title: Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve revalving system.
abstract: BACKGROUND
  Transcatheter aortic valve implantation (TAVI) is a new option for patients with severe aortic stenosis at high surgical risk. The standard retrograde approach through the femoral artery is contraindicated in case of unfavorable iliofemoral anatomy or extensive disease. In these patients, a trans-subclavian approach may be feasible.
  
  
  RESULTS
  Between June 2007 and July 2009, TAVI with the CoreValve bioprosthesis (Medtronic, Minneapolis, Minn) 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 (19.4; interquartile range, 12.5 to 29.8) versus femoral group (25.3; interquartile range, 15.1 to 36.6) (P=0.03), as well as the rate of comorbidities. Procedural success was obtained in 100% versus 98.4% of the subclavian versus femoral groups, respectively (P=0.62), with intraprocedural mortality of 0% versus 0.9% (P=1.00). The most common in-hospital complications were a new left bundle-branch block (22.4%) and the need for 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. Thirty-day mortality was 0% versus 6.1% in the subclavian versus femoral groups, respectively (P=0.13). Six-month mortality rate was 9.4% versus 15.8% (P=0.44), whereas valve-related adverse events were 13.6% versus 13.9% (P=0.79).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Cardiothoracic Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. as.petronio@gmail.com
authors.forename: Anna Sonia
authors.initials: AS
authors.lastname: Petronio
authors.forename: Marco
authors.initials: M
authors.lastname: De Carlo
authors.forename: Francesco
authors.initials: F
authors.lastname: Bedogni
authors.forename: Antonio
authors.initials: A
authors.lastname: Marzocchi
authors.forename: Silvio
authors.initials: S
authors.lastname: Klugmann
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.forename: Angelo
authors.initials: A
authors.lastname: Ramondo
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Ussia
authors.forename: Federica
authors.initials: F
authors.lastname: Ettori
authors.forename: Arnaldo
authors.initials: A
authors.lastname: Poli
authors.forename: Nedy
authors.initials: N
authors.lastname: Brambilla
authors.forename: Francesco
authors.initials: F
authors.lastname: Saia
authors.forename: Federico
authors.initials: F
authors.lastname: De Marco
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000473:pathology / Q000601:surgery; D002037:Bundle-Branch Block / Q000209:etiology*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D023903:Coronary Restenosis / Q000209:etiology* / Q000473:pathology / Q000503:physiopathology / Q000517:prevention & control; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000473:pathology / Q000601:surgery; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D006801:Humans; D008297:Male; D011183:Postoperative Complications; D011446:Prospective Studies; D013348:Subclavian Artery / Q000473:pathology / Q000601:surgery*; D016019:Survival Analysis