One year data from the NAVULTRA study published in JACC suggests that Edwards’ Sapien 3 Ultra and Abbott’s Navitor intra-annular TAVR valves have similar short-term clinical outcomes, with a few key differences.
- Until now, no comparative data was available regarding the self-expanding Navitor and the balloon-expandable Sapien 3 Ultra.
- Both are designed to sit inside the aortic valve using a stent frame instead of on top of it, which is useful when the patient’s native annulus is in good condition.
The NAVULTRA study explored data from 4k TAVR patients who received either Navitor or Sapien 3 Ultra and found that all-cause mortality was low for both (9.7% vs. 9.9%), but post-procedural outcomes were worse for Navitor.
- Navitor patients had a significantly longer average hospitalization time (4 days vs. 3.4 days).
- They also had higher rates of new permanent pacemaker implantation (20.6% vs 10.6%).
- The study’s composite safety endpoint of freedom from all-cause mortality, stroke, major bleeding events, etc was also worse for Navitor patients (73.9% vs. 82.6%).
- Navitor also showed higher rates of mild paravalvular leak (OR: 1.53).
- Finally, Navitor patients were almost 2X more likely to be hospitalized for HF within 30 days of receiving the valve (4.6% vs. 2.8%)
However, one procedural statistic swung in favor of Navitor, with the valve achieving a 91.2% implantation success rate compared to 87% for the Sapien 3 Ultra.
Now before betting on one valve over the other, it’s worth noting that this was a nonrandomized, observational, retrospective study without an independent review of clinical events.
- A future RCT with a more robust review arm would be needed to really drive home the point of which intra-annular TAVR valve is better.
The Takeaway
Before this study, interventional cardiologists had little to go off of when deciding which intra-annular valve to give patients, and while the study is observational, it gives insight into some real safety advantages for Sapien 3 Ultra over Navitor.
