Mastrorilli Davide, Forcella Edoardo, Miccoli Tommaso, De Massari Chiara, Garriboli Luca
Department of Vascular Surgery, IRCCS Sacro Cuore-Don Calabria, Negrar, VR, Italy.
Department of Vascular Surgery, IRCCS Sacro Cuore-Don Calabria, Negrar, VR, Italy.
Ann Vasc Surg. 2025 Mar;112:246-252. doi: 10.1016/j.avsg.2024.12.040. Epub 2024 Dec 26.
ProGlide is a suture-mediated vascular closure device (VCD) indicated for retrograde access closure at the common femoral artery (CFA). However, its off-label use for antegrade and/or superficial femoral artery (SFA) access has become common in many practices. This study evaluated the efficacy and safety of ProGlide for femoral artery access closure in patients undergoing antegrade infrainguinal endovascular procedures.
In this single-center retrospective study, we analyzed data from patients with peripheral arterial disease (PAD) who underwent peripheral angioplasty between January 2017 and December 2023. The inclusion criteria were infrainguinal PAD disease, Rutherford classification 3 to 6, the use of an endovascular approach, and access performed through the ipsilateral antegrade femoral artery. The primary endpoint of the study was to evaluate the efficacy and technical success of the Perclose ProGlide closure device during antegrade percutaneous endovascular procedures. Secondary endpoints included intraoperative and postoperative inguinal and vascular complications.
A total of 301 participants were included in the study. All patients were classified according to the clinical categories of chronic limb ischemia: 111 patients (37%) had severe claudication (class 3) with walking distances of less than 20 meters, 42 patients (14%) had at least one limb with ischemic rest pain (class 4), and 148 patients (49%) had at least one limb with ischemic tissue loss (class 5 or 6). A 6 Fr introducer was used in the majority of cases (88%), with a mean hospital stay of 1.5 ± 0.5 days. Technical success was achieved in 298 patients (99%), and there were no early deaths. A total of 33 hematomas were identified, with 5 patients having major complications. One of these was treated with conservative management, while 4 patients required further interventions.
This retrospective study demonstrated the feasibility and safety of using the ProGlide single VCD for antegrade femoral puncture during infrainguinal endovascular interventions. The safety of its deployment can be further optimized by routinely utilizing ultrasound (US) guidance.
ProGlide是一种缝线介导的血管闭合装置（VCD），适用于股总动脉（CFA）逆行穿刺部位的闭合。然而，在许多临床实践中，其在顺行和/或股浅动脉（SFA）穿刺部位的超适应证使用已变得很常见。本研究评估了ProGlide在接受顺行性腹股沟下血管腔内手术患者中用于股动脉穿刺部位闭合的有效性和安全性。
在这项单中心回顾性研究中，我们分析了2017年1月至2023年12月期间接受外周血管成形术的外周动脉疾病（PAD）患者的数据。纳入标准为腹股沟下PAD疾病、卢瑟福分类3至6级、采用血管腔内入路以及通过同侧顺行股动脉进行穿刺。本研究的主要终点是评估Perclose ProGlide闭合装置在顺行性经皮血管腔内手术中的有效性和技术成功率。次要终点包括术中和术后腹股沟及血管并发症。
共有301名参与者纳入本研究。所有患者均根据慢性肢体缺血的临床分类进行分组：111例患者（37%）有严重间歇性跛行（3级），步行距离小于20米；42例患者（14%）至少有一条肢体出现静息痛（4级）；148例患者（49%）至少有一条肢体出现缺血性组织丢失（5级或6级）。大多数病例（88%）使用6F穿刺鞘，平均住院时间为1.5±0.5天。298例患者（99%）实现技术成功，无早期死亡病例。共发现33例血肿，5例患者出现严重并发症。其中1例采用保守治疗，4例患者需要进一步干预。
这项回顾性研究证明了在腹股沟下血管腔内干预期间使用ProGlide单一VCD进行顺行股动脉穿刺的可行性和安全性。通过常规使用超声（US）引导可进一步优化其应用的安全性。
