A case of pseudoaneurysm after endovascular therapy with atherectomy and paclitaxel-coated balloon for superficial femoral artery lesion

Abstract

An 83-year-old woman with claudication in the right lower extremity was referred to our hospital. Since angiography showed severe stenosis with a severely calcified lesion extending from the ostial to proximal part of the right superficial femoral artery (SFA), endovascular therapy (EVT) with the Jetstream™ atherectomy system (Boston Scientific, Marlborough, MA, USA) and paclitaxel-coated balloon (PCB) was performed. Atherectomy was performed using the Jetstream™ atherectomy catheter SC 1.85, followed by an additional atherectomy using the Jetstream™ atherectomy catheter XC 2.1/3.0. Subsequently, angiography and intravascular ultrasound (IVUS) images showed the enlargement of lumen area due to the reduction of calcified plaque, but even some of the healthy media on the side free of calcified plaque had been removed. Next, a PCB dilation was performed, and the final angiography showed adequate dilation. However, the symptoms recurred 9 months after EVT. Angiography revealed an enlarged vessel suggestive of pseudoaneurysm at the ostial part of the right SFA and severe stenosis distal to the enlarged vessel. IVUS images showed a pseudoaneurysm and severe stenosis due to calcified nodules distal to the pseudoaneurysm. This case suggests that pseudoaneurysm is a potential complication of EVT with the Jetstream™ atherectomy system and PCB for SFA lesions.

Learning objective

The Jetstream™ atherectomy system (Boston Scientific, Marlborough, MA, USA) has developed to improve outcomes for femoropopliteal artery lesions with severely calcified lesions in lower extremity arterial disease by removing calcified plaque and improving vascular compliance. Several clinical reports demonstrated durable patency rates and low complication rates after endovascular therapy using the atherectomy device. However, pseudoaneurysm is a potential complication of endovascular therapy with the Jetstream™ atherectomy system.

Introduction

Due to technological advancement and the accumulation of technical expertise, the latest guidelines recommend endovascular therapy (EVT) as a first-line treatment strategy for symptomatic lower extremity arterial disease in patients with femoropopliteal (FP) lesions [1]. However, FP lesions are often caused by calcified plaque, and EVT with a balloon or stent-assisted technique may be insufficient for severely calcified lesions, which have higher risk of residual stenosis due to vessel recoil and restenosis in the chronic phase [2]. The Jetstream™ atherectomy system (Boston Scientific, Marlborough, MA, USA) has been developed to address this problem by removing calcified plaque and improving vascular compliance. Several studies demonstrated high procedural success rates, 1-year patency rates, and low complication rates after EVT with the Jetstream™ atherectomy system and drug-coated balloon (DCB) for FP lesions with calcified lesions [3]. However, we report here a case of pseudoaneurysm 9 months after EVT using the Jetstream™ atherectomy system and paclitaxel-coated balloon (PCB) for superficial femoral artery (SFA) lesion.

Case report

An 83-year-old woman who underwent EVT with a PCB for severe stenosis with a severely calcified lesion extending from the ostial to proximal part of the right SFA twice was referred to our hospital because of a recurrence of claudication in the right lower extremity. Since angiography showed restenosis with the severely calcified lesion (Fig. 1A), a third EVT using the Jetstream™ atherectomy system and PCB was performed. After a guidewire was passed through the lesion, the lesion was evaluated by intravascular ultrasound (IVUS) (AltaView™; Terumo, Tokyo, Japan), which showed an eccentric, severely calcified lesion with calcified nodules (Fig. 1B-E). IVUS evaluation was based on the clinical expert consensus document from the Japan Endovascular Treatment Conference [4]. Atherectomy was initially performed using a Jetstream™ atherectomy catheter SC 1.85. Subsequent angiography and IVUS imaging showed that lumen area had increased due to the reduction of calcified plaque, but that some of the healthy media on the calcified plaque free side had also been removed (Fig. 1H and I). However, further reduction of calcified plaque was required to achieve good expansion and patency, and additional atherectomy was performed using a Jetstream™ atherectomy catheter XC 2.1/3.0 without blades up. After the additional atherectomy, angiography and IVUS imaging showed an increase in lumen area, but also further removal of some of the healthy media on the side free of calcified plaque (Fig. 1M, N, and O). Additional atherectomy was not performed with the Jetstream™ atherectomy catheter XC 2.1/3.0 with blades-up, and pre-dilation with a 6.0 mm non-compliant balloon followed by dilation with a PCB (IN.PACT Admiral™, 6 0.0 × 80 mm, Medtronic, Dublin, Ireland) of the same size as before was performed. A final angiogram showed an adequate expansion without vessel rupture and distal embolization (Fig. 1K). On the other hand, the final IVUS images showed an enlarged lumen area, although there was insufficient dilation due to vessel recoil in some areas (Fig. 1L-O). At the 6-month follow-up, ultrasonography revealed mild enlargement of the vessel diameter at the ostial part of the right SFA, indicating potential aneurysm formation. However, she remained asymptomatic and was followed up. She had a recurrence of intermittent claudication in the right lower extremity 9 months after the third EVT with the Jetstream™ atherectomy system and PCB. Subsequent ultrasonography at 9 months after EVT demonstrated progressive aneurysm formation at the ostial part of right SFA and significant stenosis in the proximal part of the right SFA (Fig. 2F). Similarly, angiography revealed an enlarged vessel suggestive of pseudoaneurysm at the ostial part of the right SFA and severe stenosis distal to the enlarged vessel (Fig. 2A). IVUS showed a pseudoaneurysm with a maximum vessel diameter of 12.4 mm. Moreover, severe stenosis due to severely calcified plaque with calcified nodules distal to the pseudoaneurysm was also found (Fig. 2B-E). After consultation with the cardiovascular surgeon, surgical treatment was performed. The ostial right SFA was dilated and adherent to the surrounding tissue (Fig. 2G). Arterial surgery was performed to repair the pseudoaneurysm and endarterectomy was performed to treat the restenosis due to calcified plaque in the proximal part of the right SFA. The excised specimen consisted of thrombus, atheroma, and dense fibrous tissue, with the outer part consisting of fibrofatty tissue. In Elastica van Gieson stain, the vessel wall structure was not identifiable. These findings were consistent with a pseudoaneurysm. The patient's clinical course was good and she was discharged 7 days after the surgical treatment.

Fig. 1.

Angiogram and intravascular ultrasound (IVUS) images at the time of endovascular therapy with the Jetstream™ atherectomy system and paclitaxel-coated balloon (PCB). (A) Pre-procedural angiography. Angiography showing severe restenosis from the ostial to proximal part of the right superficial artery. (B-E) Pre-procedural IVUS images. IVUS images showing that the lesion was eccentric in position, severely calcified, and associated with calcified nodules. (F) Angiography after atherectomy with the Jetstream™ atherectomy catheter SC 1.85. (G-J) IVUS images after atherectomy with the Jetstream™ atherectomy catheter SC 1.85. IVUS images showing the increase in lumen area due to the reduction of calcified plaque. Yellow arrows indicate that some of the healthy media was removed on the side free of calcified plaque (H and I). (K) Angiography immediately after atherectomy with the Jetstream™ atherectomy catheter XC 2.1/3.0. (L-O) IVUS images immediately after atherectomy with the Jetstream™ atherectomy catheter XC 2.1/3.0. IVUS images showing the further increase in lumen area due to the reduction of calcified plaque. Yellow arrows indicate an increase in luminal area, but also further removal of some of the healthy media on the calcified plaque-free side (M, N, and O). (P) Angiography after dilation with PCB. Angiography showing an adequate expansion without vessel rupture. (Q-T) IVUS images after dilation with PCB. IVUS images showing an enlarged lumen area (Q, R, and S), although there was insufficient dilation in some areas due to vessel recoil (T).

Fig. 2.

Angiogram, intravascular ultrasound (IVUS) images, ultrasonography image, and macroscopic findings 9 months after EVT with atherectomy and paclitaxel-coated balloon (PCB). (A) Angiography. Angiography showing enlargement of the ostial part of the right superficial artery (SFA) and severe stenosis distal to the enlarged vessel. (B-E) IVUS images. IVUS images demonstrating a pseudoaneurysm with a maximum vessel diameter of 12.4 mm (D). Severe stenosis due to severely calcified plaque with calcified nodules distal to the pseudoaneurysm (E). (F) Ultrasonography image. Ultrasonography image showing a pseudoaneurysm at the ostial part of the right SFA (yellow arrows) and a severe stenosis in the proximal part of the right SFA (white arrows). (G) Macroscopic findings. The vessel was dilated at the ostial right SFA and was adherent to the surrounding tissue.

Discussion

Here, we report a case complicated with pseudoaneurysm 9 months after EVT with the Jetstream™ atherectomy system and PCB for SFA lesion. There are few reports of pseudoaneurysms following EVT with Jetstream™ atherectomy system and DCB, and the incidence of pseudoaneurysms remains unclear. In a previous case report, a pseudoaneurysm occurred after EVT with the Jetstream™ atherectomy system and DCB for in-stent restenosis of the superficial femoral artery [5]. However, no intravascular imaging data were available in this previous case. This is the first report of a case in which intravascular evaluation by IVUS was available at the time of EVT and at follow-up, suggesting that the cutting effect of the Jetstream™ atherectomy system may have contributed to the formation of the pseudoaneurysm.

The mechanisms of vascular injury leading to pseudoaneurysm include iatrogenic trauma, stent fractures, and angioplasty balloon oversize [6]. On the other hand, cutting by the atherectomy device risks shaving off normal tissue without calcified plaque as well as tissue with calcified plaque depending on the route of the atherectomy device passage and the guidewire bias. Therefore, it is considered that excessive ablation of the normal tissue may weaken the structure of the vessel wall and risks causing vessel rupture or pseudoaneurysm. In addition, the use of paclitaxel-containing devices may exacerbate the risk of aneurysm [7]. Paclitaxel causes cell death by arresting cell division during mitosis and inhibiting healing of neointimal hyperplasia [7]. Farb et al. showed a dose-dependent increase in medial necrosis after deployment of paclitaxel-eluting stents, suggesting that paclitaxel itself was responsible [8]. Therefore, paclitaxel-induced smooth muscle apoptosis, inflammation, and delayed neointimal healing are considered additional risk factors for the development of arterial aneurysmal dilation after using paclitaxel-containing devices [9,10].

By reducing calcified plaque that causes vessel under-expansion or recoil after EVT, it is considered that vessel preparation with atherectomy devices may improve vessel compliance as well as increase drug transfer from the DCB to the tissue. In this case, the lesion was severely calcified and associated with repeated restenosis, which was treated with the Jetstream™ atherectomy system and PCB to improve patency. However, the guidewire and Jetstream™ atherectomy catheter passed through the edge of the vessel lumen due to the eccentric position of the severely calcified lesion caused by calcified nodules. As a result, the Jetstream™ atherectomy system was used to shave off not only the calcified plaque but also the intima and media on the normal side as well. After that, the patient underwent dilation with a non-compliant balloon and PCB, which may have caused excessive arterial injury to the weakened healthy side and contributed to the formation of the pseudoaneurysm. Furthermore, the cytotoxic effect of paclitaxel and inflammation induced by paclitaxel may have accelerated the enlargement of the pseudoaneurysm.

EVT using the Jetstream™ atherectomy system and DCB can effectively treat severely calcified lesions in FP lesions [3]. However, operators need to be aware of the route of the atherectomy device passage and the guidewire bias. In particular, when the lesion is eccentric and severely calcified, we should be aware of the risk of vessel rupture or pseudoaneurysm due to excessive ablation on the healthy side. Judging from this case, although media injury may be a risk factor for pseudoaneurysm formation, it is difficult to determine whether there is media injury without the use of intravascular imaging devices. When using the Jetstream™ atherectomy system, it is recommended that the procedure be performed in conjunction with an intravascular imaging device to reduce vascular complications. In addition, if the intravascular imaging shows media disruption, it may be necessary to select a smaller balloon size, avoid the use of additional atherectomy devices and paclitaxel-containing devices, or consider stent graft placement.

The use of stent grafts has been reported as a bailout treatment for SFA pseudoaneurysms after EVT [5]. However, in this case, the lesion was located at the ostial SFA. Therefore, it was necessary to implant a stent graft from the common femoral artery to the proximal part of the superficial femoral artery to cover the pseudoaneurysm. Given the potential risk of deep femoral artery occlusion associated with stent graft placement, the use of stent grafts should have been avoided in this case. In situations without such risks, stent graft placement is as an effective salvage treatment for pseudoaneurysms.

In conclusion, this case suggests that pseudoaneurysm is a potential complication of EVT with the Jetstream™ atherectomy system and PCB for SFA lesions.

Consent statement

Written informed consent was obtained from the patient(s) for publication of this case report, including accompanying image.

Declaration of competing interest

O.I. has honoraria from Boston Scientific Japan, Medtronic Japan, W. L. Gore & Associates G.K., TERUMO Co., Cordis Japan, NIPRO, Otsuka Medical Devices Co., and Medicon Co. T.M. has a research funds from Abbott Medical Japan and Biosensors Japan. The remaining authors declare that they have no competing interests.