Factibilidad del alineamiento comisural y coronario precisos con TAVI balón-expandible / Feasibility of precise commissural and coronary alignment with balloon-expandable TAVI

Introducción y objetivos: Nuestro objetivo fue describir la factibilidad y resultados preliminares de una estrategia de alineamiento comisural preciso (ACP) con implante percutáneo de válvula aórtica balón-expandible. Métodos: Se analizó la relación entre las comisuras nativas y las neocomisuras en 10 pacientes consecutivos con estenosis aórtica grave trivalva y sintomática tras orientar el implante de TAVI basándose en la tomografía computarizada (TC) a través de un programa de análisis específicamente desarrollado. El ACP se predijo en base a modelos in silico que permitieron estimar cuantos grados había que girar la prótesis en el momento del crimpado. El grado de ACP y de solapamiento con los ostium coronarios se midió mediante TC al mes. Se recogieron gradientes transvalvulares y fuga perivalvular. Resultados: El mal alineamiento medio fue de 16,7±8°. Cuatro pacientes presentaron mal alineamiento ligero, pero ninguno moderado o grave. El análisis in silico predijo la posición final de las neocomisuras con un coeficiente de correlación de 0,983 (IC95%, 0,966-0,992), p <0,001. Se produjo solapamiento coronario severo con el ostium de la coronaria derecha en 3 casos en relación con excentricidad de su origen, pero en ningún caso con el ostium coronario izquierdo. El gradiente transaórtico medio fue de 6,1±3,3mmHg y no hubo casos de fuga perivalvular moderada o grave. Conclusiones: Es posible calcular una rotación paciente-específica de la prótesis balón-expandible en el momento del crimpado basándose en la TC preprocedimiento. De este modo, se logró evitar el mal alineamiento moderado o grave de las neo-comisuras y el solapamiento con el ostium coronario izquierdo en todos los casos.(AU)

Introduction and objectives: We aimed to describe the feasibility and preliminary outcomes of commissural alignment (CA) for the balloon-expandable transcatheter heart valve. Methods: The relationship among native commissures and transcatheter aortic valve implantation neocommissures was analyzed in 10 consecutive patients with tricuspid severe aortic stenosis undergoing transcatheter aortic valve implantation after guided implantation based on computed tomography analysis with a self-developed software. CA was predicted by in silico bio-modelling in the 10 patients and the calculated rotation was applied during crimping. Degrees of CA and coronary overlap (CO) were measured through 1-month follow up computed tomography. Transvalvular residual gradients and the rate of paravalvular leak were also analyzed. Results: Mean commissural misalignment was 16.7±8°. Four patients showed mild misalignment but none of them showed a moderate or severe degree of misalignment. The in silico model accurately predicted the final in vivo position with a correlation coefficient of 0.983 (95%CI, 0.966-0.992), P <.001. Severe CO with right coronary ostium occurred in 3 patients likely due to ostial eccentricity, and CO was not present with the left coronary artery in any of the patients. Mean transaortic gradient was 6.1±3.3mmHg and there were no moderate-severe paravalvular leaks. Conclusions: Patient-specific rotation during valve crimping based on preprocedural computed tomography is feasible with balloon-expandable devices and is associated with the absence of moderate or severe commissural misalignment and left main CO.(AU)

Feasibility of precise commissural and coronary alignment with balloon-expandable TAVI.

INTRODUCTION AND OBJECTIVES: We aimed to describe the feasibility and preliminary outcomes of commissural alignment (CA) for the balloon-expandable transcatheter heart valve. METHODS: The relationship among native commissures and transcatheter aortic valve implantation neocommissures was analyzed in 10 consecutive patients with tricuspid severe aortic stenosis undergoing transcatheter aortic valve implantation after guided implantation based on computed tomography analysis with a self-developed software. CA was predicted by in silico bio-modelling in the 10 patients and the calculated rotation was applied during crimping. Degrees of CA and coronary overlap (CO) were measured through 1-month follow up computed tomography. Transvalvular residual gradients and the rate of paravalvular leak were also analyzed. RESULTS: Mean commissural misalignment was 16.7±8°. Four patients showed mild misalignment but none of them showed a moderate or severe degree of misalignment. The in silico model accurately predicted the final in vivo position with a correlation coefficient of 0.983 (95%CI, 0.966-0.992), P <.001. Severe CO with right coronary ostium occurred in 3 patients likely due to ostial eccentricity, and CO was not present with the left coronary artery in any of the patients. Mean transaortic gradient was 6.1±3.3mmHg and there were no moderate-severe paravalvular leaks. CONCLUSIONS: Patient-specific rotation during valve crimping based on preprocedural computed tomography is feasible with balloon-expandable devices and is associated with the absence of moderate or severe commissural misalignment and left main CO.

Alineamiento comisural preciso durante el TAVI con ACURATE neo. Prueba de concepto / Accurate commissural alignment during ACURATE neo TAVI procedure. Proof of concept

Introducción y objetivos: La posición final de las neocomisuras en el implante percutáneo de válvula aórtica (TAVI) es aleatoria, lo que podría dificultar el acceso coronario y procedimientos futuros. Nuestro objetivo es desarrollar un método estandarizado para conseguir el alineamiento de las comisuras con ACURATE neo. Métodos: La relación entre las comisuras nativas y las neocomisuras de la válvula se analizó en 11 pacientes con estenosis aórtica grave sometidos a TAVI. Con base en la tomografía computarizada, se desarrolló un modelo in silico para predecir la posición final de los postes comisurales. A continuación, se desarrolló una técnica modificada de implante con alineamiento comisural adecuado (ACA) y un dispositivo específico para orientar el sistema de liberación. Por último, el implante de TAVI con alineamiento comisural se simuló en modelos impresos en 3D e in vivo. Se analizó el grado de mal alineamiento y de solapamiento coronario (SC). Resultados: El modelo in silico predijo con precisión la posición de los postes comisurales tanto para implantes convencionales (2) como aquellos con técnica de ACA (9) (coeficiente de correlación=0,994; IC95%, 0,989-0,998; p <0,001). El TAVI con una rotación del sistema específica para cada paciente se simuló con éxito en biomodelos y en 9 pacientes (mal alineamiento comisural medio in vivo, 7,7±3,9°). Ninguno de los implantes con técnica ACA presentó SC, mientras que la simulación in silico para los mismos casos pero mediante implante convencional predijo SC en 6 de los 9 casos. Conclusiones: El alineamiento comisural preciso del dispositivo ACURATE neo es factible mediante la inserción del sistema de liberación rotado específicamente para cada paciente basándose en el análisis de la tomografía computarizada. Este método sencillo y reproducible de alineamiento comisural podría utilizarse con todo tipo de dispositivos para TAVI (AU)

Introduction and objectives: Final position of the neo-commissures is uncontrolled during transcatheter aortic valve implantation (TAVI), potentially hindering coronary access and future procedures. We aimed to develop a standard method to achieve commissural alignment with the ACURATE neo valve. Methods: The relationship between native and TAVI neo-commissures was analyzed in 11 severe aortic stenosis patients undergoing TAVI. Based on computed tomography analysis, an in silico model was developed to predict final TAVI commissural posts position. A modified implantation technique, accurate commissural alignment (ACA) and a dedicated delivery system were developed. TAVI implants were tested in 3-dimensional (3D) printed models and in vivo. Commissural misalignment and coronary overlap (CO) were analyzed. Results: The in silico model accurately predicted final position of commissural posts irrespective of the implantation technique performed (correlation coefficient, 0.994; 95%CI, 0.989-0.998; P<.001). TAVI implant with patient-specific rotation was simulated in 3D printed models and in 9 patients. ACA-oriented TAVI implants presented adequate commissural alignment in vivo (mean commissural misalignment of 7.7 ±3.9°). None of the ACA oriented implants showed CO, whereas in silico conventional implants predicted CO in 6 of the 9 cases. Conclusions: Accurate commissural alignment of the ACURATE neo device is feasible by inserting the delivery system with a patient-specific rotation based on computed tomography analysis. This is a simple and reproducible method for commissural alignment that can be potentially used for all kinds of TAVI devices (AU)

Accurate commissural alignment during ACURATE neo TAVI procedure. Proof of concept.

INTRODUCTION AND OBJECTIVES: Final position of the neo-commissures is uncontrolled during transcatheter aortic valve implantation (TAVI), potentially hindering coronary access and future procedures. We aimed to develop a standard method to achieve commissural alignment with the ACURATE neo valve. METHODS: The relationship between native and TAVI neo-commissures was analyzed in 11 severe aortic stenosis patients undergoing TAVI. Based on computed tomography analysis, an in silico model was developed to predict final TAVI commissural posts position. A modified implantation technique, accurate commissural alignment (ACA) and a dedicated delivery system were developed. TAVI implants were tested in 3-dimensional (3D) printed models and in vivo. Commissural misalignment and coronary overlap (CO) were analyzed. RESULTS: The in silico model accurately predicted final position of commissural posts irrespective of the implantation technique performed (correlation coefficient, 0.994; 95%CI, 0.989-0.998; P<.001). TAVI implant with patient-specific rotation was simulated in 3D printed models and in 9 patients. ACA-oriented TAVI implants presented adequate commissural alignment in vivo (mean commissural misalignment of 7.7 ±3.9°). None of the ACA oriented implants showed CO, whereas in silico conventional implants predicted CO in 6 of the 9 cases. CONCLUSIONS: Accurate commissural alignment of the ACURATE neo device is feasible by inserting the delivery system with a patient-specific rotation based on computed tomography analysis. This is a simple and reproducible method for commissural alignment that can be potentially used for all kinds of TAVI devices.