https://doi.org/10.1007/s00392-025-02625-4
1Universitäres Herz- und Gefäßzentrum Hamburg Klinik für Kardiologie Hamburg, Deutschland; 2Universitäres Herz- und Gefäßzentrum Hamburg Allgemeine und Interventionelle Kardiologie Hamburg, Deutschland; 3Universitäres Herz- und Gefäßzentrum Hamburg Hamburg, Deutschland; 4Universitäres Herz- und Gefäßzentrum Hamburg Klinik und Poliklinik für Kardiologie Hamburg, Deutschland; 5Universitäres Herz- und Gefäßzentrum Hamburg Klinik und Poliklinik für Herz- und Gefäßchirurgie Hamburg, Deutschland
Background: Significant left ventricular outflow tract (LVOT) calcification is associated with adverse outcomes following transcatheter aortic valve implantation (TAVI). Data on the impact of LVOT calcification in patients provided with latest generation transcatheter heart valves (THV) are limited.
Objectives: This study aimed to assess the prevalence of LVOT calcification in patients with severe aortic stenosis (AS) provided with TAVI using latest generation THV and to compare procedural measures, clinical and hemodynamic outcomes using retrospective data from a single-center registry.
Methods: The analysis included 818 patients with severe AS treated with latest generation THV platforms (Evolut Pro/Pro+, Sapien 3/Ultra, Navitor, Acurate Neo/Neo2) between 2020 and 2022 at the University Heart and Vascular Center Hamburg. Patients without sufficient contrast-enhanced multislice computed tomography imaging for quantification of LVOT calcification were excluded. Significant LVOT calcification was defined as Calcium Volume >10mm3, in accordance with previously published data.
Results: Significant LVOT calcification at baseline was present in 24.9% (N=204, study group) of patients. Patients with LVOT calcification were more often male, but did not differ regarding age or comorbidities from the control group (N=601). At baseline, the study group presented with a significant higher mean aortic valve pressure gradient (Pmean) (study group: 37.0mmHg vs. control group: 32.0mmHg, p<0.001). Periprocedural data showed that patients in the study group received larger valve sizes (29.0mm [26.0; 29.0] vs. 26.0mm [25.0; 29.0], p<0.001) and more often underwent predilatation (84.6% vs. 69.6%, p<0.001) and postdilatation (49.2% vs. 38.9%, p=0.014). Additionally, fluoroscopy time (18.0min vs. 14.1min, p<0.001) and the utilization of contrast medium (162.5ml vs. 146.0ml, p<0.001) were higher in the study group.
Utilized THV platforms in the study group consisted of Evolut Pro/Pro+ (50.0%), Sapien 3/Ultra (32.8%), Acurate Neo/Neo 2 (10.8%) and Navitor (6.4%). Most frequent THV in the control group was Sapien 3/Ultra (66.2%), followed by Acurate Neo/Neo 2 (17.0%), Evolut Pro/Pro+ (10.1%) and Navitor (6.7%).
At discharge patients in the study group presented with a lower Pmean (7.0mmHg vs. 9.0mmHg, p<0.001), but higher rates of paravalvular leakage (PVL) ≥moderate (3.0% vs. 0.3%, p=0.0044).
Logistic regression analysis showed that the Sapien 3/Ultra was associated with lower rates of PVL≥mild (OR 0.23, 95%-CI 0.09-0.62, p=0.0035) and a lower rate of postdilatation (OR 0.30, 95%-CI 0.15-0.58, p<0.001) in patients with LVOT calcification compared to Evolut Pro/Pro+.
All-cause mortality at 30-days (p=0.64) and 12-months (p=0.97) showed no differences between study and control group. This finding was consistent for the combined endpoints death or stroke (30d p=0.75; 12M p=0.4) and death or rehospitalization (30d p=0.53; 12M p=0.78).
Conclusions: LVOT calcification was present in approximately one-quarter of patients undergoing TAVI with latest generation THV. The presence of LVOT calcification affected device selection, procedural measures and hemodynamic outcomes. However, it did not affect mortality, rehospitalization rates, or incidence of stroke at 1-year follow-up post TAVI.