What is the clinical evidence from this study?

Study design: Cohort. Population: aortic valve stenosis (n=46243). Intervention: Self-expanding transcatheter aortic valve replacement (SE TAVR) vs. Balloon-expandable transcatheter aortic valve replacement (BE TAVR). Primary outcome: In-hospital mortality (OR 0.98, 95% CI 0.86-1.13, p=0.799).

What does this research mean for the field?

Self-expanding TAVR showed no significant difference in in-hospital mortality compared to balloon-expandable TAVR (2.35% vs 2.37%, p = 0.799). Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

November 20, 2023Open Access

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

Key Result

Self-expanding TAVR showed no significant difference in in-hospital mortality compared to balloon-expandable TAVR (2.35% vs 2.37%, p = 0.799).

Study Design

Type

Cohort (n=46,243)

Multicenter

Yes

Structured PICO

Does self-expanding transfemoral TAVR improve in-hospital mortality compared to balloon-expandable TAVR in patients with aortic valve stenosis?

Population

46,243 patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) for aortic valve stenosis in Germany in 2019 and 2020 (19,910 balloon-expandable, 26,333 self-expanding). Patients with a baseline diagnosis of pure aortic regurgitation were excluded.

Intervention

Self-expanding (SE) transfemoral transcatheter aortic valve replacement (TAVR)

Comparator

Balloon-expandable (BE) transfemoral transcatheter aortic valve replacement (TAVR)

Outcome

In-hospital mortalityhard clinical

In a large nationwide German cohort, self-expanding and balloon-expandable TAVR demonstrated comparable in-hospital mortality across all subgroups, though they exhibited distinct periprocedural complication profiles.

Main Result

Effect estimate: OR 0.98 (95% CI 0.86-1.13)

Absolute Event Rate: 2.35% vs 2.37%

p-value: p=0.799

Limitations

No randomization of patients across treatment groups.
Data based on administrative records may introduce coding errors.

Abstract

Abstract 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. Graphical abstract

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