Haberman Dan, Czulada Evan, Lupu Lior, Chitturi Kalyan R, Abusnina Waiel, Chaturvedi Abhishek, Merdler Ilan, Galo Jason, Verma Beni R, Wallace Ryan, Rogers Toby, Ben-Dor Itsik, Waksman Ron, Bernardo Nelson L
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, USA.
Georgetown University School of Medicine, Washington, USA.
Catheter Cardiovasc Interv. 2025 Aug;106(2):1078-1087. doi: 10.1002/ccd.31598. Epub 2025 Jun 2.
Large-bore arterial access (LBAA) closure for percutaneous interventional procedures is often achieved using suture-based vascular closure devices (VCDs), most commonly Perclose ProGlide (Abbott Vascular, Santa Clara, CA). Although the rate of vascular occlusion due to suture-based VCDs is rare, there is no widely accepted percutaneous bailout treatment for this device-related complication.
This investigation sought to evaluate the percutaneous treatment of suture-based VCD-mediated closure in vivo and explain its mechanism with an ex vivo benchtop model.
This retrospective cohort study focused on patients who underwent LBAA closure complicated by vascular occlusion related to the Perclose VCD. These were managed through percutaneous endovascular interventions (PEI), in which the identified occlusions were treated using a peripheral cutting balloon. Additionally, a benchtop model utilizing silicone tubing was developed to simulate the occlusion mechanism caused by the Perclose VCD and to compare the use of non-compliant versus cutting balloons in this context.
A 6 mm cutting balloon successfully cut the monofilament polypropylene at 3 atmospheres (ATM), whereas a 5 mm non-compliant balloon failed, even at a burst pressure of 24 ATM. In this patient cohort, seven patients were found to have common femoral artery (CFA) occlusion following the tightening of the previously deployed Perclose VCD. The median age was 87 years (interquartile range: 80-87), 71% were female, and had significant cardiovascular risk factors. All patients were diagnosed with CFA occlusion at the end of the transcatheter aortic valve replacement procedure during aortoiliac angiography, following vascular closure. PEI was performed using a combined cutting balloon and balloon angioplasty approach across the entire patient cohort with complete revascularization, minimal residual stenosis, no severe complications, no covered stents required, and no reported conversions to surgery. Long-term follow-up in six patients showed no reinterventions required or related mortalities.
Based on the findings from our ex vivo model and clinical experience, peripheral cutting balloon angioplasty should be considered for the management of vessel occlusion caused by suture-based VCD.
经皮介入手术中的大口径动脉通路（LBAA）闭合通常使用基于缝线的血管闭合装置（VCD）来实现，最常用的是Perclose ProGlide（雅培血管，加利福尼亚州圣克拉拉）。尽管基于缝线的VCD导致血管闭塞的发生率很低，但对于这种与装置相关的并发症，尚无广泛接受的经皮补救治疗方法。
本研究旨在评估基于缝线的VCD介导的闭合在体内的经皮治疗，并通过体外台式模型解释其机制。
这项回顾性队列研究聚焦于接受LBAA闭合且并发与Perclose VCD相关的血管闭塞的患者。这些患者通过经皮血管内介入治疗（PEI）进行处理，其中使用外周切割球囊治疗已确定的闭塞。此外，还开发了一种利用硅胶管的台式模型，以模拟Perclose VCD引起的闭塞机制，并比较在此情况下使用非顺应性球囊与切割球囊的效果。
一个6毫米的切割球囊在3个大气压（ATM）下成功切断了单丝聚丙烯，而一个5毫米的非顺应性球囊即使在24 ATM的爆破压力下也未能成功。在这个患者队列中，7名患者在收紧先前部署的Perclose VCD后出现股总动脉（CFA）闭塞。中位年龄为87岁（四分位间距：80 - 87岁），71%为女性，且有显著的心血管危险因素。所有患者在血管闭合后的经导管主动脉瓣置换手术结束时，在腹主动脉造影期间被诊断为CFA闭塞。整个患者队列均采用切割球囊和球囊血管成形术联合的方法进行PEI，实现了完全血管再通，残余狭窄最小，无严重并发症，无需覆膜支架，也无转为手术治疗的报告。对6名患者的长期随访显示无需再次干预，也无相关死亡病例。
基于我们体外模型的研究结果和临床经验，对于基于缝线的VCD导致的血管闭塞，应考虑采用外周切割球囊血管成形术进行处理。
