Navitor Valve Proves Safe & Effective for High-Risk Aortic Stenosis Patients

The Navitor valve, a novel, intra-annular, self-expanding transcatheter heart valve (THV) for treating native aortic stenosis (AS) in high- or extreme-risk patients, had favorable 30-day outcomes and saw a reduced rate of permanent pacemaker implantation (PPI) at sites with greater procedural experience, according to a study published Jan. 14 in JACC: Cardiovascular Interventions. Santiago Garcia, MD, FACC, Vinod H. Thourani, MD, FACC, et al., included 2,958 patients (mean age 82 years; 63% female; mean STS score 6.6%) with AS treated with the Navitor valve between January 2023 and December 2024 and captured by the STS/ACC TVT Registry. The study's primary outcome was a composite of all-cause mortality or stroke at 30 days post procedure. Technical success was observed in 97.9% of cases, with in-hospital mortality occurring in 1.3% of cases. The composite primary outcome occurred in 5.2% (2.8% mortality, 2.7% stroke). Additional outcomes at 30 days were vascular complications in 1.8% and PPI in 17.8% of patients. A secondary analysis looking at case volume by site found that centers with procedural experience beyond 20 cases for Navitor Classic and Vision were less likely to require PPI post TAVR (Classic: 19.4% vs. 13.5%, p=0.0039; Vision: 19.1% vs. 10.6%, p = 0.047). The authors describe the commercial introduction of Navitor in the U.S. as "safe and effective," and highlight how the valve's design may benefit younger TAVR patients in the future. "As TAVR expands to younger patients at lower surgical risk, the lifetime management of patients with AS must be considered, such as hemodynamic performance, preservation of coronary access, valve durability, and preservation of future THV-in-THV options," note the authors. "...Ongoing studies in lower-risk patients will shed light into longer-term clinical outcomes and valve performance."