At least moderate nodular calcifications in the aortic annulus and left ventricular outflow tract significantly reduced TAVI device success to 87.8% compared to 95.4% for mild calcifications.
Observational (n=232)
No
Does the severity of nodular calcifications in the aortic annulus and LVOT affect device success and paravalvular leak in patients undergoing TAVI with new-generation devices?
Moderate or severe nodular calcifications in the aortic annulus or LVOT significantly reduce TAVI device success and increase paravalvular leak, with mechanically expandable and certain self-expanding valves performing better than others.
Tasa de eventos absoluta: 87.8% vs 95.4%
valor p: p=0.039
Background: The impact of nodular calcifications in left ventricular outlow tract (LVOT) and aortic annulus on the procedural outcome of transcatheter aortic valve implantation (TAVI) with new-generation devices is yet to be elucidated. Similarly, computational simulations may provide a novel insight into the biomechanical features of TAVI devices and their interaction with nodular calcifications. Methods: This retrospective single-center study included 232 patients submitted to TAVI with Evolut-R (53.4%), Portico (33.6%) and Lotus (13.0%) devices with available preoperative computed tomography (CT) angiography and evidence of nodular calcifications in aortic annulus and/or LVOT. Calcification severity was defined ≥moderate in presence of at least two nodules or one nodule ≤5 mm. Three virtual simulation models of aortic root presenting a nodular calcification of increasing size were implemented. Stress distribution, stent-root contact area and paravalvular orifice area were computed. Results: At least moderate calcifications were found in 123 (53.0%) patients, with no sex differences. Among the ≥moderate calcification group, lower device success rate was evident (87.8% vs. 95.4%; p = 0.039). Higher rates of ≥moderate paravalvular leak (PVL) (11.4% vs. 3.7%; p = 0.028) and vascular complications (9.8% vs. 2.8%; p = 0.030) were also observed. Among the Evolut-R group, higher rates of at ≥moderate PVL (12.1%) were observed compared to Portico (3.8%; p = 0.045) and Lotus (0.0%; p = 0.044) groups. Calcification of both annulus and LVOT (odds ratio OR 0.105; p = 0.023) were independent predictors of device success. On computational simulations, Portico exhibited homogeneous stress distribution by increasing calfications and overall a larger paravalvular orifice areas compared to Evolut-R and Lotus. Evolut-R showed higher values of average stress than Portico, although with a more dishomogeneous distribution leading to greater paravalvular orifice areas by severe calcifications. Lotus showed overall small paravalvular orifice areas, with no significant increase across the three models. Conclusions: At least moderate nodular calcifications in the annulus/LVOT region significantly affected TAVI outcome, as they were independent predictors of device success. Lotus and Portico seemed to perform better than Evolut-R as for device success and ≥moderate PVL. Computational simulations revealed unique biomechanical features of the investigated devices in terms of stent compliance and radial force.
Gorla et al. (Tue,) conducted a observational in symptomatic severe aortic stenosis (n=232). TAVI in patients with ≥moderate calcifications vs. TAVI in patients with mild calcifications was evaluated on Device success (p=0.039). At least moderate nodular calcifications in the aortic annulus and left ventricular outflow tract significantly reduced TAVI device success to 87.8% compared to 95.4% for mild calcifications.