CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
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Comparison of Manual and Automated Preprocedural Segmentation Tools to Predict the Annulus Plane Angulation and C-Arm Positioning for Transcatheter Aortic Valve Replacement.

BACKGROUND: Preprocedural manual multi-slice-CT-segmentation tools (MSCT-ST) define the gold standard for planning transcatheter aortic valve replacement (TAVR). They are able to predict the perpendicular line of the aortic annulus (PPL) and to indicate the corresponding C-arm angulation (CAA). Fully automated planning-tools and their clinical relevance have not been systematically evaluated in a real world setting so far.

METHODS AND RESULTS: The study population consists of an all-comers cohort of 160 consecutive TAVR patients with a drop out of 35 patients for technical and anatomical reasons. 125 TAVR patients underwent preprocedural analysis by manual (M-MSCT) and fully automated MSCT-ST (A-MSCT). Method-comparison was performed for 105 patients (Cohort A). In Cohort A, CAA was defined for each patient, and accordance within 10° between M-MSCT and A-MSCT was considered adequate for concept-proof (95% in LAO/RAO; 94% in CRAN/CAUD). Intraprocedural CAA was defined by repetitive angiograms without utilizing the preprocedural measurements. In Cohort B, intraprocedural CAA was established with the use of A-MSCT (20 patients). Using preprocedural A-MSCT to indicate the corresponding CAA, the levels of contrast medium (ml) and radiation exposure (cine runs) were reduced in Cohort B compared to Cohort A significantly (23.3±10.3 vs. 35.3 ±21.1 ml, p = 0.02; 1.6±0.7 vs. 2.4±1.4 cine runs; p = 0.02) and trends towards more safety in valve-positioning could be demonstrated.

CONCLUSIONS: A-MSCT-analysis provides precise preprocedural information on CAA for optimal visualization of the aortic annulus compared to the M-MSCT gold standard. Intraprocedural application of this information during TAVR significantly reduces the levels of contrast and radiation exposure.

TRIAL REGISTRATION: ClinicalTrials.gov NCT01805739.

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