Comparing balloon-expandable and self-expanding transfemoral transcatheter aortic valve replacement based on subgroups in Germany 2019/2020

Background: Previously, overall comparable outcomes were seen for balloon-expandable (BE) or self-expanding (SE) transfemoral transcatheter aortic valve replacement (TAVR). However, subgroup analyses based on large case numbers are still needed.

Methods: German national data of all BE and SE transfemoral TAVR treating aortic valve stenosis in 2019 and 2020 were analysed. We then compared different outcomes and performed a subgroup analysis for the endpoint in-hospital mortality.

Results: Overall, 46,243 TAVR were analysed, 19,910 BE, and 26,333 SE. Patients in the SE group had a significantly higher logistic EuroSCORE (13.61 vs 12.66%, p < 0.001), age (81.55 vs 79.99a, p < 0.001), and proportion of women (54.82 vs 40.06%, p < 0.001). Both groups showed a similar in-hospital mortality with 2.37% in BE and 2.35% in SE (p = 0.916). In-hospital mortality also did not differ significantly after risk adjustment (OR = 0.98 [0.86, 1.13], p = 0.799). Patients in the SE group had a significantly lower risk of major bleeding (OR = 0.83 [0.73, 0.95], p = 0.006), but a significantly higher risk of stroke (OR = 1.38 [1.19, 1.59], p < 0.001), delirium (OR = 1.15 [1.06, 1.24], p = 0.001), and permanent pacemaker implantation (OR = 1.29 [1.21, 1.37], p < 0.001). In the subgroup analysis of in-hospital mortality, there were no significant differences in any of the observed subgroups (age < 75/75-79/80-84/ ≥ 85a, logistic EuroSCORE < 4/4- < 9/ ≥ 9, gender, NYHA III/IV, previous CABG, peripheral vascular disease, COPD, pulmonary hypertension, renal disease GFR < 30 ml/min, and diabetes mellitus).

Conclusion: In the direct comparison of balloon-expandable and self-expanding TAVR, there are no differences for in-hospital mortality in subgroups.