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Efficacy and safety associated with the use of the Surfacer® Inside-Out® Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.

与使用表面活性剂相关的疗效和安全性®由内向外®接入导管系统: 来自一项前瞻性、多中心食品和药物管理局批准的研究性装置豁免研究的结果。

  • 影响因子:1.12
  • DOI:10.1177/1129729820937121
  • 作者列表:"Razavi MK","Peden EK","Sorial E","Ross JR","Aruny JE","Pflederer TA","Wasse H","Haskal ZJ
  • 发表时间:2021-01-01
Abstract

PURPOSE:Thoracic central venous obstruction is commonly associated with the use of central venous catheters. The Surfacer System to Facilitate Access in Venous Occlusions Study was an Food and Drug Administration-approved US Investigational Device Exemption study designed to evaluate the performance and safety of the Surfacer System when used to facilitate central venous access in patients with thoracic central venous obstruction. METHODS:Thirty patients were enrolled in this prospective, multicenter, single-arm study between December 2017 and May 2019. Device performance and adverse events were collected peri-procedurally and at discharge. Enrollment included 15 female and 15 male subjects with a mean age of 55.5 ± 12.9 (range: 30-79) years. Twenty-eight patients (93.3%) required central venous access for hemodialysis access. Locations of thoracic central venous obstruction were graded from 1 to 4 based on severity and extension of venous occlusions. Seven patients (23.3%) had type 1, 6 (20.0%) type 2, 16 (53.3%) type 3, and 1 (3.3%) type 4 obstruction. RESULTS:Successful central venous catheter placement was achieved in 27 of 30 patients (90.0%). The procedure was discontinued in three (10.0%) due to tortuous anatomy discovered intraprocedurally. All 27 patients with successful CVC placement achieved adequate catheter patency and tip positioning with a mean overall procedural time and time to achieve central venous access with the Surfacer System being 44.1 ± 30.6 and 19.1 ± 25.1 min, respectively. There were no device-related adverse events or catheter malposition. CONCLUSION:The results of the SAVEUS Study confirm the safety and efficacy of the Surfacer System and the Inside-Out procedure when used for the placement of right-sided central venous access in patients with thoracic central venous obstruction.

摘要

目的: 胸腔中心静脉阻塞通常与中心静脉导管的使用有关。Surfacer系统促进静脉闭塞的通路研究是美国食品和药物管理局批准的美国研究性设备豁免研究,旨在评估Surfacer系统在用于促进胸腔中心静脉阻塞患者的中心静脉通路时的性能和安全性。 方法: 在2017年12月至2019年5月期间,本前瞻性、多中心、单臂研究纳入了30例患者。在手术期间和出院时收集器械性能和不良事件。招募包括15名女性和15名男性受试者,平均年龄为55.5 ± 12.9 (范围: 30-79) 岁。28例患者 (93.3%) 需要中心静脉通路进行血液透析通路。根据静脉阻塞的严重程度和扩展程度,胸部中心静脉阻塞的位置从1到4级。1型7例 (23.3%),2型6例 (20.0%),3型16例 (53.3%),4型1例 (3.3%)。 结果: 30例患者中27例 (90.0%) 成功置入中心静脉导管。由于术中发现弯曲的解剖结构,3例 (10.0%) 停止了手术。所有27例成功置入CVC的患者均获得足够的导管通畅和尖端定位,平均总手术时间和使用Surfacer系统获得中心静脉通路的时间分别为44.1 ± 30.6和19.1 ± 25.1 min。没有装置相关的不良事件或导管错位。 结论: SAVEUS研究的结果证实了Surfacer系统和由内而外的程序在胸部中心静脉阻塞患者中用于放置右侧中心静脉通路时的安全性和有效性。

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