Comprehensive Assessment of the Safety, Durability, Clinical Performance, and Healing Characteristics of a Double Velour Knitted Dacron Arterial Prosthesis

Abstract

A resurgence of clinical reports documenting various modes of prosthetic graft failure have appeared recently in the literature. Increasing federal scrutiny and patient longevity make evaluation of graft durability and graft- related complications timely and imperative. Between October 1975 and February 1979, 298 patients underwent 310 arterial reconstructions using a single model of a porous double velour knitted Dacron graft. Average age was 61 ± 11 years (±SD) and males comprised 65% of the patient population. Two hundred forty-seven prosthetic grafts (80%) were used for aorto-iliac femoral reconstruction. Indications for operation included disabling claudi cation in 105 patients (35%), limb salvage in 71 patients (24%), aneurysm in 97 patients (33%), and other conditions in 25 patients. Follow-up averaged 1.8 years, extended to a maximum of 3.6 years, and yielded an aggregate of 475 graft-years of follow-up for analysis. Operative and late mortality rates were 10 and 10.8%, respectively; overall actuarial survival rate was 72 ± 4% (±SEM) at 3.1 years. Actuarial analysis showed that the probability of being free of unsalvageable graft thrombosis was 97 ± 1% at 1.7 years; of being free of graft infection, 96 ± 2% at 2.9 years; and of being free of major amputation, 95 ± 1% at 2.4 years. No late deaths or amputations were attributable to intrinsic graft failure, but one late death was related to reoperation for graft infection. Ongoing follow-up has failed to reveal any propensity for late graft dilatation, hemorrhage, or structural failure. Gross and histologic character istics of explanted grafts were uniformly favorable (in the absence of graft infection) including a thin, smooth, and translucent neointimal lining and densely adherent external encapsulation.