Subclavian access feasible and safe with transcatheter device

Published date : 19 July 2010
Article date : 19 July 2010

In patients undergoing transcatheter aortic valve implantation (TAVI), subclavian access may be feasible for those with anatomical or disease characteristics that discourage the standard femoral approach. The new technique appears to be associated with high rates of procedural success and few in-hospital complications, reports a study published online July 6, 2010, ahead of print in Circulation: Cardiovascular Interventions.

Study design

Researchers led by Dr Anna Sonia Petronio, University of Pisa (Pisa, Italy), and colleagues looked at 514 consecutive patients who underwent TAVI using the CoreValve device (Medtronic) from June 2007 to July 2009 at 13 Italian hospitals. Among this cohort, 54 were treated with the subclavian approach at ten of the participating centres (mean of 5.4 patients treated per hospital). The majority of patients (n = 460) underwent femoral access.

According to the researchers, surgical risk was high in the overall study population, as evidenced by the mean logistic EuroSCORE of 20.1. Patients in the subclavian group had higher mean EuroSCORE and higher rates of comorbidities including PAD, CAD, carotid artery stenosis, prior MI, and prior PCI than those in the femoral group. However, subclavian patients were less likely to be New York Heart Association (NYHA) Class III/IV.

Clinical follow-up was obtained for a median of 6.9 months. At 30 days and six months, adverse event rates did not differ between the groups. Mortality was similar with subclavian and femoral access through six months. MACCE rates were primarily driven by mortality; stroke was almost always fatal while MI and reintervention were rare. Major bleeding and valve-related events occurred at equal rates regardless of access route.

Overall, improvement in NYHA functional class was “remarkable”, the researchers comment. At 30 days, 82% of the femoral group and 77.8% of the subclavian group showed at least a 1-class increase. This improvement was sustained at six months in 80.9% and 78.1% of patients, respectively.

Based on their findings, “vascular access through the subclavian artery can be considered a valid strategy in patients with contraindications to the femoral approach, allowing for enlargement of the eligibility for TAVI with the CoreValve,” Petronio and colleagues concluded.

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