Key result
Evolut and SAPIEN valves show similar 30-day readmissions to ACURATE valves after next-day TF-TAVI discharge.
Why the study?
No data compared newer-generation transcatheter heart valves in terms of next-day discharge following transfemoral transcatheter aortic valve implantation.
Does the type of newer-generation transcatheter heart valve (Evolut or SAPIEN vs ACURATE) affect 30-day unplanned readmissions in pacemaker-naïve patients discharged the next day after transfemoral TAVI?
Cohort (n=963)
Yes
Does the type of newer-generation transcatheter heart valve (Evolut or SAPIEN vs ACURATE) affect 30-day unplanned readmissions in pacemaker-naïve patients discharged the next day after transfemoral TAVI?
Relative Risk: 0.76 (95% CI 0.38–1.52)
p-value: p=0.38
In pacemaker-naïve patients undergoing TF-TAVI, next-day discharge is safe and not associated with differences in 30-day readmissions across newer-generation transcatheter heart valve types.
Next-day discharge after TF-TAVI appears comparably safe across valves; hypothesis-generating and requires randomized confirmation before guiding selection.
BACKGROUND: No data compare newer-generation transcatheter heart valves (THVs) in terms of next-day discharge (NDD) following transfemoral (TF) transcatheter aortic valve implantation (TAVI). AIMS: We aimed to evaluate the safety of NDD in unselected patients who received ACURATE (neo/neo2), Evolut (PRO/PRO+/FX) and the SAPIEN (3/Ultra) THVs. METHODS: This multicentre registry included patients who underwent TF-TAVI without a preprocedural permanent pacemaker implantation (PPI) and were discharged the next day without a new PPI. The primary endpoint was unplanned readmissions at 30 days. Multinomial gradient-boosted inverse probability of treatment-weighted (IPTW) propensity scores (stage 1) followed by the modified Poisson regression (stage 2) approach were used to compare the average effects of the THVs on the primary outcome. RESULTS: A total of 963 all-comer patients (ACURATE=264, Evolut=306, and SAPIEN=393) were included in this study. ACURATE patients were older (p<0.001) and included a greater proportion of females (p<0.001), whereas Evolut patients had a higher risk profile as assessed by the Society of Thoracic Surgeons score (p=0.01). There were no differences between the groups in terms of right or left bundle branch block (p=0.75). At 30 days, the overall readmission rate was 8%, and there were no differences in cardiac (ACURATE 4.6% vs Evolut 4.2% vs SAPIEN 3.1%; p=0.56) or non-cardiac readmissions (ACURATE 4.6% vs Evolut 3.3% vs SAPIEN 4.6%; p=0.64). Readmission for new PPI was 2.7%, 1.0% and 1.8% (p=0.32) and for heart failure (HF) was 1.5%, 2.0% and 1.3% (p=0.76) in ACURATE, Evolut and SAPIEN patients, respectively. The IPTW propensity score model followed by modified Poisson regression indicate that, using ACURATE as the reference, no significant differences were found in 30-day readmissions (relative risk [RR] 0.76, 95% confidence interval [CI]: 0.38-1.52; p=0.38 for Evolut and RR 0.74, 95% CI: 0.44-1.22; p=0.28 for SAPIEN). CONCLUSIONS: In pacemaker-naïve patients undergoing TF-TAVI with newer-generation THVs, NDD was not associated with a negative impact on overall 30-day readmissions, cardiac or non-cardiac readmissions, readmissions for PPI or HF after discharge, or mortality, regardless of the type of THV.
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Bagur et al. (2024) conducted a cohort in Transfemoral transcatheter aortic valve implantation (TF-TAVI) (n=963). Evolut or SAPIEN transcatheter heart valves vs. ACURATE transcatheter heart valve was evaluated on Unplanned readmissions at 30 days (RR 0.76, 95% CI 0.38-1.52, p=0.38). Among patients with next-day discharge after TF-TAVI, 30-day readmissions did not significantly differ for Evolut (RR 0.76; 95% CI 0.38-1.52) or SAPIEN valves compared to ACURATE valves.
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