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内容記述 |
"被覆材として非生分解性材料を用いた新しい大口径人工血管(トリプレックス^[○!R],テルモ社製)が開発され,その有効性と安全性について検討した.対象症例は170名で,年齢は28〜85歳(69.0±10.0歳:平均値±標準偏差,以下同様)であった.術後12カ月の累積開存率は100.0%,拡張比は1.03±0.06(n=139)であった.手術時の操作性は,「良好」と評価された症例が75%以上を占めた.体温およびCRP,WBCの変動に関しては,退院時にはほぼ術前値に回復し,再上昇(再燃)は認められなかった.トリプレックス^[○!R]との因果関係が否定できない有害事象は33件発生したが,大部分は大動脈手術後の合併症として既知の事象であった.以上,トリプレックス^[○!R]は手術時に良好な操作性を示し,開存性,耐拡張性にも優れ,術後の炎症反応の遷延や再燃がみられない,大動脈用の人工血管として有用であることが確認された. We conducted a clinical study on a newly developed large diameter vascular graft (Triplex^[○!R], Terumo Corporation, Tokyo, Japan) with a non-biodegradable material used as sealing material, to evaluate its effectiveness and safety. Triplex^[○!R] grafts were implanted in 170 patients with either aneurysmal or occlusive arterial disease in either the thoracic artery, abdominal artery or iliac arteries, between October 2001 and March 2003. The patients consisted of 141 men and 29 women with an average age of 69.0±10.0 years old (mean±SD). In 82 patients, Triplex^[○!R] was implanted for the thoracic artery area, in 88, for the abdominal artery area. The cumulative graft patency rate 12 months after implantation was 100.0% in each area, there was no any abnormality such as occlusion or rupture from the trunk of Triplex^[○!R]. The distension ratio, which is the index of the dilatation resistance, was 1.03±0.06 as a whole (n=139), 1.03±0.06 in the thoracic artery area (n=73), 1.03±0.06 in the abdominal artery area (n=66). In other words the dilatation of Triplex^[○!R] was hardly observed. As manipulability during the operation, the following characteristics were evaluated ; anastomosis, resistance to fraying, hemorrhage, conformability with the host vessel. Triplex^[○!R] was evaluated as ""good"" in 75% of all items accounted for 75% or more. A transitory rise thought to be due to the surgical stress immediately after the operation because of the change of temperature and laboratory findings (CRP, WBC) between implantation and discharge was observed, but then recovered to the normal levels of each patients at discharge and the re-elevation was not recognized. In 90 patients, 277 adverse events occurred. Although in 33 adverse events in 21 patients a causal relation with Triplex^[○!R], could not be excluded, most of them were already known events as complications which could occur after operation on the aorta. Therefore, it was confirmed that Triplex^[○!R] has certain advantages : 1) good manipulability, 2) good patency and dilatation resistance, 3) no inflammatory reaction related to Triplex^[○!R], as a graft for the aorta." |
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