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Updated: Aug 17, 2026

Transcatheter Pulmonary Valve Replacement from Autologous Pericardium with a Self-Expandable Nitinol Stent in an Adult Sheep Model
Published on: June 8, 2022
Direct-access valve replacement a novel approach for off-pump valve implantation using valved stents
Christoph H Huber1, Lawrence H Cohn, Ludwig K von Segesser
1Division of Cardiac Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
Objectives:
This study validates the off-pump antegrade transventricular route for ultrasound-guided direct-access aortic valved stent implantation.
Background:
Direct-access aortic valved stent implantation offers numerous advantages over the remote-access percutaneous approach and may one day provide an alternative to surgical aortic valve replacement.
Methods:
Valved stents were implanted off-pump in 12 pigs (68.5.0 +/- 7.3 kg) via direct-access transapical approach using a left-sided mini-thoracotomy and continuous ultrasonic and fluoroscopic guidance. Acute valved stent function was studied with intravascular and intracardiac ultrasound. All valved stents were tested in vitro before insertion. Macroscopic analysis was performed at necropsy.
Results:
In 8 of 12 pigs, valved stents were delivered to the target site over the native aortic valve leaflets without interference of coronary blood flow and with good acute valve function. Two valved stents were deployed and supra-annularly occluded the coronary orifice, leading to fatal outcome. Two valved stents dislodged into the left ventricle, one because of size mismatch and one that failed to unfold correctly.
Conclusions:
Twelve pigs underwent deployment of a valved stent in the aortic position. Six valves observed for an average 4.5-h period showed satisfactory postimplantation valve function.
