Objective: To evaluate the differences between non-circular shape of FloWatch-PAB and conventional pulmonary artery (PA) banding.
Methods: Geometrical analysis. Conventional banding and FloWatch-PAB perimeters were plotted against cross-sections. Computational fluid dynamics (CFD) model. CFD compared non-circular FloWatch-PAB cross-sections with conventional banding regarding pressure gradients. Clinical data. Seven children, median age 2 months (7 days to 3 years), median weight 4.2 kg (3.2-9.8 kg), with complex congenital heart defects underwent PA banding with FloWatch-PAB implantation.
Results: Geometrical analysis. Conventional banding: progressive reduction of cross-sections was accompanied by progressive reduction of PA perimeters. FloWatch-PAB: with equal reduction of cross-sections the PA perimeter remained constant. CFD model. Non-circular and circular banding provided same trans-banding pressure gradients for same cross-sections at any given flow. Clinical data. Mean PA internal diameter at banding was 13.3+/-4.5 mm. After a mean interval of 5.9+/-3.7 months, all children underwent intra-cardiac repair and simple FloWatch-PAB removal without PA reconstruction. Mean PA internal diameter with FloWatch-PAB removal increased from 3.0+/-0.8 to 12.4+/-4.5 mm (normal mean internal diameter for the age=9.9+/-1.6). No residual pressure gradient was recorded in correspondence of the site of the previous FloWatch-PAB implantation in 6/7 patients, 10 mmHg peak and 5 mmHg mean gradient in 1/7.
Conclusions: The non-circular shape of FloWatch-PAB can replace conventional circular banding with the following advantages: (a) the pressure gradient will remain essentially the same as for conventional circular banding for any given cross-section, but with significantly smaller reduction of PA perimeter; and (b) PA reconstruction at the time of de-banding for intra-cardiac repair can be avoided.