Accurate commissural alignment during ACURATE neo TAVI procedure. Proof of concept.
Alfredo Redondo, Félix Valencia-Serrano, Sandra Santos-Martínez, José Raúl Delgado-Arana, Alejandro Barrero, Ana Serrador, Hipólito Gutiérrez, Israel Sánchez-Lite, Teresa Sevilla, Ana Revilla, Carlos Baladrón, Won-Keun Kim, Manuel Carrasco-Moraleja, J Alberto San Román, Ignacio J Amat-Santos
Author Information
Alfredo Redondo: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
Félix Valencia-Serrano: Departamento de Cardiología, Hospital Torrecárdenas, Almería, Spain.
Sandra Santos-Martínez: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
José Raúl Delgado-Arana: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
Alejandro Barrero: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
Ana Serrador: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
Hipólito Gutiérrez: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
Israel Sánchez-Lite: Departamento de Radiología, Hospital Clínico Universitario, Valladolid, Spain.
Teresa Sevilla: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
Ana Revilla: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
Carlos Baladrón: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
Won-Keun Kim: Kerckhoff-Klinik GmbH, Herz und Thorax Zentrum, Bad Nauheim, Germany.
Manuel Carrasco-Moraleja: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
J Alberto San Román: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
Ignacio J Amat-Santos: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain. Electronic address: ijamat@gmail.com.
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 stenosispatients 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.