Key result
Third-generation TAVI devices show no stroke differences across models while outperforming SAVR.
Why the study?
Stroke is a significant complication after TAVI, but comparative data on neurological outcomes across different third-generation transcatheter heart valve models are limited.
Does transcatheter aortic valve implantation with specific third-generation transcatheter heart valve models reduce the risk of stroke compared to other THV models, surgical aortic valve replacement, or clinical surveillance in patients with severe aortic stenosis?
Meta-Analysis (n=5,232)
Does transcatheter aortic valve implantation with specific third-generation transcatheter heart valve models reduce the risk of stroke compared to other THV models, surgical aortic valve replacement, or clinical surveillance in patients with severe aortic stenosis?
In patients with severe aortic stenosis, third-generation TAVI devices show no significant between-device differences in stroke or MACCE risk, though TAVI overall outperforms both SAVR and clinical surveillance.
May guide THV selection to minimize stroke; extends limited comparative RCT data via network meta-analysis.
Background Transcatheter aortic valve implantation (TAVI) with third generation devices has become the standard of care for many patients with severe aortic stenosis. Stroke is a non-negligible complication after TAVI that may affect post-procedural and long-term outcomes, leading to disability. However, comparative data on neurological outcomes across different transcatheter heart valve (THV) models are limited. Methods A Network Meta Analysis was performed including all randomized controlled trials comparing third-generation THV, surgical aortic valve replacement (SAVR) and clinical surveillance, with available data on neurological outcomes. The primary endpoint was stroke; major adverse cardiovascular and cerebrovascular events (MACCE) were the secondary ones. Results A total of seven randomized trials encompassing 5,232 patients were analysed. The mean age of the study population was 80.2 years, with a slight prevalence (54%) of females. Hypertension (84.8%), dyslipidemia (63.1%), and coronary artery disease (47%) were the most prevalent comorbidities. Procedural success was achieved in 96.6% of cases, with transfemoral access used in 95%. The majority of patients received the Edwards Sapien bioprosthetic valve (40.2%), followed by Evolut R/PRO (20.7%), Acurate NEO (14.7%), and Portico (7.1%). A small subset of patients (8.7%) underwent SAVR, while 446 patients (8.6%) received clinical surveillance alone. No significant differences in the risk of stroke or MACCE were observed across the different THV types (stroke incidence rate ratio [IRR] 0.56, 95% CI 0.21–1.52; MACCE IRR 0.59, 95% CI 0.30–1.17). In contrast, clinical surveillance was associated with significantly worse outcomes for both endpoints, while SAVR was linked to an increased risk of MACCE and showed a non-significant trend toward higher stroke rates. At SUCRA analysis, PORTICO valve resulted the device with the highest probability of preventing strokes. A Sensitivity analysis restricted to THV comparisons confirmed the absence of between-device differences. Conclusions In this comprehensive network meta-analysis encompassing different strategies of severe aortic stenosis management no device demonstrated superiority in reducing the risk of stroke or MACCE. Among THV models, PORTICO was the highest ranking in terms of stroke prevention. Conversely, both conservative management and SAVR were associated with less favorable outcomes compared to TAVI.
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Giacobbe et al. (2026) conducted a meta-analysis in Severe aortic stenosis (n=5,232). Third-generation transcatheter aortic valve implantation (TAVI) devices (Edwards Sapien, Evolut R/PRO, Acurate NEO, Portico) vs. Different THV types, surgical aortic valve replacement (SAVR), and clinical surveillance was evaluated on Stroke (IRR 0.56, 95% CI 0.21-1.52). Third-generation TAVI devices showed no significant between-device differences in stroke risk (IRR 0.56; 95% CI 0.21-1.52), while outperforming SAVR and clinical surveillance.
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