Published 2-Year Results Support Subclavian Access for CoreValve Implantation

June 20, 2012—Online ahead of print in the Journal of the American College Cardiology, Anna Sonia Petronio, MD, et al published findings from a study that sought to assess the procedural and 2-year results of the subclavian approach for transcatheter aortic valve implantation (TAVI) compared with those of the femoral approach by using propensity-matched analysis.

The investigators stated that the background of the study is that the subclavian approach with the CoreValve prosthesis (Medtronic, Inc., Minneapolis, MN) represents an interesting opportunity when the femoral access is unfeasible. Initial data from the study were presented at EuroPCR on May 19, 2011, which was reported in Cardiac Interventions Today.

As detailed in the Journal of the American College Cardiology, all consecutive patients enrolled in the Italian CoreValve Registry who underwent TAVI with the subclavian approach were included. Propensity score analysis was used to identify a matching group of patients undergoing femoral TAVI.

The investigators reported that the subclavian approach was used in 141 patients (61% men; median age, 83 years; median logistic European System for Cardiac Operative Risk Evaluation score, 23.7%). The femoral group of 141 patients was matched for baseline clinical characteristics, except for peripheral artery disease. The two groups showed similar procedural success (97.9% vs 96.5%; P = .47), major vascular complications (5% vs 7.8%; P = .33), life-threatening bleeding events (7.8% vs 5.7%; P = .48), and combined safety endpoint (19.9% vs 25.5%; P = .26). The subclavian group showed lower rates of acute kidney injury/stage 3 (4.3% vs 9.9%; P = .02), minor vascular complications at the 18-F sheath insertion site (2.1% vs 11.3%; P = .003), and all types of bleeding events related to vascular complications. Survival at 2 years was 74% ± 4% in the subclavian group compared with 73.7% ± 3.9% in the femoral group (P = .78). The 2-year freedom from cardiovascular death was 87.2% ± 3.1% versus 88.7% ± 2.8% in the subclavian versus femoral group, respectively (P = .84).

The investigators concluded that the subclavian approach for TAVI is safe and feasible, with procedural and medium-term results similar to the femoral approach. They stated that subclavian access should be considered a valid option not only when the femoral approach is impossible but also when it is difficult, albeit feasible.