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1.
Catheter Cardiovasc Interv ; 98(2): E262-E274, 2021 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-33780150

RESUMO

OBJECTIVE: We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial. BACKGROUND: As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a "real-world" environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared. METHODS: The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan-Meier curves and log-rank testing. RESULTS: 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p = .61) or any reintervention (p = .74) over time did not differ between trials. Freedom from stent fracture (p = .003) and transcatheter reintervention (p = .010) were longer in PAS, whereas freedom from explant (p = .020) and TPV endocarditis (p = .007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p = .056); the incidence of any particular event was low in both. CONCLUSIONS: Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.


Assuntos
Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Pulmonar , Valva Pulmonar , Adolescente , Adulto , Cateterismo Cardíaco/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Desenho de Prótese , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/cirurgia , Insuficiência da Valva Pulmonar/cirurgia , Resultado do Tratamento , Adulto Jovem
2.
Catheter Cardiovasc Interv ; 93(3): 455-463, 2019 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-30537348

RESUMO

OBJECTIVES: To describe a multi-center experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards Sapien S3 Valve. BACKGROUND: Off-label use of the Sapien S3 valve can allow for TPVR in patients with congenital heart disease (CHD) and large diameter dysfunctional right ventricular outflow tract (RVOT). The initial experience at five centers with the SAPIEN S3 valve for TPVR is presented with a focus on procedural techniques, success, complications, and efficacy. METHODS: A retrospective review was performed of all patients with CHD and dysfunctional RVOT who underwent TPVR using Sapien S3 valve. Imaging data, procedural elements, and clinical follow-up data were collected to evaluate acute and short-term results. RESULTS: A total of 50 patients underwent percutaneous placement of the Sapien S3 in the pulmonary position. Of these, 38 were placed into "native RVOTs", measuring 24-32 mm in diameter, as assessed by compliant balloon sizing. In all cases, the valve was implanted after introduction and there were no cases of valve embolization. On follow up (range 1-9 months, median 3 months), no patients had significant obstruction or regurgitation through or around the valve requiring intervention. There were no procedural deaths. Major complications included severe aortic compression (n = 1) and tricuspid valve (TV) injury related to valve placement (n = 2) and prestenting (n = 1). CONCLUSIONS: TPVR in patients with large diameter dysfunctional RVOTs can be effectively performed with the Sapien S3. All procedures were technically successful with no embolizations, no perivalvular leaks, and excellent short-term valve function. Tricuspid valve injury from implantation of an uncovered valve was a serious procedural complication.


Assuntos
Cateterismo Cardíaco/instrumentação , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Cardiopatias Congênitas/cirurgia , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Insuficiência da Valva Pulmonar/cirurgia , Valva Pulmonar/cirurgia , Adolescente , Adulto , Valvuloplastia com Balão , Cateterismo Cardíaco/efeitos adversos , Criança , Feminino , Cardiopatias Congênitas/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Masculino , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/fisiopatologia , Desenho de Prótese , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/fisiopatologia , Insuficiência da Valva Pulmonar/diagnóstico por imagem , Insuficiência da Valva Pulmonar/etiologia , Insuficiência da Valva Pulmonar/fisiopatologia , Recuperação de Função Fisiológica , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Adulto Jovem
3.
Catheter Cardiovasc Interv ; 91(5): 920-926, 2018 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-29280541

RESUMO

BACKGROUND: Transcatheter pulmonary valve implantation (TPVI) has revolutionized the care of patients with congenital disorders of the right ventricular outflow tract (RVOT) and is increasingly being used in patients with native outflow tracts. This is the first study to specifically report the occurrence of ventricular arrhythmias in the immediate post-TPVI period. METHODS AND RESULTS: Medical records of all adult and pediatric patients who underwent TPVI at our institution between May 1, 2011 and March 1, 2016, were reviewed for the presence of clinically significant ventricular arrhythmias occurring within 30 days of TPVI. We defined a clinically significant arrhythmia as any ventricular arrhythmia that led to hemodynamic instability, resulted in a change of dose or addition of a new anti-arrhythmic medication, caused a delay in discharge, or was the primary reason for readmission. Seventy-five patients, with a median age of 19 years (range 4-65 years), underwent TPVI. In total, 12 (16%) patients had a clinically significant ventricular arrhythmia within 30 days following TPVI. Patients with native outflow tracts were at higher risk of post-TPVI arrhythmias than non-native outflow tract (29% vs. 9%, P = 0.02, adjusted OR 4.8, 95%CI 1.2-20.2). There were no cases of hemodynamic compromise or sudden cardiac death. The arrhythmias were well controlled with beta-blocker therapy. CONCLUSION: In this single center study, ventricular arrhythmias were common following TPVI, particularly in native outflow tract patients. However, the arrhythmias were generally benign and responded well to medical therapy when indicated. Long term therapy was often not needed.


Assuntos
Arritmias Cardíacas/etiologia , Cateterismo de Swan-Ganz/efeitos adversos , Frequência Cardíaca , Implante de Prótese de Valva Cardíaca/efeitos adversos , Valva Pulmonar/cirurgia , Adolescente , Antagonistas Adrenérgicos beta/uso terapêutico , Adulto , Idoso , Antiarrítmicos/uso terapêutico , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/tratamento farmacológico , Arritmias Cardíacas/fisiopatologia , Cateterismo de Swan-Ganz/métodos , Criança , Pré-Escolar , Feminino , Frequência Cardíaca/efeitos dos fármacos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/fisiopatologia , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
4.
Catheter Cardiovasc Interv ; 91(3): 485-494, 2018 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-29193671

RESUMO

BACKGROUND: Since FDA approval of the Melody valve, transcatheter pulmonary valve replacement (TPVR) has been offered to an expanding population. Limited data exist regarding the safety and feasibility of TPVR in smaller patients. METHODS: All patients weighing <20 kg who underwent catheterization for percutaneous TPVR at four centers were reviewed. RESULTS: Of the 51 patients reviewed, 43 (84%) had successful valve implantation and 8 (16%) were found not to be candidates due to access veins too small (n = 3), coronary artery/aortic root compression (n = 3), and RVOT too large (n = 2). The 43 patients who underwent successful percutaneous TPVR had a median age and weight of 5.8 years (3.3-10) and 17.7 kg (13.5-19.8), and most had tetralogy of Fallot (TOF). TPVR was performed via femoral vein (FV) access in 24 patients and internal jugular vein (IJV) access in 19 patients. Median weight in patients with IJV implant was 1.1 kg lower than those who underwent transfemoral implant (17.0 vs. 18.1 kg, P = 0.05). There were four adverse events: one iliac vein injury, one contained MPA tear, and two patients with post-procedure femoral vein bleeding. All patients were alive at recent follow-up, a median of 2.0 years (0.1-6.0) after TPVR. There was excellent valve function with mean Doppler gradients of 3-20 mm Hg, and trivial or mild pulmonary regurgitation in all but one patient. There were no RVOT reinterventions and no cases of endocarditis. CONCLUSIONS: Percutaneous TPVR can be safely performed in patients <20 kg. The procedure frequently requires IJV access, and access site/bleeding complications may be more common in this cohort.


Assuntos
Peso Corporal , Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/cirurgia , Fatores Etários , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Criança , Desenvolvimento Infantil , Pré-Escolar , Angiografia Coronária , Ecocardiografia Doppler , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Masculino , Complicações Pós-Operatórias/etiologia , Valva Pulmonar/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento , Estados Unidos
5.
Circulation ; 131(22): 1960-70, 2015 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-25944758

RESUMO

BACKGROUND: Studies of transcatheter pulmonary valve (TPV) replacement with the Melody valve have demonstrated good short-term outcomes, but there are no published long-term follow-up data. METHODS AND RESULTS: The US Investigational Device Exemption trial prospectively enrolled 171 pediatric and adult patients (median age, 19 years) with right ventricular outflow tract conduit obstruction or regurgitation. The 148 patients who received and were discharged with a TPV were followed up annually according to a standardized protocol. During a median follow-up of 4.5 years (range, 0.4-7 years), 32 patients underwent right ventricular outflow tract reintervention for obstruction (n=27, with stent fracture in 22), endocarditis (n=3, 2 with stenosis and 1 with pulmonary regurgitation), or right ventricular dysfunction (n=2). Eleven patients had the TPV explanted as an initial or second reintervention. Five-year freedom from reintervention and explantation was 76±4% and 92±3%, respectively. A conduit prestent and lower discharge right ventricular outflow tract gradient were associated with longer freedom from reintervention. In the 113 patients who were alive and reintervention free, the follow-up gradient (median, 4.5 years after implantation) was unchanged from early post-TPV replacement, and all but 1 patient had mild or less pulmonary regurgitation. Almost all patients were in New York Heart Association class I or II. More severely impaired baseline spirometry was associated with a lower likelihood of improvement in exercise function after TPV replacement. CONCLUSIONS: TPV replacement with the Melody valve provided good hemodynamic and clinical outcomes up to 7 years after implantation. Primary valve failure was rare. The main cause of TPV dysfunction was stenosis related to stent fracture, which was uncommon once prestenting became more widely adopted. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00740870.


Assuntos
Cateterismo Cardíaco/tendências , Implante de Prótese de Valva Cardíaca/tendências , Hemodinâmica , Insuficiência da Valva Pulmonar/cirurgia , Obstrução do Fluxo Ventricular Externo/cirurgia , Adolescente , Adulto , Criança , Feminino , Seguimentos , Implante de Prótese de Valva Cardíaca/instrumentação , Hemodinâmica/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Insuficiência da Valva Pulmonar/diagnóstico , Insuficiência da Valva Pulmonar/epidemiologia , Resultado do Tratamento , Estados Unidos/epidemiologia , Obstrução do Fluxo Ventricular Externo/diagnóstico , Obstrução do Fluxo Ventricular Externo/epidemiologia , Adulto Jovem
6.
Catheter Cardiovasc Interv ; 85(5): 847-9, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25257952

RESUMO

Trans-catheter balloon angioplasty is a well-established treatment modality for pulmonary artery (PA) stenosis in children with congenital heart disease. We report a case of an unusual complication where a fistula developed between the left PA and the left atrium during balloon angioplasty in a patient with history of tetralogy of Fallot. This was successfully treated with placement of a covered stent.


Assuntos
Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Átrios do Coração/lesões , Cardiopatias Congênitas/cirurgia , Doença Iatrogênica , Artéria Pulmonar/lesões , Fístula Vascular/etiologia , Procedimentos Cirúrgicos Vasculares/métodos , Angiografia , Ecocardiografia , Humanos , Lactente , Masculino , Complicações Pós-Operatórias , Reoperação , Stents , Fístula Vascular/diagnóstico , Fístula Vascular/cirurgia
7.
Catheter Cardiovasc Interv ; 85(2): 227-33, 2015 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-25257700

RESUMO

BACKGROUND: Secundum atrial septal defect (ASD) closure devices were granted approval based on industry-sponsored, prospective, nonrandomized, single device studies, demonstrating acceptable efficacy and safety in selected patients. We sought to report community practice and outcomes. METHODS AND RESULTS: Procedure specific data was collected on cases considered for ASD closure in the congenital cardiac catheterization project on outcomes (C3PO) between February 1, 2007 and June 31, 2010. Eight centers contributed data during this time period. All adverse events (AE) were independently reviewed and classified by a five level severity scale. In 40 months (2/07-6/10), 653 of 688 ASDs were occluded with a single device using an AMPLATZER(®) Septal Occluder (ASO) in 566 (87%), GORE(®) HELEX(®) Septal Occluder (HSO) in 33 (5%), and a CardioSEAL(®) or STARFlex™ device (CSD) in 54 (8%). Most patients had an isolated ASD (93%). 85% were >2 years of age. The ASD median diameter was 12 mm [8,16] for ASO, with smaller diameters in HSO 8 mm [7,10] and CSD 8 mm [5,10] (P < 0.001). AE (n = 82) were recorded in 76 cases, 11.5% (95% CI 9.2%, 14.1%) and classified as high severity in 4.7% (95% CI 3.2%, 6.5%), with no mortality. A new conduction abnormality was detected during 15 cases and did not resolve in one. Transcatheter device retrieval was possible in 7 of 10 device embolizations. Device erosion occurred in 3 of 566, 0.5% (95% CI 0.1%, 1.5%), ASO implants. CONCLUSION: Although device closure of ASDs is associated with low morbidity and rare mortality, ongoing assessment of device safety profiles are warranted, and registries offer opportunities to facilitate the required surveillance.


Assuntos
Cateterismo Cardíaco/instrumentação , Comunicação Interatrial/terapia , Dispositivo para Oclusão Septal , Adolescente , Cateterismo Cardíaco/efeitos adversos , Criança , Pré-Escolar , Remoção de Dispositivo , Feminino , Migração de Corpo Estranho/etiologia , Migração de Corpo Estranho/terapia , Comunicação Interatrial/diagnóstico , Humanos , Lactente , Masculino , Estudos Prospectivos , Desenho de Prótese , Falha de Prótese , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Adulto Jovem
8.
Echocardiography ; 32(3): 541-7, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25039533

RESUMO

BACKGROUND: Quantitative assessment of right ventricular (RV) function is important for the management of patients with congenital heart disease. Tissue Doppler (TDI)-derived myocardial acceleration during isovolumic contraction (IVA) is an echocardiographic measure of contractility that is independent of loading conditions. The aim of this study was to establish normative data for IVA at the lateral tricuspid valve annulus (RV IVA). METHODS: This is a retrospective study of 340 children who had normal echocardiograms. We analyzed RV IVA in relation to age, body surface area (BSA), gender, heart rate (HR), tricuspid annular plane systolic excursion (TAPSE), and TDI-derived S' (RV S'). RESULTS: RV IVA showed a positive correlation with HR (r = 0.58, P<0.001) and a negative correlation with age and BSA (r = -0.44, P<0.001, for both). RV IVA ranged from 2.3 m/sec(2) (±2 SD: 1-3.7 m/sec(2) ) at a HR of <60 beats per minute (bpm) to 4.9 m/sec(2) (±2 SD: 3.5-6.4 m/sec(2) ) at a HR of >160 bpm. When RV IVA was corrected for HR (RV IVAc), it became independent of HR, age, BSA, and gender. The mean RV IVAc was 2.3 m/sec(1.5) (±2 SD: 1.1-3.6 m/sec(1.5) ). There was a correlation of normalized RV IVAc with normalized TAPSE and RV S'. CONCLUSION: RV IVA, a marker of RV contractility, shows a strong dependence on HR. HR corrected RV IVA (RV IVAc) is independent of age, BSA, gender, and HR. We suggest measuring RV IVAc routinely in patients at risk for RV dysfunction.


Assuntos
Ecocardiografia/métodos , Frequência Cardíaca/fisiologia , Ventrículos do Coração/diagnóstico por imagem , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/fisiopatologia , Função Ventricular Direita/fisiologia , Aceleração , Envelhecimento/fisiologia , Criança , Connecticut , Técnicas de Imagem por Elasticidade/métodos , Feminino , Humanos , Aumento da Imagem/métodos , Interpretação de Imagem Assistida por Computador/métodos , Masculino , Valores de Referência , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
9.
Pediatr Cardiol ; 33(7): 1183-6, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22354225

RESUMO

The reported case involved a 7-year-old girl with congenitally corrected transposition of the great arteries (ccTGA) and situs inversus who after surgical management experienced symptoms of dyspnea and left-sided obstructive heart disease. Her symptoms, chest X-ray, and cardiac catheterization demonstrated pulmonary venous obstruction, a known but rare complication associated with intra-atrial baffle obstruction. The incidence of the reported disorder, the follow-up assessment, and the current literature regarding complications of Senning/Mustard surgery are discussed in the context of patients with ccTGA.


Assuntos
Procedimentos Cirúrgicos Cardíacos/métodos , Complicações Pós-Operatórias/diagnóstico por imagem , Pneumopatia Veno-Oclusiva/diagnóstico por imagem , Situs Inversus/cirurgia , Transposição dos Grandes Vasos/cirurgia , Criança , Transposição das Grandes Artérias Corrigida Congenitamente , Ecocardiografia , Feminino , Humanos , Radiografia
10.
Circ Cardiovasc Interv ; 15(1): e010852, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34930015

RESUMO

BACKGROUND: The Melody valve was developed to extend the useful life of previously implanted right ventricular outflow tract (RVOT) conduits or bioprosthetic pulmonary valves, while preserving RV function and reducing the lifetime burden of surgery for patients with complex congenital heart disease. METHODS: Enrollment for the US Investigational Device Exemption study of the Melody valve began in 2007. Extended follow-up was completed in 2020. The primary outcome was freedom from transcatheter pulmonary valve (TPV) dysfunction (freedom from reoperation, reintervention, moderate or severe pulmonary regurgitation, and/or mean RVOT gradient >40 mm Hg). Secondary end points included stent fracture, catheter reintervention, surgical conduit replacement, and death. RESULTS: One hundred seventy-one subjects with RVOT conduit or bioprosthetic pulmonary valve dysfunction were enrolled. One hundred fifty underwent Melody TPV replacement. Median age was 19 years (Q1-Q3: 15-26). Median discharge mean RVOT Doppler gradient was 17 mm Hg (Q1-Q3: 12-22). The 149 patients implanted >24 hours were followed for a median of 8.4 years (Q1-Q3: 5.4-10.1). At 10 years, estimated freedom from mortality was 90%, from reoperation 79%, and from any reintervention 60%. Ten-year freedom from TPV dysfunction was 53% and was significantly shorter in children than in adults. Estimated freedom from TPV-related endocarditis was 81% at 10 years (95% CI, 69%-89%), with an annualized rate of 2.0% per patient-year. CONCLUSIONS: Ten-year outcomes from the Melody Investigational Device Exemption trial affirm the benefits of Melody TPV replacement in the lifetime management of patients with RVOT conduits and bioprosthetic pulmonary valves by providing sustained symptomatic and hemodynamic improvement in the majority of patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00740870.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Pulmonar , Valva Pulmonar , Adolescente , Adulto , Humanos , Desenho de Prótese , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/cirurgia , Insuficiência da Valva Pulmonar/diagnóstico por imagem , Insuficiência da Valva Pulmonar/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
11.
Circulation ; 122(5): 507-16, 2010 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-20644013

RESUMO

BACKGROUND: Transcatheter pulmonary valve placement is an emerging therapy for pulmonary regurgitation and right ventricular outflow tract obstruction in selected patients. The Melody valve was recently approved in the United States for placement in dysfunctional right ventricular outflow tract conduits. METHODS AND RESULTS: From January 2007 to August 2009, 136 patients (median age, 19 years) underwent catheterization for intended Melody valve implantation at 5 centers. Implantation was attempted in 124 patients; in the other 12, transcatheter pulmonary valve placement was not attempted because of the risk of coronary artery compression (n=6) or other clinical or protocol contraindications. There was 1 death from intracranial hemorrhage after coronary artery dissection, and 1 valve was explanted after conduit rupture. The median peak right ventricular outflow tract gradient was 37 mm Hg before implantation and 12 mm Hg immediately after implantation. Before implantation, pulmonary regurgitation was moderate or severe in 92 patients (81% with data); no patient had more than mild pulmonary regurgitation early after implantation or during follow-up (>or=1 year in 65 patients). Freedom from diagnosis of stent fracture was 77.8+/-4.3% at 14 months. Freedom from Melody valve dysfunction or reintervention was 93.5+/-2.4% at 1 year. A higher right ventricular outflow tract gradient at discharge (P=0.003) and younger age (P=0.01) were associated with shorter freedom from dysfunction. CONCLUSIONS: In this updated report from the multicenter US Melody valve trial, we demonstrated an ongoing high rate of procedural success and encouraging short-term valve function. All reinterventions in this series were for right ventricular outflow tract obstruction, highlighting the importance of patient selection, adequate relief of obstruction, and measures to prevent and manage stent fracture. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00740870.


Assuntos
Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Insuficiência da Valva Pulmonar/cirurgia , Obstrução do Fluxo Ventricular Externo/cirurgia , Adolescente , Adulto , Cateterismo Cardíaco/métodos , Criança , Ecocardiografia , Feminino , Seguimentos , Humanos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Falha de Prótese , Atresia Pulmonar/diagnóstico por imagem , Atresia Pulmonar/cirurgia , Insuficiência da Valva Pulmonar/diagnóstico por imagem , Radiografia , Stents/estatística & dados numéricos , Tetralogia de Fallot/diagnóstico por imagem , Tetralogia de Fallot/cirurgia , Resultado do Tratamento , Estados Unidos , Obstrução do Fluxo Ventricular Externo/diagnóstico por imagem , Adulto Jovem
12.
Cardiol Young ; 21(5): 490-4, 2011 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-21729505

RESUMO

Myocardial bridge is a rare congenital coronary anomaly in children, usually seen in the setting of hypertrophic cardiomyopathy and in left ventricular hypertrophy. Most myocardial bridges are believed to represent a benign anatomical variant; however, symptomatic myocardial bridge is a distinct subgroup of pathological variant, linked to myocardial ischaemia, ventricular arrhythmia, and sudden cardiac death. We present a case of a symptomatic myocardial bridge in a 5-year-old boy with mild hypertrophic cardiomyopathy who underwent supra-arterial myotomy, automatic defibrillator placement, and long-term Beta-blocker therapy. We also present 10 years of follow-up with a review of literature regarding symptomatic myocardial bridges in the paediatric age group.


Assuntos
Anomalias dos Vasos Coronários/diagnóstico , Cardiomiopatia Hipertrófica/complicações , Pré-Escolar , Anomalias dos Vasos Coronários/complicações , Anomalias dos Vasos Coronários/terapia , Humanos , Masculino
13.
Catheter Cardiovasc Interv ; 75(3): 389-400, 2010 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-19885913

RESUMO

OBJECTIVES: To describe case mix variation among institutions, and report adverse event rates in congenital cardiac catheterization by case type. BACKGROUND: Reported adverse event rates for patients with congenital heart disease undergoing cardiac catheterization vary considerably, due to non-comparable standards of data inclusion, and highly variable case mix. METHODS: The Congenital Cardiac Catheterization Outcomes Project (C3PO) has been capturing case characteristics and adverse events (AE) for all cardiac catheterizations performed at six pediatric institutions. Validity and completeness of data were independently audited. RESULTS: Between 2/1/07 and 4/30/08, 3855 cases (670 biopsy, 1037 diagnostic, and 2148 interventional) were recorded, median number of cases per site 480 (308 to 1526). General anesthesia was used in 70% of cases (28 to 99%), and 22% of cases (15 to 26%) were non-electively or emergently performed. Three institutions performed a higher proportion of interventions during a case, 72 to 77% compared to 56 to 58%. The median rate of AE reported per institution was 16%, ranging from 5 to 18%. For interventional cases the median rate of AE reported per institution was 19% (7 to 25%) compared to 10% for diagnostic cases (6 to 16%). The incidence of AE was significantly higher for interventional compared to diagnostic cases (20% vs 10%, p<0.001), as was the incidence of higher severity AE (9% vs 5%, p<0.001). Adverse events in biopsy cases were uncommon. CONCLUSIONS: In this multi-institutional cohort, the incidence of AE is higher among interventional compared to diagnostic cases, and is very low among biopsy cases. Equitable comparisons among institutions will require the development and application of risk adjustment methods.


Assuntos
Cateterismo Cardíaco/efeitos adversos , Cardiopatias Congênitas/diagnóstico , Cardiopatias Congênitas/terapia , Criança , Pré-Escolar , Humanos , Lactente , Recém-Nascido , Estudos Prospectivos
15.
Catheter Cardiovasc Interv ; 72(1): 74-9, 2008 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-18546236

RESUMO

OBJECTIVES: To evaluate all complications that occurred during or after cardiac catheterizations for Amplatzer PFO device closure of patent foramen ovale (PFO), determine the cause of the complications and recommend techniques to minimize complications in the future. BACKGROUND: Rare complications were reported to the manufacturer of the Amplatzer PFO occluder since the introduction of the device. METHODS: A panel of independent physicians reviewed all complications reported to the manufacturer to determine whether the complication was related to the device or related to the cardiac catheterization procedure. Demographic data, echocardiograms, operative reports, and time to occurrence of complications were reviewed. RESULTS: A total of 11 events were reported. Only two patients had device related complications (erosion), an incidence of 0.018%. Two patients were found to have additional atrial septal defect after PFO closure. Two patients were thought to have an inflammatory reaction without any serious sequelae. Five complications were related to the cardiac catheterization procedure (atrial appendage perforation). CONCLUSIONS: Device related complications after Amplatzer PFO occluder placement are extremely rare. Cardiac catheterization related complications appear to be the most common cause of the hemodynamic compromise. Careful manipulation of catheters and wires, recognition of the location of the catheter by fluoroscopy and echocardiography will decrease the risk of such complications.


Assuntos
Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Forame Oval Patente/terapia , Sistema de Registros , Desenho de Equipamento , Falha de Equipamento/estatística & dados numéricos , Forame Oval Patente/diagnóstico por imagem , Humanos , Complicações Pós-Operatórias/epidemiologia , Vigilância de Produtos Comercializados , Radiografia , Estudos Retrospectivos , Fatores de Tempo , Ultrassonografia
16.
Congenit Heart Dis ; 13(1): 140-146, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29148206

RESUMO

OBJECTIVE: Trans-catheter (TC) pulmonary valve replacement (PVR) has become common practice for patients with right ventricular outflow tract obstruction (RVOTO) and/or pulmonic insufficiency (PI). Our aim was to compare PVR and right ventricular (RV) function of patients who received TC vs surgical PVR. DESIGN: Retrospective review of echocardiograms obtained at three time points: before, immediately after PVR, and most recent. PATIENTS: Sixty-two patients (median age 19 years, median follow-up 25 months) following TC (N = 32) or surgical (N = 30) PVR at Yale-New Haven Hospital were included. OUTCOME MEASURES: Pulmonary valve and right ventricular function before, immediately after, and most recently after PVR. RESULTS: At baseline, the TC group had predominant RVOTO (74% vs 10%, P < .001), and moderate-severe PI was less common (61% vs 100%, P < .001). Immediate post-procedural PVR function was good throughout. At last follow-up, the TC group had preserved valve function, but the surgical group did not (moderate RVOTO: 6% vs 41%, P < .001; >mild PI: 0% vs 24%, P = .003). Patients younger than 17 years at surgical PVR had the highest risk of developing PVR dysfunction, while PVR function in follow-up was similar in adults. Looking at RV size and function, both groups had a decline in RV size following PVR. However, while RV function remained stable in the TC group, there was a transient postoperative decline in the surgical group. CONCLUSIONS: TC PVR in patients age <17 years is associated with better PVR function in follow-up compared to surgical valves. There was a transient decline in RV function following surgical but not TC PVR. TC PVR should therefore be the first choice in children who are considered for PVR, whenever possible.


Assuntos
Bioprótese , Implante de Prótese de Valva Cardíaca/métodos , Ventrículos do Coração/fisiopatologia , Insuficiência da Valva Pulmonar/fisiopatologia , Valva Pulmonar/cirurgia , Função Ventricular Direita/fisiologia , Remodelação Ventricular/fisiologia , Adolescente , Adulto , Cateterismo Cardíaco/métodos , Criança , Pré-Escolar , Ecocardiografia , Feminino , Seguimentos , Ventrículos do Coração/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/fisiopatologia , Insuficiência da Valva Pulmonar/diagnóstico , Insuficiência da Valva Pulmonar/cirurgia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
17.
J Am Coll Cardiol ; 72(22): 2717-2728, 2018 12 04.
Artigo em Inglês | MEDLINE | ID: mdl-30497557

RESUMO

BACKGROUND: Endocarditis has emerged as one of the most concerning adverse outcomes in patients with congenital anomalies involving the right ventricular outflow tract (RVOT) and prosthetic valves. OBJECTIVES: The aim of this study was to evaluate rates and potential risk factors for endocarditis after transcatheter pulmonary valve replacement in the prospective Melody valve trials. METHODS: All patients in whom a transcatheter pulmonary valve (TPV) was implanted in the RVOT as part of 3 prospective multicenter studies comprised the analytic cohort. The diagnosis of endocarditis and involvement of the TPV were determined by the implanting investigator. RESULTS: A total of 309 patients underwent transcatheter pulmonary valve replacement (TPVR) and were discharged with a valve in place. The median follow-up duration was 5.1 years, and total observation until study exit was 1,660.3 patient-years. Endocarditis was diagnosed in 46 patients (median 3.1 years after TPVR), and a total of 35 patients were reported to have TPV-related endocarditis (34 at the initial diagnosis, 1 with a second episode). The annualized incidence rate of endocarditis was 3.1% per patient-year and of TPV-related endocarditis was 2.4% per patient-year. At 5 years post-TPVR, freedom from a diagnosis of endocarditis was 89% and freedom from TPV-related endocarditis was 92%. By multivariable analysis, age ≤12 years at implant (hazard ratio: 2.3; 95% confidence interval: 1.2 to 4.4; p = 0.011) and immediate post-implant peak gradient ≥15 mm Hg (2.7; 95% confidence interval: 1.4 to 4.9; p = 0.002) were associated with development of endocarditis and with development of TPV-related endocarditis (age ≤12 years: 2.8; 95% confidence interval: 1.3 to 5.7; p = 0.006; gradient ≥15 mm Hg: 2.6; 95% confidence interval: 1.3 to 5.2; p = 0.008). CONCLUSIONS: Endocarditis is an important adverse outcome following TVPR in children and adults with post-operative congenital heart disease involving the RVOT. Ongoing efforts to understand, prevent, and optimize management of this complication are paramount in making the best use of TPV therapy. (Melody Transcatheter Pulmonary Valve [TPV] Study: Post Approval Study of the Original Investigational Device Exemption [IDE] Cohort; NCT00740870; Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692; and Melody Transcatheter Pulmonary Valve [TPV] Post-Market Surveillance Study; NCT00688571).


Assuntos
Endocardite Bacteriana/etiologia , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Complicações Pós-Operatórias/etiologia , Insuficiência da Valva Pulmonar/cirurgia , Valva Pulmonar/cirurgia , Adolescente , Adulto , Criança , Endocardite Bacteriana/diagnóstico por imagem , Endocardite Bacteriana/epidemiologia , Contaminação de Equipamentos , Feminino , Seguimentos , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/epidemiologia , Implante de Prótese de Valva Cardíaca/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/microbiologia , Insuficiência da Valva Pulmonar/diagnóstico por imagem , Insuficiência da Valva Pulmonar/epidemiologia , Adulto Jovem
18.
Circ Cardiovasc Interv ; 11(8): e006453, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-30354783

RESUMO

BACKGROUND: Percutaneous transcatheter pulmonary valve replacement (TPVR) has good clinical and hemodynamic outcomes in treating dysfunctional bioprosthetic valves (BPV) in the pulmonary position. Valve-in-valve therapy can further decrease the inner diameter (ID), potentially resulting in patient-prosthesis mismatch in patients with smaller BPVs. METHODS AND RESULTS: To evaluate feasibility and outcomes of intentional BPV fracture to enlarge the pulmonary valve orifice with TPVR, 37 patients from 13 centers who underwent TPVR with intended BPV fracture were evaluated. A control cohort (n=70) who underwent valve-in-valve TPVR without attempted fracture was evaluated. BPV was successfully fractured in 28 patients and stretched in 5 while fracture was unsuccessful in 4. A Melody valve was implanted in 25 patients with fractured/stretched frame and a Sapien (XT 3) valve in 8. Among patients whose BPV was fractured/stretched, the final ID was a median of 2 mm larger (0-6.5 mm) than the valve's true ID. The narrowest diameter after TPVR in controls was a median of 2 mm smaller ( P<0.001) than true ID. Right ventricular outflow tract gradient decreased from median 40 to 8 mm Hg in the fracture group. Cases with fracture/stretching were matched 1:1 (weight, true ID) to controls. Post-TPVR peak gradient was lower but not significant (8.3±5.2 versus 11.8±9.2 mm Hg; P=0.070). There were no fracture-related adverse events. CONCLUSIONS: Preliminary experience shows intentional fracture of BPV frame can be useful for achieving larger ID and better hemodynamics after valve-in-valve TPVR.


Assuntos
Bioprótese , Cateterismo Cardíaco/instrumentação , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Falha de Prótese , Valva Pulmonar/cirurgia , Adolescente , Adulto , Idoso , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Criança , Estudos de Viabilidade , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Dados Preliminares , Desenho de Prótese , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/fisiopatologia , Recuperação de Função Fisiológica , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
19.
JACC Cardiovasc Interv ; 10(17): 1746-1759, 2017 09 11.
Artigo em Inglês | MEDLINE | ID: mdl-28823778

RESUMO

OBJECTIVES: This study sought to evaluate the incidence of and risk factors for conduit and stent-related outcomes following transcatheter pulmonary valve replacement (TPVR). BACKGROUND: Stent fracture (SF) and right ventricular outflow tract (RVOT) reintervention are among the most important adverse outcomes after TPVR using the Melody valve (Medtronic, Minneapolis, Minnesota). The conduit environment and conduit preparation practices vary among patients who undergo TPVR. METHODS: Data from 3 prospective Melody valve multicenter studies were pooled and analyzed. All patients who had successful implant of a Melody valve that was present at hospital discharge comprised the study cohort; patients who had TPVR into a stentless conduit comprised the analysis cohort. SF was diagnosed using protocol-specified or clinical fluoroscopy or radiography, and classified as major or minor. RESULTS: Of 358 patients who underwent catheterization with intent to perform TPVR, 309 were discharged with the Melody valve in place (study cohort) of which 251 patients had TPVR into a stentless conduit (analysis cohort). Median follow-up was 5 years. New pre-stents were placed in 68% of patients with a stentless conduit, and 22% received multiple pre-stents. At 3 years, freedom from any SF and major SF was 74 ± 3% and 85 ± 2%, respectively, and freedom from RVOT reintervention was 85 ± 2%. New pre-stents were associated with longer freedom from SF and RVOT reintervention than was no pre-stent. CONCLUSIONS: Risks of SF and reintervention after TPVR with a Melody valve were reduced by implantation of pre-stents, which has become standard practice. This study supports pre-stenting as an important component of TPVR therapy.


Assuntos
Implante de Prótese Vascular/instrumentação , Prótese Vascular , Cateterismo Cardíaco/métodos , Cardiopatias Congênitas/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Valva Pulmonar/cirurgia , Stents , Obstrução do Fluxo Ventricular Externo/cirurgia , Adolescente , Adulto , Implante de Prótese Vascular/efeitos adversos , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Criança , Bases de Dados Factuais , Intervalo Livre de Doença , Europa (Continente) , Feminino , Cardiopatias Congênitas/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , América do Norte , Estudos Prospectivos , Desenho de Prótese , Falha de Prótese , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/fisiopatologia , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Obstrução do Fluxo Ventricular Externo/diagnóstico por imagem , Obstrução do Fluxo Ventricular Externo/fisiopatologia , Adulto Jovem
20.
Am J Cardiol ; 120(8): 1387-1392, 2017 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-28823485

RESUMO

This early feasibility study was designed to obtain in vivo data to confirm assumptions on device loading conditions of the Medtronic Harmony transcatheter pulmonary valve (TPV). Secondary objectives included procedural feasibility, safety, and valve performance. The Harmony TPV was developed for nonsurgical pulmonary valve replacement in non-right ventricle-pulmonary artery conduit patients. The Native Outflow Tract TPV Research Clinical Study was the first study approved under the Food and Drug Administration Early Feasibility Study guidance. Enrollment required that patient anatomy be precisely matched to the single-size Harmony TPV implant, necessitating a rigorous selection process. The study was nonrandomized, prospective, and performed at 3 sites. All patients met standard indications for surgical pulmonary valve replacement. The goal of the screening committee was to match the candidate anatomy to predetermined engineering criteria thought to be predictive of secure Harmony TPV implantation for the single-size device under study. A majority of the screening committee was required to recommend a patient as eligible for implant. A total of 270 patients underwent prescreening cardiac magnetic resonance imaging, 66 were enrolled and received a computed tomography scan (24%), 21 met criteria for implant and were catheterized (8%), and 20 underwent implant. Nineteen of 20 met criteria for implant success. In conclusion, the Medtronic Harmony TPV represents an emerging therapeutic option for patients with complex postoperative right ventricular outflow tract failure. The initial clinical evaluation of this technology was unique, and the highly variable anatomy of this population required careful screening to ensure acceptable device fit.


Assuntos
Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Ventrículos do Coração/diagnóstico por imagem , Seleção de Pacientes , Insuficiência da Valva Pulmonar/cirurgia , Valva Pulmonar/cirurgia , Adulto , Estudos Clínicos como Assunto , Ecocardiografia , Estudos de Viabilidade , Feminino , Seguimentos , Ventrículos do Coração/fisiopatologia , Humanos , Imagem Cinética por Ressonância Magnética , Masculino , Estudos Prospectivos , Insuficiência da Valva Pulmonar/diagnóstico , Fatores de Tempo , Resultado do Tratamento
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