The ABC Bicuspid Sizing Protocol for SAPIEN 3 Balloon-Expandable Valves

Figures

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  Figure 1. Sizing algorithm. The ABC sizing algorithm included evaluation of the (a) annulus, (b) below the annulus or LVOT, and (c) commissural level, sinus dimensions, and presence and distribution of calcification. The annular area was used to choose the initial valve size and deployment volume with target oversizing of 0% to 10% or 0% to 5% when annular calcium was present. The LVOT area was used to increase or decrease valve size or volume to avoid LVOT oversizing of <0% and oversizing of >10% or >5% when LVOT calcium was present. The intercommissural diameter was required to be no more than 1 mm smaller than the planned valve size while the maximum sinus diameter was required to be 6 mm greater than the planned valve size. Additional screening to avoid high-risk calcium morphologies was performed, that is, 1) calcium bridging from leaflet edges to the sinus wall/intercommissural space and 2) long, bulky calcium deposits at the leaflet edges (especially when bilateral and accompanied by small sinuses). Abbreviations: ICD, intercomissural diameter; LVOT, left ventricular outflow tract.

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  Figure 2. Patient flow diagram. Patients treated prior to September 2022 were identified from a TAVR database, while patients treated from September 2022 were identified in a TAVR and SAVR database providing data on patients who were treated with SAVR due to CT findings that showed increased risk for TAVR. Patients aged <65 years who were low risk for surgery were preferentially treated with SAVR. Abbreviations: AS, aortic stenosis; CT, computed tomography; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.

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  Figure 3. Maximum sinus dimension—planned TAVR valve size vs. aortic valve calcium score (AU) for TAVR- and SAVR-treated patients. Scatterplot demonstrating the impact of maximum sinus dimension—planned TAVR valve size—on treatment assignment. SAVR-treated patients had relatively small sinuses and/or high aortic valve calcium scores. Abbreviations: AU, Agatston units; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.

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  Figure 4. Illustrative cases of TAVR- and SAVR-treated patients: (a) A 74-year-old female with Sievers 1 (left-right fusion) bicuspid aortic stenosis. Based on the annular area, valve size/deployment is 26 + 1 cc. No change was seen after LVOT and ICD measurements. Sinus dimensions are large and calcium burden is low. Post-TAVR CT shows calcium displaced into noncoronary sinus. (b) A 77-year-old male with Sievers 1 (left-right fusion) bicuspid aortic stenosis. Based on the annular area, valve size/deployment is 29 + 4 cc. The LVOT area is smaller, and LVOT calcification is extensive, so valve deployment volume is reduced to 29 + 2 cc. Large ICD and sinus dimensions accommodate the high leaflet and raphe calcium burden, and post-TAVR CT shows calcium displacement at the raphe level and in the noncoronary sinus. (c) Eighty-three females with Sievers 0 bicuspid aortic stenosis. Annular and LVOT areas suggest a 26 + 2 cc valve size and deployment. However, maximum sinus dimension is small relative to this valve size, and calcium burden is very high. Anatomy was deemed high risk for TAVR, and the patient had SAVR. Abbreviations: CT, computed tomography; ICD, intercomissural diameter; LVOT, left…

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  Figure 5. Comparison between raphe length between pre- and post-TAVR CT. Raphe length was measured on pre- and post-TAVR CT images. Median raphe length changed from 11.1 mm (interquartile range: 9.3-13.2) pre-TAVR to 4.1 mm (interquartile range: 3.1-5.7) after TAVR (p < 0.001). Abbreviations: CT, computed tomography; TAVR, transcatheter aortic valve replacement.