title: Suprasternal direct aortic approach transcatheter aortic valve replacement avoids sternotomy and thoracotomy: first-in-man experience†.
abstract: OBJECTIVE
  Direct aortic deployment of a transcatheter aortic valve eliminates the need to traverse the aortic arch with the valve delivery system, enables placement of large sheaths in the aorta and innominate artery, provides maximal precision during deployment and ensures a safe, conventional surgical aortotomy closure. We describe the initial experience with the Suprasternal Aortic Access System (SuprAA System, Aegis Surgical Ltd, Dublin, Ireland) for direct transaortic/innominate valve delivery.
  
  
  METHODS
  Patients with severe, symptomatic aortic stenosis who were candidates for transcatheter aortic valve replacement (TAVR) via a direct transaortic approach were enrolled in the SuprAA-TAVR First-in-Man Study. Under general anaesthesia, the innominate artery and aortic arch were exposed in each patient, using the SuprAA System via a 2.5-cm incision directly above the sternal notch. The TAVR delivery sheath was positioned and the transcatheter valve deployed routinely under fluoroscopic guidance. Upon sheath removal, haemostasis at the aortotomy site was confidently secured using a double purse-string suture closure. All were extubated immediately. A meta-analysis of the direct aortic approach was done for comparison.
  
  
  RESULTS
  Four male patients (mean 82.5 years) underwent SuprAA-TAVR (2 CoreValve; 2 SAPIEN). Anatomical visualization was excellent and suprasternal valve deployment was accurate regardless of sheath size with 100% Valve Academic Research Consortium-2 procedural success. The average total procedure time was 109.5 min without perioperative wound or vascular complications.
  
  
  CONCLUSIONS
  The SuprAA System provides direct aortic/innominate access without sternal or thoracotomy incision. Patient recovery to normal activity is maximized, sheath size limitations are eliminated and valve deployment is precise. This innovative system creates a new and exciting minimally invasive approach for high-risk patients with aortic stenosis.
authors.affiliation: University of North Carolina, Chapel Hill, NC, USA andy_kiser@med.unc.edu.
authors.forename: Andy C
authors.initials: AC
authors.lastname: Kiser
authors.affiliation: Henry Ford Hospital, Detroit, MI, USA.
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
authors.affiliation: University of Miami, Miami, FL, USA.
authors.forename: Eduardo
authors.initials: E
authors.lastname: de Marchena
authors.affiliation: University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Stack
authors.affiliation: Clinica de Occidente, Cali, Colombia.
authors.forename: Mauricio
authors.initials: M
authors.lastname: Zarate
authors.affiliation: Clinica de Occidente, Cali, Colombia.
authors.forename: Antonio
authors.initials: A
authors.lastname: Dager
authors.affiliation: Houston Methodist Medical Center, Houston, TX, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Reardon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery; D004867:Equipment Design; D006801:Humans; D008297:Male; D009873:Operating Rooms; D013249:Sternum / Q000601:surgery*; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation* / Q000379:methods*
keywords: Direct-Aortic; Suprasternal; TAVR