Sapien system

From May 2011 to August 2019, a total of 2015 patients underwent TAVR with transfemoral (n = 1694, 84.1%) or transapical access (n = 321, 15.9%) and self-expandable (n = 1399, 69.4%) or balloon-expandable prosthesis (n = 616, 30.6%) at our institution. In this single-center, retrospective analysis, only patients with pre-procedural contrast-enhanced CT assessment and entirely calculated CHA₂DS₂-VASC and HAS-BLED scores, as well as logistic EuroSCORE I, EuroSCORE II, and STS-PROM scores, were enrolled. TAVR was performed according to current guidelines between 2011 and 2019, under local anesthesia for TF access and general anesthesia for TA access. TF TAVR was performed with different generations of either the self-expandable CoreValve System (Medtronic Inc., Minneapolis, MN, USA) or the balloon-expandable SAPIEN System (Edwards Lifesciences, Irvine, CA, USA); TA TAVR was only performed with the balloon-expandable SAPIEN System.

From 2009 to 2019, out of 1329 patients with either TF (n = 980, 73.7%) or TA (n = 349, 26.3%) TAVR, CHA₂DS₂-VASC and HAS-BLED scores were calculated as well as the logistic EuroSCORE I and STS-PROM scores. The combined CHADS-BLED score was calculated by adding the values of the single CHA₂DS₂-VASC and HAS-BLED scores. All procedures were performed according to the current guidelines between 2009 and 2019, respectively, and under local anesthesia for TF access and general anesthesia for TA access. TF TAVR was performed with different generations of either the self-expandable CoreValve System (Medtronic Inc., Minneapolis, MN) or the balloon-expandable SAPIEN System (Edwards Lifesciences, Irvine, CA). TA TAVR was predominantly performed by using the SAPIEN System (Edwards Lifesciences, Irvine, CA) or in very few cases the Engager System (Medtronic Inc., Minneapolis, MN).
All patients provided written informed consent for TAVR and the use of clinical, procedural, and follow-up data for research. The study procedures were in accordance with the Declaration of Helsinki. The Institutional Ethics Committee of the Heinrich-Heine University approved the study protocol (4080). The study is registered at clinical trials (NCT01805739).