ObjectiveResidual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on residual PVR after TAVR with different next-generation transcatheter heart valves.Methods642 patients underwent TAVR with a SAPIEN 3 (S3; n=292), ACURATE neo (NEO; n=166), Evolut R (ER; n=132) or Lotus (n=52). Extent, location and asymmetry of DLZ calcification were assessed from contrast-enhanced CT imaging and correlated to PVR at discharge.ResultsPVR was ≥moderate in 0.7% of S3 patients, 9.6% of NEO patients, 9.8% of ER patients and 0% of Lotus patients (p<0.001), and these differences remained after matching for total DLZ calcium volume. The amount of DLZ calcium was significantly related to the degree of PVR in patients treated with S3 (p=0.045), NEO (p=0.004) and ER (p<0.001), but not in Lotus patients (p=0.698). The incidence of PVR ≥moderate increased significantly over the tertiles of DLZ calcium volume (p=0.046). On multivariable analysis, calcification of the aortic valve cusps, LVOT calcification and the use of self-expanding transcatheter aortic valve implantation (TAVI) prostheses emerged as predictors of PVR.ConclusionsThe susceptibility to PVR depending on the amount of calcium was mainly observed in self-expanding TAVI prostheses. Thus, DLZ calcification is an important factor to be considered in prosthesis selection for each individual patient, keeping in mind the trade-off between PVR reduction, risk of new pacemaker implantation and unfavourable valve ha emodynamics.

Background: Treatment of severely calcified aortic valve stenosis is associated with a higher rate of paravalvular leakage (PVL) and permanent pacemaker implantation (PPI). We hypothesized that the self-expanding transcatheter heart valve (THV) prostheses Evolut Pro (EPro) is comparable to the balloon-expandable Sapien 3 (S3) regarding hemodynamics, PPI, and clinical outcome in these patients. Methods: From 2014 to 2019, all patients with very severe calcification of the aortic valve who received an EPro or an S3 THV were included. Propensity score matching was utilized to create two groups of 170 patients. Results: At discharge, there was significant difference in transvalvular gradients (EPro vs. S3) (dPmean 8.1 vs. 11.1 mmHg, p ≤ 0.001) and indexed effective orifice area (EOAi) (1.1 vs. 0.9, p ≤ 0.001), as well as predicted EOAi (1 vs. 0.9, p ≤ 0.001). Moderate patient prosthesis mismatch (PPM) was significantly lower in the EPro group (17.7% vs. 38%, p ≤ 0.001), as well as severe PPM (2.9% vs. 8.8%, p = 0.03). PPI and the PVL rate as well as stroke, bleeding, vascular complication, and 30-day mortality were comparable. Conclusions: In patients with severely calcified aortic valves, both THVs performed similarly in terms of 30-day mortality, PPI rate, and PVL occurrence. However, patient prothesis mismatch was observed more often in the S3 group, which might be due to the intra-annular design.

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Background Transcatheter aortic valve implantation (TAVI) is an increasing common treatment option for patients (pts) with symptomatic severe aortic stenosis (AS). Despite its proven effectiveness and decreasing complication rate, vascular access site complications still occur in 5–7% of the cases and are associated with increased mortality and morbidity. Purpose The aim of this study was to analyze pts with vascular complications during TAVI procedure to better understand underlying mechanisms and aid future risk stratification. Methods From our ongoing single center TAVI registry encompassing over 1600 pts, we recruited 200 pts with vascular complications. By using propensity score 1:2 matching 400 controls without vascular complications were identified. Matching was done for peripheral vascular disease, age, gender, sheath size and BMI using the nearest neighbor algorithm. In the femoral artery, a localized, upward calcium scoring over 10 cm starting from the bifurcation was conducted in all pts using the 3mensio structural heart software ver. 8.0 (Pie Medical Imaging BV). Comparison between groups was done using the t-test. Multiple regression analysis was used to identify risk factors independently associated with vascular complication. Results Using VARC-2 definitions 22 (11%) pts classified as major and 178 (89%) as minor vascular complications. Patients with vascular complications had a significantly longer duration of hospitalization 17.1 days vs. 14.4 days (p=0.001), were more often on oral anticoagulation in 22.3% vs. 15.1%, (p=0.03) and had low preprocedural hemoglobin (11.8 vs. 12.1 (p=0.03). Vascular complications resulted in significantly higher 30 day mortality (7.4% vs. 3.2%, p=0.02). Detailed analysis of the femoro-iliacal vessels showed a higher percentage of kinking (50.5% vs. 33%, p = <0.001) in pts with vascular complications, however the calcium score was not significantly different (269.57 vs. 267.18, p=0.94). Of interest, pts with major vascular complications had a significantly higher calcium score as compared to controls (500.3 vs. 267.2, p=0.002). Major complications also translated in an even higher mortality after 30 days (18.2% vs. 3.2% (p = <0.001) and hospitalization time (days): 27.7 vs. 14.5 (p = <0.001) Multiple regression analysis identified vascular kinking (p = <0.001) and oral anticoagulation (p=0.04) at admission to be independent risk factors for vascular complication in the overall cohort whereas calcium score was only predictive for major vascular complications (p=0.04) Conclusion This study confirms that vascular complications during TAVI are associated with increased 30 day mortality and longer hospitalization. Patient dependent factors are the main predictors for vascular complications and should be considered thoroughly.

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