cardiac surgery was associated with a reduced odds of death after cardiopulmonary resuscitation. Further studies are needed to confirm these findings and develop techniques to prevent cardiac arrest in this high-risk population. (Pediatr Crit Care Med 2013; 14:248–255)

52 citations


Journal ArticleDOI
TL;DR: In this retrospective administrative database analysis, E-CPR did not significantly influence survival and further study is needed to improve outcomes and to identify patients most likely to benefit from this resource-intensive therapy.
Abstract: To characterize the overall use, cost, and outcomes of extracorporeal membrane oxygenation (ECMO) as an adjunct to cardiopulmonary resuscitation (CPR) among hospitalized infants and children in the United States, retrospective analysis of the 2000, 2003, and 2006 Kids’ Inpatient Database (KID) was performed. All CPR episodes were identified; E-CPR was defined as ECMO used on the same day as CPR. Channeling bias was decreased by developing propensity scores representing the likelihood of requiring E-CPR. Univariable, multivariable, and propensity-matched analyses were performed to characterize the influence of E-CPR on survival. There were 8.6 million pediatric hospitalizations and 9,000 CPR events identified in the database. ECMO was used in 82 (0.9 %) of the CPR events. Median hospital charges for E-CPR survivors were $310,824 [interquartile range (IQR) 263,344–477,239] compared with $147,817 (IQR 62,943–317,553) for propensity-matched conventional CPR (C-CPR) survivors. Median LOS for E-CPR survivors (31 days) was considerably greater than that of propensity-matched C-CPR survivors (18 days). Unadjusted E-CPR mortality was higher relative to C-CPR (65.9 vs. 50.9 %; OR 1.9, 95 % confidence interval 1.2–2.9). Neither multivariable analysis nor propensity-matched analysis identified a significant difference in survival between groups. E-CPR is infrequently used for pediatric in-hospital cardiac arrest. Median LOS and charges are considerably greater for E-CPR survivors with C-CPR survivors. In this retrospective administrative database analysis, E-CPR did not significantly influence survival. Further study is needed to improve outcomes and to identify patients most likely to benefit from this resource-intensive therapy.

51 citations


Journal ArticleDOI
TL;DR: This document provides a descriptive overview of the registry referred to as Mechanical Support as Failure Intervention in Patients with Cavopulmonary Shunts, and proposes a registry of MCS/ventricular assist device in this population.
Abstract: It is now recognized that a majority of single ventricle patients, those with functionally univentricular hearts, who have survived palliative cavopulmonary connection will experience circulatory failure and end-organ dysfunction due to intrinsic inadequacies of a circulation supported by a single ventricle. Thus, there are an increasing number of patients with functional single ventricles presenting with failing circulations that may benefit from mechanical circulatory support (MCS). The paucity of experience with MCS in this population, even at high volume cardiac centers, contributes to limited available data to guide MCS device selection and management. Thus, a registry of MCS in this population would be beneficial to the field. A conference was convened in January 2012 of pediatric and adult cardiologists, pediatric cardiac intensivists, congenital heart surgeons, and adult cardiothoracic surgeons to discuss the current state of MCS, ventricular assist device, and total artificial heart therapy for patients who have undergone cavopulmonary connection, either superior cavopulmonary connection or total cavopulmonary connection. Specifically, individual experience and challenges with VAD therapy in this population was reviewed and creation of a multiinstitutional registry of MCS/ventricular assist device in this population was proposed. This document reflects the consensus from the meeting and provides a descriptive overview of the registry referred to as Mechanical Support as Failure Intervention in Patients with Cavopulmonary Shunts.

45 citations


Journal ArticleDOI
TL;DR: Infectious complications are common in pediatric patients undergoing VAD support and VAD infections do not prevent successful cardiac transplantation in children, and Continuous-flow VAD and prior cardiac transplants with rejection were significantly associated with development of Vad infections.
Abstract: Background Infectious complications constitute a major cause of morbidity and death in adult patients supported with left ventricular assist devices (VADs). The incidence and patient outcomes related to infectious complications in pediatric patients on VAD support remain largely unknown. The aim of this study was to determine the incidence of infection among pediatric VAD recipients and to characterize the microbiology, associated risk factors, and clinical outcome. Methods We conducted a retrospective record review of all patients undergoing VAD support for ≥2 weeks at Texas Children's Hospital from June 1999 to December 2011. Infections were categorized as VAD-specific, VAD-related, or non–VAD-related using the International Society for Heart and Lung Transplantation (ISHLT) definitions for VAD infections. Results Fifty-two VADs were implanted in 51 patients; of these, 35 patients (69%) had 92 infections while receiving VAD support. These included 10 VAD-specific infections, 23 VAD-related infections, and 59 non-VAD infections. The overall rate of VAD infections (specific + related) was 8/1,000 days of VAD support. The most common pathogens were Staphylococcus aureus , coagulase-negative staphylococci, Pseudomonas aeruginosa, and Candida spp. Of 8 deaths that occurred during VAD support, 3 (37.5%) were directly related to infections. Continuous-flow VAD ( p = 0.0427) and prior cardiac transplantation with rejection ( p = 0.0191) were significantly associated with development of VAD infections. Conclusions Infectious complications are common in pediatric patients undergoing VAD support. VAD infections do not prevent successful cardiac transplantation in children.

38 citations



Journal ArticleDOI
TL;DR: MCS options for short and long-term support that are currently available for infants and children with end-stage heart failure are discussed.
Abstract: Mechanical circulatory support (MCS) in the pediatric heart failure population has a limited history especially for infants, and neonates. It has been increasingly recognized that there is a rapidly expanding population of children diagnosed and living with heart failure. This expanding population has resulted in increasing numbers of children with medically resistant end-stage heart failure. The traditional therapy for these children has been heart transplantation. However, children with heart failure unlike adults do not have symptoms until they present with end-stage heart failure and therefore, cannot safely wait for transplantation. Many of these children were bridged to heart transplantation utilizing extracorporeal membranous oxygenation as a bridge to transplant which has yielded poor results. As such, industry, clinicians, and the government have refocused interest in developing increasing numbers of MCS options for children living with heart failure as a bridge to transplantation and as a chronic therapy. In this review, we discuss MCS options for short and long-term support that are currently available for infants and children with end-stage heart failure.

24 citations


Journal ArticleDOI
TL;DR: Children with all forms of diffuse lung disease who underwent lung transplantation at two pediatric centers were evaluated in terms of several pre‐ and post‐transplant factors and compared to children with other end stage lung disorders.
Abstract: Background Pediatric diffuse lung diseases comprise a heterogeneous group of rare lung disorders which may lead to end stage lung disease and referral for lung transplantation. Previous studies are limited by small numbers of patients with specific forms of diffuse lung disease. Children with all forms of diffuse lung disease who underwent lung transplantation at two pediatric centers were evaluated in terms of several pre- and post-transplant factors and compared to children with other end stage lung disorders. Methods A retrospective chart review was performed on all patients transplanted between October 1, 2002 and June 15, 2007 at Texas Children's Hospital and St. Louis Children's Hospital. Multiple pre-transplant characteristics and post-transplant morbidities and mortality were compared between diffuse lung disease, cystic fibrosis, and pulmonary vascular disease groups. Results There were 31 diffuse lung disease (DLD), 57 cystic fibrosis (CF), and 16 pulmonary vascular disease (PVD) patients included in our analysis. Patients with DLD had significantly higher pre-transplant morbidity including lower percent predicted of forced expiratory volume in first second (P = 0.013) and more patients with pulmonary hypertension (P = 0.001) and hypercapnia (P = 0.031). Compared to CF patients, more DLD and PVD patients required invasive ventilation (P = 0.001) and care in the pediatric intensive care unit (P = 0.001). After transplant, there was a difference among the three groups with regards to number of acute allograft rejections but statistical limitations preclude knowing between which group the difference lies. A difference in time to bronchiolitis obliterans was found between the PVD and CF groups but not when compared to the DLD patients. The three groups had similar time to post-transplant lymphoproliferative disease, rate of infections, and survival. Conclusion Lung transplantation is as successful for patients with end stage diffuse lung disease as compared to other lung transplant candidates. Pediatr Pulmonol. 2013; 48:490–496. © 2012 Wiley Periodicals, Inc.

24 citations


Journal ArticleDOI
TL;DR: In this paper, the authors evaluated the long-term quality of life (QOL) of children who required longterm ventricular assist device (VAD) support as a bridge to transplantation (BTT) compared with children who underwent heart transplantation without VAD support.

Journal ArticleDOI
TL;DR: A neonate in whom the entire coronary arterial system arose from the right ventricle via a single fistula with no other intracardiac defects is presented.
Abstract: Anomalous origins of both the left and right coronary arteries are rare but have been well documented when both arteries arise from the pulmonary trunk (Angelini et al., Circulation 105:2449–2454, 2002). An anomalous coronary arterial origin from the pulmonary arteries usually involves the left coronary artery (ALCPA) and less frequently the right coronary artery (ARCPA). At least three cases have been reported in which the right coronary artery arose abnormally from the left ventricle (LV), but none have been reported in which both coronary arteries took their origin from the right ventricle (Ippisch and Kimball, J Am Soc Echocardiogr 23:222.e1–222.e2, 2010; Okuyama et al., Jpn Heart J 36:115–118, 1995; Culbertson et al., Pediatr Cardiol 16:73–75, 1995). Ostial atresia with anomalous origin of a coronary artery from the right ventricle has been described only in pulmonary atresia with an intact ventricular septum and a hypoplastic right ventricle. In this setting, atresia of both coronary ostia with right ventricular origin of both coronary arteries is a rare variant. This report presents a neonate in whom the entire coronary arterial system arose from the right ventricle via a single fistula with no other intracardiac defects. To the authors’ knowledge, this anomaly has not been described previously.

Journal ArticleDOI
TL;DR: Although a challenging cohort, the majority of complex patients were successfully supported, particularly adolescents with congenital heart disease, and 67% of patients had a positive outcome: 34% were still on the TAH, 33% were transplanted, and 33% died.
Abstract: Purpose Over the past 3 decades, palliation of children with congenital heart disease (CHD) has been increasingly successful. This has created an ever-growing cohort of adolescents and young adults with congenital heart disease who unfortunately develop heart failure. Mechanically supporting such patients is possible, however, patients who have residual lesions or require multiple procedures (i.e. conduit exchange, valve repair) in order to place a ventricular assist device have a higher risk of morbidity and mortality. In complex patients, the use of the SynCardia total artificial heart (TAH) to avoid multiple procedures may be beneficial. However, the success of the TAH in the CHD cohort has not been reported. Methods and Materials All patients with congenital heart disease who had the SynCardia TAH implanted from 1986 to 2012 were identified in the Worldwide Syncardia TAH database, which contains 1091 patients. Results TAH was implanted in 24 patients with CHD (2.2% of total cohort). 25% (6/24) of the CHD patients were adolescents (12-18yo). These TAHs were implanted in 16 institutions around the world [US(9), EU(5) and Canada(2)]. Median age was 28 years [13- 56] and 25% were female. Total days of support were 1476 days with a median of 24 [1-359] days. Overall survival was 62% with a 100% survival in adolescents with CDH. Mortalities occurred in the 1st month of support in 89% (8/9) of cases. Cause of death was multisystem organ failure in 5, pulmonary hemorrhage in 1, not reported in 3. Competing outcomes analysis at 2 months demonstrates 67% of patients had a positive outcome: 34% were still on the TAH, 33% were transplanted, and 33% died. Conclusions Although a challenging cohort, the majority of these complex patients were successfully supported, particularly adolescents with congenital heart disease.

Journal ArticleDOI
TL;DR: Over the long-term, surviving children who required a long- term ventricular assist device as a bridge to transplantation experience a similar quality of life as those who went straight to transplants.
Abstract: Purpose Fifteen-percent of the more than 500 children that receive a heart transplant annually require a ventricular assist device (VAD) as a bridge to transplantation. With recent data showing improved long-term survival after transplantation, it is appropriate to focus attention on whether children requiring a VAD as a bridge to transplantation fair as well as those who went straight to transplantation in terms of their long-term quality of life. Methods and Materials This study used a cross-sectional design to evaluate the long-term quality of life in children who required long-term VAD support (greater than two weeks) as a bridge to transplantation, compared to children undergoing heart transplantation without VAD support, employing the Core and Cardiac modules of the Pediatric Quality of Life Inventory (PedsQL) survey, via a telephone interview. In a secondary analysis, factors associated with worse quality of life outcome among VAD patients were also investigated. Results Among 21 children who required a ventricular assist device as a bridge to transplantation and 42 children who went straight to transplantation, there were no significant differences in quality of life as measured by their Psychosocial Health Summary Score, Physical Health Summary Score, or Total Score in the PedsQL Core module, nor were there any differences in any of the six dimensions of quality of life assessed by the PedsQL Cardiac module. Among patients who required a ventricular assist device, only the presence of a neurological complication was associated with worse quality of life, in the form of decreased Physical Health Summary and decreased Cardiac Communication scores. Conclusions Over the long-term, surviving children who required a long-term ventricular assist device as a bridge to transplantation experience a similar quality of life as those who went straight to transplantation.

Journal ArticleDOI
TL;DR: A patient is presented with a patient with a very late complication of device thrombus after percutaneous secundum ASD device closure.
Abstract: The secundum atrial septal defect (ASD) is noted to occur in 1 per 1,500 live births and is the fourth most common congenital heart defect (CHD) [Anzai et al. in Am J Cardiol 93:426–431, 2004]. Early complications with percutaneous closure of secundum ASDs include device malposition and embolization, arrhythmias (primarily atrial fibrillation), pericardial effusion, residual shunt, and thrombus development on the left atrial disk [Chessa et al. in J Am Coll Cardiol 39:1061–1065, 2002, Co-Burn and William in Moss and Adams’ Heart disease in infants, children and adolescents including fetus and young adults. Williams and Wilkins, Baltimore, 1995]. We present a patient with a very late complication of device thrombus after percutaneous secundum ASD device closure.

Journal Article
TL;DR: The Syncardia temporary Total Artificial Heart (TAH-t) replaces a patient’s failing ventricles as a “bridge-to-transplant” that is contraindicated if insufficient space exists for a new heart to be implanted.
Abstract: Introduction: The Syncardia temporary Total Artificial Heart (TAH-t) replaces a patient’s failing ventricles as a “bridge-to-transplant” The TAH-t is contraindicated if insufficient space exists i