Verena Veulemans1, Dagmar B Sötemann2, Laura Kleinebrecht1, Stefanie Keymel1, Christian Jung1, Tobias Zeus1, Malte Kelm1, Ralf Westenfeld1. 1. Department of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, University Hospital Düsseldorf, Düsseldorf, Germany. 2. Department of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, University Hospital Düsseldorf, Düsseldorf, Germany. Electronic correspondence: dagmar.soetemann@med.uni-duesseldorf.de.
Abstract
BACKGROUND AND AIM OF THE STUDY: Although next-generation cardiac prostheses have shown favorable results in transcatheter aortic valve implantation (TAVI), these have mostly been documented in intermediate-risk patients. Whether this could be translated to high-risk patients is not known. Hence, the safety and clinical performance of the new, repositionable CoreValve Evolut R-System (ERS) was evaluated by comparison with a non-repositionable CoreValve-System (CVS), in 96 high-risk/inoperable (HRI) patients. METHODS: The primary safety end points were mortality and stroke, defined by VARC-2 criteria, at 30 days. Clinical performance end points were described by VARC-2 criteria, focusing on: (i) higher-grade atrioventricular conduction blocks with concomitant permanent pacemaker (PM) implantation; (ii) vascular complications (VCs); and (iii) aortic regurgitation (AR). The ERS and CVS patients underwent TAVI in equal proportions. RESULTS: In this study, 63% of patients in the CVS group and 82% in the ERS group were defined as HRI. One in-hospital death was documented after 30 days. With regards to the HRI cohort, no difference in rates of PM use were noted (ERS 20% versus CVS 20%; p >0.9999). ERS patients were characterized by a higher prevalence of peripheral vascular disease (PVD) (46% versus 21%; p <0.05), but fewer VCs (13% versus 41%; p <0.01). Both cohorts showed low rates of moderate-to-severe paravalvular AR (ERS 6% versus CVS 5%; p = 0.8639). However, ERS seemed to offer a favorable hemodynamic performance, with a significantly improved AR index (26.3 versus 22.3; p <0.05). TAVI with the ERS was associated with a higher stroke rate (3% versus 0%; p = 0.1232) after necessary postdilatation processes. CONCLUSIONS: In comparison to last-generation CVS, the repositionable ERS is safe and effective in HRI patients. Similar rates of PM use were noted for each group. together with a favorable hemodynamic performance and fewer vascular complications.
BACKGROUND AND AIM OF THE STUDY: Although next-generation cardiac prostheses have shown favorable results in transcatheter aortic valve implantation (TAVI), these have mostly been documented in intermediate-risk patients. Whether this could be translated to high-risk patients is not known. Hence, the safety and clinical performance of the new, repositionable CoreValve Evolut R-System (ERS) was evaluated by comparison with a non-repositionable CoreValve-System (CVS), in 96 high-risk/inoperable (HRI) patients. METHODS: The primary safety end points were mortality and stroke, defined by VARC-2 criteria, at 30 days. Clinical performance end points were described by VARC-2 criteria, focusing on: (i) higher-grade atrioventricular conduction blocks with concomitant permanent pacemaker (PM) implantation; (ii) vascular complications (VCs); and (iii) aortic regurgitation (AR). The ERS and CVS patients underwent TAVI in equal proportions. RESULTS: In this study, 63% of patients in the CVS group and 82% in the ERS group were defined as HRI. One in-hospital death was documented after 30 days. With regards to the HRI cohort, no difference in rates of PM use were noted (ERS 20% versus CVS 20%; p >0.9999). ERS patients were characterized by a higher prevalence of peripheral vascular disease (PVD) (46% versus 21%; p <0.05), but fewer VCs (13% versus 41%; p <0.01). Both cohorts showed low rates of moderate-to-severe paravalvular AR (ERS 6% versus CVS 5%; p = 0.8639). However, ERS seemed to offer a favorable hemodynamic performance, with a significantly improved AR index (26.3 versus 22.3; p <0.05). TAVI with the ERS was associated with a higher stroke rate (3% versus 0%; p = 0.1232) after necessary postdilatation processes. CONCLUSIONS: In comparison to last-generation CVS, the repositionable ERS is safe and effective in HRI patients. Similar rates of PM use were noted for each group. together with a favorable hemodynamic performance and fewer vascular complications.