Key result
Navitor matches Sapien safety but is linked to ~116% higher PPI risk and more PVL.
Why the study?
To compare the latest generation self-expandable Navitor valve with the balloon-expandable Sapien valve in TAVI.
Does the Navitor self-expandable valve improve safety and efficacy outcomes compared to the Sapien balloon-expandable valve in patients undergoing TAVI for symptomatic severe aortic stenosis?
Meta-Analysis (n=4,828)
Does the Navitor self-expandable valve improve safety and efficacy outcomes compared to the Sapien balloon-expandable valve in patients undergoing TAVI for symptomatic severe aortic stenosis?
In TAVI, the Navitor valve is associated with higher rates of permanent pacemaker implantation and paravalvular leakage but lower rates of patient-prosthesis mismatch and better hemodynamics compared to the Sapien valve, with no difference in mortality or stroke.
Answers are grounded in this paper and cite their sources.
No takes yet. Share an insight, caveat, or question.
Higher PPI and moderate-to-severe PVL with Navitor warrant caution in TAVI; leaves open confirmation by randomized trials.
Transcatheter aortic valve implantation (TAVI) has become an established treatment option for symptomatic severe aortic stenosis, particularly in older patients. In this meta-analysis, we compare the latest generations of self-expandable valves, Navitor (Abbott Structural Heart, Santa Clara, CA, USA), with balloon-expandable valves, Sapien (Edwards Lifesciences, Irvine, CA, USA), in TAVI. We systematically searched PubMed, Scopus, Web of Science, and Cochrane Library databases. Studies were considered eligible if they compared Navitor with Sapien valves in TAVI. Our search strategy yielded four studies with a total of 4,828 patients. In terms of safety and efficacy, no statistically significant differences were noted between the two groups in device and technical success, 30-day all-cause mortality, stroke incidence, or major vascular complications. Permanent pacemaker implantation (PPI) (risk ratio (RR) 2.16; 95% CI 1.67 to 2.80; P < 0.001) and moderate-to-severe paravalvular leakage (PVL) (RR 3.36; 95% CI 1.93 to 5.82; P < 0.001) rates were significantly higher in Navitor valve patients. In contrast, Navitor was associated with lower rates of moderate-to-severe patient-prosthesis mismatch (PPM) (RR 0.55; 95% CI 0.31 to 0.98; P = 0.043) and better hemodynamic outcomes compared to Sapien. In summary, both Navitor and Sapien valves were effective and safe in TAVI. However, the Navitor valve was associated with higher rates of moderate-to-severe PVL and PPI. On the other hand, Navitor had a better hemodynamic profile and lower moderate-to-severe PPM than Sapien.
Ahmed et al. (2026) conducted a meta-analysis in Severe aortic stenosis (n=4,828). Navitor valve vs. Sapien valves (Sapien 3 Ultra and Sapien 3 Ultra Resilia) was evaluated on Permanent pacemaker implantation (PPI) (RR 2.16, 95% CI 1.67 to 2.80, p=< 0.001). The Navitor valve demonstrated comparable overall safety and efficacy to Sapien valves but was associated with significantly higher rates of permanent pacemaker implantation (RR 2.16) and moderate-to-severe paravalvular leakage (RR 3.36).
Synapse has enriched 10 related papers. Consider them for comparative context: