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
  1. Alfredo Redondo: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
  2. Félix Valencia-Serrano: Departamento de Cardiología, Hospital Torrecárdenas, Almería, Spain.
  3. Sandra Santos-Martínez: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
  4. José Raúl Delgado-Arana: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
  5. Alejandro Barrero: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
  6. Ana Serrador: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
  7. Hipólito Gutiérrez: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
  8. Israel Sánchez-Lite: Departamento de Radiología, Hospital Clínico Universitario, Valladolid, Spain.
  9. Teresa Sevilla: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
  10. Ana Revilla: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
  11. Carlos Baladrón: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
  12. Won-Keun Kim: Kerckhoff-Klinik GmbH, Herz und Thorax Zentrum, Bad Nauheim, Germany.
  13. Manuel Carrasco-Moraleja: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
  14. J Alberto San Román: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
  15. Ignacio J Amat-Santos: Departamento de Cardiología, Hospital Clínico Universitario, Valladolid, Spain. Electronic address: ijamat@gmail.com.

Abstract

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.

Keywords

MeSH Term

Aortic Valve
Aortic Valve Stenosis
Heart Valve Prosthesis
Humans
Prosthesis Design
Transcatheter Aortic Valve Replacement
Treatment Outcome

Word Cloud

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