Long-Term Follow-Up After Direct-Flow Transcatheter Aortic Valve Implantation: A Single Center Experience.

Area of Science:

• Cardiology
• Biomedical Engineering
• Interventional Cardiology

Background:

• Transcatheter Aortic Valve Implantation (TAVI) is a crucial treatment for aortic stenosis.
• The DirectFlow (DF) device, a polymeric TAVI option, presents unique challenges due to its material properties and potential for degeneration.
• Understanding the long-term performance of DF devices is essential for optimizing patient selection and future valve-in-valve procedures.

Purpose of the Study:

• To evaluate the long-term valve degeneration tendencies of the DirectFlow (DF) device after TAVI.
• To assess the safety and efficacy of DF devices by analyzing clinical characteristics, echocardiographic parameters, and overall survival.
• To compare the outcomes of DF implantation with a matched cohort of patients receiving other commercial TAVI devices.

Main Methods:

• A single-center registry study included patients who underwent DF implantation for severe aortic stenosis.
• Clinical and echocardiographic data were collected at baseline and during follow-up.
• Overall survival was analyzed and compared to a matched cohort receiving alternative TAVI devices.

Main Results:

• 67 patients received DF implantation (mean age 83 years).
• DF devices showed significantly higher post-procedural mean gradients compared to the reference group (16±8 mmHg vs. 8±3 mmHg).
• No significant progression of residual gradients was observed during follow-up, and overall survival was comparable between DF and reference groups.

Conclusions:

• DirectFlow devices result in higher initial transvalvular gradients post-TAVI.
• Despite higher gradients, no evidence of accelerated valve degeneration or inferior long-term outcomes was found compared to other TAVI devices.
• Further research may be warranted to fully elucidate the long-term behavior of polymeric TAVI valves.