A new transcatheter aortic valve and percutaneous valve delivery system.

Objectives: We describe procedural and clinical outcomes in a high-risk cohort undergoing transcatheter aortic valve replacement with early next-generation transcatheter valve and delivery systems.
Background: Percutaneous aortic valve replacement is gaining acceptance as a viable option in patients at high surgical risk. Broader application will require further advances in valve and delivery system technology.
Methods: Transarterial aortic valve replacement was attempted in 25 patients (mean age 85 years) determined to be at high surgical risk due to comorbidities. A new delivery catheter system (RetroFlex 2, Edwards Lifesciences, Irving, California) was utilized in combination with either a balloon-expandable SAPIEN (Edwards Lifesciences) valve or a next-generation low-profile cobalt-chromium bovine pericardial SAPIEN XT (Edwards Lifesciences) valve.
Results: Percutaneous valve replacement was successful in all 25 high-risk patients. Aortic valve area increased from 0.59 +/- 0.15 cm(2) to 1.60 +/- 0.27 cm(2). In this high-risk cohort (Society of Thoracic Surgeons and logistic EuroSCORE estimates of surgical mortality were 8.9% and 21.0%, respectively), 30-day mortality was 0%.
Conclusions: Technical and procedural advances in catheter systems and prosthetic valves designed for percutaneous aortic valve delivery may contribute to increased procedural success and improved clinical outcomes.