Use of the novel Navitor valve during transcatheter aortic valve replacement (TAVR) shows great clinical and hemodynamic outcomes in an early U.S. experience study. These data were reported by Santiago Garcia, MD, from The Christ Hospital Network and Lindner Center for Research and Education, Cincinnati, and colleagues, in a manuscript published Friday online in JACC: Cardiovascular Interventions. In 2023, the Navitor transcatheter heart valve (THV) (Abbott Structural) became available in the U.S. for very high-risk patients with native aortic stenosis. Real world experience data has yet to be reported. The investigators in this study examined the real-world outcomes of the use of the Navitor valve. Data were prospectively collected from the STS/ACC TVT Registry (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry). A composite primary outcome included all-cause death or stroke at 30-days post-procedure. The Navitor THV sizes included 23, 25, 27 and 29 mm. Between January 2023 and December 2024, 2,958 patients (mean age=81.4 years, 62.4% female; high-risk patients=56.4%, extreme-risk patients=9.5%) with AS were treated with the valve. Technical success was observed in 97.9% of cases and 1.3% of patients died. Some comorbidities included hypertension (91.3%), diabetes (38.4%), pre-existing conduction defects (32.5%) and percutaneous coronary intervention (29.4%). At 30-days follow-up, 5.2% of patients had experienced the primary endpoint of all-cause mortality or stroke (2.8% death, 2.7% stroke). Additionally, 1.8% of patients had major vascular complications, 17.8% of patients had new permanent pacemaker implantation (PPI) and 0.7% of patients had life-threatening or major bleeding. Other specifics were also recorded at 30 days, including mean transvalvular gradient (7.3±3.8 mmHg), aortic valve area (1.98±0.64 cm2) and moderate or greater paravalvular leak (PVL) (1.8%). Patients who were treated at sites with experience beyond 20 cases had reduced PPI rates compared with those who did not for both Navitor Classic (19.4% vs 13.5%, p=0.0039) and Navitor Vision (19.1% vs 10.6%, p=0.047). Patients reported significantly better quality of life 30 days after TAVR with Navitor, too. This was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ), assessing for life, social and personal impacts of the procedure, and the Overall Summary score improved by 23.8 points overall (52.1±24.8 at baseline, 75.9±22.6 at 30 days; p<0.0001). Site-reported clinical events and lack of adjudication by an independent committee was one limitation in this study. Other limitations included the fact that patient selection and procedural specifics were up to the local heart team and did not have a centralized definition, and the Navitor 35 mm was not included in this study since it received later approval than the rest of the Navitor system sizes. Follow-up was limited to 30 days, so future studies should seek long-term outcome data. This real-world experience study demonstrated the short-term safety, clinical and quality-of-life outcomes of the Navitor THV in patients with high-risk AS. Source: Garcia S, Sultan I, Rollefson W, et al. Early U.S. real-world experience with a novel intra-annular self-expanding valve for transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2026 January 16 (Article in Press). Image Credit: Navitor THV by Abbott Cardiovascular, https://www.cardiovascular.abbott/int/en/hcp/products/structural-heart/transcatheter-valve-solutions/navitor-tavi-systems.html