Key result
Balloon-expandable valves were associated with significantly lower 30-day all-cause mortality (OR 0.77) compared to self-expanding valves in patients undergoing transcatheter aortic-valve replacement.
Why the study?
The comparative performances of TAVR with balloon-expandable valves and self-expanding valves in severe aortic stenosis remained unclear.
Does TAVR with balloon-expandable valves reduce early and midterm mortality compared to self-expanding valves in patients with severe aortic stenosis?
Meta-Analysis (n=37,958)
Does TAVR with balloon-expandable valves reduce early and midterm mortality compared to self-expanding valves in patients with severe aortic stenosis?
Odds Ratio: 0.77 (95% CI 0.71–0.83)
p-value: p=<0.00001
In a meta-analysis of nearly 38,000 patients with severe aortic stenosis, TAVR with balloon-expandable valves was associated with lower 30-day mortality compared to self-expanding valves.
Background The comparative performances of transcatheter aortic-valve replacement (TAVR) with balloon-expandable valves (BEV) and self-expanding valves (SEV) in severe aortic stenosis remain unclear. Purpose To compare the early (30-day) and midterm (1-year) mortality and cardiovascular outcomes of BEV with SEV. Data Sources PubMed, EMBASE, and the Cochrane Library from inception until February 13, 2020. Study Selection 3 randomized controlled trials (RCTs) and 12 propensity-score matched (PSM) studies, with 37,958 patients. Data Extraction 2 reviewers independently extracted study data and rated study quality. Data Synthesis: Compared with SEV, BEV was associated with significantly lower mortality at 30 days (OR 0.77, 95% CI 0.71–0.83, P< 0.00001, I 2 =0) and a trend toward lower mortality at 1 year (OR 0.88, 95% CI 0.78–1.00, P= 0.05, I 2 =15.8%), mainly driven from PSM studies, but regardless of valve generations and SEV types. 30-day and 1-year cardiovascular mortality, 30-day incidences of moderate to severe paravavular leak, procedural contrast agent volume and procedure time were lower, but transvalvular pressure gradient was higher in BEV than SEV. 30-day incidences of permanent pacemaker implantation (PPI), acute kidney injury, stroke, major bleeding, major vascular complications and rehospitalization were not statistically different between BEV and SEV. Early-generation SEV was associated with a higher 30-day PPI risk than corresponding BEV comparators. PPI risk was lower in ACURATE neo but higher in Evolut R SEV, both compared with SAPIEN 3 BEV. Limitations Study-level but not patient-level data; residual confounders in PSM studies; study designs and patient characteristics were heterogeneous. Conclusions Compared with SEV, BEV might be associated with lower early and midterm mortality. Results from adequately powered RCTs with long-term follow-up are critically needed to confirm these findings. Registration PROSPERO (CRD42020172889). Funding Source National Natural Science Foundation of China (NO. 81600312).
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Zhang et al. (2020) conducted a meta-analysis in Severe aortic stenosis (n=37,958). Balloon-expandable valves (BEV) vs. Self-expanding valves (SEV) was evaluated on 30-day all-cause mortality (OR 0.77, 95% CI 0.71-0.83, p=<0.00001). Balloon-expandable valves were associated with significantly lower 30-day all-cause mortality (OR 0.77) compared to self-expanding valves in patients undergoing transcatheter aortic-valve replacement.
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