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Background The MANTA vascular closure device (VCD) is dedicated to large bore access closure and associated with favorable results in selected study populations. Anatomical predictors for access site complications are lacking. Aim To evaluate MANTA in a real‐world population and identify predictors for vascular complications. Methods All patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) between January 2016 and May 2020 with MANTA closure were included. Baseline characteristics were collected, pre‐procedural computed tomography and post‐deployment femoral angiograms were analyzed for anatomical differences. The primary endpoint was a composite of access site related major and minor vascular complications at 30 days follow‐up according to the VARC‐2 definitions. Secondary endpoints included bleeding, time to hemostasis, procedural length and incomplete arteriotomy closure or arterial occlusion by angiography. A Cox proportional hazards model was used to compare all‐cause mortality for patients with and without an access site complication. Results The 512 patients underwent TAVR with MANTA access closure. Median age was 80 (IQR 75–85), 53% was male, median BMI was 26.4 kg/m2 (IQR 23.4–29.7). Access site related major‐ or minor vascular complication occurred in 20 (4%) and 23 (4%) of patients respectively. Median time to hemostasis was 42 s (IQR 28–98). Post deployment angiogram showed an occlusion in 24 patients (5%), incomplete closure in 60 patients (12%) or both in three patients (1%). Of these 87 patients, 36 (41%) had a vascular complication. Femoral artery diameter (OR 0.70 [0.53–0.93]), low‐ (OR 3.47 [1.21–10.00]) and high (OR 2.43 [1.16–5.10]) arteriotomies were independent predictors for vascular complications. Conclusion In this contemporary TAVR population, access‐site related complications occurred in 8% of patients and were mainly due to percutaneous closure device failure. Small artery diameter and off‐target punctures were independent predictors.

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BackgroundThe need for new permanent pacemaker implantation (PPI) after Transcatheter Aortic Valve Implantation (TAVI) remains a critical issue. Membranous Septum (MS) length is associated with PPI after TAVI. The aim of this study was to identify different MS thresholds for the contemporary THV-platforms. Methods This retrospective, case-control study enrolled all patients who underwent a successful TAVI procedure with contemporary THV-platforms in the Erasmus University Medical Center between January 2016 and March 2020. The follow-up period for new PPI was 30 days. MS-length was determined by Computed Tomography. ResultsThe study consisted 653 TAVI patients with median age 80.6 years (IQR 74.7-84.8). New PPI occurred in 120 patients (18.4%). Patients with new PPI had a shorter MS-length (2.9 mm (IQR 2.3-4.3) vs. 4.2 mm (IQR 2.9-5.7), p < 0.001). MS-length < 3 mm identified a high-risk phenotype with 30.3% PPI-rate (OR 6.5 [95%CI 2.9-14.9]), MS-length 3-6 mm an intermediate-risk phenotype with 15.4% PPI-rate (OR 2.7 [95%CI 1.2-6.2]) and MS > 6 mm a low-risk phenotype with a 6.3% PPI-rate (reference). For the Lotus valve, there was no significant difference in PPI-rates between the high-risk (45.8%, OR 3.5 [95%CI 0.8-15.1]) and low-risk group (20%). By multivariate analysis MS-length, Agatston-score, use of Lotus valve, and ECG with first-degree AV block, RBBB or bifascular block were independent predictors for new PPI. Conclusion MS-length was an independent predictor for new PPI post-TAVI. Three phenotypes were found based on MSlength. MS < 3 mm was universally associated with a high risk for new PPI (>30%). MS > 6 mm represented a low-risk phenotype with PPI-rate < 10%. PPI-rate varied per THV type in the intermediate phenotype. PPI-rate with Lotus was high regardless of MS-length.