DILATABLE PROSTHESIS FOR BANDING THE MAIN PULMONARY-ARTERY - HUMAN CLINICAL-TRIALS

The objectives of this trial are to assess the safety and effectivenes s of the prosthesis and to establish the ability of the dilatable band to provide a nonsurgical option for dilatation. Forty-six patients re ceived dilatable bands. All had congenital heart defects requiring ban ding of the main pulmonary artery. Dilatation was performed on 7 patie nts. This was successful in 6 and uncomplicated in all. In one patient the dilatable band was adjusted too tightly at implantation. In one p atient the band was adjusted too loosely. In 7 patients the dilatable band was placed too distally and partially obstructed the right or lef t pulmonary artery. Distal migration of the dilatable band after impla ntation did not occur. One band was distorted during implantation. Thi s did not compromise its function. Surgical sepsis resulted in a mycot ic aneurysm and erosion of the pulmonary artery in one patient. Surgic al pulmonary arterioplasty was performed in all 18 patients who had to tal correction and in 11 of the 13 patients who had bidirectional Glen n procedure and Damus-Kaye-Stanzell connection. There were 13 deaths. None of the deaths were related to the dilatable band. Thirty-two pros theses were surgically explanted readily and completely in 31 patients . Five bands were removed at postmortem examination. Examination of al l 37 of the dilatable bands revealed no evidence of wear or damage. Sc anning electron microscopy evaluation was conducted on 5 of the explan ted devices which had been implanted 158 to 1139 (mean 422) days. No c omponent failure was identified. The dilatable band prostheses was eff ective and safe and provided a non-surgical option for dilatation.