Why the study?
Does transfemoral TAVI with balloon-expandable valves reduce mortality and complications compared to self-expandable valves in patients undergoing TAVI?
Does transfemoral TAVI with balloon-expandable valves reduce mortality and complications compared to self-expandable valves in patients undergoing TAVI?
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In transfemoral TAVI, balloon-expandable valves are associated with lower rates of stroke and pacemaker implantation but higher rates of major bleeding compared to self-expandable valves, with no difference in 30-day mortality.
In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial.
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Vlastra et al. (2018) studied this question.
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