2-year results of CoreValve implantation through the subclavian access: a propensity-matched comparison with the femoral access

J Am Coll Cardiol. 2012 Aug 7;60(6):502-7. doi: 10.1016/j.jacc.2012.04.014. Epub 2012 Jun 20.

Abstract

Objectives: The goal of this study was 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.

Background: The subclavian approach with the CoreValve prosthesis (Medtronic, Inc., Minneapolis, Minnesota) represents an interesting opportunity when the femoral access is unfeasible.

Methods: 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.

Results: 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 2 groups showed similar procedural success (97.9% vs. 96.5%; p = 0.47), major vascular complications (5.0% vs. 7.8%; p = 0.33), life-threatening bleeding events (7.8% vs. 5.7%; p = 0.48), and combined safety endpoint (19.9% vs. 25.5%; p = 0.26). The subclavian group showed lower rates of acute kidney injury/stage 3 (4.3% vs. 9.9%; p = 0.02), of minor vascular complications at the 18-F sheath insertion site (2.1% vs. 11.3%; p = 0.003), and of all types of bleeding events related to vascular complications. Survival at 2 years was 74.0 ± 4.0% in the subclavian group compared with 73.7 ± 3.9% in the femoral group (p = 0.78). 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 = 0.84).

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

MeSH terms

  • Acute Kidney Injury / classification
  • Acute Kidney Injury / epidemiology
  • Aged
  • Aged, 80 and over
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / epidemiology
  • Aortic Valve Stenosis / surgery
  • Bundle-Branch Block / epidemiology
  • Female
  • Femoral Artery*
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / methods*
  • Heart Valve Prosthesis*
  • Hemorrhage / epidemiology
  • Humans
  • Male
  • Matched-Pair Analysis
  • Myocardial Infarction / epidemiology
  • Pacemaker, Artificial
  • Propensity Score
  • Registries
  • Stroke / epidemiology
  • Subclavian Artery*
  • Survival Analysis