Dilatable prosthesis for banding the main pulmonary artery: human clinical trials

The objectives of this trial are to assess the safety and effectiveness of the prosthesis and to establish the ability of the dilatable band to provide a nonsurgical option for dilatation. Forty-six patients received dilatable bands. All had congenital heart defects requiring banding of the main pulmonary artery. Dilatation was performed on 7 patients. This was successful in 6 and uncomplicated in all. In one patient the dilatable band was adjusted too tightly at implantation. In one patient the band was adjusted to loosely. In 7 patients the dilatable band was placed too distally and partially obstructed the right or left pulmonary artery. Distal migration of the dilatable band after implantation did not occur. One band was distorted during implantation. This did not compromise its function. Surgical sepsis resulted in a mycotic aneurysm and erosion of the pulmonary artery in one patient. Surgical pulmonary arterioplasty was performed in all 18 patients who had total correction and in 11 of the 13 patients who had bidirectional Glenn procedure and Damus-Stanzell connection. There were 13 deaths. None of the deaths were related to the dilatable band. Thirty-two prostheses were surgically explanted readily and completely in 31 patients. Five bands were removed at postmortem examination. Examination of all 37 of the dilatable bands revealed no evidence of wear or damage. Scanning electron microscopy evaluation was conducted on 5 of the explanted devices which had been implanted 158 to 1139 (mean 422) days. No component failure was identified. The dilatable band prostheses was effective and safe and provided a non-surgical option for dilatation.