
==== Front
Sci Prog
Sci Prog
SCI
spsci
Science Progress
0036-8504
2047-7163
SAGE Publications Sage UK: London, England

39279272
10.1177/00368504241278481
10.1177_00368504241278481
Medicine & Health Sciences
Endovascular Perclose ProGlide complication puncture site, treated successful by cutting balloon dilatation: A case report and literature review
Huang Yulong 1
Xie Xinsheng 1
https://orcid.org/0000-0002-1379-3906
Wang Lixin 12
1 Department of Vascular Surgery, Xiamen Branch of Zhongshan Hospital, Fudan University, Xiamen, China
2 Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China
YH and XX have equal contribution to this work.

Lixin Wang, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Fenglin Road 180, Xuhui District, Shanghai 200032, China. Email: wang.lixin@zs-hospital.sh.cn
15 9 2024
Jul-Sep 2024
107 3 00368504241278481© The Author(s) 2024
2024
SAGE Publications
https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
Perclose ProGlide were created as preferred for puncture site closure of femoral artery. Femoral artery occlusion is one of the serious device-related complications. This report presents a continuous endovascular technique combined with peripheral cutting balloon (PCB) treatment for a case of a 32s woman diagnosed with lower extremity ischaemia caused by right superficial femoral artery (SFA) occlusion following the use of the Perclose ProGlide system in minimally invasive cardiac surgery. During the primary operation, limb ischaemia symptoms were relieved with vessel perfusion and reconstruction after regular balloon dilatation. A secondary operation was conducted 6 weeks later, and the obstructive lesions were recanalised without residual stenosis after PCB dilatation. No vessel-related adverse events such as dissection, rupture or distal embolisation occurred during the perioperative period. The patient recovered uneventfully after the operation, with complete alleviation of symptoms. Follow-up computed tomography angiography 3 month post-operatively revealed an undeformed shape and excellent patency of the right SFA.

Peripheral cutting balloon
Perclose ProGlide
vascular closure devices
superficial femoral artery
occlusive lesions
endovascular treatment
Xiamen Medical and Health Guidance Project 3502220214201062 Xiamen Medical and Health Guidance Project 3502220214201088 National Natural Science Foundation of China https://doi.org/10.13039/501100001809 81970412 typesetterts19
cover-dateJuly-September 2024
==== Body
pmcIntroduction

The common femoral artery (CFA) is the most commonly used access point for endovascular punctures. Vascular closure devices (VCDs) are associated with a shorter time to achieve haemostasis, decreased perioperative time, improved patient comfort and a lower potential risk for haemorrhage and haematoma after anti-coagulant or anti-platelet use.1,2 Perclose ProGlide were created as a preferred for puncture site closure of femoral artery following various endovascular procedures like endovascular aneurysm repair (EVAR) or thoracic EVAR. 3 Potential puncture site-related complications associated with the use of suture-mediated closure devices include stenosis, occlusion, haemorrhage, haematoma and pseudoaneurysm. 4 We report a continuous endovascular technique for a case of superficial femoral artery (SFA) occlusion following the use of the Perclose ProGlide suture-mediated closure system (Abbott Vascular Inc., Santa Clara, CA, USA) in minimally invasive cardiac surgery.

Case

Patient presentation

A 32s woman complained of pain and cold sensation in the right lower extremity after the use of the Perclose ProGlide system in minimally invasive cardiac surgery 2 weeks later. The patient was admitted to the Xiamen Branch of Zhongshan Hospital of Fudan University in December 2022.Computed tomographic angiography (CTA) with retrospective electrocardiographic gating technology confirmed the presence of occlusive lesions in the right SFA (Figure 1(a) and (b)).

Figure 1. Preoperative CTA scans of a peripheral artery occlusion and postoperative CTA at 3 month's follow up demonstrated the patency of the SFA. (a) and (b) CTA 3D reconstruction image showing the occlusive lesions of right SFA (indicated by the white arrow). (c) and (d) CTA 3D reconstruction image demonstrated undeformed shape and excellent patency of the right SFA (indicated by the white arrow). 3D: three-dimensional; CTA: computed tomography angiography; SFA: superficial femoral artery.

Treatment

The procedures were performed under local anaesthesia in a catheterisation room. Left femoral artery access was established using the Seldinger puncture technique with ultrasonic guidance and manual compression was performed after operation completed. Aortic angiography was performed, which confirmed the presence of a local occlusive lesion in the right SFA without thrombosis (Figure 2(a)). A linear blood flow perfusion and severe residual stenosis post 4.0 × 40 mm balloon (Cordis Corporation, Miami Lakes, FL, USA) dilatation (Figure 2(b)). The secondary intervention was conducted 6 weeks later (Figure 2(c)), and a 2.5 × 40 mm regular balloon (Polyrey Medical, Suzhou, Jiangsu, China) was placed into the lesion for pre-dilation (Figure 2(d)). The lesion was then dilated with a 5.0 × 20 mm peripheral cutting balloon (PCB) (Boston Scientific, Watertown, MA, USA) (Figure 2(e)) and a 5.0 × 40 mm high-pressure balloon (Boston Scientific, Watertown, MA, USA). Immediately and 15 min later, angiography confirmed an excellent result with no residual stenosis. No other vascular complications occurred, including dissection, rupture or distal embolisation (Figure 2(f)).

Figure 2. DSA imaging of primary ((a) and (b)) and secondary ((c)–(f)) intervention. (a) The occlusive lesions of the right SFA occlusion (indicated by the black arrow). (b) The liner flow after regular balloon dilatation performed (indicated by the black arrow). (c) The liner perfusion was observed after primary operation 2 weeks later (indicated by the black arrow). (d) The DSA imaging after small diameter regular balloon dilatation (indicated by the black arrow). (e) The PCB dilatation performed (indicated by the black arrow). (f) The DSA imaging after PCB and high-pressure balloon dilatation (indicated by the black arrow). DSA: Digital subtraction angiography; PCB: peripheral cutting balloon; SFA: superficial femoral artery.

Results

After the primary endovascular treatment for the occlusion lesions of SFA, limb ischaemia symptoms were alleviated with vessel reperfusion, and the Ankle Brachial Index increased to 0.74. A secondary operation was conducted 6 weeks later, and the obstructive lesions were recanalised without residual stenosis after PCB dilatation.

Follow up

At the 3 months follow up after the secondary intervention, the patient was entirely free of calf fatigue and intermittent claudication symptoms and had resumed full activity; CTA demonstrated an undeformed shape and excellent patency of the right SFA (Figure 1(c) and (d)).

Discussion

VCDs have since been recommended to achieve faster haemostasis, decrease the perioperative period, increase patient comfort and decrease puncture site-related complications.5–7 The Perclose ProGlide is a second-generation suture-mediated VCD containing a single 3-0 monofilament polypropylene suture with an unbraided, preformed slipknot, which is currently widely used and is considered to be a safe and effective device. 8 The current literature demonstrates that device failure rates can be attributed to several risk factors, including sheath size, artery diameter, presence of calcification, operator inexperience, inappropriate puncture, obesity, scar tissue in the groin area and the anatomical relationship of bifurcations of the CFA and inguinal ligament. 9 Lower limb ischaemia attributed to device-related arterial stenosis or occlusion threatens limb viability and requires arteriotomy or endovascular intervention. The Perclose ProGlide system has been approved for use in patients who have undergone catheterisation procedures using 5F to 21F sheaths. The safety and efficacy of these devices have not been verified in patients with vessel sizes of less than 5 mm. Chen et al. 10 recommended that the femoral artery diameter should be greater than 6 mm. Lee et al. 11 report two cases of acute femoral artery occlusion following the use of the Perclose ProGlide in cardiac catheterisation procedures. Both patients underwent surgical repair of the FA, and a thread from the device was tied over the intima on the dorsal side of the lumen.

In this study, the contralateral SFA was used as a reference, and preoperative CTA showed a natural lumen without calcification with a diameter of 4.9 mm. We inferred that the 8F sheath that was advanced into the thinner lumen of the right SFA resulted in an intimal tear during the previous cardiac intervention and that the suture loop of the proximal ProGlide interfered with the posterior damaged intima, leading to lumen occlusion (Figure 3A.1, A.2, A.3). In addition, we also inferred that the smaller diameter of the right SFA resulted in the needle of the Perclose ProGlide puncturing the healthy intima on the dorsal side of the lumen, which may have led to vascular obliteration during the initial cardiac catheterisation procedure (Figure 3B.1, B.2, B.3). The PCB features four sharp micro-blades, fixed longitudinally on the outer surface of a noncompliant balloon, and the working height of the microtomes is approximately 0.25 mm, which enables it to effectively incise the vascular wall with concentrated and lower inflation pressure and reduce the incidence of vessel injury and restenosis compared with conventional angioplasty. PCB dilation destroys the elasticity and fibre continuity of the vascular lesion and reduces or redistributes the effects of the calcified plaque, potentially preventing acute and chronic vessel elastic recoil. 12 The suture knot associated with the occlusive lesions in the right SFA loosened after primary plain balloon dilation was performed. Owing to the longitudinal cutting force of the four microsurgical blades at, 3, 6, 9, and 12 o‘clock, PCB angioplasty cuts off the suture loop and dilates the target segment with a lower probability of vascular recoil (Figure 3D1, D2, F1, F2).We hypothesised that tight adherence around the thread hole of the anterior right SFA is formed after the initial percutaneous angioplasty, which reduces the risk of haematomas and pseudoaneurysms after the final intervention. In addition, continuous endovascular strategies demonstrates advantages over conventional surgical exposure, as indicated by access-related complications and hospital length of stay.13–15

Figure 3. The schematic diagram of the underlying cause of occlusion caused by the ProGlide. (A.1) The damaged intima caused by larger sheath. (A.2, A.3) The suture loop of the proximal ProGlide interfered with the posterior damaged intima, leading to lumen occlusion. (B.1, B.2, B.3) The needle of the Perclose ProGlide puncturing the healthy intima on the dorsal side of the lumen, leading to lumen occlusion. The PCB angioplasty cuts off the suture loop (A.4, B.4) and dilates the target segment without vascular recoil (A.5, B.5).

Conclusion

In conclusion, continuous endovascular intervention combined with cutting balloon treatment for SFA occlusion after Perclose ProGlide use may be an optional treatment that avoids unnecessary routine stents, directly incises related complications and has a favourable prognosis.

Acknowledgements

We thank the patient and staff involved in this case.

Authors’ contributions: YH, XX and LW all contributed to the data gathering involved in drafting the manuscript. YH drafted the initial manuscript. XX drew the figures. LW provided critical feedback. All three authors approve of the final manuscript.

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by the National Natural Science Foundation of China (grant number: 81970412), Xiamen Medical and Health Guidance Project (grant number: 3502220214201088) and Xiamen Medical and Health Guidance Project (grant number: 3502220214201062).

Informed consent: The authors obtained written informed consent from the patient for the publication of the case information and any images.

Statement: The reporting of this study conforms to CARE guidelines.

ORCID iD: Lixin Wang https://orcid.org/0000-0002-1379-3906
==== Refs
References

1 Saleem T Baril DT . Vascular access closure devices, in StatPearls. San Francisco: StatPearls Publishing, 2024.
2 Copyright © 2024. Treasure Island (FL): StatPearls Publishing LLC.
3 Pang N Gao J Zhang B , et al. Vascular closure devices versus manual compression in cardiac interventional procedures: systematic review and meta-analysis. Cardiovasc Ther 2022; 2022 : 8569188.36134143
4 Akbulut M Ak A Arslan Ö , et al. Comparison of percutaneous access and open femoral cutdown in elective endovascular aortic repair of abdominal aortic aneurysms. Turk Gogus Kalp Damar Cerrahisi Derg 2022; 30 : 11–17.35444858
5 Del Prete A Della Rocca DG Calcagno S , et al. Perclose Proglide™ for vascular closure. Future Cardiol 2021; 17 : 269–282.32915065
6 Marquis-Gravel G Boivin-Proulx LA Huang Z , et al. Femoral vascular closure devices and bleeding, hemostasis, and ambulation following percutaneous coronary intervention. J Am Heart Assoc 2023; 12 : e025666.
7 Thakker R Iturrizaga JC Abu Sharifeh T . Vascular closure devices after femoral arteriotomy: insight in high-risk patients. J Am Heart Assoc 2023; 12 : e028501.
8 Karaolanis G Kostakis ID Moris D , et al. Fascia suture technique and suture-mediated closure devices: systematic review. Int J Angiol 2018; 27 : 13–22.29483761
9 Bradley NA Orawiec P Bhat R , et al. Mid-term follow-up of percutaneous access for standard and complex EVAR using the ProGlide device. Surgeon 2022; 20 : 142–150.33958298
10 Sohal S Mathai SV Nagraj S , et al. Comparison of suture-based and collagen-based vascular closure devices for large bore arteriotomies – a meta-analysis of bleeding and vascular outcomes. J Cardiovasc Dev Dis 2022; 9 : 331.36286283
11 Chen IM Lee TH Chen PL , et al. Factors in ProGlide(R) vascular closure failure in sheath arteriotomies greater than 16 French. Eur J Vasc Endovasc Surg 2019; 58 : 615–622.31500989
12 Lee J Huh U Song S , et al. Acute limb ischemia after minimally invasive cardiac surgery using the ProGlide: a case series. World J Clin Cases 2022; 10 : 13052–13057.36569024
13 Joseph G Thomson VS Attumalil TV , et al. Outcomes of percutaneous intervention in patients with Takayasu arteritis. J Am Coll Cardiol 2023; 81 : 49–64.36599610
14 Mathisen SR Nilsson KF Larzon T . A single center study of ProGlide used for closure of large-bore puncture holes after EVAR for AAA. Vasc Endovascular Surg 2021; 55 : 798–803.34105422
15 Pellenc Q Girault A Roussel A , et al. Preclosing of the femoral artery allows total percutaneous venoarterial extracorporeal membrane oxygenation and prevents groin wound infection after lung transplantation. Eur J Cardiothorac Surg 2020; 58 : 371–378.32083665
