Clin Res Cardiol (2021). 10.1007/s00392-021-01933-9

A simplified approach including conscious sedation for transcatheter aortic valve implantation (TAVI): a 4-year single center experience and outcome analysis
L. Baez1, T. Kräplin1, M. Diab2, S. Möbius-Winkler1, C. Schulze1, M. Franz1
1Klinik für Innere Medizin I - Kardiologie, Universitätsklinikum Jena, Jena; 2Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena, Jena;

Background: In treatment of severe degenerative aortic valve stenosis (AS), transcatheter aortic valve implantation (TAVI) has been shown to be non-inferior or even superior compared to surgical aortic valve implantation (SAVR) in elderly high, moderate or even low-risk patients. This profound change in AS disease management is accompanied by an ongoing simplification of the TAVI procedure in increasing experience of the interventionalists, technical improvements in the design of devices and delivery systems as well as a switch from general anesthesia (GA) to conscious sedation (CS). At the University Heart Center Jena, the simplification efforts in TAVI performance, in particular with the broad application of CS instead of GA, have started in the early phase after implementation of the technique. Methods and Results: In this retrospective real-world single-center outcome analysis, we report on the entirety of AS patients that have been treated by TAVI after heart team evaluation between January 2016 and December 2019 (n=614; mean age: 79 ± 7 years; 53% female). Nearly all of these patients were treated in CS instead of GA (CS > 95%) using a transfemoral approach (transapical < 1%). With a mean STS score of 4.7 ± 3.4%, we describe a cohort of moderate surgical risk. The main devices implanted were the balloon-expandable Edwards Sapien3 (58%) and the self-expanding Medtronic EvolutR (39.5%) device. The intra-hospital mortality rate of the 4-year period was 3.26% (n=20) with a continuous decrease since 2016 to a rate of 2.0% in 2019. In 5 cases (0.8%), a conversion to surgery was required due to ventricular rupture (n=1), aortic anulus rupture (n=1), pericardial tamponade (n=1), device embolization into the left ventricle (n=1) and obstruction of the left main coronary artery (n=1). The mortality rate in these 5 patients was 100%. We could observe a continuous decline in procedural time (from first vascular puncture to final closure) over the 4-year period with 53.6 ± 26.2 minutes in 2016 to 32.2 ± 24.3 minutes in 2019 (p<0.001). With respect to procedural and in-hospital complications, we identified the following incidence rates over the study period: pericardial tamponade: 2.28% (n=14); acute vascular complications: 4.6% (n=28); overall bleedings (with and without the requirement of transfusion): 17.4% (n=107) with a significant decrease from 2016 (19.7%) to 2019 (8.5%; p<0.001); psychological syndromes (not all requiring medication): 9.5% (n=58); disabling stroke: 2.4 % (n=15); new pacemaker: 10.4% (n=64), continuously decreasing from 2016 (17.7%) to 2019 (8.5%; p=0.006); pneumonia: 11.7% (n=72). The ICU (including intermediate care) time was 1.94  ± 5.02 days and the in-hospital time 15 ± 12 days. A relevant portion of these patients has been included in our local registry (Jenaer Aortenklappenregister, JAKR) for further analysis and structured follow-up. Here, the estimated 30-day mortality rate is 3.3% and the 1-year mortality rate is 16.5% (n=121, analysis ongoing). Conclusion: We here present real-world data showing that TAVI using a simplified approach including CS instead of GA is safe with low complication rates and favorable outcomes. Our single-center results are in accordance with data from large registries, in particular the German Aortic Valve Registry (GARY) or even large randomized trials addressing elderly patients with moderate or high surgical risk.


https://dgk.org/kongress_programme/ht2021/P534.htm