Human clinical trials of the dilatable pulmonary artery banding prosthesis.
OBJECTIVE
To test the hypothesis that the dilatable pulmonary artery banding prosthesis is as effective and safe to use as conventional fixed fabric bands, and provides an additional nonsurgical option for dilation.


METHODS
Nonrandomized prospective human clinical trial.


METHODS
British Columbia's Children's Hospital for tertiary care.


METHODS
All patients admitted with congenital heart defects who required banding of the pulmonary artery during a 17 month period. The patients who received a dilatable band were selected on the basis of their cardiologist's preference.


METHODS
Surgical banding was performed using accepted techniques. Intraluminal balloon dilation of the pulmonary artery band was done using techniques accepted for intraluminal balloon dilation in pulmonary valvuloplasty.


RESULTS
Eleven patients received the dilatable bands and eight received fixed bands. There was no evidence of failure of the bands to maintain their function. One patient required intraluminal balloon dilation of the dilatable band. This was successfully accomplished without complication. The dilatable bands were easier to remove than the fixed bands, but required greater surgical dexterity to place and adjust. One of the dilatable bands was applied too distally and one too tightly. One fixed band was applied too tightly and another too loosely, requiring a second banding operation.


CONCLUSIONS
The dilatable pulmonary artery banding prosthesis is as effective and safe to use as a fixed fabric band. It is easier to remove and provides a nonsurgical option for dilation.
Vince
D J
DJ
University of British Columbia, Vancouver.
Culham
J A
JA
LeBlanc
J G
JG
D001807:Blood Vessel Prosthesis; D006348:Cardiac Surgical Procedures / Q000379:methods; D006330:Heart Defects, Congenital / Q000601:surgery*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D011446:Prospective Studies; D011474:Prosthesis Design; D011651:Pulmonary Artery / Q000601:surgery*