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TAVR Deformation, Hypoattenuating Leaflet Thickening, and Outcomes
Quick Takes
- Nonuniform expansion of prosthesis devices is common after TAVR with relative underexpansion of the midsegment for SAPIEN 3 valves and eccentric inflow expansion for EVOLUT R/PRO valves, and the extent of prosthesis frame deformation is related to smaller neosinus volume and asymmetric leaflet expansion.
- All three of these variables (i.e., prosthesis deformation, asymmetric leaflet expansion, smaller neosinus volume) are independent predictors of hypoattenuating leaflet thickening (HALT) for both valve types and across the range of all prosthetic sizes.
- Furthermore, HALT that has been prospectively determined at 30 days after TAVR was associated with a higher risk of 1-year adverse outcomes including all-cause mortality, cardiac death, and heart failure hospitalization.
Study Questions:
What are the transcatheter aortic valve prosthesis frame factors and correlation of their extent to the frequency of hypoattenuating leaflet thickening (HALT) and clinical outcomes?
Methods:
The investigators prospectively examined 565 patients with cardiac computed tomography screening for HALT at 30 days after balloon-expandable SAPIEN 3 and self-expanding EVOLUT TAVR. Deformation of the TAVR prostheses, asymmetric prosthesis leaflet expansion, prosthesis sinus volumes, and commissural alignment were analyzed on the postprocedural computed tomography. For descriptive purposes, an index of prosthesis deformation was calculated, with values >1.00 representing relative midsegment underexpansion. A time-to-event model was performed to evaluate the association of HALT with the clinical outcome.
Results:
Overall, HALT was present in 21% of SAPIEN 3 patients and in 16% of EVOLUT patients at 30 days after TAVR. The occurrence of HALT was directly associated with greater prosthesis frame deformation (p < 0.001), worse asymmetry of the leaflets (p < 0.001), and smaller TAVR neosinus volumes (p < 0.001). These relations were present in both prosthetic types and in all of their size ranges (all p < 0.05). In multivariable analyses that include clinical variables previously associated with HALT (e.g., anticoagulant therapy), variables of TAVR prosthesis deformation remained predictive of HALT. Although HALT was not associated with changes in prosthetic hemodynamics, its presence was associated with the risk of mortality at 1 year, with respect to greater incidences of all-cause mortality (hazard ratio [HR], 2.98; 95% confidence interval [CI], 1.57–5.63; p = 0.001), cardiac death (HR, 4.58; 95% CI, 1.81–11.6; p = 0.001), and a composite outcome of all-cause mortality and heart failure hospitalization (HR, 1.94; 95% CI, 1.14–3.30; p = 0.02) with adjustment for age, sex, and comorbidities.
Conclusions:
The authors reported that nonuniform expansion of TAVR prostheses resulting in frame deformation, asymmetric leaflet, and smaller neosinus volume is related to occurrence of HALT in patients who undergo TAVR.
Perspective:
This study reported that nonuniform expansion of prosthesis devices is common after TAVR with relative underexpansion of the midsegment for SAPIEN 3 valves and eccentric inflow expansion for EVOLUT R/PRO valves, and the extent of prosthesis frame deformation is related to smaller neosinus volume and asymmetric leaflet expansion. Of note, all three of these variables (i.e., prosthesis deformation, asymmetric leaflet expansion, smaller neosinus volume) are independent predictors of HALT for both valve types and across the range of all prosthetic sizes, with a stronger correlation than what has been reported for other clinical variables previously associated with HALT. Furthermore, HALT that has been prospectively determined at 30 days after TAVR was associated with a higher risk of 1-year adverse outcomes including all-cause mortality, cardiac death, and heart failure hospitalization. These findings have implications for the continued expanded use of TAVR by valve design and deployment techniques, as well as clinical management that might mitigate the risk of HALT and its potential clinical sequelae.
Clinical Topics: Anticoagulation Management, Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Computed Tomography, Nuclear Imaging
Keywords: Anticoagulants, Aortic Valve Stenosis, Cardiac Surgical Procedures, Diagnostic Imaging, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Outcome Assessment, Health Care, Tomography, X-Ray Computed, Transcatheter Aortic Valve Replacement
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