Spanish registry of percutaneous VSD closure with NitOcclud Lê VSD Coil device: lessons learned after more than a hundred implants

Solana-Gracia, Ruth; Soto, Alberto Mendoza; Moreno, J.L. Pontones; Marín, M.J. del Cerro; Aguado, Federico Gutiérrez-Larraya; Sánchez, José Félix Coserría; Mata, Roberto Blanco; Martínez, Fredy Hermógenes Prada; Álvarez‐Ossorio, Manuel Pan; Montañés, Lorenzo Jiménez; Prado, Armando Pérez de; Rey, Maria del Mar Rodríguez Vázquez del; García, Hipólito Gutiérrez; Bayón, Jeremías; Martínez, José Luis Zunzunegui

doi:10.1016/j.rec.2020.05.035

Cited by 4 publications

(5 citation statements)

References 26 publications

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“…Hemolysis is a reported complication, especially in patients who have undergone transcatheter closure using the coil. 21,23,24 Despite the fact that we detected residual shunt in some of the reported cases in this study, it should not be considered a major complication risk since the mechanism of the haemolysis is quite different in those patients with perimembraneous ventricular septal defect closure using the coil. Therefore, the non-observation of haemolysis after MFO implantation in this study was an expected result.…”

Section: Discussionmentioning

confidence: 57%

Early and mid-term outcomes of transcatheter closure of perimembranous ventricular septal defects using the Lifetech™ Konar-MF Occluder device (MFO)

Ödemiş

Kizilkaya

2022

Cardiol Young

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Background: Transcatheter closure of perimembranous ventricular septal defects is challenging. Double disk-designed devices have high adverse event rates; therefore, research into new devices persists. One such devise is the LifetechTM Konar-MF Occluder device (MFO), which is increasingly used. The purpose of this study is to present mid-term results of MFO for transcatheter closure of patients with perimembraneous ventricular septal defect. Patients and methods: Records of the 52 patients with perimembraneous ventricular septal defect who had undergone transcatheter closure with MFO were reviewed. Demographic, echocardiographic, and procedure details were investigated. Three years follow-up results were recorded. Results: We closed the perimembraneous ventricular septal defect in 51 of 52 patients (98%). The femoral venous approach was used in 27 patients (53 %) whilst no arteriovenous loop was established in the remaining patients. No significant procedure-related complication occurred. On day 1 echocardiography, the residual ventricular septal defect rate was 31%. Mean±SD (range) follow-up duration was 36 ± 7,9 (18–54) months. At 6th month follow-up, only four patients had haemodynamically significant residual defects. No severe dysrhythmia was detected including complete heart block. A right bundle branch block pattern was seen in one patient. Conclusion: This study showed that MFO is a safe and effective device in the transcatheter treatment of perimembraneous ventricular septal defect’s with mid-term follow-up.

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Section: Discussionmentioning

confidence: 57%

Early and mid-term outcomes of transcatheter closure of perimembranous ventricular septal defects using the Lifetech™ Konar-MF Occluder device (MFO)

Ödemiş

Kizilkaya

2022

Cardiol Young

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“…17 In a spanish study on closure of VSD with NitOcclud Le VSD coil revealed significant residual shunt in 3.8% patients and 1.9% had significant hemolysis requiring surgical explantation. 18 In a recent study, the incidence of post-procedural hemolysis was 1.6%, all managed conservatively with hydration and alkalinization. 19 In our study, observed results revealed that hemolysis was exclusively seen with VSD closures with PFM Nit occlude coil.…”

Section: Discussionmentioning

confidence: 99%

Short Term Outcomes of Transcatheter Ventricular Septal Defect Device Closure at Tertiary Cardiac Care Center

Imtiaz,

Rafique,

Akhtar

et al. 2023

PAFMJ

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Objective: To determine post procedural immediate and short-term outcomes of transcatheter Ventricular Septal Defect (VSD) device closure. Study Design: Longitudinal Cross-sectional study. Place and Duration of Study: Pediatric Cardiology Unit at Tertiary Cardiac Care Centre, Rawalpindi, Pakistan, from Feb to Oct 2022. Methodology: Total of 62 patients fulfilling inclusion and exclusion criteria who underwent transcatheter VSD device closure were retrospectively identified from our institutional database by non-probability consecutive sampling technique. Preprocedural evaluation [Transthoracic Echocardiography (TTE) & Electrocardiography(ECG)], procedural details and immediate post procedure outcomes were documented. Follow-up evaluations were done at 6 and 12 months. It included clinical examination, TTE and 12 lead ECG. New onset and status of old complications were documented in each visit. SPSS version 24.00 was used to analyze data. Chi-square test was used to find association between study variables. p-<0.05 wasconsidered significant. Results: Sixty-two patients were followed up for upto 1 year after VSD device closure. Mean VSD size on Echo was 4.612.52mm. Successful closure was obtained in 54(87.0%) of cases out of 62. Complications documented during and immediately after procedure were transient arrythmias in 22(35.5%), residual leaks in 9(14.6%) which reduced to 3(4.8%) on 12 months follow up, device redeployment in 3(4.8%), complete heart block (cAVB) in 1(1.6%), device embolization in 1(1.6%), hemolysis in 2(3.2%), contrast related complications in 1(1.6%), aortic regurgitation (AR) in 4(6.4%). Death occurred in 1(1.6%) patient secondary to contrast related complications. Conclusion: Transcatheter VSD closure is a promising and safe treatment modality with high success rate. Complications ..

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“…La aparición de estos eventos es baja, en consonancia con los que nos informan otros autores 19,20,106 por lo que se ve necesaria la realización de estudios multicéntricos que ayuden a corroborar los resultados imprecisos observados. En España, mediante un registro multicéntrico, se describen un 3,8% (4/104) de reintervenciones por shunt residual tras el cierre con NitOcllud Lê VSD Coil 107 . Estas cifras pueden parecer muy elevadas respecto a lo mostrado por otros estudios, pero se debe tener en cuenta que la heterogeneidad de pacientes en este registro es alta, y que más del 17% y del 12% de los pacientes presentan una cardiopatía congénita o un tipo de defecto del septo intereventricular complejos respectivamente 107 .…”

Section: Efectividad Y Seguridadunclassified

“…En España, mediante un registro multicéntrico, se describen un 3,8% (4/104) de reintervenciones por shunt residual tras el cierre con NitOcllud Lê VSD Coil 107 . Estas cifras pueden parecer muy elevadas respecto a lo mostrado por otros estudios, pero se debe tener en cuenta que la heterogeneidad de pacientes en este registro es alta, y que más del 17% y del 12% de los pacientes presentan una cardiopatía congénita o un tipo de defecto del septo intereventricular complejos respectivamente 107 . El seguimiento de pacientes que se realiza en los estudios no parece que haya podido influir en los resultados observados para este desenlace, que oscila entre uno y dos años 52,75,[78][79][80]82 y que en algunos casos alcanza hasta aproximadamente los 4 años 73,83 .…”

Section: Efectividad Y Seguridadunclassified

Tratamiento de la Comunicación Interventricular (CIV) congénita con dispositivos de inserción percutánea y perventricular

Vázquez¹,

Martín-Sánchez²,

Muñoz³

et al. 2022

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Los desenlaces analizados muestran una incidencia de eventos baja sin que el análisis haya mostrado diferencias estadísticamente significativas entre técnicas y, además, presentan limitaciones importantes por la heterogeneidad en los diseños de los estudios considerados. No hay pruebas científicas que permitan dilucidar si la técnica quirúrgica estándar o el cierre de la CIV mediante el uso de dispositivos es más eficaz que la otra. En términos de necesidad de reintervención para el control de sangrado o de necesidad de transfusión sanguínea, la técnica percutánea parece más segura que la técnica quirúrgica estándar. Si las circunstancias clínicas lo permiten, la información disponible sobre eficacia y seguridad debe ser compartida con los familiares para el proceso de toma de decisiones compartidas. Con cautela, el cierre de la CIV mediante la técnica de inserción percutánea supone una estrategia socialmente eficiente, respecto a la cirugía estándar.

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Spanish registry of percutaneous VSD closure with NitOcclud Lê VSD Coil device: lessons learned after more than a hundred implants

Cited by 4 publications

References 26 publications

Early and mid-term outcomes of transcatheter closure of perimembranous ventricular septal defects using the Lifetech™ Konar-MF Occluder device (MFO)

Early and mid-term outcomes of transcatheter closure of perimembranous ventricular septal defects using the Lifetech™ Konar-MF Occluder device (MFO)

Short Term Outcomes of Transcatheter Ventricular Septal Defect Device Closure at Tertiary Cardiac Care Center

Tratamiento de la Comunicación Interventricular (CIV) congénita con dispositivos de inserción percutánea y perventricular

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