BACKGROUND: The rate of paravalvular aortic insufficiency (AI) with transcatheter aortic valve implantation (TAVI) with first generation devices was higher compared with surgical replacement. Residual AI after TAVI has been linked to an increased mortality rate. We compared two second generation TAVI devices - the repositionable Lotus valve with the balloon-expandable Edwards Sapien 3 valve - regarding procedural and 30 day outcome. METHODS AND RESULTS: In 78 patients with severe aortic stenosis undergoing transfemoral TAVI we evaluated post-procedural paravalvular AI, device success and early safety according to VARC criteria. Valve size was based on a 256-multislice computed tomography. Patients were followed for 30 days. The Lotus valve (N = 26) and the Edwards Sapien 3 valve (N = 52) were implanted under fluoroscopic guidance. Baseline characteristics were similar between groups. Perimeter derived annulus diameter did not differ with 25.7 ± 1.6mm for Lotus and 25.2 ± 2.1mm for Edwards Sapien 3 patients. After TAVI aortography and transthoracic echocardiography revealed no moderate or severe AI. The rate of mild AI was 12% for Lotus and 15% for Edwards Sapien 3 (p = 0.62). There were no deaths, stroke, annulus rupture or coronary obstruction. Device success was 96% and 98% (p = 0.61), early safety according to VARC 11.5% in both groups (p = 1.0) and the need for pacemaker implantation 27% and 4% (p < 0.003), respectively. CONCLUSIONS: TAVI with second-generation devices was associated with no moderate or severe AI and a low rate of mild AI. Device success was high for Lotus and Edwards Sapien 3 while the need for permanent pacemaker was significantly higher with the Lotus valve.
BACKGROUND: The rate of paravalvular aortic insufficiency (AI) with transcatheter aortic valve implantation (TAVI) with first generation devices was higher compared with surgical replacement. Residual AI after TAVI has been linked to an increased mortality rate. We compared two second generation TAVI devices - the repositionable Lotus valve with the balloon-expandable Edwards Sapien 3 valve - regarding procedural and 30 day outcome. METHODS AND RESULTS: In 78 patients with severe aortic stenosis undergoing transfemoral TAVI we evaluated post-procedural paravalvular AI, device success and early safety according to VARC criteria. Valve size was based on a 256-multislice computed tomography. Patients were followed for 30 days. The Lotus valve (N = 26) and the Edwards Sapien 3 valve (N = 52) were implanted under fluoroscopic guidance. Baseline characteristics were similar between groups. Perimeter derived annulus diameter did not differ with 25.7 ± 1.6mm for Lotus and 25.2 ± 2.1mm for Edwards Sapien 3 patients. After TAVI aortography and transthoracic echocardiography revealed no moderate or severe AI. The rate of mild AI was 12% for Lotus and 15% for Edwards Sapien 3 (p = 0.62). There were no deaths, stroke, annulus rupture or coronary obstruction. Device success was 96% and 98% (p = 0.61), early safety according to VARC 11.5% in both groups (p = 1.0) and the need for pacemaker implantation 27% and 4% (p < 0.003), respectively. CONCLUSIONS: TAVI with second-generation devices was associated with no moderate or severe AI and a low rate of mild AI. Device success was high for Lotus and Edwards Sapien 3 while the need for permanent pacemaker was significantly higher with the Lotus valve.
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Authors: Mirosław Gozdek; Jakub Ratajczak; Adam Arndt; Kamil Zieliński; Michał Pasierski; Matteo Matteucci; Dario Fina; Federica Jiritano; Paolo Meani; Giuseppe Maria Raffa; Pietro Giorgio Malvindi; Michele Pilato; Domenico Paparella; Artur Słomka; Uri Landes; Ran Kornowski; Jacek Kubica; Roberto Lorusso; Piotr Suwalski; Mariusz Kowalewski Journal: J Thorac Dis Date: 2020-03 Impact factor: 3.005