TAVI with Portico was associated with significantly higher 1-year mortality compared to SAPIEN 3 (RR 1.26; 95% CI 1.06-1.51; p=0.01), as well as higher rates of moderate-to-severe PVL and PPI.
Meta-Analysis (n=20,522)
Yes
Does TAVI with the Portico valve improve procedural, clinical, and functional outcomes compared to the SAPIEN 3 valve in patients with severe aortic valve stenosis?
TAVI with the Portico valve is associated with higher rates of paravalvular leak, pacemaker implantation, and 1-year mortality compared to the SAPIEN 3 valve, despite having a lower mean gradient and incidence of prosthesis-patient mismatch.
Effect estimate: RR 1.26 (95% CI 1.06, 1.51)
p-value: p=0.01
Background/Objectives: Nowadays, transcatheter aortic valve implantation (TAVI) is widespread in patients with severe aortic valve stenosis. New prosthesis designs are becoming available to address the shortcomings of their predecessors and improve clinical outcomes. Methods: Electronic databases were screened for studies comparing outcomes of TAVI with Portico and SAPIEN 3. In a random-effects meta-analysis the pooled incidence rates of procedural, clinical and functional outcomes, according to VARC-2 definitions, were assessed. Results: Thirteen observational studies and one multi-center randomized clinical trial enrolling 20,522 patients (Portico N = 3001 and SAPIEN 3 N = 17,521) were included in the analysis. The need for more than one prosthesis during initial implantation was significantly higher among Portico recipients compared to SAPIEN 3 recipients: (RR 2.72 1.36, 5.45 p = 0.005). Pre- and post-dilatation were performed more frequently in the Portico group (RR 1.53 1.12, 2.09, p = 0.008 and RR 4.21 2.83, 6.26, p < 0.00001, respectively). Moderate-to-severe paravalvular leak (PVL) was significantly more common in the Portico arm (RR 3.27 1.80, 5.91 p < 0.0001). In contrast, the mean gradient and rate of prosthesis–patient mismatch (PPM) was significantly lower in the Portico group (MD −31.58 −37.02; −26.14 mmHg and RR 0.42 0.32, 0.55, p < 0.00001). Recipients of Portico demonstrated over 60% higher risk of permanent pacemaker implantation (PPI) compared to SAPIEN 3 (RR 1.62 1.25, 2.10, p = 0.0002). Other procedural and short-term clinical outcomes, including neurologic events, major vascular complications, life threatening or major bleeding, acute kidney injury, myocardial infarction and mortality did not differ between the devices. A difference in mortality was observed at the 1-year follow-up (RR 1.26 1.06, 1.51, p = 0.01; I2 = 5%). Conclusions: The evidence shows good short-term outcomes for both valves. Compared to SAPIEN 3, Portico was associated with a significantly higher rate of moderate-to-severe PVL and PPI, but a lower mean gradient and incidence of PPM. A significantly higher 1-year mortality was observed in the Portico group.
Gozdek et al. (2026) conducted a meta-analysis in severe aortic valve stenosis (n=20,522). Portico vs. SAPIEN 3 was evaluated on 1-year mortality (RR 1.26, 95% CI 1.06, 1.51, p=0.01). TAVI with Portico was associated with significantly higher 1-year mortality compared to SAPIEN 3 (RR 1.26; 95% CI 1.06-1.51; p=0.01), as well as higher rates of moderate-to-severe PVL and PPI.