Key result
Balloon-expandable TAVR reduces 30-day all-cause mortality ~49% vs self-expanding TAVR in high-risk patients.
Why the study?
Although transfemoral TAVR is safe and effective across risk profiles, safety and efficacy outcomes comparing balloon-expandable valves with self-expanding valves in high-risk patients remained to be clarified.
Does balloon-expandable TAVR reduce 30-day all-cause mortality compared to self-expanding TAVR in high-risk patients with severe symptomatic aortic stenosis?
Systematic Review (n=2,935)
Does balloon-expandable TAVR reduce 30-day all-cause mortality compared to self-expanding TAVR in high-risk patients with severe symptomatic aortic stenosis?
Relative Risk: 0.51 (95% CI 0.31–0.82)
Absolute Event Rate: 2.2% vs 4.5%
p-value: p=< 0.006
In high-risk patients undergoing TF-TAVR, balloon-expandable valves are associated with significantly lower 30-day all-cause and cardiovascular mortality compared to self-expanding valves.
Supports preferential balloon-expandable TAVR use in high-risk patients; extends Level 1 evidence for device-specific valve selection.
Aim Transfemoral Trans-catheter Aortic Valve Replacement (TF-TAVR) is a safe and effective therapy compared with surgical aortic valve replacement (SAVR) in patients across all risk profiles using balloon-expandable valves (BEV) and self-expanding valves (SEV). Our aim was to compare safety and efficacy of BEV vs. SEV in high-risk patients undergoing TF-TAVR. Methods and results We searched PubMed, EMBASE, Clinicaltrials.gov , Scopus, and Web of sciences for studies on patients with severe aortic stenosis undergoing TAVR. Primary outcome was 30-day all-cause mortality. Secondary outcomes defined by Valve Academic Research Consortium 2 (VARC-2) criteria were also examined. Six studies with 2,935 patients (1,439 to BEV and 1,496 to SEV) were included. BEV was associated with lower risk of all-cause mortality (2.2% vs. 4.5%; RR: 0.51; 95% CI: 0.31–0.82; p < 0.006) and cardiovascular mortality [(2.5% vs. 4.3%; RR: 0.54; 95% CI: 0.32–0.90; p = 0.01) at 30 days compared with SEV. Implantation of more than one valve per procedure (0.78% vs. 5.11%; RR: 0.15; 95% CI: 0.07–0.31; p < 0.00001), and moderate/severe AR/PVL (2.5% vs. 9.01%; RR: 0.3; 95% CI: 0.17–0.48); p < 0.00001) were also lower in the BEV arm. Conclusion BEV TAVR is associated with reduced all-cause mortality (High level of GRADE evidence), cardiovascular mortality (very low level) at 30 days compared with SEV TAVR in high surgical risk patients. Data are necessary to determine if the difference in outcomes persists in longer-term and if the same effects are seen in lower-risk patients. Systematic Review Registration identifier, CRD42020181190.
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Senguttuvan et al. (2023) conducted a systematic review in severe symptomatic aortic stenosis (n=2,935). Balloon-expandable valves (BEV) vs. Self-expanding valves (SEV) was evaluated on 30-day all-cause mortality (RR 0.51, 95% CI 0.31-0.82, p=< 0.006). Balloon-expandable TAVR reduced 30-day all-cause mortality compared with self-expanding TAVR in high-risk patients (2.2% vs 4.5%; RR 0.51; 95% CI 0.31-0.82; p<0.006).
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