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Published on: June 3, 2018
A Comprehensive Evaluation of the NAVITOR Transcatheter Aortic Valve Replacement System
Joe Aoun1, Syed Zaid2, Sachin Goel1
1Cardiovascular Medicine Department, DeBakey Heart & Vascular Center, Houston Methodist Hospital, TX, USA.
The Navitor™ valve significantly reduces paravalvular leak (PVL) and complications in transcatheter aortic valve replacement (TAVR). This advanced valve shows improved safety and efficacy compared to earlier models.
Area of Science:
- Cardiovascular medicine
- Medical devices
- Interventional cardiology
Background:
- Transcatheter aortic valve replacement (TAVR) has seen major progress, expanding use and improving valve designs.
- Complications like paravalvular leak (PVL) remain a focus for improvement in TAVR procedures.
Purpose of the Study:
- To review the Navitor™ valve, a next-generation intra-annular transcatheter heart valve (THV).
- To compare the Navitor™ valve to the first-generation Portico™ THV regarding design and clinical outcomes.
- To evaluate the impact of Navitor™'s design refinements on TAVR complications.
Main Methods:
- Review of the Navitor™ THV system, a third-generation intra-annular Portico™ valve.
- Comparison of Navitor™ THV design features and clinical outcomes against the first-generation Portico™ THV.
- Analysis of complication rates, including paravalvular leak (PVL), severe bleeding, and major vascular complications.
Main Results:
- The Navitor™ THV features a protective outer sealing skirt and a more flexible delivery system.
- Navitor™ demonstrated a significant reduction in 30-day PVL rates (0% vs. 6.3% for first-generation Portico™).
- Lower rates of severe bleeding (13.1% vs. 27.3%) and major vascular complications (0.7% vs. 5.8%) were observed with Navitor™.
Conclusions:
- The Navitor™ valve represents a significant advancement in TAVR technology.
- Key design improvements in Navitor™ lead to substantial reductions in PVL and other procedural complications.
- Navitor™ shows promise for improved patient outcomes in TAVR, though long-term durability requires further study.
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