Staged BAV-TAVR showed no significant difference in 30-day MACE compared to direct TAVR in patients with severe aortic stenosis and cardiogenic shock (HR 1.14; 95% CI 0.79-1.64; p=0.48).
Cohort (n=396)
Does a staged BAV-TAVR approach improve MACE compared to direct TAVR in patients with severe aortic stenosis and cardiogenic shock?
In patients with severe aortic stenosis and cardiogenic shock who survive to definitive therapy, a staged BAV-TAVR approach shows no significant difference in short- or long-term outcomes compared to direct TAVR.
Hazard Ratio: 1.14 (95% CI 0.79–1.64)
p-value: p=0.48
Objectives: Severe aortic stenosis (AS) with cardiogenic shock (CS) presents a complex clinical challenge. For these patients, the optimal management strategy—either direct transcatheter aortic valve replacement (TAVR) or a staged approach with balloon aortic valvuloplasty (BAV) as a bridge to TAVR (BAV-TAVR)—is uncertain. We aimed to compare the outcomes of these two strategies. Methods: We conducted a retrospective cohort study using the TriNetX database. In this study, we identified patients with CS who underwent direct TAVR or who survived to and underwent TAVR within 30 days of balloon aortic valvuloplasty (BAV-TAVR). After matching propensity scores, 198 patients were analyzed in each group (total of 396). The primary outcome was major adverse cardiovascular events (MACE) at 30 days, 1 year, and 3 years. Results: The analysis included 396 matched patients (198 in each cohort). There was no significant difference in the primary endpoint of MACE at 30 days between the staged BAV and direct TAVR groups HR 1.14 (95% CI 0.79–1.64; p = 0.48), and this finding was consistent at 1 and 3 years with HR 1.20 (95% CI 0.89–1.61; p = 0.23) and HR 1.17 (95% CI 0.89–1.53; p = 0.25) respectively. Similarly, no differences were observed in secondary outcomes including all-cause mortality, stroke, and new permanent pacemaker implantation, at 30 days, 1, and 3 years. Conclusions: Among patients with severe AS and cardiogenic shock who survived definitive therapy, staged BAV-TAVR showed no detectable difference in short- or long-term outcomes versus direct TAVR. Given the limited sample size and the exclusion of patients who did not survive to TAVR, these results are hypothesis-generating and should not be read as evidence of equivalence or of bridging safety; prospective study is warranted.
Desai et al. (Thu,) conducted a cohort in Severe aortic stenosis with cardiogenic shock (n=396). Staged balloon aortic valvuloplasty as a bridge to TAVR (BAV-TAVR) vs. Direct TAVR was evaluated on Major adverse cardiovascular events (MACE) at 30 days (HR 1.14, 95% CI 0.79-1.64, p=0.48). Staged BAV-TAVR showed no significant difference in 30-day MACE compared to direct TAVR in patients with severe aortic stenosis and cardiogenic shock (HR 1.14; 95% CI 0.79-1.64; p=0.48).