Subclavian Approach Studied for TAVI With Medtronic's CoreValve System

July 6, 2010—According to Anna Sonia Petronio, MD, et al, a transsubclavian approach may be feasible for transcatheter aortic valve implantation (TAVI) in high-surgical-risk patients with severe aortic stenosis, whereas the standard retrograde approach through the femoral artery is contraindicated in case of unfavorable iliofemoral anatomy or extensive disease. The investigators published findings from their study using the subclavian approach online ahead of print in Circulation: Cardiovascular Interventions.

As detailed by the investigators, between June 2007 and July 2009, TAVI with the CoreValve bioprosthesis (Medtronic, Inc., Minneapolis, MN) was performed in 514 consecutive patients at 13 Italian hospitals, using the subclavian approach in 54 cases. The median logistic EuroSCORE was significantly higher in the subclavian group (19.4; interquartile range, 12.5–29.8) versus the femoral group (25.3; interquartile range, 15.1–36.6) (P = .03); the comorbidity rate was also higher in the subclavian group.

The investigators reported that procedural success was achieved in 100% of the subclavian group versus 98.4% of the femoral group (P = .62), with intraprocedural mortality rates of 0% versus 0.9%, respectively (P = 1). The most common in-hospital complications were a new left bundle-branch block (22.4%) and the need for a pacemaker (16.3%). No specific complications for the subclavian access (vessel rupture, vertebral or internal mammary ischemia) were reported. The learning curve for the subclavian approach led to a wider use of local anesthesia. The 30-day mortality rates were 0% versus 6.1% in the subclavian group versus the femoral group, respectively (P =.13). The 6-month mortality rates were 9.4% versus 15.8% (P = .44), whereas the valve-related adverse events rates were 13.6% versus 13.9% (P = .79).

TAVI through the subclavian approach appeared feasible and safe, with excellent procedural success and low in-hospital complication rates. This new technique allows patients with contraindications to the femoral approach to be treated with TAVI, the investigators concluded.