Endovascular Perclose ProGlide complication puncture site,treated successful by cutting balloon dilatation: A case report and literature review

Abstract

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.

Introduction

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.