117 results on '"Sleeper L"'
Search Results
2. Impact of maternal social vulnerability and timing of prenatal care on outcome of prenatally detected congenital heart disease
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Perez, M. T., primary, Bucholz, E., additional, Asimacopoulos, E., additional, Ferraro, A. M., additional, Salem, S. M., additional, Schauer, J., additional, Holleman, C., additional, Sekhavat, S., additional, Tworetzky, W., additional, Powell, A. J., additional, Sleeper, L. A., additional, and Beroukhim, R. S., additional
- Published
- 2022
- Full Text
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3. Supplement to: Atenolol versus losartan in children and young adults with Marfanʼs syndrome.
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Lacro, R V, Dietz, H C, and Sleeper, L A
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- 2014
4. Atenolol versus Losartan in Children and Young Adults With Marfanʼs Syndrome
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Lacro, R. V., Dietz, H. C., and Sleeper, L. A.
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- 2015
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5. Supplement to: Strategies for multivessel revascularization in patients with diabetes
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Farkouh, M E, Domanski, M, and Sleeper, L A
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- 2012
6. Supplement to: Comparison of shunt types in the Norwood procedure for single-ventricle lesions.
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Ohye, R G, Sleeper, L A, and Mahony, L
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- 2010
7. Wait Times in Pediatric Heart Transplant Candidates: Impact of Size and Blood Type Following the 2016 Allocation Policy Revision
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Williams, R., primary, Lu, M., additional, Sleeper, L., additional, Urbach, S., additional, and Daly, K., additional
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- 2021
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8. DECREASED MUSCARINIC RECEPTOR BINDING IN THE ARCUATE NUCLEUS (ARC) IN THE SUDDEN INFANT DEATH SYNDROME (SIDS): 14
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Kinnev, H C, Filiano, J J, Sleeper, L A, Mandell, F, Valdes-Dapena, M, and White, W F
- Published
- 1995
9. Improved technical success, postnatal outcome and refined predictors of outcome for fetal aortic valvuloplasty
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Friedman, K. G., primary, Sleeper, L. A., additional, Freud, L. R., additional, Marshall, A. C., additional, Godfrey, M. E., additional, Drogosz, M., additional, Lafranchi, T., additional, Benson, C. B., additional, Wilkins-Haug, L. E., additional, and Tworetzky, W., additional
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- 2018
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10. Determinants of mortality when primary LV failure complicates acute myocardial infarction
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Col J, Boland J, Dens J, Van de Werf F, Hochman J S, Webb J, Sleeper L, Miller D, Slater J, Jacobs A, Forman R, Talley J D, Porway M, Sanborn T, White H, and LeJemtel T H
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- 1996
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11. 101: Are bridge to recovery patients sick enough to require ventricular assist device in refractory acute myocardial infarction cardiogenic shock?: Benchmark against the SHOCK trial
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Anderson, M., primary, Madani, M., additional, Naka, Y., additional, Raess, D., additional, Samuels, L., additional, Sun, B., additional, and Sleeper, L., additional
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- 2007
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12. 509 Hemodynamic parameters in cardiogenic shock due to myocardial infarction: a report from the SHOCK trial registry
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COTTER, G, primary, FINCKE, R, additional, LOWE, A, additional, SLEEPER, L, additional, and HOCHMAN, J, additional
- Published
- 2003
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13. BRAINSTEM ALPHA2 RECEPTOR BINDING IN THE SUDDEN INFANT DEATH SYNDROME
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Mansouri, J., primary, Sleeper, L. A., additional, White, W. F., additional, and Kinney, H. C., additional
- Published
- 1999
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14. NEUROPATHOLOGY OF INFANTS WITH CONGENITAL HEART DISEASE (CHD) DYING AFTER CARDIOPULMONARY BYPASS (CPB) SURGERY
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Panigrahy, A, primary, Chittenden, E H, additional, Jonas, R A, additional, Newburger, J W, additional, Sleeper, L A, additional, and Kinney, H C, additional
- Published
- 1998
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15. Etiology and family history of pediatric cardiomyopathy: the early pediatric cardiomyopathy registry (PCMR) experience
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Lipshultz, S.E., primary, Towbin, J.A., additional, Grenier, M.A., additional, Osganian, V., additional, Colan, S.D., additional, Sleeper, L., additional, Shaddy, R., additional, Cox, G., additional, and Lurie, P., additional
- Published
- 1998
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16. DOES VALVE REPLACEMENT SURGERY IMPROVE SURVIVAL IN PATIENTS WITH STAPHYLOCOCCLS AUREUS PROSTHETIC VALVE ENDOCARDITIS?
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Hibberd, P. L., primary, Sleeper, L, additional, John, M, additional, Karchmer, A W, additional, and Calderwood, S, additional
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- 1997
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17. Evidence for a Shift from a Type I Lymphocyte Pattern with HIV Disease Progression
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Jason, J, primary, Sleeper, L A, additional, Donfield, S M, additional, Murphy, J, additional, Warrier, I, additional, Arkin, S, additional, and Evatt, B, additional
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- 1995
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18. The reproducibility of the postcoital test: A prospective study
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GLATSTEIN, I, primary, BEST, C, additional, PALUMBO, A, additional, SLEEPER, L, additional, FRIEDMAN, A, additional, and HORNSTEIN, M, additional
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- 1995
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19. High-risk Profiles for Nursing Home Admission
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Jette, A. M., primary, Branch, L. G., additional, Sleeper, L. A., additional, Feldman, H., additional, and Sullivan, L. M., additional
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- 1992
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20. The Pediatric Heart Network: A Primer for the Conduct of Multicenter Studies in Children with Congenital and Acquired Heart Disease.
- Author
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Mahony, L., Sleeper, L. A., Anderson, P. A.W., Gersony, W. M., McCrindle, B. W., Minich, L. L., Newburger, J. W., Saul, J. P., Vetter, V. L., and Pearson, G. D.
- Subjects
- *
CARDIOVASCULAR diseases , *PATIENTS , *MEDICAL experimentation on humans , *CLINICAL trials , *PEDIATRICS ,HEART disease research ,STUDY & teaching of medicine - Abstract
Most contemporary diagnostic and treatment strategies for pediatric patients with cardiovascular disease are not supported by evidence from clinical trials but instead are based on expert opinion, single-institution observational studies, or extrapolated from adult cardiovascular medicine. In response to this concern, the National Heart, Lung, and Blood Institute established the Pediatric Heart Disease Clinical Research Network (PHN) in 2001. The purposes of this article are to describe the initiation, structure, and function of the PHN; to review the ongoing studies; and to address current and future challenges. To date, four randomized clinical trials and two observational studies have been launched. Design and conduct of complex, multicenter studies in children with congenital and acquired heart disease must address numerous challenges, including identification of an appropriate clinically relevant primary endpoint, lack of preliminary data on which to base sample size calculations, and recruitment of an adequate number of subjects. The infrastructure is now well developed and capable of implementing complex, multicenter protocols efficiently and recruiting subjects effectively. The PHN is uniquely positioned to contribute to providing evidence-based medicine for and improving the outcomes of pediatric patients with cardiovascular disease. [ABSTRACT FROM AUTHOR]
- Published
- 2006
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21. Observer variability in the diagnosis and management of the hysterosalpingogram
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Glatstein, I. Z., Sleeper, L. A., Lavy, Y., Simon, A., Adoni, A., Palti, Z., Hurwitz, A., and Laufer, N.
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- 1997
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22. Estimating the joint distribution of repeated binary responses: Some small sample results
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Lipsitz, S. R., Fitzmaurice, G. M., Sleeper, L., and Zhao, L. P.
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- 1996
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23. Six-year results of the Eastern Cooperative Oncology Group trial of observation versus CMFP versus CMFPT in postmenopausal patients with node-positive breast cancer.
- Author
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Taylor, S G, primary, Knuiman, M W, additional, Sleeper, L A, additional, Olson, J E, additional, Tormey, D C, additional, Gilchrist, K W, additional, Falkson, G, additional, Rosenthal, S N, additional, Carbone, P P, additional, and Cummings, F J, additional
- Published
- 1989
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24. 509 Hemodynamic parameters in cardiogenic shock due to myocardial infarction: a report from the SHOCK trial registry
- Author
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Cotter, G., Fincke, R., Lowe, A., Sleeper, L., and Hochman, J.
- Subjects
MYOCARDIAL infarction ,CARDIOGENIC shock - Abstract
An abstract of the study "Hemodynamic Parameters in Cardiogenic Shock Due to Myocardial Infarction: A Report From the SHOCK Trial Registry," by G. Cotter and R. Fincke, is presented.
- Published
- 2004
25. BRAINSTEM ALPHA2 RECEPTOR BINDING IN THE SUDDEN INFANT DEATH SYNDROME.
- Author
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Mansouri, J., Sleeper, L. A., White, W. F., and Kinney, H. C.
- Published
- 1999
- Full Text
- View/download PDF
26. Atenolol versus Losartan in Children and Young Adults with Marfan’s Syndrome.
- Author
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Lacro, R. V., Dietz, H. C., Sleeper, L. A., Yetman, A. T., Bradley, T. J., Colan, S. D., Pearson, G. D., Tierney, E. S. Selamet, Levine, J. C., Atz, A. M., Benson, D. W., Braverman, A. C., Chen, S., De Backer, J., Gelb, B. D., Grossfeld, P. D., Klein, G. L., Lai, W. W., Liou, A., and Loeys, B. L.
- Subjects
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DISSECTION , *MARFAN syndrome treatment , *CAUSES of death , *CONNECTIVE tissue diseases , *LOSARTAN , *ATENOLOL , *THERAPEUTICS - Abstract
The article discusses the results of a study on aortic-root dissection as the leading cause of death in Marfan's syndrome. Topics include a brief description of Marfan's syndrome as an autosomal dominant disorder of connective tissue, an overview of a randomized trial which compares losartan with atenolol in children and young adults with Marfan's syndrome, and no significant difference in the rate of aortic-root dilatation between the treatment groups.
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- 2014
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27. Observer variation and clinical decision making: Reply
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Glatstein, I. Z. and Sleeper, L. A.
- Published
- 1997
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28. MT. MORRIS, Sept. 9th, 1855.
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SLEEPER, L. C.
- Published
- 1855
29. Cardiogenic shock without flow-limiting angiographic coronary artery disease: (from the Should We Emergently Revascularize Occluded Coronary Arteries for Cardiogenic Shock Trial and Registry).
- Author
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French JK, Harkness S, Sleeper L, Wong SC, Col J, Dzavik V, White HD, Hochman JS, French, John K, Harkness, Shannon, Sleeper, Lynn, Wong, S Chiu, Col, Jacques, Dzavik, Vladimir, White, Harvey D, and Hochman, Judith S
- Abstract
Myocardial infarction often develops when thrombosis occurs at lesions that have not previously been flow limiting. However, the development of cardiogenic shock complicating acute myocardial infarction in such circumstances has received little attention. The characteristics of 15 patients with cardiogenic shock who had no flow-limiting angiographic stenoses were compared with those of 767 patients with > or =1 stenosis who were enrolled in the Should We Emergently Revascularize Occluded Coronary Arteries for Cardiogenic Shock (SHOCK) trial and registry. Compared with patients with > or =1 flow-limiting stenosis, patients with no flow-limiting stenoses were less likely to have pulmonary edema on chest x-ray (29% vs 62%, p = 0.008) and to be white (53% vs 82%, p = 0.011), and they had lower median highest creatine kinase levels (702 vs 2,731 U/L, p = 0.018). For SHOCK trial patients, 1-year survival was 49% for patients with > or =1 flow-limiting stenosis and 71% for those with no flow-limiting stenoses (p = 0.268). In conclusion, patients with cardiogenic shock without flow-limiting stenosis have different characteristics, and potentially disease mechanisms, and they do not require revascularization. [ABSTRACT FROM AUTHOR]
- Published
- 2009
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30. Acute myocardial infarction complicated by systemic hypoperfusion without hypotension: report of the SHOCK trial registry.
- Author
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Menon, Venue, Slater, Janes N., Menon, V, Slater, J N, White, H D, Sleeper, L A, Cocke, T, and Hochman, J S
- Subjects
- *
CARDIOGENIC shock , *HYPOTENSION , *MYOCARDIAL infarction - Abstract
Background: Cardiogenic shock is usually characterized by inadequate cardiac output and sustained hypotension. However, following a large myocardial infarction, peripheral hypoperfusion can occur with relatively well maintained systolic blood pressure, a condition known as nonhypotensive cardiogenic shock. The aim of this study was to determine the characteristics of patients with this condition.Methods: The SHOCK trial registry prospectively enrolled patients with suspected cardiogenic shock complicating acute myocardial infarction. We identified a group of 49 patients who presented with nonhypotensive shock, defined as clinical evidence of peripheral hypoperfusion with a systolic blood pressure >90 mm Hg without vasopressor circulatory support. Clinical characteristics, hemodynamic data, and outcomes in these patients were compared with a group of 943 patients with classic cardiogenic shock with hypotension. The age, gender, and distributions of coronary risk factors were similar in both groups.Results: Patients with nonhypotensive shock were more likely to have an anterior wall myocardial infarction (71% versus 53%, P = 0.03). Both groups of patients had similar rates of treatment with thrombolytic therapy, angioplasty, and bypass surgery. Patients with nonhypotensive shock had an in-hospital mortality rate of 43% as compared with a rate of 66% among patients who had classic cardiogenic shock with hypotension (P = 0.001). Mortality among 76 patients who presented with a systolic blood pressure <90 mm Hg but no hypoperfusion was 26%.Conclusions: Even in the presence of normal blood pressure, clinical signs of peripheral hypoperfusion, which may be subtle, are associated with a substantial risk of in-hospital death following acute myocardial infarction. [ABSTRACT FROM AUTHOR]- Published
- 2000
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31. Impact of surgical strategy and postrepair transverse aortic arch size on late hypertension after coarctation repair during infancy.
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Safi S, Hoganson D, Emani S, Sleeper L, Elia E, Lu M, Biering-Sørensen T, and Prakash A
- Abstract
Background: Late hypertension (HTN) after coarctation of the aorta (CoA) repair contributes to higher morbidity and mortality. An association between transverse aortic arch (TAA) hypoplasia and HTN has been found, but its relationship with surgical strategy is unclear. We studied the association between late HTN and initial surgical strategy pertaining to the TAA., Methods: We retrospectively reviewed patients who underwent surgical repair of CoA during infancy with at least 10 years of follow-up, excluding those with atypical coarctation, major associated heart defects, and residual isthmic narrowing. TAA diameter z-score immediately postrepair was measured as a marker of surgical strategy. Systemic HTN at latest follow-up was assessed using standard criteria., Results: A total of 130 patients underwent surgical repair of CoA (76% via thoracotomy, 24% via sternotomy) with resection and end-to-end anastomosis (62%), extended end-to-end anastomosis (30%), subclavian flap (5%), or arch repair with patch (4%), at a median age of 14 days (interquartile range [IQR], 7-62 days). The median postrepair TAA diameter z-score was -2.04 (IQR, -2.69 to 1.24). At a mean follow-up of 17.3 years, 43 of the 130 patients (33%) developed HTN. After controlling for age at repair, sex, and presence of a genetic syndrome, HTN was not associated with immediate postrepair TAA diameter z-score (P = .41), type of surgical incision (P = .99), or type of surgical repair (P = .66)., Conclusions: In patients undergoing surgical repair of CoA during infancy, late HTN was not associated with immediate postrepair TAA size or surgical strategy pertaining to the TAA. These results suggest that factors other than surgical strategy, such as differential growth of the TAA during childhood, may be important., Competing Interests: Conflict of Interest Statement The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2024 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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32. A prospective multicenter feasibility study of a miniaturized implantable continuous flow ventricular assist device in smaller children with heart failure.
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Almond CS, Davies R, Adachi I, Richmond M, Law S, Tunuguntla H, Mao C, Shaw F, Lantz J, Wearden PD, Jordan LC, Ichord RN, Burns K, Zak V, Magnavita A, Gonzales S, Conway J, Jeewa A, Freemon D', Stylianou M, Sleeper L, Dykes JC, Ma M, Fynn-Thompson F, Lorts A, Morales D, Vanderpluym C, Dasse K, Patricia Massicotte M, Jaquiss R, and Mahle WT
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- Humans, Child, Preschool, Child, Male, Infant, Female, Prospective Studies, Miniaturization, Prosthesis Design, Treatment Outcome, United States, Heart-Assist Devices, Feasibility Studies, Heart Failure therapy, Heart Failure surgery, Heart Failure physiopathology
- Abstract
Background: There is no FDA-approved left ventricular assist device (LVAD) for smaller children permitting routine hospital discharge. Smaller children supported with LVADs typically remain hospitalized for months awaiting heart transplant-a major burden for families and a challenge for hospitals. We describe the initial outcomes of the Jarvik 2015, a miniaturized implantable continuous flow LVAD, in the NHLBI-funded Pumps for Kids, Infants, and Neonates (PumpKIN) study, for bridge-to-heart transplant., Methods: Children weighing 8 to 30 kg with severe systolic heart failure and failing optimal medical therapy were recruited at 7 centers in the United States. Patients with severe right heart failure and single-ventricle congenital heart disease were excluded. The primary feasibility endpoint was survival to 30 days without severe stroke or non-operational device failure., Results: Of 7 children implanted, the median age was 2.2 (range 0.7, 7.1) years, median weight 10 (8.2 to 20.7) kilograms; 86% had dilated cardiomyopathy; 29% were INTERMACS profile 1. The median duration of Jarvik 2015 support was 149 (range 5 to 188) days where all 7 children survived including 5 to heart transplant, 1 to recovery, and 1 to conversion to a paracorporeal device. One patient experienced an ischemic stroke on day 53 of device support in the setting of myocardial recovery. One patient required ECMO support for intractable ventricular arrhythmias and was eventually transplanted from paracorporeal biventricular VAD support. The median pump speed was 1600 RPM with power ranging from 1-4 Watts. The median plasma free hemoglobin was 19, 30, 19 and 30 mg/dL at 7, 30, 90 and 180 days or time of explant, respectively. All patients reached the primary feasibility endpoint. Patient-reported outcomes with the device were favorable with respect to participation in a full range of activities. Due to financial issues with the manufacturer, the study was suspended after consent of the eighth patient., Conclusion: The Jarvik 2015 LVAD appears to hold important promise as an implantable continuous flow device for smaller children that may support hospital discharge. The FDA has approved the device to proceed to a 22-subject pivotal trial. Whether this device will survive to commercialization remains unclear because of the financial challenges faced by industry seeking to develop pediatric medical devices. (Supported by NIH/NHLBI HHS Contract N268201200001I, clinicaltrials.gov 02954497)., (Copyright © 2024 International Society for the Heart and Lung Transplantation. All rights reserved.)
- Published
- 2024
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33. Risk Factors for Death or Transplant After Stage 2 Palliation for Single Ventricle Heart Disease.
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Bucholz EM, Lu M, Sleeper L, Vergales J, Bingler MA, Ronai C, Anderson JB, Bates KE, Lannon C, Reynolds L, and Brown DW
- Abstract
Background: For infants with single ventricle heart disease, the time after stage 2 procedure (S2P) is believed to be a lower risk period compared with the interstage period; however, significant morbidity and mortality still occur., Objectives: This study aimed to identify risk factors for mortality or transplantation referral between S2P surgery and the first birthday., Methods: Retrospective cohort analysis of infants in the National Pediatric Cardiology Quality Improvement Collaborative who underwent staged single ventricle palliation from 2016 to 2022 and survived to S2P. Multivariable logistic regression and classification and regression trees were performed to identify risk factors for mortality and transplantation referral after S2P., Results: Of the 1,455 patients in the cohort who survived to S2P, 5.2% died and 2.3% were referred for transplant. Overall event rates at 30 and 100 days after S2P were 2% and 5%, respectively. Independent risk factors for mortality and transplantation referral included the presence of a known genetic syndrome, shunt type at stage 1 procedure (S1P), tricuspid valve repair at S1P, longer time to extubation and reintubation after S1P, ≥ moderate tricuspid regurgitation prior to S2P, younger age at S2P, and the risk groups identified in the classification and regression tree analysis (extracorporeal membrane oxygenation after S1P and longer S2P cardiopulmonary bypass time without extracorporeal membrane oxygenation)., Conclusions: Mortality and transplantation referral rates after S2P to 1 year of age remain high ∼7%. Many of the identified risk factors after S2P are similar to those established for interstage factors around the S1P, whereas others may be unique to the period after S2P., Competing Interests: Dr Bucholz is funded by a grant from the 10.13039/100005627Thrasher Research Fund to apply machine learning techniques for risk prediction of outcomes in single ventricle heart disease. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)
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- 2024
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34. The family burden of paediatric heart disease during the chronic phase of illness.
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Hummel K, Ludomirsky A, Burgunder L, Lu M, Goldberg S, Sleeper L, Reichman J, and Blume ED
- Abstract
Background: CHD is a lifelong condition with a significant burden of disease to patients and families. With increased survival, attention has shifted to longer-term outcomes, with a focus on social determinants of health. Among children with CHD, socioeconomic status is associated with disparities in outcomes. Household material hardship is a concrete measure of poverty and may serve as an intervenable measure of socioeconomic status., Methods: A longitudinal survey study was conducted at multiple time points (at acute hospitalisation, then 12-24 months later in the chronic phase) to determine the prevalence of household material hardship among parents of children with advanced heart disease and quality of life during long-term follow-up., Results: The analytic cohort was 160 children with a median patient age of 1 year (IQR 1,4) with 54% of patients <2 years. During acute hospitalisation, over one-third of families reported household material hardship (37%), with significantly lower household material hardship in the chronic phase at 16% (N = 9 of 52). For parents reporting household material hardship during acute hospitalisation, 50% had resolution of household material hardship by the chronic phase. Household material hardship-exposed children were significantly more likely to be publicly insured (56% versus 20%, p = 0.03) with lower quality of life than those without household material hardship (64% versus 82%, p = 0.013)., Conclusion: The burden of heart disease during the chronic phase of illness is high. Household material hardship may serve as a target to ensure equity in the care and outcomes of CHD patients and their families.
- Published
- 2023
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35. Left atrioventricular valve repair after primary atrioventricular canal surgery: Predictors of durability.
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Gellis L, McGeoghegan P, Lu M, Feins E, Sleeper L, Emani S, Friedman K, and Baird C
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- Child, Humans, Infant, Constriction, Pathologic surgery, Reoperation adverse effects, Retrospective Studies, Treatment Outcome, Heart Septal Defects diagnostic imaging, Heart Septal Defects surgery, Heart Septal Defects complications, Mitral Valve Insufficiency surgery
- Abstract
Objective: Acute outcomes after atrioventricular canal defects (AVCD) surgery in the current era are excellent; yet despite surgical advances, ∼15% of patients require future left atrioventricular valve (LAVV) repair. Among patients with AVC who undergo LAVV repair after primary AVC surgery, we sought to characterize the durability of these repairs. Specifically, we aimed to determine predictors for reintervention following an LAVV repair in patients with repaired AVCD, with a focus on postoperative transesophageal echocardiography (TEE)., Methods: We reviewed all patients undergoing LAVV repair (after a primary AVCD surgery) at Boston Children's Hospital between 2010 and 2020. Competing risk analysis was performed to evaluate cumulative incidence of LAVV reinterventions. Predictors of LAVV reintervention were evaluated using multivariable Cox regression., Results: A total of 137 LAVV repairs following primary AVCD surgery were performed in 113 patients. Median age and weight at LAVV repair were 25 months (interquartile range, 12-76 months) and 11.1 kg (interquartile range, 7.8-19.4 kg). Original anatomy was complete AVCD in 87 (63%), transitional AVCD in 27 (20%), and partial AVCD in 23 (17%) cases. Over a median follow-up of 12 months (interquartile range, 1.3 months-4 years), 47 (34%) of the LAVV repairs required LAVV reintervention. Reinterventions included a total of 27 LAVV re-repairs and 20 LAVV replacements. In multivariable analysis, age at LAVV repair younger than 72 months, partial AVCD anatomy, left ventricle dysfunction, mean LAVV stenosis gradient ≥5 mm Hg, and multiple jets of regurgitation on postoperative LAVV repair TEE were associated with LAVV reintervention. Grade of LAVV regurgitation on postoperative TEE was not an independent risk factor, but reintervention rates were high when residual LAVV stenosis gradient was ≥5 mm Hg and residual mild LAVV regurgitation was present on postoperative TEE (47%) and even higher when residual LAVV stenosis gradient was ≥5 mm Hg and LAVV regurgitation was greater than mild (73%)., Conclusions: Reintervention rates remain high for LAVV repairs that occur after primary AVCD surgery, particularly for patients with LAVV stenosis gradient ≥5 mm Hg and mild or greater LAVV regurgitation on postoperative TEE., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
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36. Longitudinal changes in extent of late gadolinium enhancement in repaired Tetralogy of Fallot: a retrospective analysis of serial CMRs.
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Saengsin K, Lu M, Sleeper L, Geva T, and Prakash A
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- Adolescent, Adult, Child, Contrast Media, Female, Gadolinium, Humans, Magnetic Resonance Imaging, Cine, Male, Predictive Value of Tests, Retrospective Studies, Cardiac Surgical Procedures adverse effects, Tetralogy of Fallot diagnostic imaging, Tetralogy of Fallot surgery
- Abstract
Background: Right ventricular (RV) late gadolinium enhancement (LGE) occurs due to surgical scarring and RV remodeling, and has been shown to be associated with clinical outcomes in Tetralogy of Fallot (TOF). However, it is not known if cardiovascular magnetic resonance (CMR) LGE extent progresses over time, and therefore, it is not known if serial reassessment of LGE is necessary. We determined the rate of progression in the extent of RV LGE on serial CMR examinations in repaired TOF., Methods: Retrospective review of 127 patients after TOF repair (49% male, median age at first CMR 18.9 years (Interquartile range (IQR) 13.3,27.0) who had at least two CMRs (median follow-up duration of 4.0 years (IQR 2.1,5.9)) was performed. 84/127 patients had no interventions between serial CMRs (Group 1) while 43/127 patients had transcatheter or surgical intervention between CMRs (Group 2). The extent of RV LGE was assessed using 2 methods: a semiquantitative RV LGE score and a quantitative RV LGE extent expressed as % of RV mass. Mixed effects linear regression modeling to estimate changes in LGE over time., Results: RV LGE was present in all patients on the first CMR. % RV LGE extent and LGE score did not increase over time in either patient group. The mean 5 year rates of change were small and negative for both % RV LGE extent [- 2.3 (95% CI - 2.9, - 1.8, p < 0.001) in Group 1, and - 1.9 (95% CI - 3.2, - 0.7, p = 0.004) in Group 2], and RV LGE score [- 0.9 (95% CI - 1.1, - 0.6, p < 0.001) in Group 1, and - 0.5 (95% CI - 1.1, - 0.0, p = 0.047) in Group 2]., Conclusions: In this serial CMR evaluation of children and adults with repaired TOF, no significant progression in the extent of RV LGE was seen on intermediate term follow-up. Given recent concerns regarding the safety of gadolinium-based contrast agents, frequent assessment of LGE may not be necessary in follow-up.
- Published
- 2021
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37. Heart block following stage 1 palliation of hypoplastic left heart syndrome.
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Mah DY, Cheng H, Alexander ME, Sleeper L, Newburger JW, Del Nido PJ, Thiagarajan RR, and Rajagopal SK
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- Child, Child, Preschool, Female, Heart Block diagnosis, Heart Ventricles diagnostic imaging, Humans, Hypoplastic Left Heart Syndrome diagnosis, Male, Retrospective Studies, Risk Factors, Treatment Outcome, Fontan Procedure adverse effects, Heart Block etiology, Heart Ventricles surgery, Hypoplastic Left Heart Syndrome surgery, Palliative Care
- Abstract
Objectives: Publicly available data from the Pediatric Heart Network's Single Ventricle Reconstruction Trial was analyzed to determine the prevalence, timing, risk factors for, and impact of second- and third-degree heart block (HB) on outcomes in patients who underwent stage 1 palliation (S1P) for hypoplastic left heart syndrome (HLHS)., Methods: The presence and date of onset of post-S1P HB occurring within the first year of life, potential risk factors for HB, and factors known to predict poor outcomes after S1P were extracted. Multivariable logistic and Cox regression analyses were performed to identify risk factors for HB and to determine the effect of HB on 3-year transplantation-free survival., Results: Among the 549 patients in the cohort, 33 (6%) developed HB after S1P. The median interval between S1P and HB was 8 days (interquartile range, 0-133 days). Regression analysis showed that tricuspid valve repair during S1P and obstruction of pulmonary venous drainage requiring pre-S1P intervention were independently associated with HB (adjusted odds ratio [aOR], 11.6, 95% confidence interval [CI] 3.3-40; P < .001 and aOR, 5.1; 95% CI, 1.3-20.6; P = .02, respectively). Transplantation-free survival at 3 years was lower for those with HB (39% vs 65%; P = .004). HB remained associated with transplantation-free survival after controlling for known risk factors (adjusted hazard ratio, 3.1; 95% CI, 1.9-5.0; P < .001). Nine children (27%) had a pacemaker implanted, and 7 of these children (78%) died or underwent heart transplantation., Conclusions: HB after S1P is rare but heralds a poor outcome. Careful monitoring of these patients is recommended given their significantly increased risks of death and heart transplantation., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2016
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38. The Congenital Heart Disease Genetic Network Study: rationale, design, and early results.
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Gelb B, Brueckner M, Chung W, Goldmuntz E, Kaltman J, Kaski JP, Kim R, Kline J, Mercer-Rosa L, Porter G, Roberts A, Rosenberg E, Seiden H, Seidman C, Sleeper L, Tennstedt S, Kaltman J, Schramm C, Burns K, Pearson G, and Rosenberg E
- Subjects
- Adolescent, Adult, Biological Specimen Banks organization & administration, Child, Child, Preschool, Clinical Trials as Topic, Confidentiality, DNA Mutational Analysis, Data Collection, Databases, Factual, Follow-Up Studies, Gene Dosage, Genetic Association Studies, Genomics, Genotype, Heart Defects, Congenital epidemiology, Hospitals, Pediatric organization & administration, Humans, Infant, Infant, Newborn, Interdisciplinary Communication, Outcome Assessment, Health Care, Patient Selection, Phenotype, Prospective Studies, Schools, Medical organization & administration, Translational Research, Biomedical organization & administration, United States, Young Adult, Heart Defects, Congenital genetics, National Heart, Lung, and Blood Institute (U.S.) organization & administration, Registries ethics
- Abstract
Congenital heart defects (CHD) are the leading cause of infant mortality among birth defects, and later morbidities and premature mortality remain problematic. Although genetic factors contribute significantly to cause CHD, specific genetic lesions are unknown for most patients. The National Heart, Lung, and Blood Institute-funded Pediatric Cardiac Genomics Consortium established the Congenital Heart Disease Genetic Network Study to investigate relationships between genetic factors, clinical features, and outcomes in CHD. The Pediatric Cardiac Genomics Consortium comprises 6 main and 4 satellite sites at which subjects are recruited, and medical data and biospecimens (blood, saliva, cardiovascular tissue) are collected. Core infrastructure includes an administrative/data-coordinating center, biorepository, data hub, and core laboratories (genotyping, whole-exome sequencing, candidate gene evaluation, and variant confirmation). Eligibility includes all forms of CHD. Annual follow-up is obtained for probands <1-year-old. Parents are enrolled whenever available. Enrollment from December 2010 to June 2012 comprised 3772 probands. One or both parents were enrolled for 72% of probands. Proband median age is 5.5 years. The one third enrolled at age <1 year are contacted annually for follow-up information. The distribution of CHD favors more complex lesions. Approximately, 11% of probands have a genetic diagnosis. Adequate DNA is available from 97% and 91% of blood and saliva samples, respectively. Genomic analyses of probands with heterotaxy, atrial septal defects, conotruncal, and left ventricular outflow tract obstructive lesions are underway. The scientific community's use of Pediatric Cardiac Genomics Consortium resources is welcome.
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- 2013
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39. Design of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial.
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Farkouh ME, Dangas G, Leon MB, Smith C, Nesto R, Buse JB, Cohen DJ, Mahoney E, Sleeper L, King S 3rd, Domanski M, McKinlay S, and Fuster V
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- Angioplasty, Balloon, Coronary, Coronary Artery Bypass, Drug-Eluting Stents, Humans, Prospective Studies, Coronary Disease therapy, Diabetes Complications, Epidemiologic Research Design, Myocardial Revascularization
- Abstract
Background: Prior randomized trials suggested that revascularization of diabetic patients by coronary artery bypass grafting (CABG) produced results superior to balloon angioplasty. The introduction of drug-eluting stents (DESs) calls into question the relevance of past studies to the current era. The FREEDOM Trial is designed to determine whether CABG or percutaneous coronary intervention (PCI) is the superior approach for revascularization of diabetic patients., Study Design: The FREEDOM Trial is a multicenter, open-label prospective randomized superiority trial of PCI versus CABG in at least 2000 diabetic patients in whom revascularization is indicated. Consenting diabetic patients with multivessel disease will be randomized on a 1:1 basis to either CABG or multivessel stenting using DESs and observed at 30 days, 1 year, and annually for up to 5 years. At the discretion of the primary physician or interventionalists, patients randomized to the PCI/DES arm will receive any approved DESs. The primary outcome measure is the composite of all-cause mortality, nonfatal myocardial infarction, or stroke. Patients will be observed for a mean of 4 years., Implications: At present, coronary revascularization with CABG surgery is the treatment of choice in diabetic patients with multivessel coronary artery disease. Drug-eluting stents have shown promising preliminary results in the diabetic population. The FREEDOM Trial is an international study designed to define the optimal revascularization strategy for the diabetic patient with multivessel coronary disease.
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- 2008
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40. Early revascularization is associated with improved survival in elderly patients with acute myocardial infarction complicated by cardiogenic shock: a report from the SHOCK Trial Registry.
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Dzavik V, Sleeper LA, Cocke TP, Moscucci M, Saucedo J, Hosat S, Jiang X, Slater J, LeJemtel T, and Hochman JS
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- Aged, Data Collection, Female, Humans, Male, Myocardial Infarction complications, Myocardial Infarction mortality, Myocardial Revascularization mortality, Prospective Studies, Registries, Shock, Cardiogenic mortality, Survival Analysis, Myocardial Infarction therapy, Myocardial Revascularization methods, Shock, Cardiogenic complications
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Aims: The SHould we emergently revascularize Occluded Coronaries in cardiogenic shocK (SHOCK) Trial showed no benefit of early revascularization in patients aged >/=75 years with acute myocardial infarction and cardiogenic shock. We examined the effect of age on treatment and outcomes of patients with cardiogenic shock in the SHOCK Trial Registry., Methods and Results: We compared clinical and treatment factors in patients in the SHOCK Trial Registry with shock due to pump failure aged <75 years (n=588) and >/=75 years (n=277), and 30-day mortality of patients treated with early revascularization <18 hours since onset of shock and those undergoing a later or no revascularization procedure. After excluding early deaths covariate-adjusted relative risk and 95% confidence intervals were calculated to compare the revascularization strategies within the two age groups. Older patients more often had prior myocardial infarction, congestive heart failure, renal insufficiency, other comorbidities, and severe coronary anatomy. In-hospital mortality in the early vs. late or no revascularization groups was 45 vs. 61% for patients aged <75 years (p=0.002) and 48 vs. 81% for those aged >/=75 years (p=0.0003). After exclusion of 65 early deaths and covariate adjustment, the relative risk was 0.76 (0.59, 0.99; p=0.045) in patients aged <75 years and 0.46 (0.28, 0.75; p=0.002) in patients aged >/=75 years., Conclusions: Elderly patients with myocardial infarction complicated by cardiogenic shock are less likely to be treated with invasive therapies than younger patients with shock. Covariate-adjusted modeling reveals that elderly patients selected for early revascularization have a lower mortality rate than those receiving a revascularization procedure later or never.
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- 2003
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41. Absence of gender differences in clinical outcomes in patients with cardiogenic shock complicating acute myocardial infarction. A report from the SHOCK Trial Registry.
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Wong SC, Sleeper LA, Monrad ES, Menegus MA, Palazzo A, Dzavik V, Jacobs A, Jiang X, and Hochman JS
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- Aged, Angioplasty, Balloon, Coronary, Australia epidemiology, Belgium epidemiology, Brazil epidemiology, Canada epidemiology, Cause of Death, Coronary Angiography, Coronary Artery Bypass, Disease Progression, Female, Fibrinolytic Agents therapeutic use, Humans, Incidence, Male, Myocardial Infarction diagnosis, New Zealand epidemiology, Patient Selection, Population Surveillance, Prognosis, Prospective Studies, Registries, Sex Distribution, Treatment Outcome, United States epidemiology, Heart Failure etiology, Hospital Mortality, Myocardial Infarction complications, Myocardial Infarction therapy, Sex Characteristics, Shock, Cardiogenic etiology, Shock, Cardiogenic mortality, Ventricular Dysfunction, Left etiology
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Objectives: The aim of this study was to assess the impact of gender on clinical course and in-hospital mortality in patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI)., Background: Previous studies have demonstrated higher mortality for women compared with men with ST elevation myocardial infarctions and higher rates of CS after AMI. The influence of gender and its interaction with various treatment strategies on clinical outcomes once CS develops is unclear., Methods: Using the SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? (SHOCK) Registry database of 1,190 patients with suspected CS in the setting of AMI, we examined shock etiologies by gender. Among the 884 patients with predominant left ventricular (LV) failure, we compared the patient demographics, angiographic and hemodynamic findings, treatment approaches as well as the clinical outcomes of women versus men. This study had a 97% power to detect a 10% absolute difference in mortality by gender., Results: Left ventricular failure was the most frequent cause of CS for both gender groups. Women in the SHOCK Registry had a significantly higher incidence of mechanical complications including ventricular septal rupture and acute severe mitral regurgitation. Among patients with predominant LV failure, women were, on average, 4.6 years older, had a higher incidence of hypertension, diabetes and a lower cardiac index. The overall mortality rate for the entire cohort was high (61%). After adjustment for differences in patient demographics and treatment approaches, there was no significant difference in in-hospital mortality between the two gender groups (odds ratio = 1.03, 95% confidence interval of 0.73 to 1.43, p = 0.88). Mortality was also similar for women and men who were selected for revascularization (44% vs. 38%, p = 0.244)., Conclusions: Women with CS complicating AMI had more frequent adverse clinical characteristics and mechanical complications. Women derived the same benefit as men from revascularization, and gender was not independently associated with in-hospital mortality in the SHOCK Registry.
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- 2001
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42. Volumetric brain differences in children with periventricular T2-signal hyperintensities: a grouping by gestational age at birth.
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Panigrahy A, Barnes PD, Robertson RL, Back SA, Sleeper LA, Sayre JW, Kinney HC, and Volpe JJ
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- Birth Weight, Brain pathology, Brain Damage, Chronic diagnosis, Cephalometry, Female, Gestational Age, Humans, Infant, Newborn, Male, Prognosis, Risk Factors, Cerebral Ventricles pathology, Infant, Premature, Diseases diagnosis, Leukomalacia, Periventricular diagnosis, Magnetic Resonance Imaging
- Abstract
Objective: The purpose of this study was to compare both the volumes of the lateral ventricles and the cerebral white matter with gestational age at birth of children with periventricular white matter (PVWM) T2-signal hyperintensities on MR images. The spectrum of neuromotor abnormalities associated with these hyperintensities was also determined., Materials and Methods: We retrospectively reviewed the MR images of 70 patients who were between the ages of 1 and 5 years and whose images showed PVWM T2-signal hyperintensities. The patients were divided into premature (n = 35 children) and term (n = 35) groups depending on their gestational age at birth. Volumetric analysis was performed on four standardized axial sections using T2-weighted images. Volumes of interest were digitized on the basis of gray-scale densities of signal intensities to define the hemispheric cerebral white matter and lateral ventricles. Age-adjusted comparisons of volumetric measurements between the premature and term groups were performed using analysis of covariance., Results: The volume of the cerebral white matter was smaller in the premature group (54 +/- 2 cm(3)) than in the term group (79 +/- 3 cm(3), p < 0.0001). The volume of the lateral ventricles was greater among the patients in the premature group (30 +/- 2 cm(3)) than among those in the term group (13 +/- 1 cm(3), p < 0.0001). Fifty percent of all the premature children had spastic diplegia or quadriplegia. Thirty-two percent of all the term children had hypotonia. There were patients in both groups whose PVWM T2-signal hyperintensities did not correlate with any neuromotor abnormalities but were associated with seizures or developmental delays., Conclusion: The differences in volumetric measurements of cerebral white matter and lateral ventricles in children with PVWM T2-signal hyperintensities are related to their gestational age at birth. Several neurologic motor abnormalities are found in children with such hyperintensities.
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- 2001
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43. Silent infarction as a risk factor for overt stroke in children with sickle cell anemia: a report from the Cooperative Study of Sickle Cell Disease.
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Miller ST, Macklin EA, Pegelow CH, Kinney TR, Sleeper LA, Bello JA, DeWitt LD, Gallagher DM, Guarini L, Moser FG, Ohene-Frempong K, Sanchez N, Vichinsky EP, Wang WC, Wethers DL, Younkin DP, Zimmerman RA, and DeBaun MR
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- Child, Humans, Infant, Magnetic Resonance Imaging, Myocardial Infarction diagnosis, Risk Factors, Anemia, Sickle Cell complications, Myocardial Infarction complications, Stroke etiology
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Objective: To determine whether children with homozygous sickle cell anemia (SCD) who have silent infarcts on magnetic resonance imaging (MRI) of the brain are at increased risk for overt stroke., Methods: We selected patients with homozygous SCD who (1) enrolled in the Cooperative Study of Sickle Cell Disease (CSSCD) before age 6 months, (2) had at least 1 study-mandated brain MRI at age 6 years or older, and (3) had no overt stroke before a first MRI. MRI results and clinical and laboratory parameters were tested as predictors of stroke., Results: Among 248 eligible patients, mean age at first MRI was 8.3 +/- 1.9 years, and mean follow-up after baseline MRI was 5.2 +/- 2.2 years. Five (8.1%) of 62 patients with silent infarct had strokes compared with 1 (0.5%) of 186 patients without prior silent infarct; incidence per 100 patient-years of follow-up was increased 14-fold (1.45 per 100 patient-years vs 0.11 per 100 patient-years, P =.006). Of several clinical and laboratory parameters examined, silent infarct was the strongest independent predictor of stroke (hazard ratio = 7.2, P =.027)., Conclusions: Silent infarct identified at age 6 years or older is associated with increased stroke risk.
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- 2001
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44. Percutaneous coronary intervention for cardiogenic shock in the SHOCK Trial Registry.
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Webb JG, Sanborn TA, Sleeper LA, Carere RG, Buller CE, Slater JN, Baran KW, Koller PT, Talley JD, Porway M, and Hochman JS
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- Aged, Canada epidemiology, Female, Humans, Male, Myocardial Infarction mortality, Myocardial Infarction therapy, Prospective Studies, Registries, Survival Analysis, United States epidemiology, Angioplasty, Balloon, Coronary, Shock, Cardiogenic mortality, Shock, Cardiogenic therapy
- Abstract
Background: The SHOCK Registry prospectively enrolled patients with cardiogenic shock complicating acute myocardial infarction in 36 multinational centers., Methods: Cardiogenic shock was predominantly attributable to left ventricular pump failure in 884 patients. Of these, 276 underwent percutaneous coronary intervention (PCI) after shock onset and are the subject of this report., Results: The majority (78%) of patients undergoing angiography had multivessel disease. As the number of diseased arteries rose from 1 to 3, mortality rates rose from 34.2% to 51.2%. Patients who underwent PCI had lower in-hospital mortality rates than did patients treated medically (46.4% vs 78.0%, P < .001), even after adjustment for patient differences and survival bias (P = .037). Before PCI, the culprit artery was occluded (Thrombolysis In Myocardial Infarction grade 0 or 1 flow) in 76.3%. After PCI, the in-hospital mortality rate was 33.3% if reperfusion was complete (grade 3 flow), 50.0% with incomplete reperfusion (grade 2 flow), and 85.7% with absent reperfusion (grade 0 or 1 flow) (P < .001)., Conclusions: This prospective, multicenter registry of patients with acute myocardial infarction complicated by cardiogenic shock is consistent with a reduction in mortality rates as the result of percutaneous coronary revascularization. Coronary artery patency was an important predictor of outcome. Measures to promote early and rapid reperfusion appear critically important in improving the otherwise poor outcome associated with cardiogenic shock.
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- 2001
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45. Trends in cardiogenic shock: report from the SHOCK Study. The SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK?
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Carnendran L, Abboud R, Sleeper LA, Gurunathan R, Webb JG, Menon V, Dzavik V, Cocke T, and Hochman JS
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- Adult, Aged, Emergencies, Humans, Length of Stay, Middle Aged, Prognosis, Prospective Studies, Registries, Shock, Cardiogenic etiology, Survival Analysis, Myocardial Infarction complications, Myocardial Infarction surgery, Myocardial Revascularization, Shock, Cardiogenic mortality
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Aims: We analysed time trends in patient characteristics, management, and outcomes of cardiogenic shock complicating acute myocardial infarction in the international, prospective SHOCK Trial Registry and pre-study Registry., Background: Despite therapeutic advances in its management, the incidence and high mortality of this complication has remained unchanged for decades. However, in recent years mortality was reported to decrease in one community concomitant with increasing use of revascularization., Methods: Thirty-six centres registered 1380 patients with suspected cardiogenic shock complicating acute myocardial infarction from January 1992 to August 1997. Patient and myocardial infarction characteristics, haemodynamics, medications, procedure use, and vital status at discharge were recorded., Results: In all, 79% of patients had shock due to predominant pump failure (non-mechanical aetiology). The aetiology, patient profile, and clinical characteristics of cardiogenic shock did not differ over time, except for increases in the incidence of prior bypass surgery (P=0.054) and transfers to tertiary centres (P=0.008). In all, 44% underwent revascularization (n=485), with angioplasty performed more often than bypass surgery (69% vs 31%). The revascularization rate increased over time (P=0.006) with a significant decrease in the time to revascularization (P=0.033). The use of Swan-Ganz catheterization decreased over time (P=0.018), as did the mean length of hospitalization (P=0.034). Overall in-hospital mortality was high (63%) but decreased over time in all patients (P=0.004) and those with pump failure (P=0.018). Mortality was lower for patients who underwent revascularization compared to those who were not revascularized (41% vs 79%, P<0.001)., Conclusions: Cardiogenic shock complicating acute myocardial infarction is associated with a high mortality rate, but mortality decreased significantly from 1992 to 1997. This partly reflects the greater use of revascularization, which was associated with better outcomes. The reported international trend towards shorter admissions for myocardial infarction was also observed in this cohort.
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- 2001
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46. Alpha2 receptor binding in the medulla oblongata in the sudden infant death syndrome.
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Mansouri J, Panigrahy A, Filiano JJ, Sleeper LA, St John WM, and Kinney HC
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- Binding Sites, Biomarkers, Humans, Infant, Newborn, Radioligand Assay, Medulla Oblongata metabolism, Medulla Oblongata pathology, Receptors, Adrenergic, alpha-2 metabolism, Respiratory Center metabolism, Respiratory Center pathology, Sudden Infant Death pathology
- Abstract
The sudden infant death syndrome (SIDS) is the leading cause of postnatal infant mortality in the United States. Its etiology remains unknown. We propose that SIDS, or a subset of SIDS, is due to a failure of autoresuscitation, a protective brainstem response to asphyxia or hypoxia, in a vulnerable infant during a critical developmental period. Gasping is an important component of autoresuscitation that is thought to be mediated by the "gasping center" in the lateral tegmentum of the medulla, a region homologous in its cytoarchitecture and chemical anatomy to the intermediate reticular zone (IRZ) in the human. Since we found that [3H]para-aminoclonidine ([3H]PAC) binding to alpha2-adrenergic receptors localizes to this region in human infants and, thereby provides a neurochemical marker for it, we tested the hypothesis that [3H]PAC binding to alpha2-adrenergic receptors is decreased in the IRZ in SIDS victims. Using quantitative tissue autoradiography with [3H]PAC as the radioligand and phentolamine as the displacer, we analyzed alpha2-receptor binding density in the IRZ, as well as in 7 additional sites for comparison, in 10 SIDS and 10 control medullae. There were no significant differences in alpha2 receptor binding in the IRZ, vagal nuclei, or other medullary sites examined between SIDS and control cases. These results suggest that the putative gasping defect in the IRZ in SIDS victims is not related to [3H]PAC binding to alpha2-adrenergic receptors.
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- 2001
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47. One-year survival following early revascularization for cardiogenic shock.
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Hochman JS, Sleeper LA, White HD, Dzavik V, Wong SC, Menon V, Webb JG, Steingart R, Picard MH, Menegus MA, Boland J, Sanborn T, Buller CE, Modur S, Forman R, Desvigne-Nickens P, Jacobs AK, Slater JN, and LeJemtel TH
- Subjects
- Aged, Female, Humans, Intra-Aortic Balloon Pumping, Male, Middle Aged, Myocardial Infarction complications, Myocardial Infarction mortality, Myocardial Infarction therapy, Shock, Cardiogenic etiology, Survival Analysis, Thrombolytic Therapy, Time Factors, Ventricular Dysfunction, Left complications, Angioplasty, Balloon, Coronary, Coronary Artery Bypass, Shock, Cardiogenic mortality, Shock, Cardiogenic therapy
- Abstract
Context: Cardiogenic shock (CS) is the leading cause of death for patients hospitalized with acute myocardial infarction (AMI)., Objective: To assess the effect of early revascularization (ERV) on 1-year survival for patients with AMI complicated by CS., Design: The SHOCK (Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock) Trial, an unblinded, randomized controlled trial from April 1993 through November 1998., Setting: Thirty-six referral centers with angioplasty and cardiac surgery facilities., Patients: Three hundred two patients with AMI and CS due to predominant left ventricular failure who met specified clinical and hemodynamic criteria., Interventions: Patients were randomly assigned to an initial medical stabilization (IMS; n = 150) group, which included thrombolysis (63% of patients), intra-aortic balloon counterpulsation (86%), and subsequent revascularization (25%), or to an ERV group (n = 152), which mandated revascularization within 6 hours of randomization and included angioplasty (55%) and coronary artery bypass graft surgery (38%)., Main Outcome Measures: All-cause mortality and functional status at 1 year, compared between the ERV and IMS groups., Results: One-year survival was 46.7% for patients in the ERV group compared with 33.6% in the IMS group (absolute difference in survival, 13.2%; 95% confidence interval [CI], 2.2%-24.1%; P<.03; relative risk for death, 0.72; 95% CI, 0.54-0.95). Of the 10 prespecified subgroup analyses, only age (<75 vs >/= 75 years) interacted significantly (P<.03) with treatment in that treatment benefit was apparent only for patients younger than 75 years (51.6% survival in ERV group vs 33.3% in IMS group). Eighty-three percent of 1-year survivors (85% of ERV group and 80% of IMS group) were in New York Heart Association class I or II., Conclusions: For patients with AMI complicated by CS, ERV resulted in improved 1-year survival. We recommend rapid transfer of patients with AMI complicated by CS, particularly those younger than 75 years, to medical centers capable of providing early angiography and revascularization procedures.
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- 2001
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48. Cardiogenic shock complicating acute myocardial infarction--etiologies, management and outcome: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK?
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Hochman JS, Buller CE, Sleeper LA, Boland J, Dzavik V, Sanborn TA, Godfrey E, White HD, Lim J, and LeJemtel T
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- Aged, Cardiac Catheterization, Coronary Angiography, Diagnosis, Differential, Female, Humans, Incidence, Male, Myocardial Infarction complications, Myocardial Infarction diagnosis, Myocardial Infarction mortality, Myocardial Infarction therapy, Prospective Studies, Radionuclide Ventriculography, Shock, Cardiogenic diagnosis, Shock, Cardiogenic epidemiology, Shock, Cardiogenic therapy, Survival Rate, Treatment Outcome, Intra-Aortic Balloon Pumping, Myocardial Revascularization, Registries statistics & numerical data, Shock, Cardiogenic etiology, Thrombolytic Therapy
- Abstract
Objectives: This SHOCK Study report seeks to provide an overview of patients with cardiogenic shock (CS) complicating acute myocardial infarction (MI) and the outcome with various treatments. The outcome of patients undergoing revascularization in the SHOCK Trial Registry and SHOCK Trial are compared., Background: Cardiogenic shock is the leading cause of death in patients hospitalized for acute MI. The randomized SHOCK Trial reported improved six-month survival with early revascularization., Methods: Patients with CS complicating acute MI who were not enrolled in the concurrent randomized trial were registered. Patient characteristics were recorded as were procedures and vital status at hospital discharge., Results: Between April 1993 and August 1997, 1,190 patients with CS were registered and 232 were randomized in the SHOCK Trial. Predominant left ventricular failure (78.5%) was most common, with isolated right ventricular shock in 2.8%, severe mitral regurgitation in 6.9%, ventricular septal rupture in 3.9% and tamponade in 1.4%. In-hospital Registry mortality was 60%, with ventricular septal rupture associated with a significantly higher mortality (87.3%) than all other categories (p < 0.01). The risk profile and mortality were lower for Registry patients who were managed with thrombolytic therapy and/or intra-aortic balloon counter-pulsation, coronary angiography, angioplasty and/or coronary artery bypass surgery. After adjusting for these differences, the extent to which survival was improved with early revascularization was similar to that observed in the randomized SHOCK Trial., Conclusions: In this prospective Registry the etiology of CS was a mechanical complication in 12%. The similarity of the beneficial treatment effect in patients undergoing early revascularization in the SHOCK Trial Registry and SHOCK Trial provides strong support for the generalizability of the SHOCK Trial results.
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- 2000
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49. Diabetes mellitus in cardiogenic shock complicating acute myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK?
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Shindler DM, Palmeri ST, Antonelli TA, Sleeper LA, Boland J, Cocke TP, and Hochman JS
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- Aged, Coronary Angiography, Diabetes Mellitus mortality, Diabetes Mellitus physiopathology, Female, Hemodynamics, Hospital Mortality, Humans, Male, Myocardial Infarction complications, Myocardial Infarction diagnostic imaging, Myocardial Infarction mortality, Myocardial Infarction therapy, Myocardial Revascularization, Prognosis, Prospective Studies, Shock, Cardiogenic mortality, Shock, Cardiogenic physiopathology, Shock, Cardiogenic therapy, Thrombolytic Therapy, Diabetes Complications, Registries, Shock, Cardiogenic complications
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Objectives: We sought to examine the role of diabetes mellitus in cardiogenic shock (CS) complicating acute myocardial infarction (AMI) in the SHOCK Trial Registry., Background: The characteristics, outcomes and optimal treatment of diabetic patients with CS complicating AMI have not been well described., Methods: Baseline characteristics, clinical and hemodynamic measures, treatment variables, shock etiologies and comorbid conditions were compared for 379 diabetic and 784 nondiabetic patients. Logistic regression was used to examine the association between diabetes and in-hospital mortality, after adjustment for baseline differences., Results: Diabetics were less likely than nondiabetics to undergo thrombolysis (28% vs. 37%; p = 0.002) or attempted revascularization (40% vs. 49%; p = 0.008). The survival benefit for diabetics selected for percutaneous or surgical revascularization (55% vs. 19% without revascularization) was similar to that for nondiabetics (59% vs. 25%). Overall unadjusted in-hospital mortality was significantly higher for diabetics (67% vs. 58%; p = 0.007), but diabetes was only a borderline predictor of mortality after adjustment for baseline and treatment differences (odds ratio for death, 1.36; 95% confidence interval, 1.00 to 1.84; p = 0.051)., Conclusions: Diabetics with CS complicating AMI have a higher-risk profile at baseline, but after adjustment, diabetics have an in-hospital survival rate that is only marginally lower than that of nondiabetics. Diabetics who undergo revascularization derive a survival benefit similar to that of nondiabetics.
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- 2000
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50. Cardiogenic shock with non-ST-segment elevation myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded coronaries for Cardiogenic shocK?
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Jacobs AK, French JK, Col J, Sleeper LA, Slater JN, Carnendran L, Boland J, Jiang X, LeJemtel T, and Hochman JS
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- Aged, Cardiac Catheterization, Coronary Angiography, Female, Hospital Mortality, Humans, Intra-Aortic Balloon Pumping, Male, Myocardial Infarction complications, Myocardial Infarction diagnostic imaging, Myocardial Infarction physiopathology, Myocardial Infarction therapy, Myocardial Revascularization, Prospective Studies, Shock, Cardiogenic diagnostic imaging, Shock, Cardiogenic etiology, Shock, Cardiogenic therapy, Thrombolytic Therapy, Electrocardiography, Registries, Shock, Cardiogenic physiopathology
- Abstract
Objectives: We sought to determine the outcomes of patients with cardiogenic shock (CS) complicating non-ST-segment elevation acute myocardial infarction (MI)., Background: Such patients represent a high-risk (ST-segment depression) or low-risk (normal or nonspecific electrocardiographic findings) group for whom optimal therapy, particularly in the setting of shock, is unknown., Methods: We assessed characteristics and outcomes of 881 patients with CS due to predominant left ventricular (LV) dysfunction in the SHOCK Trial Registry., Results: Patients with non-ST-segment elevation MI (n = 152) were significantly older and had significantly more prior MI, heart failure, azotemia, bypass surgery, and peripheral vascular disease than patients with ST-elevation MI (n = 729). On average, the groups had similar in-hospital LV ejection fractions (approximately 30%), but patients with non-ST-elevation MI had a lower highest creatine kinase and were more likely to have triple-vessel disease. Among patients selected for coronary angiography, the left circumflex artery was the culprit vessel in 34.6% of non-ST-elevation versus 13.4% of ST-elevation MI patients (p = 0.001). Despite having more recurrent ischemia (25.7% vs. 17.4%, p = 0.058), non-ST-elevation patients underwent angiography less often (52.6% vs. 64.1%, p = 0.010). The proportion undergoing revascularization was similar (36.8% for non-ST-elevation vs. 41.9% ST-elevation MI, p = 0.277). In-hospital mortality also was similar in the two groups (62.5% for non-ST-elevation vs. 60.4% ST-elevation MI). After adjustment, ST-segment elevation MI did not independently predict in-hospital mortality (odds ratio, 1.30; 95% confidence interval, 0.83 to 2.02; p = 0.252)., Conclusions: Patients with CS and non-ST-segment elevation MI have a higher-risk profile than shock patients with ST-segment elevation, but similar in-hospital mortality. More recurrent ischemia and less angiography represent opportunities for earlier intervention, and early reperfusion therapy for circumflex artery occlusion should be considered when non-ST-elevation MI causes CS.
- Published
- 2000
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