Background: Transcatheter aortic valve replacement (TAVR) has become the preferred therapy for aortic stenosis. Given the growing life-expectancy, the risk of requiring coronary interventions or of developing prosthesis degeneration that could require TAVR-in-TAVR for its treatment progressively increases. During standard TAVI procedures the native and the prosthesis commissures are randomly aligned with misalignment in up to 70% of the cases. This might hinder coronary re-access in 18% of the cases, increase the risk of coronary obstruction during future TAVR-in-TAVR procedures, and has been associated to greater residual gradients. Methods: Although several techniques have been developed to increase the degree of commissural alignment, all are imperfect or imply manipulation of the system within the patient, potentially increasing the risk of complications. The research team developed a software based on computed tomography analysis that allows planification of accurate commissural alignment by inserting the delivery system in a patient-specific degree of rotation. Aim: The proponent team aimed to prospectively validate this methodology comparing a cohort of patients harboring TAVR with Acurate Commissural Alignment (ACA) vs. a control cohort with non-ACA standard technique, in order to determine benefits in terms of coronary re-access and clinical events (coronary events, valve degeneration, and TAVR-in-TAVR).
Study Type
OBSERVATIONAL
Enrollment
274
Software based, computed tomography analysis that allows planification of accurate commissural alignment of TAVR by inserting the delivery system in a patient-specific degree of rotation.
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
RECRUITINGHospital Clinic, Barcelona
Barcelona, Spain
RECRUITINGHospital Universitari Vall d'Hebron
Barcelona, Spain
RECRUITINGHospital Universitario Reina Sofía
Córdoba, Spain
NOT_YET_RECRUITINGHospital Universitari Bellvitge
L'Hospitalet de Llobregat, Spain
RECRUITINGHospital clínico San Carlos
Madrid, Spain
RECRUITINGHospital La Paz
Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario Ramón y Cajal
Madrid, Spain
RECRUITINGHospital Universitario Virgen de la Victoria
Málaga, Spain
NOT_YET_RECRUITINGHospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
RECRUITING...and 5 more locations
Degree of commissural alignment
Mean minimum angular deviation between TAVR posts and aortic valve commissures measured in CT-scan
Time frame: 6 months
Successful coronary re-access
Coronary re-access was successful or not after TAVR implant
Time frame: 10 minutes, right after TAVR
Presence of leaflet thrombosis
Presence of clinical/subclinical leaflets thrombosis assessed by CT-Scan
Time frame: 6 months
Residual transvalvular gradients
Residual transvalvular gradients measured in transthoracic echocardiography
Time frame: 24 months
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