Burgess Jason S, Beaver Jason D, London Mark, Rohan Vinayak, Orland Paul, Yevzlin Alexander, Setum Cindy, Ross John
Surgical Specialists of Charlotte, Charlotte, NC, USA.
Flowers Hospital/Department of Surgery, Dothan, AL, USA.
J Vasc Access. 2024 Jul;25(4):1244-1251. doi: 10.1177/11297298231159691. Epub 2023 Mar 9.
The traditional sutured venous anastomosis used during arteriovenous graft implantation is associated with a high incidence of subsequent stenosis that is attributed to neointimal hyperplasia. Hyperplasia results from multiple factors, including hemodynamic abnormalities and vessel trauma during implantation. A novel anastomotic connector device was designed to provide an alternative, less traumatic, endovascular venous anastomosis that may ameliorate the clinical challenges associated with a sutured anastomosis. A prospective single-arm multicenter study was performed to evaluate safety and effectiveness of graft implantation using the study device.
Patients requiring graft creation and who met the study criteria were enrolled between February 2018 and July 2021 and observed for 6 months. Collected data included baseline characteristics, graft patency and use for hemodialysis, graft interventions, and adverse events. The primary study endpoint was cumulative graft patency, compared to a pre-specified Performance Goal of 75%. Secondary endpoints included primary unassisted patency and serious adverse events, defined as the occurrence of death, graft infection, emergent surgery, significant bleeding, and pseudoaneurysm.
A total of 158 patients were enrolled from 10 study sites, among which 144 subjects were evaluable at 6 months and 14 were censored with partial follow-up observation. Three patients died and the graft was abandoned in 12. The primary endpoint was met (-value < 0.001). By Kaplan Meier survival analysis, cumulative patency was 92.08% with a lower 95% Confidence Bound of 86.98%. Primary unassisted patency was 60.21% with a lower 95% Confidence Bound of 50.84%. Graft infections occurred in six patients, all unrelated to the study device. There were no reports of emergent surgery, significant bleeding or pseudoaneurysm.
These results demonstrate that the study device can be used for successful endovascular anastomosis of a vein to a graft for hemodialysis, with acceptable cumulative patency and safety profile at 6 months.
ClinicalTrials.gov Identifier: NCT02532621.
动静脉移植物植入过程中使用的传统缝合静脉吻合术与随后较高的狭窄发生率相关，这种狭窄归因于内膜增生。增生由多种因素引起，包括血流动力学异常和植入过程中的血管创伤。一种新型吻合连接装置被设计出来，以提供一种创伤较小的替代性血管内静脉吻合术，这可能改善与缝合吻合术相关的临床挑战。进行了一项前瞻性单臂多中心研究，以评估使用该研究装置进行移植物植入的安全性和有效性。
2018年2月至2021年7月期间，纳入了需要创建移植物且符合研究标准的患者，并对其进行了6个月的观察。收集的数据包括基线特征、移植物通畅情况及用于血液透析的情况、移植物干预措施和不良事件。主要研究终点是累积移植物通畅率，与预先设定的75%的性能目标进行比较。次要终点包括初次无辅助通畅率和严重不良事件，严重不良事件定义为死亡、移植物感染、急诊手术、严重出血和假性动脉瘤的发生。
从10个研究地点共纳入了158例患者，其中144例受试者在6个月时可进行评估，14例进行了部分随访观察后被剔除。3例患者死亡，12例移植物被废弃。达到了主要终点（P值<0.001）。通过Kaplan Meier生存分析，累积通畅率为92.08%，95%置信区间下限为86.98%。初次无辅助通畅率为60.21%，95%置信区间下限为50.84%。6例患者发生移植物感染，均与研究装置无关。没有急诊手术、严重出血或假性动脉瘤的报告。
这些结果表明，该研究装置可用于成功地进行静脉与血液透析移植物的血管内吻合，在6个月时具有可接受的累积通畅率和安全性。
ClinicalTrials.gov标识符：NCT02532621。
