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1.
Catheter Cardiovasc Interv ; 104(2): 256-263, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38967206

RESUMEN

BACKGROUND: The Alterra adaptive prestent is a novel self-expanding device designed to provide a landing zone for the 29 mm SAPIEN 3 valve to treat pulmonary regurgitation in patients with a right ventricular outflow tract that is too large for a balloon expandable valve alone. The mechanism of fixation for the Alterra prestent is radial force from the self-expanding stent frame, combined with a unique set of flared "tines" that protrude from both ends of the stent. AIMS, METHODS, AND RESULTS: In this report, we describe 6 patients who underwent uncomplicated transcatheter pulmonary valve replacement with an Alterra adaptive prestent and SAPIEN 3 valve and had surveillance chest computed tomography (CT) scans performed 1 day to 21 months after implant. In each patient, the CT scan demonstrated extravascular extension of a portion of the Alterra prestent, without clinical sequelae, but with extension into the ascending aorta in 1 patient and contact with the ascending aorta, left pulmonary vein, or left atrial appendage in 3 others. CONCLUSIONS: Surveillance CT imaging shows that the Alterra prestent can perforate the pulmonary artery and/or right ventricle. Although no sequelae were seen in these patients, prestent perforation has the potential to be clinically important. Implanters should be aware of this finding and its potential implications. As experience with the Alterra prestent grows, it will be important to further define the risk factors, incidence, and implications of this phenomenon.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Valor Predictivo de las Pruebas , Diseño de Prótesis , Humanos , Masculino , Femenino , Resultado del Tratamiento , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Factores de Tiempo , Adulto , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/efectos adversos , Válvula Pulmonar/diagnóstico por imagen , Válvula Pulmonar/cirugía , Válvula Pulmonar/fisiopatología , Insuficiencia de la Válvula Pulmonar/diagnóstico por imagen , Insuficiencia de la Válvula Pulmonar/fisiopatología , Insuficiencia de la Válvula Pulmonar/cirugía , Insuficiencia de la Válvula Pulmonar/etiología , Adulto Joven , Angiografía por Tomografía Computarizada , Adolescente , Arteria Pulmonar/diagnóstico por imagen , Arteria Pulmonar/fisiopatología , Tomografía Computarizada por Rayos X
2.
Catheter Cardiovasc Interv ; 103(2): 326-334, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-38149722

RESUMEN

BACKGROUND: Atrioventricular valve regurgitation (AVVR) is a devastating complication in children and young adults with congenital heart disease (CHD), particularly in patients with single ventricle physiology. Transcatheter edge-to-edge repair (TEER) is a rapidly expanding, minimally invasive option for the treatment of AVVR in adults that avoids the morbidity and mortality associated with open heart surgery. However, application of TEER in in CHD and in children is quite novel. We describe the development of a peri-procedural protocol including image-derived pre-intervention simulation, with successful application to four patients. AIMS: To describe the initial experience using the MitraClip system for TEER of dysfunctional systemic atrioventricular valves in patients with congential heart disease within a pediatric hospital. METHODS: A standardized screening and planning process was developed using cardiac magnetic resonance imaging, three dimensional echocardiography and both virtual and physical simulation. Procedures were performed using the MitraClip G4 system and patients were clinically followed post-intervention. RESULTS: A series of four CHD patients with at least severe AVVR were screened for suitability for TEER with the MitraClip system: three patients had single ventricle physiology and Fontan palliation, and one had repair of a common atrioventricular canal defect. Each patient had at least severe systemic AVVR and was considered at prohibitively high risk for surgical repair. Each patient underwent a standardized preprocedural screening protocol and image-derived modeling followed by the TEER procedure with successful clip placement at the intended location in all cases. CONCLUSIONS: The early results of our protocolized efforts to introduce TEER repair of severe AV valve regurgitation with MitraClip into the CHD population within our institution are encouraging. Further investigations of the use of TEER in this challenging population are warranted.


Asunto(s)
Procedimiento de Fontan , Cardiopatías Congénitas , Defectos de los Tabiques Cardíacos , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Niño , Humanos , Hospitales Pediátricos , Resultado del Tratamiento , Cardiopatías Congénitas/diagnóstico por imagen , Cardiopatías Congénitas/cirugía , Defectos de los Tabiques Cardíacos/cirugía , Procedimiento de Fontan/efectos adversos , Procedimiento de Fontan/métodos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía
3.
Catheter Cardiovasc Interv ; 102(6): 1078-1087, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37925624

RESUMEN

BACKGROUND: The Harmony TPV25 transcatheter pulmonary valve (Medtronic Inc.) is constructed with a self-expanding stent frame comprising six zigged nitinol wires sewn together and covered with knitted polyester fabric, with flared inflow and outflow ends and a porcine pericardial valve sutured to the central portion of the device. It was approved for treatment of pulmonary regurgitation after prior right ventricular outflow tract repair in 2021. Early outcomes of this procedure have been excellent, but little is known about valve durability or ultimate mechanisms of dysfunction. METHODS: We collected data on patients who underwent reintervention for TPV25 dysfunction and described findings related to distortion of the stent frame and tissue accumulation. RESULTS: We describe six patients who underwent valve-in-valve implant for TPV25 obstruction (peak catheterization gradient peak 28-73 mmHg) 10-28 months after implant. In all cases, there was tissue accumulation within the inflow and valve-housing segments of the device and deformation of the self-expanding valve frame characterized by variable circumferential narrowing at the junction between the valve housing and the inflow and outflow portions of the device, with additional geometric changes in all segments. All six patients underwent valve-in-valve implant that results in a final peak gradient ≤10 mmHg and no regurgitation. DISCUSSION: The occurrence of short-term Harmony TPV25 dysfunction in multiple patients with a similar appearance of frame distortion and tissue accumulation within the inflow and valve housing portions of the device suggests that this may be an important failure mechanism for this valve. Potential causes of the observed findings are discussed. It is possible to treat this mechanism of TPV25 dysfunction with valve-in-valve implant using balloon expandable transcatheter valves.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Pulmonar , Válvula Pulmonar , Obstrucción del Flujo de Salida Ventricular Derecho , Obstrucción del Flujo Ventricular Externo , Humanos , Porcinos , Animales , Prótesis Valvulares Cardíacas/efectos adversos , Obstrucción del Flujo Ventricular Externo/diagnóstico por imagen , Obstrucción del Flujo Ventricular Externo/etiología , Obstrucción del Flujo Ventricular Externo/cirugía , Resultado del Tratamiento , Cateterismo Cardíaco , Insuficiencia de la Válvula Pulmonar/diagnóstico por imagen , Insuficiencia de la Válvula Pulmonar/etiología , Insuficiencia de la Válvula Pulmonar/cirugía , Stents/efectos adversos , Diseño de Prótesis
4.
Am J Med Genet A ; 188(5): 1384-1395, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35025139

RESUMEN

Tetralogy of Fallot (ToF) can be associated with a wide range of extracardiac anomalies, with an underlying etiology identified in approximately 10% of cases. Individuals affected with Myhre syndrome due to recurrent SMAD4 mutations frequently have cardiovascular anomalies, including congenital heart defects. In addition to two patients in the literature with ToF, we describe five additional individuals with Myhre syndrome and classic ToF, ToF with pulmonary atresia and multiple aorto-pulmonary collaterals, and ToF with absent pulmonary valve. Aorta hypoplasia was documented in one patient and suspected in another two. In half of these individuals, postoperative cardiac dysfunction was thought to be more severe than classic postoperative ToF repair. There may be an increase in right ventricular pressure, and right ventricular dysfunction due to free pulmonic regurgitation. Noncardiac developmental abnormalities in our series and the literature, including corectopia, heterochromia iridis, and congenital miosis suggest an underlying defect of neural crest cell migration in Myhre syndrome. We advise clinicians that Myhre syndrome should be considered in the genetic evaluation of a child with ToF, short stature, unusual facial features, and developmental delay, as these children may be at risk for increased postoperative morbidity. Additional research is needed to investigate the hypothesis that postoperative hemodynamics in these patients may be consistent with restrictive myocardial physiology.


Asunto(s)
Cardiopatías Congénitas , Tetralogía de Fallot , Criptorquidismo , Facies , Trastornos del Crecimiento , Deformidades Congénitas de la Mano , Cardiopatías Congénitas/complicaciones , Humanos , Discapacidad Intelectual , Masculino , Cresta Neural , Fenotipo , Proteína Smad4/genética , Tetralogía de Fallot/complicaciones , Tetralogía de Fallot/genética , Tetralogía de Fallot/cirugía
5.
Eur Radiol ; 32(1): 112-121, 2022 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-34165621

RESUMEN

OBJECTIVES: To characterize hepatic to systemic lymphatic connections in patients with systemic lymphatic disease using intra-hepatic lymphangiography and to compare outcomes after lymphatic intervention. METHODS: In this retrospective study, patients with intra-hepatic lymphangiography from May 2014 - April 2019 at our institution were included. Imaging review was performed and hepatic lymphatic connections and flow patterns were characterized. Clinical data were reviewed and comparisons between patients undergoing lymphatic intervention with or without abnormal hepatic lymphatics were performed. RESULTS: During the study period, 105 patients underwent intra-hepatic lymphangiography. Primary clinical presentation included ascites (19/105), chylothorax (27/105), plastic bronchitis (PB) (17/105), and protein losing enteropathy (PLE) (42/105). Five categories of hepatic lymphatic connections and flow patterns were identified (%): normal (25%, 26/105), hepatoperitoneal (12%, 13/105), hepatopulmonary (10.5%, 11/105), hepatomesenteric (7.5%, 8/105), and hepatoduodenal (41%, 43/105) with four patients having more than one abnormal pattern. A comparison between clinical presentation and imaging category revealed an increased likelihood of having ascites with hepatoperitoneal (p < .0001), chylothorax/PB with hepatopulmonary (p = .01), and PLE with hepatoduodenal (p < .001) connections. Seventy-six patients had a lymphatic intervention, 24% with normal, and 76% with abnormal liver lymphatics. There was no difference in length of hospital stay or mortality between the two groups, but there was a prolonged time to symptom resolution (p = .006) and persistent symptoms after 6 months (5% vs 44%, p = .002) in the group with abnormal liver lymphatics. CONCLUSION: We identified five liver lymphatic imaging categories with a substantial correlation to presenting lymphatic disease. Abnormal imaging patterns correlated with increased morbidity. Evaluation of liver lymphatics should be considered in patients with a systemic lymphatic disease if central lymphatic imaging is normal. KEY POINTS: • We identified five liver lymphatic imaging patterns: normal, hepatoperitoneal, hepatomesenteric, hepatopulmonary, and hepatoduodenal. • Imaging patterns were correlated with disease presentation (normal - chylothorax/PB, hepatoperitoneal - ascites/chylothorax, hepatopulmonary - chylothorax/PB, hepatoduodenal - PLE). • Abnormal imaging patterns correlated with increased morbidity.


Asunto(s)
Quilotórax , Enfermedades Linfáticas , Vasos Linfáticos , Humanos , Hígado/diagnóstico por imagen , Enfermedades Linfáticas/diagnóstico por imagen , Linfografía , Estudios Retrospectivos
6.
Pediatr Cardiol ; 43(3): 685-690, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-34841467

RESUMEN

Patients with dextro-transposition of the great arteries (d-TGA) require surgical repair as neonates. These patients are at risk for post-operative chylothorax. We sought to describe the presentation, imaging, and outcomes after intervention for patients with d-TGA with post-operative chylothorax. A retrospective chart review was performed in patients with repaired d-TGA who were referred from 1/1/2013 to 4/1/2020 for evaluation of chylothorax. Patient history, lymphatic imaging, and interventional data were collected. Impact of intervention on lymphatic drainage was evaluated with a student's t-test. Eight patients met inclusion criteria for this study. Five patients had a history of central venous thrombus leading to thoracic duct outlet occlusion. Five patients underwent intervention, two were managed conservatively, and one was not a candidate for intervention. Chylothorax resolved in six patients. There was a significant difference in output from 7 days prior to first intervention (114 mL/kg/day) compared to 28 days following final intervention (27 mL/kg/day, p = 0.034). There were no procedural complications. Chylothorax in patients with repaired transposition of the great arteries is often amenable to intervention. Early surveillance and management of central venous thrombosis may reduce the burden of lymphatic disease in these patients.


Asunto(s)
Quilotórax , Transposición de los Grandes Vasos , Arterias , Quilotórax/etiología , Quilotórax/cirugía , Humanos , Recién Nacido , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Transposición de los Grandes Vasos/cirugía
7.
Catheter Cardiovasc Interv ; 95(7): 1296-1304, 2020 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-32108423

RESUMEN

OBJECTIVE: To evaluate safety and efficacy of the GORE® CARDIOFORM Septal Occluder for percutaneous transcatheter closure of ostium secundum atrial septal defects. BACKGROUND: The GORE® CARDIOFORM septal occluder is a double-disc, low profile, soft, conformable device, with distinct advantages over the GORE® HELEX® Septal Occluder. METHODS: Subjects were enrolled in this single arm prospective study from 21 U.S. sites, and followed for 3 years. Primary endpoint was 6 month composite clinical success, comprised of technical success (implantation and retention of device), closure success (normalization of right heart size), no 30 day serious adverse events, and no device embolization or reintervention. Secondary endpoints included technical success, procedure success (technical success and ≤ 2 mm residual shunt at procedure conclusion), closure success (clinically insignificant or no residual shunt), and safety (freedom from 30 day serious adverse events and 6-month device events). RESULTS: Between October 2012 and May 2015, 50 pivotal and 350 continued access subjects underwent attempted transcatheter GORE® CARDIOFORM Septal Occluder implantation. Median age was 6.9 years, and mean static defect diameter 9.7 ± 3.1 mm. Device placement was achieved in 93.5% (374/400). Composite clinical success was 90.2% and clinical closure success was 98.8% at 6 months. Freedom from serious adverse events was 98.3% at 30 days, with no device embolizations or reinterventions through 6 months. CONCLUSIONS: The GORE® CARDIOFORM Septal Occluder has high composite clinical success and safety, performing well in defects ≤17 mm by stop flow stretched diameter. Single, multifenestrated, and deficient retroaortic tissue defects were well represented and successfully treated.


Asunto(s)
Cateterismo Cardíaco/instrumentación , Defectos del Tabique Interatrial/terapia , Dispositivo Oclusor Septal , Adolescente , Adulto , Anciano , Cateterismo Cardíaco/efectos adversos , Niño , Preescolar , Femenino , Defectos del Tabique Interatrial/diagnóstico por imagen , Humanos , Lactante , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Adulto Joven
8.
Catheter Cardiovasc Interv ; 95(7): 1285-1295, 2020 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-31943749

RESUMEN

OBJECTIVE: Assess clinical performance of a new device for transcatheter closure of atrial septal defect (ASD). BACKGROUND: Previously-approved ASD Closure devices have known limitations. Device erosion has been associated with the AMPLATZER® septal occluder in patients with retro-aortic rim deficiency (<5 mm), while defects ≥18 mm are too large for the GORE® CARDIOFORM septal occluder. The GORE® CARDIOFORM ASD occluder (GCA), a hybrid of the approved devices, was designed to expand the eligible ASD population. METHODS: One-hundred and twenty-five ASD patients were enrolled in a prospective, multicenter registry. Descriptive clinical endpoints included: technical implant success, closure success, serious adverse events (SAE), clinically significant new arrhythmia, and wire frame fracture. Procedural outcomes and adverse events were adjudicated by an Echocardiography Core Lab and Independent Data Review Board, respectively. RESULTS: Median subject age was 12.3 years (range 2.9-84.7), with 72% of patients ≤18 years old. Median ASD stop-flow diameter was 17.0 mm (8.0-30.0), with 43% ≥18 mm. Deficient retro-aortic rim occurred in 57% of subjects, and 30% had both diameter ≥ 18 mm and deficient rim. Technical Implant Success was achieved in 120/125 (96%), though three devices were removed within 24 hr. At the scheduled 6-month evaluation, 112/117 returned for evaluation. All 112 had closure success. SAE occurred in 6/125 (4.8%) and 6/125 (4.8%) had clinically significant new arrhythmia. Wire frame fractures occurred in 37/104 (36%), without any associated clinical sequelae, residual shunt, or device instability. CONCLUSION: The GCA performed effectively and safely in this initial cohort, and led to FDA approval based on this data.


Asunto(s)
Cateterismo Cardíaco/instrumentación , Defectos del Tabique Interatrial/terapia , Dispositivo Oclusor Septal , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Niño , Preescolar , Femenino , Defectos del Tabique Interatrial/diagnóstico por imagen , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Sistema de Registros , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Adulto Joven
9.
Catheter Cardiovasc Interv ; 96(6): E593-E601, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-31478608

RESUMEN

OBJECTIVES: Our pilot study investigated the association between region-specific myocardial tissue temperature and tissue salvage using a novel tri-lumen cooling catheter to provide rapid localized cooling directly to the heart in an open-chest porcine model of ischemia-reperfusion. BACKGROUND: Therapeutic hypothermia remains a promising strategy to limit reperfusion injury following myocardial ischemia. METHODS: Large swine underwent 60 min of coronary occlusion followed by 3 hr of reperfusion. Prior to inducing ischemia, six temperature probes were placed directly on the heart, monitoring myocardial temperatures in different locations. Hemodynamic parameters and core temperature were also collected. Approximately 15 min prior to reperfusion, the cooling catheter was inserted via femoral artery and the distal tip advanced proximal to the occluded coronary vessel under fluoroscopic guidance. Autologous blood was pulled from the animal via femoral sheath and delivered through the central lumen of the cooling catheter, delivering at 50 ml/min, 27°C at the distal tip. Cooling was continued for an additional 25 min after reperfusion followed by a 5-min controlled rewarming. Hearts were excised and assessed for infarct size per area at risk. RESULTS: Although cooling catheter performance was consistent throughout the study (38 W), the resulting tissue cooling was not. Our results show a correlation between myocardial tissue salvage and ischemic border region (IBR) temperature at the time of reperfusion (R2 = 0.59, p = 0.027). IBR tissue is the tissue located at the boundary between healthy and ischemic tissues. CONCLUSIONS: Our findings suggest that localized, rapid, short-term myocardial tissue cooling has the potential to limit reperfusion injury in humans.


Asunto(s)
Cateterismo Cardíaco , Hipotermia Inducida , Infarto del Miocardio/terapia , Daño por Reperfusión Miocárdica/prevención & control , Miocardio/patología , Animales , Cateterismo Cardíaco/instrumentación , Catéteres Cardíacos , Frío , Modelos Animales de Enfermedad , Femenino , Hipotermia Inducida/instrumentación , Masculino , Infarto del Miocardio/patología , Daño por Reperfusión Miocárdica/patología , Proyectos Piloto , Sus scrofa , Factores de Tiempo , Supervivencia Tisular
10.
Catheter Cardiovasc Interv ; 96(4): 889-897, 2020 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-32339400

RESUMEN

OBJECTIVES: To evaluate short- and middle-term outcomes after transcatheter patent ductus arteriosus (TC-PDA) closure in small infants, specifically device-related left pulmonary artery (LPA) stenosis and aortic coarctation, risk factors, and changes over time. BACKGROUND: Recent studies have demonstrated successful transcatheter PDA (TC-PDA) closure in small infants. LPA stenosis and aortic coarctation have been seen after TC-PDA, but it is not clear whether device-related LPA/aortic obstruction persists. METHODS: A single-center retrospective study of infants ≤4 kg who underwent TC-PDA closure from February 1, 2007 to September 1, 2018 was performed, evaluating the incidence and risk factors for LPA stenosis and coarctation. RESULTS: Forty-four patients underwent successful TC-PDA with Amplatzer Vascular Plug II (AVPII; n = 30), Amplatzer Duct Occluder II-Additional Sizes (n = 10), Amplatzer Duct Occluder I (n = 3), and coil-filled AVPI (n = 1) devices, all via an antegrade approach. Median birthweight and procedural weight were 890 g (range: 490-3,250) and 2.8 kg (range: 1.2-4.0), respectively. Median follow-up was 0.7 years (range: 2 days-7 years). Thirty-eight patients had post-procedure echocardiograms assessing LPA/aortic obstruction. Of those, 17 had LPA flow acceleration/stenosis (≥1.5 m/s), which improved or resolved in all patients with available follow-up; 3 developed mild coarctation (>2 m/s), which improved in the two with more than short-term follow-up; 4 developed mild flow acceleration (1.5-2 m/s) in the descending aorta, which resolved in three and increased in one (2.4 m/s). Flow acceleration in the LPA was associated with younger procedural age, larger PDA minimal diameter, and placement of a device other than the AVPII. There was no device-related mortality or need for reintervention. CONCLUSION: TC-PDA in small infants is effective, without significant complications. Device-related LPA/aortic obstruction can improve with time/growth.


Asunto(s)
Coartación Aórtica/epidemiología , Cateterismo Cardíaco/efectos adversos , Conducto Arterioso Permeable/terapia , Dispositivo Oclusor Septal/efectos adversos , Estenosis de Arteria Pulmonar/epidemiología , Factores de Edad , Coartación Aórtica/diagnóstico por imagen , Peso al Nacer , Cateterismo Cardíaco/instrumentación , Conducto Arterioso Permeable/diagnóstico por imagen , Femenino , Humanos , Incidencia , Lactante , Recién Nacido de Bajo Peso , Recién Nacido , Masculino , Estudios Retrospectivos , Factores de Riesgo , Estenosis de Arteria Pulmonar/diagnóstico por imagen , Factores de Tiempo , Resultado del Tratamiento
11.
Catheter Cardiovasc Interv ; 96(6): 1266-1276, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-32433821

RESUMEN

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.


Asunto(s)
Cateterismo Cardíaco/instrumentación , Conducto Arterioso Permeable/terapia , Recien Nacido Extremadamente Prematuro , Recién Nacido de muy Bajo Peso , Dispositivo Oclusor Septal , Peso al Nacer , Cateterismo Cardíaco/efectos adversos , Circulación Coronaria , Conducto Arterioso Permeable/diagnóstico por imagen , Conducto Arterioso Permeable/fisiopatología , Femenino , Edad Gestacional , Hemodinámica , Humanos , Recién Nacido , Masculino , Estudios Prospectivos , Diseño de Prótesis , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos
12.
Circulation ; 138(19): 2119-2129, 2018 11 06.
Artículo en Inglés | MEDLINE | ID: mdl-30474422

RESUMEN

BACKGROUND: The arterial switch operation (ASO) is the gold standard operative correction of neonates with transposition of the great arteries and intact ventricular septum, with excellent operative survival. The associations between patient and surgeon characteristics and outcomes are well understood, but the associations between variation in preoperative care and outcomes are less well studied. METHODS: A multicenter retrospective cohort study of infants undergoing neonatal ASO between January 2010 and September 2015 at hospitals contributing data to the Pediatric Health Information Systems database was performed. The association between preoperative care (timing of ASO, preoperative use of balloon atrial septostomy, prostaglandin infusion, mechanical ventilation, and vasoactive agents) and operative outcomes (mortality, length of stay, and cost) was studied with multivariable mixed-effects models. RESULTS: Over the study period, 2159 neonates at 40 hospitals were evaluated. Perioperative mortality was 2.8%. Between hospitals, the use of adjuvant therapies and timing of ASO varied broadly. At the subject level, older age at ASO was associated with higher mortality risk (age >6 days: odds ratio, 1.90; 95% CI, 1.11-3.26; P=0.02), cost, and length of stay. Receipt of a balloon atrial septostomy was associated with lower mortality risk (odds ratio, 0.32; 95% CI, 0.17-0.59; P<0.001), cost, and length of stay. Later hospital median age at ASO was associated with higher odds of mortality (odds ratio, 1.15 per day; 95% CI, 1.02-1.29; P=0.03), longer length of stay ( P<0.004), and higher cost ( P<0.001). Other hospital factors were not independently associated with the outcomes of interest. CONCLUSIONS: There was significant variation in preoperative care between hospitals. Some potentially modifiable aspects of perioperative care (timing of ASO and septostomy) were significantly associated with mortality, length of stay, and cost. Further research on the perioperative care of neonates is necessary to determine whether modifying practice on the basis of the observed associations translates into improved outcomes.


Asunto(s)
Operación de Switch Arterial , Disparidades en Atención de Salud , Pautas de la Práctica en Medicina , Cuidados Preoperatorios , Transposición de los Grandes Vasos/cirugía , Operación de Switch Arterial/efectos adversos , Operación de Switch Arterial/economía , Operación de Switch Arterial/mortalidad , Cateterismo Cardíaco , Fármacos Cardiovasculares/administración & dosificación , Bases de Datos Factuales , Femenino , Disparidades en Atención de Salud/economía , Costos de Hospital , Mortalidad Hospitalaria , Humanos , Recién Nacido , Tiempo de Internación , Masculino , Pautas de la Práctica en Medicina/economía , Cuidados Preoperatorios/efectos adversos , Cuidados Preoperatorios/economía , Cuidados Preoperatorios/mortalidad , Prostaglandinas/administración & dosificación , Respiración Artificial , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Tiempo de Tratamiento , Transposición de los Grandes Vasos/economía , Transposición de los Grandes Vasos/mortalidad , Transposición de los Grandes Vasos/fisiopatología , Resultado del Tratamiento
13.
Radiology ; 291(3): 774-780, 2019 06.
Artículo en Inglés | MEDLINE | ID: mdl-30938628

RESUMEN

Background The Fontan operation is performed for surgical palliation of single ventricle physiology. This operation is usually preceded by a superior cavopulmonary connection (SCPC); lymphatic abnormalities after SCPC may be demonstrated at MRI and prior to the Fontan operation. Purpose To determine if the degree of neck and thoracic lymphatic abnormalities at T2-weighted MRI in patients after superior cavopulmonary connection (SCPC) correlated with surgical outcomes from the Fontan procedure. Materials and Methods Patients for whom SCPC was performed for palliation of single ventricle disease who underwent chest MRI between July 2012 and May 2015 at a single institution were retrospectively reviewed. T2-weighted images were scored as lymphatic type 1 (little or no T2 mediastinal and supraclavicular signal) to type 4 (T2 signal into both the mediastinum and the lung parenchyma). Fontan takedown, duration of post-Fontan hospitalization and pleural effusion, postoperative plastic bronchitis, need for transplant, and mortality were tabulated. The relationship between lymphatic type and clinical outcomes was evaluated by using analysis of variance (ANOVA), the Kruskal-Wallis H test, and the Fisher exact test. Results A total of 83 patients (mean age, 7.9 years ± 2.6) were evaluated. Among these 83 patients, 53 (64%) were classified with type 1 or 2 lymphatic abnormalities, 17 (20%) with type 3, and 12 (16%) with type 4. The rate of failure of Fontan completion was higher in patients with type 4 than in type 1 or 2 (54% vs 2%, respectively; P = .004). Need for cardiac transplant (one of 13 [8%]) and death (three of 13 [23%]) occurred only in type 4. Median postoperative length of stay was longer for patients with type 4 than for those with types 1 or 2 (29 days vs 9 days, respectively; P < .01). Conclusion Greater MRI-based severity of lymphatic abnormalities in patients prior to planned Fontan procedure was associated with failure of Fontan completion and longer postoperative stay. © RSNA, 2019 Online supplemental material is available for this article.


Asunto(s)
Procedimiento de Fontan , Anomalías Linfáticas/diagnóstico por imagen , Complicaciones Posoperatorias/diagnóstico por imagen , Niño , Preescolar , Procedimiento de Fontan/efectos adversos , Procedimiento de Fontan/mortalidad , Procedimiento de Fontan/estadística & datos numéricos , Cardiopatías Congénitas/mortalidad , Cardiopatías Congénitas/cirugía , Humanos , Tiempo de Internación , Anomalías Linfáticas/etiología , Sistema Linfático/diagnóstico por imagen , Sistema Linfático/patología , Imagen por Resonancia Magnética , Cuello/diagnóstico por imagen , Cuello/patología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Tórax/diagnóstico por imagen , Tórax/patología , Resultado del Tratamiento
14.
Am Heart J ; 217: 121-130, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-31654942

RESUMEN

BACKGROUND: The risks and benefits of pharmacologic treatment and operative closure of patent ductus arteriosus (O-PDA) in premature infants remain controversial. Recent series have demonstrated the feasibility of transcatheter PDA closure (TC-PDA) in increasingly small infants. The effect of this change on practice has not been evaluated. METHODS: A multicenter observational study of infants treated in neonatal intensive care units in hospitals contributing data to the Pediatric Health Information Systems Database from January 2007 to December 2017 was performed to study trends in the propensities for (1) mechanical closure of PDA and (2) TC-PDA versus O-PDA, as well as interhospital variation in practice. RESULTS: A total of 6,214 subjects at 44 hospitals were studied (5% TC-PDA). Subject median gestational age was 25 weeks (interquartile range: 24-27 weeks). Median age at closure was 24 days (interquartile range: 14-36 days). The proportion of all neonatal intensive care unit patients undergoing either O-PDA or TC-PDA decreased (3.1% in 2007 and 0.7% in 2017, P < .001), whereas the proportion in which TC-PDA was used increased significantly (0.1% in 2007 to 29.0% in 2017). Case-mix-adjusted multivariable models similarly demonstrated increasing propensity to pursue TC-PDA (odds ratio [OR] 1.66 per year, P < .001) with acceleration of the trend after 2014 (OR 2.46 per year, P < .001) as well as significant practice variation (P < .001, median OR 4.6) across the study period. CONCLUSIONS: In the face of decreasing closure of PDA, the use of TC-PDA increased dramatically with significant practice variability. This demonstrates that there is equipoise for potential clinical trials.


Asunto(s)
Análisis de Datos , Conducto Arterioso Permeable/cirugía , Sistemas de Información en Salud/estadística & datos numéricos , Unidades de Cuidado Intensivo Neonatal/tendencias , Grupos Diagnósticos Relacionados , Femenino , Edad Gestacional , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro , Masculino , Análisis Multivariante , Puntaje de Propensión
15.
Catheter Cardiovasc Interv ; 93(3): E143-E152, 2019 02 15.
Artículo en Inglés | MEDLINE | ID: mdl-30444053

RESUMEN

BACKGROUND: Pulmonary insufficiency is a consequence of transannular patch repair in Tetralogy of Fallot (ToF) leading to late morbidity and mortality. Transcatheter native outflow tract pulmonary valve replacement has become a reality. However, predicting a secure, atraumatic implantation of a catheter-based device remains a significant challenge due to the complex and dynamic nature of the right ventricular outflow tract (RVOT). We sought to quantify the differences in compression and volume for actual implants, and those predicted by pre-implant modeling. METHODS: We used custom software to interactively place virtual transcatheter pulmonary valves (TPVs) into RVOT models created from pre-implant and post Harmony valve implant CT scans of 5 ovine surgical models of TOF to quantify and visualize device volume and compression. RESULTS: Virtual device placement visually mimicked actual device placement and allowed for quantification of device volume and radius. On average, simulated proximal and distal device volumes and compression did not vary statistically throughout the cardiac cycle (P = 0.11) but assessment was limited by small sample size. In comparison to actual implants, there was no significant pairwise difference in the proximal third of the device (P > 0.80), but the simulated distal device volume was significantly underestimated relative to actual device implant volume (P = 0.06). CONCLUSIONS: This study demonstrates that pre-implant modeling which assumes a rigid vessel wall may not accurately predict the degree of distal RVOT expansion following actual device placement. We suggest the potential for virtual modeling of TPVR to be a useful adjunct to procedural planning, but further development is needed.


Asunto(s)
Cateterismo Cardíaco/instrumentación , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Modelos Cardiovasculares , Modelación Específica para el Paciente , Insuficiencia de la Válvula Pulmonar/cirugía , Válvula Pulmonar/cirugía , Tetralogía de Fallot/cirugía , Animales , Cateterismo Cardíaco/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Hemodinámica , Humanos , Modelos Animales , Diseño de Prótesis , Válvula Pulmonar/diagnóstico por imagen , Válvula Pulmonar/fisiopatología , Insuficiencia de la Válvula Pulmonar/diagnóstico por imagen , Insuficiencia de la Válvula Pulmonar/etiología , Insuficiencia de la Válvula Pulmonar/fisiopatología , Oveja Doméstica , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
16.
Catheter Cardiovasc Interv ; 93(4): 645-651, 2019 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-30511498

RESUMEN

OBJECTIVES: To report the results of the Nit-Occlud PDA prospective postapproval study (PAS) along with a comparison to the results of the pivotal and continued access trials. BACKGROUND: The Nit-Occlud PDA (PFM Medical, Cologne, Germany), a nitinol coil patent ductus arteriosus (PDA) occluder, was approved by the Food and Drug Administration in 2013. METHODS: The PAS enrolled a total of 184 subjects greater than 6 months of age, weighing at least 5 kg, with PDAs less than 4 mm by angiography at 11 centers. Patients were followed prospectively at 2 months, 12 months, and 24 months postprocedure. These outcomes were compared to the 357 subjects enrolled in the pivotal and continued access protocols. Efficacy and safety data were reported. RESULTS: Among 184 subjects enrolled for the PAS between 2014 and 2017, 180 (97.8%) had successful device implantation. After 12 months, 98.7% (150/152) had trivial or no residual shunt by echocardiography and two subjects had only small residual shunts. There were three device embolizations that were all retrieved by snare without clinical consequence. Together with the pivotal and continued access study, 97.4% (449/461) had complete echocardiographic closure at 12 months in 541 enrolled subjects. The composite success was 94.4%. There were no mortalities and no serious device-related adverse events. CONCLUSIONS: The Nit-Occlud PDA is a safe and effective device for closure of a small to moderate sized PDA. There were no serious device-related adverse events in a large cohort of three clinical trials.


Asunto(s)
Cateterismo Cardíaco/instrumentación , Conducto Arterioso Permeable/terapia , Adolescente , Aleaciones , Cateterismo Cardíaco/efectos adversos , Niño , Preescolar , Aprobación de Recursos , Conducto Arterioso Permeable/diagnóstico por imagen , Diseño de Equipo , Femenino , Humanos , Lactante , Masculino , Ensayos Clínicos Controlados no Aleatorios como Asunto , Vigilancia de Productos Comercializados , Estudios Prospectivos , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Adulto Joven
17.
Curr Opin Cardiol ; 33(1): 108-116, 2018 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-29076870

RESUMEN

PURPOSE OF REVIEW: To review current controversies in the transcatheter device closure of ostium secundum atrial septal defects (ASD). RECENT FINDINGS: Transcatheter device closure of ASD (TC-ASD) has well established efficacy and safety. For most individual patients with suitable anatomy, TC-ASD is the preferred method for treating ASD. The availability of large multicenter data sets has made it possible to study practice patterns at a range of hospitals across the United States. These studies have revealed differences in practice that were not previously appreciated. Interpretation of the indications for TC-ASD, specifically the definition of right ventricular volume overload varies between hospitals. In response to concern about device erosion, an increasing proportion of patients are being referred for operative ASD closure. Over the last decade, the average age at which ASD closure occurs has decreased. These trends demonstrate previously underappreciated differences in opinion between cardiologists across the country and suggest that further research is necessary to address knowledge gaps limiting consistency of practice. SUMMARY: As TC-ASD and congenital interventional cardiology mature as a field, studies of real-world practice provide increasingly valuable information about aspects of care in which there are disagreements about best practices and in which further research is necessary.


Asunto(s)
Cateterismo Cardíaco/métodos , Falla de Equipo , Defectos del Tabique Interatrial/cirugía , Selección de Paciente , Dispositivo Oclusor Septal , Procedimientos Quirúrgicos Cardíacos/métodos , Humanos
18.
Am J Med Genet A ; 176(8): 1711-1722, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-30055033

RESUMEN

Multifocal atrial tachycardia (MAT) has a well-known association with Costello syndrome, but is rarely described with related RAS/MAPK pathway disorders (RASopathies). We report 11 patients with RASopathies (Costello, Noonan, and Noonan syndrome with multiple lentigines [formerly LEOPARD syndrome]) and nonreentrant atrial tachycardias (MAT and ectopic atrial tachycardia) demonstrating overlap in cardiac arrhythmia phenotype. Similar overlap is seen in RASopathies with respect to skeletal, musculoskeletal and cutaneous abnormalities, dysmorphic facial features, and neurodevelopmental deficits. Nonreentrant atrial tachycardias may cause cardiac compromise if sinus rhythm is not restored expeditiously. Typical first-line supraventricular tachycardia anti-arrhythmics (propranolol and digoxin) were generally not effective in restoring or maintaining sinus rhythm in this cohort, while flecainide or amiodarone alone or in concert with propranolol were effective anti-arrhythmic agents for acute and chronic use. Atrial tachycardia resolved in all patients. However, a 4-month-old boy from the cohort was found asystolic (with concurrent cellulitis) and a second patient underwent cardiac transplant for heart failure complicated by recalcitrant atrial arrhythmia. While propranolol alone frequently failed to convert or maintain sinus rhythm, fleccainide or amiodarone, occasionally in combination with propranolol, was effective for RASopathy patient treatment for nonreentrant atrial arrhythmia. Our analysis shows that RASopathy patients may have nonreentrant atrial tachycardia with and without associated cardiac hypertrophy. While nonreentrant arrhythmia has been traditionally associated with Costello syndrome, this work provides an expanded view of RASopathy cardiac arrhythmia phenotype as we demonstrate mutant proteins throughout this signaling pathway can also give rise to ectopic and/or MAT.


Asunto(s)
Cardiomiopatía Hipertrófica/genética , Síndrome de Costello/genética , Síndrome de Noonan/genética , Taquicardia Atrial Ectópica/genética , Proteínas ras/genética , Amiodarona/uso terapéutico , Arritmias Cardíacas/tratamiento farmacológico , Arritmias Cardíacas/genética , Arritmias Cardíacas/fisiopatología , Calcio/metabolismo , Cardiomiopatía Hipertrófica/tratamiento farmacológico , Cardiomiopatía Hipertrófica/fisiopatología , Síndrome de Costello/tratamiento farmacológico , Síndrome de Costello/fisiopatología , Digoxina/uso terapéutico , Femenino , Humanos , Lactante , Recién Nacido , Síndrome LEOPARD/genética , Síndrome LEOPARD/fisiopatología , Masculino , Síndrome de Noonan/tratamiento farmacológico , Síndrome de Noonan/fisiopatología , Propranolol/uso terapéutico , Proteína Tirosina Fosfatasa no Receptora Tipo 11/genética , Proteínas Proto-Oncogénicas c-raf/genética , Proteínas Proto-Oncogénicas p21(ras)/genética , Proteína SOS1/genética , Taquicardia Atrial Ectópica/tratamiento farmacológico , Taquicardia Atrial Ectópica/fisiopatología , Proteínas ras/clasificación
19.
Pediatr Cardiol ; 39(3): 450-458, 2018 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-29134238

RESUMEN

In neonates requiring balloon aortic valvuloplasty, both anterograde and retrograde approaches are feasible. A recent comparison of these two approaches is lacking. A retrospective cohort study of neonates at a single center undergoing BAV from 9/00 to 7/14 was performed. Records were reviewed including pre- and post-intervention echocardiograms and catheterization data. Comparisons of acute efficacy and procedural safety were made based on type of approach utilized. Forty-two neonates underwent BAV. Eleven cases utilized exclusively an anterograde approach, while 31 included a retrograde approach (including 4 with both approaches used). There were no significant differences between groups in baseline demographic and clinical characteristics. Additionally, by both pre-intervention echocardiogram and catheterization, there were no differences based on approach in aortic valve gradient, degree of aortic insufficiency (AI), or degree of mitral regurgitation (MR). Both approaches were equally efficacious in gradient reduction (45 ± 17 vs. 44 ± 21 mmHg, p = 0.97), and there was no difference in post-intervention AI as assessed by both catheterization and echocardiogram (52% vs. 64% none or trivial, p = 0.74). Additionally, there was no difference in the proportion of patients with an increased severity of MR after BAV (15% vs. 22%, p = 0.52). The retrograde approach required a larger arterial catheter and was associated with a higher rate of arterial thrombosis (61% vs. 18%, p = 0.014). Both anterograde and retrograde approaches to neonatal BAV appear to be equally efficacious in the short term. The anterograde approach avoids the need for a larger arterial catheter and may reduce the risk of arterial thrombosis.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Valvuloplastia con Balón/métodos , Válvula Aórtica/cirugía , Valvuloplastia con Balón/efectos adversos , Cateterismo Cardíaco/métodos , Estudios de Cohortes , Ecocardiografía/métodos , Femenino , Humanos , Recién Nacido , Masculino , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Resultado del Tratamiento
20.
Pediatr Cardiol ; 39(2): 390-397, 2018 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-29098350

RESUMEN

Children requiring reimplantation of a branch pulmonary artery (PA) are at risk for postoperative stenosis and impaired growth of the reimplanted PA. Outcomes and risk factors for reintervention and impaired growth are incompletely described. We reviewed data on patients who underwent reimplantation of a branch PA between 1/1/99 and 5/1/15 at a single center. The primary outcome was reintervention to treat postoperative stenosis. The secondary outcome was "catch-up" growth (faster diameter growth of the affected PA compared with the unaffected PA from the preoperative to follow-up measurements.). Twenty-six patients were identified with a total follow-up of 102.2 patient-years (median 2.5 years). Diagnoses included LPA sling (n = 12) and isolated PA of ductal origin with (n = 7) or without (n = 7) tetralogy of Fallot (ToF). All had primary repair of the anomalous PA. Seventeen (65%) had reintervention with median time to first reintervention of 69 (range 1-1005) days and median of 1.5 (range 1-6) reinterventions. 94% of reinterventions were transcatheter (53% balloon and 41% stent angioplasty). Patients with reintervention were younger (hazard ratio 0.75 per log-day, p = 0.02) and lower weight (hazard ratio 0.18 per log-kg, p = 0.02) at initial repair. Of the 18 with PA growth data, 8 (44%) had catch-up growth. There were no identified differences between those who did and did not demonstrate catch-up growth. Despite a practice of primary reimplantation and aggressive postoperative reintervention, these results suggest that changes in strategy are needed or that there are intrinsic patient factors that have more influence on longer-term reimplanted PA growth.


Asunto(s)
Arteria Pulmonar/cirugía , Reoperación/efectos adversos , Reimplantación/efectos adversos , Estenosis de Arteria Pulmonar/cirugía , Angioplastia/estadística & datos numéricos , Cateterismo Cardíaco/métodos , Preescolar , Ecocardiografía/métodos , Femenino , Estudios de Seguimiento , Humanos , Lactante , Estimación de Kaplan-Meier , Masculino , Complicaciones Posoperatorias/etiología , Arteria Pulmonar/crecimiento & desarrollo , Reoperación/estadística & datos numéricos , Estudios Retrospectivos , Factores de Riesgo , Estenosis de Arteria Pulmonar/etiología , Stents/estadística & datos numéricos , Resultado del Tratamiento
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