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.

DESIGN

Nonrandomized prospective human clinical trial.

SETTING

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

PATIENTS

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.

INTERVENTIONS

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.

MAIN 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.