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Comparing Direct TAVR to Balloon Aortic Valvuloplasty-TAVR in Patients with Cardiogenic Shock and Severe Aortic
Aditya Desai1, Simran Gill1, Aparna Manoj1
1Department of Internal Medicine, University of California, Riverside School of Medicine, Riverside, CA 92521, USA.
Insights
For severe aortic stenosis with cardiogenic shock, a staged approach using balloon aortic valvuloplasty (BAV) before transcatheter aortic valve replacement (TAVR) showed similar outcomes to direct TAVR. Further prospective studies are needed to confirm these findings.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Severe aortic stenosis (AS) with cardiogenic shock (CS) poses significant management challenges.
- The optimal treatment strategy, direct transcatheter aortic valve replacement (TAVR) or a staged balloon aortic valvuloplasty (BAV) followed by TAVR (BAV-TAVR), remains uncertain.
Purpose of the Study:
- To compare the clinical outcomes of direct TAVR versus a staged BAV-TAVR approach in patients with severe AS and CS.
- To evaluate major adverse cardiovascular events (MACE), all-cause mortality, stroke, and pacemaker implantation rates.
Main Methods:
- Retrospective cohort study utilizing the TriNetX database.
- Identified patients with CS undergoing direct TAVR or BAV-TAVR.
- Propensity score matching created cohorts of 198 patients each (total 396).
Main Results:
- No significant difference in 30-day, 1-year, or 3-year MACE between the staged BAV-TAVR and direct TAVR groups.
- Secondary outcomes, including all-cause mortality, stroke, and new permanent pacemaker implantation, also showed no significant differences between the groups at any time point.
Conclusions:
- In patients with severe AS and CS who survived definitive treatment, staged BAV-TAVR demonstrated comparable short- and long-term outcomes to direct TAVR.
- These findings are hypothesis-generating due to sample size limitations and exclusion of non-survivors; prospective studies are warranted to confirm safety and equivalence.
Abstract:
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.