P3745Differences in short-term outcome between early- and new-generation TAVR devices

Abstract

Abstract Background For transcatheter aortic valve replacement (TAVR) morbidity- and outcome relevant factors like paravalvular aortic regurgitation, vascular access complications and the need for permanent pacemaker implantation remain key challenges. New-generation devices for TAVR have been optimized to improve clinical outcome. Purpose We aimed to address safety and effectiveness of new-generation TAVR devices compared with earlier generations in a single centre study. Methods We compared 30 days outcome of the new-generation repositionable MER (n=614) and MEP (n=90) and the balloon-expandable ES3 (n=414) valve with the last-generation self-expandable MCV (n=270) and the balloon-expandable SXT (n=103) in patients treated with TAVR between 2009 and 2018. TAVR endpoints and adverse events were defined according to the Valve Academic Research Consortium-2. Results Logistic EuroSCORE I as predictor for risk stratification and 30-day mortality was comparable between both cohorts (27.3%±2.9 new vs 23.0%±1.4 early; p=n.s.). Compared to early-generation devices (MCV/SXT), new-generation devices (MER/MEP/ES3) had significantly higher primary device success (98.9% new vs 96.8% early; p=0.0089), lower incidence of new renal replacement therapy (2.6% new vs 6.2% early; p=0.0028), new permanent pacemaker therapy for conduction disturbances (12.8% new vs 17.0% early; p=0.0394), and disabling bleeding (1.4% new vs 4.0% early; p=0.0040). No difference could be observed concerning incidence of moderate-to-severe paravalvular leakage (4.2% new vs 5.0% early; p=n.s.), stroke (3.3% new vs 2.1% early; p=n.s.), major vascular complications (2.8% new vs 3.5% early; p=n.s.) and 30-day mortality (2.7% new vs 4.4% early; p=n.s). Conclusion Data from the retrospective analysis indicate higher primary device success and lower incidence of renal replacement, pacemaker therapy and disabling bleeding events in new-generation devices, although praised “hot-item” advantages like paravalvular leackage/aortic regurgitation, vascular complications and mortality remain unacknowledged.