El sistema TriClip para la reparación transcatéter de la válvula tricúspide. Estudio multicéntrico español / The TriClip system for edge-to-edge transcatheter tricuspid valve repair. A Spanish multicenter study

Introducción y objetivos En pacientes con insuficiencia tricuspídea (IT), la reparación transcatéter de la válvula tricúspide (RTVT) mediante el uso de dispositivos «borde a borde» ha experimentado un creciente uso en todo el mundo. Recientemente se ha puesto a disposición un sistema dedicado de RTVT borde a borde. El presente artículo describe la experiencia inicial con este sistema en España. Métodos Estudio multicéntrico prospectivo que incluyen los centros aceptados para el uso del novedoso sistema. Entre junio de 2020 y marzo de 2021 se incluyó a todos los pacientes sometidos a una RTVT con el sistema TriClip en España. El criterio de valoración principal fue la consecución de una reducción de la IT de al menos 1 grado al alta hospitalaria. Resultados Se incluyó a un total de 34 pacientes. La mayoría de ellos refería antecedentes de fibrilación auricular (91%). El objetivo primario se alcanzó en todos los pacientes. La mayoría requirieron uno (47%) o dos clips (44%), con un claro predominio del dispositivo XT (87%) sobre NT (13%). La localización del primer clip fue principalmente anteroseptal (> 90%). Solo un paciente presentó un desprendimiento parcial que pudo ser estabilizado con clips adicionales en el mismo procedimiento. Al alta, la gravedad de la IT fue de grado 2 en el 91% de los pacientes. A los 3 meses, no se detectó ninguna muerte. Al seguimiento, el 88% de los pacientes se encontraban en clase funcional New York Heart Association 2 y el 80% presentaban IT grado 2 residual. Conclusiones La RTVT borde a borde pareció ser eficaz y segura con una reducción sostenida de la IT a los 3 meses. Serán necesarios más estudios para confirmar estos resultados (AU)

Introduction and objectives In patients with tricuspid regurgitation (TR), edge-to-edge transcatheter tricuspid valve repair (TTVR) is the strategy with the highest penetration worldwide. A dedicated edge-to-edge TTVR system has recently become available in Europe. The present study describes the initial experience with the system in Spain. Methods This multicenter study collected individual data from the centers accepted for the use of the novel system within an initial limited release. Between June 2020 and March 2021, all patients undergoing an edge-to-edge TTVR using the TriClip system in Spain were included in the study. The primary endpoint was the achievement of a TR reduction of at least 1 grade at discharge. Results We included 34 patients. Most of them reported a previous history of atrial fibrillation (91%) and only 1 had a pacemaker lead. The primary endpoint (TR reduction of at least 1 grade at discharge) was met in all patients. Most of the patients required 1 (47%) or 2 clips (44%) with a clear predominance of XT (87%) over NT (13%). The location of the first clip was anteroseptal in >90% of the patients. Only 1 patient had a partial detachment, which was stabilized with additional clips in the same procedure. At discharge, TR severity was≤2 in 91% of patients. At 3 months, mortality was nil. Overall, 88% of patients were in New York Heart Association functional class≤2 and 80% had residual TR≤2. Conclusions Edge-to-edge TTVR seemed to be effective and safe with a sustained TR reduction at 3 months. Further studies will be needed to confirm our findings (AU)

The TriClip system for edge-to-edge transcatheter tricuspid valve repair. A Spanish multicenter study.

INTRODUCTION AND OBJECTIVES: In patients with tricuspid regurgitation (TR), edge-to-edge transcatheter tricuspid valve repair (TTVR) is the strategy with the highest penetration worldwide. A dedicated edge-to-edge TTVR system has recently become available in Europe. The present study describes the initial experience with the system in Spain. METHODS: This multicenter study collected individual data from the centers accepted for the use of the novel system within an initial limited release. Between June 2020 and March 2021, all patients undergoing an edge-to-edge TTVR using the TriClip system in Spain were included in the study. The primary endpoint was the achievement of a TR reduction of at least 1 grade at discharge. RESULTS: We included 34 patients. Most of them reported a previous history of atrial fibrillation (91%) and only 1 had a pacemaker lead. The primary endpoint (TR reduction of at least 1 grade at discharge) was met in all patients. Most of the patients required 1 (47%) or 2 clips (44%) with a clear predominance of XT (87%) over NT (13%). The location of the first clip was anteroseptal in >90% of the patients. Only 1 patient had a partial detachment, which was stabilized with additional clips in the same procedure. At discharge, TR severity was≤2 in 91% of patients. At 3 months, mortality was nil. Overall, 88% of patients were in New York Heart Association functional class≤2 and 80% had residual TR≤2. CONCLUSIONS: Edge-to-edge TTVR seemed to be effective and safe with a sustained TR reduction at 3 months. Further studies will be needed to confirm our findings.

Relación entre monitorización del índice de estado cerebral y predictores clínicos de profundidad anestésica / Relation between the monitoring of cerebral status rate and the prediction levels

INTRODUCCIÓN: Las cardiopatías valvulares adquiridas presentan una notable mejoría con tratamiento quirúrgico; sin embargo, se atribuye una alta incidencia de despertar intraoperatorio, por lo que resulta necesario monitorizar el estado de profundidad anestésica, mediante la valoración de signos clínicos o registros electroencefalográficos simples o computarizados. OBJETIVOS: Comparar el grado de profundidad anestésica mediante monitorización del índice de estado cerebral y la valoración clínica intraoperatoria en pacientes propuestos para tratamiento quirúrgico. MÉTODO: Se realizó un estudio descriptivo transversal en 40 pacientes a los cuales se les administró anestesia general. Se comparó la relación existente entre el valor del índice de estado cerebral y la valoración clínica utilizándose diferentes pruebas estadísticas. RESULTADOS: La media de los valores del CSI se comportó entre 48.5 y 50 durante el intraoperatorio y en 95.5 al extubar. Se evidenció que la evaluación clínica de profundidad anestésica mediante la TAM y la FC tienen una alta sensibilidad y valor predictivo positivo corroborada según mediciones del CSI. No se registraron recuerdos intraoperatorios. La recuperación anestésica fue valorada como buena. CONCLUSIONES: La evaluación del estado de profundidad anestésica según los predictores clínicos, muestran una fiabilidad similar a la obtenida mediante la monitorización del índice de Estado Cerebral.

Introduction: The acquired valvular heart diseases have a marked improvement with the surgical treatment; however, may to have a high incidence of intraoperative wake being necessary to monitor the deep anesthesia status by clinical signs assessment or single or computarized electroencephalographic registries. Objectives: To compare the anesthesia depth level by the monitoring of cerebral status and the intraoperative clinical assessment in patients candidates to surgical treatment. Method: A cross-sectional and descriptive study was conducted in 40 patients under general anesthesia. The existing relationship between the value of cerebral status rate and the clinical assessment were compared using different statistic tests. Results: The mean of CSI values was between 48.5 and 50 during the intraoperative period and in 95.5 at extubation. It was evidenced that the clinical assessment of anesthetic depth by the mean arterial tension (MAT) and the heart rate (HR) has a high sensitivity level and positive prediction value corroborated by CSI measurements. There weren't intraoperative recalls. The recovery from anesthesia was assessed as good. Conclusions: The assessment of the anesthesia depth status according to the clinical predictors shows a similar reliability to that obtained by the monitoring of cerebral status rate.