Ravi R. Thiagarajan

Heart Disease and Stroke Statistics'2017 Update: A Report from the American Heart Association

WRITING GROUP MEMBERS Emelia J. Benjamin, MD, SCM, FAHA Michael J. Blaha, MD, MPH Stephanie E. Chiuve, ScD Mary Cushman, MD, MSc, FAHA Sandeep R. Das, MD, MPH, FAHA Rajat Deo, MD, MTR Sarah D. de Ferranti, MD, MPH James Floyd, MD, MS Myriam Fornage, PhD, FAHA Cathleen Gillespie, MS Carmen R. Isasi, MD, PhD, FAHA Monik C. Jiménez, ScD, SM Lori Chaffin Jordan, MD, PhD Suzanne E. Judd, PhD Daniel Lackland, DrPH, FAHA Judith H. Lichtman, PhD, MPH, FAHA Lynda Lisabeth, PhD, MPH, FAHA Simin Liu, MD, ScD, FAHA Chris T. Longenecker, MD Rachel H. Mackey, PhD, MPH, FAHA Kunihiro Matsushita, MD, PhD, FAHA Dariush Mozaffarian, MD, DrPH, FAHA Michael E. Mussolino, PhD, FAHA Khurram Nasir, MD, MPH, FAHA Robert W. Neumar, MD, PhD, FAHA Latha Palaniappan, MD, MS, FAHA Dilip K. Pandey, MBBS, MS, PhD, FAHA Ravi R. Thiagarajan, MD, MPH Mathew J. Reeves, PhD Matthew Ritchey, PT, DPT, OCS, MPH Carlos J. Rodriguez, MD, MPH, FAHA Gregory A. Roth, MD, MPH Wayne D. Rosamond, PhD, FAHA Comilla Sasson, MD, PhD, FAHA Amytis Towfighi, MD Connie W. Tsao, MD, MPH Melanie B. Turner, MPH Salim S. Virani, MD, PhD, FAHA Jenifer H. Voeks, PhD Joshua Z. Willey, MD, MS John T. Wilkins, MD Jason HY. Wu, MSc, PhD, FAHA Heather M. Alger, PhD Sally S. Wong, PhD, RD, CDN, FAHA Paul Muntner, PhD, MHSc On behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee Heart Disease and Stroke Statistics—2017 Update

Extracorporeal Life Support Organization Registry Report 2012.

In this article, summary data from the annual international Extracorporeal Life Support Organization (ELSO) Registry Reports through July 2012 are presented. Nearly 51,000 patients have received extracorporeal life support (ECLS). Of the patients, 50% (>25,000) were neonatal respiratory failure, with a 75% overall survival to discharge or transfer. Congenital diaphragmatic hernia remains a major use of ECLS in this population with 51% survival. Extracorporeal life support use for pediatric respiratory failure has nearly doubled since 2000, with approximately 350 patients treated per year in the past 3 years examined (56% survival). Previously stable at about 100 cases a year for a decade, adult respiratory failure ECLS cases increased dramatically in 2009 with the H1N1 influenza pandemic and publication of the Conventional ventilation or ECMO for Severe Adult Respiratory failure (CESAR) trial results and have remained at approximately 400 cases a year through 2011 (55% survival). Use of ECLS for cardiac support represents a large area of consistent growth. Approximately 13,000 patients have been treated with survival to discharge rates of 40%, 49%, and 39% for neonates, pediatric, and adults, respectively.

Extracorporeal Membrane Oxygenation to Aid Cardiopulmonary Resuscitation in Infants and Children

Background— Extracorporeal membrane oxygenation (ECMO) has been used to support cardiorespiratory function during pediatric cardiopulmonary resuscitation (CPR). We report on outcomes and predictors of in-hospital mortality after ECMO used to support CPR (E-CPR). Methods and Results— Outcomes for patients aged <18 years using E-CPR were analyzed with data from the Extracorporeal Life Support Organization, and predictors of in-hospital mortality were determined. Of 26 242 ECMO uses reported, 695 (2.6%) were for E-CPR (n=682 patients). Survival to hospital discharge was 38%. In a multivariable model, pre-ECMO factors such as cardiac disease (odds ratio [OR] 0.51, 95% confidence interval [CI] 0.31 to 0.82) and neonatal respiratory disease (OR 0.28, 95% CI 0.12 to 0.66), white race (OR 0.65, 95% CI 0.45 to 0.94), and pre-ECMO arterial blood pH >7.17 (OR 0.50, 95% CI 0.30 to 0.84) were associated with decreased odds of mortality. During ECMO, renal dysfunction (OR 1.89, 95% CI 1.17 to 3.03), pulmonary hemorrhage (OR 2.23, 95% CI 1.11 to 4.50), neurological injury (OR 2.79, 95% CI 1.55 to 5.02), CPR during ECMO (OR 3.06, 95% CI 1.42 to 6.58), and arterial blood pH <7.2 (OR 2.23, 95% CI 1.23 to 4.06) were associated with increased odds of mortality. Conclusions— ECMO used to support CPR rescued one third of patients in whom death was otherwise certain. Patient diagnosis, absence of severe metabolic acidosis before ECMO support, and uncomplicated ECMO course were associated with improved survival.

Waiting List Mortality Among Children Listed for Heart Transplantation in the United States

Background— Children listed for heart transplantation face the highest waiting list mortality in solid-organ transplantation medicine. We examined waiting list mortality since the pediatric heart allocation system was revised in 1999 to determine whether the revised allocation system is prioritizing patients optimally and to identify specific high-risk populations that may benefit from emerging pediatric cardiac assist devices. Methods and Results— We conducted a multicenter cohort study using the US Scientific Registry of Transplant Recipients. All children <18 years of age who were listed for a heart transplant between 1999 and 2006 were included. Among 3098 children, the median age was 2 years (interquartile range 0.3 to 12 years), and median weight was 12.3 kg (interquartile range 5 to 38 kg); 1294 (42%) were nonwhite; and 1874 (60%) were listed as status 1A (of whom 30% were ventilated and 18% were on extracorporeal membrane oxygenation). Overall, 533 (17%) died, 1943 (63%) received transplants, and 252 (8%) recovered; 370 (12%) remained listed. Multivariate predictors of waiting list mortality include extracorporeal membrane oxygenation support (hazard ratio [HR] 3.1, 95% confidence interval [CI] 2.4 to 3.9), ventilator support (HR 1.9, 95% CI 1.6 to 2.4), listing status 1A (HR 2.2, 95% CI 1.7 to 2.7), congenital heart disease (HR 2.2, 95% CI 1.8 to 2.6), dialysis support (HR 1.9, 95% CI 1.2 to 3.0), and nonwhite race/ethnicity (HR 1.7, 95% CI 1.4 to 2.0). Conclusions— US waiting list mortality for pediatric heart transplantation remains unacceptably high in the current era. Specific high-risk subgroups can be identified that may benefit from emerging pediatric cardiac assist technologies. The current pediatric heart-allocation system captures medical urgency poorly. Further research is needed to define the optimal organ-allocation system for pediatric heart transplantation.

Predicting survival after ECMO for refractory cardiogenic shock: the survival after veno-arterial-ECMO (SAVE)-score

RATIONALE Extracorporeal membrane oxygenation (ECMO) may provide mechanical pulmonary and circulatory support for patients with cardiogenic shock refractory to conventional medical therapy. Prediction of survival in these patients may assist in management of these patients and comparison of results from different centers. AIMS To identify pre-ECMO factors which predict survival from refractory cardiogenic shock requiring ECMO and create the survival after veno-arterial-ECMO (SAVE)-score. METHODS AND RESULTS Patients with refractory cardiogenic shock treated with veno-arterial ECMO between January 2003 and December 2013 were extracted from the international Extracorporeal Life Support Organization registry. Multivariable logistic regression was performed using bootstrapping methodology with internal and external validation to identify factors independently associated with in-hospital survival. Of 3846 patients with cardiogenic shock treated with ECMO, 1601 (42%) patients were alive at hospital discharge. Chronic renal failure, longer duration of ventilation prior to ECMO initiation, pre-ECMO organ failures, pre-ECMO cardiac arrest, congenital heart disease, lower pulse pressure, and lower serum bicarbonate (HCO3) were risk factors associated with mortality. Younger age, lower weight, acute myocarditis, heart transplant, refractory ventricular tachycardia or fibrillation, higher diastolic blood pressure, and lower peak inspiratory pressure were protective. The SAVE-score (area under the receiver operating characteristics [ROC] curve [AUROC] 0.68 [95%CI 0.64-0.71]) was created. External validation of the SAVE-score in an Australian population of 161 patients showed excellent discrimination with AUROC = 0.90 (95%CI 0.85-0.95). CONCLUSIONS The SAVE-score may be a tool to predict survival for patients receiving ECMO for refractory cardiogenic shock (www.save-score.com).

Extracorporeal membrane oxygenation for the support of infants, children, and young adults with acute myocarditis: A review of the Extracorporeal Life Support Organization registry*

Objective: To describe survival outcomes for pediatric patients supported with extracorporeal membrane oxygenation for severe myocarditis and identify risk factors for in-hospital mortality. Design: Retrospective review of Extracorporeal Life Support Organization registry database. Setting: Data reported to Extracorporeal Life Support Organization from 116 extracorporeal membrane oxygenation centers. Patients: Patients ≤18 yrs of age supported with extracorporeal membrane oxygenation for myocarditis during 1995 to 2006. Interventions: None. Measurements and Main Results: Of 19,348 reported pediatric extracorporeal membrane oxygenation uses from 1995 to 2006, 260 runs were for 255 patients with a diagnosis of myocarditis (1.3%). Survival to hospital discharge was 61%. Seven patients (3%) underwent heart transplantation and six patients survived to discharge. Of 100 patients not surviving to hospital discharge, extracorporeal membrane oxygenation support was withdrawn in 70 (70%) with multiple organ failure as the indication in 58 (83%) patients. In a multivariable model, female gender (adjusted odds ratio, 2.3, 95% confidence interval, 1.3–4.2), arrhythmia on extracorporeal membrane oxygenation (adjusted odds ratio, 2.7, 95% confidence interval, 1.5–5.1), and renal failure requiring dialysis (adjusted odds ratio, 5.1, 95% confidence interval, 2.3–11.4) were associated with increased odds of in-hospital mortality. Conclusion: Extracorporeal membrane oxygenation is a valuable tool to rescue children with severe cardiorespiratory compromise related to myocarditis. Female gender, arrhythmia on extracorporeal membrane oxygenation, and need for dialysis during extracorporeal membrane oxygenation were associated with increased mortality.

Rapid-Response Extracorporeal Membrane Oxygenation to Support Cardiopulmonary Resuscitation in Children With Cardiac Disease

Background— Survival of children with in-hospital cardiac arrest that does not respond to conventional cardiopulmonary resuscitation (CPR) is poor. We report on survival and early neurological outcomes of children with heart disease supported with rapid-response extracorporeal membrane oxygenation (ECMO) to aid cardiopulmonary resuscitation (ECPR). Methods and Results— Children with heart disease supported with ECPR were identified from our ECMO database. Demographic, CPR, and ECMO details associated with mortality were evaluated using multivariable logistic regression. Pediatric overall performance category and pediatric cerebral performance category scores were assigned to ECPR survivors to assess neurological outcomes. There were 180 ECPR runs in 172 patients. Eighty-eight patients (51%) survived to discharge. Survival in patients who underwent ECPR after cardiac surgery (54%) did not differ from nonsurgical patients (46%). Survival did not vary by cardiac diagnosis and CPR duration did not differ between survivors and nonsurvivors. Factors associated with mortality included noncardiac structural or chromosomal abnormalities (OR, 3.2; 95% CI, 1.3–7.9), use of blood-primed ECMO circuit (OR, 7.1; 95% CI, 1.4–36), and arterial pH <7.00 after ECMO deployment (OR, 6.0; 95% CI, 2.1–17.4). Development of end-organ injury on ECMO and longer ECMO duration were associated with increased mortality. Of pediatric overall performance category/pediatric cerebral performance category scores assigned to survivors, 75% had scores ≤2, indicating no to mild neurological injury. Conclusions— ECPR may promote survival in children with cardiac disease experiencing cardiac arrest unresponsive to conventional CPR with favorable early neurological outcomes. CPR duration was not associated with mortality, whereas patients with metabolic acidosis and noncardiac structural or chromosomal anomalies had higher mortality.

Extracorporeal Membrane Oxygenation for Bridge to Heart Transplantation Among Children in the United States Analysis of Data From the Organ Procurement and Transplant Network and Extracorporeal Life Support Organization Registry

Background— Extracorporeal membrane oxygenation (ECMO) has served for >2 decades as the standard of care for US children requiring mechanical support as a bridge to heart transplantation. Objective data on the safety and efficacy of ECMO for this indication are limited. We describe the outcomes of ECMO as a bridge to heart transplantation to serve as performance benchmarks for emerging miniaturized assist devices intended to replace ECMO. Methods and Results— Data from the Extracorporeal Life Support Organization Registry and the Organ Procurement Transplant Network database were merged to identify children supported with ECMO and listed for heart transplantation from 1994 to 2009. Independent predictors of wait-list and posttransplantation in-hospital mortality were identified. Objective performance goals for ECMO were developed. Of 773 children, the median age was 6 months (interquartile range, 1 to 44 months); 28% had cardiomyopathy; and in 38%, a bridge to transplantation was intended at ECMO initiation. Overall, 45% of subjects reached transplantation, although one third of those transplanted died before discharge; overall survival to hospital discharge was 47%. Wait-list mortality was independently associated with congenital heart disease, cardiopulmonary resuscitation before ECMO, and renal dysfunction. Posttransplantation mortality was associated with congenital heart disease, renal dysfunction, ECMO duration of >14 days, and initial ECMO indication as a bridge to recovery. In the objective performance goal cohort (n=485), patients with cardiomyopathy had the highest survival to hospital discharge (63%), followed by patients with myocarditis (59%), 2-ventricle congenital heart disease (44%) and 1-ventricle congenital heart disease (33%). Conclusion— Although ECMO is effective for short-term circulatory support, it is not reliable for the long-term circulatory support necessary for children awaiting heart transplantation. Fewer than half of patients bridged with ECMO survive to hospital discharge. More effective modalities for chronic circulatory support in children are urgently needed.

Extracorporeal Membrane Oxygenation for Bridge to Heart Transplantation Among Children in the United States

Background— Extracorporeal membrane oxygenation (ECMO) has served for >2 decades as the standard of care for US children requiring mechanical support as a bridge to heart transplantation. Objective data on the safety and efficacy of ECMO for this indication are limited. We describe the outcomes of ECMO as a bridge to heart transplantation to serve as performance benchmarks for emerging miniaturized assist devices intended to replace ECMO. Methods and Results— Data from the Extracorporeal Life Support Organization Registry and the Organ Procurement Transplant Network database were merged to identify children supported with ECMO and listed for heart transplantation from 1994 to 2009. Independent predictors of wait-list and posttransplantation in-hospital mortality were identified. Objective performance goals for ECMO were developed. Of 773 children, the median age was 6 months (interquartile range, 1 to 44 months); 28% had cardiomyopathy; and in 38%, a bridge to transplantation was intended at ECMO initiation. Overall, 45% of subjects reached transplantation, although one third of those transplanted died before discharge; overall survival to hospital discharge was 47%. Wait-list mortality was independently associated with congenital heart disease, cardiopulmonary resuscitation before ECMO, and renal dysfunction. Posttransplantation mortality was associated with congenital heart disease, renal dysfunction, ECMO duration of >14 days, and initial ECMO indication as a bridge to recovery. In the objective performance goal cohort (n=485), patients with cardiomyopathy had the highest survival to hospital discharge (63%), followed by patients with myocarditis (59%), 2-ventricle congenital heart disease (44%) and 1-ventricle congenital heart disease (33%). Conclusion— Although ECMO is effective for short-term circulatory support, it is not reliable for the long-term circulatory support necessary for children awaiting heart transplantation. Fewer than half of patients bridged with ECMO survive to hospital discharge. More effective modalities for chronic circulatory support in children are urgently needed.

Survival after extracorporeal cardiopulmonary resuscitation in infants and children with heart disease

OBJECTIVE We investigated survival and predictors of mortality for infants and children with heart disease treated with extracorporeal membrane oxygenation as an aid to cardiopulmonary resuscitation. METHODS Children (<18 years) with heart disease who received extracorporeal cardiopulmonary resuscitation and were reported to the Extracorporeal Life Support Organization database were evaluated. Patients were classified into one of 3 groups based on underlying cardiac physiology: single ventricle, 2 ventricles, and cardiac muscle disease. Patients with eligible procedure codes were assigned a Risk Adjustment for Congenital Heart Surgery-1 classification. RESULTS Four hundred ninety-two patients were eligible for analysis, and 279 (57%) were assigned a Risk Adjustment for Congenital Heart Surgery-1 category. Overall survival was 42%. In a multivariable logistic regression analysis, significant pre-extracorporeal predictors for mortality included single-ventricle physiology (odds ratio, 1.6; 95% confidence interval, 1.05-2.4), a history of a stage 1-type procedure (odds ratio, 2.7; 95% confidence interval, 1.2-6.2), and extreme acidosis (arterial blood gas pH < 7.01; odds ratio, 2.2; 95% confidence interval, 1.3-3.7). Right carotid artery cannulation was associated with decreased mortality risk (odds ratio, 0.6; 95% confidence interval, 0.4-0.9). During extracorporeal support, complications, including renal injury, evidence of neurologic injury, and persistent acidosis, were associated with an increased risk of hospital mortality. CONCLUSION Use of extracorporeal membrane oxygenation as an adjunct to cardiopulmonary resuscitation resulted in hospital survival in 42% of infants and children with heart disease. Underlying cardiac physiology and associated cardiac surgical procedures influenced mortality, as did pre-extracorporeal resuscitation status and extracorporeal membrane oxygenation-associated complications.