The Oxford Transplant Centre, Churchill Hospital, Old Road, Headington, Oxford, OX3 7LE, UK.
Queen Elizabeth University Hospital, Glasgow, UK.
Cardiovasc Intervent Radiol. 2021 Dec;44(12):1903-1913. doi: 10.1007/s00270-021-02953-8. Epub 2021 Sep 12.
This prospective, observational first in human study evaluated the safety and effectiveness of WRAPSODY Cell-impermeable Endoprosthesis (Merit Medical Systems, Inc.) in the treatment of arteriovenous fistula and arteriovenous graft access circuit stenosis.
Investigators conducted a prospective analysis of 46 patients with access circuit stenosis from three centres. Treatment sites included the peripheral outflow veins (e.g. cephalic arch, basilic vein swing point; 16 fistula and 10 graft patients); the graft-vein anastomosis (9 patients); and the central veins (up to, but not including the SVC; 11 patients). Primary outcome measures included 30-day freedom from access circuit-related safety events and 30-day target lesion primary patency. Secondary outcome measures included procedural success; device- and procedure-related adverse events; target lesion primary patency; access circuit primary patency; and secondary patency. In-person follow-up was scheduled at 1, 3, 6, and 12 months. An independent data monitoring/clinical event committee adjudicated all reinterventions and device/procedure-relatedness for adverse events.
All initial procedures were successful. All but one patient was free from safety events through the first 30 days (97.8% (45/46)). This event was not device-related. Over the remainder of the study, one adverse event was adjudicated as possibly device-related. Six- and 12-month target lesion primary patency rates were 97.7% (42/43) and 84.6.% (33/39), respectively. Six- and 12-month access circuit primary patency rates were 84.4% (38/45) and 65.9% (29/44), respectively.
Results suggest that the study device is safe and effective for treatment of stenoses in the peripheral and central veins of arteriovenous access circuits.
Level 2b, cohort study.
本前瞻性、观察性首例人体研究评估了 WRAPSODY 细胞不可渗透的内假体（美敦力公司）在治疗动静脉瘘和动静脉移植物通路狭窄中的安全性和有效性。
研究人员对来自三个中心的 46 名通路狭窄患者进行了前瞻性分析。治疗部位包括外周流出静脉（例如头静脉弓、贵要静脉摆动点；16 名瘘管和 10 名移植物患者）；移植物-静脉吻合口（9 名患者）；和中心静脉（至但不包括上腔静脉；11 名患者）。主要终点包括 30 天无通路相关安全事件和 30 天目标病变主要通畅率。次要终点包括手术成功率；器械和程序相关不良事件；目标病变主要通畅率；通路主要通畅率；和次要通畅率。计划在 1、3、6 和 12 个月进行现场随访。一个独立的数据监测/临床事件委员会对所有再介入和器械/程序相关不良事件进行了裁决。
所有初始手术均成功。除 1 例患者外，所有患者在第 30 天前均无安全事件（97.8%（45/46））。该事件与器械无关。在研究的其余时间内，1 例不良事件被判定为可能与器械有关。6 个月和 12 个月时的目标病变主要通畅率分别为 97.7%（42/43）和 84.6%（33/39）。6 个月和 12 个月时的通路主要通畅率分别为 84.4%（38/45）和 65.9%（29/44）。
结果表明，该研究器械治疗动静脉通路的外周和中心静脉狭窄是安全有效的。
2b 级，队列研究。
