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Eur J Cardiothorac Surg. 2015 Nov;48(5):778-83; discussion 784. doi: 10.1093/ejcts/ezu524. Epub 2015 Jan 18.

Suprasternal direct aortic approach transcatheter aortic valve replacement avoids sternotomy and thoracotomy: first-in-man experience†.

Author information

1
University of North Carolina, Chapel Hill, NC, USA andy_kiser@med.unc.edu.
2
Henry Ford Hospital, Detroit, MI, USA.
3
University of Miami, Miami, FL, USA.
4
University of North Carolina, Chapel Hill, NC, USA.
5
Clinica de Occidente, Cali, Colombia.
6
Houston Methodist Medical Center, Houston, TX, USA.

Abstract

OBJECTIVES:

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.

KEYWORDS:

Direct-Aortic; Suprasternal; TAVR

PMID:
25602054
DOI:
10.1093/ejcts/ezu524
[Indexed for MEDLINE]

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