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The aim of this study was to evaluate 30-days and 1-year clinical and echocardiographic outcome after CT-guided transfemoral implantation of the newer ESV-3 valve using the HeartNavigator algorithm (HNA) .
Transfemoral TAVI was performed in local anesthesia using the ESV-3 valve (23, 26, 29mm). CT-imaging including the HNA was used for prosthesis size selection and valve implantation plane selection. Clinical events and post-TAVI PVL was evaluated after 30 days and one year according to the VARC-II criteria.
231 pts (mean age 81.0 ± 0.4 years) with severe aortic stenosis (pmean 41.6 ± 0.99 mmHg, mean AVA 0.7 ± 0.01 cm2) and high surgical risk (mean log Euroscore-I 21.0 ± 0.9%) underwent transfemoral TAVI. Device success was 227/231 (98.3%), mean fluoroscopy time 10.6 ± 0.29 min, contrast media was 145.3 ± 3.6 ml, and the procedure time (skin-to-skin) was 101.1 ± 2.39 min. There was one In-Lab stroke and one in-lab death. Major vascular complication rate was 8.7% (VARC-1), and 68 pts (30%) showed a pseudoaneurysm after TAVI. There was 3.9% minor bleeding, 2.2 % major bleeding and 2.2 % life threating bleeding. 30 day all-cause mortality was 5.2 %, one year mortality 11.3%. 30 day stroke rate was 3.5%, but major stroke rate was only 2.1 %. After one year there were 14 strokes (6.1%). Pacemaker rate was 9.3% . 30-days after TAVI, the rate of no/trace AR was 75.6 % and mild AR 24.4 % . There was no moderate or severe AR post TAVI. After one year the rate of no/trace AR decreased to 65.4 %, mild AR increased to 33.1 % and 2 pts (1.5 %) demonstrated a moderate AR. The maximal and mean gradients were stable over time. 30 day (pmax/pmean) versus 1 Year (pmax/mean) : 19.5/9.9 mmHg versus 17.8/9.5 mmHg.
30 day echocardiographic results after ESV-3 implantation using CT and HNA are excellent and AR > 1 is extremely rare. But over a time period of one year the proportion of pts with no/trace AR decreases about 10.2% and mild AR increases about 8.7%. 2 (1.5%) pts demonstrated AR grade II after one year. The persistence of the echocardiographic results over time and the impact of mild AR on clinical longterm outcome needs to be determined in further studies.
STRUCTURAL: Valvular Disease: Aortic