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Introduction: Time-fixed analyses have traditionally been utilized to examine outcomes in post-infarction ventricular septal defect (VSD). The aims of this study were to: (1) analyze the relationship between VSD closure/non-closure and mortality; (2) assess the presence of immortal-time bias. Material and methods: In this retrospective cohort study, patients with ST-elevation myocardial infarction (STEMI) complicated by VSD. Time-fixed and time-dependent Cox regression methodologies were employed. Results: The study included 80 patients: surgical closure (n = 26), transcatheter closure (n = 20), or conservative management alone (n = 34). At presentation, patients without VSD closure exhibited high-risk clinical characteristics, had the shortest median time intervals from STEMI onset to VSD development (4.0, 4.0, and 2.0 days, respectively; P = 0.03) and from STEMI symptom onset to hospital arrival (6.0, 5.0, and 0.8 days, respectively; P < 0.0001). The median time from STEMI onset to closure was 22.0 days (P = 0.14). In-hospital mortality rate was higher among patients who did not undergo defect closure (50%, 35%, and 88.2%, respectively; P < 0.0001). Closure of the defect using a fixed-time method was associated with lower in-hospital mortality (HR = 0.13, 95% CI 0.05-0.31, P < 0.0001, and HR 0.13, 95% CI 0.04-0.36, P < 0.0001, for surgery and transcatheter closure, respectively). However, when employing a time-varying method, this association was not observed (HR = 0.95, 95% CI 0.45-1.98, P = 0.90, and HR 0.88, 95% CI 0.41-1.87, P = 0.74, for surgery and transcatheter closure, respectively). These findings suggest the presence of an immortal-time bias. Conclusions: This study highlights that using a fixed-time analytic approach in post-infarction VSD can result in immortal-time bias. Researchers should consider employing time-dependent methodologies.
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Background: Paravalvular leak (PVL) is a frequent and important complication after surgical valvular replacement that can cause heart failure and hemolytic anemia and is associated with poor clinical outcomes. Surgical reoperation has been the standard treatment, but it is associated with high morbidity and mortality. Transcatheter closure is a therapeutic alternative. The aim of the present study is to analyze the feasibility and the short- and medium-term outcomes of the transcatheter closure of PVLs. Methods: Single-center registry of consecutive patients with post-surgical PVLs that underwent transcatheter closure, between January 2006 and December 2016. Efficacy and safety results were analyzed during the procedure and at 6-month follow-up. Results: Twenty-one PVLs (15 mitral, 5 aortic, and 1 tricuspid) were closure during 20 procedures. In the initial echocardiography, 91% of the leaks were severe. The most used device was the Amplatzer Vascular Plug III® in 10 procedures (50%). The three-dimensional transesophageal echocardiography was used in 70% of cases. The device was successfully implanted in 95% of cases, a regurgitation reduction ≥ 1 grade was achieved in 95% of the cases, and the clinical success was 79%. Six-month survival was 100%; however, three cases required valvular surgery (15%). Conclusions: Transcatheter closure of PVLs is a feasible and safe procedure with high rates of technical, echocardiographic, and clinical success in the short and medium term. It is an adequate therapeutic alternative, mainly in high surgical risk patients and multiples comorbidities.
Introducción: La fuga paravalvular es una complicación frecuente e importante posterior al reemplazo valvular quirúrgico que puede ocasionar insuficiencia cardiaca, anemia hemolítica y se relaciona con malos resultados clínicos. La reintervención quirúrgica ha sido el tratamiento habitual, pero se acompaña de alta morbimortalidad. El cierre transcatéter es una alternativa terapéutica. El objetivo del presente estudio es analizar la factibilidad y los resultados a corto y mediano plazo del cierre transcatéter de fugas paravalvulares con dispositivos oclusores. Métodos: Registro unicéntrico de una serie consecutiva de pacientes con fugas paravalvulares posquirúrgicas que fueron cerradas vía transcatéter con dispositivos oclusores, entre enero del 2006 y diciembre del 2016. Se analizaron los resultados de eficacia y seguridad durante el procedimiento y a seis meses. Resultados: Se trataron 21 fugas paravalvulares (15 mitrales, 5 aórticas y 1 tricuspídea) durante 20 procedimientos. El 91% de las fugas fue grave en la ecocardiografía inicial. El dispositivo utilizado con más frecuencia fue el Amplatzer Vascular Plug III® en 10 procedimientos (50%). Se utilizó ecocardiografía transesofágica tridimensional en 70% de los casos. Se logró implantar el dispositivo con éxito en el 95% de los casos; se consiguió una reducción ≥ 1 del grado de regurgitación en el 95% de las veces y se alcanzó el éxito clínico en el 79%. A seis meses la supervivencia fue del 100%; sin embargo, tres casos requirieron cirugía valvular (15%). Conclusiones: El cierre transcatéter de fugas paravalvulares es un procedimiento factible, seguro y con tasas elevadas de éxito técnico, ecocardiográfico y clínico a corto y mediano plazo. Es una alternativa terapéutica adecuada, en particular en pacientes considerados de alto riesgo quirúrgico y múltiples comorbilidades.
Assuntos
Insuficiência da Valva Aórtica/cirurgia , Cateterismo Cardíaco/métodos , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Tricúspide/cirurgia , Adulto , Ecocardiografia Tridimensional , Ecocardiografia Transesofagiana , Feminino , Seguimentos , Próteses Valvulares Cardíacas , Humanos , Masculino , Pessoa de Meia-Idade , Falha de Prótese , Sistema de Registros , Dispositivo para Oclusão Septal , Fatores de Tempo , Resultado do TratamentoRESUMO
Abstract Background: Paravalvular leak (PVL) is a frequent and important complication after surgical valvular replacement that can cause heart failure and hemolytic anemia and is associated with poor clinical outcomes. Surgical reoperation has been the standard treatment, but it is associated with high morbidity and mortality. Transcatheter closure is a therapeutic alternative. The aim of the present study is to analyze the feasibility and the short- and medium-term outcomes of the transcatheter closure of PVLs. Methods: Single-center registry of consecutive patients with post-surgical PVLs that underwent transcatheter closure, between January 2006 and December 2016. Efficacy and safety results were analyzed during the procedure and at 6-month follow-up. Results: Twenty-one PVLs (15 mitral, 5 aortic, and 1 tricuspid) were closure during 20 procedures. In the initial echocardiography, 91% of the leaks were severe. The most used device was the Amplatzer Vascular Plug III® in 10 procedures (50%). The three-dimensional transesophageal echocardiography was used in 70% of cases. The device was successfully implanted in 95% of cases, a regurgitation reduction ≥ 1 grade was achieved in 95% of the cases, and the clinical success was 79%. Six-month survival was 100%; however, three cases required valvular surgery (15%). Conclusions: Transcatheter closure of PVLs is a feasible and safe procedure with high rates of technical, echocardiographic, and clinical success in the short and medium term. It is an adequate therapeutic alternative, mainly in high surgical risk patients and multiples comorbidities.
Resumen Introducción: La fuga paravalvular es una complicación frecuente e importante posterior al reemplazo valvular quirúrgico que puede ocasionar insuficiencia cardiaca, anemia hemolítica y se relaciona con malos resultados clínicos. La reintervención quirúrgica ha sido el tratamiento habitual, pero se acompaña de alta morbimortalidad. El cierre transcatéter es una alternativa terapéutica. El objetivo del presente estudio es analizar la factibilidad y los resultados a corto y mediano plazo del cierre transcatéter de fugas paravalvulares con dispositivos oclusores. Métodos: Registro unicéntrico de una serie consecutiva de pacientes con fugas paravalvulares posquirúrgicas que fueron cerradas vía transcatéter con dispositivos oclusores, entre enero del 2006 y diciembre del 2016. Se analizaron los resultados de eficacia y seguridad durante el procedimiento y a seis meses. Resultados: Se trataron 21 fugas paravalvulares (15 mitrales, 5 aórticas y 1 tricuspídea) durante 20 procedimientos. El 91% de las fugas fue grave en la ecocardiografía inicial. El dispositivo utilizado con más frecuencia fue el Amplatzer Vascular Plug III® en 10 procedimientos (50%). Se utilizó ecocardiografía transesofágica tridimensional en 70% de los casos. Se logró implantar el dispositivo con éxito en el 95% de los casos; se consiguió una reducción ≥ 1 del grado de regurgitación en el 95% de las veces y se alcanzó el éxito clínico en el 79%. A seis meses la supervivencia fue del 100%; sin embargo, tres casos requirieron cirugía valvular (15%). Conclusiones: El cierre transcatéter de fugas paravalvulares es un procedimiento factible, seguro y con tasas elevadas de éxito técnico, ecocardiográfico y clínico a corto y mediano plazo. Es una alternativa terapéutica adecuada, en particular en pacientes considerados de alto riesgo quirúrgico y múltiples comorbilidades.
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Insuficiência da Valva Aórtica/cirurgia , Insuficiência da Valva Tricúspide/cirurgia , Cateterismo Cardíaco/métodos , Insuficiência da Valva Mitral/cirurgia , Fatores de Tempo , Falha de Prótese , Próteses Valvulares Cardíacas , Sistema de Registros , Seguimentos , Resultado do Tratamento , Ecocardiografia Transesofagiana , Ecocardiografia Tridimensional , Dispositivo para Oclusão SeptalRESUMO
Background: Paravalvular leak is a frequent and important complication after surgical valvular replacement that can cause heart failure, hemolytic anemia and is associated with poor clinical outcomes. Surgical reoperation has been the standard treatment, but it is associated with high morbidity and mortality. Transcatheter closure is a therapeutic alternative. The aim of the present study is to analyze the feasibility and the short and medium-term outcomes of the transcatheter closure of paravalvular leaks. Methods: Single-centre registry of consecutive patients with post-surgical paravalvular leaks, that underwent transcatheter closure, between January 2006 and December 2016. Efficacy and safety results were analyzed during the procedure and at 6-month follow-up. Results: 21 paravalvular leaks (15 mitral, 5 aortic and 1 tricuspid) were closure during 20 procedures. In the initial echocardiography 91% of the leaks were severe. The most used device was the Amplatzer Vascular Plug III® in 10 procedures (50%). The 3D transesophageal echocardiography was used in 70% of cases. The device was successfully implanted in 95% of cases, a regurgitation reduction ≥ 1 grade was achieved in 95% of the cases, and the clinical success was 79%. Six month survival was 100%; however, 3 cases required valvular surgery (15%). Conclusions: Transcatheter closure of paravalvular leaks is a feasible and safe procedure with high rates of technical, echocardiographic and clinical success in the short and medium term. It is an adequate therapeutic alternative, mainly in high surgical risk patients and multiples comorbidities.
Introducción: La fuga paravalvular es una complicación frecuente e importante posterior al reemplazo valvular quirúrgico que puede ocasionar insuficiencia cardiaca, anemia hemolítica y se relaciona con malos resultados clínicos. La reintervención quirúrgica ha sido el tratamiento habitual, pero se acompaña de alta morbimortalidad. El cierre transcatéter es una alternativa terapéutica. El objetivo del presente estudio es analizar la factibilidad y los resultados a corto y mediano plazo del cierre transcatéter de fugas paravalvulares con dispositivos oclusores. Métodos: Registro unicéntrico de una serie consecutiva de pacientes con fugas paravalvulares posquirúrgicas que fueron cerradas vía transcatéter con dispositivos oclusores, entre enero del 2006 y diciembre del 2016. Se analizaron los resultados de eficacia y seguridad durante el procedimiento y a seis meses. Resultados: Se trataron 21 fugas paravalvulares (15 mitrales, 5 aórticas y 1 tricuspídea) durante 20 procedimientos. El 91% de las fugas fue grave en la ecocardiografía inicial. El dispositivo utilizado con más frecuencia fue el Amplatzer Vascular Plug III® en 10 procedimientos (50%). Se utilizó ecocardiografía transesofágica tridimensional en 70% de los casos. Se logró implantar el dispositivo con éxito en el 95% de los casos; se consiguió una reducción ≥ 1 del grado de regurgitación en el 95% de las veces y se alcanzó el éxito clínico en el 79%. A seis meses la supervivencia fue del 100%; sin embargo, tres casos requirieron cirugía valvular (15%). Conclusiones: El cierre transcatéter de fugas paravalvulares es un procedimiento factible, seguro y con tasas elevadas de éxito técnico, ecocardiográfico y clínico a corto y mediano plazo. Es una alternativa terapéutica adecuada, en particular en pacientes considerados de alto riesgo quirúrgico y múltiples comorbilidades.
Assuntos
Cateterismo Cardíaco/métodos , Ecocardiografia Transesofagiana , Doenças das Valvas Cardíacas/cirurgia , Adulto , Valva Aórtica/patologia , Valva Aórtica/cirurgia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/patologia , Valva Mitral/cirurgia , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento , Valva Tricúspide/patologia , Valva Tricúspide/cirurgiaRESUMO
Atrial septal defect (ASD) is a condition that requires early intervention because of the consequences over the right-side heart. Chronic atrial stretching promotes atrial conduction delay and the imbalance of the conduction homogeneity, which lead to the propensity to atrial arrhythmias (AA). We aim to evaluate the impact of transcatheter closure of ASD on atrial vulnerability markers leading to late AA in young adults. We conducted a prospective, longitudinal study in one hundred patients (mean age 25.2 ± 5.4 years) who underwent transcatheter closure of ASD at Cardiocentro Pediátrico William Soler. P-wave maximum (Pmax) and P-wave dispersion (Pd) were analyzed from 12-lead electrocardiogram. Left-side and right-side intraatrial and interatrial electromechanical delay (EMD) were measured with tissue Doppler imaging. Both electrocardiographic and echocardiographic analyses were performed during the study period. Compared to baseline, there was a significant reduction in P max (p ≤ 0.001) and Pd (p ≤ 0.001) after 3 months of procedure. All atrial electromechanical coupling parameters significantly reduced at 6 months of ASD closure and tend to remain at lower values till the last evaluation. Over 9.2 ± 1.6 years of follow-up, 15 subjects (15%) developed AA, of which intraatrial reentrant tachycardia (66.6%) became the main rhythm disturbance. Intra-right atrial EMD ≥ 16 ms (HR 4.08, 95% CI 1.15-14.56; p = 0.03) and Pd 45 ms (HR 1.66, 95% CI 1.06-2.59; p = 0.02) were identified as predictors of late AA. Transcatheter device closure of ASD in young adults promotes a significant reduction of electrocardiographic and echocardiographic markers of AA vulnerability, which persist during the long-term follow-up. Nevertheless, Pd and interatrial EMD were identified as independent risk factors of AA.
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Fibrilação Atrial/etiologia , Cateterismo Cardíaco/efeitos adversos , Comunicação Interatrial/terapia , Adulto , Fibrilação Atrial/diagnóstico por imagem , Ecocardiografia , Eletrocardiografia , Feminino , Comunicação Interatrial/fisiopatologia , Humanos , Estudos Longitudinais , Masculino , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
We report a case of an acquired aorta-right atrial fistula, secondary to a ruptured proximal anastomosis of an old saphenous vein graft 12 years after a coronary artery bypass surgery, in a 57 year old patient with multiple cardiovascular risk factors. On admission, he presented with congestive heart failure and on examination a continuous murmur was detected on the right parasternal border. Catheterization showed a fistula from the proximal anastomosis of an occluded right coronary artery saphenous vein graft draining to the right atrium with a large left to right shunt. The fistula was successfully occluded by a percutaneous approach with a Life Tech duct occluder with complete resolution of heart failure. The patient was discharged one week afterwards. After a two-year follow-up, the fistula remained occluded.
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Estenose Coronária/cirurgia , Vasos Coronários/cirurgia , Oclusão de Enxerto Vascular/complicações , Cardiopatias/etiologia , Veia Safena/transplante , Fístula Vascular/etiologia , Angiografia Coronária , Fístula/diagnóstico , Fístula/etiologia , Oclusão de Enxerto Vascular/diagnóstico , Átrios do Coração , Cardiopatias/diagnóstico , Humanos , Imageamento Tridimensional , Masculino , Pessoa de Meia-Idade , Ruptura Espontânea , Tomografia Computadorizada por Raios X , Fístula Vascular/diagnósticoRESUMO
El cierre percutáneo del conducto arterioso permeable (CAP) es una modalidad de tratamiento bien establecida. El Amplatzer vascular plug II (AVP II) es un dispositivo oclusor autoexpandible, indicado para oclusiones arteriales o venosas en la vasculatura periférica. Describimos nuestra experiencia clínica inicial en el cierre percutáneo del CAP, utilizando el AVP II en la edad pediátrica. El tamaño del dispositivo fue seleccionado de acuerdo al tamaño y morfología del CAP, con un diámetro mayor al 100% del diámetro mínimo del CAP. Los dispositivos fueron implantados a través de una vaina por vena o arteria femoral. En 18 pacientes, el AVP II se utilizó para oclusión del CAP. La mediana de edad fue 24 meses (intervalo: 6-51) y la media de peso, 10.5 kg (intervalo: 4.8-16.5). El diámetro más estrecho del CAP mostró una mediana de 1.1 mm (intervalo: 0.3-7.0). Se logró el implante exitoso y la oclusión angiográfica en 14 pacientes (77.8%). El tamaño del dispositivo implantado mostró una media de 3.9 ± 2.4 veces el diámetro mínimo del CAP. Dos pacientes fueron enviados a cirugía. Ocurrieron dos embolizaciones. El ecocardiograma transtorácico de 24 horas confirmó oclusión total en 13 casos (72.2%). Durante el periodo de seguimiento no se han reportado complicaciones. El cierre percutáneo de CAP < 2 mm con AVP II es una técnica segura y efectiva, particularmente para oclusión de vasos de pequeño diámetro con bajo flujo.
Percutaneous closure of patent ductus arteriosus (PDA) is a well established treatment modality. The Amplatzer vascular plug II (AVP II) is a self-expandable occluder device, indicated for arterial or venous occlusions in the peripheral vasculature. We describe our initial clinical experience in percutaneous closure of PDA using the AVP II in children. Device size was selected according to the size and morphology of the CAP, with a diameter greater than 100% of the minimum diameter of the CAP. The devices were implanted through a pod femoral vein or artery. In 18 patients, AVP II was used for occlusion of PDA. The median age was 24 months (range 6-51) and mean weight 10.5 kg (range 4.8-16.5). The narrowest diameter of the CAP showed a median of 1.1 mm (range 0.3-7.0). Successful implantation was achieved and angiographic occlusion in 14 patients (77.8%). The size of the implanted device showed a mean of 3.9 ± 2.4 times the minimum diameter of the CAP. Two patients were referred for surgery. There were two embolizations. Transthoracic echocardiography 24 hours confirmed total occlusion in 13 cases (72.2%). During the monitoring period there are no reported complications. Percutaneous closure of PDA < 2 mm AVP II is a safe and effective, particularly for occlusion of small-diameter vessels with low flow.
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Amplatzer vascular Plug II (AVP II) es un dispositivo oclusor autoexpandible, indicado para oclusiones arteriales o venosas en la vasculatura periférica. Objetivo: Describir nuestra experiencia clínica inicial con el AVP II, en el cierre percutáneo del conducto arterioso permeable pequeño. Métodos: Analizamos retrospectivamente, siete pacientes sometidos a oclusión percutánea del conducto arterioso. El AVP II se eligió con un diámetro mayor a 50% del diámetro mínimo del conducto arterioso. Resultados: Los pacientes evidenciaron un conducto arterioso con un diámetro mínimo de 1.5 ± 1.4 (intervalo: 0.8 a 4.7mm). Se logró un implante exitoso y con adecuada oclusión angiográfica en seis pacientes. Un paciente fue enviado a cirugía. Sólo observamos una complicación mayor. El ecocardiograma transtorácico a las 24 horas, confirmó la oclusión completa en estos pacientes. El seguimiento fue de 10.6 ± 9.1 meses. Conclusiones: El AVP II, en este grupo de pacientes mostró ser seguro y efectivo para el cierre percutáneo del conducto arterioso.
The Amplatzer vascular Plug II (AVP II) is a self-expanding occluder device, indicated for arterial and venous occlusion in the peripheral circulation. Objective: To describe our initial clinical experience with the AVP II, in the percutaneous closure of small patent ductus arteriosus. Method: We retrospectively analyzed seven patients who underwent percutaneous closure of patent ductus arteriosus. The AVP II was chosen with a diameter greater than 50% of the minimum diameter of the ductus arteriosus. Results:Patients showed a ductus arteriosus with a diameter of 1.5 ± 1.4 (range: 0.8 - 4.7mm). Successful implant was achieved with adequate angiographic occlusion in 6 patients. One patient was sent to surgery. We only found a major complication. Transthoracic echocardiography at 24 hours, confirmed the complete occlusion in this patients. The follow-up was 10.6 ± 9.1 months. Conclusion: The AVP II in this group of patients was shown to be safe and effective for percutaneous closure of patent ductus arteriosus.