783-1 Dilatable Prosthesis for Banding the Main Pulmonary Artery in Children Human Clinical Trials

Abstract

The objective of this trial is to test the hypothesis that a prosthesis of this design can be dilated with an intraluminal balloon dilator and is as safe and effective to use as the conventional fixed fabric band. The design of this trial is that of a unicenter non-randomized prospective human clinical trial. The controls are historical. The indications for banding and the surgical techniques for implantation are those previously described and accepted for conventional fixed fabric bands. Dilatation employed techniques described and accepted for balloon pulmonary valvuloplasty. During the 57 months of this trial, 40 patients received the dilatable banding prosthesis. Banding was successful and uncomplicated. No migration of the prosthesis occurred. In only 1 patient was the band adjusted too tightly at implantation. The device was never adjusted too loosely. There were 11 deaths. None were related to the prosthesis. Dilatation was performed on 7 patients. This was successful in 6 and uncomplicated in all except 1 who developed a transient heart block. The dilatable band prosthesis was explanted readily and completely in all 27 patients during their definitive surgery. In 7 patients stenosis of a pulmonary artery branch developed as a result of distal implantation of the device. Balloon dilatation improved the stenosis in 2 of the patients. Surgical pulmonary artery angioplasty was performed mn all 15 patients having total correction (TC) and in 4 of the 12 patients who had a bidirectional Glenn procedure (BDGP) and Damus-Kaye-Stanzel connection (DKSC). The duration of banding of the patients who had (TC) was 31 to 1139 (mean 339) days. The duration of banding of the patients who had BDGP and DKSC was 88 to 594 (mean 215) days. The longest period of banding was 1640 days. Macroscopic and radiographic examination of all 28 explanted devices revealed no evidence of wear or damage. Scanning electron microscopic examination was conducted on 5 of the explanted devices which had been implanted 159 to 1139 (mean 422) days. One of the 5 had been successfully dilated. No component failure was identified. The materials remained inert. The dilatable band prosthesis is as safe and effective to use as the conventional fixed fabric band. It is more readily explanted completely and provides a safe non-surgical option for dilatation.