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1.
Artigo em Inglês | MEDLINE | ID: mdl-32433821

RESUMO

OBJECTIVES: Characterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure. BACKGROUND: The presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature. METHODS: This was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ≥700 g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ≤2 kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6 months' follow-up. RESULTS: The implant success rate was 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ≤2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ≥700 g. CONCLUSIONS: This study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier: NCT03055858.

2.
Am J Cardiol ; 123(9): 1527-1531, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30797558

RESUMO

The purpose of this study was to define the risk for adults with congenital heart disease who underwent cardiac catheterization and to propose a precatheterization risk scoring system. Data were prospectively collected using a multicenter registry of the Congenital Cardiovascular Interventional Study Consortium. The occurrence of serious adverse events (SAE) was correlated with 12 predefined variables. Catheterization RISk in Adult patients (CRISA) score was derived using multivariate logistic regression with backward elimination model selection method. The CRISA score was compared with the American Society of Anesthesiology score and a consensus-derived, 20-point risk score based on their ability to predict SAE. From June 2008 to September 2017, 300 adjudicated SAE's occurred in 7317 catheterization procedures (overall SAE rate 4.1%) performed in adults over 18 years of age at 27 contributing centers. Nine of the 12 tested variables were ultimately included in the CRISA score. CRISA score positively correlated with risk of SAE, and was superior to American Society of Anesthesiology and the 20-point risk score in predicting SAE. Minimal (CRISA score 0 to 2), low (3 to 7), moderate (8 to 10) and high (≥11) risk categories were identified, corresponding to 0.5%, 3.2%, 7.9%, and 16.7% risk of SAE, respectfully. In conclusion, the CRISA score reliably predicts risk of SAE in adults with congenital heart disease who underwent cardiac catheterization and may be useful for preprocedural risk assessment.


Assuntos
Cateterismo Cardíaco/efeitos adversos , Cardiopatias Congênitas/diagnóstico , Medição de Risco/métodos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Adulto Jovem
3.
Catheter Cardiovasc Interv ; 93(1): 97-104, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-30196566

RESUMO

OBJECTIVES: To externally validate the CRISP score, and determine if refinements might improve clinical utility. BACKGROUND: The CRISP score estimates risk of serious adverse events (SAEs) for pediatric catheterization. METHODS: Pediatric (age < 18) procedures reported to the Congenital Cardiovascular Interventional Study Consortium registry from 05/08 to 09/17 (n = 29,830, 27 centers) were divided into a development dataset of 14,784 earlier procedures, and a validation dataset of 15,046 more recent procedures. The development dataset was used to refit the original CRISP model, and to develop a revised(r) CRISP score, consisting of entirely pre-procedurally collected data. The validation dataset was then used to compare model fit and risk prediction between CRISP, rCRISP and two existing risk scores using Akaike's (AIC), Schwarz's (BIC) Bayes Information Criteria, -log Likelihood (N2LL), area under the receiver operator curve and chi-square goodness-of-fit statistic (across 5 risk categories). RESULTS: Overall 4.31% of patients experienced at least one SAE with frequency increasing from 1.08% in CRISP category 1 to 27.34% in category 5. Both CRISP and rCRISP (entirely pre-procedural) predicted risk of SAEs well, with observed to predicted ratios ranging from 0.71 to 1.18 across the 5 risk categories. Compared to the original CRISP score, rCRISP demonstrated less optimal model fit (higher AIC, BIC, and N2LL) but similar risk prediction (C-statistic = 0.71 vs. 0.70; chi-squared statistic = 6.77 vs. 6.85). CONCLUSION: The CRISP score accurately predicts procedural risk. With minor modifications, the revised version (rCRISP) performed well with arguably greater clinical utility as an entirely preprocedural risk model.


Assuntos
Cateterismo Cardíaco/efeitos adversos , Técnicas de Apoio para a Decisão , Cardiopatias Congênitas/terapia , Feminino , Cardiopatias Congênitas/diagnóstico , Cardiopatias Congênitas/fisiopatologia , Humanos , Lactente , Recém-Nascido , Masculino , Valor Preditivo dos Testes , Sistema de Registros , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco
4.
Catheter Cardiovasc Interv ; 92(1): 88-91, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29659133
5.
Pediatr Cardiol ; 39(2): 315-323, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29181796

RESUMO

Systemic ventricular end-diastolic pressure (SVEDP) is an important determinant of pulmonary artery pressure in those with a Fontan circulation. Predictors of an elevated SVEDP have been incompletely identified in this population. All who underwent the Fontan operation at our center between 1/2009 and 12/2013 were retrospectively identified. SVEDP at the pre-Fontan catheterization and other patient variables were extracted. We identified 61 patients. Pre-Fontan SVEDP was positively associated with systemic ventricular systolic pressure (ß = 0.4, p = 0.004), aortic systolic pressure (ß = 0.3, p = 0.007), aortic mean pressure (ß = 0.3, p = 0.02), and decreased ventricular systolic function (p = 0.03). Compared to those with pre-Fontan SVEDP ≤ 7 mmHg, patients with SVEDP > 7 mmHg had higher average ventricular systolic pressure (85.0 ± 7.5 vs. 78.7 ± 8.3 mmHg, p = 0.003), higher average descending aorta mean pressure (62.4 ± 4.9 vs. 58.6 ± 8.1 mmHg, p = 0.03), and a higher incidence of decreased ventricular systolic function (36 vs. 15%, p = 0.07). For those with a systemic right ventricle, the SVEDP decreased significantly from the pre-Stage 2 to pre-Fontan measurements (8.7 ± 2.6 vs. 7.3 ± 2.0 mmHg, p = 0.02), but not for those with a systemic left ventricle (7.8 ± 2.0 vs. 7.2 ± 1.8 mmHg, p = 0.3). At pre-Fontan catheterization, decreased ventricular systolic function and markers of systemic afterload were positively associated with the SVEDP. SVEDP decreased significantly after Stage 2 for those with a systemic right ventricle, but not for those with a systemic left ventricle; the systemic right ventricle may be particularly vulnerable to pre-Stage 2 volume loading.


Assuntos
Pressão Sanguínea/fisiologia , Técnica de Fontan/efeitos adversos , Ventrículos do Coração/fisiopatologia , Pressão Ventricular/fisiologia , Cateterismo Cardíaco/métodos , Pressão Venosa Central/fisiologia , Criança , Pré-Escolar , Feminino , Técnica de Fontan/métodos , Ventrículos do Coração/cirurgia , Humanos , Síndrome do Coração Esquerdo Hipoplásico/fisiopatologia , Síndrome do Coração Esquerdo Hipoplásico/cirurgia , Lactente , Masculino , Estudos Retrospectivos , Fatores de Risco , Função Ventricular/fisiologia
6.
Circulation ; 136(21): 2009-2019, 2017 Nov 21.
Artigo em Inglês | MEDLINE | ID: mdl-28882885

RESUMO

BACKGROUND: Risk standardization for adverse events after congenital cardiac catheterization is needed to equitably compare patient outcomes among different hospitals as a foundation for quality improvement. The goal of this project was to develop a risk-standardization methodology to adjust for patient characteristics when comparing major adverse outcomes in the NCDR's (National Cardiovascular Data Registry) IMPACT Registry (Improving Pediatric and Adult Congenital Treatment). METHODS: Between January 2011 and March 2014, 39 725 consecutive patients within IMPACT undergoing cardiac catheterization were identified. Given the heterogeneity of interventional procedures for congenital heart disease, new procedure-type risk categories were derived with empirical data and expert opinion, as were markers of hemodynamic vulnerability. A multivariable hierarchical logistic regression model to identify patient and procedural characteristics predictive of a major adverse event or death after cardiac catheterization was derived in 70% of the cohort and validated in the remaining 30%. RESULTS: The rate of major adverse event or death was 7.1% and 7.2% in the derivation and validation cohorts, respectively. Six procedure-type risk categories and 6 independent indicators of hemodynamic vulnerability were identified. The final risk adjustment model included procedure-type risk category, number of hemodynamic vulnerability indicators, renal insufficiency, single-ventricle physiology, and coagulation disorder. The model had good discrimination, with a C-statistic of 0.76 and 0.75 in the derivation and validation cohorts, respectively. Model calibration in the validation cohort was excellent, with a slope of 0.97 (standard error, 0.04; P value [for difference from 1] =0.53) and an intercept of 0.007 (standard error, 0.12; P value [for difference from 0] =0.95). CONCLUSIONS: The creation of a validated risk-standardization model for adverse outcomes after congenital cardiac catheterization can support reporting of risk-adjusted outcomes in the IMPACT Registry as a foundation for quality improvement.


Assuntos
Cateterismo Cardíaco/efeitos adversos , Cardiopatias Congênitas/diagnóstico , Cardiopatias Congênitas/terapia , Adolescente , Adulto , Fatores Etários , Coagulação Sanguínea , Transtornos da Coagulação Sanguínea/sangue , Transtornos da Coagulação Sanguínea/complicações , Cateterismo Cardíaco/mortalidade , Distribuição de Qui-Quadrado , Criança , Pré-Escolar , Feminino , Cardiopatias Congênitas/complicações , Cardiopatias Congênitas/mortalidade , Hemodinâmica , Humanos , Lactente , Recém-Nascido , Rim/fisiopatologia , Modelos Logísticos , Masculino , Análise Multivariada , Razão de Chances , Sistema de Registros , Insuficiência Renal/complicações , Insuficiência Renal/fisiopatologia , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Adulto Jovem
7.
Eur Heart J ; 38(26): 2070-2077, 2017 Jul 07.
Artigo em Inglês | MEDLINE | ID: mdl-28430913

RESUMO

Aims: We sought to identify factors associated with major adverse events (MAE) after cardiac catheterization in adolescents and adults with congenital heart disease (CHD), and create the first model to individualize risk discussions in this growing population. Methods and results: Improving Pediatric and Adult Congenital Treatment (IMPACT), a National Cardiovascular Data Registry, contains congenital catheterization data from over 87 hospitals in the United States. Demographics, pre-procedure, and procedural variables were collected for patients over age 10. Multivariable logistic regression was used to identify significant predictors of MAE, a composite of death, urgent surgery or procedure due to a catheterization complication, transfusion, embolic stroke, tamponade, extracorporeal membrane oxygenation or ventricular assist device placement, and device embolization, malposition or thrombosis requiring surgical intervention. A risk score was built based on the effect sizes of each predictor and validated in a split sample. A MAE occurred in 686 (2.5%) of the 27 293 index procedures meeting inclusion criteria. The independent multivariate predictors of MAE were older age, pre-procedural anticoagulation use, renal disease, lower haemoglobin, lower oxygen saturation, non-elective procedure, higher index procedure risk and having had no prior cardiac procedures. Being underweight or overweight had borderline significance and was added to the model. The C-statistic for the model was robust at 0.787 in the derivation and 0.773 in the validation cohort. Conclusion: The factors predicting adverse events after cardiac catheterization in adolescents and adults with CHD are different than in the general population. Validation of this model in other national or multi-institutional datasets is the next step.


Assuntos
Cateterismo Cardíaco/efeitos adversos , Cardiopatias Congênitas/cirurgia , Adolescente , Adulto , Idoso , Oxigenação por Membrana Extracorpórea/estatística & dados numéricos , Feminino , Cardiopatias Congênitas/epidemiologia , Coração Auxiliar/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros , Fatores de Risco , Estados Unidos/epidemiologia , Adulto Jovem
8.
World J Pediatr Congenit Heart Surg ; 8(2): 215-219, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27927943

RESUMO

Staged palliation to achieve a total cavopulmonary connection is a common treatment strategy in patients with single ventricle congenital heart disease. Patients with bilateral superior caval veins (bilateral SVC) often require the creation of bilateral superior cavopulmonary connections as part of the staged palliation, and these patients are at increased risk of morbidity. We describe a novel technique used in two patients with bilateral SVC and very small (1-2 mm) bridging vein that encouraged bridging vein growth and facilitated creation of a unilateral superior cavopulmonary connection.


Assuntos
Procedimentos Cirúrgicos Cardíacos/métodos , Artéria Pulmonar/cirurgia , Veia Cava Superior/anormalidades , Anastomose Cirúrgica/métodos , Angiografia , Ecocardiografia , Feminino , Cardiopatias Congênitas/diagnóstico , Cardiopatias Congênitas/cirurgia , Ventrículos do Coração/cirurgia , Humanos , Recém-Nascido , Masculino , Veia Cava Superior/diagnóstico por imagem , Veia Cava Superior/cirurgia
9.
Catheter Cardiovasc Interv ; 88(6): 912-922, 2016 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-27801973

RESUMO

Current practice of sedation and anesthesia for patients undergoing pediatric congenital cardiac catheterization laboratory (PCCCL) procedures is known to vary among institutions, a multi-society expert panel with representatives from the Congenital Heart Disease Council of the Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Pediatric Anesthesia (SPA) and the Congenital Cardiac Anesthesia Society (CCAS) was convened to evaluate the types of sedation and personnel necessary for procedures performed in the PCCCL. The goal of this panel was to provide practitioners and institutions performing these procedures with guidance consistent with national standards and to provide clinicians and institutions with consensus-based recommendations and the supporting references to encourage their application in quality improvement programs. Recommendations can neither encompass all clinical circumstances nor replace the judgment of individual clinicians in the management of each patient. The science of medicine is rooted in evidence, and the art of medicine is based on the application of this evidence to the individual patient. This expert consensus statement has adhered to these principles for optimal management of patients requiring sedation and anesthesia. What follows are recommendations for patient monitoring in the PCCCL regardless of whether minimal or no sedation is being used or general anesthesia is being provided by an anesthesiologist. © 2016 Wiley Periodicals Inc.


Assuntos
Anestesia Geral/normas , Cateterismo Cardíaco , Sedação Consciente/normas , Consenso , Cardiopatias Congênitas/cirurgia , Guias de Prática Clínica como Assunto , Angiografia , Criança , Cardiopatias Congênitas/diagnóstico , Humanos
10.
Spine (Phila Pa 1976) ; 41(23): E1425-E1428, 2016 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-27898601

RESUMO

STUDY DESIGN: Case series. OBJECTIVE: To describe transcatheter closure of the Fontan fenestration prior to posterior spinal fusion in two children to prevent paradoxical venous air embolism during the operation. SUMMARY OF BACKGROUND DATA: Scoliosis is common among patients with single-ventricle congenital heart disease who have undergone Fontan operation and spinal surgery can offer physiologic benefits. Venous air embolism is a rare, but important reported complication during spinal surgery performed in the prone position. Patients with Fontan circulation can have significant right to left shunting via a patent Fontan fenestration that can increase the risk of paradoxical systemic embolization of any entrained venous air. METHODS: We retrospectively reviewed the charts of two patients with single-ventricle congenital heart disease who had undergone fenestrated Fontan operation and underwent transcatheter fenestration closure prior to spinal fusion. RESULTS: Two patients with Fontan circulation underwent successful transcatheter fenestration closure with Amplatzer Ductal Occluder II devices. Five to 6 months after closure, both underwent uncomplicated posterior spinal fusion. CONCLUSION: Transcatheter closure of the Fontan fenestration prior to spinal fusion in two with Fontan circulation and scoliosis is a rare, but important indication for fenestration closure that warrants emphasis. LEVEL OF EVIDENCE: N/A.


Assuntos
Técnica de Fontan , Cardiopatias Congênitas/cirurgia , Ventrículos do Coração/cirurgia , Fusão Vertebral , Adolescente , Cateterismo Cardíaco/métodos , Embolia Paradoxal/diagnóstico , Feminino , Técnica de Fontan/métodos , Cardiopatias Congênitas/diagnóstico , Humanos , Masculino , Estudos Retrospectivos , Fusão Vertebral/métodos , Resultado do Tratamento
11.
Anesth Analg ; 123(5): 1201-1209, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27749349

RESUMO

Current practice of sedation and anesthesia for patients undergoing pediatric and congenital cardiac catheterization laboratory (PCCCL) procedures is known to vary among institutions, a multi-society expert panel with representatives from the Congenital Heart Disease Council of the Society for Cardiovascular Angiography and Interventions, the Society for Pediatric Anesthesia and the Congenital Cardiac Anesthesia Society was convened to evaluate the types of sedation and personnel necessary for procedures performed in the PCCCL. The goal of this panel was to provide practitioners and institutions performing these procedures with guidance consistent with national standards and to provide clinicians and institutions with consensus-based recommendations and the supporting references to encourage their application in quality improvement programs. Recommendations can neither encompass all clinical circumstances nor replace the judgment of individual clinicians in the management of each patient. The science of medicine is rooted in evidence, and the art of medicine is based on the application of this evidence to the individual patient. This expert consensus statement has adhered to these principles for optimal management of patients requiring sedation and anesthesia. What follows are recommendations for patient monitoring in the PCCCL regardless of whether minimal or no sedation is being used or general anesthesia is being provided by an anesthesiologist.


Assuntos
Anestesia Geral/normas , Cateterismo Cardíaco/normas , Sedação Consciente/normas , Cardiopatias Congênitas/terapia , Guias de Prática Clínica como Assunto/normas , Sociedades Médicas/normas , Anestesia Geral/métodos , Anestesiologia/métodos , Anestesiologia/normas , Criança , Sedação Consciente/métodos , Consenso , Cardiopatias Congênitas/diagnóstico , Humanos
12.
World J Pediatr Congenit Heart Surg ; 7(3): 299-305, 2016 05.
Artigo em Inglês | MEDLINE | ID: mdl-27142395

RESUMO

BACKGROUND: Stenosis of the retroaortic pulmonary artery is common in patients with single ventricle heart disease. Intraoperative hybrid stenting at the bidirectional Glenn or Fontan operation can treat this lesion and avoid a complex surgical arterioplasty. METHODS: Patients who underwent intraoperative stent implantation to the retroaortic pulmonary artery during the bidirectional Glenn or Fontan operation at our center between January 2005 and July 2014 were retrospectively identified. RESULTS: Thirteen patients were included with a median weight of 8 kg (5.6-14.4 kg) and age of 6 months (4 months-3.8 years). All had undergone Norwood operation, and eight (62%) had hypoplastic left heart syndrome. Eight (62%) underwent stent placement during bidirectional Glenn and five (38%) during Fontan operation. Ten patients had one stent placed, and three had two overlapping stents. The median diameter of the stenotic vessel was 3 mm (2.0-5.5 mm) and diameter of the balloon used for stent expansion was 7 mm (5-10 mm). Two complications occurred including pulmonary hemorrhage from presumed wire perforation and left main stem bronchus compression requiring stent removal. No patient required stent intervention in the postoperative period, and all were discharged from the hospital. At a median follow-up of 1.3 years (2 months-7.1 years), six patients underwent interval dilation to account for somatic growth. CONCLUSIONS: Hybrid stenting of the retroaortic pulmonary artery at the bidirectional Glenn or Fontan operation is an effective treatment of pulmonary artery stenosis and prevents the need for a complex surgical arterioplasty.


Assuntos
Síndrome do Coração Esquerdo Hipoplásico/cirurgia , Artéria Pulmonar/cirurgia , Implante de Prótese Vascular , Pré-Escolar , Constrição Patológica/cirurgia , Feminino , Seguimentos , Técnica de Fontan , Humanos , Lactente , Masculino , Procedimentos de Norwood , Estudos Retrospectivos , Stents , Resultado do Tratamento
13.
Congenit Heart Dis ; 11(6): 647-655, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27225896

RESUMO

BACKGROUND: Transcatheter patent ductus arteriosus (PDA) occlusion is feasible in small infants and may improve lung function in symptomatic patients. We aimed to describe transcatheter PDA closure in small infants including predictors of technical success and rate of complication and to identify factors associated with improved respiratory status after closure. METHODS: All patients in the NICU at our center who were referred for transcatheter PDA occlusion between 1/2010 and 11/2014 were retrospectively identified. Relevant details were extracted. Additionally, a modification of the respiratory severity score (RSS) (FiO2 × mean airway pressure) was used to characterize degree of pulmonary support before and at intervals after catheterization. RESULTS: Twenty patients were identified with median age of 96 days (13-247) and weight of 3.1 kg (1.7-4.7). The PDA was type F morphology in 14 (70%) patients. The PDA was successfully occluded in 16 (80%) patients. Ratio of minimum PDA diameter/length was >0.5 in all unsuccessful attempts and <0.4 in all successful cases (P = .01). Of the 16 cases of occlusion, Amplatzer Vascular Plug II was used in 15 (94%). No deaths or pulse loss occurred. Five (25%) patients required blood transfusion and transfusion was associated with lower hemoglobin (P = .049), lower weight (P = .008), and lower aortic pressure (P = .04). Excluding 1 patient with significant congenital heart disease, the RSS improved at 3 days in 9 (60%) patients and at 7 days in 12 (80%) compared with preintervention value. Patient factors were not associated with improved RSS at 3 or 7 days. CONCLUSIONS: In our cohort of symptomatic infants, transcatheter PDA occlusion was successful in most and a ratio of minimum PDA diameter/length of <0.4 was predictive of technical success. Using a surrogate for pulmonary support, the majority of patients were on less support 7 days after closure.


Assuntos
Cateterismo Cardíaco , Permeabilidade do Canal Arterial/cirurgia , Fatores Etários , Tamanho Corporal , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Permeabilidade do Canal Arterial/diagnóstico por imagem , Permeabilidade do Canal Arterial/fisiopatologia , Feminino , Hemodinâmica , Humanos , Lactente , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Pulmão/fisiopatologia , Masculino , Recuperação de Função Fisiológica , Respiração , Estudos Retrospectivos , Fatores de Risco , Dispositivo para Oclusão Septal , Fatores de Tempo , Resultado do Tratamento
14.
Catheter Cardiovasc Interv ; 87(2): 302-9, 2016 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-26527119

RESUMO

OBJECTIVES: We sought to develop a scoring system that predicts the risk of serious adverse events (SAE's) for individual pediatric patients undergoing cardiac catheterization procedures. BACKGROUND: Systematic assessment of risk of SAE in pediatric catheterization can be challenging in view of a wide variation in procedure and patient complexity as well as rapidly evolving technology. METHODS: A 10 component scoring system was originally developed based on expert consensus and review of the existing literature. Data from an international multi-institutional catheterization registry (CCISC) between 2008 and 2013 were used to validate this scoring system. In addition we used multivariate methods to further refine the original risk score to improve its predictive power of SAE's. RESULTS: Univariate analysis confirmed the strong correlation of each of the 10 components of the original risk score with SAE attributed to a pediatric cardiac catheterization (P < 0.001 for all variables). Multivariate analysis resulted in a modified risk score (CRISP) that corresponds to an increase in value of area under a receiver operating characteristic curve (AUC) from 0.715 to 0.741. CONCLUSION: The CRISP score predicts risk of occurrence of an SAE for individual patients undergoing pediatric cardiac catheterization procedures.


Assuntos
Cateterismo Cardíaco/efeitos adversos , Técnicas de Apoio para a Decisão , Cardiopatias Congênitas/terapia , Pediatria/métodos , Adolescente , Fatores Etários , Área Sob a Curva , Distribuição de Qui-Quadrado , Criança , Pré-Escolar , Cardiopatias Congênitas/diagnóstico , Humanos , Lactente , Recém-Nascido , Modelos Logísticos , Análise Multivariada , Valor Preditivo dos Testes , Curva ROC , Sistema de Registros , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco , Resultado do Tratamento
15.
Catheter Cardiovasc Interv ; 87(2): 302-309, 2016.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1061850

RESUMO

OBJECTIVES:We sought to develop a scoring system that predicts the risk of serious adverse events (SAE's) for individual pediatric patients undergoing cardiac catheterization procedures. BACKGROUND: Systematic assessment of risk of SAE in pediatric catheterization can be challenging in view of a wide variation in procedure and patient complexity as well as rapidly evolving technology. METHODS: A 10 component scoring system was originally developed based on expert consensus and review of the existing literature. Data from an international multi-institutional catheterization registry (CCISC) between 2008 and 2013 were used to validate this scoring system. In addition we used multivariate methods to further refine the original risk score to improve its predictive power of SAE's. RESULTS: Univariate analysis confirmed the strong correlation of each of the 10 components of the original risk score with SAE attributed to a pediatric cardiac catheterization (P < 0.001 for all variables). Multivariate analysis resulted in a modified risk score (CRISP) that corresponds to an increase in value of area under a receiver operating characteristic curve (AUC) from 0.715 to 0.741. CONCLUSION: The CRISP score predicts risk of occurrence of an SAE for individual patients undergoing pediatric cardiac catheterization procedures.


Assuntos
Cardiopatias Congênitas , Cateterismo Cardíaco , Pediatria
16.
Catheter Cardiovasc Interv ; 87(2): 302-309, 2016.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-32714

RESUMO

OBJECTIVES:We sought to develop a scoring system that predicts the risk of serious adverse events (SAE's) for individual pediatric patients undergoing cardiac catheterization procedures. BACKGROUND: Systematic assessment of risk of SAE in pediatric catheterization can be challenging in view of a wide variation in procedure and patient complexity as well as rapidly evolving technology. METHODS: A 10 component scoring system was originally developed based on expert consensus and review of the existing literature. Data from an international multi-institutional catheterization registry (CCISC) between 2008 and 2013 were used to validate this scoring system. In addition we used multivariate methods to further refine the original risk score to improve its predictive power of SAE's. RESULTS: Univariate analysis confirmed the strong correlation of each of the 10 components of the original risk score with SAE attributed to a pediatric cardiac catheterization (P < 0.001 for all variables). Multivariate analysis resulted in a modified risk score (CRISP) that corresponds to an increase in value of area under a receiver operating characteristic curve (AUC) from 0.715 to 0.741. CONCLUSION: The CRISP score predicts risk of occurrence of an SAE for individual patients undergoing pediatric cardiac catheterization procedures. (AU)


Assuntos
Cateterismo Cardíaco , Pediatria , Cardiopatias Congênitas
17.
J Thorac Cardiovasc Surg ; 149(4): 1095-100, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25595378

RESUMO

OBJECTIVE: The objective of a hybrid approach to staged palliation of single-ventricle anomalies is designed to minimize the trauma of the first stage. However, the second stage is a complex procedure that may negate the advantages of the first stage. We sought to devise a "hybrid" approach to the second stage when aortic outflow is expected to remain unobstructed. METHODS: The procedure involves a simple incision into the main pulmonary artery, dilation/stenting of the ductal continuation, formation of a stented baffle between the branch pulmonary arteries' orifices, and a bidirectional Glenn connection. It avoids dissection of the distal arch and ductal continuation and obviates the need for a Damus-Kaye-Stansel connection. We carried out this procedure in 2 patients, one with unbalanced atrioventricular canal and the other with mitral atresia. RESULTS: Both patients underwent an uncomplicated operative procedure. Both patients were successfully weaned from the ventilator, with no clinically evident neurologic injury. The first patient died of complications related to thrombosis of the left pulmonary artery before initiation of anticoagulation. The second patient is alive and well 1 year postoperation with no obstruction to either systemic or pulmonary flow and no baffle leak and good right ventricle function. CONCLUSIONS: This hybrid comprehensive stage II operation appears feasible and technically simpler than the conventional comprehensive stage II procedure. It is applicable to a subset of single-ventricle cases in which aortic outflow is anticipated to remain unobstructed. We recommend early postoperative anticoagulation to avoid early left pulmonary artery thrombosis.


Assuntos
Técnica de Fontan/métodos , Ventrículos do Coração/cirurgia , Síndrome do Coração Esquerdo Hipoplásico/cirurgia , Artéria Pulmonar/cirurgia , Anticoagulantes/uso terapêutico , Arteriopatias Oclusivas/etiologia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Evolução Fatal , Técnica de Fontan/efeitos adversos , Ventrículos do Coração/anormalidades , Ventrículos do Coração/fisiopatologia , Humanos , Síndrome do Coração Esquerdo Hipoplásico/diagnóstico , Síndrome do Coração Esquerdo Hipoplásico/fisiopatologia , Recém-Nascido , Cuidados Paliativos , Artéria Pulmonar/diagnóstico por imagem , Artéria Pulmonar/fisiopatologia , Radiografia , Stents , Trombose/etiologia , Fatores de Tempo , Resultado do Tratamento
18.
Catheter Cardiovasc Interv ; 84(5): 785-93, 2014 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-24585540

RESUMO

OBJECTIVES: We examine normalized air Kerma area product (PKA ) by body weight (PKA /BW) as a reference value of radiation dose and benchmark PKA /BW in pediatric laboratories using a multicenter registry database. BACKGROUND: Reduction of radiation dose is an important quality improvement task in pediatric cardiac catheterization laboratories. Physicians need to agree on a standard method of reporting radiation dose that would allow comparisons to be made between operators and institutions. METHODS: This was a multicenter observational study of radiation dose in pediatric laboratories. Patient demographic, procedural and radiation data including fluoroscopic time and PKA (µGy m(2) ) were analyzed. PKA /BW was obtained by indexing PKA to body weight. RESULTS: A total of 8,267 pediatric catheterization procedures (age <18 years) were included from 16 institutions. The procedures consisted of diagnostic (n = 2,827), transplant right ventricular (RV) biopsy (n = 1,172), and interventional catheterizations (n = 4268). PKA correlated with body weight better than with age and best correlated with weight-fluoroscopic time product. PKA /BW showed consistent values across pediatric ages. Interventional catheterizations had the highest PKA /BW (50th, 75th, and 90th percentiles: 72, 151, and 281 µGy m(2) /kg), followed by diagnostic (59, 105, and 175 µGy m(2) /kg) and transplant RV biopsy (27, 79, and 114 µGy m(2) /kg). CONCLUSION: PKA /BW appeared to be the most reliable standard to report radiation dose across all procedure types and patient age. We recommend PKA /BW to be used as the standard unit in documenting radiation usage in pediatric laboratories and can be used to evaluate strategies to lower radiation dosage in pediatric patients undergoing cardiac catheterizations. © 2014 Wiley Periodicals, Inc.


Assuntos
Cateterismo Cardíaco/normas , Doses de Radiação , Proteção Radiológica/normas , Radiografia Intervencionista/normas , Adolescente , Fatores Etários , Serviço Hospitalar de Cardiologia , Criança , Pré-Escolar , Fluoroscopia/efeitos adversos , Fluoroscopia/métodos , Humanos , Lactente , Laboratórios Hospitalares , Segurança do Paciente , Pediatria/métodos , Sistema de Registros , Medição de Risco , Estatísticas não Paramétricas , Fatores de Tempo
19.
Catheter. cardiovasc. interv ; 84: 785-793, 2014. ilus
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1061880

RESUMO

We examine normalized air Kerma area product (PKA) by body weight(PKA/BW) as a reference value of radiation dose and benchmark PKA/BW in pediatriclaboratories using a multicenter registry database. Background: Reduction of radiationdose is an important quality improvement task in pediatric cardiac catheterizationlaboratories. Physicians need to agree on a standard method of reportingradiation dose that would allow comparisons to be made between operators andinstitutions. Methods: This was a multicenter observational study of radiation dosein pediatric laboratories. Patient demographic, procedural and radiation data includingfluoroscopic time and PKA (mGy m2) were analyzed. PKA/BW was obtained byindexing PKA to body weight. Results: A total of 8,267 pediatric catheterization procedures(age <18 years) were included from 16 institutions. The procedures consistedof diagnostic (n52,827), transplant right ventricular (RV) biopsy (n51,172),and interventional catheterizations (n54268). PKA correlated with body weight betterthan with age and best correlated with weight–fluoroscopic time product. PKA/BWshowed consistent values across pediatric ages. Interventional catheterizations hadthe highest PKA/BW (50th, 75th, and 90th percentiles: 72, 151, and 281 lGy m2/kg),followed by diagnostic (59, 105, and 175 lGy m2/kg) and transplant RV biopsy (27,79, and 114 lGy m2/kg). Conclusion: PKA/BW appeared to be the most reliablestandard to report radiation dose across all procedure types and patient age. We recommend PKA/BW to be used as the standard unit in documenting radiationusage in pediatric laboratories and can be used to evaluate strategies to lower radiationdosage in pediatric patients undergoing cardiac catheterizations.


Assuntos
Kerma , Pediatria , Peso Corporal
20.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-30593

RESUMO

We examine normalized air Kerma area product (PKA) by body weight(PKA/BW) as a reference value of radiation dose and benchmark PKA/BW in pediatriclaboratories using a multicenter registry database. Background: Reduction of radiationdose is an important quality improvement task in pediatric cardiac catheterizationlaboratories. Physicians need to agree on a standard method of reportingradiation dose that would allow comparisons to be made between operators andinstitutions. Methods: This was a multicenter observational study of radiation dosein pediatric laboratories. Patient demographic, procedural and radiation data includingfluoroscopic time and PKA (mGy m2) were analyzed. PKA/BW was obtained byindexing PKA to body weight. Results: A total of 8,267 pediatric catheterization procedures(age <18 years) were included from 16 institutions. The procedures consistedof diagnostic (n52,827), transplant right ventricular (RV) biopsy (n51,172),and interventional catheterizations (n54268). PKA correlated with body weight betterthan with age and best correlated with weight–fluoroscopic time product. PKA/BWshowed consistent values across pediatric ages. Interventional catheterizations hadthe highest PKA/BW (50th, 75th, and 90th percentiles: 72, 151, and 281 lGy m2/kg),followed by diagnostic (59, 105, and 175 lGy m2/kg) and transplant RV biopsy (27,79, and 114 lGy m2/kg). Conclusion: PKA/BW appeared to be the most reliablestandard to report radiation dose across all procedure types and patient age. We recommend PKA/BW to be used as the standard unit in documenting radiationusage in pediatric laboratories and can be used to evaluate strategies to lower radiationdosage in pediatric patients undergoing cardiac catheterizations. (AU)


Assuntos
Pediatria , Kerma , Peso Corporal
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