Direct Aortic Access for Transcatheter Aortic Valve Replacement Using a Self-Expanding Device.

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• Transcatheter aortic valve replacement (TAVR) is a superior alternative to open surgery for high-risk patients.
• Extensive iliofemoral peripheral vascular disease can preclude standard femoral access for TAVR.
• Direct aortic (DA) access presents an alternative implantation strategy.

Purpose of the Study:

• To compare outcomes of TAVR using the self-expanding CoreValve prosthesis via direct aortic (DA) versus iliofemoral (IF) access.
• To evaluate the safety and efficacy of DA access in patients unsuitable for IF access.

Main Methods:

• Analysis of patients from the CoreValve US High Risk and Extreme Risk Pivotal Trials and Continued Access Study.
• Propensity score matching to balance baseline characteristics between DA and IF access groups.
• Comparison of clinical outcomes at 30 days and 1 year post-procedure.

Main Results:

• 394 matched pairs of IF and DA patients were identified.
• Higher 30-day all-cause mortality in DA vs. IF groups (10.9% vs. 4.1%), with reduced but still significant difference at 1 year (28.1% vs. 23.2%).
• DA access showed significantly higher rates of all-cause mortality or major stroke, major/life-threatening bleeding, and acute kidney injury at 30 days and 1 year.

Conclusions:

• DA access enables effective TAVR delivery when femoral access is not feasible.
• DA access is associated with increased risks of mortality and adverse events compared to IF access.
• Procedural differences may contribute to the observed outcome disparities.