Experimental off-pump transventricular pulmonary valve replacement using a self-expandable valved stent: A new approach for pulmonary incompetence after repaired tetralogy of Fallot?

Objective: Off-pump valve replacement using self-expandable stents is an emerging technique for pulmonary valve disease. However, significant limitations are the lack of easily available valve substitute to be inserted within the stent and, in the setting of repaired tetralogy of Fallot, the existence of huge pulmonary trunk. We report the first experimental results of a transventricular approach using a decellularized porcine xenograft mounted in a self-expandable stent.

Methods: Pulmonary valve replacement was realized in 15 lambs by direct access of the infundibulum through a left thoracotomy, combined with pulmonary artery banding. Animals were followed by transthoracic echocardiography and, after control hemodynamic study, were electively killed either at day 7, month 1, or month 4 after implantation.

Results: Implantation succeeded in all lambs. Two animals died after implantation (1 pneumothorax and 1 endocarditis). Doppler echocardiographic follow-up did not show any significant transvalvular gradient and showed only mild pulmonary regurgitation. The hemodynamic control before termination revealed a systolic pulmonary valve gradient of 18.5 +/- 12.4 mm Hg at 1 week (n = 4), 13.5 +/- 10.6 mm Hg at 1 month (n = 4), and 4.3 +/- 4.9 mm Hg at 4 months (n = 5). Gross examination demonstrated the presence of connective tissue between the valved stent and pulmonary wall, which increased with time.

Conclusion: Fifteen lambs underwent successful deployment of a self-expandable valved stent in the pulmonary position using a transventricular approach. This technique combined with pulmonary artery banding could be a therapeutic option for pulmonary insufficiency after repair of tetralogy of Fallot with a transannular patch.